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Case Details (Sorted by Vaccination Date)

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VAERS ID:309092 (history)  Vaccinated:2008-04-07
Age:1.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Male  Submitted:2008-04-08, Days after onset: 1
Location:Illinois  Entered:2008-04-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: 1. Asthma 2. Ear infections
Diagnostic Lab Data: To be done on return visit to Dr. on April 9th, Wednesday.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB222AA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1307U0SCRA
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC458913IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1806U0SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pallor, Petechiae, Rash
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Called to assist supervisor with client. He had MMr, Varicella, Prevnar, & HepA around 10am. About 10:10am a WIC nurse brought to supervisor''s attention client had broken out in a rash. A pinpoint red dot like rash was noted on cheeks bilaterally-paler, sparser dots on abdomen. Child seemed slightly pale. Per standing order at 10:12am 0.1ml epinephrine (1:1000) given IM based on weight of 22 pounds in Rt. vast lat. thigh, 911 called and here about 10:14am. No shortness of breath, wheezing or respiratory distress noted. Child and mom left per private car at 10:35am. Mother was educated that child needed to be seen today and that epinephrine only lasts about 15 minutes. Mom had an appointment with Dr. at 11am. Rash noted to be more scarce and faded, but still visible slightly as pale raised areas on cheeks. Color less pale. Mom left at 10:40am and Dr.''s office called at 10:42am. Report given to nurse and IM record faxed to office. Chart tagged for possible allergy. Per mom''s telephone report Dr. sent child to emergency room. Mom reports they gave Benadryl 12.5mg and kept patient for several hours to observe reaction. Mom states child had no further reactions. She reports today child has a few red dots on face, and a small patch under right areola. Child alert, talking, no signs of repiratory distress per mom''s report. States child has an appointment with Dr. this Wednesday, April 9th for further tests.

VAERS ID:309097 (history)  Vaccinated:2008-04-07
Age:1.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-04-08, Days after onset: 1
Location:Tennessee  Entered:2008-04-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Hx of UTI''s normal VCUG, was recently on Bactrim prophylaxis for this but mom had self d/c''d recently.
Diagnostic Lab Data: n/a, but we are referring to allergist for testing and evaluation.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0800U0IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0201U0SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0726U0SCLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Periorbital oedema, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: Pt received vaccines yesterday between about 10:30-11:00 am, several hours later (came to urgent care clinic about 6pm) with widespread rash which was dx''d as urticaria, and with periorbital edema. Pt had no g.i. or respiratory symptoms at all. Rash and edema have resolved through the night and pt presents to us this am in no distress, for a recheck.

VAERS ID:309098 (history)  Vaccinated:2008-04-07
Age:56.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-04-08, Days after onset: 1
Location:California  Entered:2008-04-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Annual PAP
Preexisting Conditions: DM, HTN
Diagnostic Lab Data: none
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1382U0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Feeling cold, Local swelling
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient presented to clinic approx.15 hours after LUA injection with localized swelling in LUA. Patient states that she experienced chills approx 4hrs after injection. No hives, No itching, No SOB. Patient given hot/cold compression Ibuprofen and Benadryl.

VAERS ID:309100 (history)  Vaccinated:2008-04-07
Age:45.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Male  Submitted:2008-04-08, Days after onset: 1
Location:Maryland  Entered:2008-04-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
JEV: JAPANESE ENCEPHALITIS (JE-VAX)SANOFI PASTEUREJN232B0SCLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA0522 IDLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cold sweat, Dizziness, Flushing, Hyperhidrosis, Loss of consciousness, Nasopharyngitis, Syncope vasovagal, Tonic clonic movements
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad)
Write-up: DIZZINESS, LOSS OF CONSCIOUSNESS, TONIC POSTURING, SEIZURE-LIKE, FLUSHED, DIAPHORETIC, CLAMMY, COLD. PT. AWAKE WITHIN 1-2 MINUTES & FULLY RESPONSIVE & ORIENTED WITHOUT EMERGENCY MEASURES OR MEDICATIONS. b/p 110/70, HR-60 REGULAR. NO RASH/HIVES DISCERNED. ?VASO-VAGAL EVENT VS REACTION.

VAERS ID:309231 (history)  Vaccinated:2008-04-07
Age:1.8  Onset:2008-04-08, Days after vaccination: 1
Gender:Male  Submitted:2008-04-09, Days after onset: 1
Location:California  Entered:2008-04-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB223AA1IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF346AC3IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC499203IMRL
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Induration, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Redness, swelling, warm to the touch. Induration measuring 5 cm x 4 cm. Tx cool compress, Motrin and Benadryl as directed.

VAERS ID:309266 (history)  Vaccinated:2008-04-07
Age:63.0  Onset:2008-04-08, Days after vaccination: 1
Gender:Female  Submitted:2008-04-10, Days after onset: 2
Location:Arizona  Entered:2008-04-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (NO BRAND NAME)UNKNOWN MANUFACTURER  IDLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal distension, Blood pressure increased, Head discomfort, Headache, Hypersomnia, Injection site erythema, Injection site pain, Injection site swelling, Malaise, Somnolence, Swelling
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Depression (excl suicide and self injury) (broad)
Write-up: Shot was given approx. at 5:00 pm on 4/7/08. Around 9 am on 4/8/08 I started feeling an oppression in my head and a sick feeling to my stomach. My head felt like it was being compressed, with a slight headache. I felt also very sleepy. I am on High Blood pressure medication (Cozaar 50 mg), and I took it earlier than I usually do, because I thought it could be high. I went on feeling sick and sleepy for the rest of the day. Besides, my stomach was distended, as if my body was swollen. I was at work, so I could not have my blood pressure checked. When I did check it around 6 p.m. it was 164 over 89, when the day before (at my doctor''s office) it had been 121 over ?. I took 25 extra mg of Cozaar. Besides, I was so sleepy that I fell momentarily asleep TWICE while driving home from work! On 4/9/08, I woke up with the shot area swollen, red, and tender. But my blood pressure was back to normal, and I felt OK otherwise.

VAERS ID:309272 (history)  Vaccinated:2008-04-07
Age:60.0  Onset:2008-04-09, Days after vaccination: 2
Gender:Male  Submitted:2008-04-10, Days after onset: 1
Location:Oregon  Entered:2008-04-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1875U0SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Inflammation, Pain in extremity, Ulnar nerve injury
SMQs:, Accidents and injuries (narrow), Arthritis (broad)
Write-up: Patient reports pain in little finger and 4th finger with some joint pain at elbow. He feels it might be ulnar nerve inflammation. He wanted it reported however.

VAERS ID:309274 (history)  Vaccinated:2008-04-07
Age:30.0  Onset:2008-04-08, Days after vaccination: 1
Gender:Female  Submitted:2008-04-10, Days after onset: 2
Location:Ohio  Entered:2008-04-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none known; vaccine was given with the second step of a tuberculin skin test (results of both were negative (0mm))
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1008U0SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Client returned to the office to have TB test read & notified RN that site of varicella vaccination from 2 days prior was "red and itchy". Client stated that this reaction started on 4/8/08 in the afternoon. She received the vaccination on 4/7/08. She reported no prior history of chickenpox disease or vaccination and was required to recieve the vaccine by her school (nursing degree). Site was noted to be red, raised, warm to the touch and client reported ''itchy''. Client denied signs or symptoms of anaphylaxis but was encouraged to go to the ER for evaluation. Client returned to the office after going to the ER where she reported being told that this was a possible injection reaction and that she should return to the ER if she developed trouble breathing. The Health District RN instructed the client to contact her physician for an opinion as to whether to receive the second dose of varicella and for an exemption notice for her school of nursing, should the doctor forbid her to receive the second dose.

VAERS ID:309279 (history)  Vaccinated:2008-04-07
Age:10.0  Onset:2008-04-08, Days after vaccination: 1
Gender:Male  Submitted:2008-04-10, Days after onset: 2
Location:California  Entered:2008-04-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE REPORTED AT THE TIME
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2825AA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1779U1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: RT ARM SUBCUT WHERE VARICELLA WAS GIVEN HAD RAISED RED AREA OF 3MM X 3MM- WARM TO THE TOUCH. ADVISED COOL COMPRESSES, GIVE TYLENOL OR ADVIL - PT STATES THAT HIS RT ARM DOES NOT HAVE ANY ITCHING.

VAERS ID:309280 (history)  Vaccinated:2008-04-07
Age:0.2  Onset:2008-04-08, Days after vaccination: 1
Gender:Male  Submitted:2008-04-10, Days after onset: 2
Location:Indiana  Entered:2008-04-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: pink eye
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEUR  IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Diet refusal, Gastrointestinal sounds abnormal
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad)
Write-up: Prolonged crying for six hours. Not his normal cry. He didnt eat and when he tried he would start crying again. His stomach made loud growling noises.

VAERS ID:309302 (history)  Vaccinated:2008-04-07
Age:4.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Male  Submitted:2008-04-10, Days after onset: 3
Location:Georga  Entered:2008-04-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2156BA4IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Patient developed and increase amount of swelling at site of injection was red and hot to touch for 2-3 days after shot was given. Redness was 2" x 2" in size. On 4/10 patient still has 1/2" x 1" rash.

VAERS ID:309366 (history)  Vaccinated:2008-04-07
Age:0.2  Onset:2008-04-09, Days after vaccination: 2
Gender:Female  Submitted:2008-04-11, Days after onset: 2
Location:North Carolina  Entered:2008-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNAGIS 0.37 LOT# 06L609 GIVEN 3/13/2008
Current Illness: NONE
Preexisting Conditions: PREMATURITY, 29-30 WKS TWIN GESTATION
Diagnostic Lab Data: BACTERIAL CULTURE OF STOOL WAS NEGATIVE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME)UNKNOWN MANUFACTURERAC21B142AA0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF344AD0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC547630IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0142X0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bacterial culture negative, Culture stool, Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)
Write-up: TWO DAYS AFTER RECEIVING IMMUNIZATIONS, INCLUDING ROTATEQ, PRESENTED TO OFFICE WITH BLOODY STOOL

VAERS ID:309368 (history)  Vaccinated:2008-04-07
Age:0.3  Onset:2008-04-11, Days after vaccination: 4
Gender:Female  Submitted:2008-04-11, Days after onset: 0
Location:Virginia  Entered:2008-04-11
Life Threatening? No
Died? Yes
   Date died: 2008-04-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO NOTED ILLNESS WHEN EXAMINED AT 2 MONTH WELL CHILD CHECK ON 04/07/08
Preexisting Conditions: PREMATURE- 32 WEEK GESTATION DUE TO PLACENTAL ABRUPTION. DIAGNOSIS WHILE IN NICU: RESPIRATORY DISTRESS SYNDROME; HYPOTENSION; INTRAVENTRICULAR HEMORRHAGE GRADE 1; DIFFICULT INTRAVENOUS ACCESS; RULE OUT SEPSIS; HYPERBILIRUBINEMIA- INDIRECT; POSSIBLE MATERNAL DRUG USE; FEEDING INTOLERANCE. DISCHARGED FROM NICU ON 01/14/08 AND FOLLOWED UP IN OFFICE ON 01/16/08 FOR WEIGHT AND FEED CHECK- NOTED TO BE GAINING WEIGHT AND FEEDING WELL. SEEN IN OFFICE ON 02/02/08 FOR RECHECK WEIGHT, CONGESTION- NASAL, SLIGHT COUGH, AND SNEEZING. SEEN IN ER ON 02/02/08 FOR QUESTIONABLE APNEA EPISODE WITH CHOKING. EMS CALLED AND PT TAKEN TO ER FOR EVALUATION. NO S/S OF ILLNESS FOUND AT ER VISIT. WHEN SEEN IN OUR OFFICE ON 02/05/08 DIAGNOSED WITH COMMON COLD AND
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B139AA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF219AA/UF154AA0IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC458940IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1195U0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Death, Death of relative, Premature baby, Sudden infant death syndrome, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: ON 04/07/08, THE 2 MONTH IMMUNIZATIONS OF PEDIARIX, PREVNAR, ACT HIB AND ROTATEQ WERE ADMINISTERED TO THIS PATIENT AT HER CURRENT AGE OF 3 1/2 MONTHS. THERE WERE NO ADVERSE EFFECTS NOTED WHILE IN THE OFFICE. THERE WERE NO PHONE CALLS FROM PARENTS REPORTING PROBLEMS AFTER LEAVING THE OFFICE. MEDICAL EXAMINER CALLED THIS MORNING (04/11/08) TO MAKE DR. AWARE THAT PATIENT HAD BEEN FOUND UNRESPONSIVE ON MORNING OF 4/11/08. RESCUE SQUAD WAS UNABLE TO RESCUSITATE THE INFANT. CASE IS BEING INVESTIGATED BY COUNTY SHERIFF''S OFFICE AND IS MEDICAL EXAMINER''S CASE. AUTOPSY WILL BE DONE. AT PRESENT THE PRESUMED DIAGNOSIS IS SUDDEN INFANT DEATH SYNDROME. 6/27/08 Autopsy states COD as sudden unexplained infant death assoc w/prior sibling death, non-standard bedding & prematurity. Autopsy states no evidence of trauma, disease or congenital anomaly.

