Vaccine Adverse Reaction Reporting System Data 1 Pub 23oct09
Vaccine Adverse Reaction Reporting System Data 1 Pub 23oct09
Vaccine Adverse Reaction Reporting System Data 1 Pub 23oct09
& swelling at injection site. Skin warm to the touch. Y 2/23/2009 2/23/2009
ngestion, cough, decreased appetite, temp 104 degree F lasting 3 days. Also diagnosed with Y acute Otitis2/24/2009
Media on2/24/2009
day 3. Treated with AU
ted to office on 2/28/09 with red, swollen area on thigh where DTAP was administered. ShotYwas given on 2/26/2009
2/26/09. 2/27/2009
Family noticed redden
ing at site of injection Y 1/26/2009 1/27/2009
PREVNAR injection 2/23/2009. Late evening started having fever to 103 & fussy. Seen by Y Dr. 2/23/09 2/23/2009
- No orgin found
2/24/2009
for fever T-98.9 at
t swelling, redness, erythema, pain of left upper arm to elbow - lasting 6 days. After resolution,
Y depression 7/8/2008
remains 7/10/2008
in muscle of upper left a
& induration 10 inches around injection site. Y 2/27/2009 2/28/2009
ction redness swelling 4 cm x 5 cm LeftY thigh DTAP. U 2/23/2009 2/24/2009
o sore arm on 2-28-09. Mom noted Yredness, inflammation & warmth. Dad took patient to walk-in Y clinic on
2/26/2009
2/28/09. 2/28/2009
Dr. put him on antibiotic
ion right upper arm 2 - PNEUMOVAX RX: TYLENOL as needed ice to area as needed Y 2/24/2009 2/25/2009
l -> Per note from/by Dr. : "Patient suddenly
Y awoke from her sleep at 2:30 am early Weds. morning
U with 2/16/2009
shaking chills 2/18/2009
and "cold sweats" an
Telephonce call from school nurse to report that child came to her office in the AM with c/o U
severe itching, 3/4/2009
left upper3/5/2009
arm, after recieveing
ately 24 hours after administration ofY vaccine patient states she woke in the night feeling "hot",
Y and patient's 3/5/2009
cheeks apear3/6/2009
flushed. Patient
cine was administered on 2/13/09. As Y of 2/27/09 my son has had episodes of hives. Started Non lower extermities
2/13/2009and 2/27/2009
then moves to top (fa
e, lymph node reacted and created a big bump under the same arm that had the vaccine. Fever, very weak 3/3/2009
legs and knees.
3/3/2009 I still do not hav
6 PM vacine given- headache that night & the next day, flu like symtoms(aching, chills and diarrhea) started.3/2/2009
I still have
3/3/2009
them as of 3/6/09.
a rash 2 days after administration. She describes it as raised and hard, a big red area about Ythe size of her2/18/2009
palm. 22/20/2009
days later not as big or
eadache from back of neck up to head.Throbbing, general malaise. Sx began about 12 to 15Yhours later. Felt 2/3/2009
hot. 2/4/2009
RM AREA TO RIGHT ARM WHERE MENACTRA WAS GIVEN(03/04/2009).PATIENT WAS SEEN U BY DR.NAVE
3/4/2009 AND 3/6/2009
MOM WAS INSTRU
ps all over body that started 9 days after
Y vaccine was given. Y 2/2/2009 2/12/2009
RM AREA AROUND THE INJECTION SITE GIVEN IN THE RIGHT ARM. SEEN DR 09/06/2008 Y MOM WAS 9/4/2008
TOLD TO 9/6/2008
WATCH SITE AND A
ceived 4 vaccinations on 02-18-09. YLater in that same day, patient complained of right arm pain.
Y Per Mom,
2/18/2009
the deltoid
2/18/2009
site was erythemato
D ZOSTER VAX. ON 1/29.09. HIS WIFE CALLED CLINIC CHARGE NURSE 2/23/09 TO REPORT Y PT. 1/29/2009
HAD DEVELOPED 2/16/2009 A BLISTER WI
11/6/2003
ceived Gardasil and Menactra
Y vaccinations
Y on Y
Friday, Feb. 27th at about
2 2 pm. She also had Y completed2/27/2009
a course of3/2/2009
Zithromax, but had pr
ng after receiving the Tdap, along with a trivalent flu shot, the patient reported jaw pain on the
Y left side that "hurt
### like hell" ###
and persisted for
me swollen and red, several hours after
Y administration of vaccine. Area became painful.ThereY was quite 3/4/2009
a bit of swelling
3/4/2009
around the entire
veloped fever and light sensitive headache after receiving vaccines Y 3/4/2009 3/4/2009
nset full body myalgia and fever 102 less than 24 hours after injections. U 3/5/2009 3/6/2009
effect at injection site (R arm): round, erythematous without pustular lesion 1.5 cm x 1.5 cmYand tenderness 1/8/2009
on Right1/21/2009
arm.
er administrating ROTATEQ baby developed redness on face - chest & back. Administered Y @ 11:50 am -3/6/2009
rash 12 pm3/6/2009
(on 3-6-09).
ost vaccine child c/o pain (sharp) inYright hand (vaccine given in left arm) then later in day child
U c/o pins &3/3/2009
needle parasthesia
3/4/2009 X 4 extremitie
Y 3/24/2009 3/24/2009
turned to office 3-23-09, after vaccine 3-20-09 with rash. Reviewed sx and hx with MD who U also saw patient.
3/20/2009
Diagnosed
3/21/2009
with viral EXANTH
ceived Pneumovax 23 vaccine IM to right deltoid Y on 03/24/09. On 03/25/09
1 he presented with
Y progressive 3/24/2009
painful swelling
3/24/2009 and erythema a
mth and induraton at vaccine site. Tender aillary nodes. U 3/28/2009 3/29/2009
POL on 3/27/09 and developed hives Y within 24 hrs Y 3/27/2009 3/28/2009
inistration of GPV, patiient expressed feeling weak and nausea. Provider was notified and patientY was taken3/3/2009
to tx room.3/3/2009
Initial BP was 104/6
ted to have a thigh mass one monthYafter administration of hib3 and flu vaccines. The massYcontinued to grow### and was removed
### on 12/23
CALL A DAY AFTER AND COMPLAINS Y OF DIFFICULTY IN BREATHING, HEAD PAINS, SWOLLEN Y TONGUE/THROAT,
3/24/2009 AND LEFT SID
9 Mom reports to IM clinic at 2nd shotY visit, thatYpatient developed projectile
1 vomiting & abd.Ypain about 24 hours ###after his ###1st set of shots.
rm after Tdap vaccine given on 3/16/09. Small amount of redness noted after injection. About Y 3/19/09 employee
3/16/2009 noted
3/19/2009
increase redness, sw
d a tactile fever for 3 days after the vaccine and then developed a blanching, macular rash on Y the face, torso,
3/24/2009
arms3/24/2009
5 days later.
eloped localized eythema of injection site approx. 4-8 mm per Mother of client via phone call.Area
U reported
3/23/2009
as triangular
3/23/2009
in shape with bruis
IA/HIVES- TREATMENT ATARAX 10 MG PER 5 ML-1 TEASPOON EVERY SIX HOURS. BAKING Y SODA OR### OATMEAL### BATHS.
wing was reported by the client: Vaccines
Y given on 03-09-2009 in the morning with complaintsUof soreness3/9/2009
at the injection
3/9/2009
site and a mild he
prox 5 min after vaccination received. Recovered quickly. Y 3/30/2009 3/30/2009
clinic and later seen on 3/30/09 forYan urgent visit for complaints of non-pruritic red rash onUleft side of trunk
3/24/2009
- Per PCP
3/27/2009
physical exam: ery
r for three days (T. Max 103.7f Y 3/28/2009 3/29/2009
1/31/2009 Y Y Y 9 Y N 1/15/2009 1/30/2009
s began the same evening I received Y the influenza vaccination given at work site. Fever, body
N aches, sore throat, ###weak, lightheaded,
### dizzin
g warmth, redness injection site 2. Left axilla pain -> tender enlarged isolated 2.5 cm lymph node
U 3. Non-tender,
3/26/2009 sl. irritated rash - both axill
erythema rash, primarily to trunk and bilateral legs. Y 3/26/2009 3/30/2009
barky cough, hard time breathing red Y welt on L arm. Y 3/30/2009 3/31/2009
dministered on 3-20-09 in AM. By afternoon tips of fingers hurt. Played basketball after school.Y Noticed3/20/2009
tips of fingers
3/20/2009
had blisters. Some
o body ache, weakness, pain in left arm, behind shoulder and left upper chest. Pain and discomfortN with ROM.
thigh: No tx. Telephone advice given. Right thigh. Y 3/24/2009 3/26/2009
ger than a bean) tenderness, slight redness and warmth near L shoulder. U 3/27/2009
Y U 3/30/2009 3/31/2009
round mouth with swelling spreading Y over both cheeks over period of several days. Applied steroid
Y cream3/19/2009
which helped 3/19/2009
-> course last 5 da
hrs after receiving 6mo vaccine hadYvomiting with associated limp/pale episode. No seizure activity.
Y Returned
3/16/2009 to baseline
3/16/2009
within 60-90 min.
ns on labia - lidocaine jelly, ACYCLOVIR 200 mg/ 2tsp TID 5cc TID. 2. Fever 100.2. 3. Coughing U for 3 days. 2/27/2009
4. Colitis 3/3/2009
x 3+ days. 5. Pharyng
ve nodule. No sign of infection. U 3/18/2009 3/28/2009
minutes after administering HPV vaccine, patient fainted. No history of fainting in the past. Y 3/31/2009 3/31/2009
ought her daughter in @ 1630, with a nodule on left leg about the size of a quarter. I referredUher to PCM5/21/2008
as W/I. Patient5/21/2008
didn't seem to hav
spot, raised area, Lt upper arm where varicella was administered. Dr checked area on 3/31/09. Y 3/30/2009 3/31/2009
ic reaction, This case was reported by a healthcare professional via a sales representative and U described 3/12/2009
the occurrence3/12/2009of nonspecific rea
ction, My daughter immediately put her head back and said I don't feel very good. I feel like I'mY going to faint.
3/31/2009The nurse3/31/2009
was standing behin
n has been received from a pediatric Y medical records and a physician concerning a 15 weekNold bottle fed female ### with
1/19/2009
no known drug aller
n has been received from a registered nurse concerning her 1 year old son with milk Y allergy N and no other medical history who was vaccinat
n has been received from a consumer concerning her 42 month old son with "gene mutations" N who "when 12/1/2006
he was 15 month old" in approxi
n has been received from a consumer Y via the internet concerning her now 5 year old son who N on an unspecified date was vaccinated with
n and follow up has been received from a physician for the Pregnancy Registry for GARDASIL Y concerning1/9/2008
a 18 year 1/9/2008
old female with sulfon
n has been received from a nurse for Y GARDASIL, a Pregnancy Registry product, concerningUa 21 year old 1/15/2009
female with 1/15/2009
no medical history o
n has been received from a medicalYassistant concerning a 16-year-old female with no medical Y history or3/25/2009
allergies who 3/25/2009
on 25-MAR-2009 w
n has been received from a licensed practical nurse (L.P.N.) who was told by a patient's mother U that she heard from someone concerning 2
n has been received from a physician concerning a 19 year old female who was vaccinated U with unknown how many doses of GARDASIL.
aving severe stabbing ache in shoulder & upper arm approximately 2-3 days afterYvaccine. Began N having, numbness ### & tingling.### Discolorat
Cm red, raised, hot area c/o itching Yat the site starting the next day. TX: Ice, Benadryl and Hydrocortisone
U 3/25/2009
cream. 3/26/2009
ceived PNEUMOVAX vaccine on 3/11/09. contacted outpatient primary care clinic on 3/30/09 N with the following
3/11/2009 - c/o-3/30/2009
non-productive cough
eloped ROTAVIRUS infection after receiving vaccination. Y 1/7/2009 1/13/2009
d to clinic the day after receiving vaccine.
Y Per her report approximately 30 min after receivingY vaccine her 3/24/2009
arm started 3/24/2009
swelling, she felt feve
possible mixed with IPV form submitted per CDC recommendations No Reaction per client's parent. 3/30/2009
Mom states light rash on face yesterday prior to vaccines (not mentioned or noticed prior to injection) this 3/31/2009
morning (4-1-09) 4/1/2009
child has fine ras
heavily speckled line or band going up his arm from the injection site. U 3/12/2009 3/13/2009
ame dizzy after vaccination Y 3/30/2009 3/30/2009
vers a day, bad headaches with fever, sore throat, stopped up nose or runny, weak, upset stomach U and vomiting,
2/3/2009pale 2/9/2009
skin, cried because
as given flu shot and pneumonia vaccineY right before discharge. Patient reports that when he U got home 3/15/2009
he began experience
3/15/2009 generalized p
d one-sided facial palsy with a significant
Y droop that affected the eye early in February of 2009.
Y Went to 1/13/2009
ER. Significant 2/10/2009
change in sensatio
eloped fever and had febrile seizureYat home Temperature 102. Child is fine today. Fever was Y treated in3/23/2009
ER 3/31/2009
ular rash over chest, abdomen, and back within 15 minutes of injections. No treatment administered.
U Still
3/31/2009
present early 3/31/2009
AM the following da
LOST CONSCIOUSNESS AFTER RECEIVING THE LAST OF 5 VACCINES. CLIENT WASYSITTING IN3/31/2009 CHAIR AND 3/31/2009
HEAD FELL BACK.
post-vaccine: egg-shaped area of rash on arm below shot site; @ 30 hrs post-vaccine: sudden Y onset of moderately
3/28/2009 3/29/2009severe muscle/joint pai
ver vaccination given on 3/27/2009 @ 10:20 a.m. Student returned to Clinic at 11:35 a.m. forYswelling of3/27/2009
lower lip, left 3/27/2009
lower lip to middle of
ECAME DIZZY AFTER RECEVING THE LAST OF 3 VACCINES. CLIENT REMAINED IN CHAIR, Y FEET3/31/2009
ELEVATED. 3/31/2009
DIZZINESS ABATED
after varicella vaccine #2 developedYredness and swelling at injection site. 48 hrs post vaccine Y developed 3/29/2009
increased3/30/2009
redness, swelling and
E - REDDNESS AND ERYTHEMA LEFT Y ARM DISTAL TO THE INJECTION SITE AREA - C/O HEADACHE 3/30/2009
AND MUSCLE3/31/2009 ACHES - SAYS
emp up to 103 - today 102.6 - left arm hurts and slightly swollen - left hand pain "tingles" - fatique
U - today3/31/2009
slight cough 3/31/2009
- eyes watery - no ap
s:Shortness of Breath, Racing Heart, Y Anxiety, some Dizzyness, These symptoms got progressivelyN worse3/7/2009
over the course3/8/2009of 2 weeks. The
iarix instead of DTaP. No adverse Symptoms and do not expect any. Y 3/24/2009 3/24/2009
to clinic one day after receiving vaccinations with Right upper arm reddened, swollen and warm U to touch.3/30/2009
Patient stated3/31/2009
tenderness; denied
lts under skin, muscle feels very tight even after constant massage. Also high fever of 102.9 Udegrees. High 3/31/2009
pain in legs 4/1/2009
- enough to prevent
ceived Influenza vaccine (adult dose) instead of Hepatitis B vaccine. He is now 12 weeks of U age. To date, we have ### not experienced
### an adv
ported redness for a few days. This progressed into pain and tingling in arm, like "ants crawlingU on my arms".2/11/2009 Still itching,
2/12/2009
but was told my M
hot was given. Pain starting in arm of injection site, quickly moved to shoulders and neck. Within
U two days
3/26/2009
it included 3/27/2009
the entire back and h
spontaneous report of seizure, influenza, wheezing
Y and fever was received from a physician Y concerning a 27-month-old
### 11/2/2008 female subsequen
ven GARDASIL vaccine was informed would have to wait 20 minutes to be observed, pt wasYsitting on exam 3/27/2009
table after
3/27/2009
injection passed out
become fussy, crying - had to console approx 2 hrs- 3 vaccines were given crying lasted forYapprox 9 hours- 3/18/2009Mom had 3/18/2009
to hold Pt constantl
Y 3/17/2009 3/22/2009
Y N 3/31/2009 4/1/2009
rea @ injection site. Y 3/23/2009 3/24/2009
etting a rash of small red bumps on my face on Friday 3-27-09. Saturday rash had spread to Yneck and chest. 3/13/2009
By Sunday it had spread to ar
woke up the morning after the injection with "puffy face and L side of neck" which turned into U a rash. States
3/16/2009
also had
3/17/2009
some rash on stomac
ain, induration warmth at injection site with redness at site and extending distal to injection site
U to elbow. 3/25/2009 3/25/2009
accines 10:30 am, began with vomiting, uncontrollable crying and apnea 45 min-1 hr later. Heard Y pt on phone
3/19/2009- screaming,
3/19/2009 high pitched cry
immunization patient shaking, teeth chattering / cold - felt frozen under 3 blankets. Doesn't Y believe he had a fever.
### Achy. ### Fatigued X 12 ho
after VARIVAX developed varicella lesions on arms, legs, mouth. Y 3/23/2009 3/25/2009
n has been received from a physician Y concerning a 16 year old female patient who completed Y GARDASIL series. The patient was HPV pos
n has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product,Uconcerning a 20 year old female patient with n
n has been received from a consumer regarding a case in litigation concerning his child whoUwas diagnosed with autism shortly after receiv
n has been received from a parent concerning his 6 year old son who was vaccinated with MMR U II (Lot# not reported). The patient was on
us case was received on 26 March Y 2009 from a consumer (patient's parent). A 23 year old maleN patient with seasonal allergies received AD
74yo, Male, came to ER with - Had flu Y shot yesterday, this am developed rash right thigh, now U diffusely spread
12/3/2008to both
12/4/2008
legs, chest arm. Eyes
loss of control - 9-13-08. Hospitalized five days.
Y Diagnosed virus syndrome.
4 Home doctor saidU had Guillain10/2/2008
Barre syndrome.
10/3/2008 4/8/09 Receiv
seminated encephalomyelitisY about Y1 week afterY shot. Fever started.
27Extreme irritability and screaming.
Y Altered
12/2/2008 state of consciousness
### 12 d
ed rash over trunk, face & extremities Y with classic pox like vessels with erythematous bases. Y 3/20/2009 3/26/2009
m erythema and induration. Y
veloped fever up to 103.2 F rectally on 3/26/2009 - and an erythematous papular rash - descendant - started 3/17/2009
on face on 3/27/09. Fever res
12 hours later. Headache, couldn't move
Y arms and legs. Y 3/26/2009 3/27/2009
ent needle was in right deltoid, pt started to waver w/eyes rolling back. Pt began to wobble to N a fro. I helped
2/9/2009
him to his
2/9/2009
seat. Water was giv
about 15:40. Approximately 17:30 becameY dizzy light headed, face tingled and broke out in aYsweat. Lasted3/24/2009
about 303/24/2009
min. Later arms and le
a of redness and induration on L upper arm approximately 12x10 cm. 3/18/2009
f PREVNAR were administered on the same day. Patient's Dr. notified @ 11:30am 3-25-09. Y 3/25/2009
adache, neck soreness, vomiting, nausea,
Y dizziness and fatigue N 3/24/2009 3/25/2009
poor appetite, nausea/vomiting, left arm pain and soreness. Unable to attend school since 3-30-09.N Out of3/30/2009
character 3/30/2009
for this child. Arm pain
ine hives for 15 min. Then resolved. Clear lung. Y 3/26/2009 3/26/2009
01 degrees, rubbing @ head, increased Y fussiness There is a question of secondary viral illness Y 3/31/2009 4/1/2009
n 3/18/2009 pt. awoke with temperature
Y of 105.4 degrees @ 11 AM after waking up c/o entire Y body twitching,
3/17/2009and increased
3/18/2009crankiness. 3
TDAP vaccine 3/19/09. Developed Y sore arm within 24 hrs became indurated, red, hot in injection area around
3/19/200948hrs,
3/21/2009
felt flu like (tired, achy
ceived Tdap on 3/23/09. Came into office today 3/30/09 arm slightly red, small lump at site. Patient
N states
3/23/2009
"it is much3/24/2009
better than it was. Arm
gan to develop around the injection site and spread to my chest, neck and back. Rash began approx. 4 days 3/8/2009
ago and
3/18/2009
has steadily worsene
t B/P 106/60 Temp 98.4 Pulse 72 Resp. 20 - c/fired, dizzy. c/o feeling hot and sweating on & off. 1245 T3/27/2009
malise 1245 3/27/2009
T.C. to mother child ta
breakthrough. Had 2 doses of VARIVAX (3-2-04 & 3-4-08). Diagnosed with varicella in our office U on 3-28-09.
3/4/2008
Had 303/24/2009
vesicles. No fever.
rned pale a minute after receiving all 4 vaccines, then her lips turned blue 1/2 minute later, sheY had a seizure,
3/13/2009
with her
3/13/2009
eyes flipping upward
eloped diarrhea evening of 3/6/09. Fever
Y Sat-Mon & Tues. which mo. kept controlled with Tylenol & Advil. 3/5/2009
Caught runny 3/6/2009
nose developed ov
TdaP 3/16/09 Developed symptoms 3-17-09. State fever 104.0 F orally, chills, muscle aches, Y arm deltoid 3/16/2009
red. Taking3/17/2009
Tylenol. given (Rt) ar
ed tightness in throat 30 min. after receiving vaccines - Took BENADRYL and felt better after Y 1 1/2 hours.
tates he was in this office yesterday, received pneumonia vaccine in rt arm. Report this was Y he second pneumonia
3/25/2009 vaccine.
3/26/2009 States approx
-103.8 and diarrhea. Y Y 3/31/2009 4/1/2009
ates he felt some numbness and tingling in my 3rd and 4th digits in lower left arm along ulnaUnerve. States 3/12/2009
he is experiencing
3/12/2009 mononeuritis
U
sy (R). Pt states a few hours after vaccine
Y she noticed
Y drooping on right
4 side of face - hospitalized.
N Referral
3/23/2009
to neurologist.
3/23/2009Not resolved at v
al swelling @ site of KINRIX Y 3/30/2009 3/30/2009
diameter nodule, palpable. Y U 3/31/2009 4/2/2009
tal body itching for 1 1/2 months after
Y the injections. Flushing of skin, resolved in ER, MD and Y allergy visits. ### ###
erythematous rash and small vesicles around vaccine injection with out any treatment rash cleared Y in 3 days
3/25/2009
with out3/28/2009
any signs.
er arm swollen, warm to touch, sore, mildly red. Treating with cool compresses and IBUPROFEN Y as needed.
3/13/2009 4/2/2009
TETANUS shot a week ago, then started having pain in the area of the injection, but then in the N last couple 3/23/2009
days or so
3/24/2009
has had pain, swellin
2/24/09 Fever by report from mom.Y2/27/09 Patient
Y began experiencing
4 ankle pain. 2/28/09YAnkle began 2/20/2009
to swell with
2/22/2009
redness. 3/1/09 Pa
RECEIVED 7 VACCINES ON THE 26 OF MARCH. CLIENT HAD POSITIVE PREGNANCY TEST U TODAY3/26/2009
IN OUR ADULT 4/2/2009
HEALTH CLINIC
and erythema (~4 inches red ring in diameter) appeared on 03/06/09, 2 days after receivingYthe vaccine. 3/4/2009 Patient also complained of swelllin
in office for a 6 month physical on 9/09/08. Prior to adminsitering vaccinations black dots were U noticed on7/8/2008
the child's left thigh. It was noted
ening of the shots, she developed low grade temp that increased the following day to 104F. U She also developed
3/31/2009 emesis
3/31/2009
(NBNB) x 3 with la
ll on 4/2/09 stating that on Monday March 30 she received the Shingles vaccine. She did not U have any problems
3/30/2009for3/31/2009
greater than 24 hours
gluteal pain starting four days after vaccination and lasting for four days. Pain relieved with anti-inflammatories.
Y 2/25/2009 No other
3/1/2009
symptoms. Decli
d a vaccination from an expired vial of Hep B. (exp date was 2-2-09). Parents were advised to revaccinate 3/12/2009
the child. No adverse reactions
oral typhoid capsule as directed and within several hours had vomiting, diarrhea, fever and fatigue. Y Symptoms
3/6/2009resolved
3/6/2009
by next day. Advis
d full blown Shingles approximately Y 4 days following vaccination. Prescribed ACYCLOVIR, 800MG, ONE TABLET 3/5/2009 5 TIMES
3/9/2009A DAY FOR 10
ived subcutaneous injections of MMR and Varivax on right and left thighs respectively usingUVanishPoint synringes. ### Black### dots noticed on b
H PEDIARIX U ### ###
ND ERYTHEMA TO RIGHT DELTOID Y 16.25 CM x 16.25 CM. ADVISED PARENT ON APPLICATION U OF3/31/2009
COLD COMPRESSES,
4/2/2009 MED W\
arted to notice hives on the back of her neck, between legs and on wrist about 5 hours after U administration 3/31/2009
of the vaccine.
3/31/2009Patient has been
al reaction at the left deltoid - mild erythema, tenderness and edema. U 3/31/2009 4/2/2009
d about 5 hrs. after being vaccinated Y and still continues. He became very unresponsive at times. U He ended 3/26/2009
up getting
3/26/2009
dehydrated which ca
U 3/18/2009
r of 106F, wheezing, upper right quadrant Y pain Yand lower right quadrant
1 pain. It lasted for 8 months.
Y Treatments
8/29/2007 were
9/19/2007
antibioctics. 5/26/09
was reported by a consumer and described the occurrence of possible acute hepatitis in a female U subject of unspecified age who was vacc
was reported by a pharmacist and described
Y the occurrence of injection site soreness
Y in a 29-year-old
N female
2/11/2009
subject
2/11/2009
who was vaccinated
was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified U age 6/1/1999
who was vaccinated
5/1/2000 with LYMER
nding graduate school, this 40 year old member Y reported receipt of 7hepatitis A #1, influenza, and typhoid 8/5/1997
vaccinations11/8/1997
on 11/7/1997. Medic
d orange size lump/ swelling/ redness - sore to touch first 24h - used ice - advised use allergyYcrm & ice for4/1/2009 sx 4/1/2009
Y 3/26/2009
/2 inches red area with swelling, mild Y induration. U 3/26/2009 3/27/2009
ed ball under skin @ injection site that Y is painful DX: Cellulitis Y 3/31/2009 3/31/2009
5 min after GARDASIL Dizziness 30 min after vaccine still c/o dizziness, now on 4/2 , got vaccine Y on 3/31/09
3/31/2009 3/31/2009
izure. Temp. 105. TYLENOL. 4/30/09 Y scheduled for f/u MRI. Y 3/26/2009 3/27/2009
er gave child TYLENOL 0.4ml but did not take temp. 1pm Mom woke child for feeding. Mother Y stated he 3/26/2009
was upset, 3/26/2009
he could not decide if
in joints, muscles - constant. Periodic nausea, periodic chest pain. N 3/20/2009 3/20/2009
bumps at injection site going down into underarm & side of back started date of injection & Y still present 3/19/2009
on 4-2-09 3/19/2009
itching at injection site right delt. PtYstates "feels like sunburn" U 3/28/2009 3/30/2009
redness and swelling of Rt triceps afterY DTAP. Moderately tender. This is a minor side effectU 3/31/2009 4/2/2009
right upper arm below injection site extending to medial arm. Warm to touch. Pt reported itching Y started3/31/2009
several hours
3/31/2009
later. Warmth note
:00 PM - began experiencing rt. eyeYitching, burning, watery raw @ rt. corner of eye, later in N day blister appeared
3/25/2009corner
3/27/2009
of rt. eye went to D
ection site, malaise, nausea, photosensitivity, headache, diarrhea and trouble sleeping. U 3/31/2009 4/1/2009
n has been received from a physician Y concerning Y a 72 year old male 0 patient with heart condition
U who in August
8/1/2007 2007,2/1/2009
was vaccinated with
n has been received from a consumer concerning her 4 year old son with no pertinent medical N history or drug9/1/1995
reactions or allergies who in
n has been received from a medicalYassistant concerning her 16 year old daughter who on 11-FEB-2008 Y 2/12/2008
was vaccinated1/1/2009
the third dose of w
n has been received from a physician Y concerning Y a 12 year old female6 with allergies to Augmentin
N who on9/17/2008
10-OCT-2007,
3/27/2009
17-JAN-2008 and
n problems, dizziness, near Y fainting,Y rapid heart Y beat, broke out in rash
Y all immediately.
Y Now:N MS, Graves 6/23/2008
Disease, 6/23/2008
Fibromyalgia, daily mig
litis, pain, fever, tachycardia. Redness/pain at site Y w/ worse progression.
3 Vanc and Zosyn given Y upon presentation
3/16/2009 to 3/18/2009
ER. D/C home with p
V on 3/6/09 and AVA on 3/11/09. On 3/17/09 pt Y describes feeling fatigued,
1 he had non positional
U left sided
3/6/2009
chest pain
3/17/2009
(1-2/10), cp worse w
rash on (L) arm, neck and face; rash Y appearedY3/27/09. No fever. Patient's
2 daughter received Y live attenuated
2/23/2009
varicella
3/27/2009
vaccine 3-4 weeks p
3 degrees), headache, body aches, dizziness, fatigue. U 3/26/2009 3/26/2009
lu shot experienced headache, dizziness + flu like symptoms. Y
m pink area around where PNEUMOVAX given. Y 4/1/2009 4/3/2009
nted for a few seconds after that patient had major headache, in addition patient pain on upper Y right arm. 3/19/2009 3/19/2009
began 1 hr after injection. Today Right inner and anterior thigh- diffuse swelling from 1 1/2 above U knee to 3/16/2009
groin crease.
3/16/2009
er the vaccines, patient c/o feeling "bad".
Y Had anorexia and nausea, was very pale. The nextYday also extremely 2/25/2009 pale,
2/25/2009
weak, couldn't eat, na
Y 4/1/2009
er administration, nickel size redness. Y On 5th day after; hive looking rash appears. On 6th day Y after administered
3/18/2009vaccine
3/23/2009
entire deltoid red
me in 3/31/09 stated that the day heY got vaccines 3/23/09 his legs both got swollen and purple. Y They took 3/23/2009
to urgent3/23/2009
care, advised them jus
feel nauseous, vomited x 3 in spaceYof 2 hours. Saw ER physician for meds which stopped emesis. Y 3/10/2009 3/10/2009
htheadedness within 15 minutes of ZOSTAVAX administration. Paramedic took vital signs +Ublood sugar3/27/2009 (all WNL). 3/27/2009
Pt refused work up at h
sized swelling at site of VARIVAX reported by mom. 1-2 days after immunizations. Later pt developed Y vomiting /diarrhea illness, 2 d after i
broke out in small blisters on abdomen 2 days after receiving varicella immunization. StatedYblisters itched 2/16/2009
but no fever
2/18/2009
noted. Today in clin
+ erythema + pruritis of Rt upper arm. U 3/24/2009 3/27/2009
ome: (Location) bilateral arm. Pt. mother
Y describes it as painful. Relieving factors include: BENADRYL.
Y Associated
3/27/2009 3/29/2009
symptoms include: pain
ceived 6 wks immunization of 5 wks. Y 3/10/2009
ts today 4/1/09 with red area (about baseball - sized) + sl. raised + mild pain on right deltoid U - site of MENACTRA
3/31/2009I.M. 4/1/2009
injection given on 3/3
al reaction 9X6 cm local ice and Benadryl. Y 3/27/2009 3/28/2009
dministered to left thigh but bruisingYto left shin. Parents stated leg was swollen with bruisingYwent to ER.3/30/2009 3/31/2009
of Rt thigh area after vaccine. SwellingY started morning after vaccine. Area also has some erythema.
Y 4/2/2009 4/3/2009
soreness, swelling. Y 3/19/2009
veloped redness around back of arm about 5-6 inches long and also skin felt hot to touch and Y very itchy.3/30/2009 3/30/2009
9 Received Hep A at approx 2pm. Developed
Y hives approx 8p. Took BENADRYL. 3-31-09 noYhives visible. 3/30/2009
C/O itching
3/30/2009
all over. SOLUMEDR
s given at 9 months. 3/25/2009
ap/Hib/IPV and HebB/Hib- no sx 4/2/2009
SIZE DARK PINK RAISED AREA AT INJECTION SITE NO PAIN NO TREATMENT Y 4/2/2009 4/2/2009
oke out in shingles 6 days after vaccination
Y was administered. Pat She is being treated by her N primary care
3/24/2009
physician3/30/2009
accordingly.
r, strong crying, for many hours, fine the next day. Y 4/2/2009 4/2/2009
ized knot on right arm. Red & warmYto touch. ER MD gave steriod dose pk. & Icc pack U 3/24/2009 3/29/2009
e adn hives were around shot area and on both thighs adn stomach, the areas were itching. YSo mom gave 3/27/2009
benedryl3/27/2009
and repeated it at 9 a.m
n left deltoid where Tdap was given. Area hot, red. swollen. Smaller area of redness with heat on right deltoid4/1/2009where 4/2/2009
Menactra was given.
adverse reaction. Patient received Dtap vaccine instead of the recommended Tdap vaccine.YPatient received 4/1/2009
adequate protection with Dtap
d bilateral kidney area pain, increased thirst, increased urination approximately 20 hours after U Hep B #2 was
3/19/2009
given. 3/20/2009
No problems with vacc
MOTHER PRESENTED TO HEALTH DEPARTMENT FOR CHILD'S VACCINES. MOTHERYREPORTED 7/17/2008
THAT CHILD 7/17/2008
HAD SWOLLEN RE
o weeks after my daughter Y got the 1st
Y Gardisil vaccine shot she started having seizures, sheNhas no family 9/3/2008
history of9/18/2008
seizures and has alwa
d a vaccination from an expired vial of Hep B. (exp date 2-2-09). Parents were advised to revaccinate
Y the
3/13/2009
child. No adverse reactions have
d a vaccination from an expired vial of Hep B. (exp date 2-2-09). Parents were advised to revaccinate
Y the
3/19/2009
child. No adverse reactions have
ter developed a large red knot at injection
Y site, was raised, size of a half dollar, warm and very
Y tender. She3/26/2009
also had a4/1/2009
severe runny nose. A
0 minutes of patient receiving TdaPYand gardasil, pt had a 30 second episode of stiffening and Y blank staring.
4/3/2009
Since that
4/3/2009
time she has had
disease (rash, fever). U 3/23/2009 4/2/2009
TDaP and PNEUMOVAX L deltoid 3/31/09. Reaction of swelling, redness and immobility began U within 24 3/31/2009
hours of injection.
3/31/2009Slow resolution
d by Clinic today to report that she developed L lateral arm pain, some numbness/tingling from Y shoulder 3/20/2009
-> fingertips,
3/21/2009
quite significant at tim
ring rash in groin and hip area. U 3/27/2009 3/31/2009
x 100.5; redness, induration 2 cm x 2 cm. Y 3/30/2009 3/30/2009
-> redness + swelling at the site of injection - measures 4.5 inches + 4.5 inches. U 3/30/2009 3/31/2009
ea of redness on L thigh ice packs andY Benadryl. Y 3/30/2009 4/1/2009
ea of redness, warmth and in duration Y on L thigh. Treated with ice packs and Benadryl. U 4/1/2009 4/2/2009
arthralgias / HA (L) shoulder pain with
Y t ROM-->Bursitis Rx CALEBREX/NORCO/ROM exercises N 3/29/2009
ed varicella rash (Sib with same despite 2 VARIVAX immunizations). Y 1/21/2008 3/30/2009
ed Varicella rash (Sib with same despite 2 VARIVAX immunizations). Y 4/21/2008 4/2/2009
ort received on 20 January 2009 from a consumer, who is the patient's parent. A 5 month oldY male patient, 4/30/2008
with a history
4/30/2008
of environmental a
ort received on 13 March 2008 from Yanother manufacturer, (a report number was not identified). N The initial reporter
### to this ###manufacturer had
ort received from a manufacturer on 23 January 2009. The other manufacturer had received the original report from a health care professio
ort received on 22 January 2009 from Y a health care professional. A seven-month-old femaleNpatient with no 1/6/2009
past medical
1/6/2009
history, had receiv
rmation was received on 19 August Y 2008 from a consumer (patient's mother). A two and a half Y month old 8/11/2008
female patient
8/11/2008
with no reported m
ort received on 08 August 2008 fromYa physician. A healthy 2-year-old male patient, had received on 04 August 8/4/200820088/4/2008
a fourth intramuscula
was received from a health care professional on 09 June 2008. A five-year-old male patient with a history 6/17/2004
of asthma,5/1/2008
chronic ear infections
was received from a health professional on 03 June 2008. A 36-year-old female patient wasY accidentally6/3/2008 exposed to6/3/2008
ACTHIB (lot number
NG AFTER WAKING, CRANKY, LETHARGIC AND GROGGY X 2 WEEKS AFTER ADMINISTRATION. Y 3/11/2009
LEGS SWOLLEN
3/12/2009 UP TO 4 DAYS
s- He had extremely sore legs and Y arms even though vaccines were given only in arms. HeYwas achey 2/19/2009and felt flu 2/19/2009
like. Then had low grad
ceive.5cc pneumo-vac on 5/3/07 in their
Y Right deltoid. On 5/29/07, pt had reported c/o rash on Y face, upper chest, and forerms. Pt was given
Fever ~ 101 F, Malaise, Moderate Diarrhea, chills in evening, body aches, 4/3/2009 4/4/2009
08, pt was in clinic and C/O welts onY thigh; Shoulder reaction to flu shot; cough and sore throat.Y ONSET OF SYMPTOMS: ### ###
Ongoing since fl
as given scheduled vaccination doses Y of: Typhoid, Influenza, and Anthrax on 3/14/09. After about U a week3/14/2009
and a half3/24/2009
later, the patient notice
, 4/3/09, I received two vaccines, a Y
tdap in the left arm and a pneumococal polysaccharide vaccine N in the 4/3/2009
right arm. Within
4/3/2009 a few hours, I st
ter hives around vaccination site later
Y and to this date muscle aches, joint pain and skin hypersensitivity.
N 3/8/2009 3/10/2009
A and Hep B shots on 4/4/09. Felt sickY and nauseated at the time. Returned on 4/5/09 c/o inability U to remove4/4/2009
R arm and 4/4/2009
nausea and vomiti
Y Y 0 N
serious case was received on 24 February
Y 2009 from a health care professional. A nine yearUold patient received ###the2/24/2009
INFLUENZA vaccine (
n has been received from Y a medicalYassistant concerning
Y a 49 year 1old female with diabetes,
Y chronic obstructive
3/24/2009pulmonary
3/24/2009disease, coron
n has been received from a consumer concerning her son with no medical history or drug allergy N who was vaccinated with a dose of MMR
n has been received from a consumer concerning a male who, on an unknown date, was vaccinated U with MMR II (lot # not reported). There
n has been received from a consumer concerning her 7 year old son who on unspecified date U was vaccinated with MMR II. The patient dev
n has been received from a consumer reporting that her nephew now 30 month old male who N in approximately 2006 was vaccinated with M
n has been received from a consumer, Y concerning her 17 year old son with a penicillin and CECLOR Y allergy, sulfonamide allergy, drug hyp
n has been received from a physician Y concerning a patient who in approximately 2008 "about Y a year ago" was vaccinated 9/1/2008 subcutaneously
d fever 3/26/09/ER visit for febrile seizure
Y / URI. U 3/25/2009 3/27/2009
ter receiving DTAP, PREVNAR, ROTAVIRUS
Y & HIB vaccines child experienced right facial droop involving 2/20/2009
eye, lower 2/20/2009
face & mouth. Symp
hought to be febrile seizure, 2 days Y after receiving MMR. Was seen in ER. No labs or test were Y done. Ran 3/24/2009
fever x's 3/26/2009
24hrs. When fever subs
5 minutes after HPV (GARDASIL) vaccineY lasted about 1 minute with L arm jerking X 3 sec paleY looking 3/23/2009
referred to ER. 3/23/2009
BP 100/80, HR 78,
ped erythematous rash, urticarial type with angiodema which began on 1/29/09 and persistedY throughout1/29/2009 2/13/09-see 1/29/2009
picture. There was s
ient said arm slightly sore evening of immunization but next day fine. Patient was given TdapY by mistake since 4/1/2009 it is only recommended at a
d hives within 15 minutes of receiving vaccinations. Gave 0.1 epinephrine IM in office. Y 3/27/2009
alized reaction started day after. Increase to redness, swelling. Spreading down R arm hot toUtouch. 3/5/2009 3/6/2009
ma around injection site, non tender induration of muscle about 7cm - L thigh. U 3/31/2009 3/31/2009
KINRIX (DTaP/IPV) Rt thigh on 4/1/09, red, sore, itchy indurated warm spreading rash developed. Y 14x10cm 4/1/2009
likely allergic,
4/3/2009 but AUGMENTI
VARIVAX 3/26/09 mom noted a red area on L arm at injection site. Tender to touch, but notYsore with movement. 3/26/2009 73/27/2009
cm by 5 cm warm reac
a USAFR female service member, and was on military status on 29 March 2009, when she received N a TDaP
3/29/2009
vaccination
3/29/2009(0.5 mL, IM, L upp
given 3-20-09 AM. Seen in office 3/23/09
Y with 3"x31/2" erythematous, swollen, warm induration U @ site of3/20/2009
Td injection. 3/22/2009
very painful every time I move it. U 2/25/2009
allergic reaction U 4/1/2009 4/2/2009
ak, muscle soreness for 3-4 days two weeks after administration of Hep A and Hep B vaccines. Y Advised3/12/2009
to see his healthcare
3/26/2009 provider.
d an expired dose of Hep B. Parents were advised to revaccinate patient. No adverse reactions Y have been 3/20/2009
reported. 3/20/2009
d an expired dose of Hep B. Parents were advised to revaccinate patient. No adverse reactions Y have been 3/20/2009
reported. 3/20/2009
d an expired dose of Hep B. Parents were advised to revaccinate patient. No adverse reactions Y have been 3/17/2009
reported. 3/17/2009
d an expired dose of Hep B. Parents were advised to revaccinate patient. No adverse reactions Y have been 3/19/2009
reported. 3/19/2009
d an expired dose of Hep B. Parents were advised to revaccinate patient. No adverse reactions Y have been 3/19/2009
reported. 3/19/2009
clinic, c/o redness and blotching of the
Y left upper arm with swelling. Area was warm to touchUand swollen 4/1/2009 from shoulder 4/3/2009
to the elbow. Pt als
lled on 4-6-09 stating that patient had a fever of 103.6 for 48 hours. No other symptoms noted. Y 3/26/2009 3/28/2009
ed out as aching 1 hour after vaccination. Client states pain (Left Arm) was at it's worst 1 week U after vaccine
3/27/2009
(04-03-09)3/27/2009
when she experien
9 the employee went to the ER around Y 10 pm due to swelling in neck, change in voice and difficutly
Y speaking.
3/24/2009 States3/27/2009
he did not have diffic
ain of both knees. 4/13/09 MR and Y vax info received from PCP. In for 14 yr WCC with normal U exam 11/11/08. ### Vax given. ### Returned 12/22/
ately 24 hours after the vaccine was received the patient had severe chest pain. The chest pain Y began evening### and lasted### for over an hour
ticed on 4/5/08 at 2:00AM, soreness, itching and a knot on left arm where Zostavax was administered.
Y Patient
4/3/2009 applied 4/5/2009
alcohol to help with
9am- phone call from parent. Parent reports child right upper arm is red, swollen, & hot to the U touch. Symptoms
3/31/2009 began 4/1/2009
on 4/01/09 and is wo
alized papules. No bullae or blisters around site of injection (left upper thigh) Possible folliculitis
U but possible 4/3/2009
local varicella
4/4/2009 from vaccine.
given 3/31/09 approx. 10:30am. Pt. Y noticed it was tender an swollen 4/01/09 approx. 6:30 pm. U 4/02/09 area3/31/2009
red, raised, 4/1/2009
hot to touch & incre
otavirus) vaccine given vinitial dose at 19 weeeks of age, after the recommended start age of Y 15 weeks,3/20/2009
by mistake.3/20/2009
No physical reaction to
ived IPV and DTAP in Right thigh on 4/3/2009. Now has pink/red and hot area to site measuring U 3.5 x 4 inches.
4/3/2009 Painful
4/6/2009
to palpation. Place
r shot pt had swollen, painful area at site, 1" redY circle at site with rash
4 around it. Syncopal episode
Y on 4/1.
3/31/2009
Transported 4/1/2009
to hospital by ambu
ven Pneumovax vaccine as ordered.YLeft deltoid injection site wiped down with alcohol swab,Yand vaccine 3/2/2009 given. Site 3/3/2009
dabbed w/ cotton ball,
ed sudden and severe hair loss resulting
Y in many visits to dermatologists over the last year and
N a half. This 7/20/2007
has resulted
9/17/2007
in meds prescribe
Clinic on 4-6-09 to report that she had experienced painful, red blotchy raised rash on left upper Y arm which4/1/2009presented4/5/2009
on 4-5-09 at approxim
-Hyporesponsive Episode, onset was about 2 hours after receiving DTaP vaccine, lasted approximatelyY 3/14/2009
4 hours 3/14/2009
A TDAP SHOT ON FRIDAY(04-03-09) AND SAT. HE HAD BODY PAIN & CHILLS.LEFT ARM Y WARM AND 4/3/2009
TENDER 4/4/2009
TO THE TOUCH. TOD
en, feverish arm where shot was administered. Headache, neck ache, weakness, general feeling Y of tiredness.
4/3/2009 4/5/2009
ome numbness and tingling across the upper back and neck and extending down into his arms Y bilaterally. 4/1/2009
This was resolving
4/1/2009when seen on
was reported by a consumer and described
Y the occurrence of feels like having a heart attackY in a 60-year-old
10/1/2008female
10/1/2008
subject who was vacc
9, pt presented w/ aboutY14 hr hx ofYfever, headacheY and vomiting and
7 20 min of purpuric rash.
Y Pt directed 3/20/2009
to ER then
3/30/2009
Peds ICU. CSF incre
dmother and mother report that this Y 6-month-oldYinfant has been a bit3 fussy and out of sorts since
Y he received
3/17/2009
immunizations
3/19/2009two days ago
ve Diarrhea, Vomiting, Back Pain, Body Y Aches,YHA. From 033009 --> 1 033109 To ER Admitted Y Observation. 3/30/2009
Discharged
3/30/2009
040109. To Scho
a reddish purplish area on leg not acting sick otherwise. Recommended she watch it for a fewUdays and if3/24/2009 not better to4/6/2009
be seen.
at injection site "burning" to left arm, both arms, now legs and eyes. No rash, no swelling and U no fever, VSS. 4/2/2009
Advise;4/4/2009
Monitor.
e: onset: 3/10/09-present. OTC MOTRIN Y taken for symptoms. Lower back pain: onset:3/10/09 N x 1day. Fever: 3/9/2009
onset:3/10/09
3/10/2009 x 1day Reported
and swelling L leg. Started the day after lZ. Worsened x 24 hours then improved, used ice only. Y 4/3/2009 4/4/2009
9 - School nurse phoned HD and stated Y that student's L upper arm was somewhat red with some U swelling.
3/31/2009
Client c/o4/1/2009
nausea and L arm pai
with long periods of crying and inconsolability. Fever 101.8 rectal. Vomiting x 1. decreased oral Y intake. 4/2/2009 4/3/2009
red and swollen. Cellulitis - given antibiotics.
Y Went to urgent care - Then follow up and officeU6/23/08. 6/20/2008 6/21/2008
n has been received from Y a Nurse Practitioner
Y Yfor the Pregnancy Registry for GARDASIL concerning
Y an6/18/2008
18 year old female patient with no
n has been received from a concerning Y a 50 year old nurse female who was alsoYa nurse was Y vaccinated with a dose of ZOSTAVAX (Oka/
n has been received from a physician Y concerning a patient with milk allergy who was vaccinated U with ROTATEQ vaccine. Upon return for a
week after vaccinations - resolved Y after two days.
Y Lethargic, irritable22 Y2-3 weeks Y
later for about
N two weeks. One### month after ###
immunizations,
en thigh left - side left day #2 after vaccination.
Y ER on 4-5-09 No tx. Y 4/2/2009 4/4/2009
o site with induration x 3-4 days. Left arm. Y 3/26/2009 3/28/2009
shingle shot. Asked nurse if it would hurt, no just like flu shot. It did hurt and burned. 03-19-09 4 AM Difficulties
3/18/2009 Breathing for 1 Hr. Noticed
d petechial rash on inner thighs, abdomen, behind knees 5 days after vaccine give. No itch -YNo vesicles.3/17/2009 No rash at3/23/2009
injection site. Platelet c
n so had ADACEL vaccine (administered off -site) 10 days later, presented to me with myalgias, arthralgias, headache, 3/7/2009
malaise. Ok to conta
DISIL vaccine administered 7/8/08 pt report hives all over body within hours of injection lasting Y 3-4 days. 7/8/2008
Tx with BENADRYL.
7/8/2008
swelling & erythema of entire thigh > 72 hrs Discomfort & ambulation > 48 hrs. Y 11/1/2005 11/1/2005
cm red wheal appeared after 9 month immunizations given. No discomfort/problems noted, but N wheal has2/6/2009
persisted since
2/6/2009shots (on right th
ction right thigh with erythema and induration
Y developed nine days after immunizations. AlsoUwith low grade 3/24/2008
temp. (99.9)
4/2/2009
d rash L side neck in dermatomal pattern consistent with VZV. 3/18/2009 3/25/2009
iven 3/19/09, fever developed 3/27/09. Y Rash erythematous macular papule with palms/soles & buccal urticaria 3/19/2009 developed
3/29/2009 3/29. Looks like
Y ### ###
ed 6 mo. well baby checkup on 2/23/09. Vaccines listed below given. Pt. came in to see MDYon 2/28/09.2/23/2009 Vomiting 2/25/2009
began on 2/25 with Dia
lled, c/o erythema (L) upper arm at injection site, Sl. raised "welt" in appearance, "larger than Y half dollar"3/25/2009
in size. No3/26/2009
c/o discomfort, and dec
se events recorded 8/2/2006
d to the office on 3/31/09 with c/o rash Y all over body since Sunday 3/29/09. Spreading rash not U itchy. No 3/19/2009
fever. Non vesicular,
3/29/2009maculopapula
KINRIX 3/24/09 (R) deltoid. Seen 3/26/09
Y with swelling, erythema, warm to touch no tendernessY no induration.
3/24/2009 Negative
3/25/2009
node. Ab after vac
d headache 5/26/09 Received PCPYmedical records of 12/3/08-5/18/2009. FINAL DX:migraine Y HA; probable 12/3/2008
psychiatric
2/21/2009
illness Records rev
maculo papular rash to face, neck, Yarms, chest, abdomen, back and groin blanching and non U vesicular. 3/17/2009
Not itchy, afebrile,
3/27/2009 No V, No D. Po
ceived KINRIX as part of 4y.o. physical, in (L) deltoid 4/3/09 at approximately 9:AM; went to schoolY after appt,
4/3/2009
picked 4/3/2009
up from school at 5PM
ec. Yellow Fever Vaccine - woke upYwith itching mild noc, slight headache - In AM 3/31/09 noted Y rash (hives)
3/30/2009
chest,3/30/2009
neck, arms and legs. D
ely following injection pt. became stiff,Y eyes rolled in back of head, bluish + orange around mouth,Y + pt. was
3/31/2009
having jerking
3/31/2009motions of entire
ed of itchy throat 40 minutes after receiving multiple vaccines (TYPHIM VI, HAVRIX and yellow Y fever YF-VAX).
3/25/2009 Administered
3/25/2009BENADYL 50
ness, swelling and firmness Rt 'upperarm' 3"x2 1/2". No fever or chills. Denies cp or SOB. NoYpruritus. ROCEPHIN 3/30/2009 gram3/31/2009
+ IM, KEFLEX 500
m notices red spots on back of neck Y and a lot on stomach. 1-16-09 8AM when woke up this AM, Y red spots 1/6/2009
were all over
1/15/2009
face, back, neck and
o pneumonia vaccine given in the left arm (deltoid). Mild pain, redness and streaking from injection
U site. 4/6/2009 4/6/2009
Hep B vaccines were given to 70 newborns because the GSK products requires 10 mcg dosage, but MERCK product 2/17/2009
required only 5 mcg f
tates he was in his office yesterday, received Pneumonia vaccine in rt arm. Report this was he second pneumonia 3/26/2009 vaccine.
3/26/2009 States approx 3
tion given on 3/27/09 3 hours after going to bed woke up screaming for 5-10 min. did settle some Y fussy till
3/27/2009
TYLENOL 3/27/2009
kicked in temp 103 de
d redness around upper arm 2 d after vaccine given-Itchy c/o nausea- Rx BENADRYL, MOTRIN Y -Lasted2/10/2009
3-4 days. 2/11/2009
an two days after shot was given (103F)Y mother gave Tylenol. Child taken to ER with c/o seizure. 3/18/2009 3/20/2009
tion site reaction with mild cellulitis Y 3/31/2009 4/2/2009
X 24 hr, injection site rash, urticaria Y Y 4/1/2009
heat, swelling left deltoid area. Hard in center of redness, approx. ping- pong ball sized Y 3/21/2009 3/23/2009
D with throat itching within 5 min of shot.
Y Requiring BENADRYL 25 mg PO + Albuterol Nebulizer Y treatments
3/30/2009
X 2 given
3/30/2009
over 2 hours.
ld with spots on body, started 3 days ago along with diarrhea; cough x 4 days temp 98 R 148-38 Y Stuffy 3/10/2009
nose, yellowish
3/23/2009
nasal drainage. A
ain, left sided facial flushing, fevers up to 100.8 degrees orally after vaccine given. Also noted Y left supra3/18/2009
- clavicular3/18/2009
lymphadenopathy. Fu
and swelling to left upper arm. Y U 4/1/2009 4/2/2009
noticed itching at site of vaccination. Mild tenderness, seen at clinic 3/27. 6X5 cm warm pinkYarea surrounding 3/25/2009
2.5 cm3/26/2009
area darker pink + mi
5 cm X 5 cm; Swelling + Pallor 8X8 cm; tenderness. U 3/31/2009
Y 4/2/2009 4/2/2009
stomach,head hurt, feet felt prickly Y 3/28/2009 3/28/2009
d with ACAM2000 during pregnancy. Pregnancy resulted in full term healthy delivery. 4/10/2008 4/21/2008
3rd dose of Gardasil on 3/31/09 On 4/2/09 she had an episode where she became very angry Y and agitated3/31/2009
and had 4/2/2009
behavior not like her n
d with ACAM2000 during pregnancy. Pregnancy resulted in full term healthy delivery. 6/25/2008 7/8/2008
as given Adacel instead of Infanrix. I have told my superviser and his parents. Y 4/7/2009
sed appt for Well Child Clinic and coordinator
Y MaryBeth Hayes RN called to remind parents. Y She spoke with2/24/2009
dad and 3/1/2009
he said that child had
Optic Neuropathy leading to severe loss Y of vision right eye. Treated with high dose Y IV steroids
N with no benefit. ### 5/4/09
11/4/2008
Received Optho Clini
INTED.ASSESSED MY MD Y 4/7/2009 4/7/2009
owing vaccination, pt. developed generalized
Y itching and painful sores on her back. She went U to her doctor
3/30/2009
on the 3rd4/1/2009
day post-vaccination
fic myocarditis. This case was identified
Y as part of the H-406-005 Enhanced Surveillance Study (5000005). 2/2/2009 2/18/2009
d with ACAM2000 during pregnancy. Pregnancy resulted in full term healthy delivery. 4/29/2008 5/13/2008
ardial infarction (410.7), unspecifiedYsite (410.9). This case was identified as part of a study.U 1/30/2009 2/17/2009
Kinrix innoculations given on 3-17-09, on 3-28-09 (11 days post inocculations) Pt spiked a 102F U temperature,
3/17/2009which3/28/2009
subsided over the nex
ought child in today for assessment of oval shaped 3 inch by 6 inch reddened area on left posterior U lateral4/6/2009
upper arm,4/6/2009
site of VZV sc injectio
s after her vaccine was given the following
Y symptoms
Y were noted: weakness
1 of mouth muscles
Y with drooling 2/4/2009
and liquids
2/22/2009
running out of mou
d with ACAM2000 during pregnancy. Pregnancy resulted in spontaneous abortion. 1/14/2009 2/2/2009
d with ACAM2000 during pregnancy. Pregnancy resulted in full term healthy delivery. 5/16/2008 6/23/2008
ates he got his second injection on Friday and that his rash came back over the weekend and Y stating this3/5/2009
time the rash3/9/2009
is worse. +Pruritis,
d to toe. Not sleeping or eating. - Maculopapular
Y rash, condense together in big patches, notUsick, no cough,
3/26/2009
no URI3/27/2009
c/o, measles-like rash.
rash with blisters) on lower L back. Y U 3/25/2009 4/5/2009
1/13/2009
erythema L thigh day after immunizations. Continued to increase spread of erythema. MotherUhad given Benadryl 4/3/2009et had4/4/2009
applied ice to site.
009@09-43 from pt. States he was in this office yesterday, received pneumonia vaccine in rt arm. Report3/25/2009 this was he 3/26/2009
second pneumonia va
n has been received from a nurse for the pregnancy registry for HPV concerning a female with Y a history of2/4/2008
vulvar condyloma
2/4/2008with Trichloroa
n has been received via an internet blog from a consumer concerning her daughter who wasUvaccinated with a dose of GARDASIL. In the m
n has been received from via the physician of aYpatient whose mother 6 found the current case U online. The5/30/2007
current case concerns a female p
d focal deficits temporallyY associated Y to receipt Yof the spv. See attached.
20 Diagnosis:
Y CEREBELLARN ATAXIA/menigoencephalitis.
1/5/2009 1/20/2009 Symptom
n has been received from a physician concerning a 17 year old female who was vaccinated N with her second dose of GARDASIL, 0.5 mL, IM
orts pain & burning sensation to right Y upper arm since flu vaccination. Severe pain started approximately11/4/2008
2 wks after administration.
### She re
oid (arm) red and swollen, mother of patient stated that kid had a low grade temp. of 99.4 theYday after vaccine administered.
ma & swelling of uvula. Y Y ### ###
d swollen warm to touch. Are measures Y 8x6 cm. no pain. Temp 99. Y 3/30/2009 4/1/2009
shingle shot. Asked nurse if it would hurt. No, just like flu shot, it did hurt and burned. 03-19-09 4 AM difficulties
3/18/2009 breathing
3/18/2009for 1 hr. Noticed
ghtly raised, warm to touch pink area @ injec. site post getting VARICELLA vaccine on 3/30/09 U 14.5 cm3/30/2009
X 7cm. Reported
3/31/2009 by guardian on 4
area of blanching erythema around Yinjection site at L upper arm. Started a few hours after injection-
U zero 4/1/2009
treatment included
4/2/2009with systemic
n has been received from a nurse practitioner,
Y for the Pregnancy Registry for GARDASIL, concerning
Y a 15 year ###old female
3/1/2008 with iron deficie
n has been received from a physician Y assistant concerning a 24 year old pregnant female with Y a history 2/12/2008
of penicillin2/12/2008
allergy who on 12-FEB
on arm. Not sure if it was vaccine reaction
Y or early cellulitis. U 7/11/2007 7/13/2007
d syncopal episode, shortness of breath,
Y headache, throat felt "fuzzy" Injection site swollen,Ured, achy. 8/8/2007 8/9/2007
n has been received from a case in litigation via Litigation Reports concerning a 15 month old N male patient3/14/2000
who on 14-MAR-2000
3/30/2000 was vacc
was received from a health professional
Y on 26 March 2009, via another manufacturer (document number 45215838). A patient received Fl
Y Y 2/6/2009 2/9/2009
eveloped. Got in waiting area she began to break out with a pruritic rash and had difficulty breathing.
Y 62.53/4/2009
Solumedrol3/4/2009
IM given, 0.2 Epinep
ASIL 1-30-09 - At 2nd appt for GARDASIL 4-2-09 pt. described symptoms from first IZ admin. Y stated had 1/30/2009
severe headache
1/30/2009 with vomiting a
induration at left thigh elevated white
Y blood cell count to 13.7 K Fever to 100.5 U 4/6/2009 4/7/2009
redness, itching and swelling of the upper arm for a week followed by a general feeling of tiredness,
Y headaches### and general ###achiness lastin
Y 4/2/2009 4/6/2009
lled stating that left arm is red, swollen, warm to touch, has a red splotchy rash and is the sizeU of a "grapefruit".
4/6/2009 Patient
4/7/2009
denies any pain, bu
rned red and slightly raised the evening of the day the shot was given. Y 4/6/2009 4/6/2009
d with ACAM2000 during pregnancy. Pregnancy resulted in full term healthy delivery. 5/24/2008 6/25/2008
the tongue and throat. No acute respiratory distress. complained of mild itching around eyesYand forehead. 4/8/2009
No erythema 4/8/2009
or rash noted in th
EAMED ALL DAY RIGHT AFTER SHE RECIEVED THE IMZ. RUN 103 TEMP THE FIRST DAY Y AND 1014/2/2009 TEMP THE4/2/2009 NEXT TWO DAYS. C
nt received Tdap vaccine (Adacel) and experienced muscle aches, chills, general malaise, nausea Y and axillary
3/19/2009lymphadenopathy.
3/19/2009 Symptom
U 4/1/2009 4/1/2009
nt received Tdap and experienced nausea, vomiting, chills, low grade temp and a rash beginning Y immediately
3/19/2009
after injection.
3/19/2009Symtoms subs
s a Methicillin Sensitive Y Staph Aureus
Y left septic
Y hip and left abscess5Y on ankle with presumedU osteomyelitis3/16/2009
of femur. 3/20/2009
Patient's prenatal cou
ite blanched and cool to touch, after the blanching, the injection site had a bluish-tinged appearance.
Y Ice
3/30/2009
pack applied3/30/2009
to injection site, mo
nt received Tdap and experienced fever, bodyache and headaches. Symptoms subsided in 4Ydays. 3/19/2009 3/19/2009
nt received the Tdap vaccine and experienced nausea/vomiting, axillary lymphadenopathy, blotches, Y beginning
3/19/1968 8 hours
3/19/1968
after vaccine admin
nt received Tdap and experienced chills, diarrhea and vomiting 1-2 hours after injection. TheYsymptoms subsided 3/19/2009in 3/19/2009
2 to 3 days.
HPV vaccine Gardisil on March 31, 2009. Y The next day I was feeling soar and tired, but did not
N think anything
3/31/2009
about 4/1/2009
it. By Friday evening (
Hep B shot 3-31-09 VLL. On 4-02-09, mom notice it was reddened, hot and hives were appearing Y as well
3/31/2009
as swelling 4/2/2009
on the upper left thig
red DTAP instead of Tdap to 11 yr old, administrative error, no adverse event 3/23/2009
9@ 11:05AM, Injection site is red, swollen,
Y warm to the touch, and pain in elbow.03/16/2009@ U 3:05Pm, No 3/9/2009
pain, no3/14/2009
warmth, but still swolle
ately 48 hours after immunizations her Y left leg at injection site began swelling and turned reddish
N purple, swelling
4/3/2009continued4/5/2009 and covered he
a 62 year old African American male Y and recieved
Y the flu vaccine on 11 1/12/09. He reported a Uhistory of Diabetes.
1/12/2009 He2/24/2009
was recovering from a
ons were received on 04/06/09 (received DTaP, MMR, VZV). On 04/08/09 developed swelling, U itching, redness
4/6/2009 in left 4/8/2009
arm at site just below
had a rash on neck and chest. LipsYwere swollen. Itching at rash sites. Also complained of itching
Y throat. 4/1/2009
Went to ER4/7/2009administered Benedr
d the months up to March Y there was no local orYsystemic reaction 21 to any
Y of the Immunizations N given on 12/19/08. ###On 2/28/2009
March 3 patient came
8HRS DEVELOPED LOCALIZED REDNESS AND SWELLING IN RIGHT ARM, FEVER, MALAISE, U MYALGIAS.
4/6/2009REACTION 4/7/2009 OCCURED A
minutes of receiving theYvaccines, patient
Y developed
Y hives on his head
3 and then experienced U shortness of 4/2/2009
breath, wheezing
4/2/2009and his lips tu
er), child went to ER 2-13-09 with LLQ Y pain hadY CT- Showed ovarian 2 cyst was told by ER physician-
Y was8/25/2008
result of HPV2/13/2009
immunizations. Lap
d immunizations (FLUMIST, HepA/B, Meningococcal, Y MMR, Pneumococcal)
15 on 2/18/09. PerUthe pt he received
2/18/2009 these3/4/2009
vaccinations on 2/19
high-redness, 14x17 cm swelling and discomfort from upper thigh to knee area. Involved thigh Y 2.5cm larger 4/6/2009
in circumference
4/7/2009 - secondary e
oday that he had a reaction to RECOMBIVAX HB #2 in October 20008. Y 10/1/2008 10/1/2008
d rash around belly button and on thighs- chicken pox looking rash with temp received varicella Y 2/26/09. 2/26/2009 4/6/2009
redness, 12 cmx8cm. Noticed 4/8/09 @ 0630. Vaccine 4/7/09 2130. Y 4/7/2009 4/8/2009
e began about 3 days after ZOSTAVAX injection. N 3/24/2009 3/27/2009
ticed red welt on site of injection theYfollowing day. In the afternoon around 3 pm. she experienced
Y slight3/26/2009
itch on left3/27/2009
arm. The red welt on ri
d red itchy mark ant injection site. U 4/7/2009 4/8/2009
ncopal episode after GARDASIL. Did not fall, guided to chair by me & aroused with ammonia Y & cold wet cloth.
