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VAERS ID:478991 (history)  Vaccinated:2012-10-10
Age:  Onset:2012-10-10, Days after vaccination: 0
Gender:Female  Submitted:2012-11-30, Days after onset: 51
Location:Unknown  Entered:2012-11-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1211USA011113
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 10-OCT-2012 11:20, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not provided. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0395AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:478992 (history)  Vaccinated:2012-10-08
Age:  Onset:2012-10-08, Days after vaccination: 0
Gender:Female  Submitted:2012-11-30, Days after onset: 53
Location:Unknown  Entered:2012-11-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1211USA011100
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 08-OCT-2012 12:35, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not provided. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0395AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:478993 (history)  Vaccinated:2012-10-09
Age:  Onset:2012-10-09, Days after vaccination: 0
Gender:Female  Submitted:2012-11-30, Days after onset: 52
Location:Unknown  Entered:2012-11-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1211USA011111
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 09-OCT-2012 18:16, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not provided. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0395AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:478994 (history)  Vaccinated:2012-10-09
Age:  Onset:2012-10-09, Days after vaccination: 0
Gender:Female  Submitted:2012-11-30, Days after onset: 52
Location:Unknown  Entered:2012-11-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1211USA011107
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 09-OCT-2012 10:24, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not provided. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0395AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:478995 (history)  Vaccinated:2012-10-08
Age:  Onset:2012-10-08, Days after vaccination: 0
Gender:Female  Submitted:2012-11-30, Days after onset: 53
Location:Unknown  Entered:2012-11-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1211USA011103
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 08-OCT-2012 17:33, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not provided. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0395AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:478996 (history)  Vaccinated:2012-10-09
Age:  Onset:2012-10-09, Days after vaccination: 0
Gender:Male  Submitted:2012-11-30, Days after onset: 52
Location:Unknown  Entered:2012-11-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1211USA011110
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 09-OCT-2012 18:12, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not provided. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0395AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:478997 (history)  Vaccinated:2012-12-13
Age:9.0  Onset:2012-12-14, Days after vaccination: 1
Gender:Female  Submitted:2012-12-21, Days after onset: 7
Location:Washington  Entered:2012-12-21
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: Cats; Salmon
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS 0IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Papule, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Facial/systemic hives w/papules gave BENADRYL and MEDROL.

VAERS ID:478998 (history)  Vaccinated:2012-12-13
Age:62.0  Onset:2012-12-14, Days after vaccination: 1
Gender:Male  Submitted:2012-12-20, Days after onset: 6
Location:Michigan  Entered:2012-12-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: AUGMENTIN plus usual medications; PROVENTIL HFA 108; ADVAIR diskus; SPIRIVA; Aspirin; IMITREX; MOTRIN
Current Illness: Recent sinusitis or exacerbation of COPD apparently improving
Preexisting Conditions: COPD plus multiple diag; Multiple reactions to meds
Diagnostic Lab Data: Please obtain from ER.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204701A8IMRA
Administered by: Private     Purchased by: Other
Symptoms: Cough, Dysphonia, Dyspnoea, Swelling face, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Swollen face, shortness of breath, wheezing, cough, hoarseness. Reported by patient. Per patient given steroids & BENADRYL at ER. Not yet re-evaluated in office. Patients states having persistent difficulties.

VAERS ID:478999 (history)  Vaccinated:2012-10-23
Age:53.0  Onset:2012-10-24, Days after vaccination: 1
Gender:Female  Submitted:2012-12-20, Days after onset: 57
Location:North Carolina  Entered:2012-12-20
Life Threatening? Yes
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
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDP59107 IMRA
Administered by: Other     Purchased by: Private
Symptoms: Malaise, Meningitis, Musculoskeletal stiffness
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Arthritis (broad)
Write-up: Patient received vaccine 10/23/12 & said she started feeling ill that evening. The next day she was stiff all over. She went to her MD and was turned away & then went to a walk in clinic where she was diagnosed with meningitis. She will have to have vertebrae fused per patient. Patient had blood work approximately one week before vaccination and everything looked fine.