VAERS ID:309427 (history)  Vaccinated:2008-04-07
Age:0.3  Onset:2008-04-08, Days after vaccination: 1
Gender:Male  Submitted:2008-04-08, Days after onset: 0
Location:Minnesota  Entered:2008-04-14, Days after submission: 6
Life Threatening? No
Died? Yes
   Date died: 2008-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol given
Current Illness: None
Preexisting Conditions: H/O RSV Bronchiolitis - in 2/2004 - Resolved; GERD
Diagnostic Lab Data: Autopsy - pending from medical examiner
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B133DA1IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF255AB1IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC499191IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0141X1PO 
Administered by: Private     Purchased by: Private
Symptoms: Autopsy, Body temperature decreased, Cardiac arrest, Cardio-respiratory arrest, Endotracheal intubation, Laboratory test normal, Sudden infant death syndrome, Unresponsive to stimuli, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Note: Pt had no fever. Next day after immunization - Pt found unresponsive during nap at daycare. Asystolic at daycare - unable to be resuscitated by paramedics nor by ED physician. 5/27 Autopsy report states COD as SIDS. All labs WNL. 4/22/08 Reviewed ER medical records of 4/8/2008. Records reveal patient in cardiopulmonary arrest after being found unresponsive by daycare provider. No bystander CPR provided. EMS found patient in v-fib. No defibrillation, just epi , intubation & intraosseous line. Patient in asystole in ER, temp 95 (R), glucose 111, unresponsive & expired.

VAERS ID:309432 (history)  Vaccinated:2008-04-07
Age:6.0  Onset:2008-04-08, Days after vaccination: 1
Gender:Female  Submitted:2008-04-14, Days after onset: 6
Location:New Jersey  Entered:2008-04-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Brown''s Syndrome
Diagnostic Lab Data: N/A
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.15844/145241SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, Erythema, Injection site bruising, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Recieved #2 on 4/7/08. On 4/8/08 noted bruising at injection site. Woke up on 4/9/08 aith increase swelling and redness. Seen in our office and diagnosed with Left arm cellulitis secondary to immunization reaction.

VAERS ID:309441 (history)  Vaccinated:2008-04-07
Age:4.0  Onset:2008-04-08, Days after vaccination: 1
Gender:Female  Submitted:2008-04-14, Days after onset: 6
Location:Indiana  Entered:2008-04-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B061AA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR2106923SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1671U1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1782U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Musculoskeletal pain, Tenderness
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Mother states 4 x2 inch redness of left arm on 4/9/08. States pain from shoulder to elbow with tender to touch until 4/12/08. Ring effect redness on lateral side of Lt arm. Kept child awake at night. Seen by family physician on 4/10/08. Benadryl and ABT prescribed.

VAERS ID:309457 (history)  Vaccinated:2008-04-07
Age:11.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-04-11, Days after onset: 4
Location:Connecticut  Entered:2008-04-14, Days after submission: 3
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Advair, Flovent, Vyvanse, Zoloft, fluoride
Current Illness: none
Preexisting Conditions: Triple X syndrome, eosinophilic esophagitis PMH: allergies to nuts, shellfish, eggs, ceclor, paprika. Anxiety. ADHD. Family hx of asthma & food allergies.
Diagnostic Lab Data: none
CDC 'Split Type': CT200803
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2375BA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1784U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Chest discomfort, Cough, Dyspnoea, Erythema, Eye swelling, Hypersensitivity, Injection site erythema, Injection site swelling, Pruritus, Rhinorrhoea, Swelling face, Throat tightness, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Allergic reaction. Coughing, facial swelling and hives 15 minutes after leaving the office. Epi pen administered by mother en route to medical center. Treated in ED and discharged home same day. 5/20/08 Reviewed ER medical records of 4/7/2008. FINAL DX: allergic reaction Records reveal patient experienced itching, SOB, throat tightness, rhinorrhea, chest tightness & hives approx 2 hours s/p vaccination. Developed redness & swelling at varicella injection site. Used epi-pen & antihistamine at home. Called EMS who found patient SOB w/eye swelling, face red. Tx w/steroids. Improved & d/c to home on continued meds.

VAERS ID:309530 (history)  Vaccinated:2008-04-07
Age:29.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-04-15, Days after onset: 8
Location:Florida  Entered:2008-04-15
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No concurrent medication
Current Illness: Unknown
Preexisting Conditions: Relevant medical history included a latex allergy. Subject developed a rash from wearing latex gloves. No history of adverse events following previous vaccinations.
Diagnostic Lab Data: UNK
CDC 'Split Type': A0722846A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B020AA0UNLA
Administered by: Private     Purchased by: Public
Symptoms: Anaphylactic reaction, Cough, Dizziness, Dyspnoea, Local reaction, Pruritus, Rash macular, Wheezing, Wrong drug administered
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of shortness of breath in a 29-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Relevant medical history included a latex allergy and no history of adverse events to previous vaccinations. On 7 April 2008 at 13:05 the subject received 1st dose of BOOSTRIX (.5 ml, single dose vial, left arm). On 7 April 2008, within 20 minutes after vaccination with BOOSTRIX, the subject started to experienced shortness of breath, wheezing, coughing, itching, skin blotches and dizziness. The subject was treated with BENADRYL and Epinephrine in the office. The symptoms improves some and the subject was taken to the emergency room where Solumedrol was administered. The subject was released from the emergency room and was not hospitalized overnight. The subject also experienced a vaccination error as BOOSTRIX is recommended for 10 through 18 years of age. The physician considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were improved. The physician considered the events were probably related to vaccination with BOOSTRIX. Additional information received on 08 April 2008 from a nurse. She reported that the subject had no concurrent medications. She reported that no other vaccinations were given on the same day as BOOSTRIX. She reported that the subject experienced an anaphylactic reaction and BOOSTRIX was mis-administered per the indicated age range. She noted that the subject also had an adverse reaction to the vaccine that was initially local and then became systemic. The nurse reported that the subject received Solumedrol, epinephrine and Pepcid in the healthcare professional''s office and then was transported to the hospital by emergency medical services.

VAERS ID:309606 (history)  Vaccinated:2008-04-07
Age:28.0  Onset:2008-04-08, Days after vaccination: 1
Gender:Female  Submitted:2008-04-10, Days after onset: 2
Location:Wisconsin  Entered:2008-04-16, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: GERD, asthma, seasonal allergic rhinitis
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB163AB0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2863AA0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Chills, Diarrhoea, Headache, Injection site erythema, Injection site pain, Injection site warmth, Local reaction, Lymphadenopathy, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Pain near injection site. Local 4cm surrounding warmth erythema to injection site R arm Hep A. Infraclavicular lymphadenopathy. Nausea, diarrhea. Fevers/chills. Headache. All symptom onset within 24 hours.

VAERS ID:309608 (history)  Vaccinated:2008-04-07
Age:17.0  Onset:2008-04-08, Days after vaccination: 1
Gender:Female  Submitted:2008-04-08, Days after onset: 0
Location:California  Entered:2008-04-16, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB216AA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0523U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU256AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B019AA5IMRA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Arm was red/swollen/warm to the touch.

VAERS ID:309676 (history)  Vaccinated:2008-04-07
Age:66.0  Onset:2008-04-15, Days after vaccination: 8
Gender:Female  Submitted:2008-04-16, Days after onset: 1
Location:Michigan  Entered:2008-04-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prilosec - Glucosamine and Chondroitin - Detrol - Arthrotec - Xanax
Current Illness: None - Dog Bite
Preexisting Conditions: Codeine Allergy / Arthritis; Post Phlebotic Syndrome ; Rhinitis
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU1963DA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Area of injection (given 4/7/08) just started to redden and itch yesterday 4/1508. Area of redness is 2" x 2 1/2". Site marked by Dr.. Antibiotic Dicloxicillin and Atarax x 1 week. Pt will phone if no improvement.

VAERS ID:309732 (history)  Vaccinated:2008-04-07
Age:4.0  Onset:2008-04-08, Days after vaccination: 1
Gender:Female  Submitted:2008-04-10, Days after onset: 2
Location:Kentucky  Entered:2008-04-16, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2799AA4IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA03423SCLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1482U1SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: 4 1/2 x 2 3/4 redness with some itching Parent gave Tylenol and Benadry prior to bringing in for eval. of reaction

VAERS ID:309735 (history)  Vaccinated:2008-04-07
Age:7.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-04-09, Days after onset: 2
Location:Florida  Entered:2008-04-16, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Advair; Nexium; Replan; Flonase
Current Illness: Afebrile; Nasal congestion
Preexisting Conditions: Asthma; Esophageal reflux; IgG subclass deficiency.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Injected limb mobility decreased, Injection site induration, Pain in extremity, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Arm pain with redness, warmth, induration at injection site. Decreased limb mobility secondary to pain.

VAERS ID:309738 (history)  Vaccinated:2008-04-07
Age:42.0  Onset:2008-04-09, Days after vaccination: 2
Gender:Male  Submitted:2008-04-09, Days after onset: 0
Location:Florida  Entered:2008-04-16, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1410U4IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1491U1SCLA
Administered by: Military     Purchased by: Military
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Developed redness and swelling at and distal to injection site on L upper arm - started within one day of injection. He had a hx of delayed reaction one month ago that occurred 6 days after the injection.

VAERS ID:309740 (history)  Vaccinated:2008-04-07
Age:4.0  Onset:2008-04-09, Days after vaccination: 2
Gender:Male  Submitted:2008-04-16, Days after onset: 7
Location:Texas  Entered:2008-04-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA, febrile seizures
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B054AA4UNRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB242BA1UNLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1670U1UNRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1782U1UNLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: (R) lateral and post thigh, 3 cm firm induration with slight eyrthema. Not tender.