4/8/2009 No seizure
4/8/2009 act. Pulse alwa
n has been received from a healthcare Y worker concerning a 78 year old female who was vaccinatedY with8/30/2006
a dose of 1/26/2009
ZOSTAVAX (Merck). F
n has been received from a nurse practitioner
Y concerning a 77 year old female with SULFONAMIDEN allergy
3/1/2007
and no 1/22/2009
known medical history
n has been received from a 74 year old female with no known medical history and drug allergies, N who two 1/12/2009
weeks ago 1/23/2009
was vaccinated with
n has been received from a registered Y nurse concerning a 77 year old female patient with noNknown allergies 9/27/2007
and no pertinent medical hist
n has been received from a registered Y nurse (also reported as certified medical assistant) concerning
N a 71
1/20/2009
year old female patient with hiat
n has been received from a licensed practical nurse concerning a 55 year old female paraeducator Y (weight1/2/2009
242 pounds, 1/2/2009
height unknown) w
n has been received from a physician Y concerning a female patient who on 23-JAN-2009 wasYvaccinated1/23/2009 with a 0.651/23/2009
ml dose of ZOSTER va
n has been received from a Master Yof Science in Dentistry and a Physician concerning herself, Y a 61 year 1/9/2009
old female1/24/2009
patient with pre-osteop
n has been received from a registered Y pharmacist concerning an 87 year old female patient U with recurrent1/9/2009
shingles (about every two month
n has been received from a registered Y nurse concerning a 63 year old male patient with no pertinent
U medical
1/12/2009
history1/15/2009
and no known drug all
n has been received from a physicianY concerning a 65 year old male patient who on 21-JAN-2009 N was vaccinated
1/21/2009 with 1/23/2009
ZOSTAVAX. On 23
n has been received from a physicianY concerning a 73 year old female patient with reflux, osteopenia
Y and high### cholesterol
1/14/2009 who on 31-DEC
n has been received from a physicianY concerning a 68 year old female patient who on 21-JAN-2009 U was1/21/2009
vaccinated with 0.65 ml of a dose
n has been received from a registered
Y pharmacist concerning a 69 year old female patient with N herpes simplex
3/5/2008 and1/26/2009
penicillin allergy who o
n has been received from a 74 year old male physician with prostate cancer that was treatedUwith radiation 12/1/2007
who in approximately
1/1/2009 Decembe
n has been received from a pharmacy Y student concerning an over 65 year old female who on U 28-JAN-20091/28/2009
was vaccinated
1/29/2009 with a dose of
n has been received from a physician's
Y assistant concerning a roughly 60 year old female who U on 20-JAN-2009
1/20/2009 was1/20/2009
vaccinated with a dos
n has been received from a physician's
Y assistant concerning a 59 year old female with no drug N reactions or 1/2/2008
allergies 1/2/2008
and a history of breas
n has been received from a physician concerning a 79 year old male who on 6-JAN-2009 was N vaccinated1/6/2009
injection with
1/20/2009
ZOSTAVAX (LOT #
n has been received from a nurse concerning a 3 year old patient who on 19-JAN-2009 wasUvaccinated 1/19/2009 with a dose1/19/2009
of ZOSTAVAX instead
n has been received from a pharmacist concerning a 67 year old female patient with an allergy N to something
1/22/2009
the dentist
1/22/2009
gave her (not furth
n has been received from a pharmacy Y student concerning a 65 year old female patient with N hypertension,1/8/2009
hypercholesterolaemia,
1/16/2009 osteopor
n has been received from a pharmacist concerning a 80 year old female patient with no known N allergies 1/19/2009
who on 19-JAN-2009
1/21/2009 was vaccina
n has been received from a physicianY concerning a female patient who was over 65 year old, N who beginning
11/1/2008
November
12/1/2008
2008, was vaccina
n has been received from a physician concerning a female in her 70's who on an unknown date U was vaccinated with ZOSTER vaccine, 0.6
n has been received from a registered
Y burse concerning a 71 year old male who on 16-JAN-2009 Y was vaccinated
1/16/2009 with 1/21/2009
a dose of ZOSTAVA
n has been received from a physician concerning a 67 year old female who was vaccinated Y with ZOSTER vaccine live (Oka/Merck), lot # n
n has been received from a 63 year old male patient with headaches caused from some food N products (unspecified)
9/1/2008 and no known drug all
n has been received from a 62 yearYold male patient who on 2-JAN-2009 was vaccinated with N a dose of ZOSTAVAX
1/2/2009 1/4/2009
(No Lot # provided) 0.
n has been received from a nurse concerning a 4 year old female who on 23-JAN-2009 wasUvaccinated 1/23/2009 with ZOSTAVAX 1/23/2009
SQ, 0.65ml (lot #
n has been received from a physicianY concerning a female patient with diabetes who in February N 2007, was2/5/2007
vaccinated1/1/2009
with a 0.65 ml dose
n has been received from a 62 yearYold female registered nurse with no known drug allergy N and hypercholesterolaemia 1/13/2009
who on 13-JAN-20
n has been received form a consumer Y concerning his son in law who on unspecified date was U vaccinated with a dose of ZOSTAVAX. Five
n has been received from a pharmacist concerning a 70 year old female who on 23-DEC-2008 U was vaccinated### with1/17/2009
a 0.65 ml dose of ZOS
n has been received from a licensed Y visiting nurse concerning a 67 year old female with drug N hypersensitivity
1/14/2009to codeine,
1/17/2009
PPD and ZYBAN
n has been received from a doctor of pharmacy concerning a 60 year old male with cholesterol N and hypertension
1/8/2009who 1/18/2009
on 8-JAN-2009 was
n was received from a 80 year old male
Y patient with allergies to tetracycline; CIPRO; penicillin;
N clindamycin;
11/5/2008
erythromycin;### tramadol; metop
n has been received from a physicianY concerning a 74 year old female patient with a historyUof splenectomy 1/6/2009
who on1/20/2009
approximately 6-JAN-2
n has been received from a registered
Y 35 years old female pharmacist who reported that she N thought her1/14/2009
right eye could
1/14/2009
had inadvertently
n has been received from a PhysicianY Assistant concerning an 81 year old female patient with N hypertension, hyperlipidaemia,
1/15/2009 osteoporosis
n has been received form a female patient who was vaccinated with ZOSTAVAX (Lot # not reported). U Patient called because she wanted to
n has been received from a consumer concerning her 60 year old husband with no pertinentNmedical history 1/19/2009
and no1/19/2009
drug reactions or allerg
n has been received from a physicianY concerning a female patient who had an outbreak of shinglesU in July
12/1/2008
2008 and 1/15/2009
in December 2008 wa
n has been received from a pharmacist concerning a female patient in her 60's who on 2-JAN-2009 U was vaccinated
1/2/2009 with a dose of ZOSTAV
n has been received from a medical assistant concerning a 12 month old male patient who on U 13-JAN-20081/13/2008
was vaccinated
1/13/2009subcutaneous
n has been received from a pharmacy tech concerning a female patient in her late 60s who U on approximately 01-JAN-2009, "approximately
n has been received from a physicianY concerning a male patient who was vaccinated with a Udose of ZOSTAVAX (Oka/Merck) (lot # not pro
n has been received from a licensed Y practical nurse concerning a 76 years old male patient N with cardiovascular
8/1/2008 disorder, hypertension and
n has been received from a licensed Y practical nurse concerning an 87 year old male patient N with kidney 1/15/2009
stone, coronary1/16/2009
artery disease, dem
n has been received from a physicianY concerning a "young child" who was vaccinated with aYdose of PROQUAD ###(Merck).###Subsequently, w
n has been received from an 81 year old female with diabetes and a history of nervous breakdown, N and 1/22/2009
no drug reactions
1/28/2009who on 22-JAN-
n has been received from a physician concerning a 77 year old female who on 05-JUN-2008Ywas vaccinated 6/5/2008
with 0.65
1/20/2009
ml dose of ZOSTER
n has been received from a medicalYassistant concerning a 62 year old female patient with no Y known drug1/7/2009
allergies1/16/2009
and VARICELLA as a c
n has been received from a registered nurse concerning a 62 year old patient who on 20-JAN-2009 N was1/20/2009
vaccinated1/21/2009
with ZOSTER vaccine
n has been received from a certifiedYmedical assistant concerning a 62 year old male patientUwith no known 1/20/2009
drug reactions/allergies with ga
n has been received from a pharmacist
Y and a medical assistant concerning an 81 year old female N who on12/8/2008
08-DEC-20081/25/2009
was vaccinated su
n has been received from a nurse practitioner concerning a 68 year old female with hypertension, U arthritis
1/16/2009
and a history
1/27/2009
of genital herpes. T
n has been received from a physician concerning a patient who was vaccinated with ZOSTER N vaccine live
3/10/2008
(Oka/Merck) 1/9/2009
0.65ml (lot number
n has been received from a pharmacist concerning a 62 year old female with allergic reaction N to TETRACYCLINE
1/30/2009 and 1/31/2009
PHENOBARBITAL w
n has been received from a licensed Y practical nurse concerning a 78 year old female with hypertension,
N 2/25/2008
hyperlipidaemia
1/26/2009
and a history of pa
n has been received from a physicianY concerning a 67 year old male with colitis ulcerative, goutN and metabolic syndrome 1/26/2009
whose wife was v
n has been received from a certified medical assistant concerning a 76 year old male with hypertension
U 1/26/2009
and coronary2/3/2009
artery disease who o
n has been received from a pharmacist concerning a 66 year old female with allergic reaction Y to antibiotics
1/29/2009
who at "some
2/1/2009
time last week" w
n has been received from a female who on 23-JAN-2009 was vaccinated with ZOSTER vaccine N live (Oka/Merck)
1/23/2009(lot 1/31/2009
number, route and sit
n has been received from a 64 yearYold female with no medical history and no drug allergiesNwho on 29-JAN-2009
1/29/2009 was 1/31/2009
vaccinated with a 0
n has been received from a physicianY concerning a 60 year old female with hypothyroidism, N hyperlipidaemia,
1/15/2009
sciatica
1/30/2009
and back problems w
n has been received from a registered nurse (R.N.) concerning a 14 month old female with no U relevant medical
2/3/2009
history
2/3/2009
or past drug history
n has been received from a pharmacist concerning a patient who on an unspecified date was U vaccinated with a dose of ZOSTAVAX (Oka/M
n has been received from a 66 yearYold female patient with penicillin allergy, no pertinent medical
N history,
1/23/2009
who on 23-JAN-2009
1/30/2009 was vaccin
n has been received from a 70 yearYold female patient with blood pressure high, no drug reactions
N / allergies,
1/13/2009
who on 1/30/2009
13-JAN-2009 was va
n has been received from a 66 yearYold female consumer with no known drug reactions/allergiesN and breast
5/11/2008
cancer since
8/1/2008January 2007, wh
n has been received from a medicalYassistant concerning a 63 year old male with diabetes and N no drug allergies ###who1/30/2009
on 15-NOV-2008 was
n has been received from a medical assistant concerning a 14 month old patient who was vaccinated
U inadvertently
2/5/2009 with a dose of ZOSTAV
n has been received from a physician concerning a male who was vaccinated SQ with a 0.65 U ml dose of ZOSTAVAX (Oka/Merck) at a pha
n has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX U (Oka/Merck) 0.65ml (lot number, route an
n has been received from a certifiedYmedical assistant concerning a 66 year old female patient with no known
1/29/2009
drug 1/31/2009
reactions/allergies and
n has been received from a registered
Y pharmacist concerning a 74 year old male patient with Y no drug reactions/allergies,
2/4/2009 2/5/2009 who on 04-FEB-2
n has been received from a registered nurse concerning a female patient who on an unspecifiedU date was vaccinated with one dose of ZOS
n has been received from a registered
Y pharmacist concerning a over 60 year old male with atrial
N fibrillation and### a history of###chickenpox and
n has been received from a registered
Y nurse concerning a 63 year old female who on 25-JUN-2008
N was6/25/2008
vaccinated6/25/2008
SQ with a 0.65ml dose
n has been received from a pharmacist concerning a 72 year old female with penicillin allergyN who on 19-JAN-2009
1/19/2009 was 2/2/2009
vaccinated with ZO
n has been received from a medical assistant concerning a 77 year old female who on 03-FEB-2009
U was2/3/2009
vaccinated2/7/2009
with ZOSTAVAX (Oka
n has been received from a physician concerning himself, a 70 year old male patient, with no pertinent medical history and no known drug
n has been received from a healthcare
Y student concerning a female who on 3-APR-2008 was U vaccinated4/3/2008
with ZOSTAVAX### (Oka/Merck) (lo
n has been received from a physician concerning his father who on an unknown date, was vaccinated
U with ZOSTAVAX (Oka/Merck) (lot #
n has been received from a physician concerning a female who was vaccinated with a dose Uof ZOSTAVAX (Oka/Merck) (lot number, route
n has been received from a physician concerning a patient who on an unknown date, was vaccinated
U with ZOSTAVAX (Oka/Merck) SQ (lo
n has been received from a physicianY and a nurse. It was reported that a 62 year old femaleNwith type II diabetes,
2/5/2009 hypertension,
2/8/2009 congenita
n has been received from a physicianY concerning a male physician who was vaccinated withYa dose of ZOSTAVAX (Oka/Merck) (no lot # p
n has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX U (Oka/Merck) 0.65ml subcutaneously. Sub
n has been received from a physician concerning a 62 year old female with several autoimmune U diseases, 1/1/2009
who about1/1/2009
a month ago approxi
n has been received from a physician concerning a patient who on an unspecified date was U vaccinated with a 0.65mL dose of ZOSTAVAX
n has been received from a physicianY concerning a patient who on 10-FEB-2009 was vaccinated with a 2/10/2009
dose of ZOSTAVAX
2/12/2009(Oka/Merck).
n has been received from a licensed practical nurse concerning a 79 year old female who onN29-DEC-2008 was ###
vaccinated
1/8/2009 with ZOSTAVA
n has been received from a pharmacist
Y concerning an 89 year old male with allergies to GUAIFENESIN,
N 4/14/2008
PENICILLIN 2/13/2009
and SUDAFED, and
n has been received from a medicalYassistant concerning an 80 year old female with diastolic N dysfunction,2/10/2009
hypertension, systolic murmur, c
n has been received from a 59 yearYold female with allergic PENICILLIN, SULFONAMIDE and N ERYTHROMYCIN, 1/7/2009 and 1/7/2009
no pertinent medica
n has been received from a physicianY concerning a 77 year old female who on 12-FEB-2009Nwas vaccinated 2/12/2009
SQ with2/13/2009
ZOSTAVAX (Oka/Me
n has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX U (Oka/Merck) 0.65ml subcutaneously. Sub
n has been received from a physicianY assistant concerning a male with hypertension, osteoarthritis
Y and no drug allergies
2/9/2009
whose wife in Dec
n has been received from a 61 year old female with iodine (IVP dye) allergy and a history of Nheadaches 1/19/2009
while on therapy
1/20/2009
with DEMEROL a
n has been received from a 67 yearYold female with allergic reaction to ERYTHROMYCIN, KEFLEX,N sulfa, FLAGYL,
### BUTALBITAL,
### aspirin
n has been received from a physician concerning a patient who on an unspecified date was Yvaccinated with a dose of ZOSTAVAX (Merck)
n has been received from a pharmacy technician concerning a 60 year old female patient who N on 17-FEB-2009
2/17/2009 was2/17/2009
vaccinated with a dose
n has been received from a pharmacist
Y concerning a 78 year old male patient with a previous N cause of shingles
2/16/2009 in October
2/18/2009 2008, who on 1
n has been received from a pharmacist
Y concerning an adult female patient who was vaccinated Y with a dose of ZOSTAVAX 1/18/2009 (Oka/Merck) 0.5
n has been received from a pharmacist
Y concerning a 70 year old female with allergies to alendronate
N sodium
2/16/2009
(MSD)2/18/2009
WAES # 0902USA044
n has been received from a pharmacist concerning an 81 year old female patient with a historyN of shingles1/8/2009
on her trunk
2/8/2009
and no known drug
n has been received from a physician concerning an over 65 year old patient who on approximately
U 20-DEC-2008,### 2/20/2009
two months ago, was va
n has been received from a physician concerning a male who was vaccinated with ZOSTAVAX U (Oka/Merck) 0.65ml2/18/2009(lot # not reported). Aft
n has been received from a nurse practitioner concerning an approximately 70 year old patientU with cardiac failure who was vaccinated SQ
n has been received from a pharmacist concerning a female patient with sulfa allergy who on N 18-FEB-2009 2/18/2009
was vaccinated
2/19/2009 with ZOSTAVA
n has been received from a registered
Y nurse concerning herself with a history of osteoporosis N and borderline 8/4/2008
elevated9/1/2008
LDL who on 04-AUG
n has been received from an office Y
staff in physician office concerning a 63 year old female Y patient with a history of Fibro Myalgia who was
n has been received from a nurse practitioner
Y concerning a 73 year old female with osteoporosisN and hypertension
2/17/2009 2/19/2009
and no known drug alle
n has been received from a 67 yearYold female with penicillin allergy and high blood pressure N who on 1-JUN-2007
6/1/2007 was 2/14/2009
vaccinated with a do
n has been received from a consumerY of 77 year old female with a history of high blood pressureN and drug2/20/2009
reaction2/21/2009
to niacin and stent put
n has been received from a physician concerning a 73 year old female who was vaccinated N with a dose 1/23/2009
of ZOSTAVAX (Oka/Merck) approx
n has been received from a pharmacist
Y concerning a patient who on 23-FEB-2009 was vaccinated N intradermally
2/23/2009 with
2/23/2009
a dose of ZOSTAVAX
n has been received from a physician
Y and a licensed practical nurse concerning an 86 year N old female patient ### with hypertension,
2/3/2009 coronary
n has been received from a physician
Y concerning himself, a 61 year old male patient with a history
N of pain
2/16/2009
and vaccine 2/18/2009
reaction and no kno
n has been received from a licensedY practical nurse concerning a 61 year old male patient who U on 5-FEB-2009 2/5/2009 at 13:25
2/5/2009
was vaccinated wi
n has been provided from a physician concerning a female patient who on 13-FEB-2009 was Y vaccinated2/13/2009
with a dose 2/23/2009
of ZOSTAVAX vaccin
n has been received from a physician
Y concerning an 83 year old female patient with osteoarthritis,
N elevated
4/22/2008
cholesterol,
2/14/2009
degenerative joint
n has been received from a nurse practitioner concerning a 72 year old female homemaker N with no history 2/1/2008
of HSV I or 2/1/2008
II and allergy to aspi
n has been received from a registered
Y nurse concerning an 79 year old male with type 2 diabetes N mellitus,
11/8/2007
coronary 2/5/2009
artery disease and pro
n has been received from a 71 year old female with allergic reaction to FLAGYL who on 20-FEB-2009
U was
2/20/2009
vaccinated 2/20/2009
with a dose of ZOST
n has been received from a physician
Y concerning a patient who was vaccinated with a singleYdose of ZOSTAVAX 2/1/2008 (Oka/Merck).
1/12/2009 It was repo
n has been received from a physician concerning a female in her 70s who "about a year ago" Y was vaccinated with ZOSTAVAX (Oka/Merck
n has been received from a pharmacist concerning a 65 year old female who on 29-JAN-2009 U was vaccinated
1/29/2009 with 1/29/2009
a dose of ZOSTAVAX (
n has been received from a nurse practitioner concerning a male patient who at the "beginning Y of December 12/1/2008
2008" 12/1/2008
was vaccinated with ZO
n has been received from a 72 yearYold female with diabetes, sulfonamide and a history of tetanus
N who about one and 2/8/2009
a half to two years a
n has been received from a 71 year old female patient with a history of shingles before receiving
N the vaccine
10/2/2008
and blisters
10/9/2008
around her lips si
n has been received from physician concerning a patient who was vaccinated with ZOSTAVAX U (Oka/Merck) on an unspecified date. Subse
n has been received from a physician concerning a 61 year old female with diabetes who in N February 2008, 2/1/2008
was vaccinated
5/1/2008with ZOSTAVA
n has been received from a pharmacist concerning a 65 year old female who on 21-FEB-2009 Y was vaccinated
2/21/2009 with 2/23/2009
one dose of ZOSTAVA
n has been received from a female consumer who was vaccinated with ZOSTAVAX (Oka/Merck). Y The consumer reported my physician did
n has been received from a medicalYassistant and a nurse practitioner (N.P.) concerning an N 81 year old female
2/9/2009patient
2/11/2009
with hyperlipidaemia
n has been received from a physician's assistant concerning a girl who on an unspecified date U was vaccinated
2/12/2009 with 2/12/2009
a first dose of VARIVAX
n has been received from a 65 year old female with blood pressure and thyroid problem whoYwas vaccinated with a12/1/2008 dose of ZOSTAVAX (O
n has been received from a 60 year old female with sulfonamide, morphine, DEMEROL andNCELEBREX 1/2/2009 allergy who1/3/2009
on 02-JAN-2009 was
n has been received from a pharmacist concerning a 65 year old male who on 05-Jan-2009 N was vaccinated 1/5/2009
with ZOSTAVAX,
1/10/2009 subcutaneou
n has been received from a 60 year old female receptionist who in December 2008, was vaccinated Y with12/1/2008
a dose of ZOSTAVAX
12/1/2008 (Oka/Merck
n has been received from a pharmacist
Y concerning a 66 year old female patient with no known N drug allergies,
1/12/2009who on1/14/2009
12-JAN-2009 was va
n has been received from a pharmacy tech concerning a female patient in her late 60's who U on approximately 1/1/2009
01-Jan-2009,
1/1/2009"approximately
n has been received from a nurse practitioner
Y concerning a 60 year old male patient with a history
N of Human 1/2/2009
immunodeficiency virus expos
n has been received from a physician concerning a male patient who on an unspecified dateYwas vaccinated 6/30/2008
with a dose of ###
ZOSTAVAX (O
n has been received from a registered
Y pharmacist concerning a 22 year old female employee Y who handles the intact1/1/2009ZOSTAVAX vaccine (
n has been received from a 65 yearYold female registered nurse, who is the consumer, with Y hypersensitivity and ###
allergic reaction
### to antibiot
n has been received from a registered pharmacist concerning an 80 year old female with arthritisY and sulfa 1/2/2009
allergy who1/2/2009
on 02-JAN-2009 wa
n has been received from a nurse concerning
Y a 76 or 77 year old female patient who in MaryY 2008, was vaccinated
3/1/2008 12/1/2008
with ZOSTAVAX (Oka/
n has been received from a pharmacy student concerning a patient who about 1 month ago,Nwas vaccinated 12/1/2008
with a 12/1/2008
dose of ZOSTAVAX (O
n has been received from an office Y
manager concerning a 72 year old male who on 06-JAN-2009 Y was vaccinated
1/6/2009 with 1/6/2009
a dose of ZOSTAVA
n has been received from a registered pharmacist concerning a 72 year old female patient who Y on an unspecified date was vaccinated with
n has been received from a nurse practitioner
Y concerning a male patient who in December 2008, N was vaccinated
12/1/2008with 1/5/2009
a dose of ZOSTAVA
rmation has been received from a pharmacist concerning a 77 year old male who on 30-DEC-2008 N was vaccinated ### with
1/9/2009
ZOSTAVAX (Oka/M
n has been received from a 68 yearYold female patient with sulfonamide allergy and a historyNof blood pressure high who in ###
approximately 2
n has been received from an office Y
manager concerning a 62 year old female who on 08-JAN-2009 Y was vaccinated
1/8/2009 with 1/8/2009
a dose of ZOSTAV
n has been received from an office Y
manager concerning a 66 year old female who on 08-Jan-2009 Y was vaccinated
1/8/2009 with 1/8/2009
a dose of ZOSTAV
n has been received from a 68 yearYold female patient with breast cancer, atrial fibrillation, cardiac
N valve11/1/2007
leak, neuropathy
11/1/2007peripheral, sulfon
n has been received from a medical assistant concerning a 69 year old female who was vaccinated U with a dose of ZOSTAVAX (Oka/Merck
n has been received from a pharmacist
Y concerning a 91 year old female who on 12-DEC-2008 U was vaccinated### with a dose ###
of ZOSTAVAX
n has been received from a 74 year old female with Crohn's disease, penicillin and Keflex allergy
N who on 1/8/2009
08-Jan-2009 1/8/2009
was vaccinated with
n has been received from a 62 yearYold female nurse with penicillin and PREDNISONE allergy, N hypercholesterolaemia
1/7/2009 1/8/2009 and osteopenia and
n has been received from a pharmacist
Y concerning a patient who on approximately 1-JAN-2009 U "last week" 1/1/2009
was vaccinated
1/1/2009with ZOSTAVA
n has been received from a healthcare student concerning a male patient who on 07-JAN-2009 U was vaccinated1/7/2009 with 1/7/2009
ZOSTAVAX (Oka/Mer
n has been received from a pharmacist concerning a 62 year old female with PENICILLIN allergy N who on 1/5/2009
05-JAN-2009 1/5/2009
was vaccinated with
n has been received from a pharmacist
Y concerning a 65 year old female who on 06-JAN-2009 U was vaccinated1/6/2009
with ZOSTAVAX
1/6/2009 (Oka/Merc
n has been received from a nurse concerning a male who on an unknown date, was vaccinated N with ZOSTAVAX (Oka/Merck) (lot# not pro
n has been received from an 82 yearY old female patient with no known drug reactions-allergiesN and medical history,### who on ###16-DEC-2008
n has been received from a 75 year old female with allergic to sulfa who was vaccinated withNa 0.65 ml dose of### ZOSTAVAX
1/2/2009(Oka/Merck) (lo
n has been received from an office manager concerning a female nurse with a history of shingles
U who on 31-DEC-2008
### was
###reconstituting
n has been received from a physician concerning a patient who on approximately 24-DEC-2008 U was vaccinated ###with ZOSTAVAX (Oka/Me
n has been received from a 60 year old nurse practitioner with no pertinent medical history reported
Y and12/3/2008
no drug reaction/allergies,
### reportin
n has been received from a registered nurse concerning a patient who was vaccinated with Y a dose of ZOSTAVAX ### (lot # not ###reported) by th
n has been received from a 63 yearYold female consumer with penicillin allergy who reportedNthat she received 4/1/2008
a single
11/1/2008
dose of ZOSTAVAX
n has been received from a nurse practitioner concerning a 66 year old female patient with no N known drug reactions/allergies
### ### and asthma w
n has been received from a registered
Y nurse concerning a female who on 19-DEC-2009 wasUvaccinated with "one ### dose" of ###
ZOSTAVAX (O
n has been received from a nurse concerning
Y a 68 year old female patient with hypertensionYwho on 08-FEB-2008
2/8/2008 12/9/2008
was vaccinated in her le
n has been received from a 61 year old female with an allergy to penicillin and no pertinent medical
N history who ###on 19-DEC-2008
### was vacc
n has been received from a pharmacist
Y concerning a 63 year old female patient, with no pertinent
N medical history###and no known### drug react
n has been received from a registered pharmacist concerning a patient who was vaccinatedUwith ZOSTAVAX 12/1/2008
(Oka/Merck)
12/1/2008 about two week
n has been received from an 81 year old female who in October 2008 was vaccinated with ZOSTAVAX
U (Oka/Merck),
10/1/2008 10/1/2008
0.65ml/once, SC Sub
n has been received from a pharmacist concerning a 74 year old male with a history of cold U sores, who one year ###ago was### diagnosed with N
n has been received from a 62 year old male who "about 8 weeks ago" was vaccinated withUsingle dose of series ###of ZOSTAVAX ### (Oka/Merc
n has been received from a male with a history of herpes simplex who was vaccinated with aNsingle dose of ZOSTAVAX ### (Oka/Merck)
### (lot #
n has been received from a physician concerning a 15 year old female patient, who on an unspecified
U date, was### vaccinated ###with ZOSTAVA
n has been received from a registered pharmacist concerning a patient who was vaccinatedUwith single dose 6/1/2008
of ZOSTAVAX
6/1/2008about 6 month
n has been received from a 62 year old female with "numerous reactions to other unspecified U medication" who### on 17-DEC-2008### was vacci
n has been received from a 85 year old female patient, with codeine and sulfonamide allergy, N who on 15-DEC-2008 ### was vaccinated
### with a
n has been received from a 61 yearYold female patient with allergic reactions to antibiotics (had
N a reaction once to ERYTHROMYCIN), who
n has been received from an 86 yearY old female with blood pressure and a history of shingles N in April 2006,
12/7/2007
who on 07-DEC-2007### was vac
n has been received from a 71 yearYold female patient with hypertension and no known drugNreaction or allergies, ### who on### 20-NOV-2008, w
n has been received from a doctor of pharmacy concerning a patient who on an unspecifiedUdate was vaccinated with a dose of ZOSTAVA
n has been received from a doctor of pharmacy concerning a patient on an unspecified dateUwas vaccinated with a dose of ZOSTAVAX (O
n has been received from a doctor of pharmacy concerning a patient who on an unspecifiedUdate was vaccinated with a dose of ZOSTAVA
n has been received from a registered pharmacist concerning a 77 year old female patient who Y on 12-DEC-2008 ###was vaccinated
### subcutan
n has been received from a registered pharmacist concerning an unknown number of patients U who were12/1/2008
vaccinated12/2/2008
with a dose of ZOSTA
rmation has been received from an office
Y coordinator and follow up information has been received
N from a10/9/2007
physician 10/9/2007
concerning a 59 year ol
n has been received from a registered nurse who on unspecified date developed shingles like U blisters from giving ZOSTAVAX to patients. S
n has been received from a registered
Y pharmacist concerning a 75 year old female patient who N on 23-JAN-2008
1/23/2008was 12/9/2008
vaccinated with a dos
n has been received from a physician concerning a 71 year old male who on 09-DEC-2008 was U vaccinated 12/9/2008
with a 0.65 mL### dose of ZOSTA
n has been received from a 56 year old male patient with dialysis and allergy to tetracycline Nwho on 11-DEC-2008 ### was vaccinated
### in the ar
n has been received from a nurse practitioner concerning a 65 year old female patient with hypertension
N and osteoporosis,
### ###
who on 15-DEC
n has been received from a medicalYassistant concerning a 60 year old female patient with drugN hypersensitivity
12/9/2008 to DEMEROL
12/9/2008 and no perti
n has been received from a doctor of pharmacy concerning a 66 year old patient who on 16-Dec-2008
N was vaccinated
### with
###
a dose of ZOST
n has been received from a female who on an unknown date, was vaccinated with ZOSTAVAX U (Oka/Merck) (lot# not reported). Subsequen
n has been received from a consumerY concerning her 73 year old male husband with a pacemaker U and a1/2/2008
defibrillator,
11/1/2008
and a history of both
n has been received from a female patient who on 26-Nov-2008 was vaccinated subcutaneously N with a dose of### ZOSTAVAX ###(Oka/Merck). O
n has been received from a pharmacist concerning a 62 year old female patient with no drugNreactions/allergies, ### who on 12-DEC-2008
### was
n has been received from a nurse concerning a 75 year old male patient with a history of largeY cell lymphoma
11/2/2007
who on12/5/2008
21-NOV-2007 was va
follow-up information has been received
Y from 62 year old female pharmacist prone to fever Y blister who on12/5/2008
05-DEC-200812/5/2008
at 10:00 was vacc
n has been received from a female physician who on 10-DEC-2008 was vaccinated with a dose N of ZOSTAVAX### (Oka/Merck). ###The physician
n has been received from a 65 yearYold female with diabetes who in July or August 2008, was N vaccinated7/1/2008
with a dose12/1/2008
of ZOSTAVAX (Oka/
n has been received from a physician Y concerning a 78 year old male patient with hypertension,N artery coronary
1/5/2007 disease
10/2/2008
and diabetes and a
n has been received from a pharmacist concerning a patient who two to three days ago wasNvaccinated 12/8/2008 with a dose of ZOSTAVAX vaccine
n has been received from a health professional concerning a 67 year old female with an allergy N to latex, who on ###10-DEC-2008 was vaccina
n has been received from a registered Y nurse concerning a 61 year old male with hypercholesterolemia
Y who on### 10-DEC-2008 ### was subcutan
n has been received from a nurse practitioner
Y concerning a 13 month old female who inadvertently
U on 09-DEC-2008
12/9/2008 12/9/2008
was vaccinated SQ w
n has been received from a medicalYassistant concerning a 74 year old female patient who had U an episode 5/1/2008
of shingles prior to receiving ZO
n has been received from a nurse practitioner
Y concerning an 87 year old female patient withNhypertension, 12/1/2007
hyperlipidaemia
12/7/2008 and hypothyroid
n has been received from a store manager concerning a female patient who on 12-NOV-2008 U was vaccinated ### with a dose of ZOSTAVAX (
n has been received from a physician Y concerning a 66 year old female patient with codeine N allergy, hypertension
10/1/2008and 10/1/2008
hypothyroidism who 2
n has been received from a female patient who on an unspecified date was vaccinated with U a dose of ZOSTAVAX (Oka/Merck). Subseque
n has been received from a female consumer who on 25-NOV-2008 was vaccinated with a dose U of ZOSTAVAX ###(Oka/Merck).
### On 28-NOV-2
n has been received from a 46 year old male patient with history of drug hypersensitivity to penicillin
N and12/3/2008
shellfish based
12/3/2008
medications such
n has been received from a consumer concerning her sister, a female patient who accordingUto the consumer she had already had a very b
n has been received from a physician concerning a 1 year old patient who on 24-NOV-2008Uwas vaccinated with ###a dose of### ZOSTAVAX (Ok
n has been received from a nurse practitioner
Y concerning a 67 year old male patient with sleep
N apnoea and 9/12/2008
a history
9/12/2008
of head injury recover
n has been received from a 64 year old male with high blood pressure and shingles with post U herpetic neuralgia
10/1/2007 (PHN) and ###
a history of sten
n has been received from a physician concerning a 60 year old female who, "in last week", on U approximately 24-Nov-2008
### was vaccinated
n has been received from a female patient, who in February 2008, was vaccinated with a dose Y of ZOSTAVAX 1/1/2008
vaccine
12/1/2008
(Oka/Merck) (Lot. #
n has been received from a 73 yearYold male patient with history of prostatic disorder and noNknown drug11/1/2008reactions/allergies,
11/3/2008who on appro
n has been received from a physician Y concerning a 77 year old female patient who in February N 2007, was2/1/2007
vaccinated with### a dose of ZOST
n has been received from a pharmacist concerning a patient who about a year ago was vaccinated N with a dose of ZOSTAVAX (Oka/Merck
n has been received from an 88 year Y old female consumer with a blood pressure condition and N no pertinent medical ### history, ###who on 18-No
n has been received from a registered Y nurse (R.N.) concerning her father, an 83 year old male N with a history2/1/2008
of macular
11/1/2008
degeneration and "
n has been received from a physician concerning a 74 year old male with hypertension, dyslipidaemia
Y and penicillin
### allergy ###
and a history of
n has been received from a consumer Y concerning her 75 year old mother with leukemia, memory N loss and a history
### of two strokes, and "all
n has been received from a registered pharmacists concerning a patient who was vaccinated U with a dose of ZOSTAVAX (Oka/Merck) (Lot
n has been received from a registered pharmacists concerning a patient who was vaccinated U with a dose of ZOSTAVAX (Merck) (Lot not re
n has been received from a 54 yearYold female with a history of shingles in right eye in Feb 1998
N and no drug allergies
### who###
was vaccinated
n has been received from an 88 year old male with no pertinent medical history who on 15-DEC-2008
N was vaccinated
### 1/6/2009
subcutaneously with
n has been received from a 61 yearYold female with sulfonamide allergy and no pertinent medical U history who
1/5/2009
on 05-Jan-2009
1/5/2009 was vaccina
n has been received from a 74 year old female with sulfa allergy and allergic to an antibioticsU(unspecified) 1/6/2009
who on 6-JAN-2009
1/8/2009 was vaccin
n has been received from a registered pharmacist concerning a patient who was vaccinatedYwith a dose of ZOSTAVAX (Merck) (Lot not re
n has been received from a 66 year old male patient with high cholesterol and a history of quadruple
N vessel
1/5/2009
bypass graft
1/6/2009
in 1990, shingles
n has been received from pharmacist concerning a 73 year old female who on 03-JAN-2009Nwas vaccinated 1/3/2009
with a dose
1/3/2009
of ZOSTAVAX va
follow-up information has been received from a registered pharmacist concerning a 75 year N old male patient1/4/2009
with no 1/4/2009
known drug reaction/a
n has been received from a physician Y concerning a female patient who on 05-DEC-2008 was U vaccinated12/5/2008
with a 0.65ml dose ###of ZOSTAVAX
n has been received from a female Y Registered Nurse, who "5-6 weeks ago", was vaccinatedNwith ZOSTAVAX ### vaccine
12/8/2008
(Oka/Merck) subcuta
n has been received from a 70 year old male with sulfonamide allergy who on 24-DEC-2008Ywas vaccinated with ###a 0.65 ml ###
dose of ZOSTA
n has been received from a pharmacist Y concerning a 67 year old female patient with hypothyroidism,
N arthritis, diverticulitis
### ###
and interstitial cy
N
n has been received from Y a physician
Y concerning
Y an approximately 030 months old female who Y received 3 doses of PEDVAXHIB
5/1/2008 (lot# not re
n has been received from a Doctor Y of pharmacyY concerning a 79 year
0 Yold male inpatient for N
decompensate 4/2/2009
diabetes 4/2/2009
with hypertension, dia
n has been received from a registered nurse, for VARIVAX vaccine (MERCK), a Pregnancy U Registry product3/4/2009
concerning
3/4/2009
a 17 year old preg
n has been received from a registered pharmacist concerning a now 66 year old female whoYin approximately 2003 "about 4 to 6 years ago
rib cracked went to doctor.
Y She prescribed pain pills, week later it went popped again. YearsNwent by without 10/1/2003
problems, breast cancer show
a 16-year-old female who presents today with mother.
Y The patient states
1 she was with her momY earlier getting
3/12/2009her prom
3/13/2009
dress fitted when s
vaccines on 3-16-09. The evening of vaccine she got a fever + slept poorly. In the morningYafter the vaccine 3/16/2009
was disoriented
3/16/2009 + needed he
h swollen, red with blisters. Looks like
Y a 2nd degree burn. Almost entire thigh swollen. Very tender
U to touch.
4/1/2009
Swollen area
4/1/2009
very hard. Receiv
dizziness, vomiting low grade fever resolved spontaneously. U 4/1/2009 4/1/2009
d bilateral pulmonary embolisms
Y and Y moderateYto severe right ventrical
4 heart dysfunction. Misdiagnosed
Y originally
### as "walking
### pneumonia",
pain and swelling in arm. HeadacheYand temperature 100.2 degrees 24 hours after vaccine.Y5 cm swelling 3/27/2009
and erythema.
3/28/2009
e course on the vaccines, patient has Y developed debilitating abdominal pain. 4/15/09 MR receivedU 5/5/08
6/13/2008
to 4/13/09.8/1/2008
15 yr WCC 6/13/08 w
at 10:45 am 3/26/09, shaking. PoorYsleep night of 3/25/09. Y 3/25/2009 3/26/2009
PE complete immunization given (DTAP Y IPV MMR Varicella) 415P child started cough. 4:20pm Y wheeze A-P 4/6/2009
lungs. Benadryl
4/6/2009 12.5mg / 5ml S
ction lasting 4 days. Y Y 3/30/2009 3/30/2009
d PREVNAR vaccine @ thigh on 4/12/09 at 1021 AM. Awoke from nap approx 3PM & criedYas if in pain. 4/2/2009 Mom noticed 4/2/2009
R leg (thigh->toes)
edness and swelling of left upper thigh, plus erythema approximately 12cm. U 4/1/2009 4/1/2009
ceived the Zoster vaccine at the clinic 2/5/09. At his f/u visit 3/3/09 he reported he'd developed a shingles 2/5/2009
rash approx 2/15/2009
10 days after the vac
njection of ZOSTAVAX on 03/25/2009 about six days later developed red spots on my right leg U on the inside
3/25/2009
between 3/30/2009
ankle and knee. The
ped rash after vaccines were given. I'm sure of due to Varivax n MMR. 3/24/2009
me to pick up a sticker and she looked pale, lips were white. She said she was tired and laidYdown on the4/8/2009 floor. I picked
4/8/2009
up patient and carr
eral scattered vesicles. Some already crusting over. Y 3/10/2009 4/4/2009
roke out on left thigh as soon as theY MMR was pushed. Patient was given BENADRYL 12/5mg Y and thigh 4/9/2009
was observed 4/9/2009
for 15 minutes. Th
of redness to the right deltoid, muscle
Y aches in right arm patient unable to lift arm above hisNright shoulder.4/4/2009
Patient states
4/6/2009
" I just do not fee
lled 4/9/09 AM to notify us approximately two hrs after vacc. She felt "weak and with headache"; U this morning
4/8/2009
after 154/8/2009
min run she c/o swea
LA vaccine (along with TDAP & HEP A, and MENATRA) given 3/31/09 (1388 IM VERIVAX lot) onset (acute) 3/31/2009
Bell Palsy4/4/2009
VII on 4/4/09.
U 4/6/2009
iatric/adolescent dose of Hepatitis A instead of adult dose. Dr notified at 16:04, 3/31/09. Y 3/31/2009
as inadvertently given DTap instead of Tdap. Patient contacted today and has had no adverse Y events. 4/3/2009
elling - Pt reported fever to 101 x 2 days after 2 days on 4/3/09 redness- swelling inner L armY5"X3" - No fever 3/3/2009
- Tx BENADRYL
3/3/2009 and KEFLE
Y
3/31/2009 3/31/2009
old female presents with fever startingY 4 days after
Y vaccination. Patient 2 continued to fever for
Y 6 days with3/9/2009
102-104.7t 3/12/2009
with no other sympto
he dept and left message. Pt was contacted at 2:15pm of 04/07/2009, stated"03/26/2009 gotYinjection in3/26/2009clinic, started3/27/2009
to act out on Friday
munized with Varivax vaccine on 3/4/09. Over the next 48 hours, she developed redness and Y warmth at 3/3/2009
injection site, 3/3/2009
and surrounding are
1/30/2009 N 4/17/2008 1/30/2009
ar sized redness and warm to touch at administration site. Y 4/8/2009 4/9/2009
elt "woozy,dizzy" when got home. approx Y 1 1/2 hr later had some difficulty breathing along withY burning sensation
3/18/2009of3/18/2009
face and eyes. did not
2/18/1998 Y Y Y 1 N 1/9/1998 1/19/1998
ent at 10:15am, pt. called 9:15pm complaining of right arm pain, not red, no fever, vomiting and Y stomach3/26/2009
ache; ate out. 3/26/2009
d Herpes Zoster (C5 distribution) 03/21/2009 Y 9/2/2008 3/21/2009
s a softball sized area at the site of administration. Area is painful, red, swollen, and warm toUtouch. Patient
4/8/2009
does not4/9/2009
have a fever or other
ver 6 hours after injection. Tylenol given.Fussy. Appetite down and remains down. Awoke whimpering Y with
4/7/2009
high fever 4/7/2009
(10 pm) Temp Recta
ceived #2 VZV, #1 HPV, and #1 Tdap (had 5 previous DTP vaccines) 4-1-09 at the HC. At the Y OV on 4-1-09
4/1/2009
patient also
4/4/2009
had a viral gastroe
4/9/2009 N 4/8/2009 4/9/2009
week field exercise, patient was administered anthrax and smallpox vaccine, 05MAR09. Patient Y did follow-up
3/5/2009
note on 3/23/2009
12MAR09 with no pro
eved shots at health department-
Y behind
Y schedule.Received 6 vaccines. Around 8 hours later, Y dad found3/16/2009
child having 3/16/2009
seizure, limp, blue, dr
came cranky cried her developed rash on her lower extrimities.Rash lasted for 1 hour patientY consolable 1 n 20 minutes after the administr
hours after TD was given pt started Yto run a low grade temp and had swelling of the injection site along with 4/6/2009
a hive. Mom4/7/2009
was told to use co
ceived Kinrix (DTaP,IPV, MMR & Varicella 04/07/09. He was seen in the office this date dueYto pain, itching 4/7/2009
and swelling4/8/2009
in left arm for 2 da
o 102.5, rhinorrhea, and erythematous rash that began on cheeks and spread to neck, trunkNthen extremities. 3/26/2009 Further
3/28/2009
details can be obtain
3/12/2009 N 3/11/2009 3/11/2009
was reported by a physician (also the father of the subject) and described the occurrence ofUvaccine underdose 3/5/2009 in a 3/5/2009
31-year-old pregnant f
ped acute abdominal pain - 2 hrs after injectionYof (1) GARDASIL; (2) 1 MENACTRA, (3) TDAP. Y Pt was evaluated
3/25/2009 in ER
3/25/2009
- diagnosis acute UT
remic swelling on Rt upper arm at injection site 1"/1'/2" Y 3/19/2009 3/19/2009
9 at 1030 the pt received the TDAP and IPV in her right arm. The pt woke at about 2230 with the sensation 3/25/2009
that her3/25/2009
throat was swelling. T
and rash reaction with angioedema. 4/1/2009 4/4/2009
ew minutes client turned pale, stiffened body, arched back, arms curled to chest, eyes rolled Yback, head jerked 4/8/2009 back and
4/8/2009
forth. Lowered clie
weakness BP prior to event 114/62, S/P 96/58 pulse 60 normal breath sounds. Blood sugarY = 82. 4/2/2009 4/2/2009
s after receiving vaccine started to "hum"
Y fell over backwards hit head on floor, unconsciousUapprox 10 seconds
4/8/2009 -> head
4/8/2009
twitching
as in office to have meningococcal but was given a HIB injection instead. 3/30/2009
vaccination on 3/31/09: TDAP and TYPHOID right arm, FLUMIST and AVA #4 left arm. On 1 April 09 pt3/31/2009 noted a 3" 4/1/2009
circle of redness and s
ates she started having cold symptoms and a sore throat starting the day after the immunization. Y 2/21/2009 2/22/2009
ately 2 weeks after immunization, he states his muscles felt tight, and he states he felt more Y fatigued than 2/27/2009
normal. This 3/13/2009
lasted about 5 days
mplaining of intermittent sharp mid to low back pain since last night. Pain occurs when getting up from laying down position and forceful ex
er vaccine administered had swelling, redness, tender. To RTR- 2" by 2" - raised red & swelling Y to L deltoid-4/7/2009
15mm by 4/9/2009
15mm diffuse red.
me to our clinic on 4/9/09 at 10:05 accompanied by mother. Patient complains of body aces,Unausea no vomiting, 4/7/2009soreness4/8/2009 in bilat. arms an
rmation was received on 21 November 2008 from a health care professional. A cluster of approximately
Y 20 cases of slight bleeding at the s
ort was received on 08 December 2008 Y from a consumer (patient's mother). A 4-month-old male U with a history
10/7/2008of being
10/7/2008
33 weeks premature
n has been received from a health professional
Y for GARDASIL, a Pregnancy Registry product, Y concerning 3/20/2008
a female3/20/2008
who became pregnant
n has been received from a registered Y nurse for Y the pregnancy registry
0 for GARDASIL concerningY a 17 years
6/1/2008
old female
6/16/2008
patient with no pe
n has been received from a consumer Y concerning Y his 18 year old daughter
10 with no pertinentNmedical history
8/28/2008
or no known9/8/2008
drug allergies, wh
n has been received from a licensed practical nurse (L.P.N.) who was told by a patient's mother U that she heard from a school staff member
n has been received from a consumer concerning her now 11 year old nephew who on an unspecified U date was vaccinated with a dose of
n has been received from a consumer concerning her now 12 year old nephew who on an unspecified U date was vaccinated with a dose of
n has been received from a physician concerning Y a male who on 04-APR-2008
0Y was vaccinated
N with a dose 4/4/2008
of ZOSTAVAX3/1/2009 (Oka/Merck). In
ort was received from another manufacturer
Y (document number 45216582), who received theYreport from a health care professional, who is
n has been received from an 82 year old female patient with no drug reaction/allergies, who Non 23-JAN-2009 1/23/2009
at about
1/24/2009
12:00, was vaccinate
reporting disturbed sleep at night secondary to pain at injection site. She is reporting that she
U experiences 4/3/2009
some numbness
4/4/2009from shoulder
about 4-6 cm left deltoid. warm to touch. Y 4/1/2009 4/2/2009
d rash. She went to the doctor andYit was diagnosed as shingles. She had a fever and flu like U symptoms 3/20/2009
preceding the rash. The rash wa
on all my neck for two days, I had fever yesterday, it last only one day and I still have the swelling
N of glands
3/30/2009
starting 4/7/2009
yesterday. I haven't vi
after receiving the shingles vaccine on April 3, 2009 I had flu like smyptoms. Headache, sleepless
Y nights,
4/3/2009
chills, achy4/6/2009
all over,very weak, f
Dtap given, 04/01/09 Pt. had axillary temp of 103, 04/02/09 Pt. had 2-3cm redness at injection U site 3/31/2009 4/1/2009
ction to Dtap (given on 03/30/09), right
Y arm swollen and red (4cm). Pt. came back to office onU04/01/09. 3/30/2009 3/31/2009
mins of injections, pain, stiffness, extreme
Y fatigue, lethargic . Then experienced cont.
Y pain and N soreness,3/23/2009
stiffness on3/23/2009
and off for next week
X2 4/29/09 Received Hospital medical Y records Y for 2/8-2/9/2009 & 4/5-4/7/2009.
5 FINAL DX: newY onset seizures
2/4/2009 Records2/8/2009
reveal patient expe
d area, size of half-dollar, left arm.Swelling
Y arm/neck/shoulder. MD diagnosed cellulitis. U 8/18/2008 8/20/2008
ainful red swollen 4 X 3 1/2" area on left arm after vaccination Y 4/25/2008 4/26/2008
mm red raised area at site of injection generic benadryl given Y 4/8/2009 4/9/2009
te, fever, seizure Y N ### ###
abdomen/chest/lumbar Y Y ### ###
nt shooting pains in right arm, soreness at injection site, no redness or swelling at site U 11/5/2007 11/6/2007
red Tdap and Gardisil, pt.'s head dropped, was unresponsive, arms and legs drew up in seizure-likeY activity,
8/17/2007
pt. was8/17/2007
incontinent of urine, pt
redness, warm to touch, itches Y U 8/3/2007 8/4/2007
and high pitched screaming two hours after vaccines given, lasted for 2 hours Y 5/16/2007 5/16/2007
inistration of all 4 vaccines, upon departure and standing, client reported feeling dizzy. Assisted
Y client back 4/9/2009
to chair. 4/9/2009
Client fainted. Incohe
er MMR vaccination our daughter developed
Y a 101 degree fever. The the 6th day our daughterU had a febrile
3/30/2009
seizure due4/3/2009
to a 104 fever. Sh
d vomiting, dehydration and abdominal Y pains. 4/14/09
Y Received hospital
4 medical records of U4/9-4/12/2009.3/30/2009
FINAL DX: 4/2/2009
cyclic vomiting; abdo
n 02-25-09. States she had pain, swelling and itching lasted 2 weeks after injection (given 11/3/08).
Y She11/3/2008
didn't do anything then and about
ped a rash on right arm shortly after vaccine administration N 3/9/2009 3/14/2009
redness, very hot, doubled in size on Y the evening of 04/06/09. Mother gave Benadryl and theYnext morning 4/6/2009
pt. woke up 4/6/2009
screaming of pain. M
rea of induration over R deltoid with 13x10 cm of erythema, non-tender, no expressible d/c. Received
U DAPTACEL
4/9/20094/9/094/10/2009
R deltoid
20, 2009 - developed severe headache.
Y Seen by PMD on March 23, who diagnosed shingles. Y 3 lesions4/10/2008
on scalp - 3/20/2009
(L) side of head - culture
h large erythematous edematous puritic
Y patch around site of DTaP & varicella injections -> 5" wide x 4" long;
4/8/2009
To ER 4/8/2009
+ office.
hing, blinking, facial grimace beginning on day of administration of vaccine and has been ongoing. U Frequency
4/6/2009
about 4x/10
4/6/2009
minutes.
itis day 13 after MMR. Y 3/26/2009 4/6/2009
tous discoloration with slight induration approximately 9-10 cm, no c/o pain. Y 4/7/2009 4/9/2009
rythema 15x16cm left thigh, not tender, + warmth and itch. Continue TYLENOL and IBUPROFEN; U BENADRYL4/8/2009 for itching.
4/9/2009
after the shots, became pale around 5 sec no treatment needed. Y 4/7/2009 4/7/2009
e and pain in all of them, incontinence urinary, memory loss. N 2/10/2003
s and dizziness especially upon standing. Hot feeling in face and head - sweating on face and U head. Fasting
4/10/2009
blood 4/11/2009
sugar 131 (diabetic). Oc
ven vaccine IV push instead of subcutaneously pt HR 130's but anxious and getting respiratory Y treatment. 4/11/2009
HR in 70's in 15 min.
as extremely exciteable when his cousin that he hadn't seen in over a year came to visit us, his U grandparents.
3/30/2009
The boys
4/9/2009
love each other, bu
is red, no swelling noted, arm is warm, but so is other, painful to touch. Patient was advisedUto put ice on 1/14/2009
arm and alternate
1/16/2009with warm com
left upper arm Y U ### 1/26/2009
augh,weak, breathing problems Y Y ### 11/6/2008
us case was received on 01 April 2009 from a health care professional. An approximately 3 week Y old patient (gender
### 6/7/2008
not specified) receive
ort received 01 April 2009 from a health Y care professional, who is also the patient. AccordingUto the reporter, they developed the "flu" an uns
us case was received on 01 April 2009 from a healthY care professional.
0 A 5 month old male U patient received
4/1/2009
PENTACEL4/1/2009
(lot number C318
n has been received from a physician Y concerning a 24 year old female with allergies to tomatoes
N and pollen, migraine,
### rhinitis
### seasonal, de
n has been received from a nurse practitioner
Y concerning a 24 year old female who Y on 18-FEB-2009
N was2/18/2009
vaccinated2/18/2009
with her second dose
n has been received from a physician Y concerning a patient who was vaccinated with ROTATEQ Y (lot number not reported) oral. Subsequen
n has been received from a physician Y concerning
Y a 2-3 year old patient Y who was vaccinatedUwith ROTATEQ (lot number not reported) oral
Full clonic/tonic 1 hr 45 minutes after receiving Y routine immunizations 2 - Family describes today's
Y episode the 4/3/2009
same as4/3/2009
in the past (same sei
ays after vaccine. Hospitalized 1 week Y after with
Y erythema multiforme. 3 2 weeks after in ER with
N transient3/17/2009
synovitis and fever. Hospital recor
multiforme major possible KAWASAKI's Disease. Y 4/27/09 MR received 5 for DOS 3/24-28/2009
Y with D/C 3/16/2009
DX: Erythema3/18/2009
multiforme major s/
pasms started on the 3rd day after vaccinations
Y Yand progressed. Diagnosed
3 in January 2009,
U being treated
10/1/2008
with medications
10/4/2008(TOPAMAX, B
welling, induration + erythema at injection site - induration 4X5cm; erythema 12 X 8 1/2 cm with N some bruising
4/3/2009
onset at
4/4/2009
approximately 3hrs a
swelling, redness and pain at site 9 hrs after shot. Also vomiting. Patient called MD on 3/25/09Y regarding 3/20/2009
above instructed
3/20/2009 to take Ibuprofe
rs of vaccination, Pt developed "big knot" at the injection site, and the site turned blue. Heart Y rate became2/2/2009
elevated. 2/2/2009
She had bad headach
27-09 with c/o dizziness, pain, racing heartbeat & fever. (did not know how high). Too dizzy Yto stand up.3/26/2009
Person suggested
3/27/2009they go to urge
nto clinic after shots for immigration.Y She was given a Tdap and an MMR in left arm. Six days Y later she 3/20/2009
came back 3/26/2009
to clinic with a bruised a
a swelling and rash at site of VARIVAX. Y Y 4/7/2009 4/7/2009
eceived PC from Pt states LA started Y itching and swelling this weekend. Tdap was given on Y 1-28-09 states
1/28/2009
applied 3/14/2009
soaks to LA area. On 3/
w/ redness & warmth x 40 hours: then pain in arm radiating to shoulder/neck & elbow -> referred Y to physical
2/6/2009
therapy2/8/2009
on 4-3-09.
after receiving vaccine felt itchy, dry mouth, felt generally "bad" - low grade temp 99.1 - Following
Y day temp
2/10/2009
is PM 102
2/10/2009
degrees - TYLENOL
ed child had a tem up to 102 degrees within 24 hrs (off and on). Soreness, redness, and slight Y swelling to3/31/2009
area where4/1/2009
shot was given (L) Va
runcal pruritis (primarily B/L breasts). Sx occurred 24-48 hours s/p vaccine (GARDASIL) # TYand lasted9/23/2008
approx. 4 wks.
9/24/2008
Denies rash/ fever
ite - swollen, red, soreness, fever (at the injection site) left leg where DTAP + Polio were given.
U 3/16/2009 3/17/2009
ceived ANTRAX and Typhoid on 12 Mar 09. Smallpox on 19 Mar 2009. Patient found out thisY month that3/12/2009 she was pregnant when she recei
d with shingles along L4 - L5 distribution today. U 9/10/2008 3/31/2009
eddened, "hst to touch", swollen - takenY to Urgent care by Mom - 4-1-09 - Placed on KEFLEX Y po tid - arm
3/30/2009
resolved 4-30-09
4/1/2009
swelling to the site. Mother states approx. 5X5". Red, hot to the touch. C/o itchy. Painful. Y 4/9/2009 4/10/2009
d 3 seizures following 6 mos vaccines lasting 1 Y 1/2-2 min. 1st was tonic
2 clonic. 2nd was clonic Y with staring.4/15/2009
3rd was 4/16/2009
a staring spell witnesse
er vaccination, patient had about 10 spots of urticaria (red, raised) scattered on wrists, arms Ytrunk & behind 4/15/2009
ear. Relieved
4/18/2009 after bath in the
, rhinorrhea started the following day after vaccination, today 4/20/09 saw MD for treatment.Y 4/15/2009 4/16/2009
9 started with cold & cough, gave TYLENOL
Y for fever. On 3/26/09 Baby was very irritable RYside of body- 3/18/2009
hand & leg3/21/2009
would jerk simultaneo
and ulcers over scrotum, trunk and scalp,
Y >100 lesions. U 4/9/2009 4/16/2009
ollen feet + hands Y N 4/6/2009 4/17/2009
hours, he had an 11 cm sized area of redness at the injection site that was firm & warm & his U thigh was swollen.
4/7/2009The4/8/2009
area was non tender
R) upper arm. Started on KEFLEX - 25x 10 1/2 cm Follow-up in 2 days 4/16/2009 4/17/2009
ox. Patient had vaccine on 11/14/00 N ### 4/15/2009
ction 4x5cm, induration and erythema within 24hrs at MMR site. Advised to apply warm or cold Y compresses, 4/13/2009
TYLENOL 4/14/2009
po, or BENADRY an
perienced a seizure approximately minutes
Y after vaccine administration. Was taken to emergency
U room.4/20/2009 4/20/2009
tient on off dizziness since receiving vaccine on 4/17/09. But complaining on weekend fever U negative, vomiting
4/17/2009negative
4/17/2009
shingle negative fo
post GARDASIL and MENACTRA administration.
Y Patient fractured nose during syncope eventY (hit office 4/17/2009
counter during
4/17/2009
fall).
d fever approximately 8 hours after vaccine. (105 degrees F). Next AM, joint and muscle tenderness;
Y "whole
4/16/2009
body"4/16/2009
5x responded to Ibupr
ad fever 100.1 and chills. Student took Advil and an hour later felt fine. T.100.1 BP 130/80 P100Y 0296904/16/2009
CNRA 4/16/2009
e, nausea after 1st shot, recovered in Y 2 days. Developed rash in a week after 2nd shot. Saw Y dr, dermatologist and allergist finally diagnosed
ven VARICELLA & MENACTRA vaccinations and after he walked into lobby he passed out. YPatient set in 4/13/2009
wheelchair 4/13/2009
& assisted by Dr. . B
congestion, swallowing freq. weak Y nausea - approx. a minute and half - called mom (parents) Y this AM - 4/17/2009
but was unable
4/17/2009
to get update.
9 Mother called and spoke to call center who then called our office. Child received MMR andYVARIVAX today, 4/16/2009
rash 4/16/2009
developed on face, and
d SPV left arm on 4/4/09. On 4/9/09 the pt experienced about 60 min of central chest pressure (2/10). He 4/4/2009
states that4/9/2009
he felt like his heart r
tarted 48-72 hours after Hep A # 2 and no obvious trigger. CLARITIN 5mg/5ml qd prn. U 4/6/2009 4/9/2009
er thigh induration 10x9cm, mild tenderness to left upper thigh. Y 4/15/2009 4/16/2009
nutes of the DTAP, pt had reaction, Y wheezing, sob, tickling in the throat, appeared grayish inYmouth, 2 tsp4/17/2009
BENADRYL, 4/17/2009
alb nebs X 2, SOLU
veloped shingles 4/15/09. U 8/7/2006 4/15/2009
er of Pt; Pt arms became tender + painful (@ injection site) approx 6-7 hrs after injections, the Y hands became 4/9/2009
swollen4/9/2009
itching next day Pt re
ious, spontaneous report of administered expired product was received from a nurse concerning Y a four-year-old
2/20/2009 female,
2/20/2009
subsequent to FLU
ious, spontaneous report of administered expired product was received from a nurse concerning Y a 15-month-old
2/23/2009 female
2/23/2009
subsequent to FLU
ious, spontaneous report of administered expired product was received from a nurse concerning Y a four-year-old
2/17/2009 female,
2/17/2009
subsequent to FLU
ious, spontaneous report of administered expired product was received from a nurse concerning Y a four-year-old
2/17/2009 female,
2/17/2009
subsequent to FLU
ious spontaneous report of expired FLUMIST given was received from a company sales representativeY concerning
2/23/2009 a 2/23/2009
47-month-old male. O
n has been received from a registered nurse concerning a male who last week was vaccinated U with VARIVAX (Merck). Concomitant therap
MENACTRA 4/8/09 at 4:15PM, close Y to that time. Checked the vial for how to administer, it didn't
Y state, checked
4/8/2009refrigerator
4/9/2009(see attached)
post vaccine -> felt dizzy, diaphoretic helped to sit down no syncope no loss of consciousness Y supine x 4/14/2009
10 min then4/14/2009
sat up received orang
ted with Sx of allergic Rxn after shots.
Y No food, drink or other exposure noted. Sx started about Y 1 hr after4/9/2009
shots. No4/9/2009
probs w/ previous sho
htness of chest next day. Benadryl +Y steroids. Y 4/1/2009 4/2/2009
dasil #3 woke up with shoulder pain L now hands fingers hard to work. Tests for lupus & arthritis N - neg. Now
1/4/2008
very stiff joints hands & knees
ace and trunk extremities. Intense itching.
Y Y 4/15/2009 4/15/2009
ith vesicular rash on trunk 4/16/09 - rash appeared 4/14/09 on trunk. N 11/3/2000 4/14/2009
hysical with immunization 4/3/09 fever Y to 101 X 24 hrs, then 4/6/09 developed no fever. Developed cough, 3/30/2009
cranky, not
4/10/2009
sleeping seen by Dr
n has been received from an investigator via agency concerning a patient who on an unspecified U date was enrolled in a study. This report w
y concerning a patient who was enrolled in a study. This report was part of a post-marketingUsurveillance program. On an unknown date the
n has been received from an investigator via agency concerning a patient who was enrolled Uin a study. This report was part of a post-marke
n has been received from an investigator via agency concerning a patient who was enrolled Uin a study. On an unspecified date the patient
n has been received from an investigator via DAIDS concerning a patient who was enrolled U in a study. On an unspecified date the patient w
n has been received from a registered nurse concerning a 20 year old female with no past drug Y history, 12/6/2008
who on 06-DEC-2008
12/6/2008 was vaccina
ort received 07 April 2009 from a consumer
Y who was the patient's mother-in-law. A male patient
N (age not reported) with a history of sleep d
ort received 09 April 2009 from a health care professional.
Y A four-month-old
1 male patient withYa history of eczema
4/2/2009and4/2/2009
an egg allergy, had r
episode, fever - 102.7, partial absence
Y spell or Yseizure which resulted1 in some anoxia post ictal
Y phase, sign 4/7/2009
tachycardia.
4/7/2009
4/29/09 Received
ed child c/o pain, redness and swelling noted to (left) vastus lateralis approximately 3cm x 5 cm.Y 3/31/2009 4/1/2009
ately 15-20 minutes after vaccination Y child became unresponsive, no respiratory distress. Mother
Y emergently
4/16/2009
brought4/16/2009
infant back to office. I
0 min after vaccination given, the patient had a blank stare, turned gray, rapid breathing, gotYstiff eyes, eyes
4/15/2009
rolled back,
4/15/2009
arm and legs stiff a
02 degrees and diffuse urticaria. Began
Y the AM after vaccine administered. Given antihistamine
U as treatment.
4/15/2009 4/16/2009
4/10/09 left deltoid noted to have about 4" round increased redness, warmth and swelling. Instructed
Y to use4/8/2009
ice packs prn.
ived vaccination on 3-27-2009 and came in office with chickenpox on 4-8-09. Y 3/27/2009 4/8/2009
d swelling and hardness at site (L) arm of inj, progressed down arm to below elbow. Described Y as hard, 3/13/2009
warm, very 3/13/2009
tender, entire circumfer
hes over body, especially elbows, knees
Y and hands with swelling and redness within 5 hrs ofYvaccination. 4/13/2009 4/13/2009
male received vaccines 4/10/09. 2hrs Y after vaccine started develop rash to body, which spread Y the following
4/10/2009
day with4/10/2009
swelling. Seen in ER
cella 4/7/09. At 3:30am on 4/9/09 woke up w / 104 Temp. Used fever control methods. Saw Y PCP at 9:30am 4/7/2009
on 4/9/09, 4/9/2009
temp at 99. Large, r
d swelling and pain of injection site >5cm about 8 hours after injection. 12-18 hours after injection
N developed4/9/2009
dizziness,
4/9/2009
nausea and heada
me down with shingles within days of receiving Zostavax. Y 3/19/2009 3/24/2009
veloped painful rash with vesicles at site of injection and mid back. Y 3/19/2009 3/24/2009
vaccine administered 04/15/2009; 36 Y hrs. later I had 3.5 cm indurated, red, sore, warm vaccination
Y site w/surrounding
4/15/2009 4/16/2009erythema accompani
ived PPD and Flu vaccine 4-15-09.Next day he developed fever.Red rashes developed on forehead.Mom
Y gave a dose of benadryl elixir 1 t
s following injection of varicella and mmr to left thigh mom returned with child and wanted usUto see left thigh
4/21/2009
reddness
4/21/2009
and swelling. 2 3/4
nd 4/16 baby was cranky and crying, no fever. On 4/18/09 "baby's eyes started rolling back"Uone time. On 4/14/2009
4/20/09 "everytime
4/18/2009 MOB put bab
tching and rash on arm where vaccines were given. Benadryl cream prescribed by MD. Y 4/13/2009 4/14/2009
en, hot area where vaccine given Y 4/17/2009 4/18/2009
days after getting Proquad VMMR vaccination
Y and Pnem vaccination. My son ran 105 F fever U and I took him to the ER. His temperature w
ed disease of the pericardium. 5-000007Y 4/28/09 Received vaccine & clinic medical records of 3/20/09. FINAL 3/9/2009DX: pericarditis
3/20/2009 Records rev
en, hot area around where vaccine was given Y 4/17/2009 4/18/2009
administration, had flu-like symptoms including chills, aches, and vomited X1. Today (1 dayNafter vaccine 4/20/2009
administration)
4/20/2009she has a runny n
RSE EVENT-MD ORDERED & PATIENT RECEIVED DTaP. THIS VACCINE IS NOT RECOMMENDED Y FOR
9/3/2008
CHILDREN PAST 6 YEARS
episode fainted Y 4/21/2009
d tdap and varicella and passed out. Hit forehead on wall and recieved a lacaration steri strips Y were applied4/18/2009
Pt c/o dizziness
4/18/2009and pain. Pt st
ceived a Tdap and 1st Hepatitis A and Y within 5 minutes, broke out in a rash and had trouble Y breathing and 4/13/2009
swallowing.4/13/2009
Patient reported he
following Twinrix vaccine on 4/15, client's
Y upper lip began to swell. Swelling continued for several
N days. 4/15/2009
Client visited 4/17/2009
primary care physicia
rash starting on face and spreading. Tactile temp, fussy. Multiple papules, vesicles Y 2/18/2009 4/13/2009
y aches HA vomitng for 3 days Y U 4/18/2009 4/19/2009
V injection approx. 8:20 a.m., Immediately felt sick and dizzy, thought she was going to vomit. N There were 4/20/2009
two more4/20/2009
incidents during day on
diagnosis to vaccine-Hypothyroidism, Y Hashimotos,Acid
Y Reflux, Anxiety,
20 Y Depression, OCD and N had occassional
9/20/2007 eye 10/1/2007
tics. Exacerbation of pre
was reported via medical records forwarded by a lawyer and described the occurrence of arthritisU in a male subject in his forties who was v
was reported by a lawyer and described
Y the occurrence of joint pain in a male subject of unspecified
N age who ### was vaccinated with LYMER
vaccines 4/2, on 4/9 developed
Y fevers, sore throat
Y - unresponsiveness21 and encephalitis withNbrain edema4/2/2009
by 4/11. Suspect
4/9/2009 viral encephalit
a fever up to 104 with last vaccines Y and screamed for ten hours nonstop. Y 1/28/2009 1/29/2009
ceived DTap and VARIVAX vaccines on 3/18/09 in right thigh. Patient returned to office 3/20/09 U with large 3/18/2009
red circular3/20/2009
area around injection
ceived DTap vaccine in left thigh on 3/16/09. Parent reported large red swollen area around Y injection site3/16/2009
1 day after3/18/2009
injection. Redness and
at, difficulty swallowing, hoarsenessYand laryngitis. Told to stop VIVOTIF and use ADVIL. Throat U culture pending.
4/17/2009 4/18/2009
get lesion (7cm x 5 cm) with central clearing.
Y Raised, red and warm, but no pain or itching. Y 4/15/2009 4/17/2009
d pain at left upper arm at previous injection site with redness and tenderness (2" x 5" of size).U Pt stated scratching
4/8/2009 area4/12/2009
after 4 days of injec
cold sweats and chills 4-20-09 that evening after the vaccine was administered. Pt also c/o difficult with4/20/2009
forward flexion
4/20/2009
of neck - "mild disc
on L thigh with chicken pox lookingYlesions warm compresses + Augmentin x 5 days. Y 4/6/2009 4/17/2009
tous papular and plaque like lesions - very pruritic on extensor surface of upper and lower extremities.
U This4/7/2009
rash developed
4/18/2009 2 weeks after 2
smallpox 31 Mar 09 Lt upper arm, whichY was followed by swelling, redness, and increasing tenderness,
Y 3/31/2009
no fever, Pt stated
4/1/2009 she was vaccin
ollow-up to a previously submitted VAERS report this 47 year old patient received 4 BIOTHRAX U prior to and1/11/2003
during his
1/13/2003
deployment in 2003.
omiting and diarrhea, subjective fever
Y and hematoma to site. Y 4/8/2009 4/9/2009
Y 4/15/2009 4/16/2009
creased appetite, rash, shaky, vomiting in the 24 hours to 48 hours with the vaccine administration
N on 4/15/09
4/15/2009 4/16/2009
ines were given the patient hopped off the exam table (she was sitting on it) & fell to the floorY and became 3/16/2009
rigid and3/16/2009
looked blue and unresp
<15min) onset of facial swelling afterYvaccine delivery. Y 4/21/2009 4/21/2009
ely after vaccination, eyes rolled back,
Y color became gray/green, leaned to left; mother supported U her - nurse
4/21/2009
attempted
4/21/2009
to assist her to put
08, 2 wks after her 2nd GARDASIL shot, this girl has had severe back pain with diagnosis
Y ofNSacroileitis,7/22/2008
pain Amplification
8/5/2008 syndrome. Pai
9 Patient brought by parents. About 12-18 days after vaccines developed hives on both cheeks N and few scattered on lower legs.
uring swallowing; Febrile seizure. Y Y 4/8/2009 4/15/2009
ter immunization. Woke up next AM with severe swelling to face & eyes, very sleepy. Afebrile, Y no SOB 4/10/2009
or difficulty4/10/2009
swallowing. Took 50 m
ely after receiving 2nd GARDASIL vaccine along with DTap vaccine, patient fainted. She wasYunconscious 4/17/2009
for 2-3 seconds.
4/17/2009 Awoke with sha
is having tingling sensation up and down his left arm, and he stated that his shoulder is sore. U Asked him3/10/2008
is pain severe 4/9/2009
he said that it is eas
as given Hep A 1st, then HPV. AfterYHPV was administered pt tensed up and began to looseYher color, she 4/17/2009
then began4/17/2009
to lean backwards a
dness where injection given area approx. 6in long & 4in with with warm areas + pain. Started Y around 12 hours after inj + worsening over 48
fter vaccine with smallpox, awoke with non painful non pruritic 10 cm red patch with multiple U 2-3 mm satellite
4/13/2009
papules 4/13/2009
around path extendin
after injection erythematous confluent raised rash appeared on dependent surface of L upper Y arm. 1% Hydrocortisone
4/16/2009 4/17/2009 cream bid, extendin
hezia, twice - Fussiness - ConstipationY Y 3/25/2009 4/1/2009
4/15/2009 N 4/15/2009 4/15/2009
erythema, induration at Iz site - VARICELLA Iz right thigh U 4/8/2009 4/9/2009
ne was mixed with sterile water diluent and not HIB diluent. 3/9/2009
n has been received from a 31 yearYold female licensed practical nurse with reaction/allergy
Y Nto DEMEROL7/5/2007and a history
7/5/2007
of function kidney
additional information has been received
Y from a nurse practitioner concerning a 14
Y year old Nfemale who on 17-OCT-2006
### 2/1/2007 was vaccinated w
n has been received from a physician assistant and a licensed practical nurse concerning a U female who was vaccinated with the first dose
n has been received from a physician Y assistant concerning a 20 year old female Y with migraine,
N penicillin8/15/2007
allergy and VICODIN
8/1/2008 allergy and a
ports child woke up "Sunday night atY 1:30" (April 12) with c/o not feeling well, sore throat andYswollen glands 4/8/2009
on side4/12/2009
of neck. Reports c/o h
veloped a skin infection at the site of
Y the MMR vaccination. She had low grade fevers for days Y and was in 4/2/2009
discomfort.
4/11/2009
10 days on antibioti
IVED DTAP INSTEAD OF TDAP. U 4/13/2009 4/13/2009
arm from just above elbow to shoulder
Y joint. Had 4+ edema. Hot to touch, with deeper reddish Y black skin 4/15/2009
discoloration
4/16/2009
below where Kinrix
d loss of consciousness after vaccination, associated with tonic clonic motions of extremities. Y Complete4/14/2009
recovery. 4/14/2009
No prior history of seizu
ived 2 month vaccines as Pentacel, Prevnar and Rotateq. Vaccines given at 10:30 AM, Infant Y had inconsolable
4/21/2009 crying
4/21/2009
and mild fever (not
ceived vaccinations and about 5.5 - 6 hours later experienced weakness, fatigue and fever ofU 102.5 axillary. 4/21/2009
No other4/21/2009
symptoms other than
ARICELLA VACCINE RECEIVED. PREVIOUS DOSES ON CHILD GIVEN ON THESE DATES: U 4/21/03,4/17/2009
04/18/20074/17/2009
rned pale and diphoretic after administration of first Gardasil vaccine. Patient complained of feeling
Y like she
4/22/2009
was going4/22/2009
to pass out. Patient w
nderated at injection site. Heat and Yprednisalone Y 4/15/2009 4/16/2009
al reaction from left elbow to over left shoulder including underside of arm. Red, hot to touch,Uskin hard and 4/20/2009
swollen,4/21/2009
painful, no enlarged ax
er receiving his 4 month booster vaccines
Y patient
Y started having seizures
1 Y which have
Y resulted
N in several9/26/2007
hospitalizations,
9/29/2007
numerous medica
4 HR OF VACCINES, PT GOT RAISED Y RASH ON BOTH ARMS. RX KEFLEX 250MG TID FOR 1 WK. CLARITIN 4/20/2009 RX, 4/21/2009
BENADRYL HS PR
OID MACULAR RASH,MILD SWELLING, Y WARM TO TOUCH. CLARITIN RX/BENADRYL RX. RETURN 4/17/2009 IF NOT IMPROVED.
4/21/2009
d large local reaction at site of vaqricella
Y vaccine Y 4/17/2009 4/18/2009
was reported by a lawyer and described
Y the occurrence of joint pain in a female subject of unspecified
U age5/4/2000
who was vaccinated with LYME
was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified
U age 7/8/2002
who was vaccinated with LYMER
came dizzy, pale, clammy & sweaty lethargic stated his very tired. Pulse droped into the 50's Y - oxygen @ 4/21/2009
3 liters had
4/21/2009
patient lie down chec
telephone call from patient on 4-16-09 stating the she had slight nausea and slight swollen lymph node 4/14/2009 in (L) clavicle
4/15/2009
area. No fever. 4-21-
SM referred from aid station for left Yfacial swelling in temporal association with the receipt ofYAVA and Typhoid4/7/2009vaccines. Symptoms: Swel
njection 02/13/2009 @ 4:00pm 36 later Pt states fever of 100, chills body ache L arm, headache. Y 2/13/2009 2/15/2009
n on 4/8/2009. Pt noted symptoms. Flu like achy onset 4/18/09. Stopped 4/21/09. Rash onset 4/21/09 - ongoing. 4/8/2009Rash4/15/2009
on side of face, nec
ccinated with Hepatitis A and Hepatitis B vaccines 15-20 seconds after vaccines administered Y patient fainted.
4/22/2009Per guardian
4/22/2009"patient has al
large area redness/heat denies itching mildly painful area raised warm area breadth of thigh with central4/20/2009
clearing around
4/21/2009
vaccine site. Ben
ng office, parents report baby turned blue, when strapped in her car seat lasted few secondsY-> pinked up on her own. Brought her right ba
on 4/17 - Sore, red and itchy, and aYlittle swollen. Saturday swollen and warm.- little fever. Monday 4/20,4/17/2009
still sore and
4/18/2009
warm. Dr. prescribed
eft thigh around on a or injection and fever of 100.2 U 4/16/2009
d hives 3 days after getting HPV vaccine for the 1st time. Y 4/16/2009 4/19/2009
n has been received from a nurse practitioner
Y for the pregnancy registry for GARDASIL, concerning
Y a 23 year old female
5/21/2008
with a history of 2
n has been received from a 22 year old medical assistant who was given the second dose ofNGARDASIL "subcutaneously instead of intram
n has been received from a Nurse Practitioner concerning a patient who on 13-FEB-2009 was U vaccinated 2/13/2009
with an inadequate
2/13/2009 dose of GAR
n has been received from a physician concerning a 16 year old female who on 12-JAN-2009Uwas vaccinated 1/12/2009
with the second dose of GAR
n has been received from a medical assistant concerning a 11 year old female with a historyYof pharyngitis 2/26/2009
streptococcal
2/26/2009
who on 26-FEB-2
n has been received from a Registered Nurse concerning a 16 year old female who was vaccinated U intramuscularly with her third dose of G
n has been received from a physician Y concerning a 19 year old female with penicillin allergyUwho on 19-FEB-2009
2/19/2009 was 2/19/2009
vaccinated IM into t
n has been received from a physician Y assistant concerning a 15 year old female who on 27-FEB-2009
U was
2/27/2009
vaccinated2/27/2009
with a first dose of G
n has been received from a 25 yearYold female who on 18-FEB-2009 was vaccinated with her N first dose 2/18/2009
of GARDASIL and the patient had
n has been received from a nurse concerning
Y a 13 year old female who on 26-AUG-2008 was N vaccinated 11/2/2008
with her first
12/1/2008
dose of GARDASIL
n has been received from a physician concerning a 14 year old female patient with no pertinent N medical 2/12/2009
history and2/17/2009
no known drug allergie
n has been received from a physician Y assistant concerning a female under 18 year old who Y on unspecified date was vaccinated with her th
n has been received from a registered nurse concerning her 16 year old with no pertinent medicalU history and no ###drug reactions/allergies
### w
n has been received from a consumer concerning her daughter (approximately 17 year old) N with codeine allergy who9/1/2008had been experiencin
n has been received from a registered nurse concerning her 14 year old daughter with frequently Y injection site reaction after unspecified va
n has been received from a 41 yearYold female patient with an allergy to "cloricidin" and a history
U of bleeding3/2/2009
during pregnancy
3/2/2009 who on 2-M
n has been received from a female who was vaccinated with a first and second doses of GARDASIL U on an unspecified date, respectively. T
n has been received from a nurse practitioner concerning a female patient who was vaccinated Y with a dose of GARDASIL. 3/2/2009 On 2-MAR-2009
n has been received from a registered Y nurse concerning a 24 year old female who in approximately
Y February
2/1/2009
2009, about
2/1/2009 1 month ago, wa
n has been received from a nurse practitioner
Y concerning a 20 year old female with no pertinent
U medical9/25/2007
history or drug
2/24/2009
reaction/allergies w
n has been received from a physician concerning a 14 year old female who 25-FEB-20009 was U vaccinated 2/25/2009
with a dose
2/26/2009
of GARDASIL (lot #
n has been received from a radiologistY concerning her niece (a 14 year old female) who on 08-FEB-2008
Y 2/4/2008
was vaccinated
2/8/2008with her first dose
n has been received from a Nurse Practitioner (N.P.) concerning a female who was vaccinated N with 0.5 ml dose of GARDASIL. The patient
n has been received from a registered Y nurse (R. N.) concerning a female patient at one of the U local schools who had an aluminum poisonin
n has been received from a physician concerning a female patient who was vaccinated intramuscularly with 0.5 ml dose of GARDASIL. Co
n has been received from a mother concerning her daughter who on unspecified dates was U vaccinated with all the three doses of GARDAS
n has been received from a physician Y concerning a female teenager who on an unspecified Y date was vaccinated with the first dose of GAR
n has been received from a nurse concerning
Y a 17 year old female patient who on 28-FEB-2009
N was vaccinated
2/28/2009with 2/28/2009
the first dose of GAR
n has been received from a physician concerning a 13 year old female who on 22-DEC-2008 Y was vaccinated with ### her
2/23/2009
first dose of GARDA
n has been received from a physician Y concerning a 15 or 16 year old female who was vaccinatedU with the second dose of GARDASIL. On
n has been received from a registered Y nurse concerning an 18 year old female with an allergy U to naproxen 11/1/2008
who on 23-APR-2008
11/1/2008 was vacc
n has been received from a consumer concerning her 23 year old daughter with no pertinentNmedical history 8/1/2008
and no known
8/1/2008 drug allergies o
n has been received from a physician concerning a female who on an unspecified dates wasUvaccinated with first and second doses of GA
n has been received from a school nurse (registered nurse concerning a high school aged female U who was7/31/2007
vaccinated with a dose of GAR
swelling ANT LT Thigh, delayed onset Y after immunizations 4/9 am, either soft tissue infectionU (cellulitis) vs4/9/2009
delayed and4/9/2009
severe local reactio
m red patch on L thigh 2 days with vaccine
Y administration tender + hot no systemic signs or symptoms.
U 4/16/2009 4/17/2009
was considered medically important. Information regarding PREVNAR was received from a U consumer regarding a 5-year-old male patient
eared over mid back and buttocks 7/30/08. Progressed to localized area over left thigh, clustered, mean spots,### very7/30/2008
pruritic. Area persisted
mmunization clerical staff stating client
Y had left phone message stating that she had blistersUat the site of 3/1/2009
her shingles shot. Said area was
lled Pt. crying, unable to console X90 min. Tylenol given - phone call 4/17/09. Pt doing better,Y cried for 24/16/2009
1/2 hrs. and 4/16/2009
is fine today- had low
iving a HEP A injection pt walked to front desk & ran into the exit door. She stated "every thing
Y was purple 4/17/2009
because4/17/2009
the shot hurt so much.
hema and edema extending 10 cm X 4 cm around injection site. Decreasing edema and erythema Y daily.4/13/2009 4/14/2009
Mom called re: 4 bumps to left thigh Y with redness. 3-13-09 mom brought child to MD with increased
Y redness
3/11/2009
and selling.
3/12/2009
3-14-09 ED visit, la
A (intense when moves head) aching all over and a slight cough.Tem.101.Advised to see PCP U if T. 102-1034/21/2009
and if sxs
4/21/2009
not subsided in 48 h
ates that a few hours after the patientY received Y his shots she fed him1and put him down for aYnap. She states4/20/2009
she went
4/20/2009
in to check on him a
NURSE PHONED TO SAY RIGHT ARM RED,SWOLLEN,TENDER--REDNESS EXTENDS U 3CM BELOW 4/20/2009
ELBOW---ADVISED
4/22/2009 TO SEND T
ng of 4/22/09, the day after vaccination, parents noted that left arm was swollen above the elbow,
Y red and4/21/2009
hot to the 4/22/2009
touch. Child had not co
e on 4/15/09 at which time vaccinesYadministered according to CDC recommended schedule. Y Parents report
4/15/2009
that on4/16/2009
4/16/09 patient develo
muscle pain in the deltoid area beginning
Y withing days after the shot. It has been 9 months and
N the pain 7/15/2008
is only slightly
7/17/2008
better.
dose of oral typhoid in the morning of 4-21-09 and began to feel intestinal discomfort the in evening
Y of the4/20/2009
same date. 4/21/2009
Started with diarrhea
inistration of a subcutaneous MMR vaccination using a VanishPoint syringe, a black dot appeared U on the site of ###
injection. ###
nausea w/o emesis and Crampy abdominal Y pain 30+ episdoes of watery diarrhea no blood inY24 hours. Orthostatic
4/22/2009 and 4/23/2009
fatigue.
bcutaneous injection of the MMR vaccine using the VanishPoint syringe, a black dot appeared U on the child's left ###
arm. ###
D T-DAP 4/1/09 AT BEGINNING OF 12 HOUR SHIFT (0700) AND HER SHIFT EXTENEDED Y UNTIL 0300 4/1/2009
THE NEXT 4/3/2009
DAY. ON THE NIG
d severe pain at injection site and upper arm,prickly reddened area around site, dizziness, fever,, U nausea,lymph
4/20/2009 glands
4/21/2009
swollen in axilla
minutes after second vaccine injection(HPV) client stated that she felt hot,then did not respond Y to verbal4/23/2009
stimuli, eyes4/23/2009
open, and body beg
009, arm was sore and red at site ofYinjection. Redness gradually worsened. At time indicated N in number4/20/2009
11, patient4/22/2009
began to feel nauseate
rm redness, swelling, fever, skin hot, red rash on arm, pain in arm for one week, egg sized lump. Y Symptoms 4/14/2009
resolved 4/14/2009
on own after one wee
e shingles vaccine administered on the 21st of April at 10:00a.m., became very red, itchy andY swollen to 4/21/2009 three inches 4/22/2009
in diameter, 1/2 inch h
was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecifiedU age7/30/1999
who was vaccinated with LYMER
was reported by a consumer and described
Y theY occurrence of throat0 tingling in a 45-year-oldUfemale subject
9/17/2008
who was 9/17/2008
vaccinated with influe
ng office Pt had a delayed fainting spell - Returned to office - No injury. Y 4/23/2009 4/23/2009
ter injection - pain at site -nausea-vomiting 9 hrs- Temp -101.4 - 12 hrs. See attached for detailedY acct 4/14/2009 4/14/2009
ure starting within 24 hours of injections with lack of appetite & fatigue. Cough developed within 24 hours 3/25/2009
with positive3/26/2009
strep (rapid test) 3/3
s red, swollen, itchy Y 4/21/2009 4/22/2009
degrees (rectal) on 4/23/09, redness Y and warmth to both thighs U 4/22/2009 4/23/2009
red area on LA last night 4/15/09. School nurse (called 4/16/09). 3/4" wheel - 2" flare -red-hot; Y dermis itching
4/14/2009
- no rash-
4/15/2009
no resp. problems
after vaccines given mom stated pt vomited in bathroom. Once out of bathroom mom statedYpt feet "hot".4/17/2009 Temp was 4/17/2009
99.8 axillary 15 min la
d redness, swelling, pain 5/10 and heat stating 4 days after injection. Erythematous and edematous Y area 4/6/2009
9 cm X 7.54/10/2009
cm at injection site. St
9, he was given MMR in right upper arm. Later that evening, he developed a red whelp and Y swelling of the
4/17/2009
right upper4/17/2009
arm (deltoid area) No
cm redness & swelling around site of Y immunization left and lateral thigh Y 4/21/2009 4/22/2009
appeared on arm in vicinity of vaccines - 4 days later on 04/6/09 and 4/20 severe rash on face - 4/21 severe 4/2/2009
generalized
4/6/2009
indurated pink pap
eived varicella vaccine on 4/21/09. Y Developed edema of R arm extending from deltoid to mid forearm erythema 4/21/2009 over4/23/2009
deltoid.
m to touch, inflammation instructed to give child, children's Motrin or Advil. U 4/21/2009 4/23/2009
r arm is red, hot to the touch and feels hard @ injection site. <- hist Dx Skin is mildly red-notY hard child 4/21/2009
not ill- playful-
4/22/2009
afebrile.
egular shaped welts - No temp. - Itchy on parts of arm/legs and torso - Recommended BENADRYL U _ See4/21/2009
Dr. if not 4/22/2009
better.
iness symptomatic tx Y 4/22/2009 4/23/2009
ling, redness at site of injection (improving 4/21/09) fever & chills over night nausea. Y 4/20/2009 4/20/2009
swelling, heat (L) upper arm and developed several hrs after injection, Rx BENADRYL/VICODIN Y and cold
4/20/2009
packs. 4/21/2009
tching - burning - tired - achy Had emp. health physician check patient Y 4/21/2009 4/21/2009
post pt left boyfriend called back stating pt's tongue was starting to swell & have blisters on tongue.
Y Told4/21/2009
boyfriend 4/21/2009
to return to clinic. Dr ex
min child had cough, wheezing, difficulty
Y breathing, pale Oxy 93-96% on room air then developed Y itchy rash
4/22/2009
all over4/22/2009
the body. Got XOPEN
spot at injection site. Y 4/15/2009 4/16/2009
4/22/09 with rash. Y Y 5/30/2006 4/21/2009
ever and erythematous, blotchy rush all over - day after PENTACEL and ROTARIX Y 2/11/2009 2/12/2009
eport that after shots on 2-19-09, pt cried non stop greater than 3 hrs. Y 2/19/2009 2/19/2009
n has been received from a physician concerning Y a 12 month old patient
0 who on 20-JUN-2008, Y 06-AUG-2008 10/1/2008and 01-OCT-2008
4/7/2009 was vacc
n has been received from a physician concerning Y a 17 month old patient
0 who on 20-DEC-2007, Y 20-FEB-2008 4/17/2008and 17-APR-2008
3/16/2009 was vacci
rmation has been received from a physician
Y and follow up information has been received from Y a registered4/14/2009
nurse concerning
4/14/2009a 15 year old
ort was received 17 April 2009 from Y a consumer, who is the patient's parent. An 11-year-old male Y patient (also
6/1/2008reported
6/1/2008
as 12 years of age)
ng of the vaccine swelling developed at injection site. The next day she developed a headache, Y chills, nausea
4/22/2009and sweating.
4/22/2009Today (day 3)
nt had a seizure on the Friday after Y getting the vaccine. Patient had a seizure w/u-extension,YLP/UDS. Patient 4/8/2009
had CT 4/17/2009
scan and EEG. The E
nt received travel vaccines (yellow fever,
Y meningococcal, typhoid) at an outpatient travel clinic Y 4/1/09. He4/1/2009
developed4/1/2009
a headache about 5 m
pneumonia vaccine 4/20/09 in left arm. Y Stated it was immediately painful. Localized swellingUoccured over 4/20/2009
the next4/20/2009
6 hours. Swelling incre
had slight swelling about 5cm, redness, itching, and pain Y 4/1/2009 4/3/2009
U 4/14/2009 4/14/2009
ceived her 4 month vaccines on approximately
Y Y4/12/09 of this year (2
2 injections, 1 to the R thigh
U and 1 to4/12/2009
the L thigh4/16/2009
presumably pentacel a
s started exactly 2 months after her Y 2nd shot. Started
Y with headaches, 1 nausea, vomiting,
Y strep
N throat and11/7/2008
body aches. 1/7/2009
Continues on with no
as vaccinated 4/14. Presented for urgent care 4/23 with three patches of vesicles on left back. U 4/14/2009 4/22/2009
ere muscle pain in lower legs that continued for 7 days, and they are still sore, but not so severe Also after4/8/2009 3 days, I4/14/2009
started to have muscle
9/17/2008 N 9/2/2008 9/2/2008
d shortness of breath, wheezing,
Y cold extremities,
Y and hives within 5-152 minutes after receiving Y four immunizations
4/23/2009 and 4/23/2009
PPD. 5/14/09 hosp
perienced two episodes of syncope after receiving vaccines on 4/21/09. First episode immediately Y after 4/21/2009
receiving vaccines,
4/21/2009 then 15 minute
minutes of receiving her first Gardasil injection the patient blacked out. SHe was treated with Y smelling salts
4/17/2009
to try and
4/17/2009
rouse her and was p
hrs after receiving the immunizations Y listed below, patient's rt. arm began itching at the varicella
Y site, then 3/23/2009
she noticed 3/24/2009
swelling and warmth
ed this facility and stated that since she was administered her Td vaccination in the right deltoid on 3/27/09 3/27/2009
she has 3/27/2009
had "pain off and on in
s after receiving MMR vaccine subcutaneously,
Y developed a 1.5 cm wheal that itched and hurt Y at the site4/23/2009
of this vaccine
4/23/2009
administration. Tre
vaccination on April 16th 2009 I noticed at the injection sight his arm was swollen, red and very N hot to the4/16/2009
touch. Everyone
4/16/2009told me he was f
was reported by a lawyer and described the occurrence of joint pain in a female subject of unspecifiedU age who was vaccinated with LYME
4/21/2009 N 4/16/2009 4/21/2009
eption, Bilious vomiting, Irritability, Listlessness.
Y YIntermittent vomiting1 episodes starting on 4-12-09.
Y Increased
4/7/2009
vomiting
4/12/2009
noted on 4-21-09. D
cines emesis about 10 minutes afterYvaccines, developed
Y facial and arm rash 20 minutes after Y vaccines, 4/15/2009
Pt sleepy. BENADRYL
4/15/2009 15 mg IM a
eption, s/p surgical reduction.
Y 4/28/09
Y MR receivedY for DOS 4/16-19/2009
3 with D/C dx: Intussusception.
Y 4/14/2009
Pt presented 4/15/2009
with vomiting, fussin
ter received her second GARDASILYvaccine and had 2 30-45 second seizure 15 minutes after U the injection
4/21/2009
in the doctors
4/21/2009
office on the floor
reviewed PROTCOL questions with patient, denied steroid use 4/24/09 - patient came to pharmacy U and4/23/2009
showed pharmacist
4/24/2009shingles-like ra
headache, - flu-like symptoms, -nausea; -muscle pain Y 4/22/2009 4/23/2009
iving IM DTaP and IM PREVNAR onY 4/20/09 to (R) thigh, pt. developed red, warm area and Ytemp described 4/20/2009
as "hot"4/21/2009
per mom day after sho
t was given a DTaP immunization Y 4/20/2009
swelling, redness, and warmth to immunization
Y site (right posterior upper arm). 4/23/2009 4/23/2009
es, shortness of breath, very painfulYwith in 5 hours after injection, Pt states arm very painful Yunable to lift4/21/2009
on 4/22 + 4/21/2009
4/23 area near injection
f the she c/o itching at the site - red area appeared 3 days later 15mm x 20 mm now. StartedUsmall welting 4/7/2009
after - no 4/7/2009
fever, no swelling in ar
erebral Palsy, 1 seizure periodically Y 12/08, sees Neurologist, EEG 12/08 abnormal, on KEPPRA, U this episode4/20/2009
= day 4/21/2009
after immunization mom
r to elbow swollen twice the size & with erythema. Y 3/11/2009 3/13/2009
ived 2 chicken pox vaccines, chicken pox rash on 4/17/09 Y 6/20/2007 4/17/2009
d hives within 10 minutes of HIB / PREVNAR administration. BENEDRYL given in office. Monitored Y X 20-30
4/2/2009
min 4/2/2009
Y 4/20/2009
0PM Hep A #1 given LA. After injection, Y stated she was dizzy and tip of tongue numb. Color Ypink. 2:35PM 4/16/2009
HR 34 R 4/16/2009
20 BP 110/60 talking w
U 2/11/2009 2/12/2009
vaccines - approx 30 mins later father Y returned to clinic stating child c/o "scratchy throat" - no Y SOB - vomited 4/7/2009
x3 - c/o4/7/2009
chest tightness EPI. 3
GARDASIL shot. Approx 3-5 min. later had several vials of blood drawn. After last vial pt. became Y "rigid",4/16/2009
had muscle 4/16/2009
contractions, eyes we
by parent, Pt.'s R arm and shoulder Y at injection site became very swollen, child taken to ER.UParents thought 4/14/2009needle was in arm. Arm X ra
warm area without induration occurred 4/19 (2 days after vaccines given). U 4/17/2009 4/19/2009
red ROTATEQ orally before other vaccines - within 1 min of giving oral vaccine, infant mucous Y membranes 4/15/2009
of upper4/15/2009
and lower lips began to
here for evaluation of dizziness andYsymptoms that she thinks may be related temporally to the injection 4/14/2009 of a TDAP 4/14/2009
that was given on 4/14/
ht arm within about 4" from injectionYsite bright red, swollen, hard and hot to touch on 3/19/09. Y 3/20/09 signs
3/18/2009
and symptoms
3/19/2009 persist with larg
as brought back to office 25-30 minutes Y after injection given complaining that his chest hurt. Patient
Y exhibiting
3/13/2009welts,3/13/2009
wheezing, welt around
jection site 2" x 1" redness w/ 2" raised
Y areas w/i. No vesicle. No streaky redness. U 4/14/2009 4/24/2009
n in Rt. deltoid about 2-3 hours afterY receiving pneumonia vaccination. Pt could not move her U arm or fingers
3/18/2009
and went3/18/2009
to the ER. Pt given a
st 66, have always had a healthy, activeY lifestyle; have been energetic & chipper Y- hard to keep N me down, 6/10/2008
some favorite
6/11/2008
activities being aer
was considered medically important. Information regarding PREVNAR was received from a U healthcare professional
8/3/2004 regarding a male patie
was considered medically important. Information regarding PREVNAR was received from a U healthcare professional regarding a patient wh
was considered medically important. Follow-up information provided recovery status. Information Y regarding PREVNAR### was received form a
was considered medically important. Information regarding PREVNAR was received from a U consumer regarding her granddaughter who su
n regarding PREVENAR was received from a healthcare Y professional
0 regarding a 19-month-oldY male patient who experienced drug ineffec
was considered medically important. Information regarding PREVNAR was received from consumer U regarding
4/9/2008a 15-month-old male patien
provided Quality Assurance
Y Results. Information Y regarding PREVNAR was received from a N healthcare professional
8/28/2008 9/12/2008
regarding a 3-month-o
received provided additional patient details, medical
Y history, event details,
0 and test results. Information
Y regarding
8/14/2008PREVNAR
10/1/2008was received
n regarding PREVNAR was received form a consumer regarding a 5-month-old male patientUwho experienced### multiple seizures.
### The patien
n regarding PREVNAR was received from a healthcare Y professional regarding a 12-month-old Y male patient who experienced
10/1/2008 drug ineffecti
n regarding PREVNAR was received from a healthcare professional regarding a 6-month-oldY female patient who experienced a linear, raise
n regarding PREVNAR was received from a healthcare professional regarding a 4-month-oldY male patient 9/24/2007
who experienced
11/5/2007injection site a
information provided patient demographics, recovery status, concomitant vaccine, and doseYdetails including lot ###numbers.### Information reg
n regarding PREVNAR was received from a healthcare professional regarding a 4-month-oldU male patient 2/15/2008
who developed
2/26/2008 petechia 11 days
n regarding PREVNAR was received from a healthcare professional regarding a patient whoUwas administered the vaccine that was stored
n regarding PREVNAR was received from a healthcare professional regarding a 4-month-oldU female patient 6/16/2008
who inadvertently
6/16/2008 was given a
n regarding PREVNAR was received from a healthcare professional regarding a 2-month-oldY female patient 6/30/2008
who experienced redness at th
information was received that provided patient information and lot number. Information regarding U PREVNAR
7/28/2008
was received
7/28/2008 from a healthca
n regarding PREVNAR was received from a healthcare professional regarding a patient who experienced low antibody titers. The patient re
mation was received in dose details and source details. Information regarding PREVNAR was N received from a ### mother4/8/2008
and a physician rega
n regarding PREVNAR was received from a healthcare professional regarding a 2-month-old patient who 8/14/2008
experienced 8/14/2008
administered improp
n regarding PREVNAR was received from a healthcare professional regarding a 4-month-oldN male patient9/5/2008 who experienced
9/10/2008rash from head
Information provided test results and a possible cause for the reported events. Information regarding
N PREVNAR
9/22/2008was received from a healt
n regarding PREVNAR was received from a healthcare professional regarding a patient who received PREVNAR that had been frozen on a
n regarding PREVENAR was received from a company representative regarding a male patient who experienced decrease in babbling. Th
n regarding PREVNAR was received from a consumer regarding a 4-month-old female patient U who experienced ### administered### the 2nd dose
n regarding PREVNAR was received from a patient's mother regarding her 4-month-old sonYwho experienced 4/1/2008
injection site swelling, body t
n regarding PREVNAR was received from a healthcare professional regarding a 9-month-oldY patient who experienced facial rash. The pat
n regarding PREVNAR was received from a healthcare professional regarding a patient whoUexperienced induration. The patient received t
n regarding PREVNAR was received form a consumer regarding a 4-month-old male patientUwho experienced broke out all over with a rash
n regarding PREVNAR was received from a pharmacist regarding a 4-month-old patient whoUexperienced5/6/2008 rash and fever.
5/6/2008At 4 months of a
n regarding PREVNAR was received from a pharmacist regarding a 15-month-old patient who U experienced 5/6/2008
fever of 103.9
5/6/2008degrees. The pa
n regarding PREVNAR was received from a healthcare professional regarding a 2-month-oldY female patient who experienced red swollen l
information was received that provided medical confirmation of the events, and also included Y patient demographics,
7/9/2008 7/9/2008
and recovery status. I
n regarding PREVNAR was received from a nurse regarding her grandson, a male patient (age U unknown), who experienced reaction on the
n regarding PREVNAR was received from a mother regarding her 12-month-old female daughter N who experienced
9/2/2008 swelling
9/3/2008 and redness at
n regarding PREVNAR was received from a healthcare professional regarding a 2-month-oldY male patient9/8/2008 who experienced
9/12/2008urticaria on bo
n regarding PREVNAR was received from a healthcare professional regarding a 2-month-oldY male patient7/3/2008 who experienced
7/8/2008rash from head
n regarding PREVNAR was received from a healthcare professional regarding a 13-month-old Y male patient 8/6/2008
who experienced
8/9/2008 hives, extens
n regarding PREVNAR was received from a healthcare professional regarding a patient whoUexperienced 10/1/2008
decreased 10/1/2008
appetite and widespre
n regarding PREVNAR was received from a healthcare professional regarding a patient whoUexperienced extreme pain when PREVNAR w
n was received from a pediatrician regarding a 4-month-old patient who experienced diarrhea. The patient received a dose on an unspecifi
n regarding PREVNAR was received from a pediatrician regarding a 6-month-old patient who U experienced diarrhea. At 6 months of age, th
n regarding PREVNAR was received from a pediatrician regarding a 6-month-old patient who experienced diarrhea. At 6 months of age, th
n regarding PREVNAR was received from a pediatrician regarding a 12-month-old patient who experienced diarrhea. At 12 months of age
n was received from a healthcare professional regarding a 13-month-old male patient who experienced U injection
2/3/2009 site 2/4/2009
swelling and fever of 1
n regarding PREVNAR was received from a healthcare professional regarding a 6-month-oldU male patient2/3/2009 who experienced
2/4/2009injection site sw
n regarding PREVNAR was received from a healthcare professional regarding a 2-month-oldN male patient 12/9/2008
who experienced
12/9/2008injection site h
ped a sore throat and fever 2 days after receiving the vaccine. Fever resolved after 1 day, but U sore throat4/20/2009
persisted 4/22/2009
for several days.
injection site reaction. Softball sized slightly swollen and red injection site area in left arm inYsubcutaneous4/16/2009
upper tricept
4/17/2009
area. Received in
old me today at a sibling's visit that ~2 weeks after patient received her Varivax she developed Y a fever and4/19/2004
what looked 5/2/2004
like chicken pox lesi
edness, swelling, induration, & pain at injection site. unable to lift arm. Started taking TylenolN1000 mg per 4/23/2009
recommendations.
4/24/2009
weating, chills, fainting, pain deep in ears Y 4/24/2009
ours after the vaccine my upper arm began to swell. The injection site had a rash, my entire U upper arm looked
4/24/2009
like a4/24/2009
giant hive. It was very
rhea, crying (insolable), stopped eating
Y typical foods she liked, needed to be in constant
Y motion
N (baby jumper)to ### be happy,### didn't want to be
(pneumococcal polysaccharide) my husband had swelling at the sight and red and very hot.The Y redness4/20/2009
and swelling 4/20/2009
went down the inside
n has been received from a 45 year old female nurse who on 16-APR-2009 was subcutaneously N vaccinated
4/16/2009
with a dose
4/16/2009
of ZOSTAVAX (M
n has been received from a consumer Y concerning his now 5 year old son with developmental N delays, who10/1/2005
at the age 10/1/2005
of 18 months was vac
n has been received from a consumer concerning her approximately 12 month old male withNfood allergies and no pertinent 6/1/2007medical history
o small pox lot number VV04003a. Pt. Y Developed Rash Covering entire body 6 days after vacination.
U poc4/19/2009
fully formed 4/25/2009
then reaction accured
ENTS WIH SKIN IRRITATION AND RED SPOTWS ALL OVER BODY SINCE 25 APR 2009YPT SEEN PROVIDER 4/15/2009 ON 4/25/2009
26 SPR 2009. PT A
d TD vaccination 18 April 09. C/O increased pain over right deltoid muscle on 19 April. Pt states U that pain
4/18/2009
has been4/19/2009
stable for the past wee
es son ran high fever (102 to 103) starting
Y "about an hour after the shots" for most of weekend. Y Developed 4/23/2009
severe headache
4/23/2009and "walked in
ction at injection site. Redness, swelling heat and hardness extending from injection site at left U deltoid to4/24/2009
just aboce 4/25/2009
the elbow. Injection ad
G RIGHT ARM FROM DELTOID AROUND UNDER ARM PIT DOWN TO WRIST, STARTEDY 4/24/09 4/23/2009 4/24/2009
GIVEN TDAP AND MENACTRA AND FAINTED FOR A 15 SEC AND VERBALIZED FEELING Y DIZZY. PT. 4/27/2009
LAID ON 4/27/2009
THE FLOOR AND COL
e and fever reported on 4/3/09 via a phone call to the LPN working at the outpatient clinic. No Y treatment noted.
4/1/2009 4/3/2009
er, child started with fever of 103.7 degrees
Y Fahrenheit on 4/11/09 and she gave him TylenolYand then temperature4/7/2009 went4/11/2009
to 104 degrees so
d with severe arthus allergicY reactionY and pulmonary distress. Treated with high and prolonged U dose of prednisone
3/30/2009 -4/10/2009
ongoing at present.5/4
ather reports elevated temp at home Y 4/23/2009, for which he did administer tylenol. States childY woke up 4/23/2009
approximately
4/24/2009
5 am 04/24/2009 w
eived the flu shot I developed severYnumbness on my extremities witihn 2-3 weeks. Y After thatNI developed severe ###weakness,
11/1/2007loss of motor p
04, not responding to infant Ibuprofen. Up to 1 1/2 days prior, child's personality was a bit off Y (fussy and4/14/2008
not eating 4/21/2008
as well), but no other h
ely after receiving her second varivax in her L arm she began to have hives that would comeYand go. She4/25/2009 was given4/25/2009
2 tsp of diphenhydrami
uth pain on right leg and itching the Y day after. Five days later gave shingles 4/22/2009 4/27/2009
at site starting at 4/23 increasing toYredness and swelling at the site on 4/24. Headache, diarrhea, U nausea,
4/23/2009
vomiting, 4/23/2009
anorexia beginning on
d increased pain that evening and then had red stripe formed below injecttion site- still present U 2 days later.
4/20/2009
Lips became
4/20/2009 swollen for 2 day
ne disease fibromyalgia,Yraynods, numbness,
Y flushing/sweats, anxiety,headaches, Y exhaustionN to the point9/8/2008
where its12/1/2008
impossible to work, tot
ort was received on 21 April 2009 byYanother manufacturer that received the report from a healthcare N professional
2/26/2009on 13 April 2009. A male
ort received on 21 April 2009 from the Y patient's spouse. A male patient (demographics not provided),
N who has autoimmune reactions to milk
mptoms for two to three Yweeks. Numbness
Y in feet
Y - leg cramps - back
30 Ypain in spinal area - problem
U walking (paralysis).
### Hospitalization
### - tes
9 pt came to my office - her VARICELLA vaccine site had a 3 inch circle that was red, hot, painful Y and hard.
4/18/2009
Call to 4/18/2009
mom, ice applied, BENE
& swelling after inj. given & cont >4d after inj. while pt on AUGMENTIN for puncture injury 4/23/2009. Y 4/23/2009 4/23/2009
9 pt presented with classic herpes zoster outbreak (R) side torso (not crossing midline). U 10/6/2008 3/24/2009
anus shot in clinic on 4/21/09, seen in Y urgent care on 4/24/09, site of injection upper left arm,Uwarm, red, tender,
4/21/2009 reaction
4/22/2009
first noted by patie
/2 hr after immunization given, pt noticed slight nausea. At 5:25 PM she became very nauseated U + vomited
3/26/2009
small amt.
3/26/2009
TPR 99 degrees F
area with redness, warmth approximately 6cm X 4cm. No induration temperature 99.4 f (tympanic) U Rx: Apply
4/17/2009
cold compresses
4/19/2009 to site pm Ty
called doctors office 4/16/09 @ 1424 Y and left message for doctors office that pt was in ER on Y 4/15/09 for 4/7/2009
seizure episode.
4/15/2009 Records receive
-09-09 I started getting a 'burning - itchy' feeling on right (back) thigh - it was painful - itchy for
Y about 9 days
3/13/2009
- (and red) 4/9/2009
it was now gone.
Flu and PNEUMOVAX 3/24/09 one in each deltoid. Pain since - Limited range of motion, very Y painful. Referred
3/24/2009 to physical
3/24/2009 therapy - Given
rent called, red puffy (R) leg - local imm. reaction - 1/15/09 Parent called, fever >101 on 1/14/09. Y Red bumps 1/5/2009
on face,1/15/2009
neck, belly and arm -
injection erythema and pruiritis localized to site 1X2 L upper arm. Oral antihistamine and steroid Y cream prescribed
4/20/2009 after4/21/2009
days with injection.
swollen arm, hot tender Y 4/15/2009 4/15/2009
swelling of arm; Hot. 4/15/2009 4/15/2009
sh, few hives occurring after 15 minutes of MENACTRA Admom. Given 37.5 mg BENADRYL Y P.O. 5 minutes
4/16/2009
later c/o
4/16/2009
tight chest - given E
d first GARDASIL injection 4/10/09. On 4/12/09, noted 1cm round tender axillary node. U 4/10/2009 4/12/2009
ankles, elbows, arms, and legs. C/o rash being itchy; 0 trouble breathing. U 3/30/2009 3/31/2009
loose stools, fever Tylenol. U 4/15/2009 4/15/2009
itching, Skin Inflammation topical Cortisone,
Y Oral Prednisone Ultra violet light N 1/21/2008 ###
4 1/2 hours after patient got the vaccineY she felt light headed + dizzy and then became unresponsive,
Y eyes
4/17/2009
deviated4/17/2009
upwards, slight jerking
utes after Pt received 2nd VARIVAX, she started to c/o of sore throat, PF; bilat. wheezing, no Y swelling of4/23/2009
lips; improved
4/23/2009
after Epinephrine 0
cella at VARIAX shot site 1 - 1/2" closed up vesicles on red base. Y 4/6/2009 4/18/2009
9 around 11:30 A.M. had vaccine within minutes felt light-headed and woozy, strong feeling Yabout 2 hrs,4/16/2009 then took 3hr 4/16/2009
nap and gone when
omplained of itching at injection site within 5 mins. of administration. Red rash appeared at Y 10 mins Benadryl
4/22/2009given4/22/2009
to member.
vaccine 041409 fever low grade -> Y 101.8 from 041409 -> 042009. Anorexic, personality changes. U Fever4/14/2009
- no response 4/14/2009
to Tylenol or Motrin.
eloped on back, abd, arms & leg. RednessY & itching. 0 sob Symptoms began 4-21-09 p.m. Y 4/20/2009 4/21/2009
break along 2 T-11. Dermatome within 48hrs of receiving vaccine U 4/14/2009 4/15/2009
rted "dime" size swelling- redness at Y inj. site - "nickle" size swelling/redness itchy under injection
Y site on 4/13/2009
4-14- Child4/14/2009
to ER R/T swelling/redn
after vaccine administration, child felt sick, went to bed early. Awakened in AM with arm pain, swelling, redness 3/30/2009 increasing
3/31/2009 so much that cou
vaccine on 4-21-2009. When awoke on 4/22 didn't notice rash. Got to school + noted rash> Y went to school
4/21/2009
nurse who 4/22/2009
stated she has' hives
unable to bear weight on left leg). Per Y mom happened after given vaccine. N 4/8/2009 4/9/2009
7:50 PM Mother called to after hours triage and report states that Mom reported 'arm swollenYfrom shoulder 4/20/2009
to elbow,4/21/2009
mild redness - no red
pper arm: L red, warm, indurated. Slightly tender. Y 4/15/2009 4/15/2009
ollowing vaccinations, then labwork (Had vaccines, then labs, then syncope occurred - Nothing Y to eat today).
4/23/2009 4/23/2009
4 cm allergic skin reaction CLAITIN/ZARTAC U
OSTAVAX vaccine 4/14/09. Pt developed Y painful case of shingles 4/27/09 requiring treatment U in the ER4/14/2009
(Valacyclovir,4/27/2009
Vicodin)
nd the area itchy, raised area from the Y base and warm to touch, she had Td 10 years ago butNno reaction. 4/17/2009 4/22/2009
hy. Knee pain. Fever. Rash. Y U 4/8/2009 4/12/2009
w hours - splotches noted on both hands Y - Inj given @ 5:15 pm 4/22/2008 1) Eye swollen 2) splotches
Y - now
4/21/2009
hives on4/21/2009
chin / both ears/ rash
ved 4/20/09 - Pt states itching and feet swelling started next day - took BENADRYL - helped,Ubut is having 4/15/2009
itching and4/16/2009
swelling in feet today
tenderness & increased warmth at injection
Y site. Y 1/19/2009 1/26/2009
n has been received from a consumer Y concerning a her daughter 21 year old with Y penicillin allergy
N and no6/17/2008
pertinent6/17/2008
medical history who in
n has been received from a physician concerning Y a male patient who 0 was vaccinated, "within N the last few4/18/2009
days", with 4/18/2009
ZOSTAVAX (Oka/Me
ort received on 15 April 2009 from a pharmacist.Y A 42 year old female 1 patient, who has no known
Y allergies,4/8/2009
a history4/11/2009
of hepatitis B infection,
us case was received on 20 April 2009 Y from another manufacturer whose initial reporter wasUa consumer. A male patient (age not provided
se effects. Received the Tdap vaccination and current age is 69 years. Y 4/27/2009
PED FEVER ON 4/23/09. TOTAL BODY Y RASH(MORBILIFORM) DEVELOPED ON OR ABOUT N 4/24/09.4/15/2009 4/23/2009
8 Client received both Pentacel (DTaP, IPV, HIB) and Pediarix (DTaP, IPV, Hep B) at the same U visit. 4/22/2009 4/22/2009
as very irritable and "not himself" for a duration of 3 days after administration of the second dose Y of Hep A 4/21/2009
vaccine. 4/21/2009
tient recieved four doses of Anthrax between the dates of 02-JUN-08 and 06-AUG-08. U 3/19/2009 3/19/2009
OT SLEEP AT ALL, JOINT PAIN, SWEATS, CHILLS, SWOLLEN ARM Y 4/27/2009 4/27/2009
profuse sweating, disoriented for 10 minutes Y 4/24/2009 4/24/2009
ours of Tdap and Varivax administration,
Y patient experienced redness,itching,and swelling ofYLeft upper 4/24/2009
arm.Mom applied4/24/2009 cool compresses
minutes after IPV,Prevnar and Hep A given, child developed 3-4cm hive on right wrist and 2 Ysmaller hives 4/28/2009
on back and4/28/2009
chest.Wheals noted
ctivity taken by ambulance to hospital Y 18 hours after vaccine given. Patient has no previous U events of seizures### ever. 5/4/09 ### MR received fo
HAD VACCINE ON 4/21/2009AM, CAME BACK ON 4/22/09PM AND WAS COMPLAINING U OF PAIN AROUND
4/21/2009 THE4/22/2009
INJECTION SITE, LE
ated on a chair in exam room one with mother and younger brother present. Patient given HPV, Y Tdap, and 4/20/2009
Menactra 4/20/2009
vaccines at 4 pm by R
### N ### ###
s: hives, vasculitis, joint pain, swelling
Y of feet, hands & eyes, extremity pain, fever up to 101. Ufor 3 days. Treatment:
4/15/2009 benadryl,
4/16/2009steroid pack,
ped an egg shaped reddened, hot area on the upper back part of her right arm where she got Y her varicella
4/27/2009
shot yesterday.
4/28/2009 It was noted by
VEN 4/22/09 IN AFTERNOON. LEFT Y UPPER ARMS SORE REST OF LAST WEEK. EMPLOYEE Y DESCRIBED
4/22/2009 A FIRM
4/27/2009
LUMP AT INJECTI
oke out in hives all over her body, which was highly pruritic. Felt some throat swelling but not Y enough to 4/21/2009
constrict airway
4/21/2009
completely. This o
ped hives after injection and was seen Y in the ems - f/u at pcp today 4/23/2009
eived the influenza, pneumococcal (PPV23), Tdap, MMR, Hepatitis A, Hepatitis B, and shingles U Vaccine 4/22/2009
at 10:10 a.m. 4/26/2009
at clinic. Client then
d Tdap on 4-22-2009, IM in left deltoid swelling stated 3 days later. Redness from top of deltoid U to elbow4/22/2009
and area is4/25/2009
hard and warm to the
ates arrived home @ about 11 am. YPt. began having reaction starting @ about 11:30 am. Began Y with swollen
4/24/2009 mouth,
4/24/2009
then right eye, then c
C/O PAIN STARTING 8 HOURS AFTER Y SHOT WAS GIVEN. REDNESS ON ARMPIT AND LEFT DELTOID. 4/24/2009 4/24/2009
ived a 4th DTaP and IPV as well as a 5th Hep B when she was given a Pediarix vaccine 4/22/09 Y at less4/22/2009
than 12 mos 4/22/2009
old, 1 Pediarix not on
ately 1 minute after receiving the vaccines the patient passed out without any warning - he had Y a mild tremor
4/28/2009of the arms
4/28/2009
and legs that last
tient was quite irritable and slept a lot, maybe for the first three days. The worst symptoms IUsuspect come 4/20/2009
from the4/20/2009
rotateq vaccine, since
hange in feeding pattern and marked temporary loss/regression of social milestones approximately Y 1 week7/20/2007
following7/27/2007
routine 2 month immun
eloped bilateral buccal mucosa swelling Y 7 hours following MMR vaccine. swelling is non tender N and only 4/28/2009
from the inside.
4/28/2009
no visible external
was reported by a lawyer and described the occurrence of arthralgia in a female subject of unspecified
U age who was vaccinated with LYME
was reported by a lawyer and described the occurrence
Y of arthralgias
0 in a male subject of unspecified
U age who was vaccinated with LYME
was reported by a lawyer and described the occurrence
Y of Guillain-Barre
0 Syndrome
Y in an adultN male subject12/1/1996who was vaccinated with INFL
eption reduced 5/04/09 Received vaccine & PCP Y medical records of1 4/13-4/27 as well as hospital
Y d/c summary
4/13/2009 of 4/27-4/28/2009.
4/26/2009 FINAL
Yellow fever immunization 3-18-09 prior to trip Y to a foreign country. 3Developed flashing spells Y 3-29-09. Received
3/18/20093 L3/29/2009
IVF prior to departure.
surfaces rash on elbows, knuckles, Y knees. SkinYbx: leukoclastic vasculitis
2 consistent with erythema
Y elevatum 7/1/2008
diutinum.
7/26/2008
5/26/09 medical rec
h screams for 3 days and for 10 days: Y lethargy (limp)
Y - Non reactive - lack eye contact avoid communication
Y 3/2/2009
- stopped3/2/2009
feeding - stopped lau
Flu Vaccine on Oct. 10, 2008. 5 days Y later began fatigue which progressed to anaphylaxis,
Y episode
N 1 on October. ### Received ###corticoteroids.
aricella #2 9/26/9 (1st dose was 5/03) within 24 hrs flat rash noted on chest, face & neck. Wo Y c/o rash to chest c/o itching on neck, face wit
rm swelling red, tender, itchy after vaccines given 2 d ago- progressively worse 4/26/09 afterYpain but mostly 4/23/2009itchy. 4/23/2009
L arm few small slightly
oster type rash developing on R lower leg 6-7 days after vaccination examined today 4-27-09. N No other identifiable
4/13/2009 cause.4/20/2009
th pain at the injection site 5 1/2 hrs after immunization, low grade fever 18 hrs after injection; Y 24 hrs after4/24/2009
injection arm
4/24/2009
painful to touch, sw
le of erythema on right side of (L) thigh.
Y A bit of induration, but no underlying mass and no warmth."Y This4/21/2009
is MD's report.
4/22/2009
Also says "local rea
of breath, tingling, sweating. Y 4/28/2009 4/28/2009
es, high fever. At night chills, sweating, sore joints. Symptoms continued until Friday. Sunday U slept late4/23/2009
still had sweating/chills.
4/23/2009 Right now
4/28/2009
nto office + reported vaccine site was red, raised + warm to touch. Presently abscent disappeared Y on its own. Zero intervention needed.
s after getting vaccine, arm becameYred, swollen, and described itching at site of vaccine, pain Y to move. 4/24/2009
Applied ice4/24/2009
that evening. Mom stat
d to hospital 4/23/09 with reported edema - redness and tenderness of left deltoid. Treated with Y KEFLEX 4/20/2009
250 mg TidX7days.
4/23/20094/27/09 only s
n at injection site beginning 4/13/09 in the evening. States she noticed inflammation, redness, Y and warmth 4/13/2009
at injection
4/13/2009
site on 4/15/09. Relie
a of petechiea under right eye within 5 minutes of vaccine adm., approx 1/4" wide X 1/2" wide Y -was crying4/22/2009
vigorously4/22/2009
prior and during vaccin
shakes chills abdominal pain sore throat, headache started at 10 pm on 4/6/09. Y 4/6/2009 4/6/2009
orts rash to inner arms approx. 10 minutes after receiving vaccines on 04/09/09. Clients states Y she began4/9/2009
to experience4/9/2009
pain in Rt shoulder
ools, crying spells, abdominal pain crumps,
Y decreased appetite, diarrhea. Per mom Y 2/24/2009 2/26/2009
loped rash behind ears, back of neck and on face then went to arms, torso and legs. Had running nose : raspy 4/6/2009breathing.
4/19/2009Saw on 4/23.
ack into office. Per mother child had been crying since received vaccine. On examination swelling Y of the4/20/2009
upper R thigh4/20/2009
warm to touch red a
stered VARIVAX and DAPTACEL in (R) Thigh on 4/21/09. On 4/22/09 Pt developed quarter N size area of 4/21/2009
redness, swelling,
4/22/2009 with pruritus. Gi
eneralized 2 days after immunizations Y Y 4/15/2009 4/17/2009
en instead of TDAP. Y 9/12/2008
of LA, tender, hot, itchy - 2nd patient with same reaction to same Immunization Y 4/21/2009 4/21/2009
er vaccine developed diarrhea, > 10 times per day initially, some mucus - straining noted, noYblood. No 2/25/2009
fever, no ill 2/28/2009
contacts.
ness, itching & induration @ left thighY surrounding site of immunization within about 24 hrs. of U vaccines -4/20/2009
treated with 4/21/2009
BENADRYL
4/23/2009
er had bad stiffness on back of neck and then it went down both sides of torso. Called doctor U but said not
10/1/2008
related to vax. Pain on back sub
t 8:45am patient was vaccinated at Y the Health Department with Hepatitis A vaccine at 8:47am Y patient fainted.
4/27/2009Nurse4/27/2009
saw her unresponsive,
4/20/2009
rapid hair loss a month after administration of GARDASIL vaccine 8/1/2008 3/15/2009
eloped 2 days after shot - first on arm where shot was given then all over body. Headache today N - 4-28-09. 4/20/2009 4/22/2009
r HEP A with in 24 hr ATAVAX if needed. Y 4/8/2009 4/9/2009
ad at clinic c/o having reaction - redYrash noted on arms, legs, face - stomach and back approx U 2 min hard 4/28/2009
hot redness
4/28/2009
area noted at injecti
dness, edema 3 d after vaccine. 4/21/2009 4/24/2009
Mom reports that client "walks strange, bobs head, hands shake, and coordination is off" afterNseries of hepatitis 7/1/2001b vaccines
8/1/2001in 2001-2002.
swelling and pain at injection site. Tenderness and slight rash also noted. 4/14/2009 4/15/2009
vaccine on 4/13/09- symptoms began morning of 4/18/09, severe headache - 2 reddened areas N R shoulder;4/13/2009
one just
4/18/2009
above acromion proce
ction at injection site right thigh - warm, red & swollen Rx'd with MOTRIN & warm packs. resolving U 4/23/09
4/21/2009 4/22/2009
esented to clinic on 4/24/09 c/o right arm pain extending to neck and fever. Upon examination, U right arm 4/22/2009
edema from 4/24/2009
shoulder to elbow. Rig
hoarse and hives - She lost her voice I was very scare so I took her to her doctor. Y 4/7/2009
unk and back that started about 4 days Y post smallpox VX. U 4/10/2009 4/16/2009
VAX administered right deltoid 4/21/09 after leaving office, pt started to develop pain in rightYupper arm. 4/21/2009
During rest4/21/2009
of day and night, pain i
ped hives right after vaccinations and for 1 week has raspy voice - increased vomiting, crankiness Y and episodic
4/15/2009 hives.
4/15/2009
Was treated with 3 d
hours, developed fever - 101.8 degree - Aching joints, headache. Treated with Ibuprofen. Duration Y - 12 hours.
4/17/2009 4/18/2009
er, with bulging fontanelle and CT scanY with prominence of anterior CSF Spans over both frontal Y and temporal
4/6/2009
lobes 4/7/2009
- No hydrocephalic. Th
d rash appox. 1 1/2 " X 1 1/2. Very itchy. Pt. observed for one hour post 25mg po Benadryl. Y 4/14/2009 4/15/2009
tous area surrounding injection site 5x5 cm diameter with mild tenderness to palpation no fluctuance.
U Will try for possible infection. AUGME
e pale after the vaccination, lost consciousness
Y for 3 minutes - appeared to have a seizure vital
Y signs stable.
4/18/2009Paramedics
4/18/2009came and pt. refu
ceived BIOTHRAX in 2000. Over the last year his ankles, wrists and knees became inflamed. N He was diagnosed
6/3/2000with4/4/2008
autoimmune hepatiti
n has been received from a health careY professional
Y concerning an 311 year old female patient
Y who on an12/1/2008
unspecified 12/1/2008
date was vaccinated
n has been received from a consumer concerning her now 5 year old son with OMNICEF allergy N and a history
10/1/2004 of bronchiolitis
10/1/2005 at 5 weeks of
n has been received from a female Y patient, with iodine allergy and "severe food allergies", who
Y on approximately
5/9/197709-MAY-1977,
5/9/1977 at the age
n has been received from a consumer concerning her friends' boys who on an unspecified dates U were vaccinated with MMRII. "One week l
t was received from a health care professional Yon 16 April 2009, and 1 refers to a serious adverse
Y event experienced
11/3/2008 12/1/2008
by a subject participatin
ort was received 28 January 2009 from Y a consumer, who is also the patient. A 59-year-old female N patient with
5/1/2007
history 7/1/2007
of a recent black wido
ering entire body, swelling of joints, Y
benadryl, oral steroids Y 3/9/2009 3/9/2009
min. post injection patient had mood change, redness, swelling at injection site along with legYpain. We watched 4/27/2009 patient
4/27/2009
for a while and then
eived Tdap without any symptoms of concern. Then, immediately after HPV vaccine was given, Y the client4/29/2009
complained 4/29/2009
that her arm hurt. She
o Tdap, muscle aches, headaches, fatigue. Worst was injection site allergic reaction to pertussus U vaccine.
4/24/2009
Arm was 4/25/2009
very red, swollen, ver
a around the Shingles vaccine U 4/27/2009 4/29/2009
eports beginning to feel nauseous 6 hours after receiving vaccine. 18- 24 hours post vaccination Y member4/27/2009
reports nausea
4/27/2009
and 2 incidents of
VER WITH NORMAL CBC,PARENT REPORTED 106 DEGREE FEVER THE NIGHT VACCINE Y WERE GIVEN 4/28/2009 4/28/2009
d MMR and Varicella vaccines and immedicately developed redness and swelling at both injection Y sites 4/17/2009
and hives on 4/17/2009
abdomen. No respira
oid- 2 days sfter vaccine administration, the injection site is hard, red, warm to touch and tender upon palpation. 4/27/2009 4/28/2009
oster C34 dermatoma Greater than 20 vesicles U 4/1/2009 4/29/2009
igns begin with a pain in my right arm Y three-four Y days after my vaccine.
6 I was not able to raise
N it above my head. ### The
11/2/2008
pain moved to my sh
RASH THATS GETTING WORSE AND SPREADING U 2/15/2008 4/24/2009
njection in deltoid. developed over next 24 hours swelling, erythema, pain, and fever and general Y mailaise.
4/17/2009
this lasted
4/18/2009
for three days.
m injection site a 15x15cm soft nodule appear while appling pressure to syringe with some resistence noted. 4/29/2009
Soft nodule
4/29/2009
with reddnes and n
, facial swelling- in pts temples U 4/28/2009 4/29/2009
4/24/2009 N 4/21/2009 4/23/2009
le subject was enrolled in non-GSK study. Medical Y conditions at the0time of the event included U seizure disorder.
8/28/2003 Concomitant
8/29/2003medications i
tient consult has been requested onYa 20 y/o WM Y ADSM hospitalized for severe thrombocytopeniaU and ITP4/16/2009
in association
4/23/2009 with the receipt o
. Baby presented the day after receiving his immunizations
Y with fever,
2 vomiting and diarrhea.Y Baby had been4/21/2009
having4/22/2009
watery stools 2 to his
patient came for a well childY check, Y immunizationsY given at 9:30AM 3at around 1:30PM patient U woke up from4/27/2009
sleep cried
4/27/2009
and turned limp, ca
usea, HA, sore throat, rhinorrhea, + Ycough. Sx started hours after typhoid vaccine given. Given Y Augmentin 4/17/2009
875mg 4/17/2009
BID x 10d.
ction on R upper arm (injection site) with erythema, warmth and mild tenderness. Keflex 500Ymg PO BID4/28/2009 x 7 days BENADRYL
4/29/2009 25 ml after 6
arm was sore for 3 days. Then in a week Y she started having spasms in her arm that continueNto happen at 10/8/2008
night still.10/9/2008
Has gotten a steroid s
dministered on 4/23/09. Immediate Y bruising noted 1/2 dollar size. Bruising dissipated over weekend
Y but Pt4/23/2009
developed 4/23/2009
site of erythema, rais
udent in nurses office or immunization clinic. Rec'd 5 vaccines - after several min of sitting lookingY @ stickers
4/29/2009
leaned4/29/2009
to (L) an fell out of cha
U 4/27/2009 4/28/2009
3-4 lesions with cellulitic area on (L)Y thigh. Topical warm compress and PO Augmentin. Y 4/20/2009 4/28/2009
hematous rash under the skin on the anterior aspect of both lower legs, vaccine site normal. YRash was noticed 4/28/2009right4/28/2009
after vaccination. Obse
wollen and red about 10 cm X 6 cm Y within 1-2 hours after getting vaccine - given oral steroidsU and Antihistamine.
4/28/2009 4/28/2009
ADACEL on 4/16/09 and by 4/18/09 the right arm became entirely swollen and the injection Y site became4/16/2009
indurated, 4/18/2009
reddened, painful and s
out in hives face to legs 1 1/2 hour after receiving MMR II vaccine. Parent went to daycare, did Y confirm hives
7/21/2008
with moderate
7/21/2008 wheezing. BEN
iven 10:15 A and by 12:00 MN 102 Y deg and 4:00 increased 103.7 vomiting and fever. Seen Y by Dr later in4/20/2009
day 2 pm 4/20/2009
c/o pain (R) shoulder, r
meter redness, and warm to touch area Y surrounding shot site. U 4/23/2009 4/24/2009
ed the Zostavax vaccine on 4/3/2009. About 2 days after the injection she noticed a big, red,Uand swollen4/3/2009 area on her4/3/2009
upper arm. She repo
received the roto vaccine - by mouth - along with her other 2 month vaccinations - injections-. U She had blood in her4/22/2009stool and extreme disc
er DTAP, arm red & swollen & warmYdeltoid area. No fever. U 4/27/2009 4/28/2009
n has been received from Y a certifiedYmedical assistant concerning a 71 year old maleY who on Y 01-JUL-2008 7/1/2008
was vaccinated
7/7/2008 with PNEUMOV
n regarding PREVNAR was received from a healthcare Y professional0regarding a 2-month-oldY female patient
4/27/2009
who experienced
4/27/2009 apneic episo
was received from a health professional Y on 07 November 2008, and represents a cluster of Y 20 patients. Twenty ###
patients, ###all employees of
n has been received from a licensed Y visiting nurse, for the GARDASIL a Pregnancy RegistryYconcerning3/20/2009a 23 year old3/20/2009
female with hypothy
n has been received from a nurse concerning
Y a 36 month old male who on 07-MAR-2006 was N vaccinated4/4/2007
with a first 4/4/2007
dose of PEDVAXHIB
n has been received from a nurse, for Y the Pregnancy Registry for GARDASIL, concerning a Y27 year old 7/22/2008female with7/22/2008
cephalexin allergy and
stered to patient. Less than 3 minutes Y later patient was leaving clinic and collapsed to floor. YHe did not have
4/29/2009
any trauma.
4/29/2009He was cold and s
udent mistook Menactra as the diluent for the varicella and injected it subcutaneously. No problems Y with4/29/2009
patient therefor
4/29/2009no treatment need
veloped maculopapular rash over entire Y body 14 days after vaccine administration. Patient seen
Y 4/18 for 4/1/2009
this rash (by
4/14/2009
MD), and unclear if v
ills, Bodyaches, Nausea, Vomitting,Yand local site reaction (redness, tenderness) U 4/27/2009 4/28/2009
9 PATIENT WAS ADMINISTERED THE SMALLPOX VACCINE AS A REQUIRED PROPHYLACTIC Y BEFORE 4/3/2009
DEPLOYMENT
4/20/2009 WITH HIS U
ential swelling and redness to right upper
Y arm/deltoid, especially near area of vaccine administration,
Y +pruritis,
4/28/2009w/in 4/28/2009
the first 24hrs of vaccine
esented to the ER with R arm swelling Y with redness and puritus. Y 4/28/2009 4/28/2009
e severe pain in left arm, 'as though someone just broke it'; headache developed; 24 hours ofNjoint and muscle 2/23/2009pain;2/23/2009
within weeks, sharp sta
WAS GIVEN ALL THREE VACCINES HEP A#1 (RIGHT ARM), MCV4 AND HPV#1 (LEFT ARM) Y IN THAT 4/29/2009
ORDER,4/29/2009
WHEN I WAS APPLYI
arm to the touch and red Y 4/27/2009 4/28/2009
aricella rash began 04/28/2009 treating with Y 4/7/2009 4/28/2009
lled me the day after the administration complaining of Headache, Fever, Chills, Loss of apetite. U I explained that she was experiencing a ra
.3F and chills and Severe headache Y began at 2:30am. Pt came to health unit at 0830. Pt given Y Tylenol 650mg
4/28/2009 and 4/30/2009
slept. At 11:30 pt report
ed today, stating she had just noticed a rash around the site of injection, also c/o itching fromUrash. NO fever 4/23/2009
or other
4/30/2009
symptoms.
as seen by this physician three days after administration of Menactra. He was complaining ofU back pain,3/24/2009 shoulder pain,
3/24/2009
headache, lighthea
ening, fussiness, constant crying, poor Y appetite, vomiting, skin rash (head, face, neck, ears, Ybehind ears,4/14/2009
abdomen,4/17/2009
back, legs, arms, feet),
4/27/2009 N 4/24/2009 4/27/2009
wn with Evans SyndromeY3/15/09. Seen Y for irritability
Y 3/7/09. 5/4/0919Received
Y hospital medical
U records of 3/4/2009
multiple admits.
3/15/2009 FINAL DX: throm
d neck right arm pain immediately afterY head/neck trauma in Mar 2003; received AVA#4 Y oneNmonth later4/26/2003
with continued neck pain, intermitt
veloped severe systemic rash, elevatedY temperature, continuous crying, inabilityYto sleep. ANmonth later patient### stopped smiling,
### and devel
h stomach pains, rash on the top and Y bottom ofYboth feet. Stomach14pains were intermittent then Y became2/28/2008
constant. 13/10/2008
year later 2/09 diagno
+ swelling, heat @ site of injection erythema 130mm X 70 mm - slightly indurated. Y 4/29/2009 4/30/2009
ived above listed vaccines 11-20-08Y at routine WCC visit at 12 noon. Child developed tactileYtemp 11-21-08 around ### 1pm followed
### by pruritu
mplained of headache, ringing in ears, + occasion blurred vision. Given a Medrol Dose pack.U 4/22/2009 4/22/2009
warmth to injection site - 4/28/09 @ 8 AM followed with itching, increased heat/swelling on same morning. 4/27/2009
By 9 PM4/28/2009
on 4/28/09, she had a l
ports patient complaining of severe headache and (L) arm pain at school today (11 AM) -Become Y unruly 4/27/2009
and "violent" 4/28/2009
with staff at school. T
d 12 month vaccinations on 4/18/09. Y She had zero reaction at first, but 1 week after shots pt. Y began having 4/8/2009
a fever.4/20/2009
This lasted 4 days off
Hrs of vaccine, pt noted extreme tenderness, and swelling of upper arm. Sx worsened over next N 48 Hrs. 4/27/2009 4/27/2009
x 15 min & c/o HR. No sensitivity to light/sound, dizziness, lightheaded. Pt instructed to take U Tylenol & call
4/23/2009
if symptoms
4/23/2009
persist/worsen.
d swollen with erythema over large area. (4" x 3") Y 4/28/2009 4/29/2009
er arm with redness, swelling & warm Y to touch qcm in size Dx with cellulitis. Y 4/21/2009 4/22/2009
wollen, hot, reddened (size of a softYball) hard lump - VARIVAX. Right arm same but the sizeNof an apple4/22/2009 - MENACTRA. 4/23/2009
face and back. Y 1/12/2009 4/25/2009
erythema & swelling extending 3 cmY inferior to lower shot & 1/2 cm above upper injection site Y - supportive4/16/2009
care ZYRTEC
4/18/20091/2 tsp daily prn -
e slightly lightheaded immediately after receiving GARDASIL #3. She layed down but continued Y talking 4/17/2009
& said she 4/17/2009
felt fine. She walked ou
eloped chicken pox disease - in clinic 4-24-09. U 10/2/2008
er injection: lip swelling, nausea, redYinjection site. 48 hrs after injection: larger area of redness
Y with central4/13/2009
bullous lesions.
4/15/2009 Treated for 1 1/2
es 2 days after vaccines patient's eyesY rolled back in her head, she stiffened out and was "slobbering".
Y Denies
4/1/2009
increased
4/3/2009
temperature. Calle
miting + diarrhea 48 hours after vaccines
Y given. Went on to develop URI sx's - v/d were <24Uhours. 4/22/2009 4/24/2009
use my arm/shoulder, extreme pain & tightness. Unable to work due to some of the requirements N of my3/18/2009
job. I had 3/18/2009
X-rays taken & have be
s, odynophalgia, nausea, vomiting, decrease appetite, dizziness. Y 4/20/2009 4/20/2009
immunization site reaction 4cm X 6cm Y erythematous area on upper right arm. Warm, clearlyYdemarcated2/25/2009 area, tender2/27/2009
to touch, no streakin
pain, local reaction seen in office 2/25/09 T97.7 P75 R16 Erythema at injection site rest of exam U normal,2/18/2009
BP 124 / 76 2/18/2009
Wt 215 lbs, 4/7/09 sti
was reported by a pharmacist and described the occurrence of injection site pain in a subject U of unspecified age and gender who was vacc
was reported by a healthcare professional
Y and described the occurrence of wrong route of administration
N 1/7/2009
in a 19-year-old
1/7/2009male subject wh
was reported by a healthcare professional
Y and described the occurrence of wrong route of administration
N 1/7/2009
in a 19-year-old
1/7/2009male subject wh
was reported by a consumer and described
Y the occurrence of watery eyes in a 58-year-old male
N subject who was ### vaccinated### with (FLULAV
reported by a healthcare professional via a sales representative and described the occurrence U of injection site reaction in a subject of unsp
was reported by a consumer and described
Y the occurrence of itchy rash in a 75-year-old maleN subject who 11/5/2008
was vaccinated
11/7/2008 with (FLULAVA
: SM contacted VHC reporting receipt Y AVA #2 on 4/8/2009 (lot# unknown). The next day he U had numbness 4/8/2009
to right 4th/5th
4/9/2009 digits. 4/10/09 th
ter was given all three doses
Y of Gardasil
Y on 8/28/08,
Y then on 11/1/08,3 and the last on 3/7/09.NOn April 11,3/7/2009
2009 my daughter
4/11/2009suffered with t
BALL SIZE NODE IN ARMPIT OF SAME ARE ARM AS INJECTION SITE. MADE SLEEPINGUDIFFICULT4/20/2009 AND ARE4/30/2009
MOVEMENT PAINFUL
00.7F, body aches, HA, sore throat, fatigue, dizziness, sore arm Y 4/27/2009 4/28/2009
indegestion, lack of appetite, weightloss,
Y dizziness, abdominal pain, fever, fainting, listlessness
Y and nausea. 1/7/2009
This lasted
1/8/2009
from date of vacci
erythema Left shoulder and axillaryYarea. Lymphadenopathy. Y 4/17/2009 4/27/2009
r chest, back, and arms. ITCHING,YNO DRAINAGE. Y 4/17/2009 4/27/2009
ports client with elevated temperatureY (average 101) following vaccinations,also reports moderate Y cough.4/24/2009
Temperature 4/24/2009
continued elevated
ardened red area mid clavicular, leftYside, pea-sized. Vaccinatiion site, left deltoid, erythematous.Keflex
Y 500
4/18/2009
mg 1 tab 4/18/2009
4Xday X10 dys
mom stated symptoms of redness and Y swelling at injection site on left upper arm developed on Y 4/28/09 in4/27/2009
the evening.4/28/2009
Arm felt hot to the to
dministered on 04/28/2009. Within 24 hours swelling, fever at injection site, tenderness,and N increasing redness
4/28/2009 appeared.
4/28/2009 Within 48 hours
stated sylmptoms of redness and swelling @ injection site of left deltoid on 4/29/09 in the morning.
Y Arm4/27/2009
felt hot to the
4/29/2009
touch Dr. Knox at No
hrs after DTaP pt had fever with seizure.
Y He had had a febrile seizure the night before with diagnosis of4/29/2009
ear infection.4/29/2009
nd Pain at injection site, increasing Y
in size. Cramping in stomach with meals. Cellulitis LeftYArm. Keflex 4/18/2009
EQ 250mg 4/30/2009
4 times daily X10 day
SEIZURE ON 28APRIL2009, MOTHER Y OF PATIENT CALLED 911 AND WAS TAKEN TO THE Y ER BY 4/20/2009
AMBULANCE 4/28/2009
Erythema Multiforme on back associated
Y with puritis and uncomfortable. No respiratory distress.
Y Epinphrine
4/16/2009
0.3mg4/30/2009
IM, Benadryl 50mg IM
area at site of each injection. N 4/23/2009 4/24/2009
MATELY 3-5 MINUTES AFTER RECEIVING THE VACCINE THE PATIENT SUDDENLY PASSED Y OUT4/27/2009
- SHE HAD 4/27/2009
NO WARNING - SHE
after administration of MMR client noticed reddness the size of 50 cent coin. The following day Y (5/1/09) swelling
4/24/2009 had 4/30/2009
increased to 50mm in s
Left legs had cellulitis, redness. DidYrequire IV Yantibiotics for 4 days.1 5/22/09 Received hospital
Y medical4/27/2009
records of 4/28/2009
4/29-4/30/2009. FINAL
N
he day after receiving the vaccine) Y the patient returned to the provider's office with-3 spots ofU maculopapular
4/28/2009
rash on 4/29/2009
9, Pt came in for #2 GARDASIL. Pt had no adverse reaction to #1 dose. Pt had a vasovagalYepisode immediately 4/24/2009after 4/24/2009
vaccine given. Pt ha
hours after admin of vaccines began Y vomiting Q 30 min- was taken to ED- called night clinic X2. 4/29/2009 4/29/2009
ea on right deltoid of erythema and induration, noted about 24-36 hours after vaccine. Ice applied. Y 4/29/2009 4/30/2009
ke a size of a baseball hot and red. Y 1/14/2009 1/15/2009
eaded with tunnel vision (compared to distorted vision experienced with ocular migraine headaches Y experienced).
5/1/2009Bp5/1/2009
156/90, pulse and res
area red and swollen about half of back arm, hot to touch, hurts to touch and itching. Y 4/29/2009 4/29/2009
on (MD): Pt had dried like zoster rash Y to forehead X 3 days with mild fever only. Now has vesicular (urticaria) 4/16/2009
rash with
4/26/2009
sciatica without feve
thy 4 mo. old admitted toY ER statusYepilepticusYand intubated upon 7 arrival. During hosp. hadYposs. aspiration
3/23/2009
pneumonia
4/13/2009
(+) culture Moroxe
area right upper arm warm, pink sl. firm. Symptoms decrease today with papular at injectionYsite. No anaphylaxis 4/25/2009sx4/26/2009
- no encephalopathy s
m Erythemic warm rash on Lt thigh. Mom putting salve on it. That is helping. Pt mom statesNgot whole body 4/24/2009
rash @ 2 months with vacc.
open cut. used rubbing alcohol to clean at home. Has clear liquid at injection site after couple Y of days, then12/2/2008
it scabbed
12/2/2008
over and got better.
welling and redness of whole right upper arm for 3 weeks. Hives and welts everyday for several U months, stomach ### shut down for about 3 we
Y Y 4/10/2009
Y U 4/29/2009 4/30/2009
ported severe injection site soreness. Y N 3/12/2009 3/12/2009
rm redness with swelling slight induration 10cm X 8cm. Y 4/22/2009
as given Pediarix vac. but was supposed to get a DTAP vac. 4/27/2009
d region w/ 7x7 cm round, well circumscribed
Y erythema. Are defined by rash is tender & indurated.
Y Dx cellulitis
3/6/2009 + abscess
3/6/2009
Keflex 500 mg o
in a rash that evening. Rash is on the face, neck, both arms legs and abdomen. No temperature. Patient4/24/2009 stated her4/24/2009
Band Aid at home she
neralized weakness + malaise. Y 4/20/2009 4/20/2009
vaccine was administered first. Then PENTACEL (IPV-DTAP-HIB) was administered IM in the U right thigh, 4/30/2009
then PCV75/1/2009
administered IM left
ocalized redness + swelling, hot to touch, no pain or tenderness. Complaints of itchiness. No Y fever, patient
4/14/2009
took Benadryl
4/18/2009
for allergic reacti
action - hives - severe wheezing, breathing,
Y throat. U 4/28/2009 4/28/2009
as given HEP & DTAP vaccine in the (L) arm on 4/28/09, 1 day later was noted to have swelling, Y redness4/28/2009
itching on the (L) deltoid area, les
ven MMR vaccine instead of MENACTRA. Y 4/27/2009
EP B & MMR given in (L) upper arm. Arm swollen with hive - like rash from elbow to deltoid on U 2/3 of arm4/27/2009
circumference.
4/28/2009
Cold compresses
was given MMR & VAR pt started crying. Y When pt was given HEP A. pt started crying and gaspingY for air.
3/23/2009
Pt also sweating.
3/23/2009
multiforme - minor. U 4/17/2009 4/25/2009
r VARICELLA was given on 4-16-09 Pt developed a red swollen area located where vaccineYwas given. 4/16/2009 4/25/2009
s swollen, puffy and red with peelingYof skin and crusting. Y 4/27/2009 4/28/2009
lesion trunk with scabbing and diagnosis of herpes zoster. Y 8/30/2007 4/18/2009
ped a local rxn one day after vaccine DTAP was administered. Also papular lesion developedY on chest area. 4/29/2009 4/30/2009
hours, pain, swelling at injection site. Low grade temperature 99 degree to 100 degree. Myalgias, U malaise. 8/27/2008
At 48 hours8/29/2008
with squamous eryth
called stating child complains of seeing snakes. Anxiety and hallucinations. U 4/30/2009 5/1/2009
rs, ipsilateral axillary pain, fullness. Low grade (unmeasured) fever. Local tenderness, swelling Y at the injection
4/20/2009site. 4/22/2009
was reported by a consumer, the subject's
Y mother, and described the occurrence of swellingNin a 5-year-old 3/31/2009
male subject
3/31/2009
who was vaccina
was reported by a healthcare professional
Y and described the occurrence of injection site redness
N in a 5-year-old
4/9/2009female4/9/2009
subject who was v
was reported by a healthcare professional
Y and described the occurrence of erythema i a 4-year-old
N female
4/10/2009
subject 4/12/2009
who was vaccinated wit
was reported by a healthcare professional
Y and described the occurrence of injection site redness
U in a 4-year-old
4/13/2009male 4/15/2009
subject who was vac
was reported by a physician via a GSK representative and described the occurrence of red N spot at injection
4/16/2009
site in a4/16/2009
4-year-old female sub
was reported by a healthcare professional via a sales representative and described the occurrence U of swelling in a child subject of unspeci
was reported by a healthcare professional via a sales representative and described the occurrence U of swelling in a child subject of unspeci
was reported by a healthcare professional via a sales representative and described the occurrence U of swelling in a child subject of unspeci
vaccination 10/30/07; returned to doctorY with pain
Y in left shoulder (same
3 as vaccinated
Y arm) Nwithin two months;### began1/2/2008
experiencing pain, n
he, lethartic onset 48 hours after vaccination with guardisil Y 4/24/2009 4/26/2009
er, very tired and rash (skin raised, hot, not itchy, red) on upper left leg appeared. Shot put U in back of left4/21/2009
arm. 4/27/2009
e rash all over legs and arms appeared 2 days following injection. Rash lasted 8 days and continued Y to leave
4/17/2009darkened
4/19/2009
spots for over 2 ad
numb for approximately 30 minutes after receiving Anthrax vaccine, event has happened forYthe past 2 doses 4/30/2009 4/30/2009
mptoms, shaking, "bobblehead" mannerisms,
Y "dizzy appearing" per parents starting 3 days after
U vaccinations.4/22/2009Self-resolved
4/25/2009 by 6 days, but
LITTLE OVER 24 HOURS. FIRST SIGNS, SEVERE SORE THROAT, NECK PAIN, ARM PAIN, U STOMACH 4/20/2009PAIN,4/22/2009
A PINK EYE TYPE INF
ide of cheeks. Y Y 4/28/2009 4/28/2009
rned to office - stated "my son passed out" - Found seat belted into passenger seat - eye opened Y responded 5/2/2009
by name. 5/2/2009
Asked what happen
a tetanus shot for an infection, and received the tdap. I experienced a sort coughing spell within Y 10 hours, 4/30/2009
mild cold 4/30/2009
symptoms the next mor
njection 5/1/09 yellow fever vaccine.Y Noted arthralgias, myalgias, swollen hands and fingersUand bilateral5/1/2009 lower leg red5/2/2009
rash. Specific manu
ustular rash extending from L shoulder Y near vaccination site, across back and upper chest, few U lesions on4/22/2009
thighs 5/28/095/2/2009
ED records receiv
Vision,Blood restal,soryasisY 6/8/09 Received medical records from 7/20/2006-6/4/2009. Records N reveal patient
4/23/2003 experienced:
6/20/2006exacerbation o
n has been received from a TV news Y report and the patient's father concerning his 16 year oldY daughter who 3/1/2008
in March 3/1/2008
2008, was vaccinate
n has been received from a consumer concerning her son, an 11 year old male who was born N prematurely and was diagnosed with cerebra
n has been received from an 83 year Y old male with no pertinent medical history or no allergyYwho on 31-MAR-2009
3/31/2009 was 4/3/2009
vaccinated with ZO
n has been received from a registered Y nurse concerning a 25 year old female with no medical N history or 3/13/2009
drug allergy3/24/2009
who on 13-MAR-2009
n has been received from a registered nurse, for the GARDASIL, concerning a 17 year old female Y patient3/19/2009
with a history
3/19/2009
of pelvic inflammat
us case was received on 21 April 2009 from a healthY care professional.
3 A 29 year old femaleYpatient received 1/26/2009YF VAX1/27/2009
(lot number UF428A
ort received on 24 April 2009 from aYhealth care professional. A 35-year-old female patient, who U had a concurrent
4/20/2009urinary
4/20/2009tract infection, had
us case was received on 27 April 2009 Y from a health care professional. A female patient (age N not specified)
4/24/2009
with a history
4/24/2009 of high blood pre
ated at approx. 0830 4/22/09. Mother Y reports that
Y pt. had increased temp
2 starting at 1200 4/22/09.
N Mother 4/22/2009
reports to4/22/2009
clinic 4/22/09 with child
ven SQ left arm of VARICELLA vaccine #2. Soon after applying band aid pt complained of itching. Y I talked
4/10/2009
to M.D. and
4/10/2009
he ordered 50mg IM
ter shot, fever, headaches, chills, body aches, nausea symptoms resolved completely- 4 pmY4/28/09 4/27/2009 4/27/2009
heet - mom reports infant spit up milk Y and some "white" stuff and declared it had to be due toYthe liquid medicine
2/20/2009 we2/21/2009
gave. Had 2 mos shots
as given initial dose of ROTARIX @ 28 weeks. Then follow up dose 4 weeks later was given. Y However ROTATEQ
3/24/2009 was given at that point.
nal chest tightness without wheezing - within 5 min of HAVRIX (Hepatitis A) & POLIO (IePV)Yvaccine Resolved 4/23/2009 in 204/23/2009
min after liquid BENAD
darkened raised area on Pt's left upper arm over deltoid muscle that measures 8 MM X 5 MM. N Pt. C/o dull 5/13/2008
pain when 5/13/2008
spot is touched. Also
ived 2 vaccines, MENACTRA and GARDASIL # #3, in opposite deltoids. Within 5 seconds after Y receiving 4/17/2009
the 2nd shot4/17/2009
child had a seizure
er vaccine was administered site was red and "bumpy". Y 4/23/2009 4/23/2009
llowing vaccine, swelling distal to vaccination site - specifically dorsum of hand & wrist (left arm
Y only); pain 4/21/2009
and reddish
4/23/2009
(blanching) discolor
ost vaccine rash "mini measles" all overY trunk. Not ill. Y 4/13/2009 4/24/2009
3, start at 9pm & vomited x2. Y 4/27/2009 4/28/2009
d screaming/crying. Y 2/24/2009 2/24/2009
hours of shot fever,paleness, weakness, dizziness,tight chest, hard to breath.Patient remains N sick still after
4/28/2009
6 days with
4/29/2009
contiued fever, dizz
nd swelling, painful at site of injection, approx 4 inches in diameter Y 4/28/2009 4/30/2009
pain and swelling at injection site Y 4/20/2009 4/23/2009
ports extreme pain at site of injectionY which began immediately and continues x 11 days. NoUfever, no local 4/23/2009
redness, 4/23/2009
swelling or induration
er receiving the for about 4 weeks after the shot I experienced deep aching of my muscle and Y arm and couldnt
2/13/2009 move 2/15/2009
my arm without pain.
nd pain at site of injection and medial arm. Redness approx 5-6 inches medial to injection site. Y 4/14/2009 4/20/2009
ceived Zostavax Vaccine on 4-29-09Y and had been warned about the localized red itchy weltUthat could occur 4/29/2009at the injection
5/2/2009sight and it did
the MMR vaccine on 4-20-09. I amYexclusivelyYbreastfeeding a 14 3 week old infant. On 4-29-09Y she developed4/20/2009 a fever
4/29/2009
of unknown origin.
red yellow fever vaccination to rt deltoid.