VAERS ID:310053 (history)  Vaccinated:2008-04-07
Age:1.6  Onset:2008-04-07, Days after vaccination: 0
Gender:Male  Submitted:2008-04-11, Days after onset: 4
Location:Massachusetts  Entered:2008-04-18, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: GE reflux PMH: several family members w/URI & 1 with strep. 37 wk delivery, resp complications & kept in NICU x 3 days. Has aunt w/epilepsy.
Diagnostic Lab Data: lumbar puncture; CBC; electrolytes; urine LABS: WBC 3.27 (L), H/H 9.8/29.3 (L). CSF WNL, c/s neg. Rapid strep neg. Neutro # 1.47 (L), lymph # 1.41 (L), eos # 0.00 (L), monos 12% (H). Sodium 134 (L), CO2 21 (L), glucose 120 (H).
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU2354AA3IMRA
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC413363IMRA
Administered by: Private     Purchased by: Public
Symptoms: Blood electrolytes, Blood glucose increased, Blood sodium decreased, CSF culture negative, CSF test normal, Carbon dioxide decreased, Convulsion, Ear infection, Eosinophil count decreased, Febrile convulsion, Foaming at mouth, Full blood count, Gaze palsy, Haematocrit decreased, Haemoglobin decreased, Lumbar puncture, Lymphocyte count decreased, Monocyte count increased, Neutrophil count decreased, Otitis media acute, Pharyngeal erythema, Pyrexia, Somnolence, Streptococcus identification test, Streptococcus identification test negative, Tonsillar hypertrophy, Urine analysis, Viral infection, White blood cell count decreased
SMQs:, Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad)
Write-up: Fever onset less than 24 hr after vaccines with seizure lasting less than 10 minutes. Treated symptomatically and with azithromycin for otitis. Temp decreased. Fever reoccurred 24 hr later with 2nd seizure. Child admitted to hospital. Maximum temp 104.5. 5/9 Received only partial hospital medical records for 4/8-4/10/2008 consisting only of lab reports. 8/5/08 Reviewed hospital medical records of 4/8-4/10/2008. FINAL DX: complex febrile seizures & acute viral illness. Records reveal patient experiened fever of 104.5 & seizures w/flexion, clenched fists, shaking, eyes rolled up, frothing at mouth for approx 10 min then sleepy afterward. Seen in ER & dx w/OM & febrile seizures. Tx w/antipyretic & d/c to home. Following day, fever of 102 despite antipyretic & had another seizure lasting 15-30 min. Exam revealed injected TMs bilaterally, erythematous oropharynx w/enlarged tonsils & shotty lymph nodes. No further seizure despite additional fevers. D/C to home w/outpatient EEG & neuro f/u.

VAERS ID:310066 (history)  Vaccinated:2008-04-07
Age:32.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 7
Location:Colorado  Entered:2008-04-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None-Health Main Exam
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2767AA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pain at injection site. Nausea, redness and swelling, chills and body aches, Mild fever, headache

VAERS ID:310078 (history)  Vaccinated:2008-04-07
Age:2.0  Onset:2008-04-08, Days after vaccination: 1
Gender:Female  Submitted:2008-04-18, Days after onset: 10
Location:Rhode Island  Entered:2008-04-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: very mild eczema
Preexisting Conditions: mild eczema, NKDA
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB256AA1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow)
Write-up: Woke up crying and having urticaria around 4AM on the night after receiving of Hepatitis A vaccine, resolving with Benadryl.

VAERS ID:310090 (history)  Vaccinated:2008-04-07
Age:1.0  Onset:2008-04-15, Days after vaccination: 8
Gender:Male  Submitted:2008-04-18, Days after onset: 3
Location:Ohio  Entered:2008-04-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: none
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 3  
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 0  
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 3  
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Irritability, Rash maculo-papular, Sleep disorder
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow)
Write-up: Diffuse macular papular rash 7 days after vaccines. No vesicles. No fevers. He has been irritable and not sleeping well for 2-3 days.

VAERS ID:310406 (history)  Vaccinated:2008-04-07
Age:61.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-04-15, Days after onset: 8
Location:Virginia  Entered:2008-04-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fibromyalgia
Preexisting Conditions: Hypertension, DM type 2, RA, anxiety, hypothyroidism, fibromyalgia
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0990U0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pharyngeal oedema, Pyrexia, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow)
Write-up: Patient reports she received Pneumovax on 4/7/08 and approx. 6 hours later she developed temperature of 103.9 by 1. She was covered in hives, throat was swollen - completely covered in rash. Took Tylenol temp decreased to 102 the next day and on Saturday temperature was 104 and on Sunday April 13 no further fever.

VAERS ID:310415 (history)  Vaccinated:2008-04-07
Age:0.3  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-04-21, Days after onset: 14
Location:Arizona  Entered:2008-04-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: strawberry yogurt/hyperbilirubinemia
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B0420UNRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF208AA0UNLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01090UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH808679E0UNLL
Administered by: Private     Purchased by: Public
Symptoms: Rash erythematous, Thirst
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Rash (red) to both cheeks. Also developed increased thirst.

VAERS ID:310502 (history)  Vaccinated:2008-04-07
Age:38.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 7
Location:Minnesota  Entered:2008-04-22, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Epi pen prn
Current Illness: None
Preexisting Conditions: Egg allergy when young - does not receive flu shot. Penicillin; sulfa and erythromycin.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2767AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Fatigue, Feeling hot, Headache, Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling, Injection site warmth, Pain, Pruritus, Pyrexia, Rash papular, Stomach discomfort, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: 4/7/08 - Painful, became swollen, redness, bump day of administration (tired and itching). For next 3 days - headache, extreme fatigue, stomach boiling, fever (101), injection site very swollen, itchy, red, and hot to the touch (about soft ball size). One week later - area golf ball size. Lump under skin. Still painful and itchy - HA, fever, fatigue gone. Still has lump. Some pain & itching.

VAERS ID:310572 (history)  Vaccinated:2008-04-07
Age:37.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-04-22, Days after onset: 15
Location:California  Entered:2008-04-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1631SCRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA03942IMLA
Administered by: Military     Purchased by: Military
Symptoms: Headache
SMQs:
Write-up: Constant headache with two episodes of Migraine.

VAERS ID:310578 (history)  Vaccinated:2008-04-07
Age:21.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-04-22, Days after onset: 15
Location:California  Entered:2008-04-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: Patient is being worked up for Cushing''s syndrome.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1210U0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: 21 yo female with fever 100.8, vomiting and diarrhea about 4-5 hours after administration of first HPV (Gardasil) shot. Patient recovered within 24 hours.

VAERS ID:310725 (history)  Vaccinated:2008-04-07
Age:1.2  Onset:2008-04-16, Days after vaccination: 9
Gender:Male  Submitted:2008-04-22, Days after onset: 6
Location:California  Entered:2008-04-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: unknown - Foster child
Diagnostic Lab Data: DRI/Poss measles vs vaccine (MMR) reaction
CDC 'Split Type': CA080008
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB171AA0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF119AA3IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0287U0SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0729U0SCRL
Administered by: Private     Purchased by: Public
Symptoms: Decreased appetite, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Pt is a foster child that was seen in our office for well child exam and immunizations; MMR #1, varicella #1, Hib #4, and Hep A #1 were administered on 04/07/08. On 04/16/08 pt was seen x fever, poor appetite and exanthema over legs x 12-24 hr duration.

VAERS ID:310761 (history)  Vaccinated:2008-04-07
Age:68.0  Onset:2008-04-15, Days after vaccination: 8
Gender:Female  Submitted:2008-04-21, Days after onset: 6
Location:Illinois  Entered:2008-04-23, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: CBC
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU2067CA SCUN
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Full blood count
SMQs:
Write-up: Cellulitis left upper arm; Treated with Levaquin 750 daily for 10 days

VAERS ID:310810 (history)  Vaccinated:2008-04-07
Age:1.0  Onset:2008-04-14, Days after vaccination: 7
Gender:Female  Submitted:2008-04-16, Days after onset: 2
Location:Massachusetts  Entered:2008-04-24, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB211AA0UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1499U0UNLL
Administered by: Private     Purchased by: Public
Symptoms: Rash vesicular
SMQs:, Hypersensitivity (narrow)
Write-up: Vesicular rash 1 week following vaccination. On 4/16/08, 5-6 vesicles on trunk and face.

VAERS ID:311002 (history)  Vaccinated:2008-04-07
Age:70.0  Onset:0000-00-00
Gender:Male  Submitted:2008-04-25
Location:Unknown  Entered:2008-04-28, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: aspirin; LIPITOR; lisinopril
Current Illness: Allergic reaction to antibiotics; Hypertension
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0804USA04468
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Pancreatitis
SMQs:, Acute pancreatitis (narrow)
Write-up: Information has been received from a pharmacist concerning a 70 year old male with allergic reaction to CIPRO and hypertension who on 07-APR-2008 was vaccinated with ZOSTAVAX. Concomitant therapy included LIPITOR, lisinopril and aspirin. Subsequently the patient developed pancreatitis and was hospitalized. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.

VAERS ID:311033 (history)  Vaccinated:2008-04-07
Age:70.0  Onset:2008-04-14, Days after vaccination: 7
Gender:Female  Submitted:2008-04-18, Days after onset: 4
Location:Wisconsin  Entered:2008-04-28, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: baby aspirin, vitamin, calcium (Tums)
Current Illness: None
Preexisting Conditions: Mild hyperlipidemia, osteopenia
Diagnostic Lab Data: Viral testing of vesicular draining - not detected with culture
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0967U0SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Pruritus, Rash vesicular, Virus culture negative
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Clusters of vesicular rash on coccyx area, left gluteal cleft & left perineum, 1.5 cm diameter. For last 5 days. Itching sensation prior for approx 24 hours. Pt applied Neosporin for 3-4 days.

VAERS ID:311052 (history)  Vaccinated:2008-04-07
Age:0.3  Onset:2008-04-14, Days after vaccination: 7
Gender:Male  Submitted:2008-04-28, Days after onset: 14
Location:Tennessee  Entered:2008-04-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Hemoccult positive on 4/14/08; Hemoccult negative on 4/21/08
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2933AB1IMLL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1610U1IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA034221IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC451531IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0017X1PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Haematochezia, Occult blood positive
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)
Write-up: Blood in stool-- noted by parents with positive Hemoccult approximately 1 week after vaccine (on 4/14/08).

VAERS ID:311089 (history)  Vaccinated:2008-04-07
Age:1.4  Onset:0000-00-00
Gender:Female  Submitted:2008-04-09
Location:California  Entered:2008-04-28, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B060AB1IMLA
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC458931IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Prevnar/TDAP was given 04/07/08. Local erythema and edema noted. Tennis ball size. Both vaccines given proximal to each other.

VAERS ID:311209 (history)  Vaccinated:2008-04-07
Age:15.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-04-29, Days after onset: 22
Location:Oklahoma  Entered:2008-04-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.AHAVB222A0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2484AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B019AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: MOM REPORTED PATIENT HAD ITCHING AND RASH 1 HR AFTER ADMINISTRATION LASTING LESS THAN 45 MINUTES; EXACERBATE BY HOT SHOWER; CLEARED WITH BENADRYL.

VAERS ID:311216 (history)  Vaccinated:2008-04-07
Age:0.4  Onset:2008-04-22, Days after vaccination: 15
Gender:Female  Submitted:2008-04-29, Days after onset: 7
Location:Pennsylvania  Entered:2008-04-29
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Gastroesphageal reflux. PMH: reflux. NKDA
Diagnostic Lab Data: Labs and Diagnostics: Abd X-ray concerning for IS. Abd US (+) for IS. Barium Enema (+) for IS. Stool Rotavirus antigen (+). Stool cx (-). UC (-).
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2935AA1IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF355AA1IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA08051IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC499191IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0017X1PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal X-ray, Abdominal tenderness, Barium double contrast, Culture stool negative, Culture urine negative, Diarrhoea, Haematochezia, Intussusception, Laparoscopy, Large intestinal obstruction reduction, Rotavirus infection, Rotavirus test positive, Surgery, Ultrasound abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)
Write-up: PATIENT WAS DIAGNOSED WITH INTUSSUSCEPTION ON 4/28/08. 6/06/2008 MR received for DOS 4/29-30/2008 with d/C DX: Intussusception. Rotavirus. Infant presented to local ER with 1 week hx of diarrhea and recent onset of vomiting as well as irritability and abdominal tenderness. Transferred to current facility due to concern for IS. In ER had bloody stool. US confirmed IS and pt taken for Air Contrast Barium Enema reduction which was only partially successful x 2 attempts. To OR for Laparoscopic reduction of IS. Taking po well post-op and D/c next day. F/U 5/6/08-doing well with well healed incision.

VAERS ID:311255 (history)  Vaccinated:2008-04-07
Age:0.1  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-04-29, Days after onset: 22
Location:California  Entered:2008-04-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: laboratory test, 04/??/08, positive for blood in stool
CDC 'Split Type': WAES0804USA04597
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1702U PO 
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Frequent bowel movements, Haematochezia, Laboratory test abnormal, Occult blood positive
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a registered nurse concerning a 6 week old female with no drug allergies who on 07-APR-2008 was vaccinated PO with a dose of Rotateq (lot# 659913/1702U). On 14-APR-2008 the patient experienced diarrhea and had 5 watery bowel movements within 20 hours. The patient sought medical attention through an office visit. In April 2008, laboratory diagnostics studies revealed a positive results for blood in the stool. Subsequently, the symptoms have since resolved and the patient was recovered on 21-APR-2008. There was no product quality complaint. Upon internal review, positive for blood in stool was determined to be an other important medical event. Additional information has been requested.