Y 20 minutes after vaccination, pt. left clinic and reportedly
U walked 5/1/2009
to another 5/1/2009
building to complete th
2 HOURS: SEVERE DROWSINESS; Y 24 HOURS: Y VERTIGO, DIZZINESS;
2 36 HOURS: NUMBNESS
N &4/30/2009
TINGLING LEFT 5/1/2009 ARM, SHORTNE
ted thigh swelling at injection site two days after immunization. Patient was seen in office and Y examined: 4/22/2009
left thigh with
4/24/2009
10x6 cm indurated,
ablity and rash about 9 days after the well visit on 04/14/09. Patient seen in office on 04/24/09 Y for rash-4/14/2009
five petechial4/23/2009
on neck and chest.
minutes post injection patient developed redness, swelling, 30 mm in size4 with warmth andYhardness at 5/4/2009 the injection5/4/2009
site. Dr. notified, and
on was received on 4/28/2009 in LeftY Arm. Client was brought back in the HD on 05/01 with Y very red swollen
4/28/2009
LA, with4/29/2009
a temperature of 100
, projectile vomiting, lethargic, dehydration, stopped
Y breathing while4sleeping - we were ableYto resuscitate 5/27/2003
him, lips turned
6/1/2003 blue,
eaction to right deltoid after Tdap administered
Y "started two days after the shot was given." (Hep
U B immunization
4/21/2009 was
4/23/2009
administered to patien
00-102 within 24 hours. Muscle spasms Y x5 days now. 4 inch area of swelling around injection U site. Pustule 5/1/2009
at injection
5/1/2009
site. Soreness limi
scribed onset of large 'orange sized' hot lump in the area of administration, onset was approx Y 72 hours after
4/29/2009
admin. 5/2/2009
patient stated lump wa
d regular vaccines at two months and began spitting up blood for the following 24 hours. AtY4 months we 4/30/2009
administered4/30/2009
only one vacc/week
awoke with severe pain and weakness in Right deltoid. Significant Pain and weakness continued N for 2-3 days.### Then the pain ### decresed to m
cellulitis developed at immunizationYsite 2 days after immunization given. Pt initially treated with
U Keflex and 5/1/2009
Bactrim but5/3/2009
cellulitis worsened
9 patient started to develop red rash in which progressively increased in numbers and intensity. Y Rash was 4/16/2009
coalescent.4/26/2009
Patient seen on 04
king across the leg from the site of Y injection, as well as a swollen, firm leg. She was given injections
U today5/4/2009
with Pentacel,
5/4/2009 HepB, and Prevn
after injection - mom noted swelling tenderness and erythema - 36 hours after he has swelling 1.5 inches lareger 5/1/2009 on that
5/2/2009
arm with tendernes
N 4/29/2009
sle like red, raised bumps all over body.Y Y 4/8/2009 4/20/2009
RSE EVENTS, SYMPTOMS, OR TREATMENT Y 4/2/2009
TIS LEFT LEG DIAGNOSED IN ER Y MAY 3, 2009. CELLULITIS BEING TREATED WITH SEPTRA ORAL 5/1/2009 ANTIBIOTIC. 5/1/2009
er administration of rotateq child developed fever to 102, and a few episodes of loose stool and Y vomiting-- 4/27/2009
report being4/29/2009
filed at mom's reque
honed clinic and left a message on 5-04-09.
Y Her call was returned and the following information
Y was received. 5/2/200929 hours
5/3/2009
after immunizations
n R hand started 12-24 hours after injections.
Y Dizziness - resolved.5/18/09 records received-office
N visit 12/28/08
5/1/2009 C/O 5/2/2009
swollen glands, lethar
out with 9 blisters on 5-3-09 Mom states looks like chickenpox. Blisters on back and neck. 4/27/2009 5/3/2009
ven 2nd dose of Hep B series at 2:00pm Y 4-13-09 - At 5:00pm noticed a rash around belt line Y - progressed4/13/2009
to entire body
4/13/2009
- He had also recei
cellulitis at administration site - Started on OMNICEF. U 4/29/2009 4/30/2009
syncopal episode after taking 2 steps when she got off the exam table - 11 feet and hit headYagainst door frame. BP was low and remained
ped shingles 7 days after ZOSTAVAX injection. N 3/25/2009 4/2/2009
ed from stating pt seems to be in severe Y pain; severe hard crying off and on since vaccines received today. 5/4/2009
Pt states5/4/2009
left thigh is slightly sw
nted to GARDASIL clinic 7-22-08 to begin series. Completed series 4-17-09 after reporting LMP U 3-26-09.4/17/2009
Presented to health department fo
& Lg redness at injection site Y 4/28/2009 4/30/2009
wollen from upper thigh to knee. 3 cm larger than (R) thigh. Area a little reddened. Afebrile. U 4/28/2009 4/29/2009
asting 15 seconds - returned to normal LOC. Y 5/4/2009 5/4/2009
R upper chest welt 3 cm raised macule + dermatographism benadryl given PO - will give benadryl Y + MMR -> #2.
ed left upper arm approx size quarter. Pt able to use arm. Y 4/28/2009 4/30/2009
B #3 vaccine given on 4-29-09. Pt. c/o swelling and redness of (L) arm where injection givenYon 4-30-09.4/29/2009 Pt. stated on 4/30/2009
5-1-09 that redness w
ld given Hep A vaccine instead of Hep B. No immediate adverse reaction. No treatment given. U 5/4/2009
r vaccine site (deltoid) was reddened, Y warm + itchy on 4/25-4/26 worsened @ 48 hrs after inj. U Patient went 4/24/2009
to ED to4/25/2009
have checked. Now re
0 min after vaccinations (HEP A #1,YVARIVAX #2) child started vomiting and became increasingly Y lethargic,
4/29/2009
No total4/29/2009
LOC. Non discrete urti
rts eyes red, puffy & warm red area right upper arm Y 4/21/2009 4/22/2009
ed 6 mon vaccinations at 2 hrs after Yhe ran a Temp of 100.4 and large warm red lumps formed Y at inj sites.4/27/2009
Tylenol and 4/28/2009
bath given with some
rash trunk after 8 hrs. Temps are as high as 101. Maculopapular rash chest abdomen, legsYface. Rash became 4/6/2009cellulitis
4/11/2009 in 240 with contin
4/26 - Rt arm swollen, hot, red. Y 4/25/2009 4/26/2009
es reddened area around injection site Y that goes down arm to elbow. Also reports pain under Y arm sore.4/27/2009
Knot increased4/28/2009
from under quarte
patient returned to clinic 2 days after vaccination to have right arm evaluated. Raised reddened Y area 9 cm 4/27/2009
X 6 cm right
4/28/2009
upper posterolatera
4-17-09, 7 PM. On 4-18-09 upon awakening had eyes swollen shut, face incl tongue puffy and U red, eyes4/17/2009
were also red.4/17/2009
Facial swelling/redn
ash with pain and swelling; fever atYinjection site; cough, red throat; post-nasal drip; bruisingU- treated with 4/17/2009
ZITHROMAX 4/17/2009
antibiotic; cough s
ort was received 05 June 2008 from a health care professional. A 54-year-old male patient had U received an 6/3/2008
intramuscular
6/4/2008right deltoid inject
of four cases of injection site swelling, heat and tenderness in addition to large nodule at injection
Y site out6/30/2008
of an unknown number of patients
ort received from a consumer on 08 August 2008. A 63-year-old female patient received a leftNdeltoid intramuscular 3/20/2008 injection of DECAVAC (
ort received form a health professional on 04 November 2008. A cluster of three cases of flu-like U symptoms 10/1/2008
and injection site tenderness ou
old male patient with a history of back pain and previous eye injury received an intramuscular U left deltoid injection### of11/1/2008
DECAVAC (lot numbe
-old female patient, who has medical Y condition of hyperlipidemia for which she takes ZOCOR, Y had received 1/13/2009
a left deltoid
1/15/2009
booster dose of D
-old male patient, who had medical Y condition of glaucoma and erectile dysfunction , had received
Y a left deltoid ###
booster dose ### of DECAVAC (
ort received 27 February 2009 from a health care professional. A 31-year-old female patient had received2/23/2009 an intramuscular right deltoid inje
ort received from a health care professional on 23 April 2008. A 21 year old, male patient (with Y no medical 4/16/2008
history) reported
4/17/2008 having symptom
ort was received 15 May 2008 from a Y health care provider. A 26-year-old patient had received Y an intramuscular
5/14/2008 left deltoid
5/14/2008 infection of DECA
ort was received 20 May 2008 from a consumer, who is also the patient. Additional information Y was also 21 4/1/2008
May 20084/2/2008
from the patient's phy
1 mo after receiving vaccine that beginning night of vaccination nausea and vomiting persisting Y X 2 weeks, 3/20/2009
SOB 243/20/2009
hrs after vaccine, insom
d Immunization on 4/22/09. Onset of symptoms on 4/23/09. Nausea, headache, Stiff neck,Narm weakness, 4/22/2009
flushing,4/23/2009
dizziness, lethargic, fe
lt dose of HEP A instead of Pediatric dose Y 4/24/2009
lt dose of Hep A instead of pediatric dose. Y
zed inflammation to left upper extremity - no streaking noted. No fever - began morning afterUvaricella SC 4/29/2009
injection. 4/30/2009
s. High pitched crying x1 hour - inconsolable; slowly resolved over next hour - onset = 5 hours Y after injection
4/29/2009
- on follow
4/29/2009
up exam - family rec
accine 4/16/09 - Mother called with complaint of half dollar size of local swelling where shot given.
Y Told 4/16/2009
to ice ibuprofen
4/17/2009or TYLENOL
ection site swollen and painful - o/v 24 hrs later. (2) glomerulonephritis (post strep) Dx'd 4/21/09.
Y 4/6/2009 4/7/2009
m and itchy area over TRIPEDIA injectionY site. U 4/26/2009 4/29/2009
ameter area of erythema on LT deltoid around immunization site. Instructed to apply cool compresses U and
4/27/2009
call if area4/28/2009
increases.
nted, difficult to arouse (12 sec) utilized
Y ammonia to arouse. Patient stopped breathing during Y fainting spell.
4/29/2009
Patient 4/29/2009
cold, pale and clammy
ived Kinrix injection in R thigh on 4/27/2009. On 4/28/09 - child seen by doctor diagnosed with U (hives) reaction
4/27/2009 to Kinrix.
4/28/2009 Given Benadryl.
4/30/2009
today 4/29/09 at 12:10 PM to reportYbreaking out with rash around injection site on 4/26/09. Y States has other
4/23/2009
areas 4/26/2009
involved now (legs, face
d vaccine on 4/24/09. She called on 4/27/09 to report that later 4/24/09 in the pm she brokeYout with a rash 4/24/2009
that looked
4/24/2009
liked chickenpox an
n has been received from a consumer Y concerning her approximately 24 month old Y son with N no medical history
1/1/2006
or drug 1/1/2006
allergies who in Janu
n has been received from a physician Y concerning Y a 15 year old female
0 Y who on 13-AUG-1998 U was vaccinated
8/13/1998
with the4/22/2009
first and only dose o
n has been received from a physician concerning a 22 year old female who on 23-APR-2009Nwas vaccinated 4/23/2009
with the4/23/2009
second dose of GAR
n has been received from a registered Y nurse concerning a 19 year old female with no medical Y history and2/5/2009
no known drug 2/5/2009 allergies who on
rmation and follow up has been received Y from a nurse and consumer for the Pregnancy Registry Y for GARDASIL
8/22/2007 concerning
3/24/2008 a 17 year old fe
site still itches. Recently blistered &Ykeloid. Pt c/o severe itching @ vaccination site. 5/26/09 Received clinic 9/9/2008
medical 10/1/2008
records of 9/3/2008-4
m area of redness 1" diameter No fever. Y 4/27/2009
njection site Benadryl 25 mg PO + triamcinolone cream to site. 1/13/2009 1/13/2009
en lump at injection site (R arm). Benadryl given by mother (day after injection) Y 4/2/2009 4/3/2009
over all of body, tongue + lips. Referred to Dr at Health office. U 4/29/2009 4/29/2009
esions eruption 4/27/09 AM U ### 4/27/2009
ceived both TWINRIX & TYPHOID before Y collapsing on the chair. Immidiately patient startedY to cease. 3/24/2009
Patient was3/24/2009
moved to the floor and
came lightheaded, pale, and unresponsive for approx. 1 minute. BP 90/48. Placed on couchYw/ feet elevated. 5/5/2009
Given 5/5/2009
apple juice after alert &
oncerned that vaccine (s) have caused Y chronic pain. Has had ulcers and cholecystectomy (abnormalN gallbladder
7/30/2008 scan),
8/26/2008
but persists with ab
d Varicella vaccine on 4/30/09. On Y 5/1/09 pt's parent reporting approximately 1" swollen area U around injection
4/30/2009
site. Was5/1/2009
seen in clinic on 5/
dness + swelling at injection site afebrile;
Y no pain; warmth to touch Y 4/29/2009 4/30/2009
swelling @ upper arm - 8" length 5th" width Benadryl/Tylenol. 4/27/2009 4/28/2009
& fussiness 9 days after MMR vaccine given (along with PENTACEL). Patient's fever resolved Y by 48 hours 4/20/2009
and there 4/29/2009
were no other assoc
ction swollen redness injection site left T size right to left 25 X 25 mm up and down sore andUhard. 4/21/2009
Rash on Rt leg above knee- both feet - rash is spotty and puffy, worse in AM - better in PM. Took Y Benadryl4/6/2009
4/09 rash 4/6/2009
still present -not as re
experiencing rash/hive type symptoms on his arms + legs. This started on 4/25/09 and wasUstill present4/24/2009 on 5/1/09. 4/25/2009
Pt was advised to take
ction right arm Y 4/27/2009 4/29/2007
.8 at 5:00 pm day following vaccine. Continued with fever 5/1/09 - sibling sick with otitis startedY on ZITHROMAX.
4/27/2009 4/28/2009
ction left arm Y 4/27/2009 4/28/2009
ur after vaccine administration c/o flushing of face with temp elevation to 99.6 F. Also reported U vomiting. Vomiting
5/4/2009 and 5/4/2009
facial flushing contin
ured 9 days after administration of HPV,Y HepA and Varicella vaccines Y 4/22/2009 5/1/2009
on, some lost of vision 1/13/2004
S ADMINISTERED 4-13-09 ON 4-21-09 Y PATIENT DEVELOPED A FEVER AND HAD A SEIZURE Y LASTING
4/13/2009
2 MINUTES.
4/21/2009 TRANSPORTED
with heat and edema surrounding injection
Y site with erythema ring approx 3-4 cm surrounding Y pale area 4/24/2009
appearing 44/28/2009
days after vaccination
ted for pre-travel vaccinations prior toY travel. Vital signs at presentation were as follows; B/PY120/62, T 97.7, 5/4/2009
R 12 and 5/4/2009
HR 60. Cursory phy
from pt. wife stating husband c/o sore throat and one side of his tongue is sore, being tired and Y that injection
4/17/2009
site is 4/18/2009
swollen and warm and i
er vax on 2/4/09. Rcvd call from pt.Yon 4/24/09 10:16a. She reports the following: on 3/28, she U experienced 2/4/2009
pain in3/28/2009
scalp and jaw and blur
CALLED AND STATED HE HAD SHOTS Y YESTERDAY, WHEN SHE GOT HOME WITH THE Y CHILD HIS5/4/2009
LEGS WERE 5/4/2009
VERY SWOLLEN,
owing, swelling, itchiness and pain at site of injection increasing to giant hives on neck, trunkUand arm. Considerable
4/10/2009 4/11/2009
pain, throbbing and itc
arre' Syndrom 6/8/09 Hospital
Y records
Y and DCYsummary received 14 DOSY 4/03/09 to 4/17/09. Final
Y Diagnosis:
3/13/2009
Guillain-Barre
3/28/2009 syndrome. Post
ates that he developed diffculty breathing and chest Y pain on 3/18/09
10and went to the EmergencyY room where 3/6/2009
he was3/18/2009
admitted for a pulmon
VAX .5 CC GIVEN R DELTOID IM APPROX 10 A.M.. PT STATES THAT EVENING ARM TENDER, Y SOME
4/30/2009
SWELLING,4/30/2009 WARMNESS AT
ived the MMR vaccine and varicellaYvaccine at one time. Developed measles from the vaccine. Y No treatment
4/17/2009prescribed.
4/26/2009 Began with rash
swelling of the site w/ redness and painY same day as vaccine. pain, swelling slowly resolved Y over few days.4/29/2009
No respiratory
4/29/2009 complaints or dy
came lightheaded and lost color in her skin. Patient also complained of ringing in the right ear. Y Symptoms5/5/2009
occured approximately
5/5/2009 1 minute
ling, itching on back of arm and neck. Also has been vomiting. Y 5/4/2009 5/4/2009
ated area of injection had egg-size swelling the evening after injection. Over the next 2 days,Yswelling appeared 4/29/2009 to spread
4/29/2009 down to elbow ar
ately 4-5 hours after receiving the vaccine, I broke out in hives large about 5 in in diameter and Y raised. These
4/30/2009 were on4/30/2009
my stomach. I had re
was reported by a physician and described the occurrence of rectal bleeding in an infant male U subject of unspecified age who was vaccina
was reported by a physician and described the occurrence of rectal bleeding in a 4-month-old Y male subject
4/13/2009
who was 4/13/2009
vaccinated with ROTA
fever, 2 days of rash. Had CSF, blood & urine cultures
Y & stool culture
3 obtained & viral panel.YGiven CEFTRIOXONE
4/28/2009 4/28/2009X3 days. 5/18/09 ED
mergency Rooms. 6 days Y Hospital Stay.
Y 6 daysYIn House Rehab. 5/13/09
12 hospital records received
N DOS11/5/2008
12/4/08-12/9/08.### FINAL DIAGNO
redness & swelling @ sites of injection,
Y diagnosed in ER on 4/30/09 with right thigh cellulitis,Y treated with
4/28/2009
KEFLEX 4/29/2009
& BACTRIM
TYLENOL at home. Pt. received MENACTRA Y on R deltoid on 5/1/09. About 30 hours later on Y 5/2/09; mother5/1/2009
noticed5/2/2009
redness, induration pa
24 after shot, erythema tender (swollen started 3 days after shot , all erythema approximately U 4cm disterl4/29/2009
to shot site.
U 4/24/2009 5/1/2009
nd out pregnant 2 wks after receiving vaccinations. Due date of 9/01/09. Client gave permission on 5/1/09 to report ### to VARIVAX registry fo
d been diagnosed with shingles on 04/29/2009 U 5/7/2008 4/29/2009
x 5 cm swelling and redness to RPUA. Y 4/22/2009
d swelling, redness, and itching at injection site week after injection. Pt stated sxs was resolvingY without 4/29/2009
tx. 4/30/2009
tion administered - child sitting in chair with mom at side. Approx. 10 min. passed and then finger Y stick hgb.5/5/2009
done. Child 5/5/2009
uncomfortable with
d combination vaccine of DTAP, HEPB, Y & POLIO on 4/24/09. Pt. had no fever or s/s of anyNillness @ time 4/24/2009
of vaccination.
4/27/2009 Pt. returned to c
dness, swelling at injection site 9-10 days after vaccine. At time of visit, no fever, swelling subsided
Y 4/23/2009 5/2/2009
child called Health Dept 5/1/09 withYcomplaints of redness and swelling in child's arm - childYhad Tdap inject. 4/30/2009L delt. 4/30/09.
5/1/2009Mother was re
child was in the ER last night. AfterYleaving our office @ 2:06 pm. Patient was fussy, throwing Y up, and swollen
4/15/2009 on 4/15/2009
the admin. site.
h present on knees, elbows & buttocks. Bx of elbow Y lesion -> herpetiformis
2 dermatitis. Treatment
U with DAPSONE
2/15/200825mg 9/29/2008
twice daily - revise
e 2008, noticed large ecchymoses on Y left flank. On June 10, a CBC showed platelets to be 36, U 000 (normal3/11/2008
140, 0006/10/2008
-250,000). Saw hema
red 4:05pm. Reacted at 4:20pm with Y anaphylaxis - Left eye swelling, shallow breathing, no airway
Y edema,5/5/2009
+tongue swelling.
5/5/2009Given Epineph
, Tiredness and poor appetite, Non-Stop
Y cry for more than 3 hours, complains of pain in the N nose, Difficulty5/4/2009
breathing, 5/4/2009
wheezing, paleness,
n has been received from a consumer concerning her husband who in approximately 1970, U was vaccinated with MMR II. The consumer rep
n has been received from a female consumer who stated that her uncle received on an unspecified U date an unspecified MUMPSVAX (man
n has been received from a physician Y assistant concerning a 61 year old female Y patient withNcodeine allergy,
4/20/2009 post menopausal,
4/21/2009 lipid and an
n has been received from a nurse concerning a her great-niece 13 year old female with no known N allergies
4/28/2009
or medical 4/28/2009
history reported, who
n has been received from a physician Y who reported that a patient's mother told him Y that her U 24 year old daughter, on an unspecified date w
rned red, very sore, itchy.erythema Ymedial aspect left uppr arm, none at outer deltoid at sited Y of pneumovax
4/29/2009injextion.Area
4/29/2009 tender, erythem
A vaccine--became dizzy and was lowered to the ground. BP 80/50, color pale. Color returned Y quickly, BP4/28/2009
110/70 twenty
4/28/2009minutes later
hot child had some congestion, but normal
Y temperature. Shot received at 9AM. Fever first noticed
Y at 2PM4/15/2009
(approx. 4/15/2009
101-102 degrees). Tre
PRESENTED WITH TEMP OF 104.1, Y STIFF NECK,Y & ELEVATED 2WBC COUNT ONE WEEK U AFTER ADMINISTRATION
4/30/2009 5/2/2009 OF IMMUNIZAT
C/O BEING COLD, DIZZY, THEN MOUTH, Y ARMS, AND HANDS STARTING TWITCHING, ALONG Y WITH 5/6/2009
BIG TOE. AMBULANCE
5/6/2009 CALLED
female had foot stuck with pin. Had cellulitis and susuptiple to Tetnus. Physician did not have any Td on4/23/2009hand so administered Tdap off-lab
ported to student health services 2 days
Y after receiving his Varicella Vaccine (04/08/2009). He Y present with 4/6/2009
right upper 4/7/2009
arm mild swelling an
ately 2 minutes after receiving 3rd HPV immunization, client fainted. Client was unconsciousYapproximately 5/6/2009
10 seconds, 5/6/2009
for 3-5 of those se
shot in a.m. on Monday 4/29, symptoms started in the late afternoon: fatigue, pain in arm, sudden Y nausea,4/27/2009
dizziness,4/27/2009
fever of 102 degrees,
RTS DIFFICULTY BREATHING 2 HRS AFTER INJECTION. SHINGLES RASH ON HIPS WITHIN N 12 HRS 5/4/2009
OF INJECTION5/5/2009AND CONTINU
after vaccine pt. reports a "different rash at a different spot every morning and at night whenUI go to bed". 4/28/2009
"I have a4/30/2009
red ring and a big knot
s after gardasil #1, patient reports left index and middle finger is mildly swollen and difficult toUbend. Vaccine 5/5/2009
was given 5/6/2009
in the same left arm
H AROUND INJECTION SITE Y 5/4/2009 5/6/2009
NJECTION-LEFT ARM IS SWOLLEN, WARM TO TOUCH,ITCHES AND HURTS Y 5/4/2009 5/5/2009
ed vaccines listed below at 4:30pm. After receiving vaccines, pt. was walking in the waiting room Y and sat down 5/6/2009 in one5/6/2009
of the waiting room c
ours of vaccine child had high fever, red bumps on her face, very lethargic when not screaming, U excessively 5/6/2009
tired. 5/6/2009
eceived TdaP and menactra and felt dizzy and like she was going to faint yesterday. Still feels Y "terrible"4/13/2009
today. Some 4/13/2009
headache but she a
us case was received on 23 April 2009 Y from a consumer (patient's mother). A 13 year old female U patient4/20/2009
with a history 4/20/2009
of asthma and gastri
ort received on 28 April 2009 from aYconsumer. A female patient (demographics not reported)Nhad received 7/3/2008
on 16 June 2008 a dose of Hep
was considered medically important. Information regarding PREVNAR was received from a U healthcare professional ### regarding a male patie
n/v fever, headaches 12-24 hours after every AVA Y vaccine, but had 32 episodes cp/sob after AVA #3/SMPX 6/28/2004
vac, wt loss,
6/28/2004
hungry, insomnia..
onsolable. Swelling of thigh (left) knee
Y to hip, hotY to touch. Shots given
1 at about 1040a. Still Y crying presently5/6/2009
3pm.5/13/09-records
5/6/2009 received
mins of receiving immunizations, left warm + nauseous. Stood up + opened door at which point Y fainted. I saw5/4/2009
her + helped
5/4/2009
her to floor so no
vaccine received 24MAR2009. Symptoms began 13APR2009 with lesions on arms, legs, face, Y and trunk 3/24/2009
with clear4/13/2009
discharge. Biopsy was
ely after receiving GARDASIL injection, Y pt passed out with her head on a desk. She quickly Y regained consciousness
5/4/2009 5/4/2009
& required sutures.
Y 5/6/2009
cellulitis 5 cm X 5 cm red, warm U 5/4/2009 5/5/2009
cellulitis at administration site. Started on OMNICEF. 4/29/2009 4/30/2009
nch area of redness, warmth and induration
Y treated with KEFLEX 500 mg BID x 7d 5/1/2009 5/2/2009
R on 4-29-09 c/o fever nausea and Ydiarrhea and pain left arm - Followed up @ doctors officeY 4-30-09 and 4/28/2009
5-6-09 4/29/2009
g joint pain, numbness (left leg/hand), Y leg coldness, and stroke after AVA #4: 06 Jan 2003 AVA N 1 w/o AE.1/6/2003
AVA2 was given ###23 JAN 2003 w
veloped itching on his back 3 days Y after receiving the vaccine; 1 day later, he developed swelling
Y + 3 lesions
4/17/2009
on his4/20/2009
right jaw; 1 day later h
Y 4/30/2009
eared at site of vaccination. It was warmY to touch and slightly itchy. 2 small spots appeared next
Y to it. Rash 4/17/2009
lasted 5 4/29/2009
days.
after 24 hours and warmth after injection Zero fever. U 5/4/2009 5/5/2009
10ml around injection of chicken pox Vax. Y 5/4/2004 5/6/2009
ed, warm with pain -> treated with KELFEX -> seen next day on 5/5/9 with response to antibiotic Y 5/1/2009
njection site showed redness, warmth, swelling. Area was also tender to touch. Also startedYw/temp 99.35/4/2009 today 5/4/2009
al reaction redness & swelling down into elbow. Clarinex 5 mg Y 3/31/2009 4/1/2009
@ throbbing pain L arm + hand. Info given by son. Pt does not speak English. U 1/29/2009
nt developed shingles on left side back Y and lateral chest wall. Antiviral medication not given asU it was 1 week
4/21/2009
after onset
4/30/2009
of symptoms. The
of the Rt upper arm, temp of 101 XY2 days, itching and pain and tender axillary Adenopathy.YPt given Keflex 4/24/2009
500mg4/25/2009
tby mouth QID on 04-2
lling, redness, large circle @ inj site.Y Taken to PCP & informed to switch from Ibuprofen to TYLENOL.
U 5/4/2009 5/5/2009
given @ 4:30 pm- Pt C/0 itching @ approximately 7:00 pm. Noticed both legs and R arm hadYhives approximately 4/27/200910:004/27/2009
pm. Low grade tem
ined of having dizziness, pain at injection site, fever with joint pain. Y 5/1/2009 5/2/2009
ght tricep area with induration, warmth, confluent fine papules Y 4/27/2009 4/28/2009
er erythema 1-2mm vesicle in center - has burst Y 4/27/2009 4/28/2009
n right arm post receiving VARICELLA vaccine. Swelling & reddness began 4/29/09. Tx'd with Y XYZAL 54/28/2009
mg daily. Was already on MINOC
0 minutes after vaccinations (Hep AY#1, VARIVAX #2) child started vomiting and became increasingly Y lethargic;
4/29/2009 no total
4/29/2009
LOC, non discrete
-103, rash on face - dry cheeks. Vomited
Y once resolved in 24 hour without further fever, rashY on new symptoms.
3/31/2009 4/4/2009
was received from a health professional. A 41-year-old female patient, with a history of asthma, N received3/31/2008
an intramuscular
3/31/2008 left deltoid third
ort received from a health care professional in the USA on 23 April 2008. A 21 year old, maleYpatient (with 4/16/2008
no medical 4/17/2008
history) reported havi
ar-old female patient, who was hospitalized from 18 July 2008 to 19 July 2008 because she became U confused
7/21/2007
and angry after receiving a fir
-serious case received from a healthY care professional on 17 September 2008. A 40-year-old N female patient
9/3/2008
received
9/15/2008
the first three doses
rmation was received on 01 December 2008 from a consumer. A 59 year old female patient U with an allergy9/5/2008
to penicillin
9/1/2008
received an injection
-serious case received from a patient Y on 05 August 2008. A 68-year-old female patient experienced
N headache,
7/29/2008 forehead
7/29/2008
swelling, sleepless
n has been received from a physician Y and a nurse concerning her 13 year old daughter
Y withNasthma and4/22/2009
no known 4/22/2009
allergies who on 06-AU
n has been received from a consumer concerning her friend's 15 year old daughter who wasUvaccinated with two doses of GARDASIL. Afte
n has been received from a pharmacist concerning a 23 year old female who on 08-FEB-2008 Y was vaccinated
2/8/2008with her second dose of GA
n has been received from a consumer Y concerning Y her son with neutropenia, who when vaccinated
U with any vaccine including RECOMBIVA
ort received 29 April 2009Y from a health care professional.
Y An 8-week-old female infant had received
U a first
4/27/2009
dose of right
4/27/2009
thigh injection of PE
us case was received on 30 April 2009 Y from a health care professional. A 57 year old (correctedU on 05 May
4/21/2009
2009) female
4/22/2009 patient with high
was received on 01 May 2009, via another
Y manufacturer (document number 956545). The event occurred to a subject enrolled in a study.
n regarding PREVNAR was received from a healthcare professional regarding a 2-month-oldY female patient 1/15/2009
who vomited
1/15/2009blood. The patien
ever with chills - arm swollen 4/30 threw
Y up. U 4/28/2009 4/28/2009
ere migraine headache unresponsive Y to prescription meds. Onset 10/08. Abdominal pain and N some dizziness.
7/14/2008 Treated
10/1/2008
by pediatrician and
9 Mom called on her son who had shots Y on 4/27/09. His left leg is sore, red and hot today. Y
I told mom to 4/27/2009
put ice on4/28/2009
his leg and have him u
er flu shot, I developed a rash. This rash was all over my body except my face. The dr's that U treated me10/6/2008
were dermatologist, ### family dr., Al
rm was red/irritated no pain no fever didn't feel hot. Y 4/6/2009 4/21/2009
ATEQ vaccine 4-14-09. Developed vomiting on 4-17-09 - lasting 24 hours then had 4 days ofYwatery diarrhea. 4/14/2009
No fever.
4/17/2009
Sibling then develo
ver body, swollen and hot. Y 4/20/2009 4/22/2009
102 for 3 days with mild posterior lymph Y node swelling and one left axilla, and neck tenseness gradually resolved.
alls the day after immunization was given c/o fever low back and B/L hip pain. States "difficult Y to walk" due4/28/2009
to pain. 4/28/2009
Symptoms occurred (o
reaction 13x26mm induration with redness. Y 5/5/2009 5/6/2009
0 cm length width erythema, edema, Y tenderness, dryness to right arm Y 5/4/2009 5/5/2009
or 5 hours crying, given Tylenol with Y some relief. Y 5/6/2009 5/6/2009
er administration of TDAP vaccine in Y right deltoid, patient developed severe pain and bruising U at injection4/27/2009
site with report
4/29/2009
of chills, nausea.
arm red, warm to touch, swollen, indurated
Y Y 5/5/2009 5/5/2009
tired, muscle ache lasting 1 1/2 weeks. No treatment. Y 4/9/2009 4/11/2009
patient states patient received vaccine and then "slumped over in chair". Mother left room toYget addional 4/23/2009
help. When 4/23/2009
mother returned to ro
Imm given in AM. The following day he woke at 6AM with bilateral eye pruritis. He notices eyelids N red and5/1/2009
whites of eye5/2/2009
a little red. Pruritis
E FUSSINESS AND 103 DEGREE FEVER 24 HOURS AFTER GIVEN. TREATED WITH MOTRIN. Y CBC 5/5/2009
WITHIN NORMAL 5/6/2009LIMITS AND N
hest 104.6, hives off and on all over body Y 4/28/2009 5/1/2009
Telephone consult) rash on face andYback of neck, no respiratory distress per mother. AtaraxUq6 hours as4/27/2009 needed. Mother
4/29/2009instructed to sche
ely 28 hours after vaccination the patients
Y Right forearm began to have hives on it. The following
Y morning
4/30/2009
approximately
5/1/2009
42 hours after va
d 5 pox blisters/spots 11 days after vaccination. No other symptoms i.e. fever. Site of injection Y is itchy as4/21/2009
of today. 5/2/2009
4 months and was given vaccine that was for 5yrs and up..... Y 5/1/2009
negative BHCG on 30Mar2009. SM received Anthrax and Smallpox on 2Apr2009. SM tested U positive BHCG 4/2/2009on 4May2009.
5/4/2009 Last Menstru
accines at 11a.m. and returned to clinicY at 1p.m. due seizure like activity as witnessed by mom. Y Per mom 5/7/2009
pt began drooling,
5/7/2009clenched jaw l
accines at 11a.m. and returned to clinicY at 1p.m. w/ twin sibling. Upon examination pt was found Y to have temp 5/7/2009
of 104.35/7/2009
(rectally), content, im
aP INSTEAD OF Tdap U 4/24/2009 4/24/2009
proximately 5-10 minutes of vaccineYadministration, pt. c/o momentary changes in vision, was U pale and diaphoretic
5/7/2009 and 5/7/2009
vomitted. VS as fol
-umbilical follicultis on 2 May 09. No tx. required. U 4/30/2009 5/1/2009
ness and swelling 4 cm x5 cm Y 5/6/2009 5/6/2009
ncopal episode 15 min after administration of vaccines. Y 5/6/2009 5/6/2009
se event reported. RN gave Tdap instead of a Dtap. Y 5/5/2009
or after getting vaccines. Pt was paleY and staring straight ahead with 2 shakes of head. RN was U able to arouse5/6/2009
pt and5/6/2009
handed pt to father. A
muscle was extremely painful, pain also felt in L side of neck on day of administration. Approx Y 36 hours5/6/2009
later, L deltoid
5/7/2009
reddened, somew
ctivity 3-4 hrs after receiving vaccine on 5/5/09,Yseen in ER - Head CT 2 and CBC WNL, admitted U to Hosp. Plans5/5/2009for o/c5/5/2009
5/7/09 - Temp in ER
up blood, chest pain, and Y acute onset.
Y Complete Y heart failure. Two10thrombi
Y also Y
noted in leftNventricle. Pt has defibrillator
### 1/6/2009 now on Chronic m
11 AM 4/28/09 - taken by ambulance Y to E.R. In-patient
Y 2/28/09 - 4/29/09
1 - high fever. 4-30-09U - Back to Dr.
4/27/2009
office, severe
4/28/2009diarrhea. 5/18/09
s: 1. Rash 2. local swelling. SuspectY Drug #1 Dosing: one time vaccine dose. U 3/18/2009 3/18/2009
opted at about 7 m/o from a foreignYcountry. Her Y shot records weren't2 available to us. With consultation,
Y 10/1/2008
the recommendations
10/2/2008 was to immu
and swelling at injection site/entire upper arm; Left swelling 2-3 times normal size of arm. Fever, U vomiting5/5/2009 5/5/2009
thigh - fever 101.7 given Rx KeflexY5/1/09. Seen in office 5/7/09 - given Rx for Omnicef. FluUoffice visit in 4/30/2009
1 week. 5/1/2009
AM shaking arm when reaching, falling Y over after waking in am by 3/16/09 condition in am + N pm - falling over,
3/9/2009
trouble3/10/2009
balancing 3/19 - not a
& swelling noted at injection site Y 5/4/2009 5/5/2009
degrees. Diarrhea. Vomiting. RashY/ red / swollen right arm. Antibiotics by PCP. Y 4/24/2009 4/25/2009
sicular rash over torso / proximal extremities and fever present x 2 days. U 4/27/2009 5/7/2009
9 - Injection given R shoulder. ClientY describes pain in R shoulder joint, trouble lifting arm. Pain
U was immediate
4/29/2009 after4/29/2009
shot then next day, we
seizure like episode and stopped breathing
Y per mom. Pt was admitted to hospital for observation.
Y 5/6/2009 5/6/2009
mo vaccines on 4/24/09. Initially had Y a knot (no reddness or drainage) at site of PCV + VZVYshots. She now has some redness of skin with
cm area of erythema with slight induration,
Y minimally tender. Y 4/28/2009 4/28/2009
rythema at injection site. Y 4/27/2009 5/4/2009
ccines (shots) for flu, polio, & yellow fever- She also started oral typhoid vaccine on 5/05/09. YShe awoke 5/06/09 5/5/2009@ 6am 5/6/2009
with nausea by 9a
vaccination in left arm on April 14, 2009.
Y On April 16th, noted tenderness on left hip which spread
U to groin.
4/14/2009
Pain continued
4/16/2009 and days later a
reas other various locations of diamond shape rash. C/o itching 0 SOB or other signs of distress. Y
after vaccination given, patient passed out, lost consciousness for about 3 seconds, then spontaneously
Y 4/28/2009
woke up. Patient was given water
redness, and warmth. Y 5/4/2009 5/7/2009
- No initial local reaction until 4 day post injection, 0 fever 0 change in appetite, sleep or play.N 9 days post4/6/2009
injection 4/10/2009
site increased size, war
ZOSTAVAX was given got warm, swollen & sore. It was the size of a half dollar Y 5/1/2009 5/1/2009
adache and feeling of inside of scull on fire - lasted 3 hr and lifted. Went to ER. Y 4/29/2009 4/28/2009
0 - vaccination administered 0933 - pt. stated "light - headed, clammy, body feels tense, "really
Y hot" BP = 5/7/2009
120/80 P = 5/7/2009
76 RR = 20 0945 - "in
t a lump on left arm after administration of vaccine, and evaluated 5/1/09. Returned 5/5/09 with
U redness/4/20/2009
warmth at 4/20/2009
injection site and compl
n has been received from a 24 yearYold femaleYwith citric allergy who2 on an unspecified dateNwas vaccinated with a single dose of MMR II .
n has been received from a consumer concerning her brother who on an unspecified date was U vaccinated with MMR II and then developed
n has been received from a 74 yearYold female registered nurse with no allergiesYand a history N of hip replacement,
6/18/2008 24/24/2009
TIA (transient ischaem
was considered medically important. Information regarding PREVNAR was received from aUconsumer, the mother of a patient who experie
was received on 01 May 2009, via another
Y manufacturer (document number 956545). The event occurred to a subject enrolled in a study.
ort received from a health care professional
Y on 15 August 2008. A 39 year old, female patient, U with a medical7/31/2008
history1/23/2009
of no known allergies a
er Mother walked into Center. Pt received immunizations 05/04/09. Pt now c/o of dizziness, headacheU & chest
5/4/2009
discomfort.
5/5/2009
Follow-up phone
rs, significant Local Reaction - Site erythematous, warm to touch - Softball size area. Y 5/5/2009 5/6/2009
9 Tetanus/Diptheria toxoid was given in the left arm along with influenza and pneumonia which Y were given 3/12/2009
in the right
3/12/2009
arm. That night the p
sh back of both hands and both elbows since getting small pox 16 Apr 2009. U 4/16/2009 5/1/2009
emperature of 100 F within 24 hours Y of injection as well as tenderness; both were controlledUwith Tylenol.5/6/2009
After 24-hours
5/7/2009
warmth and swelli
swelling upper arms 5/7/2009 5/7/2009
EK AFTER SHINGLES VACCINE CLIENT HAD DEVELOPED RASH ON ENTIRE BODY AND Y IT LASTED4/3/2009FOR ONE 4/10/2009
MONTH. NO FEVER
d with ACAM2000 during pregnancy Pregnancy resulted in full term healthy delivery 7/8/2008 7/22/2008
U 4/21/2009 4/21/2009
as given his 2 month routine Vaccines which included the Rotavirus. This was done on Wednesday May 6, 5/6/2009
2009 about 10:30am. On Friday
p Lt upper arm at injection site notedY soon after vaccination 4-3-09. Presented for care on 5-1-09
Y with 2d4/3/2009
history increasing
4/29/2009 size of lump an
was reported by a healthcare professional
Y and described the occurrence of injection site redness
Y in a 4-year-old
4/13/2009male 4/14/2009
subject who was vac
ived oral Rotavirus vaccine
Y Jan 30 Y 2009. Had some
Y nausea, vomiting,
3 fever for 24 Hrs then Yresolved but1/30/2009
5 1/2 wk later3/5/2009
developed intussus
d fever 3/14/09 - 3/18/09 with rash head
Y to toe -Yrash eventually peeled. 1 Hospitalized after 2 ERY visits - had3/4/2009
a/c for Kawasaki
3/14/2009 with cardiology
ness pain, swelling at and around injection site. Y 3/20/2009 3/20/2009
circle around shot. Now white circle, swollen arm, 6 inches across red circle. N 4/28/2009 4/29/2009
alized erythema/ induration on left shoulder after vaccines placed Y 5/7/2009
appetite Tremors Loss of mobility Dizzy
Y Weight loss. N 1/22/2009 1/29/2009
ven shots on 5-1-09. 45 mins after shots
Y started fever, body aches, nausea, on sat started reaction
Y around 5/1/2009
shot area5/1/2009
red, very itchy hot to t
mpanying note. Y 4/29/2009 4/30/2009
controllably for 5 days after shots given. Y 11/4/2008 11/4/2008
vaccine breakthrough diagnosed by Dr in our office on 5-1-09. Had VARIVAX X 2. Sibling also U has varicella. ### 4/30/2009
Vaccine Breakthrough. Diagnosed in office by Dr. on 5-1-09. Had 30 lesions. VARIVAX X 2. U 11/5/2008 4/29/2009
change. Sleepy day after vaccines. A few days later, more resistant behavior in this easy going Y toddler- irritable,
3/3/2009clingy,
3/4/2009
decrease appetite
ates pt has red, swollen, itchy area where shot was given. Left arm, 1/2 dollar size. U 5/6/2009 5/8/2009
eived immunizations (Preona #4 Hep Y A + VARIVAX) then developed raised red itchy rash 5/7/09. Y No fever,
4/29/2009
illness or5/5/2009
fussiness.
as lethargic moaned and maintain a fever in excess of 103 degrees for six hours. Unable to U fully wake up. 9/18/2006 9/18/2006
him a shot by annual check up. AndYhe had UGI. 90 minutes later after shot he start havingYhives, itchy, slight 5/5/2009dyspnea.
5/5/2009
We brought him b
rgic reaction, rt arm redness, & swelling
Y U
sig. facial swelling Benadryl + Epinephrine
Y given. Y 5/4/2009 5/4/2009
edness and hardness pt. denied any pain except when someone touches with hand. Mom noticed U 48 hours5/5/2009
after immunizations
5/7/2009 treatment
eived vaccinations @ approximatelyY2 PM 5/7/09 fussy @ 5 PM 8-9 Developed fever 104.0 FY even with TYLENOL 5/7/2009 every5/7/2009
4 hrs @ 1 am fa g
s red, swollen, hot to touch, tender.YRt thigh 2 hrs 6 x 10cm, Lt thigh 8 x 12 cm. Started with U redness + swelling
5/4/2009-> dramatically
5/5/2009 worsening
ess-instructed to lay down waited for 15 min and sat up slowly. No further problems. Y 4/21/2009 4/21/2009
mph nodes @ neck, rapid heart rate dizziness, weakness, headache, shake, nervious feeling Y feeling, nausea,
2/9/2009
rash,2/10/2009
body aches, tiredness.
after receiving MMR she broke into a rash all over body with hives. She was extremely fussyYand miserable 4/22/2009
for the next
4/24/2009
48 hrs No treatmen
ted 6 days after vaccines - lasted 3 days; Temp 104.8 degrees no other symptoms but of above Y from mother 2/2/2009 2/11/2009
ver 102 degrees - 103 degrees axillary,
Y cranky saw Dr (PMD) 5/01/09 Rash face, neck, chest, U underarms, 4/21/2009
abdomen 4/28/2009
& back - progressed t
vaccine break through. Diagnosed in office by Dr with varicella on 4-28-09. Had 7 lesions. NoYfever. Had VARIVAX ### x4/26/2009
2.
multiforme- started 5/2/09. ThoughtYto be hives- nuclear by E multiforme on 5/4/09. BENADRYL Y tried w/o 4/15/2009
relief. 5/2/2009
4/23/2009 4/23/2009
ort received on 02 April 2009 from aYphysician. A 16 year old female patient, with no medicalYhistory, received 3/6/2009
the following
3/8/2009vaccines in the
with Very sore arm (painful to touch in shot area), a general headache (which I normally do not U get), and achiness
5/8/2009 all5/9/2009
over. I had received th
eizure lasted 60 seconds self-resolved,seen
Y in ED dxed with Bilateral Otitis Media treated with
Y Amoxicillin 5/1/2009 5/8/2009
tly serving my 4th deployment since 2003. I received
Y 6 doses of the4 Anthrax vaccination between
U December 2003 and April 1st, 2009. I n
he day the first dose rabies vaccine Y was given symptoms included swolen lymph glands, soreness Y in left 4/20/2009
arm, dizziness,
4/20/2009
exaustion, headach
id with induration, mild erythema, slight itching. 5/8/2009 5/10/2009
swelled up to double its size and was Y very hot and painful. I couldn't lift my arm for two days.YThe day after5/6/2009
the vaccination
5/6/2009I developed flu li
n has been received from a consumer Y concerning her son who on an unspecified date was vaccinated
N with the first dose
4/1/2008
of MMRII (lot not
follow-up information has been received
Y from a consumer concerning a 13 year old Y female with
N no pertinent9/26/2008
medical history and no drug re
n has been received from a registered Y nurse, for the Pregnancy Registry for GARDASIL, concerningY a 21
10/2/2008
year old female
11/1/2008 with CECLOR al
n has been received from Y a physician's wife concerning her daughter, an 15 year old femaleNwho was on unspecified dates vaccinated with
n has been received from Y a physician's wife concerning her daughter, an 11 year old femaleNwho was on unspecified dates vaccinated with
n has been received from a nurse practitioner
Y through a pregnancy registry for GARDASIL, Y concerning a7/31/2008
20-year-old 7/31/2008
female, with prior hist
n has been received from a licensed Y practical nurse through a Pregnancy registry concerning Y an 18 year 8/1/2007
old female who3/5/2008
in June 2007 and
n has been received from a physician Y concerning Y a 15 month old patient who was Y vaccinated
U with a dose of ROTATEQ (lot number and ro
n has been received from a physician Y concerning Y a 15 month old patient
0 who on YunspecifiedUdates was vaccinated with all three doses of R
time of injections noted client flinched
Y mildly. 5/6/09 Contacted client after receiving a phoneYcall from his 5/5/2009
employer of5/5/2009
an adverse reaction.
ld received immunizations of DTap,Yhepatitis B, rotavirus, HIB, PCV, and IPV on 5/04/2009. YHad 5 minute5/4/2009 generalized5/4/2009
seizure and when p
d patient's father returned to clinic approximately
Y three hours after Varicella vaccine administrered
Y (administered
5/5/200905/05/09).
5/5/2009 Patient had de
ARTED ON 5/10/2009 FROM FACEYCOVERED ALL LIMBS BY 5/11/2009 5/1/2009 5/10/2009
f injections got fussy, then had generalized
Y fine shaking. Prior to shaking had episode whereYshe straightened 5/5/2009
out. Spell
5/5/2009
lasted less than 2
d fevers, malaise and headache within 24 of administration of Menactra. Now feeling somewhat better 4 days 5/7/2009
after administration.
5/8/2009 Previou
h and/or Hives, swollen feet, hands, Y face and entire
Y body. Extremely2itchy. went to the EmergencyN room on4/17/2009
4/20/09 and
4/17/2009
was kept overnight
after the injection (5/2), developed injection
Y site pain and swelling, shoulder pain. On 5/7 developed
U rash4/30/2009
on upper back 5/2/2009
and increase in pa
AR bill redness c some swelling and itching on Left Upper Arm subcutaneous Y 5/8/2009 5/9/2009
XN R>L THIGH W/IN MINUTES - BLOTHCY ERYTH. Y 5/8/2009 5/8/2009
administered in school setting on 4/30/09.
Y Mother reports that arm appeared ok that night andY next am.4/30/2009
Child began 5/1/2009
complaining of arm h
XN R THIGH W/IN MINUTES WITH BLOTCHY ERYTH. Y 5/8/2009 5/8/2009
0 hours after receiving vaccine, patient developed nausea, vomiting, vertigo, abdominal cramps, Y and temp. 5/8/2009
of 102.5. 5/9/2009
Symptoms lasted appr
ates that patient had on left arm- swelling,
Y red streaks, knot, fever up to 101 degree after varicella
Y injection
1/13/2009
in left arm.
1/14/2009
Went to Dr. Williams
ht swelling of the left deltoid muscle with redness, itching and skin warm to touch. Mother verbalized
Y that 5/8/2009
patient had5/8/2009
severe headache hou
ovitis (L) hip. 6/24/09 Hospital recordsY receivedYDOS 5/2/09 to 5/3/09. 1 Assessment: Toxic (Transient)
Y synovitis
4/29/2009of hip.5/3/2009
Patient presents with
second dose of GARDASIL. Approximately 16 hours later developed dizziness and fooling fainted and nausea. 5/6/2009Fever5/7/2009
weakness continued
5/8/2009
ns in left hip with weakness and nauseaY - developed rash on left side of back that radiates toNhip. Received 5/5/2009
ZOSTAVAX 5/7/2009
on Tues - 5/5/09. S
ped a right upper extremity tremor sites
Y after administration of vaccines persists at 48 hrs. No U other neurological
5/6/2009 findings.
5/6/20095/14/09 Receive
ported C/o redness and soreness at injection site. Observed slight bruising / redness at injection Y site area 4/14/2009
on 4-30-09.4/15/2009
s after 3rd dose of GARDASIL, Pt developed, headaches, dizziness, abdominal discomfort, N various aches 2/27/2008
/ pain, dairy
6/15/2008
sensitivity, elevated
redness, pain. Entire deltoid area was swollen + red warm compress, Benadryl and Ibuprofen Y given w/ good 5/5/2009
response 5/6/2009
decrease swelling.
iven instead of VARIVAX (ZOSTAVAX) 5/11/2009
gan around 6pm on 4/28/09 started on her face, 4-29-09 in morning woke up with all over still N with hives4/28/2009
today 4-30-094/28/2009
has had 5 doses of
er shot arm sore and some swelling. May 7 arm swollen and Erythema 4 inchs aprox. May 8 arm swollen5/6/2009 and " 4 inches
5/7/2009
aprox. May 11 ar
ensation in right arm; arm is hot, red,Yswollen; Pt has "extreme fatigue" Blood pressure has been U elevated5/8/2009
about 1S5/11/2009
points has a rash on rig
9 Severe Seizures < 3 days TransportedY by ambulance to renown medical center. OngoingNseizures until 2/23/2009
under control
2/24/2009
with phenoborbitol
ction, quarter sized erythema to arm. Blanches, non tender, not raised. Y 5/8/2009 5/10/2009
Swelling itching warm to touch > Onset later that right mom gave BENADRYL & ice over the Yweekend 5/8/2009 5/8/2009
d tender mildly pruritic erythematousYpapules over bilateral hands, dorsal > palmar surfaces,Yonset approximately 4/3/2009184/18/2009
days following receipt
hrs following vaccinations c/o swelling, pain + warmth @ injection site Rt deltoid (MENACTRA). Y 5/7/2009 5/8/2009
gave oxygen and checked vitals. Y 5/11/2009 5/11/2009
m area of erythema with slight induration,
Y minimally tender. Y 4/28/2009 4/28/2009
pular/macular erythematous rash and Y fever X 2days. U 4/22/2009
lling + tenderness at injection site. 4 days after Typhim developed soreness in arm, tenderness U (no swelling)
4/28/2009
in axilla,5/4/2009
Tingling in L fingers b
acular erythematous rash Y U 4/28/2009
c 4:30 p 4/27. Pt went to school 4/28 Y - was fine then. 4/28 night developed red area, hot to touch,
U 9x9 cm 4/27/2009
approx at4/28/2009
vacc site. Talked to on
ours after shot developed generalized Y arthralgias, headache, hot touch but no fever, chills. Severe
Y leg and
4/20/2009
arm pain.4/20/2009
Seen in ED @ hospita
local. Myalgias. Arthralgias. Fever >Y 102. Palpitation. Onset hours > vaccine. Pt seen 2 d > vaccine
U rx. NSAIDS
5/9/2009 / TYLENOL.
5/9/2009
RICELLA vaccine on 4/20/09 - On 5/9/09 Y developed some itchy spots on truck with eye pain and frontal 4/20/2009
headache - On 5/9/2009
5/11/09 Dx'd with c
:10 AM Pt. c/o ears tingling, L side of shoulder, face (L side) feeling slightly numb - No c/o difficulty
Y in breathing,
4/17/2009 No 4/17/2009
c/o throat tingling, No c
episode - hit head. Y 5/1/2009 5/1/2009
ceived shots on 4-14-09. Returned to clinic on 4-17-09 with report of swelling in right arm and Y face and itching
4/14/2009 starting
4/14/2009
on Tuesday night.
HONED 5/5 @ 1 pm. Reports that at 3am. Child awakened screaming & banging head. Head Y hot, no fever5/4/2009
& remainder5/5/2009
of body not warm
was reported by a healthcare professional
Y via a GSK representative and described the occurrence
U of diarrhea in a 2-month-old
4/16/2009 male subje
N
ort received on 04 May 2009 from a Y health care professional. This patient, who is a 54-year-oldU male is one8/13/2008
of a cluster
8/14/2008
of five patients who
ACEL, MENACTRA, varicella 3/11/09. Onset 3/20/09 Y - fever, headache,
14 Y lethargy; evaluationNat hospital: 3/11/2009
MRI, LP. Dx 3/20/2009
cerebritis. 5/12/09 VA
n has been received from a consumer concerning her three friends' children, who were vaccinated U with MMR II and became autistic. Upon
n has been received from a consumer concerning her currently 14 year old niece who as a toddler U was vaccinated with a dose of MMRII. C
n has been received from a 21 yearYold femaleYconcerning herself with 7 no medical history orNdrug allergy 1/8/2008
who experienced5/1/2008 seizures the nex
within 1 week change in cognitive abilities & behavior. Within 1st 24-48 hours rash Y over upperN forequarter9/5/2008
resolved within
9/6/2008
2 more days (No
n has been received from a nurse practitioner
Y concerning
Y a 22 week4 male who on 31-JAN-2007 Y was vaccinated
4/23/2007 with
4/23/2007
a first dose of ROTAT
t injection site of varicella. ER vs 3xYFri-Sun. AdmY hosp Sun 5-1-09 4pm through ER. Culture Ydone at injection4/29/2009
site = staph.
5/1/2009IV antibiotics wh
d 5/1/09, c/o pain. "limping". Temp 103 degrees during the night, shaking, Temp 102 degrees Y am of 5/1/09
4/30/2009
c/o tummy4/30/2009
ache, gagging, 0 vo
5/6/2009
4/29/2009
induration, fever, chills, myalgia, BP stable, No anaphylaxis. 5/4/2009 5/4/2009
n initially & then recurred with deep muscle pain U 4/23/2009
out in bumps all over his body, is in the nurses office @ school. Some are fluid filled. does not have PCP. 4/29/2009
Instructed 5/3/2009
to go to PCP.
ash on R deltoid began 5/4/09 and today 5/6/09 erythema and in eye itchy spread to both forearms U in addition
4/18/2009
3-5m papule
5/4/2009 have appeared
ness, fever, joint pains, headache w/in 24 hours of vaccine. Y 5/6/2009
ministration of L arm erythema & firmness 2-3 cm, Local reaction. Noted 5/7/09. U 5/5/2009 5/6/2009
24 hrs after injection site where administered extremely tender, unable to lift arm. 24 hrs after Y fever began4/23/2009
at 99 degrees,
4/24/2009extreme fatigue,
male was administered VARIVAX onY5/4/09 at Health Unit . On 5/6/09 mother presented to health Y unit with5/4/2009
child to report
5/5/2009
vaccine reaction.
eared 3 days after vaccine, with no Y associated signs or symptoms. Rash consistent with erythema Y multiforme.
4/30/2009 Coincided
5/3/2009with day 7 of AM
hours post vaccination: Fever/chills X 3 days; redness/swelling in large area over injection site, Y generalized3/20/2009
arthrolgias;
3/21/2009
started to resolve
r, painful. 3rd day reaction. Swelling at site of injection. Y 5/4/2009 5/6/2009
(2) SOB, (3) Throat swelling, (4) Stiffness
Y of upper & lower extremities. Oxygen SAT decreased Y 94% on4/30/2009
RA. Rx: 6 lit 4/30/2009
oxygen, EKG, SOLUM
warmth, induration - diffuse tighteningY + pain with touch. Treated with augmentin and will follow U up tomorrow 5/5/2009
05/08/09. 5/6/2009
iven 4/23/09 - Pt began having myoclonicY jerk seizures about 5 hours later. Pt told to go to ER
Y ASAP. LP, 4/23/2009
EEG, MRI, 4/23/2009
CT had all WNL. Curr
U 4/14/2009
meter redness, warmth, swelling, with Y superficial oozing of serum. Y 5/1/2009 5/4/2009
eived Td. - Should have received dTap) 4/11/2009
tool noted 4-29-09 5 days after vaccine Y given. Y 4/24/2009 4/29/2009
t weak, lost balance, became pale, eyes rolled around, pulse and blood pressure went decreased. Y With rest,
5/6/2009
a drink,5/6/2009
and a snack patient s
oid swelling, heat, pain. Large palpable nodule in right axilla. Rx: Augmentin E S 600mg 1 Y 1/2 tsp po BID
4/27/2009
x 10d. Warm4/27/2009compresses to af
seizure activity, brief alteration of consciousness.
Y Y 1/2/2009 1/9/2009
r followed by seizure 24 after vaccine Y Y 3/25/2009 3/26/2009
arm red, swollen and fevered. Mother Y stated used ice packs, ibuprofen and BENADRYL withUno improvement. 5/5/2009
Advised 5/5/2009
to go to ER or child
0-09) - site irritation only through Sunday 5-03-09 - Rash began Monday AM. Covering - Neck U to back of 4/30/2009
thighs. Covering 5/4/2009
torso.
.7 Po since evening after TDAP given until seen in office on day 2. Fatigue + Myalgia X 2 days. U 5/4/2009 5/5/2009
4/29/2009
ling and pain at the site of injection. Y 4/28/2009 5/1/2009
ling & pain at the site of injection. Y 4/7/2009 4/24/2009
st administration child had redness up & down 22 mm left & right 20 mm right thigh upper & slightly Y warm. 4/28/2009
Mom advised 4/30/2009
to watch & use wa
ver 11 days post vaccine 4/24/2009 5/4/2009
noticed behind ears, now on stomach, arms fine red rash behind ear papular rash scattered U on thorax + 4/29/2009
extremities - 5/5/2009
2 hours vaccine on 4/2
throat, difficulty swallowing, stiff neck am of 4/25; and R arm pain Sun am 4/26. Fever blisterYlip. Evaluated 4/24/2009
by Dr and 4/25/2009
started on NAPROSY
tient received immunization at 11:00 and then developed hives that afternoon, no respiratoryYdistress, gave 5/1/2009
patient Benadryl.
5/1/2009Claritin, and O
ed & hot to the touch. Y 4/28/2009
FTER RECIEVING ANTHRAX VACCINE MEMBER HAD A RING OF RAISED BUMPS AROUND U INJECTION
5/1/2009SITE THAT
5/4/2009 ITCHED. MEMB
ed fever (102.0 degrees F) and soreness at injection site (left deltoid region) 24 hours after Y receiving injection.
4/29/2009 Had4/30/2009
stomach discomfort 2
rent says that patient only slept about an hour and a half last night after his immunizations. Says U that he5/11/2009
cried nonstop
5/11/2009
for 3 1/2 hours unco
oticed rash on upper arm and redness size of 50 cent piece. Parents gave Benadryl 1 dose.Y 5/1/2009 5/2/2009
sore, low grade fever, felt tired. Parent unsure which arm was sore. Y 4/29/2009 4/30/2009
low grade fever, fatigue (parent not sure which arm was sore) Y 4/29/2009 4/30/2009
TELY AFTER GIVING MMR SQ ON LT THIGH PT THIGH BECAME RED, SWOLLEN AND Y BLANCHING 5/11/2009
WAS NOTED 5/11/2009
DR NOTIFIED AND
and swelling at injection site. Fatigue. Y 5/8/2009 5/10/2009
the patient called the office to say that as of 1/7/09, her arm from the injection site to the elbow
Y was red, warm,
1/5/2009 and swollen.
1/7/2009
ceived the vaccination on Monday 5/4/2009.
Y Mother called office on 5/5/09 and stated that child's
Y Right arm
5/4/2009
where he 5/5/2009
had received his Dta
eaming in tantrums which would last 15minutes to one hour off an on. Flailing arms, legs, shaking N head. 5/1/2009
Diarhea, vomiting,
5/1/2009 no fever. Initia
hysician varicella rash on back, stomachY and arms with no fever Y 4/30/2009 5/12/2009
pneumococcal vaccine trial, with severe COPD, Y was admitted to the 10 hospital fro severe colitis
Y on 11/8/2008.
9/10/2007
Vaccination
11/8/2008 took place on 9/1
pneumococcal vaccine trial, with severe COPD, Y was hospitalized on 8 11/18/2008 with CHF. Y Vaccination 9/10/2007
took place on 9/10/2007.
### Accordin
d Tdap injection 3/17/09. 3/24/09 reported
Y as walkin to PCP reporting that arm is red and swollen.
Y Per NP3/17/2009
note that3/24/2009
day "left deltoid area ha
d no signs of complicationsY after birth. Shortly after receiving hepatitis vaccination by the nurse U the baby5/11/2009
began experiencing
5/11/2009 stopped bre
ying, sore arms, couldn't move arms; Y temp 105 degrees F; mother gave Tylenol suppository;Ychild projectile 5/6/2009
vomiting.5/7/2009
Tylenol lowered fever
LOPED SIGNS AND SYMPTOMS OF hERPES zOSTER OPHTHALMIC BRANCH OF 5TH YNERVE l SIDE 5/1/2009
4 days after
5/5/2009
receiving Zostavax
d lump the size of a blueberry appearedY behind his right ear (this was diagnosed as lymphadenitis
U by Dr.4/28/2009
Chevez) the 4/29/2009
day after his vaccina
esday May 13th I visited my primary care physician for a routine physical examination. He recommended Y 5/6/2009
that I receive
5/6/2009
both Tetanus and P
ETWEEN 102.5 AND 103.7 FOR 50 HOURS; DIFFICULT TO CONTROL WITH MOTRIN AND Y UNRESPONSIVE4/28/2009TO5/7/2009
TYLENOL // RASH: P
halitis etiology unkonwn.YFive weeksY after administration
Y pt experienced
100 Y stiffnessYof neck. NeckN pain, back 8/16/2007
pain, lethargy,
9/19/2007 no appetite fever
m, I fainted, had possible seizure, unconscious
Y for 1 hour, several months of testings,
Y Dr's can'tN find what's wrong, ###since vaccine
### have sever
warmth & hardness at site, pain at site.Y Y 5/5/2009 5/6/2009
-> Lt scapular pain - gen OXYCONTIN 20mg. ? nerve root. 1/1/09 - shingles --> given FAMVIR N 500mg: PO Q8### hours. ###
elling w/ slight tenderness 12 days after Merck vaccine. Lasted approximately 12-24 hours. YCould move 4/8/2009 neck freely;
4/10/2009
R swollen upper arm
ion , tenderness left upper arm Tylenol or Ibuprofen cold pack to and comfort. U 5/5/2009 5/6/2009
ssible granuloma. Y U 3/19/2009 5/11/2009
nted after administration of yellow fever vaccine, also received IM vaccines for Havrix & Adacel. Y Lasted 5/11/2009
about 30 seconds
5/11/2009 recovered comp
minutes after receiving immunizations Y had syncopal episode and fell onto concrete outside clinics,Y V/s normal,
5/6/2009
hadn't5/6/2009
eaten that day, Dad s
child reports that child had redness, swelling and warmth at injection site within only a few minutes
U (<30).4/13/2009
Site remained
4/13/2009tender to touch un
ped urticaria (generalized) after receiving DTP/aP (TRIPEDIA), PREVNAR & HIB. Per mother Y rash quickly4/24/2009
subsided4/24/2009
within 10 Min & comple
into clinic at 10:00 am on 11-3-08. She reported 4-5 hrs after getting vaccines pt noted redness, Y warmth, soreness
### and itching### on upper le
ine give with expired date Lot 00114 Exp 21 Mar 09 - Saw date as 21 May 09. U 5/12/2009
ately 24 hrs post receiving vaccines, pt reported temp of 102 degrees F. Temp went down inYthe evening 5/5/2009 but next afternoon
5/6/2009(48 hrs later, te
ite {erythema warm sensation pain} with in 4 hrs of shot; then in 24 hrs --> pruritis + (increased) Y redness4/24/2009
5 treatment4/24/2009
(resolved in 1 wk).
ZOSTAVAX injection 5/28/09. Awakened this morning (5-1-09) with a raised, red rash over U "upper chest."
4/28/2009
States the5/1/2009
rash "itches and burn
n, loss of eye sight for 2 weeks. Nerve Y pain. Experience - still being treated for nerve pain in U head. 7/9/2008 ###
apules + pustuls on back + arms. Y ### 5/12/2009
me 1 1/2 hrs post vaccine & stated Y to faint (Dad is a Dr. (cardiologist) and called it a "near syncopal
Y episode
5/11/2009
she also
5/11/2009
felt nauseous & tired.
ain and swelling saw Dr 5/9/09 Y 5/6/2009 5/7/2009
tis left arm s/p Tdap placed on Keflex per clinic & now doing well. 5/8/2009 5/9/2009
developed cough and congestion in lungs, Dr prescribed antibiotic (Amox-clav 500 mg) 3 days N later they gave
4/7/2009
no relief
4/8/2009
or made any differen
ministered @ thigh on 5-3-09. On 5-4-09 in office for eval -- leg pain & refusal to walk since vaccineY administered.
5/3/2009 Are 5/3/2009
firm. Are on L thigh
ma, pain, redness. Y 4/30/2009 4/30/2009
secondary transmission of vaccinia:YPatient is not vaccinee. VAERS filed on vaccinee. 26 year U old female 4/16/2009
patient whose
4/30/2009boyfriend received
n has been received from a pharmacist Y reported that a 25 year old female Y with no allergies received
U PNEUMOVAX
1/31/2009 1/31/2009
(Lot# 662742/1117X), u
s a PNA vaccine on 5-2-09 on her left deltoid. Develop a big red mark on the injection site c/o pain and feels 5/2/2009
swollen5/2/2009
then put a marking on
around 2100 on 5/2/09; spoke with one RH to report that her (L) arm where they injected Pneumococcal vaccine 5/4/2009 started
5/5/2009
to get swollen. Pt w
ingling and respiratory symptoms 4/15/2009
ates awoke to arm red swollen tender to touch. Noted hard spot near tender arm size of prune. Y Patient able 5/8/2009
to use arm5/9/2009
c/o area itchy. Wil
back itchy, especially on ABD. Trunk/Buttocks
Y groups of vesicular/ papules/few tiny pustules U on erythem. base.
6/7/1999 Clinically - varicella (status
ve hep B (peds) on 5-1-09 vac exp date 4-28-09 5/1/2009
dministered to pt on 4-1-09 after she Y denied any allergies about 6pm. Client states on 4-2-09 Y a red slightly
4/1/2009
raised rash 4/2/2009
developed on neck,
length area of redness + local temp - started ? 2cm x 2 in and elevated to 5cm X 5cm overnight. Y Fever 4/29/2009
> 99.8 (A)
m area of erythema + warmth -> L biceps.Y U 5/6/2009 5/7/2009
Y Y 4/13/2009 4/22/2009
on, some lost of vision. ###
was reported by a lawyer and described the occurrence
Y of joint pain0 in a male subject of unspecified
N age 8/1/1999
who was vaccinated
11/1/1999 with LYMER
o hve severe joint pain Y U 5/11/2009 5/11/2009
as given a Zostavax vaccine as opposed to a varicella vaccine. Contacted patient's mother. Patient is having 5/11/2009
no symptoms.
hospital on May 11, 2009 Y with bilious
Y emesis, Y and low grade fever. 2She was sent home with the diagnosis 4/3/2009
of acute5/10/2009
gastritis. The patient pr
received 2nd dose of Hep A/B TwinRix Y on 5/11/09.She had no problems with 1st dose on 1/12/09. U Within
5/11/2009
an hour of 5/11/2009
receiving the shot, he
tions administered at 12:40pm, 12:45pm face red, hives noted on face. Benadryl administered. Y 2:40pm face 5/11/2009
no longer5/11/2009
red, hives gone.
N AS THE VARICELLA AND MMR WAS GIVEN LOCAL REACTION OCCURRED IN THE FORM Y OF WHEAL,
5/13/2009TWO5/13/2009
OF THEM AND SOME
ped a raised red area on back of Left Y arm on Sunday, 4/26 after immunization on 4/16. AreaYwas hot and 4/16/2009
itchy when 4/26/2009
noticed. Presented @
that a couple of hours after taking 1st
Y typhoid pill developed rash on wrists with swelling of one eye. No 5/8/2009difficulty breathing.
5/9/2009 After taking
ated she had received a MMR vaccine Y and later that night her jaw appeared swollen and painful. Y She stated
4/14/2009
that she 4/14/2009
felt feverish. She cam
n a 102 fever, breathing very fast and Y red cheeks and a very congested nose. Pediatric emergency N number
5/8/2009
advised 5/8/2009
us to go the hospital w
to clinic 4/21/2009 with swollen cheeks,
Y upper lip and left periorbital areas. Hives on trunk and Y arms since4/6/2009
4/6/2009 when4/7/2009
he had his vaccin
S MOTHER REFERS RASH IN ARMS, LEGS, BACK AND IN THE BACK OF THE NECK. Y 3/9/2009 3/9/2009
s and swelling at site of Varivax and Hep A vaccine, persisting swelling at site for 2 weeks. Y 4/27/2009 4/27/2009
DEVELOPED ITCHY HIVES SIMILAR Y TO VARICELLA LESIONS ON HER FACE AND BODY. U 4/9/2009 5/9/2009
eveloping warts on inside of vagina which had never occured before. Three weeks later they N were still there
4/24/2009
and getting
4/28/2009
uncomfortable so i w
CP on 2/4/09 for GYN/PAP and received #1 GARDASIL Y that day. Urine2 HCG on 2/4/09 was negative.
N Pt subsequently
2/4/2009 2/4/2009had (+) pg test 2/16/0
on 1 week prior to abnormal labs, cough x 1 week, Y nasal congestion1 x 1 week, croup 2 months Y prior to admission
2/24/2009- 3/16/2009
3/16 plts 12,000 receive
wing day, noted increased fever, increased rash to chest & arms (red pimples). 3-5Y days later,Ndecreased speech, 1/3/2008clumsiness,
1/4/2008 huge dilated
by MD 5-12-09 in Dermatology - note enclosure. Y 4/10/2009 5/8/2009
uration with redness R lateral thigh Y 4/29/2009 5/1/2009
ook child across street to groc store. She was crying when suddenly went limp + eyes rolled Yback in her head. 5/8/2009 She had
5/8/2009
mild inflammation o
onds after injection became diophoretic, lightheaded, passed out for 15-20 seconds. C/o swelling Y in throat
5/12/2009
and throat5/12/2009
soreness, no SOB or
days vomiting X 2 days U 5/5/2009 5/5/2009
ness approximately 10mm. Vesicles. U 5/12/2009 5/13/2009
d immediately to VAR + MMR with redness + swelling @ sites, generalized urticaria on legs, Y arms, + back5/13/2009
+ abdomen. 5/13/2009
Given 0.2cc of Bena
30mm area of induration on L lateralYthigh. Y 5/1/2009 5/2/2009
se event of symptoms, wrong vaccine given. In clinic 1hr. Past injection with no problems. Y 5/13/2009
dache, fatigue, tremors, arm swelling, myalgias, weakness. U 5/11/2009 5/12/2009
h "milk protein allergy" atY1 month ofYage, developed
Y diarrhea about 3003Y weeks after getting only
N dose of ROTATEQ.
10/8/2008 Found
11/5/2008
to have rotavirus
hing pain in Rt arm, very tender to the Y touch, very red and very hot. Dr put her on antibiotics. U 4/26/2009 4/28/2009
plaint was neck arm stiffness of left side,
Y which continued, confustion (goofy like she was drunk), N conti complaints
5/11/2009of5/11/2009
neck arm, then exhaus
n has been received from a nurse practitioner
Y concerning
Y her 18 year4 old daughterY who on 29-AUG-2007
N 8/29/2007
was vaccinated9/5/2007
with her first dos
n has been received from a consumer concerning Y her approximately1 12 month old son with N allergic reaction to antibiotics who in 2001 was
n has been received from a consumer concerning, the patient's mother, her son (a twin, whoYalso had the same experiences reported in W
n has been received from a consumer, the patient's mother, concerning her son (a twin, whoUalso had the same experiences reported in W
n has been received from a Registered Y Nurse concerning a 2 month old male who on 30-APR-2009 Y was4/30/2009
vaccinated 5/4/2009
orally with the first 2 m
d with rotavirus on 4/30/09 at 6:38. Was taken to Y hospital by mother1after vomiting & diarrheaYfor 2 days. Was 7/2/2008
admitted
4/29/2009
to hosp & tested for
ospitalization for IVIG - extreme weight
Y loss. Tripping,
Y falling, loss of5 muscle mass, inability to
N walk without11/5/2008
assistance. Now ###is in a wheelch
ient seen for F/U s/p hospitalizationY4-5thMay09 Y @ hospital for Acute 2 Myopericarditis following
Y receipt of4/22/2009
primary Smallpox
5/2/2009and Anthrax #1
p with CP and SOB in the early morning Y hours Yon 1/22/09 and got tachycardic
1 and SOB tryingY to climb stairs
1/11/2009
later that
1/22/2009
day. Went to health
e on lower lip within 48 hours of injection."
Y Upper
Y chest pain waking 2 pt. @ 0300 1 wk after injection.
Y No cause
4/15/2009
or change
4/22/2009
of routine other tha
d, slightly warm to touch, area was Y 1 1/2 inches wide x 3 inches in length. Y 5/5/2009 5/6/2009
o fever 102,less of appetite, and fussiness.
Y Y 5/12/2009 5/12/2009
ven Rotarix vaccine. On first dose of Rotarix, my baby had symptoms of vomiting, blood in stools. N These 5/13/2009
symptoms 5/14/2009
stopped after giving ant
5/16/2009 Y Y Y 4 N 5/11/2009 5/12/2009
vaccination on Friday, by Saturday Y evening developed rash at site of injection. Two days later U reaction (rash,
5/1/2009
swelling)5/3/2009
was appro 2" x 2". A
d, hard 2.5 X 3 inch cellulitis, left upper deltoid with left arm pit lymph node involvement. Father U is a MD and 5/12/2009
put child5/13/2009
on Keflex. Child has fe
9 mom called and spoke to nurse, statedY that son got imm on 5-6-09 and now has a swollenYarea on this 5/6/2009 left thigh that
5/10/2009
is the size of a tenn
hours of taking the vaccine, headache,lowY body temperature.next morning, low blood pressure, N nausea, 5/11/2009
body ache, 5/11/2009
stiffness in right arm, th
Varicella and Hepatitis A vaccines on Y 5/13/09 at 1500 hr. Around 1830 hr., developed urticaria, Y swelling 5/13/2009
on eyes and 5/13/2009
mouth. He began cou
n 786.5 (5-000008) 5/19/09 medical records received Y DOS 1/27/09 to 2/5/09. FINAL DIAGNOSIS: U Atypical
1/6/2009
chest pain,
1/27/2009
Hypertension (Sys
nistered Tdap, no previous allergy toY Td, was being Y worked up for allergy
13 - tested + seafood N and almond;4/15/2009
approx 154/15/2009
minutes after vaccine d
m, red, bruised spot on the left arm at Y injection site. Prednisone given orally. Y 5/12/2009 5/13/2009
er arm redden and swollen. Child complains of pain. Mother Bendryl. Applied ice. Y 5/7/2009 5/7/2009
esented to the emergency department Y complaining of generalized rash and itching. Patient was Y treated with 4/6/2009
benadryl4/9/2009
and released home a
ite red and swollen x 1 day, diagnosed with cellulitis at injection site, treated with Sulfatrim xU10 days 5/12/2009 5/13/2003
e series of 3 injections and after the Ypatient developed
Y utis, uris, strep
3 throat 3 times, joint pains,
N muscle weakness, ### numbness, ### insomnia, m
ports that after receiving shot of gardasil abd menectra on 02/25/2009 she became very sleepy Y but not lethargic
5/13/2009 and5/13/2009
experienced a severe
SEEMED TO HAVE PROFOUND HEARING LOSS FOR 2 DAYS AFTER HER VACCINATIONS. Y SHE DID2/26/2009
NOT RESPOND
5/13/2009 TO HER NAM
en hpv vaccine pt was then found to be pregnant Y 6/8/2007
was reported by a healthcare professional
Y and described the occurrence of shoulder pain inNa 40-year-old 4/14/2009
female subject
4/19/2009 who was vaccina
ations. - Fever, chills. - Local cellulitis. 5/15/09 YMedical records received2 (hosp discharge summary
Y included)
4/29/2009
DOS 4/29
4/29/2009
and 5/1/09 to 5/3/0
nd decreased appetite started
Y after he
Y receivedY5/1 immunizations - developed night sweats,Ncold symptoms, 5/1/2009
bruising5/3/2009
- hospitalized 5/11/09
esented to hospital with 1-day history of bleeding, Y bruising and low platelets.
3 History includedY epistaxis, left
4/20/2009
elbow bruise
5/11/2009
and a platelet coun
elling, redness within 48 of receivingYDTAP R deltoid. Y 5/9/2009 5/9/2009
d redness, swelling locally in Rt. deltoid
Y where administered. Systemic chills without fever, myalgias. Y 5/6/2009 5/7/2009
d Varicella vaccine (lot #0336Y) SCYin L lateral thigh on 5/4/09, as well as Hep A vaccine IM.YSeparate areas 5/4/2009
of induration
5/4/2009found on L thigh
ed vaccines TDAP, Hep A + VARIVAX @ 2:30 pm, Pt waited 15 min after vaccines. Pt was fine. U It was around
5/13/2009
3:07 5/13/2009
pm when Pt came to Do
redness, pain, warmth at injection site. Patient seen at clinic and back in primary physician'sYoffice. 5/11/2009 5/13/2009
1/4 inch upper arm redness, blanches, not warm, no streaking c/w immunization reaction Y 5/12/2009 5/14/2009
Erythematous Wheals all over bodyY+ itchiness TX: Benadryl 25mg to tabs PO 4-6 Hrs for itchiness. Y 5/11/2009 5/11/2009
d redness, heat and swelling yesterday. Area red hot, 0 induration noted, minimal swelling toYsite. Approx 5/11/2009
12cm across.
5/10/2009
No itching or pain.
Mother noticed L arm red @ injection site. 5/4/09 blisters on L upper arm with redness + tenderness Y at the
4/21/2009
base. Mom 5/3/2009
called child's Dr + h
gnant female, ADSM, reports receiving Flu Mist vaccine on 17 October 2008 despite being 38 U weeks gestation. ###
The service ###member decid
rgic reaction at site of injection. Y Y 4/25/2009 4/25/2009
female presents for walk-in appt, with "itchy, little red bumps that look like mosquito bites" on Y arms, chest,3/10/2009
abdomen3/16/2009
and back 10-days s/p
ale, ADSM, is referred to the Transition Y Unit for several day h/o nausea and vomiting associated U with his receipt ###of Flu Mist ###
vaccine on 28 O
linic (06May09) re 22 y/o AD WM SM Y w/ 10-12 tiny vesicular lesions surrounding primary SPV Y injection site
4/29/2009
RUE. SM5/6/2009
received primary SP
h left arm, swelling, no fever or vomit. Pt was seen today Doctor 5-22-09. U 5/12/2009 5/13/2009
tchiness, redness at site of injection (L deltoid) 5 - 6 cm reaction - round - slightly erythematous U lesion. Slight
5/1/2009
induration,
5/3/2009
no fluctuance.
s down on R side of face when crying or drinking. Began 1 week ago (approximately 4/30) ?Nmild Bells Palsy. 4/28/2009 4/30/2009
2" urticarial patch over injection sites on right thigh - started at the MMR site - enlarged to cover Y both sites. 4/24/2009 4/24/2009
ination on way home mom said lips got swollen and child broke out in fine whelps. Gave TYLENOL Y and BENADRYL.
5/7/2009 5/7/2009
On 5-7-09 left arm at
swollen lymph nodes under jaw on April 30. N 4/21/2009 4/30/2009
ptoms 2 wk recovery complete physical breakdown felt as if hit by a truck" weak, chills, pain back Y + ribs; chills;
4/2/2009
nausea;
4/24/2009
loss of appetite; che
d rash on 1 thigh, warm to touch Y 5/6/2009 5/7/2009
njection given - HEPA. HEPB & INFLUENZA given 0845 - Patient feeling weak, dizzy, chestYtightness, HR60 5/14/2009
blood5/14/2009
pressure 60/40 0850 -
vaccination: Next few days had increased swelling hardness, heat (hot) Redness cont to spread Y also itching 5/4/2009
+ aching5/4/2009
+ soreness - spoke w
erythema - mom described as the size of a baseball tx with BENADRYL 5/13/2009 5/15/2009
Feverish, C/o "feeling sick" 5-15-09 Employee came to Employee health with pea sized knotYleft upper inner 5/11/2009
arm. lymph
5/12/2009
node also red blot
tion (KINRIX) given on 5/12/2009; mom noticed and reported localized swelling of L arm on 5/14/09, U arm5/12/2009
swollen to 5/14/2009
twice the normal size fr
hives occurred that pm or next am. Patient has DX of urticaria Dermatitis. HX of local reaction Y to latex band
4/29/2009
aids- only
4/29/2009
RX for this incidence
Rt arm inflamed and swollen from shoulderY to elbow - no pain, no fever - when picked up from U day care. 4/28/2009
4/30/09 - Arm 4/29/2009
unchanged - still no
blisters up both arms. Treated with BENADRYL 25mg x 2 doses and antibiotic cream to blisters. 4/30/2009 4/30/2009
treated with BENADRYL 6.25mg Q4hr prn. Y 5/6/2009 5/6/2009
reaction at IM injection site left deltoid. + redness, swelling and warm to touch. Treated with YTYLENOL, BENADRYL 5/8/2009 5/9/2009
and warm compresses
e fever (101), diarrhea, mild irritability starting 48 hours after vaccination. Y 3/19/2009
ness and swelling in L arm 24 hours after injection at site of Sub Q injection of VARIVAX. Y 4/29/2009 4/30/2009
nset one hour after vaccination, at site. Treated with 25 mg Diphenhydramine P.O. . Y 4/29/2009 4/29/2009
Tdap around 9:00-9:30 am at school; Y felt drowsy all day afterwards. Later that evening felt tired,
Y weak, dizzy, 5/5/2009
chills and
5/5/2009
fever of 102.6. com
ministered 0.5 cc of Tdap to client. Expiration date was checked before administration of vaccine U but still was
5/4/2009
not realized til entered into gr
IZ's 4.29.09 - 5-1-09 pale, fever by evening was in Reno all day that day. 5-1-09 Fever increased- Y unknown temp as no thermometer. W
->72 hours : 5 x 7 cm erythematous raised area with small papules (no vesicles). RecoveredYwith Rx. Sl.4/27/2009 increased 4/28/2009
color. Afebrile.
an at injection sites on right arm. Patient received Varicella and Hep A vaccines in right arm.YHives spread5/6/2009 to legs, groin
5/6/2009
and upper arms. N
creased temperature. Seen in Hospital Y emergency room. Y 5/7/2009
- red and swollen with small hard lump. Y 5/5/2009 5/6/2009
ay 8- joint and muscle pain, fatigue Y and lymph node swelling. 2/28/09 Day 9- symptoms became severe,2/20/2009 site painful.2/28/2009
3/3/09 Day 12- evalua
site red and swollen x 1 day, diagnosed with cellulitis. Treated with a 7 day course of amoxicillinU 5/12/2009 5/13/2003
brought in for office visit two days after
Y immunizations d/t fever and localized rash to L thigh.YDescribed 4/13/2009
by NP as tennis4/14/2009
ball sized, raised,
brought in for an office visit six daysY after immunizations were given for localized rash of R armY around injection(s)
4/7/2009 site.4/12/2009
Was treated for dia
vaccine on may 12,2009 at 4:19pm. Later in evening developed body aches, chills and "fever in side". Left 5/12/2009
arm became 5/12/2009
swollen and red.
esented to our office on 5/14/09 with a 2.5in circular swelling @ the injection site. She was diagnosed
Y with
5/11/2009
either cellulitis
5/14/2009
of the injection si
, swollen, hot area on left upper thigh, no discomfort and gait problems Y 5/12/2009 5/14/2009
d her first rabies vaccine on 3/25/09Yand 2 days later had flu-like symptoms, sore throat, "bad" N cough, fever,
3/25/2009
chills, excessive
3/27/2009 tiredness and
er aspect of arm extending light redness 100mm radiating from injection site with darker redness N extending 5/13/2009
50mm from 5/15/2009
injection site radially
d chest pain and palpations after second Y gardasil vaccine. Cardiac evaluation is underway. 5/26/09
N Medical records### received ### DOS 12/30/0
ythamatous, tender lesion at injection Y site U 5/13/2009 5/14/2009
ollen and knot the size of a quarter Y at first on5/13/09 pm. Arm s/s increased and pt seen in Y ER and tx with5/13/2009
Benadryl. 5/13/2009
Mom reported on 5/1
5 yo vaccines today, kinrix, MMR and Y var.ÿ Rash developed about 20 minutes after they leftYthe clinic.ÿ Very 5/14/2009
itchy.ÿ5/14/2009
Started on neck and w
as given Gardisil instead of Menactra Y 5/12/2009
n (786.59) 5-000009 6/10/09 Medical records Yreceived DOS 1/21/09 to 2/3/09. CLINICAL IMPRESSION: U 1/13/2009
Palpitations 2/3/2009
resolved. Post vacci
ew days of receiving Menactra vaccine, Dylan developed Y toe numbness
10 then headache, nausia, Y followed3/19/2009
by foot dragging,
3/20/2009impaired joint po
esented 24 hours later with redness about the size of a half dollar, with tenderness to the touch. U Recommended
5/14/2009 cool
5/15/2009
compresses and trea
ELTS" ON LT ARM TOWARDS THE OUTSIDE-MENACTRA GIVEN IM ON OUTER ASPECT Y OF DELTOID 5/14/2009
MUSCLE 5/15/2009
& HEP A GIVEN TO
month old male presents with c/o Skin Check: for 4 days had Immunizations on 4/17/09 and now Y has a red, 4/17/2009
hard, warm 4/19/2009
to touch area below
ssion from E.R.,recieved Pneumovax in ER, c/o R tricep swelling, pain, itching, observed swelling, Y edema,4/16/2009
warmth,redness,
4/16/2009notified Dr. Ea
ame in to my office 5/15/09 1350 to report neck stiffness and head pressure that started 5/15/09 U PM. 5/13/2009 5/14/2009
as given MCV4 and Var #2 in her left arm. Mom stated that patient had a history of feeling light Y headed with 5/15/2009
any type 5/15/2009
of procedure/lab test.
experienced a short duration of minor pain and redness at injection site each time the vaccine Y was administered.
5/8/2008I was 1/22/2009
pregnant during my
lt with swelling and redness within 4-6 hours after immunization Y 5/12/2009 5/12/2009
arm injection site swelling but not painful, with some redness. Y 5/2/2009 5/15/2009
d erythematous rash at site of vaccine. Y 5/15/2009 5/15/2009
day after shot with a rash widespread over the body and some puffiness to her eyes. Urticaria. U 5/11/2009 5/12/2009
ss Criteria: Other- Medically Significant.
Y Initial report received from another manufacturer
Y (other manufacturer's
4/21/2009 control
4/22/2009
number: WAES 090
9 cm, warm, erythematous area @ previous injection site. Mom states area doubled since injection. N 5/11/2009 5/12/2009
d reaction right thigh. Y 5/5/2009 5/6/2009
was reported by a healthcare professional
Y and described the occurrence of fainting in a 13-year-old
Y female
5/12/2009
subject 5/12/2009
who was vaccinated wi
ceived vaccine 5-8-09; noticed erythema,Y tenderness and warmth 5-9-09 (10x10 cm area at Y injection site).5/8/2009
Doctor visit 5/9/2009
5-11-09. Prescription
ced redness @ swelling to right deltoid area this morning. Y 5/14/2009 5/15/2009
of inflammation occurred immediately after injection given at injection site. Red are had pin point Y areas and5/13/2009
facial areas
5/13/2009
also flushed. MD n
red skin in roughly rectangular shape over left anterior thigh surrounding the injection site. About
Y 9cm x 5cm.5/5/2009
Emerged5/11/2009
6 days after vaccina
mplaints of dizziness, Pt put head on desk. At 1:38 pt vomited small amt, color pale, clammy, Y alert oriented
5/15/2009
B/P 100/72
5/15/2009
- Pt states she is h
urs after receiving injection size 2X2 inch in circumference pruritus, pain + Erythema Tx Benadryl Y + Cold compress.
5/8/2009 5/9/2009
d 4.5mm x 5mm areas + redness, swelling Y and tenderness at site of injection L upper thigh. No
Y significant 5/13/2009
systemic 5/13/2009
reactions due to vaccine
ction Left deltoid; erythema/ edema Y and pain. U 5/13/2009 5/14/2009
red and swollen. Y 4/28/2009 4/29/2009
ves over entire body, headache, itchy throat. Y 5/15/2009 5/15/2009
ed vaccinia with diffuse rash, myalgias,
Y fever, and robust take. Treatment with indocin and benadryl..
Y 4/29/2009 5/4/2009
y of the shot, the injection site had minamal
Y swelling; however the following starting occuringUthe day after 5/11/2009
the shot, 5/12/2009
Severe swelling of lymp
Mom reports body rash for 9-10 days and vomiting 1-2 times daily from 11-28-08 until 12-2-08; Y also "change of### attitude" screams
### loudly at t
n has been received from a consumer Y concerning her 24 month old nephew who was vaccinated U with MMR II when he was 18 months old.
n has been received from a consumer Y concerning her 2 years old son with a history of cross-eyes
N operation
11/1/2005
who in November
4/1/2007 2005, was v
n has been received from a registered Y nurse concerning
Y a 16 month0 old male with Down's syndrome
N and7/1/2008
cardiac issues,
5/8/2009
and a history of a
n has been received from a registered nurse for the Pregnancy Registry for GARDASIL concerning Y a 2512/4/2006
year old female
8/30/2007who is a Guillain B
n has been received from a nurse, for Y the Pregnancy Registry for GARDASIL concerning a 22 Y year old patient
9/20/2006 who 9/20/2006
on 20-SEP-2006 was v
n has been received from a nurse concerning aY14 month old female 0 who was vaccinated with U all three doses of ROTATEQ (dates, route a
n has been received from authors of a published Y literature article concerning
Y an 11 year old N male patient who was vaccinated with PNEUM
vaccines rec'd 10/18/07 and 11/20/07. Y 3 mos later
Y developed Guillain-Barre
5 syndrome/was hospitalizsed
Y for acute
### lower
2/5/2008
extr. weakness. 5
4/28/09 after sx has resolved. Stated that 12 hr after Td-had arm soreness, faint pain in knees, Y felt like fever,
4/24/2009
enlarged4/24/2009
lymph node under (L
ches erythematous area on left arm, Mildly elevated. Still present 72 hours after vaccination. U 5/15/2009
@ injection site edema pain. Y Y 5/11/2009 5/12/2009
c received HPV, MENACTRA, Hep A, Tdap - observed pt. 15 min. after vaccinations. Pt. later Y reported she5/13/2009
couldn't 5/13/2009
quite hear several hour
ceived VARIVAX immunization 5/11/09, mom noticed rash on arms, legs and trunk 5/13/09. Y 8-10 small slightly
5/11/2009 raised5/13/2009
lesions on arm, leg an
Y U 4/28/2009 5/15/2009
vaccination, (hours later) redness andY swelling developed around injection site. At ER, patient U was given 5/13/2009
ibuprophen 5/13/2009
and benadryl. 2 day
alergic reaction to left thigh Y 5/12/2009 5/15/2009
apular rash post auricular nodes U 4/24/2009 5/3/2009
esented to the Emergency Room approximately
Y 27 hours post vaccination with injection site Ycellulitis. Symptoms
5/13/2009 included
5/14/2009 reddness, heat
ven Menningicoccal vaccine at approx. 9 am. at 930 am she started to feel dizzy and was beginning U to get
5/18/2009
a headache. 5/18/2009
Her father was calle
9 Adriana returned to have a TST read. PHN observed right arm triceps area reddened, firmYand warm 5/12/2009 to touch in an 5/13/2009
area 3 1/2 by 2 inche
plained swollen area about size baseball
Y noted under left arm noticed soreness under arm to U chest area5/14/2009
. This was5/16/2009
first noted on 05162009
erated vaccine well, but upon leaving office (within 5 minutes) was "not feeling well" per mom. Y While in car,
5/14/2009
continued 5/14/2009
to complain of not fee
E OUT WITH PIMPLES ON FACE. SLIGHT REDNESS Y 5/18/2009 5/18/2009
slight fever and flu like symptoms and a base ball size knot that was warm and tender and decreased
Y ROM5/8/2009
2 days 5/10/2009
post shot. When pt repo
baby on 5/11/09. Got MMR while still Y in hospital on 5/13/09. 2 hours later c/o numbness of tongue.
N Later5/13/2009
c/o pain and 5/13/2009
tingling of l neck and
d localized swelling at injection site which lasted 48 hrs. Y 5/15/2009 5/16/2009
d hard bump in arm that grew in size. She felt itching in the arm of injection that spread over Yentire body.5/18/2009
She had the 5/18/2009
previous two hepatitis
s administered vaccines, before giving Y vaccine client said he had taken some Benadryl recently Y for allergies.
5/14/2009After receiving
5/14/2009 vaccines client
as given Vaccines and 48 hours later began having Y fevers and resultant 3 febrile seizure. HadYan ear infection 5/13/2009noted 5/16/2009
at the appointment whe
9 the patient was given the meningitis vaccine: Meningococcal (MENACTRA) Polysaccharide Y accination4/28/2009
injection given
4/29/2009
in the left deltoid b
atigue, migraines, nose bleeds, muscle Y & joint pain, sensitivity to light, mood swings, irritable,Nbrain fog, dizzy
5/10/2007spells,6/11/2007
trembles, numbness, b
where the vaccine was adminstered, which is the left shoulder, has been extremely sore and N I am unable 4/25/2009
to lift my arm 4/28/2009
up over my head, ne
hing began less tan 12 hours after first
Y hepatitis B vaccine; no hives/blisters; mother treated Y today for poison
5/11/2009
ivy exposure
5/18/2009
eltoid from Prevnar administered on 05/13/2009. left deltoid 5x4 erythemetous lesion, not indurated,
Y nontender.
5/13/2009 ice 5/14/2009
and 12.5mg benadryl tw
e of vaccine(prevnar) left deltoid 7x7 indurated erythemetous tender macualar eruption Ice, benadryl
Y and5/13/2009
motrin 5/14/2009
e weak and dizzy while walking outside to car. Pt had syncopal episode and fell on sidewalkYoutside clinic. 4/27/2009
Her sister
4/27/2009
reports seeing her st
eived Zostavax in am on 05/14/2009. The visit was uneventful. On 05/15/2009 she came back Y to the HD 5/14/2009
stating her 5/15/2009
r. lower arm was sore
1.9), achiness, headache, throwing Y up the morning after the shots, feeling week Y 5/12/2009 5/12/2009
NDURATED AND ERYTHEMATOUS. AREA 5CM BY 10CM STARTING AT INJECTION SITE U AND EXTENDING
5/12/2009DISALY
CINE WAS INJECTED ON HER UPPER LEFT LEG. THE AREA WHERE SHE HAD THE VACCINE Y GOT5/4/2009
INFECTED. 5/11/2009
IT WAS PURPLE AN
ted 4/15/09, chicken pox. Elevated IGG 1550 on 4/16/09. Transmitted to 9 mon old sib whoUalso tested IGG 4/7/2000
positive.
4/15/2009
after vaccines Y 5/18/2009 5/18/2009
d raised, reddened, approx 4 1/4 in x 3 1/2 in area painful and warm to touch. Left arm Posterior Y subqutaneous
5/4/2009 area 5/7/2009
has reddened area ap
ed in clinic Td and Pneumovax injection. Pt states that evening she was ambulanced to ER with U severe body 5/15/2009aches,5/15/2009
chills, and diaphoresis
sh all over body, no urticaria, feels sandpapery
Y 5/18/2009
er her first shot patient started having
Y episods of what we thought were panic attacks. She had N a hard time 6/11/2008
breathing,
6/12/2008
her heart would race
ad dizziness, nausea and vomiting Y on and off since HPV was given 3/16/09, associated withUbody malaise. 3/16/2009
There was4/2/2009
no reported fever.
rst booster injection given (April 8, 2009
Y I think) I experienced left arm itchiness with small bumps
U 1 week5/15/2009
post the injection.
5/16/2009The injection si
p at injection site. Sore arm. Achey muscles. Y 5/12/2009
hing, unresponsive. Fussiness, fever, Y decreased Y appetite. 6/3/09 Hospital
1 records receivedYDOS 5/15/09 5/15/2009
to 5/16/09.5/15/2009
FINAL DIAGNOSIS:
d swollen with redness and pain. Y 5/13/2009 5/13/2009
was reported by a pharmacist and described the Y occurrence of decreased
0 oxygen saturationY in a neonate4/6/2009
male subject
4/6/2009
who was inadverte
-104 X 2 days Y 5/12/2009 5/14/2009
en/red 2 days after vaccine administeredY (left thigh). Y 5/15/2009 5/17/2009
A and Influenza shot on 4/14/09 and SPV 4/16/09. She returned to the Imm Clinic on 4/23/09 for evaluation 4/14/2009
of SPV4/23/2009
(major take); pt reques
g of day of shots - She developed chills vertigo, nausea (still able to drink.) confined to bed - Ymissed school 5/12/2009
next day.5/12/2009
Mom states " this sens
given in R thigh- 48 hours later, thighY with edema + splotchy erythema. R thigh 33 cm diameter, Y L thigh 29 5/13/2009
cm. At 72 5/12/2009
hours, rash worsened
S B #2 (accelerated schedule) given Y 4/15/09 - later on 4/14/09 pt called with "arm burning". YNo other symptoms
4/13/2009advised
4/14/2009
ADVIL/cold comp
nflammation 3 cm Rx for Benadryl given. Y 4/21/2009
systemically see clinical data report.Y Y 5/5/2009 5/6/2009
swelling-hard and warm to touch . LeftY upper thigh 8"x5" (redness). Seen at hospital. DX: cellulitis.
Y RX: BACTRIM.
5/8/2009 5/9/2009
5/11/2009
Y Y 5/8/2009 5/9/2009
tous, swollen, large local reaction greater then 30cm 1 week after vaccine for DTAP. Y 4/16/2009 4/21/2009
4/14/2009
h red, indurated 1 1/2 - 2" area Y 5/5/2009 5/6/2009
which began a couple of hours after receiving vaccine. U 5/12/2009 5/12/2009
per right arm appeared red, swollen and hard with a measurement of 60mm induration. Patient N denied any itching or difficulty breathing.
called back 2 days after ER visit to notify
Y us that patient was very weak + had drowsiness, a Y "knot on the4/15/2009
left arm". The
4/15/2009
was patient last dos
was reported in a literature article and described the occurrence of hepatitis B antigenemia in Y a 111-day-old subject of unspecified gender
me in for Flu vaccine, Right and TDAP, Left. Complaint of pain and swelling next day- c/o very painful. Called 5/1/2009
PMD today-appointment
5/2/2009 mad
injection site, right arm. Erythema right
Y arm. Taking BENADRYL about every 8 hours. Y 5/8/2009 5/9/2009
d 13X14 CM Swollen, Redness, warm Y to touch. Apply cold compress (ice) every 2 hrs for 15Umin. Then warm. 5/5/2009 5/5/2009
ould have received a Tdap patient was administered a DTaP. No adverse event reported. Patient Y notified
5/11/2009
of mistake.
orts that after HPV vaccine given on 2/27/09 she went home, started feeling dizzy, had chestYpain, rapid 2/27/2009
heart rate and2/27/2009
vomiting for 3-4 day
en lump L thigh. Y 5/7/2009 5/7/2009
esicles at injection site, followed by patch
Y of erythema & induration expanding to 8 X 10 cm by 5/13/09. Borders
4/28/2009 slightly
4/30/2009
raised, mildly tende
ceived VARIVAX vaccine on 12/19/97 and 6/27/08. Exposed to chicken pox vaccine 2 weeksY ago. Developed 6/27/2008
chicken
5/10/2009
pox rash on 5/10/09.
iven 5/1/09 pri 5/1 - 5/09 Redness + swelling at site 5/5 - 8/09 no fever/chills. No antibiotics Ygiven. 5/1/2009 5/1/2009
receiving vaccine, mild swelling and tenderness of left upper arm / L axilla. Y 5/6/2009 5/8/2009
sicles at site of injection of varicella #1 - Occurred ~ 2wks after inj. U 4/9/2009 4/30/2009
5/21/2009
ped diffuse Myalgias approx 12hrs after Pt vaccination given. N 4/27/2009 4/27/2009
mall) of red flat rash in upper arm; tender to touch; started yesterday. U 5/18/2009 5/19/2009
VZV injection site on 5/12/09. No treatment needed. Y 5/12/2009 5/12/2009
ction on left and right anterior, upper thigh, 2 inch by 3 inch red, indurated area. Pain eliated U
due to pt. crying
5/18/2009
upon touch.
5/19/2009
No fever. TYLENO
lled the office at 230 PM on 5/20/09 to report that child broke out in hives all over 10 minutesYafter she left
5/19/2009
office yesterday
5/19/2009AM She did not
vaccine breakthrough. Had VARIVAX-2 doses. Diagnosed with varicella in our office on 5-19-09. U 6/18/2007 5/17/2009
5/19/2009
5/19/2009
as given twice, no adverse reaction noted. Y 5/26/2009
ports a gradual onset of edema and erythema, first to the vaccine site, then spreading to theYentire arm. 5/21/2009
She reports5/22/2009
the site was warm to th
air loss (alopecia) around temples (around
Y ear area, mainly in front) and some hair loss around
N hair line and crown. Has happened the last
d via EMS to Emergency Dept on theY morning of Y 08/11/2006 00:57 actively
1 seizing.
Y Symptoms N began 308/10/2006
minutes prior
8/11/2006
to arrival to ED. No
ceived the Typhoid Vaccine 0.5ml IM Left Deltoid at Approximately 8:15am. Left Health Center Y approx. 8:30am.
5/27/2009Health
5/27/2009
Center alerted at 9
dom twitches and involuntary muscle movement/spasms in my legs, calves, quads, ankles, feet, N and toes 11/1/2008
and sometimes
2/1/2008
in my fingers and
tion red, hot and swollen and tender to touch U 5/27/2009 5/27/2009
ncing flu like symptoms with hot/cold, some sweating, nausea and dizziness. Legs hurting. Y 5/26/2009 5/27/2009
after vaccine administration he presented with widespread urticaria rash. Of note he also finishedU a course
5/21/2009
of Bactrim
5/27/2009
the day before rash s
First Anthrax vaccination was issued in my left arm. Two days later my arm started to swellYand became 5/4/2009 red at the injection
5/5/2009site. This adv
s after experienced fever of 103, chills,
Y body aches, chest pain and shortness of breath. U 5/21/2009 5/24/2009
n chest, shortness of breath, EXTREME fatigue, chronic joint pain, muscle fatigue. N 5/4/2008 5/14/2008
OF GRAVES DISEASE SINCE 2006. UNDER TREATMENT AND MEDICATION. NEEDED IMMUNIZATIONS Y 5/27/2009
TO OBTAIN
5/27/2009JOB TO DO SO
ZOSTAVAX 4/16/09. Developed herpes Y zoster 4/26/09 over T9 on right. Y 4/16/2009 4/26/2009
AX given to 5 year old without complications. Called patients mom on 5/23/09 & 5/26/09 Y 5/22/2009
max 103.8. Multiple tonic / clonic seizures
Y in 1st 24hrs after vaccine admin. (currently 5). ER:UCT+LP. Still5/26/2009
febrile lasts
5/26/2009
seizure 1030 am 5/2
n at ED on 5/11/09 for c/o scratchy Ythroat feeling as if was swollen.Had received vaccinations Y that am for HepA/B and meningococcal. Was
ted to our clinic by patient's PCP: J.YDohemann MD (415)923-3447. 4 hours after receiving vaccines
U pt reports
5/19/2009
fever5/19/2009
of 102 with rigors and
after vaccine administration the patient reported experiencing some fever, chills, and muscleYpain at site 5/18/2009
of injection.5/21/2009
5/25 to report severe muscle pain in left arm with limited ROM. Pain started after 2nd dose of Y Twinrix 5/4/09
5/18/2009
but became
5/19/2009
worse after 3rd do
ed varicella-like rash, greater than 50 lesions on face, neck, trunk, arms, buttocks, and legs U 5/22/2009 5/27/2009
nally gave expired Pneumovax dated 04/02/2009 Lot#0963U on 5/26/09 5/26/2009
d and forearm had slight swelling Y 5/27/2009 5/27/2009
ias of bilateral feet and lower legs, bilat forearms, R hand and inability to fully extend R indexNfinger; started 5/26/2009
the morning
5/27/2009
after the vaccine; s
r 103 F 12 hours later lasting for 4 days with no appetite, listless and not very responsive, would U only take 5/21/2009
some water.5/22/2009
Followed by 2 days
ure 101-103 approximately 24 hrs. post vaccination and loose stools - presented in clinic - noUother symptoms. 5/26/2009 5/27/2009
en- immediately after patient received vaccine he fainted. Y 5/27/2009 5/27/2009
veloped hives about 22 hours after receiving 4yr boosters- DTap, IPV, MMR and VZV. No previous Y reaction,
5/18/2009
no respiratory
5/19/2009 or GI symptoms
ceived DTAP, HIB + HEP A ~ 5-11-09. Patient noticed redness + swelling at injection site ~ 24 Y hours after 5/11/2009
vaccination 5/12/2009
(5-12-09). Left thigh
me to office 5-26-09 + reported sheYhad warmth + redness to injection site 5-20-2009 which Uresolved; then 5/18/2009
on 5-22-2009
5/20/2009
she began to hav
vaccination 2/20/09 - only 2 mo - Between 1st and 2nd dose -should be 6 mo. 4/24/2009
o itching at the site, 5min later startedY coughing. Mom stated he was having an asthma attack, Y but did not 5/26/2009
have inhaler.
5/26/2009
Dr. notified and neb
jection site right deltoid (1) day after injection was given. Seen by Dr. 2 day after c/o rash and Y itching BENADRYL
5/18/2009 was 5/19/2009
prescribed by Dr.
se event. Mis administration of TDAP. Rt is 9 yrs old - should of been TD. ###
was reported by a healthcare professional
Y and described the occurrence of joint pain in an adult
U female 4/29/2009
subject who 5/1/2009
was vaccinated with B
VARICELLA vaccine given into (R) arm 4x4 cm area of erythema and 9x7 cm area of erythema Y surrounding 5/20/2009
injection
5/21/2009
site to: Septra
EL and VARIVAX vaccines given into (L) leg. 8 x 11 cm area of erythema and warmth on anterior Y (L) thigh.
5/20/2009
Septra. 5/21/2009
arm next day, took BENADRYL heart flutter was noticed on Thursday (2 days later). By Friday Y arm was swelled
5/19/2009 went5/20/2009
down by Sunday.
n has been received from a registered Y nurse (R.N.) concerning a female patient who received U two doses of GARDASIL. The patient had no
n has been received from a certifiedYmedical assistant concerning a 17 year old female whoNon 17-MAR-2009 3/17/2009was intramuscular
4/28/2009 vaccinate
n has been received from a physician concerning a 22 year old female with no medical Y history
U who was 3/19/2008
vaccinated with 5/4/2009
her first (lot# 6582
n has been received from a nurse practitioner
Y concerning a 19 year old female who experienced Y fever a5/13/2009
few hours after
5/13/2009
receiving the first d
n has been received from an investigator concerning a 35 year old female with no known drug N allergies, 1/12/2009
with HIV and5/4/2009
alcohol use who ente
n has been received from a consumer concerning a male family member, now 8 years old, who U experienced autism after receiving vaccine
n has been received from a consumer concerning a male family member, now 10 years old,Uwho experienced autism after receiving vaccin
n has been received from a nurse practitioner
Y for the Pregnancy Registry for VARIVAX (Oka/Merck)
Y concerning
9/26/2008 a 26 year### old female with a
n has been received from a pharmacist Y concerning a 62 year old hospitalized
Y female with pneumonia,
Y urinary
5/19/2009tract infection,
5/20/2009diabetes, hype
n has been received from a licensed Y practical nurse for GARDASIL and MMR II, Pregnancy YRegistry products, 2/11/2009 concerning
2/11/2009 a female patient
Y 5/28/2009 5/28/2009
Hives neck back, abdomen arms and leg started 5/21/09 in the evening. Treated with ZyrtecYX 7 days. 5/20/2009 5/21/2009
PD" testing using ANTHRAX Vaccine - 5m experienced area of erythema 3' X 2 1/2: with 1 cm Y central induration.
5/12/2009Tender,
5/13/2009
not hot - Resolve
V vaccine ordered by physician and nurse administered it. The child was 5 yrs old and the vaccine Y should 5/26/2009
not have been given, as it is indic
aised) rash in crops over the antero-medical aspect of left thigh no erythema. Y 3/26/2009 5/1/2009
at Inj site. Red itchy rash. U 5/20/2009 5/22/2009
ous patch over the vaccine site left upper arm - lateral posterior aspect no warmth; no tenderness; Y full range
5/12/2009
of motion
5/13/2009
nsider this a vaccine failure for him to Y be fully immunized and get pertussis at age 7 Y 5/23/2007 5/1/2009
was administered to left deltoid on Tuesday May 26, 2009. Came to office today to show me Yhis left arm 5/26/2009 which was reddened
5/26/2009around the en
zed area of enduration 2-4 inches above right elbow. Nickel-sized area of enduration 2-4 inches Y above 5/13/2009
left elbow. 5/15/2009
Slight erythema to both
ad small pox vaccine on the 17th of May. He returned for follow up on the 26th. His skin reaction Y showed 5/17/2009
local redness
5/27/2009
and white blister. H
ld probably be considered a vaccineYfailure since the child was fully immunized and was diagnosed Y with 7/18/2007
pertussis at age 6.
e fever (not even 100) 5/26 in the evening followed by redness and swelling at the site on 5/27. Y Fever gone 5/26/2009
5/28 although
5/26/2009redness & swellin
ced swelling and redness at injection site 5/27/2009. Prescribed keflex and benadryl. U 5/19/2009 5/27/2009
ONE CALL FROM MOTHER STATING CHILD HAD RASH ON BODY WHICH APPEAR 45 MINS POST 5/28/2009 IMMUNIZATION. 5/28/2009CLIENT RETURN
fter receiving TdaP imm., pt. was sitting
Y sewing at approx. 10:30am and had magnified circles Y in front of 5/12/2009
both eyes. 5/14/2009
Vision was not affected
reased sensation and decreased strength in the Y left arm. 7/7/09 Hospital
4 records received DOS 5/11/092/12/2009to 5/15/09. Assessment: Disturbed
d rash c/ second injection, but thought it was due to starting a new OTC product. 3rd immunization Y given,1/22/2009
and rash reappeared.
2/5/2009
numbness, pain, limited ROM and inabilityY to perform many normal activities of daily living. Diagnosed
N with
4/15/2009
axillary nerve
4/15/2009
dysfunction... put o
cines given to pt, Lt leg Varicella was administered, Rt leg MMR and Kinrix administered. Lt leg area 35cm/25cm 5/27/2009red 5/28/2009
and swelling. Rt leg
eloped 48 hours after immunization. Low grade temp. U
this second HB shot during a 9:30 am appointment on 5-20-09. The first HB shot I receivedYwas from the 5/20/2009
same physician
5/22/2009 a month earlier o
d stated Pt had started getting a rash Y to both legs, mom informed to bring back to clinic, then Y mom called 4/24/2009
and stated 4/24/2009
he was getting swolle
th reddened raised area at site of VARIVAX injection. Approximately 1/2 hour after injection-Yseen by MD5/28/2009 recommended 5/28/2009
ice and BENADRY
ble crying with head twitching - lasted for about 30 minutes - low grade fever 1st 24 after shots. 5/27/2009 5/27/2009
arm, legs + face. Y 5/26/2009 5/26/2009
ody aches, arm pain. Approx 1 in rednessY @ injection site. - Recommended IBUPROFEN 600 Y mg q 6 hrs5/26/2009
prn. - Went 5/26/2009
to ER - 5-27-09
mplained of "high" fever several hours after injection (although did not have a thermometer).YSweating, could 1/14/2009
not sleep,
1/14/2009
numbness and ting
1; eyes and lips became swollen and Y puffy after leaving office. Returned 30 minutes later; pulse
Y 98%, BP 5/27/2009
112/68. BENADRYL
5/27/2009 1tsp po give
painful - swelling (L) thigh - 3cm X Y4 cm 1day post vaccination Y 5/26/2009 5/27/2009
4/9/2009 5/26/2009
st 1st dose pt noted flashes in visualY field and fatigue. Inc in flashes after 2nd dose. Reported Y dec in visual
2/23/2005
field 2-3 days post 3rd dose, In
Y 4/16/2008 5/27/2009
ed rash developed within past 3 days Y 5/25/09. Blisters - vesicles with fluid - fatigue. Y 5/4/2009 5/25/2009
uscle pain and swelling. Supra clavicular adenopathy Y 5/26/2009 5/26/2009
veloped myalgias in the neck and back within 24 hours of administration of Td booster. AlsoYhad some nausea 5/26/2009 and5/27/2009
some wheezing startin
n has been received from a nurse practitioner
Y concerning a 22 year old female with unspecifiedN drug reactions/allergies
4/6/2009 4/30/2009and medical history
n has been received from a pharmacist Y concerningY an 81 year old male
0 with hypertension, cancer,
U diabetes
10/8/2008
and a history
5/5/2009of heart attack w
n has been received from a physician concerning a 9 week old male with no pertinent medical N history reported
5/13/2009who 5/22/2009
on 13-MAY-2009 was v
ed from a consumer the following information on 14 May 2009: A female patient was vaccinated N with Influenza
11/1/2007virus11/1/2007
vaccine (batch no. or m
red ZOSTAVAX vaccine 5/20/09 at 9:30am. Reported she awoke next am with generalized hives N over body
5/20/2009
including5/21/2009
buttocks and scalp. N
nt to ED with swelling to right leg. Red
Y and warm to touch. Y 5/7/2009 5/9/2009
firm area on Rt deltoid approx 2minYwide running 1/2 to elbow. Parent reports started 1 afterNadministration 3/31/2009
vaccine.3/31/2009
Mother plans PMD visi
back, abdomen, arms, face after vaccine Y (24 hours) no high fever. Mother plans PMD visit due N to current 3/31/2009
ear infection4/1/2009
also.
mplaint (1/1): This 12 month old female Y presents today for evaluation of a rash. Rash-Associated Y Signs and 5/22/2009
Symptoms: 5/23/2009
The following chara
ed after vaccination and bumped head on floor. Monitored for 50 minutes. Sent home with mom Y to monitor 5/26/2009
s/s concussion.
5/26/2009 BP 94/60, P 72
ax- rash and pain. Treated with BACRIM DS initially and changed to Acyclovir treated x 1 week. Y Treatment 3/30/2009
started 4/09-
4/1/2009
4/24/09. Folliculitu
ight thorax returned after 2nd Hep. B vaccine - came to clinic on 5/7/09 - 'Shingles'. Treated U with ACYCLOVIR 5/4/2009
X 3 weeks-
5/7/2009 5/22/09 still symp
VARIVAX 5-21-09, seen in office 5/23/09 arm, red, warm to touch for 2 days. 15 x 14 cm erythemas Y with5/21/2009
4 x 6 cm central
5/21/2009induration and 5-
9 given VARIVAX, developed erythema with 3 mm central papule vesicle seen on 5/21/09. Y 5/18/2009 5/18/2009
Y U 5/27/2009 5/29/2009
ate 4 minutes after receiving vaccines; I started getting dizzy, nauseated, cold sweat, and a headache.
Y There
5/4/2009
was a 5/4/2009
burning in my arm goin
ular redness with warmth. no s/s infection. supportive care : compresses and motrin prn. Y 5/27/2009 5/28/2009
ates that he had vaccinations administered on Tuesday and wednesday afternoon around 1:30 Y p.m. he began
5/26/2009
having5/27/2009
fever and chills. He a
ate 2 minutes after receiving vaccines: Y I passed out. Right after I woke up I started throwingYup and the Rn 5/5/2009
clinic was5/5/2009
unable to stop it and
utes after i got the 1st shot, body felt warm and tingly. then i had a small seizure according toYthe tech, but did not lose consciousness. the
ter given approx 10 am on 5/27/09 r del im. spoke with pt on 5/29 and she reports on 5/28/09 Y she awoke5/27/2009
with headache
5/28/2009
and chills took tem
LN,VOMITING,URI.sYMPTOMS STARTED Y IN THE PM AFTER SHOTS. Y 5/28/2009 5/28/2009
y AM 5/19/09 with frequent vomiting and fever. Frequent vomiting lasted until 0700, then final, Y isolated emesis
5/18/2009at 1700.
5/19/2009
Temp max 103. F
her called and reported that Kahlyndra Y c/o not feeling well approximately 2 hours after vaccine Y administration.
5/27/2009
Following
5/27/2009
am c/o nausea, an
a pharmacy clinic to receive Zostavax. Pt is s/p renal transplant and on chronic immunosuppression.
N Screening
5/1/2009questionnaire used was d
ap administered R deltoid. 1-9-09 Soreness reported to Employee Health Nurse. 2-27-09 - AppointmentU scheduled
1/2/2009 due 1/9/2009
to report of persiste
hrs after vaccination, arm became red, swollen,Yand painful. admitted 2 to hospital 48 hrs afterYvaccine receive,
5/11/2009
and treated
5/12/2009
for cellulitis of arm
adm. 2:30pm,Fri.22 May 2009. 3 days later 2am woke up with difficulty breathing, productive N cough with5/22/2009
green phlegm,
5/25/2009
no fever. All day (
eaction distal to injection site(whihcYwas on right deltoid) extending about 6 cm with induration Y to inner bicep.
5/28/2009
Has minimal
5/28/2009 warmth, not too
, generalized body aches and chills. Reports that they do not have a thermometer so have not U been able5/28/2009
to take a temperature.
5/29/2009 Some loca
, 1991. "Hold up four fingers. That's right, you're four years old!" On patient's birthday
Y he was N coming down8/19/1991
with a cold.
9/20/1991
August 19, 1991. O
ted 13 days s/p vaccination of MMR, TDaP & Varicella w/ rubella type rash; pink macular papular U rash involving
5/16/2009 face,
5/28/2009
UE's & torso; Pt also
rash on trunk 26 days after Immunization administration, rash non tender, pre eval. Y 5/1/2009 5/27/2009
ceived vaccines at 12:00 at 14:45 became
Y hoarse and felt like he was having difficulty breathing,
Y also mild
5/28/2009
cough. Developed
5/28/2009 flat, red rash
en lethargic, decreased appetite. Bright red rash on cheeks and face. Rash on legs, had slight U rash prior5/26/2009
to administration
5/26/2009on legs now mor
MMR and VARIVAX vaccine 4/3/09. Missed period 4/17/09, did not know was pregnant at time. 4/3/2009
d area on arm; Warm to touch. Swollen Y (1.5X10 cms). Placed on MEDROL DOS-PAK. Dx:YLocalized allergic 5/12/2009
reaction.
5/13/2009
er, redness 2-3 " down arm, warm to Y touch. Ached. 0 Fever. 3rd day stinging, less redness. Y 5/26/2009 5/28/2009
on. mild edema, tenderness, slight erythema. Y 5/28/2009 5/29/2009
ch area around injection site is warm, swollen and red with nodule. Painful. Difficulty raising arm U and lifting 5/27/2009
arm. Recommended
5/27/2009 medical eva
as given initial dose of Gardasil vaccine in (R) deltoid. Almost immediately after vaccine wasYgiven she c/o 5/19/2009
dizziness5/19/2009
& then lost consciousn
swelling, warmth, bruising with a few hours of administration. Patient + presented with aboveUsymptoms 5/26/2009 in office 725/26/2009
hours later. Temp 96.9
was reported via a statement of injuries received via a lawyer and described the occurrenceUof joint pain in 8/1/2000
an adult male subject who was
me in clinic stating that she could no longer move her left arm. Patient had had some Y swelling
N in left arm12/4/2007
after a Td 12/4/2007
vaccine on 12/04/07. It
on 5/26/09 c/o feeling nervousness. States that it started ~ 3 days after receiving Adacel inj. N which he is still
5/13/2009
having the5/16/2009
SX. as of appt on 5/
ed-macular rash to left thigh. Warm to touch, swollen. U 5/27/2009 5/28/2009
cine given, Patient with h/o fainting with shots, became weak, laid down, had episode of emesis, Y VSS, patient5/28/2009treated5/28/2009
and recovered, mothe
ceived Subcutaneous dose of ZOSTAVAX 5/26/09. Patient returned to pharmacy 5/29/09 with N questions5/26/2009
about localized
5/29/2009
reaction to injectio
0 mm after immunizations were given (Hep A - Varicella - Meningococcal). Pt developed throat Y tingling sensation
5/20/2009and 5/20/2009
dizziness, then collap
5 min after 1 mms given, child dev. hives near injection site, L leg. variable hives on trunk back Y & face. Pt5/21/2009
given diphenhydramine
5/21/2009 10 mg in
.7 degrees F, vomiting, irritability, pallor,
Y poor feeding, sleepy presented to ED approximately Y 7:30pm on5/22/2009
5/25/2009.5/25/2009
05/18/2009 pt told mom left upper arm Y hurts. Mom noticed left arm red, swollen warm to touch. Mom called 5/18/2009
Dr, she5/18/2009
told mom to put heat o
was reported by a healthcare professional and described the occurrence of arm swelling in aY child subject of unspecified gender who was v
was reported by a healthcare professional and described the occurrence of arm swelling (injection Y site) in a child subject of unspecified gen
was reported by a healthcare professional and described the occurrence of arm swelling in aY child subject of unspecified gender who was v
was reported by a healthcare professional and described the occurrence of arm swelling (injection N site) in a child subject of unspecified gen
was reported by a healthcare professional and described the occurrence of arm swelling (injection Y site) in a child subject of unspecified gen
was reported by a healthcare professional and described the occurrence of arm swelling (injection Y site) in a child subject of unspecified gen
was reported by a healthcare professional and described the occurrence of arm swelling (injection Y site) in a child subject of unspecified gen
was reported by a physician and described the occurrence of bruise injection site in a 4-year-old Y female subject
4/9/2009 who4/9/2009
was vaccinated with c
was reported by a physician via a GSK Y representative and described the occurrence of armUswollen in a child subject of unspecified gende
was reported by a physician and described
Y the occurrence of injection site blisters in a 4-year-old
U male subject
5/6/2009 who was
5/7/2009
vaccinated with KI
was reported by a physician and described the occurrence of rash in a subject of unspecified U age and gender who was vaccinated with KIN
ash at vaccine site and on upper extremity
Y Y 5/27/2009 5/30/2009
hot;It was not until 3rd day of the Shot . The area of the vaccination became very hot, achedYand red.(Felt 5/25/2009
inflamed)5/25/2009
Two days later the pro
02.7; Headache; Fatigue; Was given tylenol 480 mg every 4-6 hours for 16 hours; slept mostYof the day; drank 5/27/2009 liquids
5/28/2009
but did not eat; no oth
a of induration at injection site with swelling
Y and pain. Y 5/28/2009 5/29/2009
d gunk in her eyes real badY the morning
Y of theY10th. She had a fever
14 of 104.9 when we tookUher to the emergency
5/8/2009 5/10/2009
room where they gave
as vaccinated with Smallpox on his left arm on 20 May 2009. Pt's Smallpox blister 'popped' in U his sleep the
5/20/2009
night of 30 6/1/2009
May. He noted that
rm swelled up to the wrist and is hot to the touch. 5/27/2009 5/28/2009
body aches - Patients relates having fever with pertussis as a child. Y 5/5/2009
for immunizations on 5/28/2009. Child received DTAP, HPAC, IPV & MMR. Mother telephoned Y this morning5/28/2009
& stated 5/28/2009
that child began to br
lled, client had high temperature 103.9.
Y Went into convulsions. Sent to ER, diagnosed with UTI. Y Took her 4/22/2009
to pediatrician,
4/24/2009stated no diagnos
rate, fever, vomiting, diarrhea. U 5/22/2009 5/28/2009
d 4/29/09. Mother noticed small "pimple Y like" lesion at site of VARIVAX injection (Left thigh) Yon 5/1/09. Small
4/29/2009
cold sore
5/10/2009
like blister on mouth
Typhoid cap appropriately --> 6 hrs. later had dizziness, light-headed followed by nausea andY vomiting assoc. 5/20/2009with movement.
5/20/2009 Hx of 2 episo
swelling pruritus in place of injection. Y 5/15/2009 5/17/2009
14 hours after vaccines administered Y (102 degrees F). Y 5/26/2009 5/27/2009
bout 12:00 patient became weak, pale, Y collapsed to floor, febrile, tachycardia. Patient seen inY ER, monitored, 5/26/2009
labs (CBC,
5/27/2009
BASIC chemistry a
area of redness over the skin at the site of injection 7 1/2 x 4 cm. No further reported problems U as of 5/26/09.5/5/2009 5/5/2009
severe hives. Y Y ### ###
mplain of muscle pain in left deltoid muscle. Pain persists one month after injection. N 4/28/2009 4/29/2009
is not to be started after 12 wks of age this pt. is 6 mons old. Y 3/9/2009 3/9/2009
n has been received from a physician concerning a female patient who on an unspecified date U was vaccinated with the second dose of GA
n has been received via a literature article regarding a case in litigation concerning a male who U in November 11/1/2004
2004, 11/1/2004
was vaccinated with a d
turned to clinic on 5-13-09. Lft arm injection site with 4-5 cm area of swelling. Area red and non U tender to5/11/2009
touch. Patient5/12/2009
reports itching to ar
n has been received from a case in litigation from a lawyer concerning a patient who on 19-SEP-2003 U was
9/19/2003
vaccinated with a dose of Hep B
d spinning, stomach sore, throat hurt for short time. Patient presents to clinic 4/24/09 at 8:50am, Y report "stomach
4/23/2009still 4/23/2009
hurts" to lower abdom
ed redness and swelling began around Y 1500 on 5/20. She applied cool compress around 1700 U applied ice 5/18/2009
pack, at 2000
5/20/2009
applied lotion "aloe
x 2 1/2 cm indurated, increased warmth. Fever 39 degrees C. Prescribed Keflex. 5/28/2009 5/29/2009
lling, redness, heat, and rash at injection site. Y 5/20/2009 5/25/2009
nto office and never was immunized. She was going to camp and needed imms. Dr. Asked nurses Y to work
5/29/2009
on seeing5/29/2009
what imms could be g
as administered the DTaP vaccine instead of the Tdap vaccine. There has been no known orYreported adverse 5/15/2009 reaction
5/15/2009
to the patient. In the
er dose of Rota vaccine given patient developed Y intussuception requiring
3 surgery for repair. Y6/2/09 ER records
3/30/2009 received
4/3/2009
DOS 4/3/09. FINA
atient was given the MCV vaccine early. The recommended age to administer is between ages Y 11-12, it 5/29/2009
is approved5/29/2009
for ages 2-55. He was
d a 12 year old female who was alert Y and oriented but appeared nervous, comfort measuresYwere taken.5/20/2009 I proceded5/20/2009
to administer the vacc
ceived MMR and Varicella vaccine'sYon May 21, 2009 from Merck and Co. Came into office today with rash 5/21/2009
on face 5/31/2009
and chest patient has n
elling in lympyh node on side of chest. Site swollen, warm to the touch. Lasted approx. 5 days. Y Doctors perplexed ### at the ### location of the sw
photographs the patient developed right sided ptosis and an enlarged pupil between Y September N 1st and 7th.9/4/2008
The parents
9/7/2008 noticed abnorma
e up the night of vaccination (5/26)withY pain. The Y next morning the mother
1Y noticed a red, round,
N hard area 5/26/2009
approximately
5/27/2009
4-5 inches. The c
der soft tissue infection with tender Yindurated area central eschar surrounding cellulitis. Treateed with Zithromax and 5/23/2009
Bactrim.Cultured are
Tenderness at surrounding injection site (Left Deltoid) U 5/31/2009 5/31/2009
l Saturday 05/30/2009 with headache, stomachache. Also injection site of menactra (r arm) Yred and swollen 5/29/2009
approx.5/30/2009
1cm.
wing administration of vaccine the patient developed stomache ache, fever, and headache. Highest U fever5/29/2009
was 101. 5/30/2009
iven on 5/26/09. Day after arm hurt, administration site, red, swollen,firm to touch and warm.YWorsened on 5/26/2009
Thursday. 5/27/2009
Saw Employee Healt
post vaccine 2 days ago, no fever, no previous vaccine reaction. Recieved DTaP IM and VZV SQ but reaction 5/27/2009started
5/27/2009
around DTaP area, p
nic Seizure acttivity lasting 2 minutes. Y 6/29/09 Y Hospital records received
2 DOS 5/19/09 to 5/21/09.
Y Assessment:
5/18/2009 Acute
5/19/2009
onset seizure second
ace torso arms and legs onset 05-29-09. Pt. c/o itching. Parent is giving Benadryl. Possible Fifth Y Disease5/29/2009 5/29/2009
vaccine was administered, the patient Y complained of pain in the right arm, started crying, becameU diaphoretic,
6/1/2009
ashen,6/1/2009
and lost consciousnes
aculopapular rash on face, exerting,Ytrunk, back starting on 29 May 2009. U 5/21/2009 5/29/2009
over injection site - X 2 days - cool compresses. Y 5/13/2009
at injection site x 2 days. Treatment cool compresses. Y 5/13/2009 5/14/2009
ely following injection patient had syncopal episode for 15 seconds. She had Flailing of arms/YLegs when5/29/2009 she was unconscious,
5/29/2009 as nurse wa
on 5/29/09, raised, itchy, painful x 2dY seen in the office 5/29/09: T: 98.2. Exam: dry papules upper Y forearms,
6/26/2007
back, trunk, scattered = 6 = blis
at site of injection up to 15 cm. Peak with underlying induration almost entire extent of quad.Y(right). 5/29/2009 5/30/2009
s receipt of third AVA vaccine on 5/2/2009
Y (AVA #1 8/2/05, #2 8/17/05). He reported no problems Y for 2 days.
5/2/2009
5/4-7/2009
5/2/2009
he c/o: 1) a roun
ceived Tdap IM R arm on 4-8-09. Right Y arm red and swollen; warm to touch. Good ROM. Pt.Ustate she took 4/8/2009
pain medication
4/12/2009 for discomfort.
sented in clinic on 4/3/09 @ 10:45 AM c/o swelling and redness of left arm. Client denies difficulty U breathing 4/1/2009
and negative
4/1/2009
for rashes. Client
e and vomiting within a few hours following vaccine administration. Client had a fever and had Y a racing pulse
1/28/2009
the evening
1/28/2009
following vaccine
tion were given at 5:25pm. Bil Redness of upper arms noticed at 5:35pm 6:50 redness receding. Chest - 4/8/2009 CTA ; No SOB,4/8/2009
A&O x 3, NAD, 18
eralized itching right shoulder increased back + legs, welts noted above RD site + upper back Y - Benadryl4/13/2009
12.5 mg 15ml 4/13/2009
PO Given @ 1640.
eived Immunization on 3/26/09 (DTAP Y and MMR). Mom states, "Started on TYLENOL and MOTRIN, Y but3/26/2009
spiked temperature
3/28/2009104 on 3/28/09
witnessed seizure on 5/21/09. H/O probable
Y seizure
Y activity in the past
4 6 wks. After seizure, Y pt has had complaint
5/20/2009of5/21/2009
headache, dizziness, w
l cord, right vocal cord, polyps
Y cancer.
Y Lost of voice.
Y Rash in skin complete
5Y body.YPain to joints
N complete11/4/2003
body. Gallbladder
11/5/2004 removal with, m
4/14/09, diarrhea, diaper Y rash - rash
Y - face, scrotum
Y bruised w/infection.
8 7/13/09 Hospital DC summary3/24/2009received DOS 4/14/2009
4/15/09 to 4/22/09.
s in face, body, hands, feetY BELL's Palsy
Y in face.
Y Losing ability to walk.
14 Y Low blood pressure readings.
Y Kidney (not
###normal
11/1/2008
readings). MRI's (
brile seizure; Negative workup at Hospital.
Y 6/22/09
Y Medical records2DC summary received DOS Y 5/20/095/19/2009
- 5/22/09. 5/20/2009
Assessment: Seizure w
eloped poor appetite with associatedY vomiting, Y sudden in onset, worsening
1 over a few hours.YChild evaluated5/13/2009
at office
5/22/2009
exam consistent with
U
ollen, itchy & hot to touch. Y Y 5/26/2009 5/27/2009
vaccine breakthrough. Diagnosed in office with varicella on 5-26-09. Had over 100 lesions noUfever. 2/11/2009 5/24/2009
+ redness at injection site. N 5/20/2009 5/20/2009
n left arm, jaw, left leg for two weeks after vaccination. U 5/15/2009 5/15/2009
veloped an erythematous patch in right Y thigh hours after shot was given. It got indented andYbigger, with some 5/7/2009
induration,
5/18/2009 measures: 3x 1 c
veloped furuncle abscess site of vaccine
Y about 1 wk after shot given. It is probably unlikely this
Y was secondary 5/6/2009to shot.
5/13/2009
Furuncle was in upp
erythema and induration around vaccination site. Reaction probable cause from VARIVAX. Y 5/27/2009 5/27/2009
days after inj pt was seen in ER forYrash that was felt to be eczema. Y 4/28/2009
n has been received from a physician concerning Y a 24 year old female 1 patient who on 26-AUG-2008
U was5/21/2009
vaccinated 5/21/2009
with the first dose of G
was received from a consumer via Y Sanofi Aventis on 20 May 2009. A female patient, with a history of Type II diabetes, Hashimoto's thyroid
ately two minutes after injection of vaccines Mom noticed and questioned to nurse about bilateral Y lower extremity
5/21/2009redness.
5/21/2009 Nurse called Dr.
009 24 hours after immunizations were given L upper arm started to swell & redden. They were advised5/26/2009 to use Tylenol
5/27/2009
+ cold packs by clin
t a Tdap 5/14/09 and developed cellulitis
Y on the (L) upper arm site of the injection. Then was seen at the5/14/2009
doctors office on 5/21/09.
d ADACEL 4/27/09- And developedYcellulitis on site of injection. She was seen at ER. Y 4/27/2009 4/29/2009
9 Patient received DTaP #5 and Varicella #2 to the (R) Deltoid by RN and IPV #4 and MMRYII #2 to (L) Deltoid. 4/16/2009 Family
4/17/2009
brought pt to clinic a
Y 5/28/2009 5/28/2009
d PENTACEL 3/3/09 @ 2mo. well-child on 3/16/09 called nurse line - (mom) stating child non Y stop screaming.
3/3/2009 This 3/3/2009
office called back 3/9 -
as given Tdap in error as this has only been studied to age 64 and recommended for ages 11-64. U Patient5/22/2009
having no adverse symptoms per
vaccine breakthrough. Diagnosed with Varicella on 5-26-09. Had over 200 lesions. No fever.U 6/7/2007 5/23/2009
and bruising at site with pain. SterileYabscess Lt. leg. Y 5/22/2009 5/23/2009
ingles of L chest and arm 7 monthsYafter vaccine. Zoster/Shingles. Y ### 5/25/2009
5/27/2009
d area developed erythema and edematous swelling 5 1/2 6 1/2 cm. There is also warmth to the area though 5/27/2009
no induration
5/28/2009 or fluctuance of
en, hard to touch, painful with bruising
Y large lesion 5" X 5" sterile abscess. Y 5/22/2009 5/23/2009
d diarrhea for 3 weeks, fever, speech and motor regression, has been evaluated for autism by N specialist,11/5/2008
results inconclusive.
11/8/2008 MRI and EE
Y 11/5/2008 ###
e right deltoid since injection. also with small lump. parathesia intermittently radiating down to U right elbow,5/29/2009
with loss 5/29/2009
of strength to right arm.
e and dizziness s/p Tdap and HPV #3. Y Immunization given at 1515, gradual onset of headache U over course 6/1/2009
of the day. 6/1/2009
Patient to ED at 220
ng ataxia with onset approximately 11/08.
Y Severe gross motor and fine motor impairment noted. N 6/15/09 Received ### PCP
11/1/2008
medical records fo
oss of felling in left arm, hand afterward
Y and left arm had chills.There ia a golf ball size swelling Y to the upper5/28/2009
left arm.5/28/2009
ceived dose #4 of DTAP IM on 5/26/09. Parents report they noted large reddened area with Y mild swelling5/26/2009
at site on 5/27/2009
5/27/09. Client without
administered instead of MMR as requested by parents. No adverse event noted. Y 5/29/2009
nt recevied 3rd dose of Rotateq
Y on May
Y 15, 2009. Y She developed intussusception
1 on May 25,Y 2009. 7/14/09
5/15/2009
Hospital 5/25/2009
records received DOS
was administered on 5/26/09. Client had reaction to vaccines on 6/01/09. Came in clinic today Y 6/02/09, 5/26/2009
left deltoit sligtly
6/1/2009
redness and swell
oke up the next day with raised, itchy rash all over body except on face, chest and upper trunk. U Took OTC 12/9/2008
medicines and ### rash lasted 3 wee
turned to clinic 3 days post vaccination with right thigh erythemic, slightly swollen and warm to Y touch. Mother
5/26/2009
states5/27/2009
that symptoms started
d fever 103 with diffuse sweats x 24 hrs, irritability x 48 hrs, 7 days after vaccinations. Rash Y broke out about5/7/2009
24 hrs 5/14/2009
after fever broke - macu
MA, EDEMA AND INDURATION 1.25"X Y 1" TO RIGHT DELTOID. ICE PACKS, IBUPROFEN YAND TYLENOL 5/28/2009
FOR AGE 5/29/2009
PRN.
ter fainted and was taken to the ERYto be monitored, after going home she began with a fever... U this is the6/1/2009
day after receiving
6/2/2009 her rd HPV sh
was reported by a healthcare professional
Y (also
Y the subject's mother)0 and described the occurrence
N of cyanosis
9/27/2006 in a9/27/2006
2-month-old male sub
izures - 5-20 minutes of seizures - VALIUM
Y 2 milligrams
Y given - tachypneic
1 spell 5-10 seconds
Y recovered 5/18/2009
without ventilation.
5/19/2009 6/12/09 Hosp
ccines given Pt c/o dizziness, fan on pt - cool cloth on forehead - B/P checked, decreased 88/46 Y -head of5/18/2009
bed down5/18/2009
- foot of bed elevated.
20/09 Spoke to Dad - baby doing well, no ill effects. Child here for visit, received overdue imms Y / MICR was 5/18/2009
"down" - Child had these imms
munizations Thurs. PM 5/21/09, but didn't notice swelling & erythema until Saturday 5/23. Pt Y reports "extreme
5/21/2009
pain" Sat/Sunday
5/23/2009 but feels be
idmorning patient developed a fever and sweats (soaked clothes), dizziness and felt like sheYwould blackout 5/20/2009
if stood5/21/2009
up. Also started mens
ution-Progressive swelling, tenderness, erythema at a site 5/20/2009 5/21/2009
ped petechiae of lower extremities below knees. (R) greater than (L). These areas appearedYwithin 48 hours 5/19/2009
of vaccinations.
5/21/2009No squeezing
ted Saturday 5/23/09 102.2- gave MOTRIN and TYLENOL to help bring fever down. Rash started N on Sunday-was
5/13/2009 flat 5/23/2009
and then red pimple
chicken pox lesions- head, trunk, and scalp extremities. Friend broke out 5 days ago. U 5/17/2000 5/24/2009
ed urticarial rash at site L arm Y U 5/21/2009 5/24/2009
Tdap to right deltoid 5/22; developed Y chills and fever and headache that evening. Seen in UC Y 5/24; right5/22/2009
UE was not 5/22/2009
red, warm or tender. O
e, too warm, flushing and nausea. Y U 6/2/2009 6/2/2009
HPV she was weak, T.100, decreased eating, hives runny nose & sneezing. Y 6/1/2009 6/2/2009
d muscle and tender pain sustained since TWINRIX injection 05/04/09. U 5/4/2009 5/4/2009
en, shortness of breath. Mom statedYallergic to VARIVAX event though she got MMRV. 5/19/2009 5/21/2009
redness, and soreness left upper arm. 13cm by 14cm. Y 5/19/2009 5/20/2009
ately 3 weeks post ZOSTAVAX, developed 8 lesions, dime sized, left upper arm. A couple ofYweeks later,3/23/2009 developed 4/1/2009
sever, debilitating kne
len, cellulitis (TYLENOL). Y 5/18/2009 5/21/2009
and edema, warm to touch, measuring 6x7 cm oval on right deltoid. 5/28/2009
ted 1 day after receiving vaccine. Pt vomited x 1, was lethargic for about 48'. Slight sore throat Y 2 days later.
5/19/2009 5/20/2009
eck, Day 7, c/o some nausea, 2 episodes Y of vomiting. Told to go to hospital ER if couldn't keepY fluids down 5/22/2009
over weekend.
5/31/2009Nausea & vomiti
tomach", shaky, jittery, chills/hot + "feeling
Y just different, not myself" No diff. breathing, swelling
U or rash. Patient
5/7/2009 vomited
5/7/2009
while talking with h
d bump at the injection site; small red dots from injection site spread to arms, also on torso and Y back 5/11/2009 5/20/2009
adiating to her jaw, shoulder and neck.Y Stiffness lower back painful and stiff making it difficultYto walk. Went 5/7/2009
to PMD on 5/8/2009
Fri 5-8-09. c/o " ever
mother at approx. 9 pm on 5/13/09. Pt c/o- H.A.; No relief with ADVIL; 5/14/09 at 11am - Pt. still Y experiencing5/13/2009
H.A. and 5/13/2009
given 1 TYLENOL by
rts child vomited on Thursday pm. Friday
Y developed red, raised rash on buttocks which spread U to entire 5/28/2009
body by Sunday,
5/29/2009MD appointment
5/19, 20 c/o pain lt side of chest & shoulder back c/o bad H/A 5/19 LT deltoid upper arm swollen (9 cm 5/18/2009 10 cm) warm 5/19/2009
to touch. c/o could n
s after 3 17-09 injections (not sure which day) noticed decreased mobility of R shoulder and N"lightening bolts" 3/17/2009
down3/20/2009
arm to fingertips. Patien
th c/o rash on chest and bilateral arms.
Y generalized itching. Y 5/22/2009 5/23/2009
MMR shot on 1/16/09. Diagnosed with Y measles on 1/15/09. Broke out entire body with red bump. Y Fever up 1/6/2009
to 105. Irritable.
1/15/2009 Rash and symp
turned to the pharmacy complaining of itching within 10 mins the area was slightly raised, red, Y and hot to5/23/2009
the touch -5/23/2009
it extended about 3" di
cal swelling and erythema. Local and distant urtitaria. @ 3rd p shot. N 5/26/2009 5/27/2009
n 5/28/09 patient noticed next day some
Y redness then next day redness increased and swelling Y up to 6 inches
5/28/2009 pain 5/29/2009
in area. Itched all over w
theaded & thinks she may have fainted (briefly) while sitting in chair 3-4 min. after HPV #3 inject. Y 6/1/2009 6/1/2009
Tdap to R Deltoid 5/22; developed Ychills + fever and headache that evening. Seen in UC 5/24, Y (R) UE was 5/22/2009
not red,5/22/2009
warm or tender. On 5
5 AM on 5/27/09 T 102 Crying unconsolable
Y - vomited X T - ate only 5 grapes - Temp 102.6 U ax in office at
5/26/2009
11:30 AM5/27/2009
on 5/27/09. Physical e
Y Y 5/19/2009 5/30/2009
ven a TB vaccine while he had a fever Y of 104 and a case of Strep throat. He began to have neurological
Y problems ### about 24 ###hours later. (Tro
9 - pt had swelling & redness of the (L) thigh. Pt instructed to Ice area & admin APAP. Pt was U seen in ofc.5/13/2009
5/15/09. Was5/14/2009
given XY2al 2.5 m
arm became very red, warm to touch, Y tender. Limited ROM with inflammation. TX= P.O. Antibiotics, Y pain
5/13/2009
meds, subsequent
5/15/2009IV antibiotics.
n has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning Y a female patient who was vaccinated with
n has been received from a registered nurse who heard from another contact concerning a 22 U year old female patient who was vaccinated
hile at home developed 104 temp and seziure. Presented
Y to hospital4for treatment. Y 5/19/2009 5/19/2009
ENTED WITH COMPLAINTS OF N/V AND ABD PAIN X 2hrs POST VACCINATION. PT TREATED N WITH5/22/2009
PHENERGAN, 5/22/20091 LITER NS, SIQ
to clinic 5/29/09 with 1 day of body, joint aches, radiating up from legs, associated with low grade U fever. 5/27/2009 5/28/2009
rs of receiving vaccines pt developedY localized cellulitis with red dermatitis of fluid filled blisters.
Y This occured5/19/2009in the5/19/2009
area where the DTaP v
d chest pain and was admitted for myocarditis
Y on
Y 25 May 2009. Admitted
1 to medical center. N Received call 5/14/2009
through call5/25/2009
center reporting post
mitted to hospital with paralysis below the neck. History of GARDASIL vaccination; Y Last dose U 04/17/2008. 4/17/2008
No definite3/10/2009
diagnosis. Described
above is simply the most recent event, one of many Y throughout the past 9 months. This dateUreflects the 8/20/2008
diagnosis given
5/20/2009
by a neurologist o
with erythema, mildly inflamed with induration, per pt. it already subsided. Y 5/27/2009 5/28/2009
mmunizations administered at an exam. Y 5/31/09 Fever 100-101 degrees. No or rash. 6/1/09 Fever Y and malaise - no other localizing signs. 6
rash Tylenol given as needed Fever 102 degrees F Diarrhea 11-12 days after vaccinations Y 5/18/2009 5/29/2009
ain in left arm w/tingling sensation inYleft fingers 5/6/2009 5/9/2009
omiting, fatigue. Y 6/1/2009 6/1/2009
daughter to a physician she had never Y been to before. While we were there the nurse suggested my daughter 5/18/2009 get the
5/18/2009
GARDASIL injection.
ccinated on 5/28/09, went to schoolYon 5/29/09 and upon return home from school mother noticed Y swelling
5/28/2009
and redness
5/29/2009
on right arm. Patie
ng our office, the patient passed outYwith increase tone. Taken to the ER for evaluation of possible Y seizure6/3/2009
activity. CTScan
6/3/2009 & blood work a
er receiving the MMR vaccine, Evan came down with 103 degree fever. The following day (8U days after 5/26/2009 vaccine), his6/2/2009
fever is 104 degrees.
d approx 1530 on 6/3/09 stating "my son got shots there yesterday now he is having an allergic reaction."6/2/2009 Mom questioned
6/3/2009 as to what kind
fort in abdomen, like cramping or feeling of gas. began approx 8 hours after injection ( 4:30 PM Y ) and lasted 6/1/2009
through the6/1/2009
night. 2. aching in a
RED BUMP FIRST SHOWED ON WEDNESDAY, Y 27 MAY, THEN AS THE DAYS PROGRESSED U THE 5/26/2009
BUMP STAYED 5/27/2009
BUT THE REDNE
f right arm where vaccine was given. Y Antibiotics and antihistamines given. U 6/1/2009 6/2/2009
se headaches and fainted and had a seizure. Y 5/29/2009 5/29/2009
ours after receiving the third of three injections of GARDASIL, I began to experience intense muscular pain and headache 5/23/2009 which continued
months after being given the GARDASIL
Y vaccine. I had a ct scan done, which showed that my lymph nodes 5/7/2007
were enlarged. ###A little over a
ay arm (R) became painful - swollen and red. Pt took TYLENOL all day. On Wed 6/309 Pt begins N with "spinal
6/1/2009
pain" body
6/2/2009
aches, headaches
edema erythema hyperemia measuring 15X12 cm oval. 6/1/2009 6/2/2009
pprox. 10:45 AM - Pt fainted outsideYclinic in the front passenger side of her car. Revived when Y her arm was 5/29/2009
shook by5/29/2009
nurse. Ambulance w
5/21/09 LDT - RTC 5/27/09 and large red warm localized reaction to Td. Y 5/21/2009 5/27/2009
hematous, macular rash on her back, trunk. No fever. U 6/2/2009
eral 5 inches x 2 inches tender, erythematous swelling. Y 6/1/2009 6/2/2009
e red rash raised bumps (hive-like) 1 patient sat for 1/2 hr gave Benadryl 12.5 melt tablets (1)Y+ 1 to take home 6/3/2009(2prn)6/3/2009
= 4 tablets (iced rash
ed Health center on 6/3/09 2:20 PM to report flushing, palpitations. Had 2-3 episodes of palpitations U and flushing.