VAERS ID:311380 (history)  Vaccinated:2008-04-07
Age:27.0  Onset:2008-04-28, Days after vaccination: 21
Gender:Female  Submitted:2008-04-30, Days after onset: 2
Location:Virgin Islands  Entered:2008-04-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Positive pregnancy test 4/28/08
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHABVB431AA0IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1307U0SCLA
TD: TD ADSORBED (NO BRAND NAME)MASS. PUB HLTH BIOL LABTD1740IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1781U0SCLA
Administered by: Public     Purchased by: Public
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Patient came to immunization clinic 4/07/08. Stated that she was not pregnant. Patient made aware that MMR and varicella should not be given if pregnant and that she should avoid getting pregnant for at least one month after vaccination. Patient called clinic 4/2808 to report she had a positive pregnancy test 4/28/08.

VAERS ID:311620 (history)  Vaccinated:2008-04-07
Age:2.0  Onset:2008-04-08, Days after vaccination: 1
Gender:Female  Submitted:2008-04-09, Days after onset: 1
Location:Michigan  Entered:2008-05-05, Days after submission: 26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergic to PCN
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B054AA3IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB215AA0IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1314U0SCLA
Administered by: Public     Purchased by: Public
Symptoms: Rash, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Nurse received telephone call from client''s parent stating child woke up with "rash and swelling on face" the morning after vaccines were administered. Parent took child to pediatrician, was given hydrocortisone cream and Tavist prescription. 4-9-08 TC from mom. Client much improved. Nurse advised mom to follow up with ped for future vaccines. Bring note from doctor if returning to clinic.

VAERS ID:312769 (history)  Vaccinated:2008-04-07
Age:0.8  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 37
Location:Minnesota  Entered:2008-05-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0804USA04532
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Information has been received from a certified medical assistant concerning a 9 month old female who on 07-APR-2008 was vaccinated with her third dose of ROTATEQ. The patient was administered her first dose on 12-SEP-2007 and her second dose on 06-DEC-2007. No other information. There was no product quality complaint. Additional information has been requested.

VAERS ID:312563 (history)  Vaccinated:2008-04-07
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2008-04-16
Location:Georga  Entered:2008-05-19, Days after submission: 33
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type': GA08015
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB103AA0IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration, Medication error
SMQs:
Write-up: Administered TWINRIX vaccine to client. Misadministration of vaccine. No licensed for this age pt.

VAERS ID:312865 (history)  Vaccinated:2008-04-07
Age:13.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 37
Location:California  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Upper respiratory tract infection
Preexisting Conditions: Seasonal allergy
Diagnostic Lab Data: blood pressure, 04/07/08, 142/8; blood pressure, 04/07/08, 122/6 - 15 minutes later; total heartbeat count, 04/07/08, 47; total heartbeat count, 04/07/08, 85 - 15 minutes
CDC 'Split Type': WAES0804USA01838
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0133X1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure, Dizziness, Heart rate decreased, Syncope, Urticaria, Vaccine positive rechallenge
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a health professional concerning a 13 year old female with an upper respiratory tract infection and a history of seasonal allergies who on 07-APR-2008 was IM vaccinated with her second dose of GARDASIL (lot number reported as 654490/0133X). Concomitant therapy included TYLENOL, VICKS DAYQUIL (OLD FORMULA) and VICKS NYQUIL (OLD FORMULA). On 07-APR-2008 the patient fainted. Initially she was dizzy, then collapsed. Additionally she had a urticaria rash on her left amber blood pressure at that time was 142/80 and pulse rate was 47. Fifteen minutes later her blood pressure was 122/68 and pulse rate was 85. There was no sign of anaphylactic shock. The patient had and upper respiratory infection for the past 3 days with some symptoms that include coughing and mucous. The MA also reported that then patient fainted with Dose #1 but did not have any other details. The patient has recovered from the fainting but it is unspecified if her rash has also resolved. The patient sought unspecified medical treatment while at the office. Additional information has been requested.

VAERS ID:313096 (history)  Vaccinated:2008-04-07
Age:  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 37
Location:Unknown  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0804USA03738
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a company representative reporting that a physician reported that a female (age not reported) who during the week of 07-APR-2008 was vaccinated with the first dose of GARDASIL (lot not reported) and experienced hives all over her body. By the next morning the hives were gone. No further information is available.

VAERS ID:313087 (history)  Vaccinated:2008-04-07
Age:17.0  Onset:2008-04-08, Days after vaccination: 1
Gender:Female  Submitted:2008-05-14, Days after onset: 36
Location:Missouri  Entered:2008-05-23, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Upper respiratory tract infection
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0804USA02499
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U1UNRA
Administered by: Private     Purchased by: Private
Symptoms: Hypokinesia, Muscle spasms, Musculoskeletal pain, Neck injury, Neck pain, Rhinorrhoea, Torticollis
SMQs:, Rhabdomyolysis/myopathy (broad), Dystonia (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Ocular motility disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: Initial and follow up information has been received from a physician and emergency room records concerning a 17 year old female student who at 3:45PM on 07-APR-2008, was vaccinated into the right arm with her second dose of GARDASIL (lot# 659964/1978U). The patient had an upper respiratory infection at the time of vaccination. On 08-APR-2008 (reported as 2:00PM and also as "in the AM") the patient experienced severe pain in the left shoulder and had a hard time moving her neck. She was sent to the ER where she received IV fluids. Follow up information from the physician indicated that the patient woke up in the AM on 08-APR-2008 with a severe spasm of her left neck and left shoulder. The emergency room records indicated that the patient presented at 14:45 with right side neck spasm which had progressively worsened through out the day. Torticollis along with palpable muscle spasms were noted in the emergency room evaluation. There was no known trauma or abnormal activities. The patient had pain with movement and no systemic symptoms, no fever, no nausea, vomiting or diarrhea. She denied paresthesia/weakness. She was reported to have tried heat and BENGAY with relief. Emergency room diagnosis was neck strain. The patient was treated with one shot of TORADOL, 30 mg IV and VALIUM, 20 mg IV. She was discharged to home with instructions to take either ibuprofen or TORADOL, apply heat and follow up with primary physician. The reporting physician also indicated that patient stayed on TORADOL for a few days and did well. Further information is not expected. 5/29/08-records received for DOS 4/8/08-DX: Neck strain. ER visit with C/O right side neck pain began morning of ER visit and worsened throughout day. Now with Torticollis. Pain with movement. Denies paresthesia and weakness. URI symptoms recently. PE: yellow discharge from nose. Palpable muscle spasm neck left neck.

VAERS ID:313125 (history)  Vaccinated:2008-04-07
Age:16.0  Onset:2008-04-08, Days after vaccination: 1
Gender:Female  Submitted:2008-04-14, Days after onset: 6
Location:Unknown  Entered:2008-05-23, Days after submission: 39
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Acyclavir 400 mg TID PRN
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1060U1IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA11064IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.A70CA603A1SCRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 1 inch red, indurated area at site of varicella injection. No systemic symptoms.

VAERS ID:313847 (history)  Vaccinated:2008-04-07
Age:0.6  Onset:2008-04-08, Days after vaccination: 1
Gender:Female  Submitted:2008-04-16, Days after onset: 8
Location:Tennessee  Entered:2008-05-28, Days after submission: 42
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type': TN08016
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B138BA2UNLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF330AA1UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC458922UNRL
Administered by: Public     Purchased by: Unknown
Symptoms: Cellulitis, Irritability, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad)
Write-up: Infant had immunization 4-7-08 was fussy that afternoon; When infant woke up 4-8-08 had fever 103deg - took infant to ER and was diagnosed with cellulitis of right leg.

VAERS ID:314716 (history)  Vaccinated:2008-04-07
Age:27.0  Onset:0000-00-00
Gender:Male  Submitted:2008-04-07
Location:Massachusetts  Entered:2008-06-03, Days after submission: 57
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURAC52B010IMUN
Administered by: Other     Purchased by: Unknown
Symptoms: Wrong drug administered
SMQs:
Write-up: Gave Tdap BOOSTRIX as ordered on encounter form; Should have been ADACEL

VAERS ID:316102 (history)  Vaccinated:2008-04-07
Age:41.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-06-03, Days after onset: 57
Location:Idaho  Entered:2008-06-12, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Imitrex, Wellbutrin XL, Lorazepam
Current Illness: None
Preexisting Conditions: Anxiety, Allergic to morphine
Diagnostic Lab Data: MRI of left shoulder ordered
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2888AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Joint range of motion decreased, Nuclear magnetic resonance imaging, Pain in extremity
SMQs:, Arthritis (broad)
Write-up: Patient presents to office with left upper arm pain and decreased ROM due to pain with abduction.

VAERS ID:316131 (history)  Vaccinated:2008-04-07
Age:15.0  Onset:2008-04-08, Days after vaccination: 1
Gender:Female  Submitted:2008-06-12, Days after onset: 65
Location:Ohio  Entered:2008-06-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0188U0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Dyspnoea, Oxygen saturation normal, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Client went to emergency room approximately 24 hours after receiving first dose of HPV vaccine with complaints of difficulty breathing (wheezing). Denied itching, rashes or history of asthma. Denied sensation of throat closing. Pulse ox was 99%. Client was treated at the ER with Prednisone PO 60 mg; Pepcid PO 20 mg and Benadryl PO 50 mg with good results. Discharged to home with instructions to follow up at Health Dept in 2-4 days.

VAERS ID:317217 (history)  Vaccinated:2008-04-07
Age:23.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-04-10, Days after onset: 3
Location:Texas  Entered:2008-06-24, Days after submission: 75
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data: NONE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF303AA0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Dyspnoea, Injection site erythema, Pruritus, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: LEFT ARM, REDNESS AROUND THE VACCINE SITE. HEAD WAS ITCHING, FACE WAS SWOLLEN HAD TROUBLE BREATH, BENADRYL WAS GIVEN @ THE EMERGENCY ROOM

VAERS ID:317232 (history)  Vaccinated:2008-04-07
Age:5.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-04-07, Days after onset: 0
Location:Texas  Entered:2008-06-24, Days after submission: 78
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NO
Preexisting Conditions: ALLERGY ISSUES RASHES EASILY USUALLY ENVIRONMENTAL
Diagnostic Lab Data: CHILD WAS GIVEN BENEDRYL IN ER & SENT HOME PER ER PHYSICIAN.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2354BA4IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB214AA0IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURAD170-23SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0417U1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Rash, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: DTAP, IPV, MMR, HEP A ADM RASH STARTED ON LA & MOVED TO TRUNK. AND RT EXTREMITY WITHIN A FEW MINUTES

VAERS ID:317235 (history)  Vaccinated:2008-04-07
Age:1.0  Onset:2008-04-08, Days after vaccination: 1
Gender:Female  Submitted:2008-04-10, Days after onset: 2
Location:Texas  Entered:2008-06-24, Days after submission: 75
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB171AA0IMLA
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC451503IMRA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Induration
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: ERYTHEMA & INDURATION 30 X 30 MM OVER R-ARM (PCV7) - NO TREATMENT EXCEPT FOR WARM COMPRESS

VAERS ID:319219 (history)  Vaccinated:2008-04-07
Age:64.0  Onset:2008-04-08, Days after vaccination: 1
Gender:Female  Submitted:2008-06-24, Days after onset: 77
Location:Unknown  Entered:2008-07-11, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LOTREL; NEXIUM; MAXZIDE; BONIVA; SYNTHORID
Current Illness: Hypertension; Hyperthyroidism; Osteoporosis
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type': WAES0804USA02258
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0158X SC 
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a nurse practitioner concerning a 64 year old female consumer with hypertension, hyperthyroidism, osteoporosis and no known allergies who on 07-APR-2008 was vaccinated SQ in the right upper arm with a single dose of zoster vaccine live (Oka/Merck) (lot # 659268/0158X). Concomitant therapy included LOTREL, MAXZIDE, BONIVA, NEXIUM and SYNTHORID. On 08-APR-2008, the patient developed soreness at the injection site. On 09-APR-2008 the patient was examined in the office. There was no lab studies performed. The exam revealed a 4X4 cm area of redness at the injection site. There were no lesions. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.