6/2/2009Vaccination
6/3/2009 for Typhoid g
wollen arm. was seen a ER & followed Y up with us 5 days after initial shot 3 days after ER vistis. Y 5/28/2009 5/30/2009
ven Pneumovax on 5-26-09. He states Y that he became nauseated within a few minutes, then vomitted. 5/26/2009
The following 5/26/2009
day, he developed b
ARICELLA vaccine given all following info received from clinic 5-6 DEPO PROVERA shot - 5-11 U " Lump 4/30/2009
on arm" - Pain5/11/2009
shoulder to elbow"
iving immunizations and walking to office to be checked out he became "light headed" fainted hitting desk.6/1/2009
Small abrasion
6/1/2009 R eye brow + bo
103 for 3 days, loss of apetite, body aches, fast breething, fussiness Y 5/28/2009 5/29/2009
utes of receiving the 1st does of gardisil she was dizzy, pale, light headed, saying that she couldn't
Y breathe.
6/3/2009
it sounded6/3/2009
like she was gaspin
F 101.8, ACHY ALL OVER WITH SHOOTING PAINS DOWN ARMS AND LEGS OCCASIONALLY. Y PATIENT
6/2/2009
ALSO6/3/2009
FELT PAIN IN MIDDL
minutes cheeks were red and swollen with urticaria Y 5/20/2009 5/20/2009
n has been received from Y a pharmacist regarding a case in litigation concerning a young female
Y relative (exact age unknown) of a healthca
n has been received from a registered Y nurse concerning
Y a child male
0 patient who on approximately
Y 27-MAY-2009
5/27/2009 was 5/30/2009
vaccinated with the
rmation has been received from a nurse and follow up information from a medicalYassistant who U reported4/21/2009
that a 49 year4/21/2009
old female was on 2
n has been received from a pharmacist reported Y that a patient was believed
0 to received a dose
U of PNEUMOVAX4/1/2009235/29/2009
in April 2009 but no do
ness, swelling and itchy @ site 3cm x 2cm raised rash R upper arm with Sl blistering . Benadryl Y + Ibuprofen
5/26/2009
PRN, cold 5/28/2009
compresses to area
ed nodular papular rash 6/3/1996 5/29/2009
swelling, heat @injection site Y 5/3/2009 5/3/2009
on the area of injection 5x8 cm with 2x3 cm of - induration. U 5/27/2009 5/27/2009
vaccine break through. Diagnosed with varicella on 5-29-09 U 2/2/2007 5/22/2009
g motor paralysis 6/9/09 Hospital ER Y records received DOS 5/28/09. Post immunization patient Y c/o shoulder
5/27/2009
pain, knee
5/28/2009
pain, generalized a
5/29/2009
me to the clinic 6-1-09. Stating sheYhad a red area on left thigh. States the red area startedYon Sat and5/29/2009
has gotten 5/30/2009
larger. Band aids are s
of chest tightness within 5 min after immunization with HEPA, HPV, TDAP. PPD test done also Y at same5/28/2009
time. Symptoms5/28/2009persisted for 3 da
being preg. 12/31/08. Had US on Feb'2009 and was informed baby had problems and abortion Y done 3/18/09 ### at OB.3/18/2009
9 MILD Other - Fatigue, Some dizziness U 6/3/2009 6/4/2009
vaccine 5/27/2009 and seen 5/29/2009 with red very swollen arm treated with BENADRYL, Y ice, Hydrocortisone
5/27/2009 1% 5/28/2009
cream for itching.
mildly itching rash, 10 cm, over injection site U 5/27/2009 5/28/2009
Neuropathy. 3-6mo after vaccine. Tests,Y pain medication. Y N ### 1/1/2003
owing vaccination, child developed erythema
Y and edema of lower, lateral aspect of upper right
U arm, in region
6/1/2009
of subcutaneous
6/2/2009 varicella vacc
D TDAP, GARDISIL, MENINGOCOCCAL Y INJECTION,
Y TOLERATED 1 WELL, WALKED OUTUOF EXAM ROOM 6/3/2009AND 6/3/2009
PASSED OUT (5 -7 M
HAD PNEUMOVAX ON RIGHT DELTOID Y AREA ON 3/30/09 .ON 3/31/09 HE HAD MUSCLE Y ACHES AND 3/30/2009
ON 4/1/09 3/31/2009
DEVELOPED FEVE
STATED THAT SHE EXPERIENCED Y DEEP THROBBING PAIN AT THE SITE OF INOCULATION Y ON 5/20/2009.
5/15/2009 SHE 5/20/2009
SOUGHT MEDICA
munization clinic 6/04/09 at 12:30 PM, C/O headache on 6/03/09 (the evening of taking the vaccines.) Headache 6/3/2009worse 6/3/2009
6/04/09 with Naus
with rash and fever of 102 on 05/30/2009 and continued with pruritic rash that developed into U red oval shaped
2/2/2006areas5/30/2009
with vesicular lesion o
d vaccines on 6/2/09. On 6/3/09 after Y pt got home from school, mom called office stating arms N were now6/2/2009
both red at6/3/2009
injection sites and sor
ess, swelling at site, started 2 days after injection. Y 6/1/2009 6/3/2009
lling morning after vaccine, no fever, no treatment needed Y 6/3/2009 6/4/2009
symptoms appears one week after receiving
Y vaccine. U 5/26/2009 6/1/2009
min after receiving immz, pt appeared Y to have a seizure; loss of consciousness <45 seconds, Y jerky movements,
6/1/2009 urinated
6/1/2009
on self. Ammonia
baby check-up and vaccination
Y on 4-20-09,
Y visited
Y physician on 4-23-09
41 Y with N/VYand lethargy.
N By that 4/20/2009
evening, she 4/23/2009
was taken to the ED w
ding in line 5-10 minutes after the injection
Y making an appointment when she lost conciousness Y and suffered
5/29/2009
tonic clonic
5/29/2009
movements for 30
GARDASIL on 5/27/2009 - swelling/ redness started within 24 hours - seen 5/29/09 - treatedY with MOTRIN, 5/27/2009
BENADRYL.5/28/2009No previous Rxn
fter receiving MMR, patient developed Y measles like rash. Y 5/20/2009 5/30/2009
Y 5/28/2009 5/29/2009
ast PM (about 5-6 hours after injection) very fatigued then this AM 6/4/09 dizzy, nauseated. Now Y slightly better.
6/3/2009No rash
6/3/2009
- No difficulty breath
rash on chest, abdomen, and eyes 6/4/2009 6/4/2009
nced (L) arm pn @ injection site with approximately 1 cm surrounding ecchymosis, arm has U erythema/induration
6/1/2009heat6/2/2009
approximately 115x1
eloped one month after the vaccine Ywas given. Rash is red, bumps, painful on arms and legs. Y Was seen by 2/4/2009
PCP and3/1/2009
given PREDNISONE.
d, papular to trunk & limbs 3 days after vaccine - lasted one week - No treatment Y 3/4/2009 3/7/2009
vomiting approximately 8-9 hours afterY vaccines given - administered @ ~1500 on 06/03/09 U Started vomiting
6/3/2009
~ 0100 6/4/2009
- 0200 06-/04 /09
d immunization 9:05 AM, pt went out to smoke a cigarette, 15 mins later started feeling dizzyYand sweating. 6/4/2009
Pt went inside
6/4/2009 to sit, started to
had c/o nausea with emesis after injection by another nurse earlier that day. He was told toYcheck with this 2/5/2009
nurse before
2/5/2009leaving his shift.
EDIARIX given simultaneously Y 5/28/2009 5/28/2009
was reported by a healthcare professional
Y and described the occurrence of rash in a 58-year-old
U female4/27/2009
subject who5/7/2009
was vaccinated with B
was reported by a physician via a GSK representative, and described the occurrence of a rash Y in an adult 3/30/2009
subject of3/31/2009
unspecified gender wh
nduration (R) arm 4/29/2009 4/30/2009
n VYANESE doses after vaccines. YA couple of hours later hyperactive behavior had escalated U more than6/3/2009
normal. Called
6/3/2009pediatrician but d
d shot Fri - Pt brought in Monday to be seen. Noted markedly erythematous area that measures Y probably 5/29/2009
3 x 2 cm.5/31/2009
around that faint redne
was reported by the mother of a consumer and described the occurrence of swelling at the injectionU site3/25/2008
in a 5-year-old male subject who w
was reported by an other manufacturer
Y via a nurse and described the occurrence of nauseaYin a female subject who was vaccinated with (
was reported by a physician via a sales representative and described the occurrence of swelling N in a subject
4/2/2008
of unspecified
4/3/2008 age and gende
was reported by a physician via a sales representative and described the occurrence of swelling N in a subject
3/19/2008
of unspecified
3/19/2008 age and gende
was reported by a physician via a sales representative and described the occurrence of swelling U in a subject of unspecified age and gende
was reported by a physician via a sales representative and described the occurrence of swelling U in a subject of unspecified age and gende
was reported by a physician via a sales representative and described the occurrence of extensive Y swelling
3/18/2008
of vaccinated
3/20/2008
limb in a subject o
was reported by a healthcare professional and described the occurrence of swelling of legs U in a subject of unspecified age and gender who
was reported by a healthcare professional and described the occurrence of swelling of legs U in a subject of unspecified age and gender who
was reported by a physician and described the occurrence of swollen buttocks in a 4-year-old U male subject3/25/2008
who was 3/26/2008
vaccinated with INFAN
was reported by a healthcare professional
Y and described the occurrence of swollen axillary N nodes in a 5-year-old
5/7/2008male 5/8/2008
subject who was va
was reported by a physician via a representative and described the occurrence of erythemaUin a child subject of unspecified gender who w
was reported by a physician via a representative and described the occurrence of swelling inY legs in a subject of unspecified age and gend
was reported by a healthcare professional via a sales representative and described the occurrence U of nonspecific reaction in a subject of u
was reported by the mother of a consumer and described the occurrence of nausea in a 4-year-old N male 8/5/2008
subject who8/6/2008
was vaccinated with
was reported by a healthcare professional and described the occurrence of injection site reaction U in a subject of unspecified age and gend
was reported by a physician, via a GSK sales representative, that described the occurrenceUof swelling at the injection site in an unspecifie
was reported by a healthcare professional and described the occurrence of swelling injection Y site in an 18-month-old
8/19/2008 8/19/2008
female subject who w
was reported by a healthcare professional and described the occurrence of swelling of injection Y site in a8/19/2008
5-year-old 8/19/2008
female subject who was
was reported by a healthcare professional and described the occurrence of swelling injection Y site in a 5-year-old
8/20/2008male8/22/2008
subject who was vac
was reported by a pharmacist and described the occurrence of an unspecified adverse event U in a child subject of unspecified gender who w
was reported by a healthcare professional and described the occurrence of crying in a 4-month-old U male subject who was vaccinated with
was reported by a healthcare professional and described the occurrence of limb swelling in U a child (15 months to 5 years) subject of unspe
was reported by a healthcare professional and described the occurrence of limb swelling in U a child (15 months to 5 years) subject of unspe
was reported by a healthcare professional and described the occurrence of limb swelling in U a child (15 months to 5 years) subject of unspe
was reported by a healthcare professional and described the occurrence of limb swelling in U a child (15 months to 5 years) subject of unspe
vaccine administered, mother reportsY fever of 99.5,
Y then began having 2 myoclonic jerks of arms,Y legs and5/14/2009
head. No 5/14/2009
decrease in level of aro
o BPH, intra-cranial hemorrhage 10yrs ago admitted
Y on 5/25 with a 41 Ywk h/o HA, fevers, rigors and progressively
5/7/2009worsened
5/13/2009 weakness, with
Y N 6/28/2008
0.5 degrees F, achy joints/neck, HAYeyes sensitive to light, numbness in feet/hands. 5/21/09.Y5/27/2009 Follow 5/15/2009up with
5/20/2009
parent. Parent state
KINREX + MMR on R deltoid on 5/29/2009 - came into office 06/02/09 necessary with cellulitis Y + reddened 5/29/2009
@ site. 5/30/2009
minutes after injection Pt became rigid all over, very stiff, and fell down to table. After severalYminutes then6/2/2009
began to arise
6/2/2009
but was very grog
degree F fever, body aches, joint pain: Rash at injection site. Symptoms began to subsideYafter 36-48 5/24/2009 hours. 5/25/2009
ected with 2nd GARDASIL inj. About Y 30 seconds later pt fainted fell head first off of bed. Pt hit
Y right forehead
5/29/2009
on floor
5/29/2009
and ice was applied. P
30 papules on trunk and groin - No vesicles - very itchy 4/11/2007 5/29/2009
m red whelp to (R) deltoid, not tender to touch, cellulitis. Treatment - BACTRIM DS U 5/27/2009 5/29/2009
ed pt came home form Daycare on Thursday 5-28-09 and c/o pain in (L) arm, Mom also stated Y it was itchy.
5/27/2009
Area was5/28/2009
reddened, itchy and s
rs after receiving vaccines became irritable, crying & inconsolable for 1 1/2 hrs. Left leg hadYnickle sized3/31/2009
bruise at injection
3/31/2009 site. Left thigh l
redness, heat, bruising after 3 days. Pt was Pt used cold packs and warm packs Y 5/27/2009 5/28/2009
Q site redness, heat. Pt saw physician
Y who prescribed "Steroid Inj and BENADRYL OD Y 5/19/2009 5/20/2009
n arms / legs about 1 hour after receiving,MENACTRA, HPV #1, HEP A #1, on 5/27/09 no other complaint. 5/27/2009 5/27/2009
n has been received from a physicianY concerningY a female with unspecified
0Y reported drug reactions/allergies
U 4/30/2009
with Behcet's Syndrome and a
orted in a news magazine article that a male who on an unspecified date was vaccinated with U a dose of MMR II. Subsequently the patient d
n has been received from a physicianY concerningY either 15 or 16 years 0 old male patient whoUon an unspecified date was vaccinated with a
n has been received from a physician concerning a female patient who on an unspecified date U was vaccinated with a dose of GARDASIL (
xperienced swelling in the lymph node of the left armpit. 5/25/09 chills, generalized malaise,YTemp 99.8 5/15/20095/26/09 Malaise
5/24/2009
continued, fever a
ema and induration at arm injection site. Y 5/26/2009 5/27/2009
thigh red/warm swollen with itching within 24 hours of vaccines given. Y 5/29/2009 5/30/2009
ven dose #2 of GARDASIL, seems to Y tolerate well. No c/o offered - fainted upon preparing to leave facility,
5/13/2009
hitting back
5/13/2009
of head hard on doo
and erythema at Lt site of immunization
Y 10 days after immunization. No signs of injection - NoY treatment given
5/14/2009
- Local
5/24/2009
reaction presumed to
with erythema and purpura skin in large circular area 8cm - no adjacent to but not symptom surrounding
U needle
5/29/2009 insertion
5/30/2009
site from vaccinatio
substantial swelling of injection armYfrom shoulder to elbow, skin sensitivity, stiffness - joint pain
Y (ankles,4/30/2009
knees, elbows, 5/1/2009
wrists, neck) - feve
Multiforme rash started on 5-22-09 started in groin area spread allover started on BENADRYL Y change to5/15/2009
ZYRTEC 5/22/2009
on 5-26-09 PRELONE
swelling of R deltoid area. ErythemaYand induration surrounding injection site. Y 5/26/2009
min of receiving JE vaccination, client had a seizure lasting 1-2 min. Alert & oriented after, though
Y very pale6/4/2009
and unsteady.
6/4/2009 BP 122/80 No s
ss on neck, arms, legs, about 10 minutes after shots were given, no difficulty breathing, nor Y swallowing, no 6/4/2009
rash noted. 6/4/2009
BENADRYL 25 mg
e swollen warm to touch. Swelling from Y knee to hip Y 6/3/2009 6/3/2009
was reported by a healthcare professional and described the occurrence of limb swelling in U a child (15 months to 5 years) subject of unspe
was reported by a healthcare professional and described the occurrence of limb swelling in U a child (15 months to 5 years) subject of unspe
was reported by a healthcare professional and described the occurrence of limb swelling in U a child (15 months to 5 years) subject of unspe
was reported by a physician, via a GSK sales representative, that described the occurrenceYof injection site hot to touch 9/4/2008
in four child subjec
was reported by a physician, via a GSK sales representative, that described the occurrenceYof injection site hot to touch 8/21/2008
in four child subjec
was reported by a physician, via a GSK sales representative, that described the occurrenceYof injection site hot to touch 8/14/2008
in four child subjec
was reported by a physician, via a GSK sales representative, that described the occurrenceYof injection site hot to touch 8/20/2008
in four child subjec
was reported by a healthcare professional
Y via a sales representative and described the occurrence
U of erythema
9/15/2008 in a9/16/2008
5-year-old male subje
was reported by a healthcare professional and described the occurrence of swollen thigh (injectionY site) 8/22/2008
in a 5-year-old female subject who
was reported by a physician, via another health care provider, and described the occurrenceYof injection site hot to 8/29/2008 touch in a 3 year old fem
was reported by a healthcare professional
Y and described the occurrence of floppy in a 6-month-old
Y female subject
### who was ###vaccinated wit
was reported by a consumer, the subject's grandmother, and described the occurrence of seizure Y in an infant female 11/1/2008
subject who was vacc
was reported by the grandmother of a consumer and described the occurrence of hyporesponsive U reaction (unspecified) in a 4-month-old f
was reported by a healthcare professional and described the occurrence of an unspecified adverse U event in a subject of unspecified age a
was reported by a healthcare professional and described the occurrence of an unspecified adverse U event in a subject of unspecified age a
was reported by a healthcare professional
Y and described the occurrence of swelling injection Y site in a 4-year-old
3/16/2009female3/16/2009
subject who was v
nd swelling in a 6x6 are to Right thigh where MMR vaccine was administered, swollen area was Y hot to touch 6/2/2009
and painful6/3/2009
d shot Tues afternoon; minor discomfort at injection site. - Started to feel extreme fatigue Weds. Y afternoon6/2/2009(approx 1300hrs)
6/3/2009quickly followe
n 2 days following the injections. It began as a ring about an inch from every injection and onU the next day6/1/2009had covered 6/3/2009
her whole body exc
of malaize approximately 12 hours after Y injection. 36 hours later, muscle pain in the upper insideN of calf of5/21/2009
lower left5/22/2009
leg. Pain in upper bod
rts child developed night terrors and feels it is due to DtaP. Had first night terror night vaccine
U given, has5/29/2009
had one again 5/29/2009
2 other times when
@9:16am MOC t.c. c/o mild dizziness 1 hours post vaccinations then severed ha, lbp and dizziness U with falling
6/4/2009this morning
6/4/2009on ambulation
d urticaria all over body 3 days after receiving vaccinations. Also on a new med - flonase, and U has tried a 6/1/2009
new food - 6/4/2009
cherries, so etiology u
ent had 3 vaccines administered on Y 5/26/09 @ approximately 12:00 pm. Client called @ approx Y 1:25 and5/26/2009
stated "I'm5/26/2009
having trouble breathin
, Swelling, Tenderness, fevers, Elevated
Y white Yblood cell count. 6/26/2009
3Y MR received for DOSU 6/4-7/2009 6/3/2008
with D/C6/4/2008
DX: Cellulitis. Pt pres
MOTHER REQUESTING LIST OFYIMMUNIZATIONS GIVEN AT LAST VISIT ON 05.27.2009 U (MOTHER 5/27/2009
WAS GIVEN 6/4/2009
RECORD THE DAY
ived rotateq on 4/3/09 and was admitted to theYhospital for intussusception
4 on 4/9/09. 7/24/09
Y Hospital records
4/3/2009 received
4/9/2009
DOS 4/9/09 to 4/2
n left arm wth mild erythema on the site not likely cellulitis. U 6/4/2009 6/5/2009
mother calls to report that about 3 hours after immunizations received client began feeling "lethargic"
U and then
6/3/2009
later in6/3/2009
the evening develope
ed Hib and DTP/DTap vaccinations on 04/Jun/2009 and developed pain and sore at the injection N site. He6/4/2009
cried when6/4/2009
I was holding him up,
LA FROM VACCINE Y 5/28/2009 6/3/2009
rts child had 1st seizure 6-3-09 at 2030
Y lasting approx. 1 min. taken directly to hospital ER. CT Y of head and 6/3/2009
CXR done. 6/3/2009
Ativan and Tylenol
OF DIARRHEA (5 TIMES DAILY), VERY ODOROUS Y 1/5/2008 5/25/2009
days after Hepatitis B vaccine my thumbY and pointer finger on right hand were numb and i went N to my family 5/16/2007
doctor 5/20/2007
and within the next wee
vomiting, headaches, pain in joints,Y backache, aches in the arm that was injected. Bad mood U and sleepnessness.
5/26/2009 5/27/2009
rienced generalized macular papular rash over body with "strawberry toungue" beginning 06/03/09 U afebrile
5/20/2009 6/2/2009
d vaccine on 6-2-09. on 6-5-09 patient still complains of injection site redness, warmth and itch. U i advised 6/2/2009
pt to take some 6/3/2009
ibuprofen for the
ak out in hive after MMR and Varirex, the right thigh swell up and swollen where MMR was administered.
U Gave
6/5/2009
Benadryl 6/5/2009
2.5 ml po x1 , no re
ain in deltoid area, swelling and slight fever. Pain for 3 days. 6/2/2009 6/2/2009
ion site became itchy within 1 hour & Y became very red that evening. 6/4: Site became painful, U swollen, tneder,
6/3/2009
redness 6/3/2009
spread, and she be
U 6/5/2009 6/5/2009
e evening on the day of injection the patient developed a egg sized lump on the back of the right Y arm. When 5/28/2009
the arm5/28/2009
was reassessed in the
bed itching during the night and small red dots over her body. She took Benadryl during the am Y and now (6-5-09,1:00pm)
6/4/2009 6/5/2009 reports no S/S.
NOTICED ON 06/04/2009 2 SMALL WHITE SPOTS ON ROOF OF MOUTH. NO FEVER, DID U HAVE DAY 6/1/2009
OF IMMUNIZATIONS.
6/4/2009 ANOTH
ion site was found to be swollen, firm, red, and hot to touch. Patient temp of 99.00 in the afteroonY after the
5/25/2009
injection 5/25/2009
resolved by 2300 that s
for evaluation of red swollen right thigh.
Y Warm to touch. Sore. Treatment advised: supportiveYmeasures. Cool 6/3/2009
compresses
6/5/2009 and Tylenol.
ater of administration of the vaccine Pt called the pharmacy complaining of numbness and tingling sensation. 6/3/2009
From the6/3/2009
talk to Doctor at offi
ing, erythema (10 x 10 cm area) itching,
Y mild induration directly under injection site (2 x 2 cmUarea). 6/2/2009 6/3/2009
.5 cm erythema around injection site. Warm non tender. U 6/3/2009 6/4/2009
welling, tenderness, redness and warmth Y over right deltoid appeared 2 days after injection. Mild
U erythema 6/2/2009
without warmth6/4/2009
left upper arm.
of left arm with edema and erythema. U 6/2/2009 6/3/2009
reaction. Sore and swelling. Y 5/26/2009 5/29/2009
d severe localized reaction to this immunization. N 6/2/2009 6/4/2009
was reported by a healthcare professional
Y (also the subject) and described the occurrence
Y of
U injection site
5/12/2009
pain in a5/12/2009
45-year-old female sub
ented to clinic 6-4-09 w. cc "crying a lot", 7 cm reddened swollen LAT at site of 4th INFANRIX. Y Mom advised 6/2/2009
to warm6/3/2009
packs, return to clinic
was reported by a consumer (also the subject)Yand described the occurrence
6 of pneumonia Yin a 81-year-old male subject
2/24/2009who was vaccina
of breath and dizziness Y 6/4/2009 6/5/2009
mitted to clinic with warm red areasYon bilateral upper extremities. Pt rec'd vaccines on 6/3/09. MENACTRA 6/3/2009
in (R) arm
6/4/2009
and Tdap in (L) arm
meter induration with 2 in wheal on LA surrounding VARIVAX adm site. Normal pulses. bilat.Y 6/3/2009 6/5/2009
2 days after vaccine T. 102 + moreYjerky movements after 3 days of vaccination as per mom less of balance 6/1/2009and frequent falling lethargy,
pain, swelling left arm onset day after
Y rec'd VARICELLA vaccine in left arm. Low grade fe. Y T 99.2. 10 X 6/3/2009
6 cm red tender
6/4/2009lesion below inj s
chest & back rash red, bumps mild itching
Y x 1 1/2 hrs without fever, general malaise saw MD 5/23/09. 6/1/09 5/21/2009
Blood work
5/23/2009
showed low white
ted skin under bandage around vaccination site. Individual, isolated rash clusters under arm & across chest 5/22/2009
and abdomen.
6/1/2009
ped intussusception requiring
Y surgical reduction.Y Also had symptoms4 of resolving virus + viralYexanthem 5/28/2009
c/w parvovirus5/30/2009
(fifth's disease) on t
e fever, overall "joint aching" + head "feels too big for her body" 6/3/2009 6/4/2009
scle spasms to arm x 24hrs. Nickel sized area "bullseyes" at injection site. Unable to do promY because pain. 6/4/2009 6/4/2009
oid with erythema and swelling. Y N 6/4/2009 6/5/2009
excessive of arm, shoulder & neck involving
Y throat. U 5/31/2009 6/1/2009
and swelling after 6 hours on date ofYvaccine. Then rash that became larger the next day. The Y next she mad5/29/2009
an observation,
5/29/2009was on 6/3/09
et of wheezing approx 10 minutes post Y vaccine administered nebulized albuterol given. Y 5/22/2009 5/22/2009
d received the Typhoid vaccine first.Y Then she was administered the Hep. A. As soon as theYHep, A was5/21/2009 removed the 5/21/2009
nurse, patient slump
Tetanus booster and Hep B shot at 4:30pm on Thursday June 4th. Woke up at 5:30 June 5th Y very dizzy.6/4/2009
Called Dr.6/5/2009
He said to wait it out
IN TO RECIEVE ANTHRAX AND SMALLPOX Y VACCINES AT 141 MDG WA ANG. PT RECIEVED Y INITIAL
6/6/2009
ANTHRAX 6/6/2009
VACCINE. HE WA
echiae & edema - transient & self resolving. Y 6/2/2009 6/3/2009
in all muscle groups, Fatigue, rectal bleeding. (On initial series 6 doses bleeding remained for Y several months)
6/6/2009 Concurrent
6/7/2009 doses 1-2 week
t from a typically developing boy, to full regression in to Autism within one week of Y his MMR Nshots. He also7/18/2000
recieved7/18/2000
the Varicella vaccine o
in hives (10/19/07). Developed a allergy
Y to peanuts which had not been presentYprior to theNimmunization. Long ### term adverse
### affect PDD
thigh was red, warm, swollen
Y & itchy shortly after the injections. He was in pain & wanted to U be carried because
6/1/2009his6/1/2009
legs were weak. Arou
s after the vaccination, I'm getting weaker and Y weaker. Have cold symptom
6 like. Went to dinner.
U After 103/24/2004
minutes, experience
4/6/2004 hiccup. My c
ke a huge hive 2 x 3 1/2 inches. It was red and hot and lasted 5 days. (It was on the injection Y site). 5/15/2009 5/15/2009
, swelling and warmth to site whereYvarivax was administered. 5/28/2009 5/29/2009
h rabies vaccine, had progressively worse
Y headaches, sweats/chills, facial redness, muscle fatigue, general fatigue, ### uncoordinated,
### confusio
mom, states she tried to feed her in the AM and she vomited. Vomiting x 3 from 7:30 Am - 12UN. Refuses to 5/6/2009
eat or drink.
5/7/2009
No fever or diarrhe
red swollen area at one injection site (believes to be varicella) running fever. (Right arm siteYof injection). 5/26/2009 5/27/2009
immunizations @ 9AM - broke out in Y rash starting @ 12 N 1 place under eye (looked like blister-
Y went away-
5/26/2009
2 under5/26/2009
neck @ 1:30 they wen
ely following administration of GARDASIL she was sitting on exam table, felt lightheaded andYfainted. falling 6/3/2009
to floor. 6/3/2009
Mother in room reporte
2/20/09 ----> mom reports LA (left arm)Y injection sit on 03/03/09 became red, raised, warm toYtouch physician 2/20/2009
diagnosed
3/3/2009
as cellulitis. Paren
all area of urticaria @ flexor surface of (R) arm on day of vaccination, but four days later, she Y developed urticaria
5/4/2009over 5/4/2009
entire upper body &
n has been received from a medicalYassistant concerning a 17 year old female with a historyYof convulsions 5/28/2009
and under5/28/2009
the care of an unspe
ped severe urticaria over entire bodyY several hrs after administration of several vaccines. This Y resolved with5/8/2009
BENADRYL 5/8/2009
& PREDNISONE
n has been received from a 17 yearYold femaleYwith no medical history or drug allergy who was N vaccinated 12/1/2007
with 1st,12/1/2007
2nd and 3rd doses of G
and induration at injection sites. Pain to touch at injection site. 5/27/2009 5/29/2009
n has been received from a pharmacist concerning a female who "one or two years ago" on Uunspecified dates was vaccinated with the first
n has been received from the author of a literature article, title stated above concerning a healthyY 16 old male who more than 8 years after
n has been received from an office Y manager concerning
Y a 12 year old
0 female who on 19-MAY-2009Y was5/19/2009
vaccinated5/19/2009
with a dose of VARIVA
m rash 24-36 degrees after immunizations 5X care - tylenol and/or motrin. U 6/2/2009 6/3/2009
RIVAX + PCV given. 5/15/09 Dx Ataxia DM T 100.5. 5/29/09 Ataxia persists. 6/5/09 Child back Y to normal 5/7/2009
no signs of 5/15/2009
ataxia.
d, raised, tender, warm to touch area approx 2" x 3" at Varicella injection site. T. 99.3. C/o slightY nausea, seen 6/3/2009
in our Public
6/4/2009 Health Office at
om brought child in, Dr saw a red, hot to touch area to (L) deltoid, measured 5in by 5in in diameter.
Y 6/4/2009 6/5/2009
ated 18 hrs after vaccine child was sitting in cart at Kmart and fell over and was very pale andYappeared to3/4/2009 have fainted.3/5/2009
This lasted 15 min
diarrhea, vomiting, fatique, temperature of 100, left work, did not see a doctor Y 5/29/2009 5/29/2009
and itching palms on evening of June Y 1. Some itching
Y during the week,
1 with bad hives on eveningY of Friday,6/1/2009
June 5. Visited
6/5/2009 urgent care clin
ollowing vaccination with Anthrax, Smallpox,
Y Typhoid (18 May). Pt. with pruritic papular lesionsU which started5/18/2009
on distal6/5/2009
extremities (wrists/an
occal vaccine given at 0907 IM prior to discharging. Pt. had no knownYallergies and not allergic Y to eggs. At 5/17/2009
1015 pt c/o5/17/2009
back and rt flank pai
e and diplopia accompanying Y a cerebellar
Y hemorrhage occurring within about 24 hrs of an influenza
Y vaccination. ###7/31/09 Hospital
### records r
zure lasted 1 min about 2 mon after Ygiving the 0.5 ml IM shot of DT.Tdiphteria-tetanus) Y 6/8/2009 6/8/2009
SED A 12 YEAR OLD FEMALE WHO WAS ALERT AND ORIENTED. THE MOTHER STATED Y THAT THE6/5/2009CHILD WAS 6/5/2009
DUE HER LAST HP
al congestion, lost voice, body aches, rash at injection site Y 5/20/2009 5/20/2009
hours: Significant swelling at injection
Y site and redness, 101 - 102 Fever, Chills, Muscle pain.U After 30 hours: 5/29/2009
Wet Cough
5/30/2009
(diagmosed as br
administered on Tuesday,6/2/09. On Thursday a 2.5 inch x 2 inch erythematous, raised, tender, Y area noted 6/2/2009
around injection
6/4/2009 site. This area
/ 6 days post vaccine noticed warmYto touch /redness / swelling / itchy at around injection site Y on left arm. 5/26/2009 6/2/2009
oke up with a very sore arm. The site of the injection was swollen and tender. He complainedYof feeling overall 5/27/2009weak5/28/2009
and achy. He was runn
ely after having vaccines, patient had a seizure that lasted a few seconds. Dr. did a neurologic Y exam 5 minutes 6/8/2009and 306/8/2009
minutes after episod
ceived injection on 5/26/09 and was fine until the evening of 5/27 when she had a red spot the Y size of a quarter
5/26/2009 at the
5/27/2009
injection site. The are
head ache, nausea, bloating and diarrhea 2 days after taking last of four live virus oral typhoid U vaccine capsules.
5/27/2009 Treatment
6/4/2009 not sought. Imp
RECORD OF FEVER x48 HOURS AFTER VACCINATION; "RASH" FIRST APPEARING AROUND Y NECK, 6/2/2009
THEN TRUNK 6/4/2009 TO UPPER AND
side of injection swelled significantly, with hard raised lumps, lasting 5 days Y 6/2/2009 6/3/2009
s her arm was very swollen. She had a temp. of 104 degrees and she was in bed for 4 days.Y She did not 2/10/2009
call our office
2/10/2009
or report this to any
d a large local reaction at site of DTaP 3 days after the injection. Resolved with ATARAX. Y 6/3/2009 6/6/2009
4 hours, body ache and sore arms x 48 hours. Welts to left arm- (1) anthrax, (1) Tdap >x 5 days. Y 6/1/2009 6/2/2009
hot was given on Friday, June 5th appointment was at 9:15 for a physical. Left arm hurt immediately N after6/5/2009
and began6/6/2009
to swell and was very
n has been received from a consumer Y concerningY his 24 years old fiancee
1 who on 25-MAY-2009 N received5/25/2009
the first dose
5/25/2009
(0.5ml) of GARDA
n has been received from a physician Y concerningY a 15 year old female3 patient who Y on 14-NOV-2006,
N 16-JAN-2007
6/12/2007 and 3/1/2009
on 12-JUN-2007 w
n has been received from a consumer concerning Y his son with general0 sensitivity to all vaccines
U (no specific vaccine or manufacturer given
n has been received from a medical assistant concerning a 55 year old female with Y a historyNof chronic obstructive
5/5/2009 pulmonary
5/5/2009 disease and
.7, Myoclonic movements, joint pain,- Y given ibuprofen,
Y TYLENOL, IV 4 ROCEPHIN: adverse reaction
U began5/28/2009
within 1 hour
5/28/2009
of vaccine adminis
L vaccine - neuritis (LUE) - thoracic outlet syndrome - no strength (L) arm/(R) arm (decrease U strength)- 4/16/2008
decrease vasc 4/16/2008
(L) arm (with elevat
in arms & shoulders. Evaluated by Geneticist & Rheumatologist. 6/9/2008 7/14/2008
n in LDMIM. 30 minutes after shot client upper arm had some swelling, heat to touch and reddened Y raised6/4/2009
area L- 3inch6/4/2009
W 3inch. Light rash
and induration at site injection (L) Deltoid 6x7 cm. Area pruritic. Y 5/27/2009 5/28/2009
ports pain at site, fever, sore throat for 2 days post injection following sores at site, left shoulder
U pain and4/15/2009
decreased4/15/2009
strength and range of
y urticaria, agitation about 1 hr following
Y MMR/VARIVAX increase RR increase HR also, chills. Y BENADRYL, 6/4/2009
EPI, ORAPRED
6/4/2009administered -
and warmth to left thigh area. About Y 10x10 cm area. Y 6/2/2009 6/4/2009
action to KINRIX DTAP-POLIO- Friday 4-17-09 child had small knot. Saturday 4-18-09 childYhad knot 6 4/16/2009 inches in diameter,
4/18/2009 hot to touch.
ceived PENTACEL vaccine on 6/1/09. Leg became red and large amount of swelling on thigh. Y Very fussy,6/1/2009
cried for over an hour.
6/3/09 she noticed onset of itching, redness,
Y and that area was (hard). Pt states 12-15 hoursUafter injection6/2/2009
Sx began6/3/2009
to appear. She denies
and low grade temperature. Y 4/4/2009 4/4/2009
e temperature and lethargic. Y 6/2/2009 6/3/2009
ven PENTACIL at 9:00 am on 6/1/09. He went to daycare and when mom picked him up in Y afternoon noticed6/1/2009
area around
6/1/2009 shot on anterior
arm swollen below injection site 10 Y by 15 cm. Also complained of chest pain: NL EKG; NL enzymes. Y 5/1/2009 5/3/2009
t states: Left upper extremity is difusely
Y reddened, starting around glenohumeral area extending Y towards5/27/2009
elbow. Covers5/28/2009
area of superior &
rash at injection site. Rash is 2-3" long and 2" wide. Patient sought medical attention but only U a hot compress 6/1/2009was recommended.
6/2/2009
inconsolable crying. DTaP/IPV/HIB/PREVNAR
Y and ROTATEQ given at 9:45 am 6/1/09. Crying Y began 9:00 6/1/2009
pm, stopped
6/1/2009
9:00am 6/2/09.
e swelling approximately 15 minutes after vaccines. BENADRYL PO given upon return to clinic. Y 6/3/2009 6/3/2009
diarrhea 12-15 x 1 day. Lasting > 2 weeks. All stool studies normal. Y 4/16/2009 4/26/2009
diarrhea 12-15 x 1 day lasting > 2 weeks All stool studies normal. Y 4/16/2009 4/26/2009
nt legs broke out in hives evening of injection 6/1/09. Woke up next AM & hives on arms & legs. Y Patient took 6/1/2009
25 mg BENADRYL
6/1/2009 8 AM on 0
s, fatigue, rapid HR, abd pain, numb legs- sx's intermittent since then and continue. 7/2/09 Medical
N records received
### 1/15/2008
DOS 11/11/08 to 6/12
other states that pt was a little feverish the morning following her vaccines and that she had some
U redness6/1/2009
at the DTAP 6/2/2009
vaccine site. Yester
cry for 4 hrs - hard to console 6/2/2009 6/2/2009
thigh, redness, some pain and getting bigger. Can walk normally. Started later the night of shots.
U Treatment,
5/26/2009
warm5/26/2009
compress for swelling a
ced hives on torso, no fever and injection site look ok per patient mom. U 6/1/2009 6/1/2009
accines and approximately 4 minutes later skin turned lace like pink and blotchy resembling Y hives. Dr. notified
6/1/2009
eval pt6/1/2009
and given 10 mg Ben
ool IZ's 5/26/09, when child came back fur PPD reading father states child's leg had some rednessY we examined
5/26/2009it and
5/27/2009
measured it.
Y 5/26/2009 5/26/2009
5 min after 3rd GARDASIL injection - Had received injection then walked on to waiting area Y to get father. 6/2/2009
Fainted after 6/2/2009
return to exam soon
-102 rash on 6-3-09 seen in office. Y Y 6/1/2009 6/3/2009
ed rash. Started on 5/30/09 after a fever. Y 5/21/2009
helps, cellulitis treated with BACTRIM. U 5/27/2009 5/29/2009
d to toe entire body on 5/27/09. Started with fever 104 @ 2-3 days prior then rash. ReceivedNMMR immunization 5/14/2009 of 5/27/2009
5/14/09.
er arm red, swollen, and warm to touch.Y Measures about 7 inches in length. Mom took child N see APN. APN 5/18/2009
is treating
5/20/2009
area with butt paste,
er, T: 99 - 101 degree F from the evening to next day, then started having cough - o/e: Chest: Y some wheezes 5/21/2009
and crackles
5/21/2009 (rales) on base
reaction to INFANRIX vaccine in (L) thigh" (MD) Parent "(L) Leg swollen. Onset was Tues. after Y vaccines." 5/26/2009
Rectal temp
5/27/2009
101.5, Tylenol give
vaccine break through. Diagnosed in office on 6/2/09 with varicella. Had about 20 pox. U 4/29/2008 6/1/2009
ven HIB that was expired. Y
edness pain at injection site x 4-5 days - better slowly over 3 wks but left with residual brachial
Y neuritis. 3/26/2009 3/26/2009
6/4/2009
d ENGERIX B vaccine IM in both RYand L deltoids on 5/4/09. At approx 2:30 PM 5/6. Pt wake Y from ncp and 5/4/2009
noted her 5/6/2009
right arm was numb-
redness, and swelling extending over Y entire upper left arm and shoulder. Began 1 day after N injection. Prescribed
5/27/2009KEFLEX
5/28/2009 x 7 days, Predni
dvertently received ZOSTAVAX instead of Chickenpox varicella, CDC called no further f/u. Parent Y informed 6/8/2009
of local reaction to look for. Sup
ut after received shot with brief tonic/clonic activity of upper extremities lasted 3-5 seconds. No
Y loss of bladder
5/21/2009
control.
5/21/2009
ceived #2 GARDASIL on 5-12-09 and called 5-15-2009 reporting c/o itching / have several hours Y after she
5/12/2009
had GARDASIL
5/12/2009 5-12-09. Pt took
thematous indurated lesion on thigh, developed 24-48 after immunization (L thigh). U 6/6/2009
stomach felt queasy; sat down; says her vision was fuzzy; became pale; fainted; assisted toYa lying position 6/8/2009
et fanned;6/8/2009
regained conscious
Y Y 6/1/2009
given 5th HEP B today within 10 min of injection being given in (R)D. Employee noted backNteeth became 6/8/2009
numb on both6/8/2009
sides upper & low
e named patient was seen in my office on February 7th, 2009 with a complaint, which I witnessed one bump on### her shoulder area. Two day
cess @ site of injection. Negative Gram Y stain Negative Culture. Y 1/3/2009 2/5/2009
es high temp starting 1 hour after administration
Y around 101.3 degrees F. Mom gave motrin Yand temp came 6/5/2009
down to6/5/2009
normal soon after dos
NKA, PMH: Dementia, Hypertension, CVA,OA/DJD, hyperlipidemia Patient also has h/o stroke. Y Patient was 2/19/2009
admitted 2/19/2009
for fracture following m
d not know she was pregnant at the time of vaccination and was vaccinated with Anthrax andUHPV 6/2/2009 6/2/2009
d meningitic like illness while
Y out of Y
state. Ultimate
Y diagnosis is Acute 7 Disseminated Encephalomyelitis
U (ADEM).
5/18/2009 Had5/29/2009
ataxic gait, stiff neck w
es after receiving Pediarix on Left thigh.Entire leg became red/purple per mom- bled small amt Y at site. stopped
6/9/2009with bandaid
6/9/2009-then blotchy/v
with 2nd gardasil vaccination, beenYhaving myriad of symptoms. Initial symptoms included N headaches that12/1/2008
started12/1/2008
after the first vaccinatio
s sister also received an immunization and was discussing other shots she'd received in theYarmed forces. 6/9/2009
Client stated
6/9/2009
she felt dizzy. I ha
<5 min. after admin of vaccines. From a sitting position while assuming standing position, she Y fell to floor. 6/4/2009
Syncope duration
6/4/2009 <5 sec. First aid
Y DEVELOPED HIGH FEVERS 101.5-103 FOR 2 DAYS THAT STARTED 10 DAYS AFTERYSHOTS WERE 5/29/2009
ADMINISTERED.
6/7/2009 OTHER TH
s of L facial drooping since 730 am Y this morning. Episodes last about 30 seconds, pt gets glazed over look 6/8/2009
in eyes and6/9/2009
becomes lethargic.
Y 6/8/2009
#1 (1423X) given in right arm on 4/23/09.
Y Adverse reactions symptoms began 4/24/09 exhibitedN by: dizziness,
4/23/2009
headache,
4/24/2009
stomach pain, nau
ness, swelling of about 3 inches. Slight itchiness. Slightly sore. Y 6/8/2009 6/9/2009
re, drooling, swelling of injection site.
Y SOB, passed out completely. No response X 10 min. This Y occurred 6/8/2009
several hours 6/8/2009
after the injection w
sh on arms and hives + joint pain, leftY arm. Y
hours of vaccine c/o sore throat - light headiness U 6/8/2009 6/8/2009
n with TYLENOL, fussiness, decreased eating U 6/8/2009 6/8/2009
degrees about 12 hours after immunizations Y 6/8/2009 6/9/2009
en 2X NL size, Red, hot vesicules aroundY injection site had given Benadryl in ER. Y 6/5/2009 6/6/2009
- large hives at site of injection - myalgias and arthralgias Y 6/2/2009 6/2/2009
r the immunization, child developedY~ 2" red raised tender area surrounding VARIVAX site - Yno vesicules5/30/2009 - now it brown
5/31/2009
skin surrounding s
tous swelling, right deltoid area. DayYafter shot was given. Y 6/5/2009 6/6/2009
old male patient received a first time dose of MENACTRA (lot number U2816AA) intramuscularly N in the right
5/5/2009
deltoid on5/6/2009
05 May 2009. On 0
serious case was received on 08 May 2009 from a health care professional. A 12 year old female Y patient 5/7/2009
received a second
5/8/2009dose of ADAC
ted on (L) ear - Spread down face and Y trunk with a fine, flat, red rash that continued down hisY body - No 5/27/2009
fevers noted.6/8/2009
d syncope episode immediately after MENACTRA vaccine + HGB blood draw. Pt was sitting Y on exam table 6/5/2009
and stated.
6/5/2009
I didn't feel good, I
Y 11/6/2008 11/6/2008
ours, fever (up to 101 deg. F) headache, bodyaches, redness and soreness at site. Bodyaches, Y fever and 5/29/2009
headache 5/29/2009
intermittent for 2 1/2 m
and small purpuric areas on R lower Y leg. Y 5/29/2009 5/29/2009
4-36 hours after vaccine (R) deltoid. Swelling at injection site according to mother- 3 1/2 in high Y 2 1/2 in wide.
5/28/2009Described
5/29/2009
red firm- like 2 go
n has been received from a staff member in a physician's office concerning a 46 Y year old female
U who on4/13/2009
13-APR-2009, 4/13/2009
at 9:40, was vaccin
n has been received from a consumer concerning two of her friend's children who on an unknown U date were vaccinated with MMR II and d
ort received on 29 May 2009 from a Y health care professional. A 58 year old male patient received
U DECAVAC 4/28/2009
intramuscularly in the left delto
ort received on 05 June 2009 from a health careYprofessional. A 47 year old female patient who N delivered twins
6/3/2009vaginally on 02 June 2009 r
MMR II and HAVRIX vaccine on (R) thigh, and Dtap, VARIVAX and IPV on (L) thigh. Noted N large area of 6/8/2009
swelling and redness on (R) thigh
ceived DT on 6/1/09. Started feeling ill 6/2/09; l.g. -HA, fatigue, red sore arm. On 6/3/09 had Ysignificant episode
6/1/2009 of dyspnea
6/2/2009 with headache
given 5/26/2009. Left leg appeared red, warm to touch and painful when touched. Mom noticed Y this on 5/26/2009
6/9/09. Subsequent
6/5/2009appt. 6/6/09.
all" sized area around injection site. YDr Wright believes it is a shingles lesion. Being treated with
Y Acyclovir.6/5/2009 6/6/2009
w fever, broke out in tiny hives (scalp, tummy, back, not legs). Hives light not raised, itchy. Fatigue,
Y diarrhea,
6/8/2009
very thirsty.
6/8/2009
Now only has a c
e within 2 hours. Had fasting blood test on 6/1/09. Arm was swollen at injection site, lump, fever Y 102, nausea,5/29/2009
stomach5/29/2009
ache, vomiting, swol
d severe vaso response and faintedYat check out window approximately 8 minutes after receiving Y vaccine.6/8/2009
She fell hard
6/8/2009
and hit the floor w
er extremity cellulitis. Swollen, red, warm to touch. Painful to patient at administration site. U 6/1/2009 6/3/2009
ceived Tdap vaccine during school Tdap clinic on 5/13/09. On 5/18/09 PHN received phoneYcall from school 5/13/2009
nurse.5/18/2009
She reports patient's a
o right thigh 5 cm around and warm to the touch and redness. Mom stated child had fever as Y high as 1026/8/2009
F - temp today6/9/2009
98.5.
d Hep B #2 dose on 06/08/09. She Y had a little redness at the site and went to bed. She woke N in the middle 6/8/2009
of the night6/8/2009
with neck pain. The
and diarrhea, dehydration. Vaccine given at another Y facility. do not have
2 lot information. 6/18/09
Y ER records 6/1/2009
received6/6/2009
DOS 6/10/09 to 6/11/
led clinic approximately 2 hours after Y receiving Menactra Vaccine stating client complaining Y of headache 6/8/2009
and shaking. 6/8/2009
Advised to follow up
5/28/2009 N 5/26/2009 5/28/2009
s given an adolescent dose of Hep B in lieu of the adult dose. U 6/10/2009
mother reported patient had fevers and Y headache pain since immunizations on 12/15/2008. Patient Y had high fever### and also ###
seemed to be h
was given shots 05/06/09. On 5/11/09 Y the mother noticed a rash on her face which she bestY describes as 5/6/2009
looking like
5/11/2009
heat rash. On 5/13/
ed papules. Red base withe yelllowish vesicles. Rash noticed 48 hours ago. Mom was usingYcortisone cream. 5/26/2009Per Drs 6/8/2009
order patient was to
GIVEN ON THURSDAY, JUNE 4, 2009. SUNDAY A.M. WHEN I AWAKENED MY BODY WAS Y HURTING 6/4/2009
ALL OVER, 6/7/2009
AND MY SKIN HUR
ERYTHEMA 1"X 2" TO RIGHT DELTOID. Y TX-ICE PACK PRN PAIN AND BENADRYL FOR AGE U PRN ITCH.
5/21/2009 5/22/2009
xis (w/in 30 min, irritability,
Y vomiting,Yhives, wheezing). EPI SQ x1, albuterol/atrovent neb, decadron
Y IM, prednisolone
6/10/2009 6/10/2009x5 days. 6/12/09 Me
received DTaP and Prevnar vaccine in January at age 16 months, parents state child was often Y quiet, less
1/8/2009
active than 1/8/2009
usual, and often sta
given 5/20/09. Vomited starting 5/28. Y Temp to 104.6
Y starting 5/29. Mild
2 rash, cough also. Developed
Y severe
5/20/2009
red rash 5/28/2009
5/29 - eventually spre
nning on bilateral arms. On and off Yx 1 wk. Rash Y down bilateral legs1and cont. on arms x 3-4Ndays. Began 4/21/2009
with rash4/23/2009
to face and neck 6-8-0
ools 24 hours after administration ofYROTOVIRUS - continuous for 6 d N 6/3/2009 6/3/2009
vaccine on 1-23-09. Since that date until present date pt c/o pain in rt deltoid area- no swelling,
U edema or 1/23/2009
temperature 1/23/2009
noted.
Juvenile Rheumatoid Arthritis-> seen at medical center. Tx Prednisone, Methotrexate, LEUCOVORIN. N 1/09 started
### 1/14/2009
having back pain, unila
owing inj - inj site slowly turned red and swollen "looked like a spider bite" x 1wk- Cont. to getY red and turned
4/30/2009
into a calloused
5/7/2009 blister appea
0 minutes after receiving vaccine, childY broke out in rash. It started above his eye lids, and inYthe anticubital 6/9/2009
fossa of both
6/9/2009
arms, then progre
ion, redness and tenderness to left Y shoulder area measuring 5cm by 5cm. Pt treated oral Antibiotics.
U 6/8/2009 6/10/2009
mins after rec'vg all imm. appeared fine; started to stand then fainted x 20-30 secs. Revived w/coolY water 6/10/2009
compress &6/10/2009
light stimulation. Rema
started (L) thigh increased on 24 hr and worsened in 48 hr, gotten better, no trouble. Y 6/8/2009 6/9/2009
5/13/2009
DIARIX but didn't need a dose of DTaP or IPV. Y 5/19/2009 5/19/2009
-"Kiwi size"- approx. 3-4 in diameter. Swelling - 1/4 in -raised, painful Afebrile. U 6/8/2009 6/8/2009
inic 1 week after vaccine 6-9-09. According to dad 1 day after receiving the vaccine her attitude N changed 6/1/2009
she became 6/9/2009
compulsive, says she
next day with increased redness and knot under site. Tx with ice. 6/10/09 Pt was seen in office Y today with6/5/2009
pain left arm,
6/6/2009
firm nodule at injec
n: 11/10/98. Received anthrax vaccine Y #1- denies problems. 11/24/98. Received anthrax vaccine N #2- denies
1/8/1999
problems. 12/11/98. Received
medical conditions diagnosed since starting
Y ANTHRAX
Y vaccine series, including fatigue,
Y reproducible
N arthralgias
1/22/1999 / myalgias, and obstructive
Dermatitis, focal Start: 01/2004 Comment:
Y Tinea capis. Symptom: Lymphadenopathy, axillary N Start: 09/2004 ###Comment: bilat axillary a
ceived FLUMIST and ADACEL vaccines Y on 10/31. She developed severe arm pain and swelling Y in the left shoulder ### and arm a few hours af
ceived Tdap into the left shoulder onY 10/31, the arm developed pain, swelling, heat, and itching at the site since### then.
Fever start: 10/31/2006 - Comment: Undocumented, no temperature taken. Symptom: Chills Start: 10/31/2003### - Comment: Have occurred
n: 37 y/o female developed severe Y right shoulder and arm pain and swelling a few hours after Y receiving ADACEL ###vaccination. Symptom: P
old female received DTaP on 12/12/2006 Y at the clinic. Mother noticed child developed a largeU erythematous and ###indurated area on the left
11/4/2001 N 6/6/2000 11/1/2001
U 4/19/2009
n has been received from a consumer Y concerning her approximately 36 month old son with N no pertinent medical
4/9/2007history or drug reactions o
n has been received from a nurse concerning
Y a 23 year old female who on 29-MAY-2009 was U vaccinated 5/29/2009
with the first
5/29/2009
dose of GARDASIL,
n has been received from a consumer, for the Pregnancy Registry for GARDASIL concerning Y herself, a 2/12/2008
26 year old 2/12/2008
female, who on 12-FEB
n has been received from a physician Y concerningY a 16-year-old female2 patient withY no medicalN history who 5/18/2009
was vaccinated
5/28/2009 with the second
Y 5/4/2009 5/7/2009
DACEL and MENACTRA 05-12-09 pm., Y Wed pm 5-13-09 adolescent woke up with "baseballYsize knot" -5/12/2009 "hard to touch 5/13/2009
and large red whelp
degree and rigor 12 hours after injection - Resolved 12 hours later without treatment. Y 10/3/2008 10/3/2008
ed Urticaria Patient treated with Prednisone
Y Y 5/29/2009 5/29/2009
was given to me months ago in my left arm. It was understood that it was result in some soreness N for a while.
2/23/2009But there is a numbness and
m to touch 2x2 circumference. 6/3/2009 6/5/2009
vaccine breakthrough. Diagnosed with varicella in office today. U ### 6/2/2009
r vaccine. Severe local reaction: swelling, erythema, warmth, itching. Given Loratidine. 6/4/09- patient states 3/10/2009
after seeing
3/13/2009Dr and taking the
on 6/5/09 c/o pain in (L) arm with swelling and pain radiating to upper scapulae area. This occurred U when he awoke. T-102 in am. Seen at c
er arm area of induration and erythema 156 mm X 75mm. Right upper arm circumference 7Y1/8 "and left is 6/1/2009
6 1/2". T-99.9
6/2/2009 area hot to touch
hed side effects which have been checked. Abdomen cramps; ache: joints; aches: whole body; bowels:9/27/2007 irritable, cellulitis; chills, chills feve
ceived PNEUMOVAX 23 vaccine in her left deltoid muscle at her place of employment on 04/09/2007. Y She 4/9/2007
experienced 4/9/2007
swelling and pain in
n the clinic on 5/20. Mom states that on 5/19/09 pt had fever 105 and rash. Today rash is worst but no fever. 5/18/2009
Red bump 5/19/2009
raised pink on abdo
ction with marked erythema, warmth,Y and pain at injection site within 12hrs of administration.USize of affected 5/27/2009
area 12cm
5/28/2009
X 10 cm Treated w
on neck after 1st shot (4-5 days later) thought it was from something else, itching also. After Y2nd shot rash 4/24/2009
widespread 4/28/2009
on trunk, neck, arms
n after injection (s/s) Pt got hot, very moist feeling, felt nauseated, dizzy. After she sat for about
Y 5-10 min 6/9/2009
and had drank 6/9/2009
of H20 she felt bet
swelling from shoulder to elbow - MOTRIN - rest- elevation Y 6/9/2009 6/10/2009
red, swollen, bruised, warm to touch. U 6/4/2009 6/6/2009
ven ADACEL instead of DAPTACEL at age 4 yrs 10 mths. No adverse reaction. All other vaccines given in6/2/2009 another state.
omiting 24 degrees after vaccines. Advised pedia lyte (5m. am'ts) Then gradually elevated toYformula. Same 6/9/2009
symptoms6/10/2009
after 1st series of v
tchy, warm, sore, rash 6" long x 4" wide went to my doctor, prescribed KEFLEX generic cephalexin Y 500 mg 6/5/2009
twice daily6/6/2009
for 7 days.
was reported via medical records that were forwarded by lawyers and described Ythe occurrence U of polyarthralgia
7/27/1999in an adult male subject w
d Tdap vaccine in the ED. The vaccine is to be given to patients between 11-64 years of age.Pt Y reported5/27/2009
to our office6/2/2009
on 6/8/09 that 6 days
sician note: "her right arm shows an inflammation, some redness and mild induration at the Y site of her recent
6/6/2009
injection
6/7/2009
when she got her pn
r to 101F responded to NSAID's, nausea, sattelite lesions, marked inflammation of shoulder Y with bilateral5/24/2009
swelling of 6/3/2009
axillary and cervical ly
eived vaccines MMR, and Hep. B. on Monday 06/08/2009. Called today.Stated on Tues nightYtongue became 6/8/2009
sore and6/9/2009
swollen. Still sore an
erythema, swelling 3-4" in diameter 24 hours after receiving shot. Warm compresses and Benedryl Y advised.
6/9/2009 6/10/2009
ug reaction of head chest back armsY and legs. U 6/9/2009 6/11/2009
ely after vaccine was given, the patient developed pallor and was dizzy. Y 4/6/2009 4/6/2009
HE, DIZZINESS, PROBLEMS WITH SPEECH, NAUSEA, STOMACH ACHE, SLEEPINESS,NNO APPETITE. 5/29/20096/12/095/29/2009
Medical records rece
pular, red in color, blanching, generalized in arrangement U 5/29/2009 6/10/2009
unk and forearms presented after second pill administered. Y
unk and back with some itching. Y 6/9/2009 6/10/2009
e long seizure associated with feverY2 hours after administration of Dtap and Prevnar Y 6/8/2009 6/8/2009
et 6/7/09, duration of 3 days; Eye sensitivity
Y to light: onset 6/8/09, duration 1 day; Runny Nose: Y onset 6/7, 5/28/2009
duration still6/7/2009
ongoing as of 6/11/0
perienced yesterday (6/10/09) on the body from face to upper thigh, fever. Mom gave Tylenol- U steaspoonsful
6/4/2009
and applied
6/10/2009 Calamine lotion.
mm area of induration, warm to touch, erythematous Y 6/9/2009 6/10/2009
nduration, pain, itching, warmth, 14cm x 11.5 cm area surrounding injection site. Local cellulitis Y 6/2/2009 6/9/2009
: Pt. had conjunctivitis in both eyes Yand was tx'd with antibiotic gtts x5 days. 8 May 09: Annual Y physical exam
5/29/2009
was normal.
5/29/2009 Conjunctivitis ha
ose of Hepatitis A given by error too early from first dose.CDC called and verified that this dose Y would not 6/11/2009
be valid and6/11/2009
should be repeated
0 seconds after the first injection myYdaughter became faint and passed out, she then began U having a seizure,
6/11/2009
the entire
6/11/2009
episode lasted app
tly, but want to report now. 3 Influenza vac, with identical reactions each time of visual change Y (marked) 11/1/2004
& headache. 11/1/2004
Recovered all 3 times
Molluscum after previous dose of PROQUAD. Y 7/31/2006 6/9/2009
rom a nap around 5pm on 6/9/09 and Y noticed (L) arm was red, swollen, and warm to touch. Y Gave TYLENOL 6/9/2009
d/t LG fever
6/9/2009
of 99 per mother,
ts with red, raised area on outer Lt thigh + tender to touch, about size of a baseball -SX began this a.m. 6/11/09- 6/10/2009 Area
6/11/2009
is site of KINRIX inj.
ter Tdap, Menactra , Varicella vaccines administered - Vital taken rest, fluids, EKG. Y 6/11/2009 6/11/2009
ash within 6 H of administration of PREVENAR Lt - MMR, VARIVAX, HAV 6/11/2009 6/11/2009
eaction. Injection site, swelling, red Yand hot Fever treated with Motrin and Benadryl. Y 6/8/2009 6/10/2009
2 cm red, cellulitic area were INFANRIX given - x2 days - warm compresses-PO AUGMENTIN, Y 400 POBID 6/8/2009 6/10/2009
Y 8/14/2008 5/5/2009
syndrome, headache + fever treatedYwith Keflex 500mg - PO TID X 10 days. Y 6/9/2009 6/9/2009
with blisters on mouth. Y Y 6/7/2009
of the eyelids, dizziness, feel sick. top center of head tender to touch, hurts. "This feeling" will N not go away!1/9/2009
I called1/10/2009
the Doctors Office the
01) 24 hours after immunizations - red rash on trunk 10 days after immunization U 5/25/2008 6/5/2009
nger rash, erythematous nodules well demarcated. N 5/20/2009 6/3/2009
meter redness no induration or tenderness
Y - no cellulitis - no treatment necessary Y 6/5/2009 6/7/2009
ther of the client reported the following
Y events occurred after vaccination of client for Yellow U Fever and Typhoid
5/27/2009 VI at5/28/2009
clinic on 5/27/09. 5/28
y swollen upper left arm shoulder toYelbow. No fever good movement in shoulder, elbow, and wrist prescribed 6/4/2009
Keflex6/7/2009
for cellulitis.
e out in hives within 24 hrs. Y 6/4/2009 6/4/2009
veloped rash about 1 1/2" in diameter at injection site. White in center. U 6/2/2009 6/4/2009
er vaccine administration, approximately
Y 15-25 minutes child had syncopal episode that wasYprolonged with 6/5/2009
noticeable 6/5/2009
pallor, and fluctuan
ped redness, swelling & induration of R thigh approximately 48 hrs after receiving vaccines. YMinimally tender, 6/3/2009
no fever 6/5/2009
or other systemic sy
MMR, varicella, PREVNAR with Hep A 6/8/09. Began with erythematous rash that night thatYbecame a generalized 6/8/2009 urticarial
6/8/2009RXN the next
d spots located on her scalp, forehead and face Lt is bilaterally. Spots itchy. no blistering -TreatmentY - acyclovir
5/15/2009 X 7 5/28/2009
days
icellaform rash on chest, back, abdomen,
Y buttocks, upper thighs. Treated with diflorasone diacetate
N ointment
5/14/2009
for itching.
5/22/2009
Y 6/1/2009 6/1/2009
inistration of GARDASIL patient got dizzy + started perspiring. Y 6/8/2009 6/8/2009
n has been received from a physician, Y for GARDASIL, a Pregnancy Registry product, concerning Y a 15 year old### female with ###
no medical hist
n has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product,Yconcerning6/26/2008 a 17 year old 8/6/2008
female patient with n
n has been received from a physician concerning Y a 16 year old female 7 patient who is a tampon U user and who on an unknown date was vac
n has been received from a pharmacist Y concerning Y a 69 year old female
0 patient who
Y on 11-MAR-2009
N was
3/11/2009
vaccinated3/15/2009
SQ with 0.65 mL of
d vaccines 6/10/09. Had High fever (TMAX 104.1) (6/11/09), given TYLENOL/MORIN; No vomiting, Y no seizures.
6/10/2009Also 6/11/2009
with runny nose, mild
and warmth at the site of injection the Y size of a golf ball. Entire thigh was swollen. U 6/10/2009 6/11/2009
ection site. Low grade fever; back pain started 6/4 in pm; lethargic; aches; cough; weaknessYin limbs, decreased 6/3/2009PO6/4/2009
all lasted 2 days. No l
on- Red, itchy, warm 2 1/2 U 6/8/2009 6/10/2009
er patient received shots child began Y to run a high fever of 104 - 105 degrees, and developed Y a cough. Stated
6/9/2009 also had
6/9/2009
decrease in appeti
VAQTA and MENACTRA. After MENACTRA (approx 1 min) Pt slumped to side and fainted. Recovered Y immediately
6/12/2009 6/12/2009
c/o dizziness and head
d vaccines approx. at 2:30 pm on 6-11-09 mom states at 8:00 pm that night pt began with redness Y and itching
6/11/2009to palms
6/11/2009
of hands. Hands ha
tvaccinial lymphadenitis beginning post-vaccine
Y day 5, involving left axillary, supraclavicular U
and cervical nodes,
6/1/2009 non-suppurative,
6/5/2009 no system
9 developed headaches that progressed to lethargy, Y slurred speech22and imbalanced gait. HeUwas hospitalized 5/6/20096/2/09
5/23/2009
(and remains hospital
Patients Mother called office and reported
Y that Left arm at site where daughter received vaccine U is red, hot
6/9/2009
and swollen.
6/10/2009 Provider Dr. mad
cine administered pt became flushed,tachycardia,thick
Y tongue.tingleing in lips and throughYout body. Pt 6/10/2009
evaluated6/10/2009
in Occ Health. Remai
ted for a few seconds. I held her in chair until she came to and then we got her on the examYtable and let 6/12/2009
her rest for6/12/2009
about 15 minutes. S
4 hours from the vaccination time patient stated that she had a raised reddened area aroundUthe injection 6/9/2009 site(left deltoid)and
6/10/2009she started ex
d sensation in left arm, left arm weakness, and cold left hand U 6/5/2009 6/6/2009
ately 24 hrs after vaccination. Noted left arm swelling and c/o numbness from shoulder to wrist. U After 48 6/10/2009
hrs remains6/11/2009
swollen but no erythem
periencing itchy palms and Y also had pressure in his ears. Pt was red and flushed. Pt also had Y itching on the
6/8/2009
back of his
6/8/2009
head. Epi was adm
ounding vaccine site was red 2-3 inches Y in diameter in right arm, no induration,no heat present U 6/3/2009 6/3/2009
28 year old male with complaints of hives that started showing up within the first week of getting N home from 5/16/2008
deployment.
5/25/2008
He reports it was
immunizations began having neck pain with radiation down back; right arm discomfort and then N later in week6/4/2009
right knee
6/5/2009
lateral discomfort a
developed a maculopapular rash at the varivax injection site, on 5/25/2009. Y 5/15/2009 5/25/2009
ash and swelling noted in left deltoid. Received 2 vaccines on 06/11/09, noticed soreness inULeft arm 146/11/2009 hours later.6/12/2009
Awakened next morni
d muscle red/swollen and warm to touch 1 and 2 days after administration. Size of tennis ball. Y Improving 6/10/2009
today on day6/11/2009
2.
ECEIVED VACCINE ON 06/09/09 AT MARYMOUNT PRIMARY CARE AROUND 4PM WENT HOME AND6/9/2009 HOUR LATER 6/9/2009
ARM BECAME S
was reported via a statement of injuries received via a lawyer and described the occurrenceUof flu-like symptoms in an adult male subject w
ain at injection site (~ 3" inch diameter), oval shape rash /redness. U 6/10/2009 6/11/2009
n with what looked like bug bites - Mom Y stated they appeared with VARCELLA shot + gettingYworse - Mom 5/27/2009
took child5/29/2009
to hospital - trans. Pt t
with swelling to right arm. Y 6/10/2009 6/10/2009
hematous rxn to both legs, 6 x 6". Y 6/8/2009
rm and tender indurated area at site of VARIVAX- 7x9cm. Y 6/10/2009 6/11/2009
NACTRA injection. Child had brief syncopal episode. Lasted about 30 seconds, then alert, normal Y neurologically.
6/12/2009 6/12/2009
confluent smooth area L deltoid. Local Rx. Y 6/10/2009 6/11/2009
09 after receiving immunizations the child had Y rhythmic movements1of arms and legs followed Y by lethargic5/26/2009
periods where
5/26/2009
baby was unresp
mplains of headache after 1 hour ofYHep A shot, muscle cramps on the left arm, tingling of the U left fingers.
6/12/2009 6/12/2009
tes she has muscle cramps over both Y shoulders, back neck, these symptoms appeared 15 minutes U after6/12/2009
shot, nausea,6/12/2009
sweating. 3 hours a
reaction at site of VARIVAX. Slightly tender. 6x6 cm. Y 6/10/2009 6/11/2009
esented to office with redness, hot to touch, knot at injection site, and treated with VERIPRED Y 20mg. 6/9/2009 6/11/2009
d ZOSTAVAX vaccine on 6/10/09 - RTC on 6/12/09 C/o pain, red, warm to touch at injectionUsite. Advised 6/10/2009
warm compresses.
6/11/2009 Given RX for
elling and redness at injection site. Ice pack applied. BENADRYL given one per day. Y 6/11/2009 6/11/2009
and redness at injection site 1 week Y after administration. Y 6/4/2009 6/11/2009
oid pain with radiating to neck and forearm.
Y Paraesthesia in right arm following Tdap immunization.
N 6/8/2009 6/8/2009
ad to toe rash. Blisters mostly on chest. 6/12/09 Rash almost gone. 0 blisters. Y 6/3/2009 6/7/2009
, in chest, pale, warm, nauseated. Cold packs were applied, she denied any difficulties breathing Y and recovered
6/12/2009 completely
6/12/2009within a few m
f 5/27. arm pain On 5/28. abdominal pain, leg pain; tingling backs of legs & feet. Light headed, Y passed out 5/27/2009
in shower.5/27/2009
Temp 100.8.
at daycare. He took a longer than average
Y afternoon nap and woke up a little warm. He wasYstanding at the 6/3/2009
window6/11/2009
with his caregiver whe
nization on 5/26/09, had episodic spells
Y of rhythmic movements of arms and legs followed by Y lethargic episodes.
5/26/2009Baby 5/26/2009
felt cold to mother d
eloped Abnormal Seborrheic dermatitis after vaccination,
Y also Failure
6 to Thrive. N 6/7/2007 6/8/2007
MR 10 days post vaccine Y 6/2/2009 6/12/2009
days after my 2nd vaccine, my was swollen and extremely red above the injection site. Soon N after, I developed
6/1/2009 a rash6/3/2009
(starting on my back
d vaccine in the hospital. Approximately 1.5 days after administration RN noticed moderate swellingU and6/13/2009
redness of6/14/2009
right upper extremity w
Y 0 N
ort was received 04 June 2009 fromYa consumer, who is also the patient. A 67-year-old female U patient with1/1/2008
a history of1/2/2008
penicillin, seafood an
ort received on 08 June 2009 from another
Y manufacturer whose initial reporter was a health careU professional. A 24 year old female patient
n has been received from a physician Y for the Pregnancy Registry for GARDASIL regarding an Y 18 year old female ###with6/1/2008
depression and a his
n has been received from a physician concerning an approximately 80 years old Y female whoNwas vaccinated 8/2/2007
with a 0.65ml
8/2/2007dose of ZOSTA
n has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning Y an 18 year6/13/2008
old female who on 13-JUN-2008
n has been received from a physician concerning a 29 year old female who on 14-MAY-2009 Y was vaccinated
5/14/2009
with VARIVAX
5/14/2009(Oka/Merck) (
n has been received from a nurse, for the pregnancy registry for GARDASIL, concerning a female Y with no7/1/2007
known allergies
5/24/2008and no pertinent
n has been received from Y a physician
Y concerning Y a 10 month old female
0 with a history
Y of wheezing
Y who was vaccinated 12/1/2006
with 3 doses of RE
n has been received from a consumer Y concerning Y his 15 year old daughter
0 who was vaccinatedU with GARDASIL. After the patient received
arted sneezing approx. 20 minutes after gettingYimmunization. Left eye 1 swelling and pt. c/o itching
Y - rash 6/10/2009
on thigh. BENADRYL
6/10/2009 40 mg given
s (not just in shoulders with shots - though it is worst there), sore lymph nodes (at back of neck),N sore throat, 6/5/2009
aching ears,
6/5/2009
loss of appetite (n
AY, JUNE 4TH, RIGHT SIDE OF FACE Y STARTED Y SWELLING. PARENT 5 TOOK HER INTO Y EMERGENCY 6/4/2009
ROOM. BY 6/4/2009
THE TIME THE M.D
and briefly passed out a few minutes after vaccines administered. Client laid on exam table and Y given juice.6/15/2009 6/15/2009
RECEIVED ALL THE VACCINES LISTED Y IN ITEM NUMBER 13 ON 06/10/2009 SHE STATED N HAD AN 6/10/2009
OUTBREAK 6/11/2009
OF HIVES THE FOLL
ection patient complained of left arm pain rest of day. Next day had headache, chills, body aches, Y and hives
6/12/2009
to arms6/12/2009
and torso. 2 days late
ching under armpits 10/30 red and Y itchy under arms, down side of breasts, on stomach and Y down to the pelvic### area. 10/31### went to stat care
anthrax vaccination, member states she had 5 menstration flows in a 6 week period. This reaction Y has never
8/15/2007 happened
8/22/2007
to her prior to vacc
ped zoster rash within 24hrs of receivingY vaccine. Pt was seen in office 6/15/09 and started on U Famciclovir6/9/2009
and Prednisone.
6/9/2009
on given at 9:20 a.m. Patient showed signs of excessive tiredness at 7:45 p.m. Vomiting occured Y beginning6/12/2009
at 4:00 a.m.
6/12/2009
er receiving DTaP #4 and Hepatitis Y A #1, patient presented to ER with c/o redness and swelling Y at injection 6/9/2009
site. Today
6/13/2009
(6/15/09)mom repo
e given on 5/20/09. Shot site got swollen,
Y hot and erythematous. Was adv to try ice and BenadrylY initially.