VAERS ID:319492 (history)  Vaccinated:2008-04-07
Age:70.0  Onset:2008-04-24, Days after vaccination: 17
Gender:Female  Submitted:2008-06-24, Days after onset: 61
Location:Unknown  Entered:2008-07-11, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure high; Cholesterol high; Diabetes
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0805USA01331
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  IJUN
Administered by: Other     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a pharmacist concerning a 70 year old female with high blood pressure, high cholesterol and diabetes who on 07-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included clonidine, ezetimibe (+) simvastatin (MSD), MICARDIS, alendronate sodium (MSD), metformin, metoprolol and minoxidil. Two weeks after injection, the patient developed a rash that went down her arm. It was indicated the patient''s rash improved. Unspecified medical attention was sought. No further information is available.

VAERS ID:319493 (history)  Vaccinated:2008-04-07
Age:68.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-06-24, Days after onset: 78
Location:Ohio  Entered:2008-07-11, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Leukaemia
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0805USA01326
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SC 
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Rash generalised
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse concerning a 68 year old female with leukaemia who, on approximately 07-APR-2008, was vaccinated SQ with one dose of zoster vaccine live (Oka/Merck). On approximately 12-APR-2008, the patient experienced injection site reaction (soreness) and mild rash over different parts of her body. Subsequently, the patient recovered from injection site reaction (soreness) and mild rash over different parts of her body. VZV analysis was not necessary. Additional information has been requested.

VAERS ID:320178 (history)  Vaccinated:2008-04-07
Age:20.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 99
Location:California  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type': WAES0806USA09011
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U0IMAR
Administered by: Private     Purchased by: Private
Symptoms: Immediate post-injection reaction, Lymphadenopathy, Pharyngolaryngeal pain
SMQs:, Hypersensitivity (narrow)
Write-up: This is in follow-up to report(s) previously submitted on 7/15/2008. Information has been received from a nurse practitioner concerning a 20 year old female, weight 115lb, with no relevant medical history or allergies who on 07-APR-2008 was vaccinated with a first dose of GARDASIL vaccine by intramuscular injection (lot number 659964/1978U) in deltoid. There was no concomitant medication. About one hour post vaccination, the patient developed swollen neck glands and a sore throat. The patient sought medical attention with a telephone call. The symptoms lasted for 3-4 days and then self resolved. Additional information is not expected.

VAERS ID:319862 (history)  Vaccinated:2008-04-07
Age:0.3  Onset:2008-05-22, Days after vaccination: 45
Gender:Male  Submitted:0000-00-00
Location:California  Entered:2008-07-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: Labs and Diagnostics: CT scan (+) for IS. Contrast enema (+) for IS. Abd X-ray suspicious for IS. CBC and Chem unremarkable.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B060AB1IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01271IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC575391IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1598U1PO 
Administered by: Private     Purchased by: Public
Symptoms: Abdominal X-ray, Abdominal mass, Appendicectomy, Barium enema abnormal, Computerised tomogram abnormal, Decreased activity, Diarrhoea, Enema administration, Full blood count, Haematemesis, Haematochezia, Intussusception, Laboratory test, Laparoscopy, Large intestinal obstruction reduction, Rash
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Patient had intussusception on or before 5/24/08. Over a month after his second dose of rotavirus vaccine, he had failed reduction in a local facility, hence sent to hospital for laparoscopic reduction. 07/28/2008 MR received for DOS 5/23-24/2008 with D/C DX: Intussusception. Infant presented following transfer from another hospital with diarrhea, vomiting blood, blood in stool and decreased activity. PE (+) for a mass in the abdomen and rash. Contrast enema x 2 unable to fully reduce IS and pt taken to OR for Laparoscopic reduction of IS with appendectomy. F/U visit 6/9/08-doing well post-op. Labs and Diagnostics: CT scan (+) for IS. Contrast enema (+) for IS. Abd X-ray suspicious for IS. CBC and Chem unremarkable. 07/28/2008 MR received for DOS 5/23-24/2008 with D/C DX: Intussusception. Infant presented following transfer from another hospital with diarrhea, vomiting blood, blood in stool and decreased activity. PE (+) for a mass in the abdomen and rash. Contrast enema x 2 unable to fully reduce IS and pt taken to OR for Laparoscopic reduction of IS with appendectomy. F/U visit 6/9/08-doing well post-op.

VAERS ID:321047 (history)  Vaccinated:2008-04-07
Age:15.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-07-23, Days after onset: 107
Location:Indiana  Entered:2008-08-01, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergy to honey
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1487U1IMRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt returned for 3rd dose of GARDASIL (HPV) vaccine and reported on questionnaire that she broke out in hives around injection site after 2nd dose on 4.07.08, relieved with ice pack. Denied any difficulty breathing. Indicated allergy to honey on 4.07.08. This writer decided not to give 3rd dose.

VAERS ID:322206 (history)  Vaccinated:2008-04-07
Age:13.0  Onset:2008-04-08, Days after vaccination: 1
Gender:Female  Submitted:2008-08-14, Days after onset: 128
Location:Vermont  Entered:2008-08-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U1IMLA
Administered by: Private     Purchased by: Public
Symptoms: Abdominal pain, Asthenia, Influenza like illness, Malaise, Pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: 24 hours after 2nd HPV injection patient became ill with flu like symtoms, body aches, abdomial pain, decreased energy, generlly feeling unwell.

VAERS ID:323686 (history)  Vaccinated:2008-04-07
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-09
Location:Georga  Entered:2008-08-29, Days after submission: 112
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: N/A
CDC 'Split Type': GA08059
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (FOREIGN)MERCK & CO. INC.0608F2UNRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHA1B163AB1UNLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0524U2UNRA
Administered by: Public     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: No adverse events. HPV #3 given to early. No event/misadministration.

VAERS ID:324603 (history)  Vaccinated:2008-04-07
Age:20.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-09-08, Days after onset: 154
Location:Ohio  Entered:2008-09-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Colposcopy, 05/29/08, positive HPV; Cervix biopsy, 05/29/08, 11 o''clock - squamous mucosa and endocervical glandular mucosa with mild chronic inflammation; Cervix biopsy, 05/29/08, 11 o''clock - squamous mucosa and attached endocervical glan
CDC 'Split Type': WAES0808USA01664
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1486U0IMGM
Administered by: Private     Purchased by: Other
Symptoms: Biopsy cervix abnormal, Colposcopy abnormal, Drug administered at inappropriate site, Mucosal inflammation, Papilloma viral infection
SMQs:, Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Uterine and fallopian tube tumours of unspecified malignancy (broad)
Write-up: Initial and follow-up information has been received from a nurse concerning a 20 year old female who on 07-APR-2008 was vaccinated intramuscularly into the left gluteus with the first 0.5 ml dose of GARDASIL (lot no. 659655/1486U). On 29-May-2008, the patient had a colposcopy done which showed positive for human papilloma virus. The biopsy showed squamous mucosa and attached endocervical glandular mucosa with mild chronic inflammation and reactive changes. Focal changes suggestive of human papillomavirus-associated cytopathic effect. The patient stated that she had only one sexual partner (1st partner for each other). On 06-JUN-2008 the patient was vaccinated intramuscularly into the left deltoid with the second 0.5 ml dose of GARDASIL (lot no. 660387/1967U). At the time of this report, the patient was still positive for human papilloma virus. The patient sought unspecified medical attention. The reporter considered human papilloma viral infection to be other important medical event. Additional information is not expected. All medical records are available upon request.

VAERS ID:327064 (history)  Vaccinated:2008-04-07
Age:17.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-09-15, Days after onset: 161
Location:California  Entered:2008-09-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type': WAES0808USA02854
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1486U1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Dizziness, Nausea, Palpitations, Pyrexia, Vaccine positive rechallenge
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: Information has been received from a physician concerning a 17 year old female, who on 06-FEB-2008 was vaccinated with the first dose of GARDASIL (lot# 654488/1264U). On 07-APR-2008, the patient was vaccinated with the second dose of GARDASIL (lot# 659655/1486U). After receiving the first and second dose of GARDASIL, the patient experienced dizziness, nausea and heart palpitations. The patient also experienced fever after the second dose. The patient''s symptoms started the same vaccination days. The AE symptoms began in the physician''s office and unspecified medical attention was sought. Follow-up information was received which reported that the patient recovered from dizziness, nausea, heart palpitations, chills and fever the same date that the adverse events started. The patient also experienced a Fever on 06-FEB-2008. Also, chills and fever were reported in one occasion all day long. No further information is available.

VAERS ID:326978 (history)  Vaccinated:2008-04-07
Age:0.4  Onset:0000-00-00
Gender:Male  Submitted:2008-09-29
Location:Michigan  Entered:2008-10-03, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: GERD; dermatitis
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (TRIHIBIT)SANOFI PASTEURUF105AB0IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR208721IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC413351IMRL
Administered by: Private     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: DTaP-HiB combo given before 15 months of age.

VAERS ID:327644 (history)  Vaccinated:2008-04-07
Age:66.0  Onset:2008-04-21, Days after vaccination: 14
Gender:Female  Submitted:2008-09-24, Days after onset: 156
Location:Unknown  Entered:2008-10-08, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLEGRA
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type': WAES0806USA02009
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.659761/0157X SCUN
Administered by: Other     Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a pharmacist concerning a 66 year old female with not known allergies or pertinent medical history who on 07-APR-2008 was vaccinated SQ with a dose of ZOSTAVAX (Merck) 0.65 ml (Lot # 659761/0157X). Concomitant therapy included ALLEGRA and Prevacor. The pharmacist reported that the patient who received ZOSTAVAX (Merck) developed welts at the panty line, bra line, and near the neck that manifest after taking an evening shower and subside by the morning. The patient noticed the welts first appearing about two weeks on approximately 21-APR-2008 after receiving the ZOSTAVAX (Merck) injection. The welts persists although less intense. No other symptoms or treatment reported. The patient''s physician did not attribute the welts to ZOSTAVAX (Merck). The patient sought medical attention, he was seen in the office visit. There was no product quality complaint. Additional information has been requested.

VAERS ID:328566 (history)  Vaccinated:2008-04-07
Age:0.9  Onset:0000-00-00
Gender:Female  Submitted:2008-10-06
Location:Michigan  Entered:2008-10-15, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (TRIHIBIT)SANOFI PASTEURUF105AB0IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ08721IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC413351IMRL
Administered by: Public     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: DTaP-HIB combo given before 15 months of age. No side effects reported.

VAERS ID:329527 (history)  Vaccinated:2008-04-07
Age:20.0  Onset:0000-00-00
Gender:Female  Submitted:2008-10-14
Location:Unknown  Entered:2008-10-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NUVARING
Current Illness: Contraception
Preexisting Conditions:
Diagnostic Lab Data: serum beta-human, negative; urine beta-human, negative
CDC 'Split Type': WAES0809USA02678
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Amenorrhoea, Blood human chorionic gonadotropin negative, Urine human chorionic gonadotropin negative
SMQs:, Fertility disorders (broad)
Write-up: Information has been received from a patient''s mother, an employee at the physician''s office, concerning her 20 year old daughter who on 07-APR-2008, last day of her menstrual period, was first vaccinated with GARDASIL (dose was unspecified and route was injection). Concomitant therapy included NUVARING for birth control. When NUVARING was discontinued the patient still continued to have her menstrual periods. Subsequently the patient experienced amenorrhea since then. The following dose of GARDASIL (MSD) was not reintroduced. On an unspecified date the patient took pregnancy test via blood and urine and all tests were negative. The patient sought medical attention. At the time of report the patient''s amenorrhea persisted. Patient didn''t have medical history and drug allergies. Additional information has been requested.