5/20/2009
Came into 5/21/2009
offc on 5/22/09 & wa
w fever INJECTION ON 6/10/09 DEVELOPED A 4 INCH RED BLOTCH ( NO FILLED) ON LEFT Y BACK 6/10/2009
OF ARM AND 6/11/2009
FELT MALAISE x 1
d zoster pain 48 hours after administration
Y and classic rash 6 days after vaccine. U 6/8/2009 6/10/2009
extreme swelling to injection site per mom. Witnessed by Dr. at home visit. Y 6/10/2009 6/11/2009
d vaccinations on 6/9/09. He was up most of the night after vaccine with pain in his left thight. U On 6/10/09,6/9/2009
thigh was 6/9/2009
red & still painful. Also
pells started in January 2009. They Yoccurred multiple times per day and continued for over 2Nmonths. She 11/4/2008
also experienced
1/9/2009 nausea, dizzin
ng, redness, irritation at injection site with little blister bubbles at site. Y 6/11/2009 6/12/2009
ike rash developed 3 days after given Zostavax Y 6/10/2009 6/13/2009
en dots around injection site. Hives on upper deltoid to elbow. Pt to take BENADRYL q 6 hours Y prn call if5/18/2009
worse. 15cm 5/19/2009
hive around injection
n site approximately equal to 2 X 2" red swollen, hot to the touch, raised area. The next day injection has 6/12/2009
gotten approximately
6/13/2009 1 " bigger t
ddenly fell to the floor about 1 minute after. Y 6/8/2009 6/8/2009
ateral lower extremity edema. Assoc Y with pain that makes walking difficult. Also assoc with malaise
Y and 4/17/2009
fatigue. Occurred
4/23/2009both times she w
d erythema multiforme w/in 96' of DTaP, Y Hep A, PREVNAR and MOTRIN. Y 6/3/2009 6/7/2009
was reported by a healthcare professional
Y and described the occurrence of labial swelling inYa 16-Year-old 1/22/2009
female subject
1/23/2009who was vaccin
rts she noticed hives on baby's back; Buttocks at 8 PM on 5/27/09 - approximately 4 hours after Y injection5/27/2009
- and a fever5/27/2009
of 99.9 gone by noo
een on 6/9/09 for pap smear - during course of visit she advised provider that she refused any Y further GARDASIL. Stated that apx 3 hours a
in waiting area. Y 6/11/2009 6/11/2009
11/11/08 - 1st sore on outer vaginalYarea/left side. 11/12/08 - fever 101. 11/14-18/08 - more Y sores-outer 11/7/2008
left vaginal area. 11/20/08
### DR. take
s red rash, left side of forehead and surrounding Lt eye, consistent with shingles. N 6/2/2009 6/4/2009
.T. Congestion; 6/2/09 Fever, leg pain; Y 6/6/09 headache,
Y vomiting;126/10/09 - broad-based gait, facial weakness/?
5/13/2009asymmetry.
5/31/2009 7/21/09 Hosp
pain, erythema in (whole upper right) arm of injections. Symptoms started within 24hrs. At 4 U days starting6/11/2009
to improve.
e on 6/5/09 mother noticed left arm was red and swollen from shoulder to elbow. Afebrile. Cold Y compress 6/4/2009
applied. 6/5/2009
erve palsy "Bell's palsy" Y U 6/11/2009 6/12/2009
cines 6/3/09, started with fevers to 104-105 on 6/4/09, seen in clinic 6/5/09 with fever to 104.4, Y no S/S URI, 6/3/2009
UA dip (-).
6/4/2009
F/U call 6/6/09 fever
9-4AM started vomiting/diarrhea, 11:00AM
Y Fever 100.7. By 7:00 PM fever 102.8. ContinuedYto vomit, went 5/28/2009
to emergency
5/29/2009
room. Received I
s in wrist, elbow and shoulder of arm ADACEL was administered, began within a few minutes Y of injection.5/21/2009
Numbness 5/21/2009
was in (R) arm. Full ra
ped body aches, myalgias on 5/29/09. Y The next day, she was much better. Y 5/28/2009 5/29/2009
ling R Deltoid Y 6/4/2009 6/8/2009
d rash on hands, chin 6/12 taken to Medical Center Rx for Prednisone 20 mg Qd II tabs 6/15Yspoke with 6/11/2009 mother, patient6/12/2009
is doing well today.
n waiting room. Fell and hit her head on chair in waiting room ~ 5 min after receiving vaccines. Y Possibly 6/15/2009
hit head on6/15/2009
seat cushion or possibl
th large area of erythema, warm to touch Y 6/10/2009 6/11/2009
deltoid ~ 3 cm oval shaped area erythema, edema + warmth + induration 0 fluctuation + tender U to palpation.6/10/2009
given Bactrim
6/11/2009DS #14, T by mo
vaccine adm. on 6/10/09. Mother noted "small red bump" at site yesterday. Larger red round Nspot today. 6/10/2009 (Left triceps6/11/2009
area) (6cm diameter) S
ceived her vaccine on 4/20/09 am and began screaming at 4/23/09. She was seen in the ERYafter 2018 on 4/25/09, when abdominal x ray,
e headache and swelling RT arm - Aspirin Y TYLENOL. Ice pack initially. (2) Repetition of above U q 2 weeks2/27/2009
with shooting2/28/2009
pains RT side body
he had swelling and pain at injection site. Y 6/4/2009
9 Pt saw Doctor reports received TdYBooster at Hospital on 5/19/09. Left arm erythema induration Y 2 degrees.
5/19/2009DX: Local
5/21/2009
allergic reaction to
within 4 hours, cellulitis picture 48 Y
hours later. U 6/9/2009 6/10/2009
d MENACTRA) Tdap 8/407. Head ache /st over time developed fatigue (sleep up to whole day) N and headache 9/19/2007 (1st 10/8/2007
concerning Reaction). (
A on 10/29/08 HA started that he did not have at time of apt & vaccine. Seen 10/31/08 for abd N pain & HA. ### ###
red 5/22/09; on Sunday, 5/24/09 Pt developed papular rash on upper back and chest, with itching. Y Both 5/22/2009
itch and rash 5/24/2009
diminished over next
n has been received from a physician concerning a patient who on unspecified date was vaccinated U with a dose of GARDASIL (LOT# not r
n has been received from a physician Y concerning Y a 19 year old female0 with sulfonamide allergy,
Y allergy to2/2/2007
PEDIAZOLE 2/2/2007
and AUGMENTIN,
n has been received from a nurse concerning
Y aYfemale with no allergies
0 who on 20-JUL-2007 Y and on 24-SEP-2007
1/25/2008 1/25/2008
was vaccinated IM 0.5
n has been received from a nurse practitioner concerning 3 children who was vaccinated with U GARDASIL. The nurse practitioner reported
n has been received from a physician
Y concerning a teenage female who within the last two years
Y (approximately 2007) was vaccinated IM
n has been received for the Merck pregnancy
Y registry, from a nurse concerning a female patient,
Y who was 9/28/2006
vaccinated with### two doses of GA
n has been received from a registered nurse, for the pregnancy registry for GARDASIL concerning
Y a 21 1/16/2008
year old female
1/16/2008
with a history of la
n has been received from a physician for the Pregnancy Registry for GARDASIL, concerningY a 17 year old female ### with
2/12/2008
no known allergies
n has been received from a Nurse Practitioner, for the Pregnancy Registry for GARDASIL, concerning
Y a 19
5/9/2008
year old 5/9/2008
female with thrombocy
n has been received through the Merck
Y pregnancy registry from a registered nurse concerning Y a 21 year 4/3/2008
old female with
6/5/2008
no pertinent medic
n has been received from a physician concerning four female patient's who were vaccinatedYwith dose of GARDASIL. Subsequently the pa
n has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning U a 21 year 2/20/2009
old white female with no significant
n has been received from a registered
Y nurse concerning an 11 year old female who on 11-MAR-2009
U was
3/11/2009
vaccinated 3/11/2009
with GARDASIL (lot
n has been received from a registered nurse concerning a 11 year old female who on 24-MAR-2009
U was3/23/2009
vaccinated3/23/2009
with the first dose of G
n has been received from a registered nurse for the pregnancy registry for GARDASIL concerning
Y a 16 year
5/19/2008
old female,
5/19/2008
who on 26-FEB-20
n has been received from a registered
Y nurse, for the GARDASIL a Pregnancy Registry product U concerning 3/20/2009
a 14 year 3/20/2009
old female patient wh
Client received MMR and Varicella vaccines.
Y Mom was instructed to observe carefully for fever
Y 5-12 days5/28/2009
after vaccine 6/3/2009
administration and to
Y
n has been received from a medicalYassistant concerning a female who was vaccinate with on U unspecified3/3/2008
dates (doses and LOT# were no
n has been received from a caller concerning her daughter a 17 year old who became very ill U after receiving5/1/2008
injection5/1/2008
the first dose of GAR
n has been received from a 20 year old female patient with parakeratotic cells evidenced in N
previous PAP 4/28/2009
test, who4/29/2009
on 20-APR-2009 was v
n has been received from a consumer concerning herself with no previous pregnancies and Nno reported past 5/1/2009
drug history
5/1/2009
who on 01-MAY-
n has been received from a physician concerning a 17 year old female with no pertinent medical
Y history 4/15/2009
reported and 4/16/2009
no known drug allerg
n has been received from a nurse practitioner
Y concerning a 15 year old female who on 27-Feb-2009
Y was2/27/2009
vaccinated2/27/2009
intramuscularly. 0.5ml
n has been received from a nurse practitioner concerning a 16 year old female patient with aNhistory of epstein-barr
5/1/2009 virus5/2/2009
infection and lymp
n has been received from a physician concerning a teenager female who was vaccinated with N the first dose of GARDASIL in April 2007 and
n has been received from a physician
Y concerning a 15 year old female with PENICILLIN allergyN and no pertinent
11/5/2008medical1/1/2009
history who was v
n has been received from a registered
Y nurse (RN) concerning a 17 year old female who on 24-JUL-2008
U 7/24/2008
was vaccinated
12/9/2008
with the first dose
n has been received from a mother concerning a her daughter who on 3-JUN-2008 was vaccinatedU with her
6/3/2008
first dose of GARDASIL (dose
n has been received from a physician concerning a female patient who on 04-MAY-2009 was Y vaccinated 5/4/2009
with the first5/4/2009
dose of GARDASIL (
n has been received from a physician
Y concerning a female patient who was vaccinated with YGARDASIL and experienced syncope, the pati
n has been received from a consumer concerning her 12 year old daughter who on an unspecified
U date was vaccinated with her first dose
n has been received from a doctor of
Y osteopathic medicine (D.O.) concerning a female who Yon an unspecified date was vaccinated with the
n has been received from a registered nurse concerning a 21 year old female with no pertinent
U medical history5/1/2009or drug
5/1/2009
reactions/allergies w
n has been received from a medicalYassistant and the patient's mother, for GARDASIL, a Pregnancy
N Registry
4/21/2009product,
4/21/2009
concerning an 17 ye
n has been received from a licensedY practical nurse, for the Pregnancy Registry for GARDASIL
Y (Lot # 659184/0843X),
8/21/2008 8/21/2008 concerning a 25 yea
n has been received from a 25 year old female certified medical assistant concerning herselfYthat she was vaccinated IM with the third 0.5 m
n has been received from a Certified
Y Medical Assistant concerning a 14 year old female withNno pertinent 4/7/2009
medical history
4/24/2009
who on 07-APR-2
n has been received from a healthcare worker concerning her 18 year old daughter who wasUvaccinated11/9/2007with the third11/9/2007
dose of GARDASIL a
n has been received from a 23 year old female who on 04-MAR-2009 was vaccinated with with N second dose 3/4/2009
of GARDASIL.
5/4/2009The patient ha
n has been received from a consumerY concerning her daughter a 23 year old female with a history
N of eczema and Dairy allergies (cause of
n has been received from a physician
Y concerning a 15 year old female who on 06-MAY-2009 Y was intramuscular
5/6/2009 vaccinated
5/6/2009 with her 05ml d
n has been received from a pharmacist who heard from a nurse (mother of the patient) concerning
U the female patient who on unspecified d
n has been received from a 23 yearYold female with no medical history or drug allergy who onN 01-May-2009 5/1/2009
was vaccinated
5/1/2009with the first do
follow up information has been received from a registered nurse concerning a 27 year old female
Y with penicillin
3/9/2009 allergy
3/9/2009
and no pertinent me
n has been received from a physician
Y concerning a female patient about 20 years old who on N an unspecified date was vaccinated with a do
n has been received from a nurse practitioner
Y concerning a female who in October 2007, was N vaccinated 10/1/2008
with the first
10/1/2008
dose of GARDASIL.
n has been received from a nurse manager
Y concerning a 25 year old female who on 08-MAR-2009
Y was vaccinated
3/8/2009 with 3/8/2009
GARDASIL. There
n has been received from a physician
Y concerning a 14 year old female who on an unspecified U date was intramuscular vaccinated with GAR
n has been received from a licensed practical nurse concerning her 16 year old daughter withY DURICET allergy8/3/2007 and no pertinent medical h
n has been received from a female who in 2006 was vaccinated orally with GARDASIL and U just recently had been diagnosed with human p
n has been received from a consumerY concerning her 16 year old daughter with lactose intolerance
N and4/22/2009
not other drug 5/9/2009
reactions or allergie
n has been received from a physician,
Y a consumer and a secretary concerning a 15 year oldNfemale patient 5/8/2009
with no history
5/8/2009 of allergies who
n has been received from a medical assistant concerning a 21 year old female with no allergies
Y or medical 4/23/2009
history who4/25/2009
was vaccinated intra
n has been received form a physicianY concerning his 33 year old daughter who had been vaccinated
Y with GARDASIL series. During one of
n has been received from a physicianY concerning a 17 year old female patient who on 27-Feb-2009
Y was2/27/2009
vaccinated with 3/1/2009
the first dose of G
n has been received from a physician concerning a patient who was vaccinated with GARDASIL. U Subsequently the patient experienced co
n has been received from a physician concerning a 21 years old female with no pertinent medical
Y history 5/6/2009
who was vaccinated
5/6/2009 with GARDA
n has been received from a registered
Y nurse in a physician's office and a registered nurse inUa county health2/5/2009
department,
2/5/2009for the Pregnancy
n has been received from a medicalYassistant concerning a 26 year old female who on 08-MAY-2009
Y was5/8/2009
vaccinated5/8/2009
with her first dose of
n has been received from a physician's assistant who reports an office had several patients Ufaint after receiving GARDASIL. It was unknow
n has been received from a medicalYassistant, for GARDASIL, a Pregnancy Registry Product, Y concerning5/4/2009
a 17 year old 5/9/2009
female who was va
n has been received from a nurse concerning a 24 year old female who on 11-MAY-2009 was U vaccinated 5/11/2009
with a 0.5 mL first dose of GARD
n has been received from a certified medical assistant concerning a 14 year old female with Yno pertinent5/14/2009
medical history
5/14/2009who on 14-May-20
n has been received from a nurse practitioner
Y concerning a female patient who in 2008 startedN the series of GARDASIL. Concomitant thera
n has been received from a receptionist
Y concerning her daughter who on an unknown date was U vaccinated with a dose of GARDASIL (lot n
n has been received from a certifiedYmedical assistant concerning a 25 year old female patient
N who on 17-APR-2009
4/17/2009 4/17/2009
received the first dose
n has been received from a nurse concerning
Y a female who on an unknown date, was vaccinatedY IM with the first dose of GARDASIL 0.5m
n has been received from a physicianY concerning a 15 year old female with a history of headaches
Y who on unspecified dates were vaccina
n has been received from a physician and a registered nurse concerning an 18 year old female Y who on 18-Mar-2009
3/18/2009 3/18/2009
was vaccinated with t
n has been received from a nurse practitioner concerning a 25 year old female who on 20-OCT-2008
U was
4/16/2009
vaccinated4/16/2009
with the first dose of
n has been received from a licensed practical nurse concerning her 25 year old female friend N who on 18-MAY-2009
5/18/2009 5/19/2009
was vaccinated with he
n has been received from a nurse practitioner
Y concerning a 16 year old female who was vaccinated
U with10/2/2007
the first dose
11/1/2007
of GARDASIL on 02
n has been received from a physicianY Assistant and a Licensed Practical Nurse concerning N a 16 and half 1/9/2009
years old 1/14/2009
female with familial risk
n has been received from a physicianY concerning a female who was born on 09-Jun-1988 was U vaccinated8/7/2007
the first dose of GARDASIL (Me
n has been received from a Nurse Practitioner concerning a 17-year-old female patient who Yon 07-AUG-2007 7/24/2008
was vaccinated
7/24/2008 with the first
n has been received from a physicianY concerning an 11 year old female with no illness at time
Y of vaccination4/8/2009
or pre-existing,
4/8/2009birth defects o
n has been received from a licensed practical nurse concerning a female who was vaccinated U with a dose of GARDASIL. Subsequently, th
n has been received from a physicianY concerning a 20 years old female who was vaccinatedUwith GARDASIL 4/8/2008
three times:
5/8/2009 1st dose given o
n has been received from representative reported experience as reported by a nurse concerningY a female5/18/2009
patient who
5/18/2009
on 18-MAY-2009 wa
n has been received from a nurse concerning
Y a female who was vaccinated with a first doseUof GARDASIL. Subsequently the patient expe
n has been received from an office manager concerning a 15 year old female who on 11-NOV-2008U was vaccinated 5/1/2009
with the first dose of G
n has been received from a Registered Nurse (R.N) concerning a female patient who on an U unspecified date was vaccinated with a dose o
n has been received from a medical assistant concerning a 23 year old female with not reported
Y drug reactions/allergies
3/10/2009 3/11/2009 and medical histor
n has been received from a physicianY concerning a teenage female who within the last two years
Y (approximately 2007) was vaccinated IM
n has been received from a certifiedYmedical assistant concerning a 12 year old female patient
U with cystic 5/13/2009
fibrosis, no
5/20/2009
drug reactions/allergi
n has been received from a 34 year old patient registered nurse with allergies to IMITREX, COMPAZINE,
U 5/21/2009
MACROBID, 5/21/2009
for the Pregnancy R
n has been received from a physician concerning a teenage female who within the last year Uwas vaccinated 1/1/2008
with a dose of GARDASIL vac
n has been received from a consumer Y for the pregnancy registry for GARDASIL concerning U his 17 year 4/21/2009
old girlfriend4/21/2009
with anemia, irregular
n has been received from a physicianY concerning a 16 year old female patient who "a coupleUof months ago" was vaccinated with the first a
n has been received from a physician concerning a 25 year old female with a history of miscarriage
N before
5/12/2009
the vaccination
5/19/2009 who on 12-MAY
n has been received from a physicianY concerning an 11 year old female who on 19-MAY-2009 Y was vaccinated
5/19/2009 with5/19/2009
the second dose of GA
n has been received from a mother concerning her daughter who on 31-MAR-2008 was vaccinated N with3/31/2008
first dose of3/31/2008
GARDASIL (Lot # 659
n has been received from a nurse practitioner for GARDASIL, a Pregnancy Registry product,Y concerning a 23 year old 3/3/2008
female with allergies
n has been received from a physician concerning a 15 year old female student with no medical U history and 2/25/2009
no known 2/25/2009
drug allergy who on 2
n has been received from a Certified Medical Assistant (C.M.A.) concerning a 24 year old female
N patient who
5/1/2009
on 13-MAR-2009
5/27/2009 was vaccin
n has been received from a consumer concerning his 16 year old daughter with "brachial plexus"
N of her 10/1/2008
right arm which
10/1/2008
was diagnosed a fe
n has been received from a Registered
Y Nurse concerning a 25 year old female patient with no Y pertinent 5/15/2009
medical history
5/16/2009
and no drug reactio
n has been received from a physician concerning a "14 year" old female patient who was hospitalized
Y couple days for "Helicobacter pylori"
n has been received from an emergency
Y medical technician concerning a 15 year old femaleNpatient with5/21/2009
no drug reactions
5/21/2009 or allergies who
n has been received from a physician concerning a female who was vaccinated with a dose Uof GARDASIL. One or two months after the GA
n has been received from a physician concerning a female patient who on an unspecified date N was vaccinated with5/22/2009the first dose of GARDA
n has been received from a nurse concerning
Y a 23 year old female patient who on 20-MAY-2009N was vaccinated
5/20/2009with 5/26/2009
a second dose of GA
n has been received from a consumer,Y for the Pregnancy Registry for GARDASIL, concerning Y her 15 year old ### daughter with ###seasonal aller
n has been received from a registered
Y nurse (R.N.) concerning a female who on 27-MAY-2009 U was vaccinated with a dose of GARDASIL (
n has been received from another physician
Y (not the patient's physician) concerning a female
U who was vaccinated with a dose of GARDAS
n has been received from a physician concerning four female patients who were vaccinated Ywith doses of GARDASIL vaccine. Subsequen
n has been received from a physician concerning four female patients who were vaccinated Ywith doses of GARDASIL. Subsequently the pa
n has been received from a physician concerning four female patients who were vaccinated Ywith doses of GARDASIL. Subsequently the pa
n has been received from a nurse through a representative concerning a female patient whoYwas vaccinated with the first dose of GARDAS
n has been received from a medical assistant concerning a female patient who was vaccinated Y with the first dose of GARDASIL and had fa
n has been received from a nurse practitioner concerning a 11 year old female who on 19-MAY-2009 U was
5/19/2009
vaccinated 5/28/2009
with her first dose of
n has been received from a physician concerning a patient who on an unspecified date was U vaccinated with a dose of GARDASIL (LOT# n
n has been received from a Nurse Practitioner
Y concerning a female about 14 years old who Y was vaccinated5/29/2008
with the5/29/2008
first 0.5 mL dose of GA
n has been received from a physician Y concerning an approximately 25 year old female who U on "20-MAY-2009"
5/20/2009was vaccinated, 0.5 ml, with
n has been received from a medical assistant concerning a female patient who was vaccinated Y with the first dose of GARDASIL and had fa
n has been received from a medical assistant concerning a female patient who was vaccinated Y with the first dose of GARDASIL and fainted
A ROUTINE PHYSICAL, I WAS GIVEN Y A TETANUS Y AND GARDASIL 2 VACCINE SHOT. APPROXIMATELY
Y 6/10/2009
FIFTEEN 6/11/2009
AND A HALF HOUR
n has been received from Y a medicalYassistant concerning
Y a 9 weeks2old female patient with Y
no pertinent5/28/2009
medical history
6/3/2009
and not known alle
n has been received from a physician Y concerning Y a 7 months old female
0 with unknown drugYallergies and 4/16/2009
unknown 5/26/2009
medical history who on
n has been received from a hospice nurse concerning a 16 years old female withYunknown drug N allergies and unknown medical history who
n has been received from a health professional for the pregnancy registry for GARDASIL concerning Y a female
10/7/2007with a history of atrial septal
d Alopecia Areata Universalis beginning three days after receiving third GARDASIL booster, Tetanus with 10/1/2008
Pertussis injection, and Flu vacci
the vaccine and a month later was diagnosed with Grovers disease which is a rash Y on the back and chest. 12/1/2007
Seems to me it### very coincidenta
en 6/8/09 for 5 year WCC and received MMR, VZV, PV, DTaP, Hib and Hep A. He woke up this a.m. c/o itchy 6/8/2009
red rash
6/9/2009
on (L) upper thigh w
ce visit: Red, warm area on left thigh, painful (to touch), Y 6/1/2009 6/3/2009
dedness, dizziness since vaccine series completed one year ago. Fainted 6/4/09. U 4/1/2008 4/1/2008
Y 5/8/2009 5/8/2009
numbness of the Rt fingers & right Y arm & nose 2 weeks seen by 5.26.09. No symptoms after Y 6-12-09 4/24/2009 5/12/2009
ely after receiving vaccine, right armYbecame very sore. Redness developed at 11:00 PM. Warm Y to touch.
6/10/2009
Area is 6/10/2009
very swollen.
ain at the injection, Limited movement. Fever, chills, body aches for 2 days. Y
nderness and swelling at site. Lasted for 2 weeks. Required medication for several days - ADVIL Y 5/20/2009
me in for office visit - Urticaria on Rt thigh, warm to touch, non-tender. Y 6/1/2009 6/3/2009
fice visit- firm, red, tender, warm area on (L) thigh. Y 6/8/2009 6/9/2009
action rash, swollen area around injection site. Itchy hand etc. Rash is 40mm in length. 6/10/2009 6/10/2009
TIVE ERYTHRODERMA - required Y hospitalization
Y due to dehydration. 1 Treated with steroids U
for over 2 wks.
5/11/2009
6/17/095/13/2009
Medical record receive
cribed area on (R) leg is approximately 1 inch from injection site. 3 inches wide and 2 inches U tall and red and6/4/2009
hot to touch. Per mom spoke w
iven on 6/5/09. On 6/7/09 area on left leg - raised, warm, measuring at 6 x 8 cm. Y 6/5/2009 6/7/2009
s a quarter-sized red area at the injection site that is warm to touch. There is also significantYbruising in a 6/5/2009
3-4 inch area6/6/2009
surrounding the red
PCV-7 in (R) thigh and PENTACEL (DTaP-IPV-Hib) in (L) thigh on June 5 in PM. Increased Y sleepiness rest 6/5/2009
of June 5,6/6/2009
2009. On 6-6-09 not
a 6cm x 3cm erythematous rash on her (R) upper anterior thigh Laterally & anteriorly is the injection
U site. 6/2/2009 6/4/2009
woke during night with chills, painful skin irritation. Full body aches, light-headedness, exhaustion,
N lack of focus,
6/6/2009
periods
6/7/2009
of mild confusion, re
7cm x 5 1/2 cm warm to touch. 6/3/2009 6/8/2009
g, redness, pain 4/23/2009 5/1/2009
hr. - hives and swelling throat, took BENADRYL - 50 mg, then another 25 mg 6 hrs. later. Ok Y next day. 4/21/2009 4/21/2009
d and swollen 35 mm X 35 mm Y 6/4/2009 6/5/2009
ived PENTACEL, PREVENAR, GENHEVAC B, and ROTATEQ on 5/4/09. On 5/5/09 child dev'd Y factile fever 5/4/2009
and red5/5/2009
maculopapular rash o
oid, red, warm to touch. Swollen, raised,
Y 6cm x 3cm. Y 6/9/2009 6/10/2009
adache "head pounding" chest tightness and some shortness of breath (although speaking Y normally) and6/8/2009
"feeling cold"
6/8/2009
- visibly shivering. v
d Immunisation and then in about 2Yhrs developed so many hives on face, neck, arm, abdomen- Y had swollen
6/2/2009
upper lip.
6/2/2009
Was seen at emerg
ven MENACTRA - Vaccine given 5/28/09 Y redness 5/29 then seen 5/31 in ER Hosp. for right armY swelling5/28/2009
shoulder to5/29/2009
hand - Numb/tingling h
ed shingles like rash in left T8-9 dermatoma,
Y 2 days after receiving the vaccine. 6/11/2009 6/13/2009
days post vaccination seen in office Y for rash. ATARAX Rx. U 6/3/2009 6/13/2009
vd MMR SubQ @ Health Dept. 6-11-09 Y Pt. returned to HD. Exhibits approx 10 mm by 15 mm Y reddened6/2/2009
& inflamed6/5/2009
area upper outer aspe
lls, headache, sore throat achy arms and legs. Y 6/1/2009 6/1/2009
Y 7/1/2008 7/2/2008
irritability with green/mucus colored stool with presence of blood, which was Hemacult + andY in office, pt 6/4/2009
improving. 6/6/2009
at 2 AM on 6/9/09 with temp of 101.4 & feeling dizzy. As of 8 am was feeling better, temp gone. Y 6/8/2009 6/9/2009
urred 5 to 7 days after shingles vaccine on sides of neck and other places shingles would appear.
N Was 3/13/2009
taking NITROFURANTOIN
3/18/2009 MACRO
vaccines 4/21/09. That night he had chills and temp of 100 degrees. Stayed home from school Y on 4/22 AM.4/21/2009
Had been4/22/2009
treated with MOTRIN
6/8/2009
m red area with 3x4 cm raised x 6cm area. No drainage - warm to touch. Doctor advised Benadryl cream to 6/2/2009
area with6/3/2009
ice packs. If no better
itching, erythema, and swelling aboutY 2 days after injection. Improved with BENADRYL administration,
Y no
6/9/2009
pain/tenderness.
6/11/2009
ss, swelling, erythema. No treatment necessary. Y 6/11/2009 6/11/2009
m neck back, chills fever sweating. Dizzy,
Y nausea, fatigue, muscle weakness. U 5/27/2009 5/29/2009
6/10/2009
/9/09, on 6/11/09 MOC called, stated pt. had red area back of rt. arm, size 1"x2", hurts a little,
U not itchy 6/9/2009 6/11/2009
6/9/2009
se reactions previously
d fever and a seizure afterwards. WasY taken to the ER at medical center. Y 6/4/2009 6/5/2009
n and stated that 2 months after ZOSTAVAX, she was dx with shingles. Pt had never had shingles Y disease
3/24/2009
before. 6/1/2009
dema, tenderness, fatigue onset 15 hours after injection. Felt arm pain with movement 15 hours after injection.
6/8/2009
Unable6/9/2009
to move arm withou
ough. Chicken pox 6-8-09 Lesions- neck- face. hands + arms. Y 5/28/2009
ng at menactra injection site within Yhours of administration. later same evening pt c/o heat swelling
Y redness
6/12/2009
at site pt
6/12/2009
taken to care now dx
was given Typhoid at 0915 on 06/06/2009.Y He had onset of localized pain and discomfort at site.
Y Approximately 6/6/20091 hour6/6/2009
later his pain spread
pneumococcal vaccine trial, with severe COPD, Y was hospitalized on 5 10/28/2008 with Pneumonia.
Y Vaccination
9/22/2008took place ###on 9/22/2008. Ac
pneumococcal vaccine trial, with severe COPD, Y was hospitalized on 4 12/21/2008 with atrial fibrillation.
Y Vaccination
9/22/2008 took place ### on 9/22/2008
pneumococcal vaccine trial, with severe COPD, Y was hospitalized on 2 3/26/2009 with vertigo Yand small bowel
6/13/2007
obstruction.
3/26/2009
Vaccination took
th and 13th day after receiving the MMR, Client experienced fever (She didn't take her temperature),chils,
Y 5/11/2009
sore throat5/23/2009
and tiredness. These
h after injection the patient woke upYwith loss of function in her left arm. Went to ER and for therapy.
Y She 6/5/2008
was told it was
7/4/2008
nerve damage, un
Was hospitalized with meningococcal meningitis Y and bacteremia. 6/24/09
3 Hospital ER records
Y received DOS### 3/29/09.
3/28/2009
Assessment: Menin
p given, employee experienced nausea, vomiting, dizziness, palpitations, pain @site. No swelling. Y 5/14/2009 5/14/2009
d smallpox vaccination on June 6, 2009,Y a Saturday. On the following Tuesday, his right armUstarted to hurt 6/6/2009
and gradually
6/9/2009
worsened. On Fr
10 p.m. - phone call from cl reporting he woke up at 3 a.m. this morning with severe muscle and joint pain6/2/2009 in shoulders,6/3/2009
elbows and hips. E
N 6/4/2009 6/5/2009
ollowing 1st gardasil injection patient reports muscle weakness or pain, non-progressing. Also N c/o fatigue. 3/25/2009
Medical records
4/27/2009 received DOS 5
len, Painful, warm to touch. Symptoms started one hr after administration and continued for Y 7 days. 6/10/2009 6/10/2009
as given Hepatitis A vaccine instead of Hepatitis B vaccine Y 6/16/2009 6/16/2009
am: Two days after vaccination, patient reported that site of injection was red, swollen and warm Y to the touch.6/10/2009
Pt reported
6/12/2009
that size of area o
l asleep on the car ride home (very unusual at that time of day). He then became feverish and Y fell asleep6/10/2009
for the night
6/10/2009
at 7:00--two hours af
ot his vaccinations on Thursday
Y morning.
Y Then Y
on Saturday night he2was sleeping, started vomiting,
U when
5/21/2009
I went to 5/23/2009
clean him up he was sta
reddened, swollen and painful some Y itchy. Mother stated notice swelling last evening 6/16/09Y at about 8.00pm.
6/15/2009 Mother
6/15/2009
did not massage ar
ccines on 6-5-09, and on 6-14-09 child began to have a rash that looked like clots on back, Y no drainage or 6/5/2009
raised areas.
6/14/2009
It is now everywhe
es child has been seizure free sinceY8/08. Has had 10 seizures since start of rabies vaccine Y series - Has5/28/2009
2 doses left.6/1/2009
1st dose given here o
en around 11am 6-12-09. Mom called Y around 2pm- patient crying, unable to console. Eft egYinjection site 6/12/2009
swollen, red.
6/12/2009
Advised to apply he
a to injection site- Rt. leg (upper) started 9 days after vaccines. U 6/5/2009 6/13/2009
n has been received from a 63 year old female patient who was on 17-DEC-2008 vaccinatedNwith the first 2/18/2009
dose of GARDASIL 0.5 ML on bu
n has been received from a 36 yearYold female patient who in 2006 was vaccinated with the Nthree doses4/25/2007 of GARDASIL. The patient was no
n has been received from a nurse concerning her daughter a 14 year old female with amoxicillin Y allergy and 3/6/2008
no other3/6/2008
medical history who in
G AND REDNESS ON RIGHT THIGH,LATERAL ASPECT MEASURING 55cm X 70cm. Y 6/10/2009 6/11/2009
Y Y N
er had a seizure with vomiting. Date immunization Y given rash on back 1 and abdomen. No prior Y fever. 8/26/09 6/8/2009
Hospital
6/10/2009
records received DO
5/29/2009 N 5/27/2009 5/29/2009
### N ### ###
mbness, tingling, burningYof feet, progressing
Y toYcalves and near knees.8 8 days hospitalization.
Y N Immunoglobulin
10/1/2008 - 5 days.
12/6/2008 7/13/09 Hospital
ep shot on 4-22-09. it was put in my right arm. still today it still hurts and has pain in it. neverUhad a problem 4/22/2009
until i got
4/23/2009
the shot.
ng gardasil shots my daughter has complained of frequent headaches, hair loss, and joint pain.
ous chills and pain in the left arm with Y swelling and muscle aches. Low grade fever. Large 4x6" U round, raised,6/8/2009
indurated,
6/11/2009
red warm area aro
as sore for the remainder of the day after receiving his 2 shots on 6/12/09. He refused to allow Y me to look, 6/12/2009
and thinking6/13/2009
he was only sore (a
urs after immunizations patient developedY severe headache. At bedtime patient's mouth wasYdistorted to right 6/4/2009
and was 6/4/2009
numb and tingling.
as administered vaccine. Patient then began to have a vasovagal syncope reaction. Patient was Y immediately 6/16/2009
given oxygen.
6/16/2009 Patient was lay
after vaccine was given, onset of temperature
Y to 102 axillary and diarrhea. Illness resolved inY3 days total. ### ###
breath, extreme shortnessY of breath.Has
Y never experienced this before. Rash on upper torso. U Patient crawled
3/26/2009 to front
3/28/2009
door and opened do
ceived approx 8 hrslater edema andYitching at site. Returned to clinic approx 18 hrs later withY 3.5 x 3.5 cm 6/16/2009
warm, red, 6/16/2009
indurated itchy rather
4) reduced with acetaminophen, but resumed, red/warm/pain at injection site, arm is swollenYand slightly6/12/2009 hard/firm to6/12/2009
the touch.
Left brachial neuritis after HPV/Gardasil vaccinations..History of Illness: 1/20/2009 Y - Presented
N for initial 8/28/2008
evaluation by 8/31/2008
hand surgeon. By his
GIVEN VACCINES BECAME DIZZY AFTERWARD FEET ELEVATED AND GIVEN COOKIE.YDIZZINESS6/17/2009 ABATED AFTER 6/17/2009 FIVE MINUTES
veloped bacteremia without focus and tested positive Y for Neisseria meningitidis
2 from her blood.
Y 6/24/092/13/2008
Hospital records
3/25/2009received DOS 3/2
my Zostavax DS PWD #1 ON jANUARY 12, 2009. I feel fine 95% of the time. The other 5% U my shingles 1/12/2009
are on fire.2/1/2009
Kind of like a hot pok
r, greater than 103F, axillary. Gave Tylenol
Y and Advil with temp remaining elevated next dayUwhen grandparent 6/15/2009 placed
6/15/2009
call to vaccine admin
d to wait immediately after vacine. Felt Y ok for a minute or so, got onto the elevator started toYfeel dizzy and 6/17/2009
blacked 6/17/2009
out and face planted in
n: Had febrile illness within 24 hours for both vaccines. 1st episode required hospitalization.NDeveloped chronic ### headaches after 2000 dos
n: diffuse puritic rash 2 days post anthrax, HBV, and meningococcal vaccines. Comment: Initial VAERS 5/25/2003
completed Oct 03. Symptom: Le
n: Diffuse maculopapular rash of both Y UE/LE and trunk within 48 hours of anthrax #2 and yellow fever vaccines. 3/11/1999Symptom: Joint Pain, mu
mpetent w/ past - MMR rash. Decreased Y WBC count 1.7, ANC700. Resolved within 1wk. Y 5/29/2009 5/31/2009
received spv, yellow fever, typhoid, and flu vaccines.
Y On that day 29 after
Y the vaccinations, gradually started to feel###"exhausted ### and weak" - h
n on 06-11-09. Began having an elevated temperature on 06-12-09. Also c/o headache, stomach Y ache,6/11/2009
+ diarrhea.6/12/2009
Highest temperature w
redness and swelling from injection site to approx. 1 inch of elbow. Client not c/o pain or discomfort.
Y 6/15/2009 6/16/2009
and red reaction with induration approx. 10 cm in size less than 30 minutes following vaccination. Y These reactions
6/16/2009noted 6/16/2009
at VARIVAX vaccin
a phone call from patient 6-9-09 stating c/o fever, headaches, generalized body aches and nausea hours after receiving Tdap on 6-8-09.
d rash on face and upper body. Over in 3 days. Terribly itchy, hives, swelling right side eye-chin-collar
Y bone.
6/10/2009
lethargic.
6/11/2009
Took benadryl on
9 grandmother presented to Health YUnit and reported that health care professional went to pediatrician
Y today
6/9/2009
& was6/10/2009
sent to E.R. for "high f
Y Y 6/15/2009 6/15/2009
accine #1, #2, #3- no problems. 10/06/03- received Y anthrax #4- along 10 with Hep A #2 and Hep U B #2- few 10/6/2003
weeks later ("by the ###end of Octobe
seizure that evening after receiving vaccines in office. Dad report stiffening & shaking episode Y < 1 min while
2/17/2009
in highchair
2/17/2009at restaurant. The
Kinrix on 6/11/09, IM/L arm. Mom noted redness + swelling on 6/12/09, arm warm to touch Y in the upper6/11/2009
deltoid area; 6/12/2009
good ROM. Mom re
Kinrix on 6/10/09 IM/Larm; mom noted redness + swelling on 6/11/09. No impaired ROM, c/o sore to touch; 6/10/2009
arm red,6/11/2009
warm swollen from e
received ANTHRAX vaccine #1 - no problems 2/27/04 Y - deployed to7foreign country 4/21/04 - received ANTHRAX
4/21/2004vaccine
4/22/2004 #2 and HEP B va
e, fever, right hand swelling, arm, leg Y pain. N 6/12/2009 6/13/2009
n: 1/21/05- received primary FLUMIST- no problems. Y 1/23/05- "felt run
2 down". 1/24/05- c/o n/v,
U diarrhea,1/21/2005
fever (temp 1/23/2005
not taken), chills and n
not around injection site. Rxd Benadryl 25mg 1-2 a day LORATADINE 10mg 1 a day. Y 6/15/2009 6/16/2009
on site erythema, induration, tenderness lasting more than 1 month; worsening after each anthrax vaccination. Right sided axillary adenopa
administered 06/10/09 at about 11am. By 2pm child began to scream uncontrollable until about Y 7pm. No6/10/2009
treatment necessary.
6/10/2009 Was adminis
oke out on forehead, face and neck. Benadryl 12.5mg/ml given (PO). Y 6/17/2009 6/17/2009
, reproducible arthralgias after each anthrax vaccination. Currently stationed in Qatar. Joint Pain, multiple joints### Start: 5/22/2004 comment:
received smallpox vaccine on his left upper arm Y (3 jabs)- denies any 2 problems. 08/27/04 - onset
U 0600 while
8/27/2004
sleeping - bilat chest pain ("du
tous, non-fluctuant, indurated area. Warm to touch, no exudate or focus of fluctuance or purulence. Y 6/15/2009 6/15/2009
urated, mildly erythematous lesion over deltoid Y 6/15/2009 6/16/2009
ction to vaccine Y 6/15/2009 6/17/2009
d - swollen, red AMOXICILLIN RX started w/DTAP. 6/15/2009
area of erythema/swelling (L) biceps, 2 by 2 cm area of erythema/swelling (R) bicep low grade Y fever x 24 6/15/2009
hours. 6/15/2009
, induration, swelling, itching left deltoid! - treated for cellulitis with Keflex. U 6/15/2009 6/15/2009
hly circular red/warm/itching raised Y patch surrounding injection site. Few clear vesicles (central ) noted started
6/15/2009less 6/16/2009
than 24 hrs after injectio
received anthrax vaccine #1 along with SPV- about a week later, noticed rash on left inner thigh- c/o moderate 1/31/2003pruritus-
2/7/2003
was dx'ed with "poi
received from patient on 11/2/04 No problems with first three ANTHRAX vaccines 10/09/03 - received anthrax 11/1/2003
vaccine #4 (foreign country)-
ve L arm / shoulder pain with weakness. Medical records requested. Symptoms: Joint Pain, isolated start: 6/12/2003
6/12/2003 comment: left shoulde
n: 2/3/05- received SPV (3 pokes, left upper arm) along with flu vaccine (right upper arm)- states
U was "getting
2/8/2005
over a cold" (only sx= nasal c
n: SM developed, N&V, HA, diarrhea about 72 hrs post anthrax vaccination #1, which recurred U with second 7/8/2007
anthrax in Sept. Symptom: Fati
le, ADSM, presents as a referral fromY clinic for chest pain after smallpox vaccine. Symptoms:Y Chest pain,5/28/2009
fever, headache,
6/5/2009 general.
n : progressive fatigue, cognitive loss, anhedonia, myalgias, arthralgias after each anthrax vaccine Comment: ### med records requested Sym
n: This patient reports back pain, knee pain, headache, fatigue, memory loss, sleep disturbance, and hair 3/22/2003
loss since starting ANTHRAX vac
n: Headache, arthralgias, memory loss, fatigue, visual change, fever after anthrax vaccine #2. Symptom: Head,### general; Symptom: Joint P
ve, persistent bilateral shoulder pain, bilateral UE, numbness / fatigue, diffuse headaches failing to improve with ###
NSAID'S muscle relaxants,
n: Headache, Myalgias, UE/LE paresthesias worsening after each anthrax vaccine; SX beyond Y 30 days. Symptom:
2/2/2003 Headache, general star
n has been received from a medical assistant (MA) concerning a 41-day-old patient who on U 08-Apr-2008 4/8/2008
was inadvertently
4/8/2008 vaccinated with
n has been received from a health professional
Y concerning a 3 year old male who on 29 OCT U 2007 was vaccinated### with 0.5 ###ml, a second d
n has been received from a physician Y concerning a male with obsessive-compulsive disorder N diagnosed7/23/2007
prior to vaccination on 23-JUL-200
n has been received from a registered nurse concerning a 1 week old infant who on 21-MAY-2008 U was vaccinated
5/21/2008 at 5/21/2008
the pediatrician's offic
n has been received from a physician concerning a 11 year old male with no pertinent medical Y history or drug
7/1/2007
allergies who in July 2007, w
n has been received from a consumer who is the mother of the patient, reported that her sonUwent in for his 2 month immunization shots an
n has been received from a physician concerning a 2 year old male who on 24-JUN-2008 was N vaccinated 6/24/2008
with VAQTA 6/24/2008
vaccine, 0.5 ml, IM
n has been received from a nurse concerning a male who was vaccinated with VAQTA. It was U reported that the patient developed hepatitis
n has been received from a registered nurse concerning a 36 year old female patient who onU28-FEB-2008 2/28/2008
was vaccinated
2/28/2008 with an 0.5 mL
n has been received from a consumer Y concerning Y a approximately 15 1 months old male with Y egg allergy,10/1/2007
peanut allergy
10/1/2007
and beef allergy wh
n has been received from a nurse concerning
Y a female with allergy to nuts who on 06-JAN-2006
Y was vaccinated
1/6/2006with1/6/2006
the first dose of VAQ
n has been received from an office manager concerning a female who on 06-AUG-2008 wasUvaccinated with 8/6/2008
a dose 8/6/2008
of VAQTA. On 06-AUG
n has been received from a registeredY nurse with no allergies or medical history who on 26-JUL-2004
U and
1/31/2005
on 31-JAN-2005
8/27/2008 was vaccinated
n has been received from a physician concerning a 6 day old patient who was intended to receive U RECOBIVAX
10/3/2008 HB,10/3/2008
was inadvertently adm
n has been received from a nurse practitioner concerning a female patient who was vaccinated U with a dose of VAQT. The patient showed
n has been received from a physician Y concerning a patient who on 04-NOV-2008 was vaccinated N with VAQTA
11/4/2008vaccine. Subsequently the p
n has been received from a physician concerning a 14 year old female who on 19-JAN-2009Nwas vaccinated 1/19/2009
intramuscularly
1/19/2009with a first dos
n has been received regarding a case Y in litigation concerning a 49 year old female who on 19-Nov-2007
N was vaccinated
### with
### first dose of h
n has been received from a registered nurse concerning a patient's uncle who on an unspecified U date was vaccinated with MMR II. Subseq
n has been received from a physician concerning Y a "very old" female0 who was vaccinated withU MMR II. The patient recently received MMR
n has been received from a physician Y concerning a 14-year-old male with type 1 Ydiabetes mellitus,
Y no known
8/5/2008
drug allergies,
8/6/2008and a family hi
n has been received from a physician concerning Y a 4 year old male 0with egg allergy and a history
U of asthma
8/8/2008
who on 8/8/2008
08-AUG-2008 was vac
n has been received from a consumer concerning Y her 32 year old daughter
0 who recently received
U a booster dose for MMR II. It was reporte
n has been received from a physician concerning a 5 year old female who received her first Y dose of MMR II at 15 months of age (approxim
n has been received from Y a physician concerning Y his wife, who as a0child
Y was vaccinated
Y with
Y MMR II. Subsequently the patient experienc
n has been received from a consumer concerning her now 6 year old son with "family genetic N history (predisposition)
8/1/2003 8/1/2003
of motor skill problem
n has been received from a medical assistant concerning an adult male who was vaccinatedUwith a dose of MMR II as a child. The patient h
n has been received from a healthcare worker concerning a nurse regarding MMR II. The nurse U was cut on shattered vials of vaccine recei
n has been received from a nurse practitioner concerning a 32 year old male who on 09-DEC2008 N was vaccinated
12/9/2008 with MMR ### II SQ, 0.5ml.
n has been received from a consumer concerning her 12 month old son who was vaccinatedYwith a dose of MMR II (lot# not provided) 0.5m
n has been received from a physician Y concerning a female with DEMEROL allergy, arthritis, Uosteoporosis,4/3/2006
hyperlipidaemia### and hypothyroid
rmation has been received from a pharmacist and follow-up information was received from aUregistered nurse 3/12/2007
concerning
3/25/2008
a 34-year-old fem
n has been received from a consumer Y concerning her daughter with no pertinent medical historyN or drug8/10/2005
allergies who3/29/2008
on 01-MAR-2001 an
n has been received from a registered nurse concerning a 22 year female health worker withUno pertinent medical ### history
3/28/2008
who, on 16-Sep-1
n has been received from a licensed practical nurse (LPN) concerning a patient who on approximately
Y 20-MAR-2008
3/20/2008 ("in the last 2 weeks")
n has been received from a nurse practitioner (NP) concerning a 19 year old female, with noUprior medical conditions, who was vaccinated
n has been received from a PharmD. Y concerning a 5-year-old male with an allergy to porcineY and bovine gelatin who in approximately 2006
n has been received from a pharmacistY concerning a 19 year old female with a history of convulsions
N in childhood
### who on### 19-NOV-2007 w
n has been received from a 47 year old female pharmacist reporting on herself with an unknown N medical history and unknown drug allergie
n has been received from a physician Y concerning a 1-year-old male with a history of stroke andN heart problems
4/10/2008 who4/10/2008
on 10-APR-2008 was
n has been received from a physician Y concerning an approximately 28-year-old female with no medical history or allergies who as a child w
n has been received from a physician concerning a white male who, on an undisclosed date,Nwas vaccinated 8/17/2004
with a10/1/2004
second dose of MMR I
n has been received from a physician
Y concerning a 15 month old female no pertinent medical N history, drug4/3/2008
reactions 4/15/2008
or allergies who on 03
n has been received from a registered nurse concerning a now 25 year old male medical studentU who on 8/3/1995
10-Apr-2008 8/3/1995
was vaccinated with
n has been received from a physician
Y concerning a 12 month old male with no pertinent medicalY history, drug
4/3/2008
reactions
4/3/2008
or allergies who on
n has been received from a registered nurse concerning a male with no pertinent medical history and no8/24/1999
drug reactions/allergies
4/1/2008 who on 09
n has been received from a physician concerning a 12 month old female who was vaccinated U with MMR II. Concomitant therapy included V
n has been received from a physician
Y concerning a 14 month old female with a history of urinary
U tract infection
4/16/2008 and 4/22/2008
no known drug reaction
n has been received from a health professional concerning an adult patient who was vaccinatedU with MMR II as a child and had a negative
n has been received from a health professional
Y concerning a 15 month old female with a penicillin
Y allergy
1/31/2008
who on 31-JAN-2008
2/11/2008 was vaccin
n has been received from a physician
Y concerning a patient who was vaccinated with 2 dosesUof MMR II. Subsequently,
9/2/2003 3/7/2008 the patient develop
n has been received from a registered nurse concerning a female allergic to porcine who "atU5 years of age", in approximately 2001, was va
n has been received from a pharmacist concerning a female who in the past was vaccinatedUwith a dose of MMR II. Subsequently the patie
n has been received from a physician
Y concerning a 12 month old male who, in February 2008, Y was vaccinated
2/1/2008 with MMR
2/1/2008II. Concomitant th
n has been received from a physician concerning a patient who on 01-MAY-2008 was vaccinated U with a second
5/1/2008 dose5/1/2008
of MMR II. Concomit
n has been received from a registered nurse concerning an approximately 27 year old male N consumer with no known allergies or pertinent
n has been received from a consumer concerning a 12-month-old male who, on an unknownNdate, was vaccinated subcutaneous with 0.5 m
n has been received from a health professional
Y concerning a 5 year old female on 06-MAY-2008U was vaccinated
5/6/2008with5/6/2008
MMR II (lot number 6
n has been received from a physician
Y concerning a 4 year old female, with no pertinent medical
N history, 4/25/2008
drug reactions 5/4/2008
or allergies who on
n has been received from a pharmacist concerning an approximately 30 year old female whoU was vaccinated with her second dose of MMR
n has been received from a physician concerning a 24 month old female who was vaccinated U with MMR. Concomitant therapy included VA
n has been received from a physician concerning a 5 year old female who was vaccinated with U MMR II. Suspect therapy included VARIVAX
n has been received from a licensedY practical nurse concerning a 5 year old female with no Upertinent medical
4/25/2008history or drug allergies who,
n has been received from a licensed practical nurse (LPN) concerning a patient who on approximately
Y 20-MAR-2008
3/20/2008 ("in the last 2 weeks")
n has been received from a licensed practical nurse (LPN) concerning a patient who on approximately
Y 20-MAR-2008
3/20/2008 ("in the last 2 weeks")
n has been received from a physician
Y concerning a 12 month old female who, in February 2008, Y was vaccinated
2/1/2008with2/1/2008
MMR II. Concomitant
n has been received from a consumer concerning her male son with allergies to eggs, soy, wheat,
U mustard, peaches, maple syrup, milk, sh
n has been received from a health professional
Y concerning a 51 year old female with drug allergies
N to penicillin,
2/11/2008 iodine
4/23/2008
and Acetaminophen
n has been received from a NP concerning
Y a male with no known medical history or allergiesU who on 07-MAY-2008
5/7/2008 5/20/2008
was vaccinated sc with
n has been received from a physician concerning a 9 year old male patient who in 2003 wasUvaccinated with 1/1/2003
a second
5/22/2008
dose of MMR II (Me
n has been received from a nurse practitioner concerning a 13 month old female with no pertinent
N medical
4/28/2008
history or4/28/2008
drug allergies who on
n has been received from a pharmacist concerning a patient (age, gender unspecified) who U thought the patient was vaccinated with a dose
n has been received from a physician
Y concerning a 4 year old male child who on 25-FEB-2008 U was vaccinated
2/25/2008 with4/12/2008
a second dose of MMR
n has been received from a physician concerning an "approximately 12 or 13 month old" male Y child with egg
5/1/2008
allergy, 5/1/2008
"very allergic and atop
n has been received from a health professional
Y concerning a 9 year old male who sometimeUin 2000 was 6/9/2008
vaccinated6/9/2008
with his first dose of M
n has been received from a physician concerning a 26 month old female patient who was vaccinated
U with a dose of MMR II vaccine and th
n has been received from a physician
Y concerning her "approximately 2 year old" son who onUan unspecified date was vaccinated with MMR
n has been received from a licensedY practical nurse concerning a male patient with sulfa eyeNdrop hypersensitivity
8/1/1991 and 6/2/2008
a history of migraine
n has been received from a health professional concerning an adult patient who was vaccinatedU with MMR 1/1/2007
II as a child
1/1/2007
and had a negative
n has been received from a health professional concerning an adult patient who was vaccinatedU with MMR 1/1/2007
II vaccine1/1/2007
as a child and had a n
n has been received from a registered nurse concerning a patient who on 17-JUN-2008 wasUvaccinated IM 6/1/2008
instead 6/16/2008
of SC with a dose of MM
n has been received from a physician
Y concerning a 4 year old female patient who was vaccinated
U with a dose
7/3/2005of MMR II at 16 months of ag
n has been received from a medicalYassistant concerning a 21 month old female child with no Y known allergies,
6/10/2008 or pertinent
6/23/2008 medical history
n has been received from an office Y
manager concerning a 12 month old male child with no knownY allergies,
6/10/2008
benign 6/14/2008
heart murmur and ecze
ported that her daughter experienced fever about 7 days after vaccination with her first doseYof MMR II, injection, when the child was 3 and
n has been received from a physician concerning a 19 year old female with penicillin allergyNand AUGMENTIN allergy who had two doses o
n has been received from a physician concerning a 13 month old female old female with portNwine naevus 6/23/2008
and sensitivity
6/23/2008to OMNICEF who
n has been received from a nurse practitioner concerning a 4 year old female with a history Uof eczema who 9/4/2004
on 04-SEP-2004 was vaccinate
n has been received from a health professional
Y and healthcare worker concerning a 21 yearUold female who 11/1/1996
on 01-NOV-1996 was vaccina
n has been received from a physician
Y concerning a female patient with an "autoimmune disease"Y who on 1/5/1998
an unspecified2/1/2008
date was vaccinat
n has been received from a registered
Y nurse concerning a 50 year old female employee withYpenicillin and 6/6/2008
codeine allergies
6/8/2008and an unspec
n has been received from a physician concerning a 15 month old male patient who in approximately
Y July 7/1/2003
2003, was vaccinated
7/1/2003 with a first d
n has been received from a registered
Y nurse concerning a 42 year old female patient who onUan unspecified date was vaccinated with MMR
n has been received from a medical assistant concerning a female who (on an unreported date) U was vaccinated with7/1/2008 MMR II (Lot # not rep
n has been received from a licensed practical nurse concerning a male patient with no known U allergies or pertinent medical history who on
n has been received from a pharmacist concerning a patient who received her primary series U received a third dose of MMR II about four ye
follow-up information has been received
Y from a physician concerning a 4 year old female patient
Y with a protease
7/23/2008sensitivity
7/24/2008 and no pertinen
n has been received from a CMA and physician's assistant concerning a 38 year old female Nsmoker with6/17/2008hypertension, penicillin allergy, co
n has been received from a pharmacist concerning a pregnant female who is "due any day now" N that was vaccinated with MMR II and is te
n has been received from a physicianY concerning a female patient in her "mid 40's" with no allergies
N or pertinent
7/7/2008 medical
7/19/2008
history who on 07
n has been received from a consumer Y concerning his adult wife, who was undergoing fertilityUtreatments, whom he believes was vaccinated
n has been received from a physicianY concerning a female who has negative titers for RubellaU after she was already given 2 doses of MMR
n has been received from a physician concerning a 33 year old male, affiliated with another Uunspecified 7/29/2008
practice, who 7/29/2008
on 29-JUL-2008 was
n has been received from a pharmacist
Y concerning a 46 year old female who on approximately N 19-JUL-2008, 7/19/2008"about7/19/2008
3 weeks ago" was vac
n has been received from a physician concerning a 5 year old male patient with congenital heart
Y disease who was vaccinated at an unspec
n has been received from a physicianY concerning a 55 year old female with a history of breast
N cancer who 7/29/2008
on approximately
8/7/200829-JUL-2008 w
n has been received from a healthcare worker concerning a 1 year old female who, on 06-JUL-2008,
U was6/6/2008
vaccinated with MMR II (lot numb
n has been received from a certifiedYmedical assistant concerning a 22 year old male who on U an unspecified date ###was 7/1/2008
vaccinated with a fir
n has been received from a registered nurse concerning a 45 year old male who on 31-JUL-2008 N was vaccinated
7/31/2008SQ8/3/2008with the first dose of
n has been received from a physician concerning a 4 year old female with no medical historyUwho, in 2004, 7/23/2008
was vaccinated
7/31/2008 with a first dose
n has been received from a pharmacist concerning a "post menopausal" female volunteer atUher facility who was vaccinated as a child with
follow up information has been received from a mother concerning her son with a history of N premature birth10/8/2007
who on 08-OCT-2007### was vac
n has been received from a female Y consumer with penicillin, naproxen and ezetimibe (MSD)Nallergies who "14 years ago" in 1994 was vacc
n has been received from a 30 year old female with a history of adhesions in 1997 who on 17-JUL-2008
N 7/17/2008
was vaccinated7/17/2008
with MMR II (lot# n
n has been received from a medial Y assistant concerning a 4 year old male who received theNsecond dose8/4/2008 of MMR II 8/6/2008
(rHA) (Lot # 655380/13
n has been received from a medicalYassistant concerning a 5 year old male patient with no known
Y allergies
8/12/2008
or pertinent
8/14/2008
medical history who
n has been received from a physicianY concerning a 12 month old female with no medical history
N or allergies, 8/5/2008
who on8/15/2008
05-AUG-2008 was va
n has been received from a patient's mother concerning a 5 year old female with peanut oil allergy
U who in approximately 2006 was vaccina
n has been received from a certifiedYmedical assistant concerning an 18 month old male, who Y is otherwise 7/23/2008
healthy, 7/30/2008
who on 23-JUL-2008 at
n has been received from a female nursing student who was vaccinated in the past (unsure U of how many doses she was given) with MMR
n has been received from a registered
Y nurse concerning a 36 year old female with drug reaction
U to NORGESIC 8/4/2008 FORTE
7/30/2008
which causes naus
n has been received from a consumer concerning a female child who was vaccinated with aUdose of MMR II on an unspecified date. Subse
n has been received from a consumer concerning a male child who was vaccinated with a dose U of MMR II on an unspecified date. Subsequ
n has been received from a consumer via the internet concerning her healthy toddler child whoU on an unspecified date was vaccinated with
n has been received from a physicianY concerning
Y a now 29 year old female
Y patient, who in 1980,
Y at age one1/1/1980
was vaccinated
1/1/1980with the first d
n has been received from a physicianY concerning an approximately 5 year old female who inUNovember 11/1/2007
2007 (when 6/1/2008
she was 4 years old),
n has been received from a physician concerning a male who on 26-AUG-2008 was vaccinated U with the8/26/2008
first dose of8/26/2008
MMR II. Suspect thera
n has been received from a physician concerning a male who was vaccinated with MMR II. The Y patient developed erythema after getting M
n has been received from a nurse atY a health department concerning a 39 year old male, who Y on 17-JUL-2008,
7/17/2008 was8/10/2008
vaccinated with MMR
n has been received from a nurse concerning
Y a male with no known allergies and reported noU pertinent medical history who was vaccinate
n has been received from a physician concerning a 23 year old male with no known allergiesUor medical history who 6/6/2006 in approximately 1986
n has been received from a consumer Y concerning a 14 year old female who was vaccinatedYwith a dose of MMR II when the patient was a
n has been received from a physician concerning a 12 month old male with a history of kidney Y transplant7/30/2008
waiting list,7/31/2008
feeding tube, congeni
n has been received from a patient's mother concerning her 7.5 year old daughter with no allergies
U or pertinent
9/26/2005 medical
8/1/2008
history who was va
n has been received from a nurse concerning
Y an adult female who on 29-AUG-2008 was vaccinated
N with8/29/2008
a booster9/10/2008
dose of MMR II. On 10
n has been received from a nurse concerning a 42 year old male with allergy to Prozac whoNreceived dose 1/2/2008
1 of MMR 8/18/2008
II as a child tested ne
n has been received from a registered
Y nurse (RN) concerning a 30 year old female with no allergies
U or medical history 9/5/2008
who was vaccinated
n has been received from a pharmacy student concerning a 48 year old female with drug reactions/allergies
N 6/1/2008
to NSAIDS, lidocaine, morphin
n has been received from a consumer concerning her 35 year old son who received MMR IIUwhen he was a young child. It was reported tha
n has been received from a registered nurse concerning a 36 year old female who has received U two doses 9/18/2008
of MMR9/18/2008
II in the past (date not r
n has been received from a consumer, who is a nurse, concerning her 15 month old male son Y with no medical9/9/2008history
9/10/2008
or allergies who on 0
n has been received from a certified medical assistant (CMA) concerning a 5 year old male whoN around the 8/1/2008
second9/25/2008
or third week of August
n has been received from a physician concerning a 19.5 year old female patient with penicillin
N and AUGMENTIN allergy who had two dose
n has been received from a pharmacyY student concerning a 4 year old male who on 23-SEP-2008 U was vaccinated
9/23/2008 with9/23/2008
MMR II (lot # 66179
n has been received from a consumerY concerning her 3 year old son with no pertinent medical Y history or8/27/2008
allergies who 9/3/2008
on 27-AUG-2008 wa
n has been received from a licensed practical nurse concerning a 34 year old pregnant female U with seasonal
7/30/2008
allergy8/15/2008
and thyroid disorder b
n has been received from a physician concerning a male patient with no medical history andUno drug reactions/allergies who on an unspeci
n has been received from a nurse at a physician's office that a "12 month old" patient with noU medical history,
10/3/2008
received a dose
### of MMR II, in
n has been received from a physician
Y concerning a 12-month-old female who in September N 2008, was vaccinated
9/1/2008 with 9/1/2008
MMR II, Hep A (ma
n has been received from a pharmacist concerning a patient who was vaccinated with MMRUII. It was reported that the patient was given M
n has been received from a consumer concerning her older son who on an unspecified dateUwas vaccinated with a dose of MMR II (lot num
n has been received from a 31 year old female licensed practical nurse with no medical historyN or allergies who on an unspecified date whe
n has been received from a consumerY concerning a 1 year old female who on 10-OCT-2008Nwas vaccinated via ###injection with
### MMR II. Seco
n has been received from a consumer concerning his son who was vaccinated with a dose of U MMR II. Subsequently the patient developed
n has been received from a nurse concerning
Y a male who was vaccinated with both doses ofY MMR II and 4/13/2006
subsequently, the ###patient develop
n has been received from a patient who was vaccinated with MMR II (route and site not reported).
U The patient had a previous experience w
n has been received from a patient's
Y mother concerning her 15 month old son with hypersensitivity
Y to Amoxicillin
1/31/2006who 2/15/2006
on 31-JAN-2006 was
n has been received from a nurse concerning
Y a patient who in 2007 was vaccinated with a doseU of MMR II, RECOMBIVAX HB (MSD) (lot #
n has been received from a nurse practitioner
Y concerning a 31 year old female student with Y depression and9/26/2008
no drug10/7/2008
reaction or allergy who
n has been received from a nurse concerning
Y a female patient who on 24-DEC-1999 was vaccinated
N with a dose
###of MMR II (lot #625634/0
n has been received from a registered
Y nurse concerning a male adult patient who on 20-NOV-2007 U was vaccinated
### subcutaneously with a
n has been received from a Doctor Y of pharmacy concerning an adult female patient who in September
N 2008
9/1/2008
was vaccinated with a dose of
n has been received from a registered nurse concerning a 4 year old female with no medicalNhistory who on 10-NOV-2008
### ###
was vaccinated
n has been received from a consumer concerning her child with a history of anaphylactic reaction
U to latex who on an unspecified date was
n has been received from a physician
Y concerning a patient who was vaccinated with a dose Uof MMR II "years ago". It was reported that the
n has been received from a certified medical assistant concerning an unidentified patient who U on unspecified date in the past "may" have b
n has been received from a physician
Y concerning a 5 year old "healthy" female with a historyYof skin irritation at### injection site
###(onset 24-OCT
n has been received from a pharmacist concerning a patient who was vaccinated with MMRII. U The pharmacist reported that the patient exp
n has been received from a caller concerning a 14 year old male patient with allergy to GEODONN and a 12/3/2008
history of slight
12/3/2008
emotional difficultie
n has been received from an adult female
Y consumer who in her childhood was vaccinated with U a dose MMR II. In approximately
1/1/2009 January 20
n has been received from a consumer concerning her a 36 month old son who, "probable when Y he was 18 7/1/2007
months to 2 1/2 years old", was
n has been received from a consumer concerning her son, a 12 month old male with allergies Y to formaldehyde
1/10/2006and 1/11/2006
fragrance mix and histo
n has been received from an office Ymanager concerning a 14 month old female who on 13-JAN-2009
Y was
1/13/2009
vaccinated1/13/2009
with a dose of MMR
n has been received from a registered nurse who on 14-JAN-2009 was administering MMR N II and some vaccine splashed1/14/2009into her eyes. Th
n has been received from a physician
Y concerning a patient who "several months ago" was vaccinated
Y with a dose of MMR II (lot# not provi
n has been received from a registered
Y nurse concerning a 30 year old male patient with no pertinent
U medical history and no drug reactions
n has been received from a consumer concerning her son with reaction to all vaccines and medications
Y he
5/7/2001
has received
5/7/2001
that contain gelatin
n has been received from a medical assistant concerning an 18 year old female who in approximately
U 1991, "when
### she was 1 year of age"
n has been received from a physician concerning a 5 year old male with drug reaction to flu Y shot a year ago who on12/1/2008
unspecified date was v
n has been received from a nurse practitioner concerning a now adult male who was, on unspecified
U date, vaccinated with 2 doses of MMR
n has been received from a nurse practitioner
Y concerning a now 36 years old male who on unspecified
U dates was vaccinated with two dose
n has been received from a consumer concerning his 9 year old son with attention deficit disorder
U (ADD) diagnosed when he was very you
n has been received from a consumer concerning her 4 year old daughter with no medical historyY and drug
1/19/2009
allergies1/26/2009
who on 19-JAN-2009
n has been received from a nurse concerning an approximately 28 year old male student who U was possibly vaccinated with MMR II and ha
n has been received from a physician concerning a 5 year old patient who on an unknown date U was vaccinated with the second dose of MM
n has been received from a registered
Y nurse concerning a 35 year old female with problemsUwith fertility11/5/2008
and a miscarriage### in July 2007 and
n has been received from a consumer concerning her son who was vaccinated with MMR II.USubsequently the patient experienced severe
n has been received from a consumer concerning his daughter who was vaccinated with MMR U II. The consumer reported that the patient h
n has been received from a Registered
Y Nurse concerning a patient who was vaccinated withUall three doses of MMR II. The patient's antibo
n has been received from a consumer concerning her four and a half year old son with no pertinent
Y medical
8/1/2005
history and no known allergies
n has been received from a consumer whose husband on an unspecified date was vaccinated U with MMR II and had reactions like fever and
n has been received from a physician
Y concerning an approximately 12 month old (reported as U "1 year of age")
2/6/2009
patient who on approximate
n has been received from a licensed visiting nurse concerning a 30 month old male patient withY a history2/13/2009
of jaundice2/13/2009
at 3 weeks old who on
n has been viewed on the internet concerning a 15 month old female who was vaccinated with U a dose of MMR II. Concomitant vaccination
n has been received from a registered
Y nurse concerning a 27 year old female who in 1981 was U vaccinated 9/10/1981
with a first dose of MMR II, in 19
n has been received from a consumer concerning her now a 5 years old son who in approximately Y 2005 ("when he was 1 year old") was va
n has been received from a healthcare
Y worker concerning a 30 year old male who was vaccinated U with a dose of MMR II when he was a ch
n has been received from a registered
Y nurse (R.N.) concerning an 8 year old male with 1 siblingY who on 6/29/2001
29-JUN-2001 2/2/2009
was vaccinated subc
n has been received from a consumer concerning his 6 year old son who on an unknown dates U was vaccinated with both doses of MMR II.
n has been received from a consumer,
Y who is the uncle of the approximately 24 months old N male patient with no previous medical history w
n has been receive from a registered
Y nurse concerning of himself a 27 year old male with sulfonamide
U allergy
8/9/1982
who in 1983 was vaccinated
umer reported that 10 years ago, in 1999 her son had a very severe reaction. He experienced Y a seizure and a high fever. The consumer sta
n has been received from a health care worker concerning himself. It was reported that in 1947U the patient was vaccinated with 2 doses of
n has been received from a consumer concerning her 8 year old son who was vaccinated with U a dose of MMR II. It was reported that the pa
n has been received from a consumer concerning her son who on an unspecified date was vaccinated
U with MMR II. It was reported that he
n has been received from a registered nurse concerning her daughter with frequently injection Y site reaction after unspecified vaccination wh
n has been received from a licensed practical nurse concerning a female with no medical history
U or drug allergies
9/1/1983who was vaccinated with
n has been received from a nurse practitioner concerning a 12 month old female who on 19-FEB-2009
N was
2/19/2009
vaccinated
2/23/2009
with a dose of MMR
n has been received from a nurse practitioner concerning a female infant with allergies to seafood
Y and shellfish who was vaccinated with a
n has been received from a physician
Y and a nurse concerning a 13 month old female who on N 23-FEB-2009 2/23/2009
was vaccinated
3/4/2009 with MMR II. Th
n has been received from a consumer concerning her now 4 year old son with an intolerance N to gluten and 1/1/2006
a history 1/1/2006
of "GI Issues" who "wh
n has been received from a nurse practitioner concerning a female who on an unspecified date U was vaccinated with a dose of MMR II (dos
n has been received from a patient concerning his wife who on an unspecified date, was vaccinated
U with a dose of MMR II vaccine. The re
n has been received from a consumer concerning her now 15 year old daughter who was vaccinatedY with "one dose" of a MMR II "when sh
n has been received from a case inYlitigation for WAES #0610USA022225 from a physician U via medical records concerning a 55 year old fe
n has been received from a consumer concerning her 12 month old daughter with no pertinent Y medical history
12/1/2008
or drug
12/1/2008
reactions or allergies
n has been received from a consumer concerning her 10 year old son who on an unspecified Y date was vaccinated with a dose of MMR II (L
n has been received from a consumer concerning her son who on an unspecified date was vaccinated
U with a dose of MMR II. It was report
n has been received form a consumer concerning her 5 year old daughter with no pertinent Y medical history 8/1/2005
and no drug8/1/2005
reactions or allergi
n has been received from a physician
Y concerning a 12 month old male with no pertinent medical N history 2/25/2009
and no drug3/13/2009
reactions or allergies w
n has been received from a consumer concerning her 12 month old son who was vaccinatedNwith a dose of MMR II. Concomitant therapy i
n has been received from a consumer concerning her daughter 4 years old who at 15 months U old (2005) was vaccinated with a dose of MM
n has been received from a consumerY concerning her 6 year old son who on an unknown date N was vaccinated with the first dose of MMR I
n has been received from a consumer concerning herself (a "37 year old" female) with food N allergies who received MMR II series as a child
n has been received from a physician concerning a male patient with unknown drug reactions U and asthma who was vaccinated with a seco
n has been received from a pharmacist concerning a patient who was vaccinated with a dose U of MMR II on an unspecified date. Subseque
n has been received from a Physician Assistant concerning an 8 week old patient who on 20-MAR-2009
U 3/20/2009
was vaccinated
3/20/2009
with MMR II due t
n has been received from a consumer concerning her approximate 14 month old daughter with N no drug allergy
3/31/1999who on 31-MAR-1999 was v
n has been received from a consumerY concerning a friend's 19 month old daughter "who went Y to the emergency room 1/1/2009
with a 105 degree fe
n has been received from medical assistant
Y concerning a 35 year old female with asthma, seasonal
N allergy
8/28/2008
and tetracycline
3/16/2009 and erythromy
n has been received form a consumer via e-mail, who was vaccinated with a dose of MMR IIU(lot# not reported), on 5 different occasions an
n has been received from a Registered Nurse concerning a 47 year old male with benign prostatic
U hyperplasia
2/20/2009
and no drug allergies who o
n has been received from a consumer concerning a male who on an unspecified date was vaccinated
U with a dose of MMR II (dose, route a
n has been received from a Registered
Y Nurse (R.N) concerning her 4 year old son with no pertinent
N medical
2/1/2006
history and
2/1/2006
no known drug alle
n has been received from a consumer concerning her child who on an unspecified date wasUvaccinated with a dose of MMR II. It was repor
n has been received from a consumer concerning her child who on an unspecified date wasUvaccinated with a dose of MMR II. it was repor
n has been received from parents via e-mail concerning their son who was vaccinated with aUdose of MMR II on an unspecified date. The p
n has been received from a consumer concerning her son who on an unspecified date was vaccinated
U with MMR II. The consumer reporte
n has been received from a medical assistant concerning a 13 month old male who on 17-MAR-2009Y was
3/17/2009
vaccinated 3/17/2009
with MMR II (lot # 66
n has been received from a female consumer who was vaccinated with a dose of MMR II (HSA) U over 20 years ago. Over 20 years ago the
n has been received from
Y a physician
Y concerning a female patient who was vaccinated
Y with NGARDASIL. The patient received the first dose
n has been received from
Y a registered
Y nurse (R.N.)