VAERS ID:332113 (history)  Vaccinated:2008-04-07
Age:21.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-11-12, Days after onset: 219
Location:Utah  Entered:2008-11-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1758U1IMRA
Administered by: Private     Purchased by: Public
Symptoms: Dizziness, Fall, Suture insertion
SMQs:, Anticholinergic syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (broad)
Write-up: Pt was dizzy after getting the injection of Gardasil and fell and needed sutures.

VAERS ID:333965 (history)  Vaccinated:2008-04-07
Age:20.0  Onset:0000-00-00
Gender:Female  Submitted:2008-11-14
Location:Maryland  Entered:2008-11-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: YAZ
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, within normal limits; physical examination, ears within normal limits; complete blood cell, within normal limits
CDC 'Split Type': WAES0810USA00535
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure normal, Dizziness, Full blood count normal, Physical examination normal
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Information has been received from a nurse concerning a 20 year old female with drug hypersensitivity to sulfamethoxazole and trimethoprim (BACTRIM), sulfamethoxazole (+) trimethoprim (SEPTRA), and Amoxicillin Clavulanate (AUGMENTIN) with costochondritis (for past year), who on 07-APR-2008, was vaccinated with her first dose of GARDASIL (lot# 659964/1978U), 0.5 ml, intramuscularly. On 09-JUN-2008, the patient received her second dose of GARDASIL (lot#60553/0070X). Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). Subsequently, in 2008, days or weeks, after receiving the second dose, the patient experienced intermittent dizziness. There is an orthostatic component to the dizziness, but not always. She was seen by her doctor and a complete blood count, her blood pressure and her ears were all within normal limits. The patient''s doctor cleared her for receiving the third dose. The third dose may possibly be given on 03-OCT-2008. The patient''s intermittent dizziness persisted. Additional information has been requested.

VAERS ID:332707 (history)  Vaccinated:2008-04-07
Age:22.0  Onset:2008-04-29, Days after vaccination: 22
Gender:Female  Submitted:2008-11-18, Days after onset: 203
Location:Massachusetts  Entered:2008-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: unknown
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04-003A   
Administered by: Military     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Vaccinated during pregnancy Pregnancy resulted in spontaneous abortion

VAERS ID:338646 (history)  Vaccinated:2008-04-07
Age:12.0  Onset:2008-11-26, Days after vaccination: 233
Gender:Female  Submitted:2009-01-16, Days after onset: 51
Location:Pennsylvania  Entered:2009-01-20, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown 2/4/09-records received- HA. Holter monitor normal EEG normal with mild swelling of background. Chemistry normal. Chest x-ray no evidence of infiltrate or pleural effusion.
CDC 'Split Type': WAES0812USA03713
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Arthralgia, Chest X-ray normal, Electrocardiogram ambulatory normal, Fatigue, Headache, Laboratory test normal, Neck pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)
Write-up: Information has been received from an office manager at the physician''s office, concerning a female patient, who was vaccinated with first, second and third doses of GARDASIL (dose, route, lot # not reported). The office manager reported that the patient completed her GARDASIL vaccination series a couple of months ago and started experiencing hip pain and headaches. At the time of the report, the patient had not recovered. Follow up information was received from the Registered Nurse on 23-DEC-2008 which reported: The patient was vaccinated with three doses of GARDASIL on 19-SEP-2007, 29-NOV-2007 and 03-APR-2008 respectively. The patient experienced hip pain, headaches, and stomach pain and that were all still ongoing. The patient also experienced fatigue but that has resolved. Follow up information has been received from a Registered Nurse on 30-DEC-2008 which reported that the lot number that was administered was: 660387/19670. The patient was administered the vaccine at her pediatrician''s office. The patient was also administered varicella virus vaccine live (Oka/Merck) (MSD) and hepatitis B virus vaccine rHBsAg (yeast) (MSD) on the same day the patient received her third dose of GARDASIL. Additional information has been requested. 2/4/09-records received-presented on 11/17/08 with C/O run down, tired. 11/24/08 still very fatigued, dizzzy, occasional. 12/16/08 C/O headache. Possibility treated by another physician prior to presenting on 11/17/08. 2/23/09-records received-office visit 1/20/09-C/O headache, neck in pain for past 3 months. Holter monitor supraventricular ectopic beats noted. 12/30/08 increasing headaces.

VAERS ID:344736 (history)  Vaccinated:2008-04-07
Age:14.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2009-04-14, Days after onset: 372
Location:Unknown  Entered:2009-04-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 2/6/2008); Attention deficit disorder
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 06/02/08, normal; diagnostic laboratory, 11/05/08, normal; beta-human chorionic, results not reported
CDC 'Split Type': WAES0805USA04750
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U0UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Foetal disorder, Laboratory test normal, Pregnancy test, Ultrasound scan normal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)
Write-up: Information has been received through the Merck pregnancy registry, for GARDASIL, concerning a 14 year old female patient with attention deficit disorder and no drug allergies reported, who on 07-APR-2008 was vaccinated with the first dose of GARDASIL (Lot # 659964/1978U). Concomitant therapy included a dose of HAVRIX, a dose of MENACTRA and RITALIN. Subsequently, it was reported that the patient was pregnant at the time she received the GARDASIL. At the time of this report, the patient is presently fourteen weeks pregnant. The patient did not have any adverse experiences as a result of the vaccine. The patient sought unspecified medial attention. A pregnancy test was performed. At the time of this report the patient''s outcome was unknown. No product quality complaint was involved. Follow up information indicated that the patient delivered a 6.8 pound normal baby boy on 03-NOV-2008 at 39 weeks. There were no complications, abnormalities or congenital anomalies. The patient also used vitamins and calcium during pregnancy. Pediatric medical records were received. On 12-NOV-2008 the 9 day old baby went in for a pediatric visit. The newborn screen results were normal. The birth history included the baby being induced due to possible leakage. The Apgar score was 8/9.5. The physician commented the baby was alert and looking about. The assessment was the baby was back to the birth weight. The plan was feeding and G&D was discussed. Weight check was in 3 weeks. On 26-NOV-2008 at the age of 3 weeks the baby came in for a well child visit for weight check and growth. There was occasional spitting. The baby was having bowel movements daily; does grunt/cry with stooling. Diluted juice was used if needed. There were no hard stools now but did have. The baby was waking up 2 to 3 times a night. Impression was a 3 week infant with excellent growth. Discussed stools - normal versus constipation. Discussed fever and illness again. Call if any concerns. On 17-DEC-2008 at the age of 6 weeks. There was no spitting. Bowel Movement was good, an occasional use of apple juice. Tends to be fussy with gassy; gas drops were used. The assessment was a 6 week infant with good growth. The plan was a follow-up in 2 months. The outcome of grunting, crying and flatulence was not reported. On 12-DEC-2007 the baby had the following immunizations DTAP (unspecified), HIB (unspecified carrier), POLIO (unspecified), PREVENAR, Hep B (unspecified) and ROTATEQ. Pediatric medical records were received and reviewed and the following experience was identified: grunting, crying, feces hard, infantile spitting and flatulence. Additional information not expected.

VAERS ID:358916 (history)  Vaccinated:2008-04-07
Age:11.0  Onset:2009-06-03, Days after vaccination: 422
Gender:Female  Submitted:2009-09-30, Days after onset: 119
Location:New York  Entered:2009-09-30
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none - vaccination was given at regular 11 yr old well child care check up
Preexisting Conditions: allergic to sulfa medications PMH: Diabetes , scoliosis Allergies: Sulfa
Diagnostic Lab Data: blood tests
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB256BA1IJRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.19878U1IJLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood test, Pollakiuria, Type 1 diabetes mellitus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)
Write-up: Diagnosed with Type 1 diabetes two months later. Frequent urination started 6 wks after vaccination and diagnosed with diabetes 8 wks after vaccination. 1/7/2010 PCP records for 2 wellness visits, 4/2008 and 5/2009, on second visit it states patient on an Insulin pump x 2 months, stable HgbA1C, Dx IDDM

VAERS ID:372938 (history)  Vaccinated:2008-04-07
Age:15.0  Onset:2009-10-06, Days after vaccination: 547
Gender:Female  Submitted:2009-12-11, Days after onset: 66
Location:Pennsylvania  Entered:2009-12-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: She had a goider on her thyroid.
Diagnostic Lab Data: They tested for lymes disease, cancer, lupus, etc. All tests come back negative so they told us she hs reflex neurovascular dystrophy but weare not sure that the diagnosis fits.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB233AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2370AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Antinuclear antibody negative, Antiphospholipid antibodies negative, Arthralgia, Borrelia burgdorferi serology negative, Complex regional pain syndrome, Cyanosis, Disturbance in attention, Fatigue, Feeling cold, Influenza serology negative, Insomnia, Joint dislocation, Joint swelling, Laboratory test, Migraine, Myalgia, Oedema peripheral, Oropharyngeal pain, Pain, Palpitations, Physiotherapy, Pyrexia, Tremor, Vision blurred, Wheelchair user
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: After the first shot, Her eyes stopped focusing and she got migraines. After the second shot, which she recieved on 8/3/09 Her ankles started to swell and be very painful. Her legs turn blue. Her knees, ankles, hips, elbows, and shoulders fall out of place. Her hands, feet, and legs also swell. She is constantly cold. her hands and her head shake uncontrollably. She has heart palpatations. She cant sleep.At times it is to painful to get out of bed. She has trouble concentrating. She has been to the er, then doctor, then the er again, then the rheumatologist, the er again, and the childrens institute where she may have to stay for two or more weeks for intense physical therapy, although to week at this time. She has to be built up before she can begin.

VAERS ID:391010 (history)  Vaccinated:2008-04-07
Age:20.0  Onset:2008-07-24, Days after vaccination: 108
Gender:Female  Submitted:2010-06-20, Days after onset: 696
Location:North Carolina  Entered:2010-06-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: Numerous CT scans and MRI''s, labs, and test.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U1IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Abasia, Abdominal pain, Anaemia, Balance disorder, Blood potassium increased, C-reactive protein increased, Chills, Complicated migraine, Computerised tomogram, Computerised tomogram normal, Confusional state, Constipation, Diarrhoea, Dizziness, Dysphemia, Electroencephalogram normal, Eosinophil percentage decreased, Flank pain, Gait disturbance, Haematocrit decreased, Haemoglobin decreased, Headache, Hemiplegia, Hypertension, Hypoaesthesia, Laboratory test, Lethargy, Lymphocyte percentage decreased, Mean cell haemoglobin concentration, Mean cell haemoglobin decreased, Migraine, Muscular weakness, Nerve conduction studies normal, Neutrophil count, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain normal, Oedema peripheral, Paraesthesia, Postural orthostatic tachycardia syndrome, Red cell distribution width increased, Scan brain, Serum ferritin decreased, Syncope, Urine abnormality, Vision blurred, Vomiting, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Hypertension (narrow), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad)
Write-up: Blurred vision, fainting, paralysis on left side, numbness, tingling, lethargic, stuttering, headache, constipation, abdominal pain.

VAERS ID:310925 (history)  Vaccinated:2008-04-07
Age:0.4  Onset:2008-04-07, Days after vaccination: 0
Gender:Male  Submitted:2008-04-24, Days after onset: 17
Location:Foreign  Entered:2008-04-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: None provided
CDC 'Split Type': ITWYEG01447708
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME)UNKNOWN MANUFACTURERA21CA368A IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH29238 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Rash macular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information regarding Prevenar was received from a healthcare professional via a regulatory authority regarding a 5-month-old male patient who experienced macular rash on trunk and erythema facial. The patient received a dose on 07-Apr-2008. Relevant medical history was not provided. Concomitant medications were not reported. The patient experienced macular rash on trunk and erythema facial on 07-Apr-2008. The patient was hospitalized and treated with antihistaminic. Outcome of the events was reported as recovering. No additional information was available at the time of this report.

VAERS ID:311247 (history)  Vaccinated:2008-04-07
Age:10.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Male  Submitted:2008-04-28, Days after onset: 21
Location:Foreign  Entered:2008-04-30, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DESLORATADINE
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': E200803639
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypotension, Muscle rigidity, Pulse abnormal, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was initially reported on 16-Apr-08. This case concerns a 10 year old male patient. Details of the patient''s medical history have not been reported. The patient was also receiving Desloratadine for an unknown indication. On 07-Ap-07, the patient received a typhoid vaccine, Typhim Vi, batch number, route and site not reported. On 07-Apr-08, one vaccinated the patient became rigid, unresponsive with a slow thready pulse and hypotension. The patient recovered consciousness in a few minutes but needed supervision of vital signs for one and half hours due to the hypotension. The patient has fully recovered. Both the reporter and the agency considered this to be a serious reaction. No more information is available, this case is closed.

VAERS ID:311351 (history)  Vaccinated:2008-04-07
Age:14.0  Onset:2008-04-08, Days after vaccination: 1
Gender:Female  Submitted:2008-04-30, Days after onset: 22
Location:Foreign  Entered:2008-04-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0804USA06280
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0466U0UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Sudden hearing loss
SMQs:, Hearing impairment (narrow)
Write-up: Information has been received from a pediatrician concerning a 14 year old female with no medical history, who on 07-APR-2008 was vaccinated into the left upper arm with a first dose of Gardasil (Lot# 0466U; Batch# NG46490). On 08-APR-2008 the patient experienced acute sudden hearing loss and was referred to an ear, nose, and throat doctor. At the time of the report, the patient''s symptoms were ongoing. Upon internal review sudden hearing loss was considered to be an other important medical event. Other business partner numbers included: E2008-03436. Additional information is not available.

VAERS ID:311937 (history)  Vaccinated:2008-04-07
Age:5.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Male  Submitted:2008-05-09, Days after onset: 32
Location:Foreign  Entered:2008-05-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0519258A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Anaphylactic reaction, Blood pressure systolic, Cardiac murmur, Cold sweat, Heart rate decreased, Hypotonia, Pain in extremity, Pallor, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of anaphylactic reaction in a 5-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 7 April 2008 the subject received unspecified dose of INFANRIX (.5 ml, intramuscular, unknown, lot number not provided). On 7 April 2008, 10 minutes after vaccination with INFANRIX, the subject experienced an anaphylactic reaction. He complained of leg pain, became pale and had cold sweating. The heart frequency was measured at 50 pulse/minute, systolic blood pressure was 50 mmHg. The boy recovered fairly quickly, it was initially interpreted as a vasovagal reaction and the subject went home where he reacted again with stomach and leg pain, cold sweating and pallor. During 15 minutes, the subject was floppy and then showed no signs of distress. He visited the emergency room and was feeling well, heart status showed systolic murmur degree II of V I. He was hospitalised for 24 hours. No more reaction was noted. At the time of reporting the events were resolved. The regulatory authority reported that the events were probably related to vaccination with INFANRIX.

VAERS ID:315536 (history)  Vaccinated:2008-04-07
Age:0.2  Onset:2008-04-07, Days after vaccination: 0
Gender:Male  Submitted:2008-06-06, Days after onset: 60
Location:Foreign  Entered:2008-06-09, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Body temperature (results: 38.2 deg. C.) was done on 07-Apr-2008.
CDC 'Split Type': NLWYEG01630408
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSA21CA340D0IMUN
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSA21CA340D0IMUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSA21CA340D0IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA21CA340D0IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH254230IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Crying, Cyanosis, Eye rolling, Hypotonic-hyporesponsive episode, Pyrexia, Respiratory arrest, Tremor, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (narrow), Hypersensitivity (broad)
Write-up: Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding an 8-week-old male patient who experienced hypotonic-hyporesponsive episode, eyes rolling, no noticeable breathing, cyanosis peripheral, trembling, fever and crying. The patient received the first dose on 07-Apr-2008. About 7 hours after the vaccination on 07-Apr-2008, the child was sleeping and was woken up for feeding. The patient experienced hypotonic-hyporesponsive episode and eyes rolling. There was no noticeable breathing and cyanosis peripheral. The child did not respond to blowing and subsequently was put under the running tap and starting crying fiercely. The child was brought to the hospital and on the way over, the child was trembling. He had a fever and 2 hours later during crying, the child again experienced HHE and eye rolling for 5-10 minutes. Then he started crying again and subsequently again experienced HHE. The child was hospitalised. The outcome is unknown. No additional information was available at the time of this report.

VAERS ID:315572 (history)  Vaccinated:2008-04-07
Age:12.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-06-09, Days after onset: 63
Location:Foreign  Entered:2008-06-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Parotitis
Diagnostic Lab Data: UNK
CDC 'Split Type': B0523574A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Oedema peripheral, Pain in extremity, Yellow skin
SMQs:, Cardiac failure (broad), Cholestasis and jaundice of hepatic origin (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of skin on arms turned yellow in a 12-year-old female subject who was vaccinated with ENGERIX B pediatric (GlaxoSmithKline). Previous vaccination included MO-PA-RU vaccine (non-GSK manufacturer) given in 1998. At unspecified time after vaccination (1998) the subject had parotitis. On 7 April 2008 the subject received 3rd dose of Engerix B pediatric (intramuscular). On 7 April 2008, less than one day after vaccination with ENGERIX B pediatric, the subject experienced skin on left arm turned yellow, swelling arm and hand pain (pronation and supination of fist was painful). This case was assessed as medically serious by GSK. At the time of reporting the events were improved. The regulatory authority reported that the events were probably related to vaccination with ENGERIX B pediatric.

VAERS ID:318270 (history)  Vaccinated:2008-04-07
Age:0.3  Onset:2008-04-14, Days after vaccination: 7
Gender:Female  Submitted:2008-07-03, Days after onset: 80
Location:Foreign  Entered:2008-07-07, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: The patient''s concurrent illness includes fallot''s tetralogy, for which she underwent a surgery to open right ventricular-pulmon
Preexisting Conditions: The patient has a past history of malaise (at the age of three weeks).
Diagnostic Lab Data: None Provided.
CDC 'Split Type': FRWYEG01794008
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Gaze palsy, Malaise, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Information regarding PREVENAR was received from a healthcare professional via foreign regulatory authority regarding a 4-month-old female patient who experienced eye revulsion and vagal malaise. The patient received the second dose on 07-Apr-2008. The patient experienced malaise with eye revulsion on 14-Apr-2008, i.e. 7 days after the second doses of vaccines. She was hospitalized in cardiology for 24 hours and was diagnosed vagal malaise. The patient recovered without sequelae. No additional information was available at the time of this report.

VAERS ID:318824 (history)  Vaccinated:2008-04-07
Age:27.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-07-11, Days after onset: 95
Location:Foreign  Entered:2008-07-14, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0807USA01402
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Fatigue, Inappropriate schedule of drug administration, Injection site inflammation, Local reaction, Off label use, Pyrexia, Vaccine positive rechallenge
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a Health Authority via a health professional concerning a 27 year old female who on 07-APR-2008 was vaccinated with a first dose of GARDASIL IM in her arm. On 07-APR-2008, the patient experienced local inflammation at site of injection, fever and fatigue. On 17-APR-2008, the patient fully recovered. On 07-APR-2008, the patient was vaccinated with a second dose of GARDASIL IM in her buttock. On 11-JUN-2008, the patient experienced inflammation at site of injection (5 cm around the site of injection), fatigue, and fever. On 18-JUN-2008, the patient recovered. This is a case of misuse with serious adverse events: Off label use (patient of 27 years old) who experienced adverse events. The reporter felt that the events were serious (Other Important Medical Events). Other business partner numbers included: E2008-06265. No further information is available.

VAERS ID:323031 (history)  Vaccinated:2008-04-07
Age:26.0  Onset:2008-04-07, Days after vaccination: 0
Gender:Female  Submitted:2008-08-21, Days after onset: 136
Location:Foreign  Entered:2008-08-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives (unspecified), Unk - Unk
Current Illness: Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0808USA02866
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0466U2IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Contraception, No reaction on previous exposure to drug, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Information has been received via Health Authority (HA ref. No. PEI2008011493), concerning a 26 year old female patient with allergy against paracetamol and no previous medical history reported, who on 07-APR-2008 was vaccinated with a third dose of GARDASIL (Lot # 0466U and Batch # NG34890), I.M., on a deltoid muscle. Concomitant medication included unspecified hormonal contraceptives. The same day, the patient developed chills and fever. The patient was hospitalized on an unknown date, length of stay was not reported, no hospital report or findings were provided. The patient received symptomatic treatment (no details reported) and recovered within approximately 24 hours. The previous doses of GARDASIL were well tolerated. The case is closed. Other business partner numbers included: E2008-07640. No further information is available.

VAERS ID:324597 (history)  Vaccinated:2008-04-07
Age:27.0  Onset:2008-05-27, Days after vaccination: 50
Gender:Female  Submitted:2008-09-08, Days after onset: 104
Location:Foreign  Entered:2008-09-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: No reaction on previous exposure to vaccine
Diagnostic Lab Data: cervical smear, 21Nov07, PAP II; cervical smear, 27May08, PAP IVa
CDC 'Split Type': WAES0809USA00495
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1068U1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Carcinoma in situ, Cervical conisation, Cervical dysplasia, Cervix carcinoma stage 0, Human papilloma virus test positive, Inappropriate schedule of drug administration, Smear cervix abnormal
SMQs:, Reproductive premalignant disorders (narrow), Malignant tumours (narrow), Uterine and fallopian tube malignant tumours (narrow)
Write-up: Information has been received from a physician concerning a 27 year old female, who on 24-JAN-2008 was vaccinated IM in the deltoid muscle with a first dose of GARDASIL (Lot# 0352U; Batch# NG00320). No adverse event occurred. On 07-APR-2008 the patient was vaccinated IM in the deltoid muscle with a second dose of GARDASIL (Lot# 1068U; Batch# NH06410). On 27-MAY-2008 PAP IVa (suspicion of carcinoma in situ) was diagnosed. A conisation was performed in an outpatient department. The result showed carcinoma in situ (CIN III). On 21-NOV-2007 a PAP smear showed normal finding (PAP II). The patient recovered on an unspecified date. The physician considered the cervical intraepithelial neoplasia III, carcinoma in situ, abnormal Pap smear, and positive Human papilloma virus serology test to be other important medical events. Other business partner numbers included: E2008-08110. Additional information is not available.

VAERS ID:332346 (history)  Vaccinated:2008-04-07
Age:25.0  Onset:2008-04-29, Days after vaccination: 22
Gender:Female  Submitted:2008-11-13, Days after onset: 198
Location:Foreign  Entered:2008-11-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives (unspecified)
Current Illness: Hypothyroidism
Preexisting Conditions:
Diagnostic Lab Data: magnetic resonance imaging, 29Apr08, Cranial MRI: normal NMR tomography of cranium, no indication of lesions typical of multiple sclerosis; cardiac electrophysiology, 02May08, SEP of median nerve (bilateral) normal findings; visual evoked p
CDC 'Split Type': WAES0811USA00926
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Albumin CSF normal, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Blood thyroid stimulating hormone increased, Borrelia burgdorferi serology negative, CSF cell count normal, CSF glucose normal, CSF lactate abnormal, CSF oligoclonal band absent, CSF protein normal, Cardiac electrophysiologic study, Dizziness, Electrocardiogram normal, Hypoaesthesia, Hypoaesthesia facial, Hypothyroidism, Immunology test, Laboratory test normal, Neurological examination abnormal, No reaction on previous exposure to drug, Nuclear magnetic resonance imaging brain normal, Post lumbar puncture syndrome, Red blood cells CSF positive, Ultrasound thyroid normal
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypothyroidism (narrow), Hyperthyroidism (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad)
Write-up: Information has been received from a gynaecologist concerning a 25 year old female patient who was vaccinated with a second dose of GARDASIL (Lot #, site and route not reported) on 07-APR-2008. Concomitant medication included unspecified hormonal contraceptives. On 29-APR-2008, she was hospitalized for numbness of the left arm and face (left half) for 6 days. Additionally, she complained of dizziness. Neurological findings showed hypoesthesia of the left half of the face and the left arm. Overall clinical examination was normal. Lab findings revealed TSH: 6.26 uIE/ml. Routine laboratory findings showed normal results. Thyroid sonography was normal. Diagnosis of latent hypothyroidism was established. CSF puncture on 30-APR-2008: cell count: 1/3, glucose 63 mg/dL, protein: 21 mg/dL, lactate: 1.7 mmol/L. Albumin and IgG/IgA/IgM (CSF and serum) showed normal values. TPHA screening procedure was negative, specific IgG and IgM antibodies to borrelia (CSF and serum) were negative. No oligoclonal bands detectable. No CSF-blood barrier disorder. ECG showed normal results. Cranial MRI on 29-APR-2008: Normal NMR tomography of the cranium, no indication of lesions typical for multiple sclerosis. Electrophysiology on 02-MAY-2008, SEP of median nerve (bilateral): normal findings. VEP on 05-MAY-2008: normal findings. MEP (arms) on 05-MAY-2008: normal findings. MEP (legs) on 05-MAY-2008: normal findings. On 01-MAY-2008, the patient experienced headache caused by lumbar puncture. The patient''s condition improved under treatment with infusions, Ibuprofen and caffeine tablets and at discharge on 05-MAY-2008 she had completely recovered from headache. Outcome from hemihypaesthesia was not reported. The first dose of GARDASIL (Lot # not reported) was administered on an unspecified date and was well tolerated. Other business partner numbers included: E2008-10187. Additional information has been requested.