Y concerning her daughter nowY18 year old, Y with drug hypersensitivity
6/1/1998 7/1/2008 to PHENERGAN w
was received on 09-June-2009 from Y a consumer. A male patient of unknown age received the N following vaccination
6/1/2009 on 6/9/2009
01-June-2009: sma
ort was received 11 June 2009 fromYa health care professional. A 35-year-old female patient with a history of chronic hepatitis B had receiv
ENTED TO MEDICAL C/O RASH AND SWELLING X 1 DAY. PT STATES THAT RASH STARTED Y APPROXIMATELY
3/18/2009 3/18/20095 HRS AFTER HE R
Y 6/16/2009 6/17/2009
oke out with shingles in his eye and Yon scalp 102 weeks after receiving vaccine. Y 6/5/2007 4/22/2009
ceived pneumococcal vaccine on 5/13/09.Y On 5/14/09, developed pain, redness, warmth, erythema Y at injection
5/13/2009 site.5/14/2009
WBC elevated at 11.8
Fainting episodes x2 after vaccinesYgiven. Recovered x1 after glass of water given. Second Y time it was6/17/2009
difficult to 6/17/2009
wake her, shallow breat
6/17/2009 6/18/2009
d vaccine 9/11/08 and became pregnant Y in 2/09. She then had a fetus that "was not thriving"Y and she had 9/11/2008
a D&C done 5/26/2009
5/26/09. Please no
ted to our office on 6/18/09 with left Ysided rash. Rash began one day after varivax was administered in the6/9/2009 left arm. 6/10/2009
Rash is present on the
after vaccine patient complained to parents
Y that her R arm was hot and redness and swellingNwere noted.6/15/2009 She was given 6/16/2009
Ibuprofen and col
accine exceeded the recommended temperature range. Shipping and Handling requirements Y were discussed.6/4/2009 6/4/2009
hroat 10 minutes after the injection Y got dry and felt like an object was in it, and his left arm atYthe shoulder 6/18/2009
felt like it 6/18/2009
was numb. Had a little h
d papule rash and itching face,upper and lower body. I took the vaccine 2/24/09, but since then N as a RN I2/24/2009
have administered
6/17/2009at least 30-40
accine exceeded the recommended temperature range. Shipping and Handling requirements Y were discussed.6/1/2009 No harm 6/1/2009
done to patient.
accine exceeded the recommended temperature range. Shipping and Handling requirements Y were discussed.6/1/2009 No harm 6/1/2009
done to patient.
accine exceeded the recommended temperature range. Shipping and Handling requirements Y were discussed. No harm done to patient.
ng of continued pain and soreness in the muscle of the left arm in the deltoid region. Pain with deep palpation 6/7/2009of the6/18/2009
lymph nodes under the
sters on lt arm where varicella vaccineY was placed. Pt also has erythema/induration of 4cm xY5cm surrounding 6/16/2009 area6/16/2009
where varicella vaccine
have the following symptoms about 3 hours following the shot: high Fever, Hallucinations, soreness,Y joint
7/20/2006
pain, aches 7/20/2006
and fatigue. Once th
alled stating that he was running a fever up to 101 on day 10 of small pox vaccine and was complaining
Y of6/7/2009
discomfort 6/17/2009
under the arms from
mergency room twenty-four hours after Y vaccinesY were administered with 1 apenic spells and cyanotic
U episodes,
5/22/2009along 5/23/2009
with fever. 7/7/09 Hosp
accine exceeded the recommended temperature range. Shipping and Handling requirements Y were discussed.6/2/2009 No harm 6/2/2009
done to patient.
as entered into the electronic medical record as a female. The nurse gave the patient an HPV Y as indicated 5/4/2009
for female patients. Upon return
lls, muscle aches, sore joints, swollen glands, headache, fatigue all started the day after the Yvaccines were 6/16/2009
given. Patient
6/17/2009
had to leave work
, body aches, blotchy redness, and severe swellingY to right upper arm
2 especially near & surrounding
N PPSV6/15/2009
injection6/17/2009
site. 7/2/09 Hospital r
walk 5 hours after shot was given. Limped
Y on leg where shot was given. Gave tylenol and was Y able to walk 6/17/2009
again after
6/18/2009
2 hours. Expected th
dministered, vaccine 2 weeks out of date; No adverse event observed in patient. 6/16/2009
sted that these side-effects be reported. DTAP given at Left Deltoid (IM). Mother reported Left Y arm red, sore,
6/15/2009
had hard 6/17/2009
knot, and warm to to
ollen, red, + bump Dxper Dr L leg cellulitis
Y vaccine Rxn. Y 6/16/2009 6/17/2009
igh with induration, red 4x4 cm. U 6/16/2009 6/17/2009
OC onset about 10 minutes post injection with 10-15 seconds tonic posturing. Patient recovered Y consciousness6/18/2009 in less
6/18/2009
than 30 seconds - B
arm pain and swelling. Noted arm, area red slight swelling confined to injection site, size of U .50 cents piece.
6/15/2009
Able to6/16/2009
move extremity well. S
Y Y 9/23/2008 10/7/2008
and swelling onset 1 day after immunization given. 2/24/2009 2/28/2009
given left Deltoid on 2-7-09 On 2-9-09 pt had small welt at site. On 2-10-09 it had increasedUin size to 4.5"2/7/2009 X 3" with warmth
2/9/2009& swelling at th
01 degrees, - fever at 5:00 p.m day of vaccine given 2/11/09. Next morning 2/12/09 arm very Y sore at site2/11/2009
and hand 2/11/2009
swollen. Had rings cute
as in her car seat, after grandparents Y had come out of the grocery store. Grandparents noted Y child was twitching.
12/3/2008 Unresponsive ### & had som
n has been received from parents, aY physician Yand a medical assistant 2 concerning a 19 yearUold female 2/20/2009with anxiety, 2/20/2009
depression, asthma, t
ay of vaccine 17 hr HA and arm hurt at injection. Took EXCEDRIN - no relief. No redness at injection U site.6/10/2009
Pain L arm 6/10/2009
with movement at inje
and ZOSTAVAX on 5/4/09. Y He started experiencingY numbness/tinglingY (R) feet and hand with U weakness 5/4/2009
one week5/15/2009
later which has been p
nutes of injections, pt became acutely droopy, nauseated and vomited profusely. He was flushed Y and sweating.
6/17/2009 3x4 6/17/2009
cm. Wheal at site of VA
ns (seizures) approx. 1 day after shots. 6/26/09 Y Received hospital medical
1 records for 6/18-6/19/2009
U admit.
6/15/2009FINAL6/16/2009
DX: seizure-like spells
ching and drooling Y N 6/3/2009 6/15/2009
ter injection. No adverse affects. Y 5/28/2009 5/28/2009
d, swollen red lesion on Rt, posteriorY upper arm. U 6/16/2009 6/17/2009
er 4 month shots, developed raisedYrash all over body. Change in personality -> lethargic, decrease N in babbling
3/12/2009 and3/14/2009
cooing, screaming, dec
LA complications: None - mild illness with rash, no fever 6/19/2002 6/10/2009
aria. ZYRTEC. N 5/6/2009 5/8/2009
d Tdap @ 9:30 am on 6/10/09. At 12 00 pm on 6/11/09 pt developed nausea. Had to lie down Y for 15 hrs6/10/2009
and fell asleep.
6/11/2009
Woke up 3am on 6
oid where Tdap administered on 6/6/09 became indurated, erythematous, swollen, warm, painful. Y On Monday 6/6/20096/8 patient
6/6/2009
seen in office and
nt received DTaP vaccine IM in left thigh on 6/10/09. Patient was seen in the office on 06/12/09 U with a 3 6/10/2009
cm x 3 cm irregular
6/11/2009 area of redness
ticed the injection site was red and swollen
Y on 6/16/09, mother marked the swelling with a pen U and over 6/15/2009
the course of 2 days it was increas
nting episodes with 1st dose of GARDASIL on 4/7/09. With this 2nd GARDASIL & within seconds Y pt. got6/15/2009
pale, as she 6/15/2009
was laying down her
Y Y 5/22/2009 5/23/2009
me to IMMs complaining of redness rash, itching and soreness under arm of ACAM2000 vaccination site.5/5/2009
me to IMMS complaining of rash, redness, and itching at and around ACAM2000 vaccination site. 5/5/2009
eported "it looked like hives all over"Y - Rash-1wk- after MMR II, VARIVAX, HAVRIX given. Red Y itchy papules3/18/2009
2mm-1cm3/28/2009
varying site and loc
7, 2009, I noticed a rash on my back Y (right side). Two days later, the rash was spreading withU blisters and 3/5/2009
itching. Saw
3/7/2009
doctor, confirmed
ES EVERY TIME HE RECEIVES ANTHRAX VACCINE SINCE 1999, HE SUFFERS TEMPORARY Y MEMORY7/11/2008
LOSS.7/12/2008
HE RECEIVED 5 SER
given at about 12:15 PM June 16. Headache began immediately upon leaving the clinic. At 10:00 Y PM her 6/16/2009
R arm began6/16/2009
significant muscle tw
n has been received from a nurse practitioner, for the pregnancy Registry for VARIVAX (Merck), U concerning 7/3/2008
a 25 year7/3/2008
old female with a his
n has been received from a nurse concerning
Y a 31 year old male with anaemia macrocytic,
Y aNhistory of immune
6/8/2009 thrombocytopenic
6/9/2009 purpura
n has been received from a pharmacist Y concerning a 48 year old female who on 08-JUN-2009 Y was vaccinated6/8/2009with a6/9/2009
dose of PNEUMOVA
n has been received from a physician's office. The physician's office reported that they read Uan article about GARDASIL (MSD) and at the e
n has been received from a consumer concerning his 5 year old son who on 01-JUN-2009 was Y vaccinated 6/1/2009
with a second
6/8/2009
dose of MMR II 0
n has been received from a physician's office. The physician's office reported that they read Uan article about GARDASIL (MSD) and at the e
n has been received from a physician Y for the Pregnancy Registry for GARDASIL concerningYa 22 year old 11/8/2007
female who11/8/2007
on 06-SEP-2007 wa
n has been received through the Merck pregnancy registry for GARDASIL from a registeredYnurse concerning ### a female
2/1/2009
patient who on 17-J
n has been received from a physician who heard from the mother of one of his patients that U she was told by a pediatric rheumatologist that
n has been received from a 25 yearYold femaleYwith a history of overgrowth
0 bacterial and "ZIPORO"
N (therapy
3/1/2009
unspecified)
3/1/2009
allergy who in Ma
n has been received from a Registered Pharmacist Y (R. Ph.) concerning
0 a 96 year old femaleUwho was vaccinated subcutaneously with a 0.
n has been received from Y a medicalYassistant concerning a 11 week old male patient with oxygenY therapy6/12/2009
since birth
6/12/2009
and a history of prem
ving client home. Client c/o not feeling well, became hot, eyes rolled back and head went down. Y Mother6/18/2009
called the6/18/2009
EMS. When the squad
accine exceeded the recommended temperature range. Shipping and Handling requirements Y were discussed.
6/2/2009 No harm
6/2/2009
done to patient.
accine exceeded the recommended temperature range. Shipping and Handling requirements Y were discussed.
6/2/2009 No harm
6/2/2009
done to patient.
accine exceeded the recommended temperature range. Shipping and Handling requirements Y were discussed.
6/2/2009 No harm
6/2/2009
done to patient.
accine exceeded the recommended temperature range. Shipping and Handling requirements Y were discussed.
6/3/2009 No harm
6/3/2009
done to patient.
her called clinic on 6/19/09 after child received third dose of the HPV vaccine on 6/17/09. Per U Grandma,6/17/2009
the child had
6/18/2009
no immediate proble
o upper right arm noted that evening . Continued to spread and covered entire upper arm. Tx- Y cool cloths, 6/15/2009
tylenol for
6/15/2009
discomfort. At presen
nd swelling at site of vaccination in right arm that started on the day of vaccination. U 6/16/2009 6/16/2009
ness and swelling on site. Tender and Y hard subcutaneous tissue. No other symptoms. Prescribed U Motrin 6/15/2009
and told to 6/15/2009
soak area in warm wate
ability, muscle/joint aches, headache, diarrhea X4 days U 6/15/2009 6/16/2009
U 6/16/2009 6/16/2009
welling and redness. No fever. Recommended ice, motrin and benadryl. Three patients within U one week6/16/2009
with reaction
6/16/2009
to Varivax.
accine exceeded the recommended temperature range. Shipping and Handling requirements Y were discussed.
6/3/2009 No harm
6/3/2009
done to patient.
njection site, Left upper arm erythema and edema surrounding and below immunization injection Y site (13.5/10cm)
6/17/2009 6/18/2009
welling and redness. No fever. Recommended ice, motrin and benadryl. Three patients seenUwithin one 6/17/2009 week with reaction
6/17/2009 to varivax
accine exceeded the recommended temperature range. Shipping and Handling requirements Y were discussed.
6/3/2009 No harm
6/3/2009
done to patient.
dministered 6/16 @ 10am then on 6/17 in late afternoon, pt noticed L head tenderness in hair Y and tender 6/16/2009
glands in 6/17/2009
neck on L side. This oc
accine exceeded the recommended temperature range. Shipping and Handling requirements Y were discussed.
6/3/2009 No harm
6/3/2009
done to patient.
EACTION TO VACCINE U 6/16/2009 6/18/2009
veloped Shingles on 1st branch right Y trigeminal. Patient has pain, swelling, itching, redness N
to right side 6/11/2009
of face and6/14/2009
forehead. Temp 99.0.
accine exceeded the recommended temperature range. Shipping and Handling requirements Y were discussed.
6/3/2009 No harm
6/3/2009
done to patient.
accine exceeded the recommended temperature range. Shipping and Handling requirements Y were discussed.
6/4/2009 No harm
6/4/2009
done to patient.
7 pm on 6/17/09, client had small bruise on R deltoid where 1 of the vaccines was administered. On 6/18/09, 6/17/2009
redness
6/17/2009
was noted to R delto
ceived Pneumo vaccine right deltoid mm post alcohol swABBING. c/o small amount reddness Y - @ 1 " in 6/15/2009
area with a6/17/2009
small 1"" track towards
accine exceeded the recommended temperature range. Shipping and Handling requirements Y were discussed.
6/4/2009 No harm
6/4/2009
done to patient.
accine exceeded the recommended temperature range. Shipping and Handling requirements Y were discussed.
6/4/2009 No harm
6/4/2009
done to patient.
ODE ENLARGED ON L INGUNAL REGION ABOUT 1CM IN DIAMETER MMR GIVEN SQ IN L THIGH 6/2/2009 6/19/2009
e of the flu shot there is a 5cm areA of macular erythema with multiple confluent vesicles . Across
Y the mid
12/9/2008
chest large patches
### of macular e
ollowing administration of Hepatitis A, Meningococccal and HPV vaccine, 6-18-09, patient ran Y a fever of 100.6
6/17/2009
degrees
6/18/2009
F and complained o
eceived Havrix (Peds Hep A) vaccine Y on 6/16/2009. Developed fevers to 101+ farenheit thatYevening. Had 6/16/2009
acute mental
6/17/2009
status changes th
d varivax on 11-21-1997, pt presented in our office on 6-17-2009 with scattered 10-15 nacular U lesions some sl ### papular
6/15/2009
without vesicles 2 da
6/15/2009 6/19/2009
ed the prescription for the Oral Typhoid vaccine from the Health Dept on 6/15/09. Ct started U the capsules6/16/2009
on Tuesday, 6/19/2009
6/16/09. Ct took her
orts back on 6-18-2009, one day after Y receiving dose #3 of HPV, that she now has Knots on back of head 6/17/2009
that are tender
6/18/2009to touch. No prob
IVED VARIVAX ON 1-14-2002 AND 3-3-2009. PT PRESENTED IN THE OFFICE ON 6-17-2009 U WITH 25-303/3/2009
SCATTERED
6/15/2009 MACULAR LES
R on 6/11/09. Kristin states had bumps on face and right knee 6/15/09 about the size a dimeYwith a little head 6/11/2009
in center.
6/15/2009
Exam on 6/19/09 fe
veloped afebrile Seizures Y on 05.23.2008, was Y diagnosed with Infantile
11 Y Spasm. Now
Y has SeizureN disorder5/17/2008
and global 5/23/2008
developmental delay.
shot was uneventful. After scab fell off while overseas wound started to heal up. Wound didYnot heal like 8/23/2007
everyone else.
4/1/2008Scar did not hard
came faint, diaphoretic and was eased onto the floor. Her VS stayed normal, she was givenYO2 and within 6/16/2009
1 minute 6/16/2009
was conscious and or
vaccine 6/16/09, each day following the site of injection became increasingly redder, more painful U and swollen.
6/16/2009 By 6/18/2009
6/19/09, began itching,
rsistent low grade pain since time. No Y functional ROM deficits, pain 1-2 of 10 in nature. ClinicalY exam normal 9/19/2008
w/palpation
4/3/2009
of deltoid. No palp
@ 2:30 pm immunization given. 6.17.09 @ ~ 5:30 pm --> fever (1m 104) - Hives @ 11:00 pm.UNo facial swelling 6/17/2009or difficulty
6/17/2009 breathing. Histor
9 patient felt generalized joint pain. Noticed swelling both ankles. Reported as non-pitting. DeniseY treatment.
6/9/2009
Joint pain
6/10/2009
resolved by 6/11/09
swelling at injection site (lower deltoid at left arm). Recommended Diphenhydramine 25mg and U Ibuprofen. 6/16/2009 6/17/2009
at site of injection - 6/17/09 2hrs. Body ache and joint pains 6/18/09. High fever. Y 6/17/2009 6/17/2009
redness and edema around the injection site, significant swelling of leg even 2 days, later, warm Y to touch6/17/2009
advised parents
6/12/2009 to put warm com
was reported by a physician,Y via a GSK representative
Y and described
4 the occurrence
Y of intussusception
Y 5/27/2009
in a 4-month-old
6/4/2009male subject who
d zoster PCR confirmed. Y Y 9/28/2005 4/9/2009
htness in throat, pale, wheezing
Y andYcollapsed Y in clinic lobby. Mom took
1 him right to ER. He Y had anaphylaxis 6/2/2009
to vaccines.
6/2/2009
Received Epinep
- 04-24-09 = left arm, shoulder,
Y neckY and rib pain
Y with muscle spasms. 2 No treatment. 04-27-09 N - severe pain
4/20/2009
in left side
4/27/2009
of my back, more p
6/7/2007
t pain in her back on 6/10/09. Patient Y didn't realize that she had a rash till 6/14/09. The rash Uwas approx.5/22/2009
6" in diameter
6/10/2009
in a circular pattern
VRIX in prefilled syringe in the left thigh with 1" needle. After immunization given, realized that Y it was an adult
6/9/2009
dose. Evaluated child for 20 m
swelling at site of injection. Red, swollen, warm to touch. Ranging 3 in by 1 in by 1 in. Encouraged
U mother
6/18/2009
to place 6/19/2009
ice pack, give appropria
t 6.18.09 Acute URI 4 mo check-up vaccines given see below- Return visit 6.19.09. Fever within 24 hrs of 6/18/2009
vaccine administration
6/19/2009 probably v
d 1/2 dollar size hive around area of injection - c/o pain & itching. Y 6/18/2009 6/18/2009
ped localized redness and swelling over (L) Vastus Lateralis sites within 24 hrs. Now 2 wks later Y has an erythematous
6/4/2009 6/4/2009
ring about 10 cm with
soon after immunization followed by vomiting some hours later symptoms resolved within 48 Yhours never had 3/4/2009
fever. 3/4/2009
and swelling at injection sites. Fever 99.3. Y 6/9/2009 6/10/2009
hemic area approx 3cm diameter, LYdeltoid. Y 6/17/2009 6/19/2009
d with C. difficile on 2/27/09 and 4/21/09 Y 2/6/2009 2/15/2009
6/11/2009
, Redness around injection site right thigh area, warm to touch. Tx-Infant TYLENOL liquid, Hydrocortizone
Y 6/16/2009
0.5% 2x 6/17/2009
a day for few days
cough.. mother brought child to car - before leaving child c/o itching all over and turned brightYred. Brought 6/10/2009
back into6/10/2009
office c/o cough sweati
welling/redness, pain and blister at the injection site. U 6/17/2009 6/19/2009
ven a DTaP rather than a Tdap. He had no adverse reactions. 5/20/2009
4/29/2009
hargy began 24 hrs after shots. The entire upper R arm swollen, red, hot, tender not localized Y abscess. 6/16/2009 6/17/2009
ular raised red area at (R) thigh. Y 6/17/2009 6/18/2009
opal reaction minutes after vaccination. Hypotensive + bradycardia immediately after near syncopal Y episode
6/17/2009
and cool,
6/17/2009
pale, diaphoretic. La
s, started 11 hours after the injection. Fever 101 deg; shaking chills; no localized reaction; noYparathesias.6/8/2009Severe headache.
6/8/2009
ema (notable lips & (L) eye), SOB. BENADRYL
Y & SOLUMEDROL given. Y 6/9/2009 6/11/2009
receiving Pneumovax & Zostavax, pt began having head fullness/pressure, ears tingling, walk Y fatigued. 5/28/2009
Some lightheadness.
5/28/2009 1 wk later st
iven 6/4/09. Pt developed within 24 Yhours fever, swelling, chills and generalized hives. She was U seen on 6/9/096/4/2009when6/5/2009
a large erythematous
on LUE with YF Vax 2:30pm 6/15/09Yafter screening. At approx. 2:35 pt c/o redness, swellingYand itching6/15/2009 at injection6/15/2009
site- 25 mg BENADRY
redness at site one day after vaccine administered. Knot under (L) arm two days after. U 6/12/2009 6/14/2009
swollen to shoulder & down to end of deltoid muscle observed in office. Dad reported red swollen Y - req. Abx.
6/10/2009
therapy.6/11/2009
at Gyn which came back positive forY high risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56 N after receiving
6/18/2007
3 dose 6/5/2009
GARDASIL 8/11/06, 1
6/9/2009
ame lethargic, flushed, diphoretic and vomited. A 3x4 cm eccentric wheal developed at the left Y arm site, followed
6/19/2009 by 6/19/2009
a wheal at the right arm
ur hours after the PPV vaccine (administered at 2:00 PM Thursday, 6/18 PCT)or Friday, 6/19Y around 5:00 6/18/2009
PM my temperature
6/19/2009 dropped per
; Severe and continuing headache;YUnusual and continuing sleepiness; Unusual tiredness, Yweakness (sudden 6/18/2009 and6/19/2009
severe); Severe and co
e, chills, unwell, slightly swollen glands.
ministered the Anthrax Vaccine
Y by the on 2 October 2006 due to the fact I was an Y active duty Nservice member 10/2/2006assigned10/4/2006
to a foreign country.
redess within 1 hour of vaccine. Within 2 hours of vaccine, headache and fever of 103 degrees N F. Fever 6/19/2009
and headache 6/19/2009
reduced by Motrin
eal hipertension after 1.5 months afterY the secon Y dosis and finally results
8 in neuropatic painY( 1 week after 3/9/2009
the first symptons)
5/25/2009
gerated reaction at site of injection.YRed, swelling, temp. 99.9, painful 6/19/2009 6/20/2009
RECEIVED HEP B, POLIO, PNEUMOCOCCAL DISEAS, DTAP, AND HIB. THE INJECTIONS Y WERE GIVEN 6/18/2009AT 4 PM 6/19/2009
ON 6-18-2009, WIT
ad his 4th dose of DTAP and his 3rd of Polio on June 18,2009 at appr. 3:30pm. He was fine Ybefore the shots 6/18/2009and the 6/19/2009
evening after. First th
n has been received from a pediatrician
Y concerning a 15 month old male patient who on 14-APR-2008
N was
4/14/2008
vaccinated 4/22/2008
with a dose of MMR
n has been received from a physician concerning a 1 year old female who on 02-OCT-2008 Nwas vaccinated 10/2/2008
with the10/2/2008
first dose of MMRII. S
n has been received from a consumer concerning her 6 year old daughter who was vaccinated N with a dose of MMRII (lot number not provid
Y Y Y N 12/9/2008
was received from a health professional
Y on 09 June 2009. A 49-year-old male patient, with aNhistory of seasonal ###allergies,### received an inje
was received from a health care professional
Y on 09 June 2009. A female patient received anUinjection of FLUZONE ### SV '2005-'2006 USP (l
n has been received from a physician Y concerningY a 6 month old male 8 patient who on 06-JAN-2009
Y was vaccinated
1/6/2009 with 1/6/2009
one dose of ROTA
n has been received from a 17 yearYold female, for the pregnancy registry for GARDASIL, with Y asthma and 3/21/2008
VICODIN 3/21/2008
allergy, who in Janua
n has been received through the pregnancy registry for GARDASIL from a registered nurse Y concerning a8/18/2008
14 year old 8/18/2008
female with no pertine
n has been received from a consumer Y concerning her approximately 17 year old Ydaughter with N no medical 3/31/2008
history or 9/1/2008
allergies who was vac
ng after receiving the vaccine (06/18/2009) she woke up with severe body aches, felt like the Y flu, and Rt.6/17/2009
deltoid warm 6/18/2009
and tender to the tou
for doctor's visit and was ordered Gardasil
Y vaccination. Patient received vaccination and wasY instructed 6/19/2009
to remain in6/19/2009
waiting are for 20 minu
ately 2 to 4 days after 2nd rabies vaccine, pt developed widespread, wheal-like rash to lowerUarms, lower6/15/2009 legs, back6/17/2009
of neck, & upper chest
me in 6/22/09 stating that child has been fussy, running a low grade fever and unwilling to take U a bottle since
6/19/2009vaccines6/19/2009
given. No fever toda
6/11/2009 N 5/21/2009 6/11/2009
ng of lesions on right wrist, hand, andY genital region 8 days after small pox inoculation. Instructions
U on keeping
6/12/2009 lesions
6/20/2009
convered, good han
esented with red, swollen, painful area on arm where vaccine was administered approximately Y 72 hours after 6/8/2009
shot was 6/9/2009
given. We told her to
ely after Pt received second vaccine: Twinrix, Her head went forward towards knees. Pt wasYreturned to 6/18/2009 sitting position6/18/2009
and regained aware
amined - tender, urticarial type reaction distal to injection site. Large tender, raised urticaria,Uwith central6/19/2009
dusky discoloration
6/19/2009on forearm, w
out 3-4 hours I had a tight chest and nagging cough when I took a deep breath. Little dizzy on N day 2 and6/19/2009
blood spot6/19/2009
in my eye (never had t
n 4/07/09- she developed a rash onYtrunk 6 days Y later on 4/13/09-it 2was scattered over her upper trunk area- 4/7/2009
she called
4/13/2009
Employee Health o
a (from knee to buttock) of redness and swelling. Warm to touch. Starte >36 hours after injection Y 6/15/2009 6/17/2009
ved HPV and had fingerstick for hemoglobin.
Y left exam room and was sitting alone in conference
Y room began
6/22/2009 to feel
6/22/2009
light headed and was
2009, ONE DAY AFTER RECIEVING DTAP, MOTHER REPORTED MODERATE TO LARGE Y AMT. OF SWELLING
6/16/2009 6/17/2009
AT INJECTION SITE. R
& throbbing headache Y 6/22/2009 6/22/2009
derness and swelling over posterior Y aspect of left upper arm on 5/28/09 @16:53. Treatment: Y Ice to area 3-45/14/2009
times daily,
5/14/2009
Medrol dose pack,
tified office approx 45 minutes to 1 hour after vaccination that patient was having chills and wasY shaking.6/15/2009
Denies pain 6/15/2009
in arm. Instructed m
pneumococcal vaccine trial, with severe COPD, was hospitalized on 02/23/2009 with COPDYExacerbation. Vaccination ### 2/23/2009 took place on 10/1
ax 23 was given 6/17/09. Within 24 Y hours, he began to feel some discomfort in that arm and Ydeveloped a6/17/2009macular red 6/20/2009
rash around the injec
WAS GIVEN ALONE IN DELTOID YAREA. NEXT DAY PT RETURNED WITH SWELLING, PRURITUS Y OVER
6/15/2009 WHOLE 6/16/2009
DELTOID AREA.
as given a HPV injection and within Y seconds she fell over with loss of consciousness and jerkingY movements. 6/9/2009Fell off6/9/2009
of exam table. Pt. wa
o Pneumovax with the sweeling, induration,erythema,
Y warthm and pain in the R arm and forearmY 5/20/2009
d with Win. 9/29/09. Hospital records receivedYDOS 4/8/09 to 4/9/09. Assessment: Idiopathic Y Thrombocytopenic
3/28/2009Purpura. 4/8/2009 Child presents w
ned she had warm facial cheeks and red rash on facial cheeks - both facial cheeks - warm toYtouch. Received 6/15/2009 vaccine6/19/2009
on 06-15-09.
MR given Left arm. 2nd in series #/MMR 5/14/09. 6/20/09 Noticed bruising, swelling, tender. 6 inch oblong 6/19/2009
area of redness
6/19/2009 and warm to tou
ncopal event after administration of 4 vaccines (see below). Was caught before fell to floor, Ywas sat on chair, 6/16/2009 as soon6/16/2009
as sat, her eyes ope
tavax was administered in the R deltoid area, Ms. Cubelic has had intermittent intense itching in the right arm distal ### to the ### injection site. Th
easles vaccination rash. Red, raised areas over all of body. Low Grade temp. Y 1/20/2009 1/29/2009
lling of from deltoid to just above elbow
Y with redness and increased heat to palpitation. plus increased
Y bleeding
4/3/2009 at injection
4/5/2009 site with subseq
2 days post injection. Left deltoid area became swollen and inflamed with a 1/2 dollar red lump Y that was6/12/2009
painful and6/14/2009
warm. Generalized mu
h rash (small red dots) in diaper area 06/19/09) on 06/20 and 06/21/09 had red checks, low N grade temp.6/18/2009
slow progression6/20/2009of rash up abd to
feeling well. Generalized weakness. Cold hands and goose bumps noted. V/S HR 88/minute Y RR 20; B.6/15/2009
P 90/60. Placed 6/15/2009
in supine position
ing dizzy. V/S - HR 100/minute, RR 20, BP 100/60. Pt placed in supine position with feet elevated.Y Observed
4/13/2009for other
4/13/2009
reactions. Pt reporte
ed pain and swelling of 3" x 3" in L tricep
Y area. Site showed no redness, duration x 2 days, character
U is constant,
6/17/2009alleviating
6/17/2009 factors: nothing
came faint for about 15 seconds then woke up fine. Was checked (provider) then discharged. Y Was watched 6/15/2009
for 30-456/15/2009
minutes. Pt had clon
se events reported by patient. Y 6/9/2009
cm, overlying cellulitis. U 6/14/2009 6/14/2009
eived MMR and Hep A on 4-10-08,Yat age 2. - Mom noticed increase bruising 1 wk prior to office N visit for4/10/2008
the same. 5/20/2008
She was seen on 5-20-
n has been received from a healthcare worker who worked with 15 patients with no medical U history who were vaccinated with a dose of MM
3.8) and febrile seizure 12 hours after vaccines administered. Y 6/8/2009 6/9/2009
ult diphtheria/tetanus vaccine on 06/16/2009. The following day experienced headache, muscle and joint6/16/2009 aching, flushing
6/17/2009
of skin, and mala
sized red area back of right arm. U 6/9/2009
13 1/2 cm x 17 1/2 cm, swelling at left deltoid, upper arm Y 6/8/2009 6/10/2009
eltoid 10 cm bruise. Warm/Induration, Rash. Y 6/9/2009 6/11/2009
pt states she developed a hive on her face approx 48 hrs after receiving vaccines. Then 12Nhrs later developed 6/12/2009 hive-like
6/14/2009
rash on arms, but
's left deltoid was red + swollen. Redness measured 4cm, swelling measured 3-4 cm. Y 5/28/2009 5/28/2009
8/09. Vaccines were administered and the patient remained in the exam room in a supine position Y for 15 5/28/2009
minutes, with5/28/2009
an additional 10 minu
ys ago. No pain or fever. Itching @ site - no one else has had reaction very large redness & U swelling right
6/15/2009
ant thigh6/16/2009
10.5 cm X 9 cm
DASIL given 5/11/09. She called my office on 6/17/09 to say she had itching in her fingers and Y water blisters
5/11/2009
after inj.
5/11/2009
She gets same rxn w
his am with shot area painful - per mother.
Y U 6/17/2009 6/18/2009
ed LPN to give Hep A and PREVNAR. Y PENTACEL given by LPN instead of PREVNAR. Patient Y recalled 6/15/2009
same day /6/15/2009
stable / no adverse effe
ARICELLA left deltoid on 6/15/09 approximately
Y 9:30 am, child noticed redness, induration and
Y hard bump 6/15/2009
36 hr later
6/16/2009
as he showered, deni
5-8/day) for 2 weeks following the vaccine. Finally changed from Soy to Alimentum and so far Y is better. 6/5/2009 6/5/2009
o 103.3 within 24 hours of 2nd set of immunizations Y 6/16/2009 6/16/2009
he day of the vaccine, had diarrhea for the week after reported to me 6/22/09 Y 4/20/2009 4/20/2009
lands on left side of neck. 6/18/2009 6/22/2009
check-out area stating "i just don't feel right". Skin clammy patient escorted to exam room, had Y her lay down,6/19/2009
lower 6/19/2009
extremities raised. Oran
after PPD placement and GARDASIL Y < 10 second witnessed ?generalized tonic/clonic seizure. Y No post ictal6/19/2009
no incontinence.
6/19/2009
with dizziness and SOB Y 6/22/2009 6/22/2009
a hospital. I was informed about the meningitis vaccine which is a series of 3 shots. It was suggested that I3/8/1989have the vaccines.
3/8/1989 After the first
as given ZOSTAVAX on May 22, 2009. Developed Zoster from neck to wrist on June 8, 2009. 5/22/2009 6/9/2009
ema erythema hyperemia from elbow extending to shoulder. 6/19/2009 6/20/2009
en; red and 3 in x 4 in area- warm to touch. Today blisters on leg. Using MOTRIN and ice onUleg. 6/19/2009 6/20/2009
er called 6-19-09 reporting redness, swelling and warmth to touch at injection site on right arm. Y She stated 6/17/2009
not sure how
6/19/2009
long, but patient jus
B vaccine booster administered @ 3:45 PM. At approx. 8PM, health care worker (HCW) began Y to experience5/20/2009
numbness,
5/20/2009
tingling @ injectio
left arm red and swollen. Treatment - Benadryl 1/2 tsp TID U 6/10/2009
ecking out after check-up appointment Y and fell to the floor, white and pale. After 5 minutes, pt's
Y color is good6/17/2009
and pt6/17/2009
is A and O. Pt's vs norm
d rash c/w very mild VARICELLA Y 5/14/2009 5/19/2009
lla given, supposed to be HAV. No reaction seen. 6/22/2009
m red area (L) Thigh. DTaP and Varicella given on 6-19-09. Y 6/19/2009 6/19/2009
d redness/swelling, fatigue 2 days after
Y PNEUMOVAX injection. U 6/15/2009 6/15/2009
orted a rash that developed on back, neck and arms. Rash cleared up the same day. Y 6/11/2009 6/12/2009
cine 6/3/09. Fever 101 degrees 6/4/09. 101 degrees-103 degrees 6/5/09. Pain at vaccine site. Y 6/3/2009 6/4/2009
ess starting 6/11/2009. R arm 8cm x 9cm redness, warmth, slight indurated area, faint bruise Y under erythema
6/10/2004
able6/11/2009
to move arm. Ice/tylen
dasil 1st dose on Aug 23, 2007, 2nd dose on Oct 23, 2007. I got pregnant in JanY2008. MyNunborn baby then ### diagnosed
1/22/2008with ring chromos
ort was received 10 June 2009 from a newspaper Y article: A female college freshman student had received an unspecified meningococcal va
ort was received 10 June 2009 fromYa newspaper article: Two college students (one identified Y as a male and the other unidentified), had rec
n has been received from a 21 yearYold female patient with a history of previous miscarriageYand anaemia2/1/2009 who in February
2/1/2009 2009, was vacc
n has been received from a physician concerning a 15 year old female with depression who Uin November5/1/2008 2007 was vaccinated
8/1/2008 with her firs
n has been received from a pharmacist Y concerning his friend's daughter who on unspecifiedNdate was vaccinated with a dose of GARDASI
n has been received from a pharmacist concerning two patients who within the last 30 days U were vaccinated5/9/2009
with ZOSTAVAX
5/9/2009 (Merck) (sub
103 degrees - diarrhea -Yloss of appetite
Y - severe
Y stomach pain - weight
3 loss - weak/pale - lasted
Y over 75/11/2009
days. Hospital
5/14/2009
stay was 3 days, tre
Pt c/o pain in feet; 112508 pain cont, Y now can'tYpick up objects with44hands; 112608Y requires Yassist to walk 11/7/2008
into ER; 112708### is now bedboun
ceived ZOSTAVAX vaccine on 5/26/09 and began having adverse reactions on 5/28/09 of body U aches, headache
5/26/2009and 5/28/2009
fever.
(Dtap) whole arm swollen noticed 6/16/09 received imm on 6/15/09 4pm gave Rx Dermatop Y- watch give6/15/2009 tylenol Benadryl
6/16/2009as needed.
urticarial lesion w/o any systemic symptoms. Non pruritic papular lesion surrounds the punctum U where MMR 6/16/2009
was given.
6/16/2009
eddened, feverish knot with redness going to axillary area. Itchy 3 1/2X2 " knot redness 7 1/2" U X 4 1/2" no 6/16/2009
streaking down arm (bubbly look
dministered 6/17. Arm turned pink immediately following, then cleared. Several hours later arm N turned red 6/17/2009
and slightly6/17/2009
swollen in a 3" diame
iven to early per manufacturer. 5/22/2009
TDAP on 6/9/09 noticed hives to injection site and just below injection site to anterior upper Y arm. Had swelling
6/9/2009blotchiness
6/11/2009 to areas and mu
der swelling. U 6/15/2009 6/16/2009
ed and swollen. Y 6/10/2009
d swollen, warm, red and hard to touch-client
Y mother encouraged to seek help at MD or ER. No U drainage noted6/9/2009 at injection
6/9/2009 site.
c/o L upper arm redness Y 4/29/2009 5/2/2009
OUR OFFICE FOR 4 YEAR OLD WELL Y CHILD VISIT. RECEIVED 4 YEAR OLD BOOSTERS: Y Dtap, MMR, 6/17/2009
IPV, AND 6/19/2009
Varivax ON 6/17/09.
nt is a 46-year-old man who had Pneumovax
Y vaccine here on June 17. Within 1 or 2 days, he Y developed6/17/2009
localized redness
6/20/2009 and irritation tha
days after receiving MMR, Prevnar Yand Varivax vaccinations. U 5/13/2009 5/22/2009
ceived the shingles vaccine on Monday, and she came back today on 6/11/09 due to allergic reaction. She 6/8/2009
was told6/11/2009
if she had any problem
other reports 3 to 4 hours after reciving
Y immunizations yesterday, child started running fever U ranging from6/22/2009
99 to 101,6/22/2009
Child very fussy and cr
er called pt complained of soreness Y at the site and feeling cold. The next day she c/o her heart Y racing and 6/17/2009
feeling some 6/18/2009
discomfort in her ch
by Father, stated school nurse called Y that daughter face was swollen. Father instructed to take U daughter 6/22/2009
to ER. 6/23/2009
a Shingles vaccination at 2:30 PM last Friday (06/19/09) and am STILL experiencing headaches N today, Tuesday
6/19/2009(06/23/09).
6/20/2009 I was told at t
e vaccine around 9:00 am, became tired, and went to sleep from 5 to 7pm, then back to bed Y later that night.
6/18/2009
Complained6/18/2009
of excessive night
ble crying, would not nurse or drink. Seen by physician within 4 hours of onset of symptoms.Y Eposide lasting 6/19/200924 hours.
6/19/2009
Physican dx pertu
dap immunization yesterday. At 1100 Y pm she developed onset of HA/dizziness/chills/ nauseated. Y She also
6/22/2009
reported6/22/2009
to her mom some lowe
N OF REDNESS, WARMTH, AND SWELLING TO RIGHT ARM 1 DAY AFTER RECEIVINGYVACCINES. 6/17/2009
REDNESS 6/18/2009
COMPLETELY AROU
2/21/2009 N 2/19/2009 2/21/2009
eloped a few small, raised, red dots on the face and in the hair line area. U 6/23/2009 6/23/2009
er and Grandmother after receiving second series of vaccinations "child will not play as before". U 4/1/2009 4/15/2009
earing Loss and balance problems 5 days after injection. MRI and MRA normal. ETN Y doctors
N (started week 5/7/2009
folowing5/12/2009
SHL) put me on sterio
/1:32pm-Anthrax vax rec'd IM L. Delt. 13 Jun 09/2:00am-Sore throat/fever/chills/flu-like symptoms Y noticed.
6/12/2009
Went to6/13/2009
ER later in the day wh
e fever, polymorphous rash, bilateral bulbar conjunctivitis, cervical lymphadenopathy, erythematous U palms4/30/2009
and soles, 6/21/2009
swelling of hands and
of both ankles, purple/red color on heals.
Y Extreme pain in left ankle/ achillies tenden/ lower leg.
N Began December
11/6/200808-12/1/2008
Present. Can not stan
d the initial left bicep muscle aches toY a common reaction to injections; however deep throbbing U and aching 9/8/2006
in left bicep
9/8/2006
continued; and eve
d a headache shortly after receiving vaccine 3/10/09. He also experience throbbing of the head Y and near3/16/2009
his left eye4/12/2009
thereafter. On 04/12
omplains of "severe itching" from head Y to toe. Member given Benadryl + Clairton by Doctor.Y 6/22/2009 6/22/2009
omplains of "severe itching" from head Y to toe. Member given Benadryl and Claritin by doctor.Y 6/22/2009 6/22/2009
omplains of "severe itching" from head-to-toe.
Y Member given Benadryl and Clartin by doctor.Y 6/22/2009 6/22/2009
omplains of "severe" itching head-to-toe.
Y Member given BENADRYL & CLARITIN by doctor.Y 6/22/2009 6/22/2009
omplains of "serve itching" from head-to-toe.
Y Member given Benadryl and Claritin by doctor.Y 6/22/2009 6/22/2009
omplains of "severe itching" head-to-toe.
Y Member given BENADRYL and CLARITIN by doctor. Y 6/22/2009 6/22/2009
omplains of "severe itching" from head-to-toe.
Y Member given BENADRYL and CLARITIN byYdoctor. 6/22/2009 6/22/2009
omplains of "severe itching" from head-to-toe.
Y Member given BENADRYL & CLARITIN by doctor. Y 6/22/2009 6/22/2009
935 Upon rising client stated "feeling dizzy, laid client down B/P 108/80 P64, R14, skin w/d appropriate
Y for
6/23/2009
race, c/o 6/23/2009
legs feeling week", able
d c/o pain + swelling (LD) area. Observed
Y redness, swelling at area warm to touch. Y 6/17/2009 6/17/2009
hours post administration of HPV 1st seizure - no other risk factors. 7/9/09 Hospital ED records Y received6/15/2009
DOS 6/15/09. 6/15/2009
Assessment: New
t- MENACTRA 5/21/2009
ot- MENACTRA 5/11/2009
the typhoid vaccine on 26 May 1982. He was seen Y in the clinic the50following day Yfor a reaction
N to typhoid5/26/1982
with a temperature
5/27/1982of 100.6; diagn
ot-MENACTRA 5/12/2009
as shaking violently for less
Y than 20 seconds accompanied by pallor & diaphoresis. No loss of Y consciousness.
6/23/2009 7/14/09
6/23/2009
Records rec'd from P
ately equal to 2 hours after eye and cheek swelling. No dyspnea, no vomiting. Y 6/12/2009 6/12/2009
doses of varicella on 2-17-04 and 2-19-08. Pt dx today with chickenpox. Y 2/19/2008 6/23/2009
tes that after the receipt of all three AVA vaccinations she experienced a "knot" at the injection site the day of the ###vaccination.### Additionally
t induration, redness, tenderness atYinjection site (13 cm), fever 102. Y 6/9/2009 6/10/2000
vaccinations 6/8/2009, developed quarter-sized
Y reaction at injection site. Progressed to aboutY grapefruit sized
6/8/2009reaction,
6/8/2009
took BENADRYL a
ven at the site of redness and swelling. Y 6/18/2009 6/19/2009
e she received Tdap is red, swollen and warm to touch on Wed 6-17-09. 6/16/2009 6/17/2009
ports an itching bump at site of injection. She says that she didn't notice it until 3 days after U receiving vaccine.
6/18/2009 I advised
6/21/2009
her to use Benadr
, 2009 12:04 PM After pt was given TDAP and MENACTRA vaccines he jumped off the bedYand sat next 6/19/2009
to his mother,
6/19/2009
while his brother re
other, patient c/o headache on 6/6/09 Y - spent 6/7/09 in bed with nausea, h/a - diarrhea beganYon 6/8 - 6/10. 6/5/2009
Seen in hosp
6/6/2009
on 6/10 - dehydra
ntly gave PEDIARIX at same visit as PENTACEL. Infant's mother aware - informed of possible Y increase local
6/18/2009
reaction per CPC, and to repo
X given inadvertently @ same visit as PENTACEL. Infant's mother aware. Spoke to her 6/22, Y reports no6/18/2009
adverse reactions, no site redness
ogressive body aches. Then weakness + dyspnea. ER visit x1 MD x3. Y 6/16/2009 6/17/2009
t swelling involving the whole L deltoid where vaccine was injected. Y 5/12/2009 5/13/2009
adaches - Given medication for headaches,
Y bed rest. Y 6/15/2009 6/17/2009
episode after MMR vaccine and TBYskin test. While checking out of clinic with parent struck tile floor resulting 6/22/2009 in laceration
6/22/2009 to head and 10
ocal erythema of skin approx 10 cm in diameter, no induration. Y 4/1/2009 4/1/2009
elling from elbow to neck. TX - BACTRIM Y 4 tsp po BID. Y 6/17/2009 6/19/2009
, given & explanation of possible Rx. Took infant home & 2 hours post shots started crying almost Y non stop.
6/22/2009Brought6/22/2009
back to clinic & right
h ~ 2" diameter with corresponding Y axillary lymphadenopathy. Y 6/1/2009 6/2/2009
ollowing vaccine pt - had swelling and Y redness @ injection site with itching. Saw MD. ? cellulitis Y - no tx other6/17/2009
than cold/hot
6/18/2009 packs, resolved w
, deltoid region : 4x6 cm indurated. Pink, non-tender, itchy. 6/16/2009 6/17/2009
ke up screaming @ 2am. Patient had raise red spots over body. They called ER- Couldn't say Y without seeing
6/15/2009her. They
6/16/2009
put her in Aveno ba
utes after intramuscular; injections of PEDIARIX and PREVNAR vaccines to anterior and latYsides of left6/15/2009 thigh, patient's
6/15/2009
left thigh became w
ceived VARIVAX 5/21/09 patient had Y rash 6/17/09 was seen in office 6/18/09. 5/21/2009 6/17/2009
econds after vaccines given. Started on L leg extending to Abd (Very mild). Benadryl 12.5 1/2 Y tsp given &6/4/2009
rash resolved 6/4/2009
after 45min period
tous circular area around site of injection on (L) deltoid. This rash showed the day after shot Y was given. No 6/9/2009
fevers. 6/10/2009
d lump at injection site. Y 5/11/2009 5/11/2009
macular rash trunk, limbs and face. U 6/19/2009 6/23/2009
ite pain after 20 mins. 2 weeks laterYdevelopedYsevere headaches, treated1 with percocet.
Y gained
N 40lbs in1/28/2000
the months 1/28/2000
that followed. extreme
ave two knot very swollen and red around the shot site in his two arms and fever 100.7 for two U days. It wont6/21/2009
go away 6/21/2009
wit tylenol or motrin .w
was received from a physician on 18 Y June 2009. A 14-year-old female patient, with no reported U medical3/26/2009
history, received
4/26/2009the following vacc
n has been received from a certifiedYmedical assistant, for the pregnancy registry for GARDASIL, Y concerning a### 20 year
3/31/2009
old female with a hi
n has been received from a lawyer Y concerning Yher approximately 6 0year old grand daughter Uwho on an unspecified date was vaccinated wi
n has been received from Y a nurse concerning
Y aY4 month old female 1who on 15-APR-2009 was Y vaccinated 4/17/2009
with a first6/4/2009
dose of ROTATEQ (L
n has been received from a physician Y concerning Y an approximately1514-week-old male patient N who was vaccinated
4/1/2009 with 5/1/2009
the first dose of RO
he felt sinus congruent with sore throat, muscle aches allover, Temp, congestion (sinus), general Y malaise6/16/2009
swollen lymph 6/16/2009
Glands @ neck.
s legs + arms heaviness arm R where shot administered nausea + dizziness. N 10/4/2007 10/6/2007
o injection site 3x3 round raised. Orapred + Altabax Y 6/11/2009 6/11/2009
ame pale and lightheaded at clinic, Ybut recovered on own. Mother called in this AM to reportYtaking client 6/19/2009
to ER on 6/19/2009
06/19/09 PM near midn
warmth and swelling at administration site. Y 6/17/2009 6/17/2009
d with ACAM 2000 (lot VV04-003A)Yvaccinia live virus vaccine on June 12 2009. Normal take U documented 6/12/2009
on June6/22/2009
18, 2009. No adverse s
reamed inconsolably for 3.5 hours. Y He also apparently went limp for a few seconds, but did not Y turn blue.3/23/2009
He had a 3/23/2009
fine pinpoint rash and s
nt inadvertantly received a Hepatitis A vaccine instead of the appropriate Hepatitis B #1 vaccine Y at 3 months 6/16/2009
of age.6/16/2009
The patient had no ad
ceived 4 immunizations in the officeYat approx. Y 3:15 PM. Mother called
1 after hours at7:23 to Yreport the child 5/21/2009
was grey/pale
5/21/2009 and limp. No re
en 1st varicella on 06/12/2009 pt returned to the office 6/24/2009 with the c/o spots on belly,Yfever, vomiting. 6/12/2009
Pt was6/24/2009
dx with chicken pox.
ceived Rabies Post Exposure Vaccine (Imovax)Yfor Dose #2/Day 3, 6on 6/18/2009 at 10:00 a.m. U At 1:35 am, 6/18/2009
patient 6/19/2009
was transported to hos
ght parotid gland without fever. chills, malaise, myalgias or fatigue. Y 6/3/2009 6/18/2009
fter administration of zostavax patient stated she had redness at injection site about the size of a quarter, 6/22/2009
3rd day after6/24/2009
injection, site is red,
edness and swelling approximately 4 inches in diameter. Warm to touch, fever 2 days post vaccination.Y Dr.
6/22/2009
saw pt. Advised
6/23/2009 parents to ice a
r i recieved the vaccination i did not Yfeel well and slept all afternoon i recieved the shot in theYmorning. I was 6/18/2009
vomitting,
6/19/2009
almost fainted, swea
ng of immunizations he threw up 2 times,
Y became chilled, spiked a fever, and began having U breathing difficulty
6/22/2008 similar
6/23/2008
to the reaction at 2 m
site the day after immunization. Warm Y red rash extending 5-7 cm around site 6 days after immunization.
U 6/17/2009
No fever, 6/18/2009
chills, drainage. Seen i
immunizations on 06.16.09. Fever and Y vomitingY started on 6.17.09. 3Ataxia started on 6.20.09. N Hospitalized 6/16/2009
from 6.20.09
6/17/2009
- 6.22.09. Post inf
ed Pt developed hearing loss to both ears Dec 07 shortly after completing GARDASIL Y series.UDose #1 1/23/078/6/2007- Dose#2
12/1/2007
3/29/07 - Dose#3 8
009 center was notified by hospital Y of a vaccineY adverse event following
3 involving this patient.
Y The event4/29/2009
occurred in5/11/2009
May 2009. Review of r
ed Tdap and then GARDASIL. she was sitting on end of exam table talking. She stopped talking Y fell forward 6/24/2009
into my6/24/2009
arms and I laid her bac
ates "bumpy rash" to both arms & legs Y 1 day after vaccine. Followed up with pediatrician & dermatologist
N 5/13/2009
who Rx cream 5/14/2009
& rash subsided te
male who presented as walk-in to clinic Y reporting development of itchy red rash over bilateral Y hands evening 6/7/2009
of 6/16/2009;
6/16/2009possibly spreadin
. Soreness at site (L arm). Hives/rash - legs & ankles. Stable no other SX. Y 6/23/2009 6/24/2009
3PM increased fussiness & strangeY eye movement. "Out of it" & fever started. 6/20/09 - Tired Y & diarrhea. 6/19/2009
6/21/09 - "Very out of it". Limited
rts that approximately 7 hours after vaccine was administered, infant became very irritable and Y cried inconsolably.
6/22/2009 Infant6/22/2009only slept 1 1/2 ho
n upper arm swelling, warm to touchYwith some induration. Pt c/o some itching, denies pain. Advised Y to use
6/16/2009
cold compress
6/16/2009 and take BENAD
PNEUMOVAX (L) deltoid 6/23/09. PtYhad pain later same day (+) redness of skin. Rash spread U (+) tender6/23/2009
(-) drainage 6/23/2009
(+) felt warm (-) chills
ash involving mainly the axilla and groin area appearing 48 hrs after vaccine. No associated U fevers. BENADRYL
6/22/2009 3/46/24/2009
Tsp every 4-6 hours.
RN at Dr's office called stating pt had
Y a Hepatitis B shot at our clinic and now was having a Y reaction. Complains
6/22/2009 of 6/22/2009
nausea, "feeling woozy
ened skin from elbow to shoulder onYL UE. Benadryl if needed. Y 6/19/2009 6/21/2009
ed "low grade fever" the evening of 6/19/09
Y -> reported warmth pain and redness at site of the Y PNEUMOVAX 6/18/2009
vaccination
6/19/2009on 6/20/09. Repo
rmth eryth and 1 vesicle just inferiorYto injection site. Itchy, no fever, no malaise. Y 6/23/2009 6/24/2009
ing of day she received vaccines, developed fever, left deltoid redness, swelling and warm to touch and 6/22/2009 soreness. 6/22/2009
vaccine at 830 AM and by 1030 AM left deltoid swollen, hard to touch and soreness. 6/24/2009 6/24/2009
ythematous plaque to L deltoid posterior to injection site. No heat, no streaking, no tenderness, no s/s of6/17/2009infection. Pt 6/23/2009
denies pain, has FRO
pprox 2 pm ZOSTAVAX given approx 1:30 am. Pt experienced rapid pulse of 80-93; BP 146/84, Y went down 6/11/2009
to normal 6/12/2009
after 2 hours, reporte
n has been received through the Merck pregnancy registry from a physician concerning a 23Yyear old female 9/10/2007
who on 12-JUL-2007### was vac
n has been received from a 16 year old female consumer for the Pregnancy Registry for GARDASIL Y concerning
3/19/2008 herself
3/19/2008
who on 19-MAR-20
n has been received from a medical assistant concerning a female in her 20's, who in December Y 2008, was12/1/2008
vaccinated12/1/2008
with the first dose o
n has been received from a nurse practitioner
Y concerning her 13 year old daughter who on 16-JUN-2009
Y 6/16/2009
was vaccinated
6/16/2009 with the first dose
oke-like symptoms such Yas muscle Y weakness on Y one side, slurred speech,
3 confusion,
Y sent toN Emergency Room ###
- Brain scan ###- no stroke, se
ven a flu shot on Monday. Y On Thursday,
Y pt experienced
Y muscle weakness4 on oneYside, slurred
N speech, confusion,
11/3/2008 trouble
11/6/2008 swallowing. He w
PNEUMOVAX 0.5 ml IM 6/5/09. Seen Y @ ER 5/7/09.Y DX: cellulitis (R)
3 upper arm. Treated in Yhospital till 6/10/09.
6/5/2009 Discharge
6/7/2009 6/10/09. 7/2/09
o hospital for routine medical check Yup. 14 y/o female no past medical hx. Pt rec'd three immunizations
U GARDASIL-Merck
6/19/2009 6/19/2009 Lot 0389U Exp 2
given in high left shoulder 6-8-09. (Patient is 65 and should have received plain DT.) Patient developed general 6/8/2009pain & stiffness in left sho
y, cranky, clingy, sl. decreased appetite
Y and developed rash on abdomen, neck, legs overall U scattered on6/20/2009
body incl. 6/21/2009
hands/feet consistent w
swelling, warm to touch at injection site. Pt also has low grade temps. Y 6/15/2009 6/18/2009
econds after injection, patient became pale, diaphoretic and fainted. LOC about 10-15 seconds. Y Responded 6/22/2009
to stimuli
6/22/2009
and had no other pro
h erythema, swelling, warmth to touch Y area of erythema 9x9 inches. 6/18/2009 6/20/2009
and redness, tenderness in area of shotsY on (R) Leg/thigh very large approx. 10x12 cm redness. Y Went to ER-placed
5/7/2009 on 5/8/2009
antibiotics.
d patient reports that patient felt depressed about two weeks after receiving GARDASIL. Also N reports that6/10/2008
she had mood 6/1/2008
swings. Did not se
leg pain and refusal to walk 48 hrs after 5 yr vaccines given in legs. Lasted several hours without Y parents 1/16/2009
being able1/18/2009
to see redness, tende
akness, SOB on exertion (mild) left arm felt tingling & cold however felt warm to provider, no U edema. 6/17/2009 6/18/2009
d on 5-27 and stated child developed Y rash and fever several days after imm - mom states rash Y was very5/12/2009
bad and on 5/20/2009
May 23 they took him
n 6-10-09 c/o headache then at 01:00 Y c/o "whole body shaking" last 1/2 hour then c/o "heaviness Y in the legs
6/9/2009
". Ran 6/10/2009
low grade fever x 4days
exam table - gave MENACTRA im to LD then HPV im RD. A few second later patient feels dizzy Y and passed 6/17/2009
out and 6/17/2009
lying on exam table, f
the shingles vaccine hoping it would help me - I have had 2 episodes a year for about 5 years, after the vaccine that accelerated to 5 episo
Y 6/11/2009
Y 6/17/2009
Y 6/11/2009
esented with Bell's Palsy on 4/28/09. Symptoms. Symptosm began on the 27th with right sided Y facial paralysis,
4/16/2009 blurred
4/27/2009
vision, excessive te
eumococcal vaccine in the ER on 6/18/09 in the Lt posterior arm. Left posterior arm noted with Y red raised 6/18/2009
erthema, swollen and very warm
Y 6/15/2009
Y 6/17/2009
d temp 100.3, unable to work, numbnessY of hands & feet pupils dilated, moaning. BP 120/70Y RR rapid 40, 6/17/2009
headache 6/18/2009
(+) Blood sugar 70. P
3/23/2009 N 3/13/2009 3/23/2009
njection site, feels tender and is somewhat reddened but not warm or infected feeling. U 6/2/2009
atient felt some pain in her upper left arm and felt a small bump.Seen at this office 6/25/09. She U has a 1 cm 5/19/2009
soft cyst-like
6/19/2009
nodule which is in
3, 2009, client returned to health department for PPD reading. During visit, she c/o redness and Y warmth in6/1/2009
her left arm. Visual inspection o
N RED PATCH ON RIGHT DELTOID. U 6/23/2009 6/24/2009
a 61 year old MALE who presents to Y clinic with a 4 day history of R upper arm pain/swelling Y which started6/8/2009
after he received
6/10/2009 the Zostavax o
ever of 102, vomiting, and congestion. Y Was seen in emergency room 6/18/09 because symptoms Y persisted,
6/15/2009
diagnosed
6/15/2009
with pneumonia.Pat
ven VFC DTAP. No adverse reaction. Y 6/15/2009 6/15/2009
recieved 4 vaccines, Hep B, Td, MMR, Y and PPD. 30mins after, she came back complainingYof dizziness6/22/2009 and light headedness.
6/22/2009 Employee
red 2 doses of hepatitis B vaccine on the same date of service Y 6/25/2009 6/25/2009
ceived Hep A and Tdap vaccinations. Y Approximately 1 minute later patient complained of nausea U and she 6/25/2009
was pale. 6/25/2009
Patient lost conscious
e myalgias after injection. On 6/24/09 Y (6 d after inj). Woke up itchy, indurated, local injection site 4 x 8cm.6/18/2009
(B) wrist edema.
6/24/2009Hurt with arthralg
es listed given at 29 days old. 5/1/2009
KINRIX on 6.22.09. Per mom, noticed Y swelling, increase - after 24 hours - 6.23.09, went to ER Y around 11 6/22/2009
pm. Thought6/23/2009
insect bite caused s
lled @ 10 am 6/24/09 to say pt had large reddened area on R upper arm ~ about 4" in triangular U shape -6/22/2009
indurated and6/23/2009
sensitive to touch. C
asovagal reaction abut 5 mins. after administration. Pt responded immediately to verbal commands. Y She6/16/2009
was oriented6/16/2009
- kept pt until her mo
6/23/2009 6/24/2009
by T-99. Red, swollen at site. Advised TYLENOL, cool compresses. Y 6/23/2009 6/24/2009
ould present himself off & on with anger outbursts, mood swings & getting in his "zone" whichUwas like he4/22/2009 couldn't process what I said until a
of right thigh and bruising. U 6/17/2009 6/18/2009
dness, heat, tender, firm area 5" horiz Y and 3" vert just below site of injection in (L) upper arm....2
U days after 6/9/2009
injection6/10/2009
- (started itching 1 day
macular rash started 2 days after vaccine
Y was given & a fever of ? degree was reported by U his mother. He had no fever when seen 6/19/09
ve decreased motor skills LE >> VE Dxd - " transverse Y myelitis". 7/2/09
5 Hospital records received
U DOS 5/29/09
5/4/2009 to 6/2/09.
5/28/2009Assessment: Tra
ontacted by pt mid-Jun 2009 & reported Y recurrent headache, dizziness, nausea, blurred vision, N & fatigue 3/31/2009
which developed
4/13/2009about 2 weeks fo
after administration of vaccine, patient developed erythema, pain, vesicle at site of innoculation/fever
Y of 102
6/16/2009
degrees6/18/2009
approximately 48 hrs a
f injection: Chills, Nausea, Diarrhea & fatigue. 2nd day vomiting & fatigue persists. Y 6/10/2009 6/10/2009
Y 6/11/2009
Y 6/15/2009
Y 6/17/2009
lar rash at injection site - (R) SQ-thigh.
Y U 6/15/2009 6/24/2009
d AM of 6/25/09 L upper arm redness, induration, swelling, and increase warmth. Suspect cellulitis. N Tx with
6/23/2009
KEFLEX6/25/2009
250/5ml one tsp TID x
ceived from a physician on 23-APR-2009 (via a sales representative). The reporter is also the patient. A 3/25/2009 male patient3/27/2009
(initials: EF, age unkn
Migraine with loss of central vision. Y Felt sickly. Diarrhea. Slight headache. Fatigue. Chills. Aches.
Y Report received ###from a consumer
### on 05-N
ceived from a nurse on 03-11-2008. An 80 year-old male patient received AFLURIA 0.5 ml pre-filled U syringe on### 14-Oct-2008.### Concomitant
ceived from a paramedic/fire fighter on 05-Nov-2008. Reporter stated that four (4) patients experiencedU flu-like ###symptoms
11/1/2008
(nasal congestion
ceived from a paramedic/fire fighter on 05-Nov-2008. Reporter stated that four patients experienced U flu-like symptoms
### 11/1/2008
(nasal congestion, ch
ceived from a paramedic/fire fighter on 05-Nov-2008. Reporter stated that four (4) patients experiencedU flu-like###symptoms
11/1/2008(nasal congestion
ceived from a paramedic/fire fighter on 05-Nov-2008. Reporter stated that four (4) patients experiencedU flu-like ###symptoms
11/1/2008
(nasal congestion
ite pain lasting 3 months U ### ###
n has been received from a consumer Y concerning her cousin's 15 year old son who was vaccinated N with MMR II (lot number not available)
n has been received from a physician Y for the pregnancy registry for GARDASIL concerning aY 22 year old 8/5/2008 female with 8/12/2008
a history of papanicol
n has been received from a Physician Y Assistant (P.A) concerning a 15 year old female
Y patient
Y who on 13-JUN-2009
6/13/2009 6/13/2009
was vaccinated with th
information received from the healthcare provider upgraded the case to serious. It also provided U additional
5/18/2007
concomitant
4/9/2009
vaccines, test resu
given MMR and Varicella. Y Whelps atY 5 mins after given. Benadryl given, whelps smaller. Sleeps Y no wheeze, 6/18/2009
cry when6/18/2009
woke 30 minutes afte
rying baby in severe pain- can't calm down, mom can't put baby down. Y 6/22/2009 6/22/2009
me to health dept today and reported Y the following: Client left building where she received IZY"body went6/19/2009
stiff, eyes 6/19/2009
were open x 2-3 minute
Y 4/22/2009
child spiked temp of 101.4 tues. 6/16/09 after vaccinations received Mon. 6/15/09. Fever broke tues afternoon. 6/15/2009 Symptoms
6/16/2009 include runny no
Bright red blood in stool - size: about
Y a quarter occurred twice in the evening on the day sheY received her2/9/2009 2 months 2/9/2009
vaccinations. I took he
nd throat swelling, chest pain 1 1/2-2 Y hours after vaccine was given IV BENADRYL and PEPCID Y given in6/17/2009
ER. 6/17/2009
phenhydramine N
ever, went to ED -> Dx with otitis media. Y Y 5/19/2009 5/20/2009
d elbow and knee burning joint pain. One month after vaccination had Parvovirus infection. Pain Y continues, 2/21/2008
no other3/30/2008
rheumatologic disease
pain in left arm after receiving flu shot. U 10/9/2008 ###
r reported to me that 3 days ago he started with some numbness to left axilla and lateral upper arm. 6/17/09 5/18/2009
50% better.
6/12/20096/22/09 90% bett
nny nose, coughing Dx 6/1/09 with pneumonia
Y Rx AMOXICILLIN. Y 5/29/2009 5/30/2009
fussy, screaming, inconsolable for 2 days. Mom could not put baby down. Y 6/12/2009 6/12/2009
@ injection site Y 6/17/2009 6/18/2009
ely after varicella vaccine, which was given last, client c/o nausea & dizziness. BP 100/60 x2.YJuice was given.6/23/2009
Remained
6/23/2009
seated for 15 min
unization client developed hives thatYitched until she scratched and drew blood. They covered N neck to toe6/10/2009
of her body. 6/12/2009
fter shot, arm swell up, turn red, working down to forearm, painful ! 6-13-09 Medical office provider:
Y PA =6/11/2009
Fexofenadine 60mg = Benadryl =
, pt. called & left a message that following having received VARIVAX, she developed a rash Yon her arm.5/21/2009The message was misplaced, but
ted about 6 to 8 hours after HIB and Prevnar vaccine. Temperature 103 degrees. ContinuedYfever 101 to 6/5/2009 103 for 3 additional
6/5/2009 days. Evaluat
6-3-09. Severe pain in arm,shoulders,knees,back
Y and fever of 103.7 6-4-09. ER on 6-5-09 wasN given Levaquin,
6/3/2009 Vicoden,Ultram.
6/3/2009 6-6-09 pa
d symptoms of dizziness with near Y syncope, sensation of throat constriction with tightness atYthe base of6/20/2009
his neck. 6/21/2009
This was then accompa
ht hours after vaccine administration,Y at about 4:00 AM, patient experienced sensation of throatY constriction6/24/2009
and inability
6/25/2009
to breathe deeply.
d nausea and vomiting, insomnia and mild fever approx. 10 hours after vaccine administration. Y Vomited repeatedly
6/23/2009 during
6/24/2009night. Able to eat
esents to clinic at approximately 1745Y on 6/25/09 for MMR immunization - enrolled in medical Y assistant program
6/25/2009 at local
6/25/2009
school, cannot find
s given a Dtap/Polio IM injection in the left deltoid on Wednesday 6/24/2009. Client and mother U returned 6/24/2009
to clinic at 9:00AM
6/24/2009 on Friday 6/26/2
HAD KINRIX ON 06-23-2009.DEVELOPED RED RAISED SWELLING AT INJECTION SITEUON 06-24-2009.SEEN 6/23/2009 6/24/2009
BY DR.KALIL ON 06-2
welt, larger then usual Y 6/25/2009 6/26/2009
a of erythema with a slight hemorrhagic
Y appearance, encompassing almost entire L thigh U 6/23/2009 6/23/2009
hy, hard, swollen around the injection site. 4-inch diameter around the injection site. Localized U 6/24/2009 6/26/2009
d swollen area approx 4x4 inches bendryl taken Y 6/19/2009 6/25/2009
ours after receiving Oral RotaRix vaccine,
Y 2 month old baby developed fever (100.9-101.2) for U four days,6/22/2009
acute onset 6/22/2009
copious watery non-b
hours after the vaccination, I felt my head starting to ache. Then later I felt like there was anNelephant on6/24/2009
my chest. 6/24/2009
I was having difficulty b
was swollen all the way down to elbow. It is really sore and she had very back headache and joint pain 6/23/2009 6/23/2009
accine administered inadvertantly. Y 4/17/2009 6/26/2009
accine administered inadvertantly. Y 6/24/2009 6/26/2009
ceived Menactra and varivax injection. Patient fainted 3-5 minutes after injection was given Y while in the elevator.
6/26/2009 6/26/2009
ely following vaccine, patient
Y began Y to complainYof mild symptoms (my 5 shoulder hurts,
Y my wrist
N hurts, look at these### spots on ###
my leg. On the
WINRIX 1ml, Tdap 0.5 ml, IPV 0.5 ml, Y MMR 0.5 ml and PPD 0.05 ml. Pt passed out in 1 minute Y and was 4/8/2009
given smelling 4/8/2009
salt and recovered
as given an MMR by agency while was 5 weeks pregnant. 6/9/2009
sweats, dizziness. Y 6/24/2009 6/24/2009
ticaria that started about 12-24h after vaccine administration. Treated with diphenhydramine.U 6/22/2009 6/22/2009
ng - 1 1/2 cm circumferential difference, irritable. Shoulder --> wrist, dorsum of hand slight edema.
Y 6/23/2009 6/23/2009
er of child: See attachment telephone Y conversation 6/25/09 3:30 PM. Y 5/20/2009 5/20/2009
en 6/24/09. 6/26/09 woke with painful, red and swollen arm. Y 6/24/2009 6/26/2009
s after receiving GARDASIL vaccineY Pt. developed dyspnea, dysphagia, stabbing, sharp pain Y (R) arm and 6/12/2009
hip, neck6/12/2009
pain. Dx: Allergic react
minutes of MMR + Varicella vaccines administration child's right thigh became red and indurated. Y 6/25/2009 6/25/2009
3hr prolonged crying episode. Started roughly 3hrs after getting vaccines. Resolved with warm Y compresses 6/23/2009
to the thighs.
6/23/2009
imms. 6/9/09. On 6/10/09 was achy and 102 degrees fever. On 6/13/09 pt again at clinic c/oYnausea, abd6/9/2009 cramping,6/10/2009
and fever.
with warmth ~ 6-7 cm diameter no induration. 6/24/2009 6/25/2009
24,2009 received injection of Zostavax
Y and byYApril 8th, experienced 15 Yextreame anxiety, inability
N to sleep, 3/24/2009
and by May4/8/2009
7th was hospitalized
s of appetite, fever as high as 102.9 after having pneumococal conjugate and hepA vaccinesUon 6/23/08.6/23/2009 6/27/2009
thma attack, no fever, sinus infection.
Y pt treated with iv decadron followed by po taper of prednisone
Y 5/29/2009 6/5/2009
STARTED WITH A FEVER 6/27 ON THE MORNING OF 6/28 BROKE OUT WITH A RASH U WHICH CONSISTED
6/18/2009 OF 6/27/2009
ABOUT 10-20 ERYT
n has been received from a healthcare professional through a Pregnancy Registry for GARDASIL Y concerning
4/21/2008
a 17 year
4/21/2008
old female with dep
n has been received from a physician concerning an 18 year old female who on 18-JUN-2009 Y was vaccinated
6/18/2009IM, 0.5
6/18/2009
ml with the first dose
n has been received from Y a healthcare
Y student concerning a 19-year-old female patient whoYwas vaccinated 4/20/2009
with the4/20/2009
first dose of GARDAS
n has been received from a consumer Y concerningY his fiancee who on 0 22-JUN-2009 was vaccinated
U with6/22/2009
the first dose6/22/2009
of GARDASIL. Subs
perienced two episodes of debilitating inflammatory arthritis after the second andYthird rounds Y of Hepatitis8/29/2008
B vaccination. The ### interval of ons
s, pt experience moderate intense muscle tightness and aching and a sense of limps feeling Ylimp. This interfered 2/9/2009with2/9/2009
her ability to play spo
ed Merck first to report adverse effects. Merck faxed notification to agency and nurse calledYto follow up4/28/2009
with pt. Pt had reported to Merck
ives...They were first noticed around mid January 2009. We first saw our pediatrician who thought
N it was6/11/2008
viral. Then 1/15/2009
we went to see an All
pt called to report GI sxs: nausea, upset stomach. Day later, she reported swollen lymph node Y in armpit 6/23/2009
of left arm where
6/24/2009she got vaccine
7 TO 100.8 FOR 2 DAYS, INCREASE ON SLEEP, INCREASE SPIT UP, RUNNY DIARRHEA/STOOL U 6/25/2009 6/26/2009
started getting red over 24 hrs with lump
Y forming underneath skin. By 36 hrs, arm swollen toNsize of tennis 6/25/2009
ball with 6/26/2009
red color & warmth at to
ection site, R leg "hundred-ish tiny bumps with white pink tips"; later rash appeared on face and U neck; T 6/18/2009
max 102 F;6/20/2009
diarrhea. the night of 6
t 4 days after vaccine (2nd) dose...vaginal
Y lesions,
Y nausea,vomitting, 3 headache -E.R visit diagnosed
Y with1/24/2009
herpes, all1/28/2009
subsequent tests nega
DTaP, MMR, IPV, Varivax on 6-17-2009. Y Had Yhad brief joint pain and
2 mild rash approx 5 daysY prior and6/17/2009
only faint pinpoint
6/18/2009 macular rash on
eived Menactra, Gardisil, Adacel, and, and Havrix. She became pale and nauseated. Her skin Y was cool and
6/29/2009
clammy. 6/29/2009
Her head went down a
2009 CLIENT NOTICED THAT LEFT ARM WAS SORE AND WARM TO TOUCH ALSO REDYAND SWOLLEN, 6/25/2009 INSTRUCTED
6/27/2009 TO TAKE BE
hes in joints, especially injected arm. Began severe headache, nausea, vomiting. Body wasUquivering, jaw 6/23/2009
quivering6/26/2009
bad pretty bad. Did no
able crying, arching back and restlessY no sleeping, High fever N 6/25/2009 6/25/2009
ed that she developed hives on both arms and had a headache approximately 1 hour after receiving Y the6/22/2009
vaccine. She 6/22/2009
called her doctor's o
HY BUMPS ON BADY NOW SPREADING U 6/30/1999 6/29/2009
ceived Zostavax vaccine on 6/17/09. Y States symptoms of pain in upper thighs began on 6/19/09, U pain then
6/17/2009
elevated6/19/2009
to lower back. Visited
er vaccination temp. - sore throat, cough. This lasted 2 1/2 weeks. Then on the 30th of May N I awoke to a5/14/2009
painful left 5/30/2009
knee. This got worse o
Right hand swollen, numb - its mainly in my pointer finger, middle finger & thumb now. I've had N my left arm5/14/2009
go numb5/27/2009