VAERS ID:341415 (history)  Vaccinated:2008-04-07
Age:9.0  Onset:2008-05-19, Days after vaccination: 42
Gender:Male  Submitted:2009-03-09, Days after onset: 294
Location:Foreign  Entered:2009-03-10, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant therapy included Cyclosporine, Vesicare and Ferrous Gluconate.
Current Illness: The patient''s concurrent illnesses include renal transplant (In Apr-2001), urinary tract infection, anaemia, neurogenic bladder
Preexisting Conditions:
Diagnostic Lab Data: Biopsy kidney (results: unknown) was done in May-2008.
CDC 'Split Type': GBWYEG03252309
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Biopsy kidney, Catheter placement, Kidney transplant rejection, Renal impairment, Urethritis, Urinary tract infection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Tumour lysis syndrome (broad)
Write-up: This case is an IOP and therefore maybe a duplicate report to boards of health as this may have been reported by investigator. Information regarding PREVENAR was received from an independent study regarding a 9-year-old male participant in a study who experienced acute rejection of transplanted kidney and urethritis. The participant received the first dose on 07-Apr-2008. The patient was admitted to hospital in May-2008 from a transplant clinic with severe urethritis and a deterioration of renal function which began on 19-May-2008. A suprapubic catheter was subsequently inserted to allow the urethra to rest and a renal biopsy was performed. The patient was also noted to be suffering acute rejection of transplanted kidney. In response to the event the patient was treated with immunosuppressant therapy which included IV methylprenisolone from 20-May-2008, Prednisolone from 22-May-2008 and Mycophenolate Mofetil from 23-May-2008. The patient recovered from the events on 23-May-2008. Subsequently the patient commenced a weaning therapy regime for Prednisolone and Mycophenolate Mofetil continued. It was also reported that the patient was treated with Ciprofloxin for a UTI infection on 20-May-2008 until 22-May-2008. It was also noted that the patient was not withdrawn from the study in response to the event. The investigator assessment for urethritis and kidney transplant rejection was unknown. The medical monitor(s) considered urethritis and kidney transplant rejection not related to the study product. See related case(s): GB-WYE-G03252509 (adverse event, expedited). No additonal information was available at the time of this report.

VAERS ID:345898 (history)  Vaccinated:2008-04-07
Age:1.0  Onset:2009-04-16, Days after vaccination: 374
Gender:Female  Submitted:2009-05-07, Days after onset: 21
Location:Foreign  Entered:2009-05-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Rotavirus test, Apr2009, positive
CDC 'Split Type': B0572370A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 1PO 
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Rotavirus infection, Rotavirus test positive
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a healthcare professional (biochemist and subject''s mother) and described the occurrence of rotavirus infection in a 1-year-old female subject who was vaccinated with live attenuated ROTARIX, GlaxoSmithKline. Concomitant medication: none. On 7 April 2008 and 17 June 2008 the subject received 1st dose and 2nd dose of ROTARIX (oral). She did not present any systemic or local reactions to the vaccines. On 16 April 2009, 10 months after vaccination with the 2nd dose of ROTARIX, 12 months after vaccination with the 1st dose of ROTARIX, the subject experienced watery diarrhea. She did not develop fever, vomiting or dehydration. She was not hospitalized. Laboratory test confirmed that it was a Rotavirus infection. This case was assessed as medically serious by GSK. On 21 April 2009, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with ROTARIX.

VAERS ID:436775 (history)  Vaccinated:2008-04-07
Age:24.0  Onset:2011-05-16, Days after vaccination: 1134
Gender:Female  Submitted:2011-10-04, Days after onset: 141
Location:Foreign  Entered:2011-10-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = Unknown); Pregnancy
Preexisting Conditions: Ex-smoker
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1109USA02967
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Empyema, Intensive care, Maternal exposure during pregnancy, Sepsis, Thoracotomy, Vaccination failure
SMQs:, Agranulocytosis (broad), Lack of efficacy/effect (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information was obtained on a request by the company from the agency via a public case detail form (local reference #AUS/11/1231 and OPR # 286724) concerning a 24 years old female ex-smoker patient who on 04-JUL-2008, was vaccinated subcutaneously with a dose of PNEUMOVAX 23 (dose, batch and lot number not reported) (1 dose unspecified, 1 time). On 16-MAY-2011 (when she was 30 weeks pregnant), patient developed right sided empyema resulting in sepsis. On an unknown date, the patient was admitted to Intensive Care Unit (ICU) and had a thoracotomy surgery, also was treated with midazolam and benzylpenicillin. The report was serious due to caused or prolonged inpatient hospitalization. The agency considered that vaccination failure and right sided empyema were possibly related to therapy with PNEUMOVAX 23. The original reporting source was not provided. Additional information is not expected.

VAERS ID:310922 (history)  Vaccinated:2008-04-08
Age:75.0  Onset:2008-04-08, Days after vaccination: 0
Gender:Female  Submitted:2008-04-24, Days after onset: 16
Location:Foreign  Entered:2008-04-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 200813303
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED18201 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Deafness unilateral, No reaction on previous exposure to drug
SMQs:, Hearing impairment (narrow)
Write-up: Report received from a health professional on 18-APR-2008. A 75-year-old female patient received FLUVAX (batch 18201, exp: 12/2008) on 08-APR-2008 for influenza immunisation. The patient had received influenza vaccine in the past, and had tolerated therapy. Eight hours after vaccination, the patient developed deafness in one ear on the same side as vaccination. The patient received treatment with antibiotics. The deafness is complete and has not improved at the time of reporting. This case was reported as serious as it was medically significant.

VAERS ID:311337 (history)  Vaccinated:2008-04-08
Age:16.0  Onset:2008-04-08, Days after vaccination: 0
Gender:Male  Submitted:2008-04-30, Days after onset: 22
Location:Foreign  Entered:2008-04-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0517917A
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNC: MENINGOCOCCAL (MENINGITEC)PFIZER/WYETH  UNUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS  UNLL
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Headache, Muscle spasms, Myalgia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a consumer via a regulatory authority (# 84007) and described the occurrence of fainting in a 16-year-old male subject who was vaccinated with Boostrix (GlaxoSmithKline), Meningitec. On 8 April 2008, the subject received unspecified dose of Boostrix (unknown route and injection site), unspecified dose of Meningitec (unknown route and injection site). The lot numbers were not provided. On 8 April 2008, less than one day after vaccination with Boostrix and Meningitec, the subject experienced fainting with myalgia, cramp, asthenia and headache. This case was assessed as medically serious by GSK. The subject was treated with Tachipirina. At the time of reporting the events were resolved with unspecified sequelae. The regulatory authority reported that the events were possibly related to vaccination with Boostrix and Meningitec.

VAERS ID:312133 (history)  Vaccinated:2008-04-08
Age:16.0  Onset:2008-04-09, Days after vaccination: 1
Gender:Female  Submitted:2008-05-12, Days after onset: 33
Location:Foreign  Entered:2008-05-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: diagnostic laboratory test Comment: global check-up; neurological examination Comment: normal; magnetic resonance imaging Comment: normal; electroencephalography Comment: normal
CDC 'Split Type': WAES0804USA06004
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Amnesia, Disorientation, Electroencephalogram normal, Global amnesia, Laboratory test, Malaise, Neurological examination normal, Nuclear magnetic resonance imaging normal, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a general practitioner concerning a 16 year old female, who on 08-APR-2008 was vaccinated with a second dose of GARDASIL and a dose of IPOL. The day after the vaccination the patient experienced a vasovagal malaise, and a transient global amnesia with a loss of memory and temporospatial disorientation. The patient fully recovered in 3 to 4 hours. The patient went to the hospital to perform a global check-up. A neurological examination, magnetic resonance imaging (MRI), and encephalogram were normal. Upon internal review vasovagal reaction, transient global amnesia, and temporospatial disorientation were considered to be other important medical events. Other business partner numbers included: E200803850. Additional information is not available.

VAERS ID:315844 (history)  Vaccinated:2008-04-08
Age:0.1  Onset:2008-04-08, Days after vaccination: 0
Gender:Female  Submitted:2008-06-09, Days after onset: 62
Location:Foreign  Entered:2008-06-10, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported.
CDC 'Split Type': 200801829
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20906002D SCUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER0430047 IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURA9712 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying
SMQs:, Depression (excl suicide and self injury) (broad)
Write-up: Case received from the Health Authorities on 02 June 2008. An 01-month-old female patient, with no reported medical history, experienced crying uncontrollable on 08 April 2008, i.e. 2 hours after receiving an intramuscular dose of ACT-HIB, batch number A9712-2, an intramuscular dose of HEPAVAX-GENE (other MFR, batch number 0430047) and a subcutaneous dose of DTP (other MFR, batch number 20906002D). Two hours post-vaccination, the patient presented with sudden, continuous crying, "escaled with every attempt to change the body position". The patient had no vomiting or nausea and no meningeal symptoms. The patient was referred to the hospital on an unspecified date and was still "there" at the time of the report. This case was assessed as medically significant. The patient recovered.

VAERS ID:316665 (history)  Vaccinated:2008-04-08
Age:0.4  Onset:2008-05-22, Days after vaccination: 44
Gender:Male  Submitted:2008-06-19, Days after onset: 28
Location:Foreign  Entered:2008-06-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal x ray showed scarce distal air and air-fluid levels.
CDC 'Split Type': B0523639A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 1PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal mass, Abdominal pain, Appendicectomy, Crying, Dehydration, Gastrointestinal hypermotility, Haematochezia, Hyperaemia, Intussusception, Mucous stools, Oedema, Pyrexia, Surgery, Vomiting, X-ray abnormal
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a physician in the frame of study and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included first dose of ROTARIX given on 8 February 2008. On 8 April 2008, the subject received 2nd dose of ROTARIX (1 ml, oral). On 22 May 2008, 44 days after vaccination with ROTARIX, the subject experienced intussusception, crying, vomiting, bloody stools, mucus in stool, fever, pharyngeal hyperemia, abdominal pain, bowel peristalsis increased, current jelly stool, abdominal mass, dehydration, edema and hyperemia. The subject was hospitalised for 5 days. Relevant test results included abdominal x ray that showed scarce distal air and air-fluid levels. The subject was treated with cefotaxime, ranitidine, metamizole, ketorolac, nalbuphine, paracetamol and surgery. Surgery was performed on 23 May 2008, ileocolic invagination was found and corrected with the pharmacologic relaxation during surgery, besides, appendectomy was also done because it has hyperemia and edema. On 27 May 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.

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