VAERS ID:479000 (history)  Vaccinated:2012-07-17
Age:0.2  Onset:2012-07-17, Days after vaccination: 0
Gender:Male  Submitted:2012-12-20, Days after onset: 156
Location:Foreign  Entered:2012-12-20
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: Stool culture, 14sep2012, Escherichia coli; Ultrasound scan, 14Sep2012, no abnormality
CDC Split Type: B0848915A
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  SCUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA428CA0PO 
Administered by: Other     Purchased by: Other
Symptoms: Culture stool positive, Diarrhoea, Enema administration, Escherichia test positive, Haematochezia, Klebsiella test positive, Mood altered, Mucous stools, Ultrasound abdomen normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a physician and described the occurrence of bloody mucus in stool in a 12-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included ACTHIB (non-GSK manufacturer, subcutaneous0 and PREVENAR (non-GSK manufacturer, subcutaneous) given on 20 August 2012. On 17 July 2012, the subject received 1st dose of ROTARIX (1.5 ml, oral). On 17 July 2012, in the evening, less than one day after vaccination with ROTARIX, the subject experienced slight diarrhea. On 25 July 2012, the event was resolved. On 14 September 2012, 59 days after vaccination with ROTARIX, the subject experienced strawberry jam-lie bloody stool with mucus. An ultrasonography performed on the same day showed no abnormality but Escherichia coli and klebsiella pneumonia were detected in stool culture. On 18 September 2012, pink-colored bloody stool with mucus and slight diarrhoea were observed. On 21 September 2012, watery diarrhoea occurred and the second vaccination with ROTARIX was postponed. On 28 September 2012, strawberry jam-like bloody stool with mucus was observed twice and diarrhoea was noted. On 3 October 2012, the subject''s stools returned to normal and the 2nd vaccination with ROTARIX was given. The physician considered the events were clinically significant (or requiring intervention). The physician considered the events were related to vaccination with ROTARIX. Follow-up information received on 14 December 2012: Concurrent vaccination also included PREVENAR (non-GSK manufacturer, subcutaneous) given on 17 July 2012. On 17 July 2012, the subject had experienced diarrhoea tendency from the early evening after the vaccinations until 25 July 2012. On 17 July 2012, at night, the subject experienced diarrhoea once. Thereafter, slight diarrhoea-lie symptom persisted until 25 July 2012. On 25 July 2012, the subject experienced watery diarrhoea twice but the symptom did not develop afterwards. On 14 September 2012, the subject suddenly experienced strawberry-jam-lie diarrhoea in the morning. The subject was taken to the hospital due to a bad mood. The subject received an enema, and presented with mucous and bloody stool. On 18 September 2012, the subject presented with pinkish stool once or twice. The frequency of loose stools decreased to once a day, and the symptoms were considered to be resolving. On 21 September 2012, the subject again experienced watery diarrhoea every hour. The second vaccination with ROTARIX was postponed. On 28 September 2012, the subject experienced episodes of strawberry-jam-like stool (bloody stool) and diarrhoea afterwards. The symptoms subsequently improved. The subject experienced no diarrhoea thereafter. On 3 October 2012, the subject presented with normal stool and received 2nd vaccination with ROTARIX. The third vaccinations with PREVENAR and haemophilus influenzae type B vaccine were simultaneously performed. Although the subject presented with mucous and bloody stool over 2 months after the vaccination, ROTARIX was suspected to be a causative drug as the reporter had successively experienced 2 similar cases. The physician considered that the watery diarrhoea noted 1 week after the vaccination on 17 July 2012 was an adverse drug reaction, but the strawberry-jam-lie diarrhoea was hard to assess as the symptom developed almost 2 months after the vaccination. The abdominal ultrasound confirmed that the symptom was not invagination of intestine.

VAERS ID:479001 (history)  Vaccinated:2011-09-20
Age:32.0  Onset:0000-00-00
Gender:Male  Submitted:2012-12-20
Location:Foreign  Entered:2012-12-20
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: D0078140A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB205BG UNUN
TBE: TICK-BORNE ENCEPH (NO BRAND NAME)UNKNOWN MANUFACTURERVNRIK09A UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Depression, Fatigue, Headache, Musculoskeletal discomfort, Nausea, Nerve injury, Weight bearing difficulty
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow)
Write-up: This case was reported by a regulatory authority (# DE-PEI-PEI2012062584) and described the occurrence of depression in an approximately 33-year-old male subject who was vaccinated with TWINRIX adult, PRIORIX, INFLUSPLIT, TYPHIM VI, FSME IMMUN, rabies vaccine (unspecified and RABIPUR) and MENVEO.

VAERS ID:479002 (history)  Vaccinated:2012-12-17
Age:29.0  Onset:2012-12-17, Days after vaccination: 0
Gender:Male  Submitted:2012-12-20, Days after onset: 3
Location:Foreign  Entered:2012-12-20
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: Blood pressure, 17Dec2012, 158/85; Blood pressure, 17Dec2012, 130/70; Pulse rate, 17Dec2012, 70; Pulse rate, 17Dec2012, 78
CDC Split Type: B0854075A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB266AB0SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Hyperhidrosis, Loss of consciousness, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a nurse via the GSK outsourced product information (reference 112463) and described the occurrence of loss of consciousness in a 29-year-old male subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). The subject had no concurrent illnesses and no allergies. On 17 December 2012, the subject received 1st dose of TWINRIX adult (unknown route and injection site). On 17 December 2012, 10 to 15 seconds after vaccination with TWINRIX adult, the subject experienced pallor, started sweating, lost consciousness and started to have convulsion. This case was assessed as medically serious by GSK. The subject''s blood pressure was 158/85 and the pulse 78. The subject was monitored for 1.5 hours. He was in good condition when he left. Blood pressure returned to 130/70 and pulse was 70. Neither arrhythmia nor collapse of the blood pressure occurred. On 17 December 2012, the events were resolved.

VAERS ID:479003 (history)  Vaccinated:2012-12-14
Age:0.2  Onset:2012-12-14, Days after vaccination: 0
Gender:Male  Submitted:2012-12-20, Days after onset: 6
Location:Foreign  Entered:2012-12-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Test to confirm whether the anaphylactic shock was induced by infection: Negative
CDC Split Type: B0853738A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEUR  SCUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  SCUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS  PO 
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic shock, Laboratory test normal, Oedema peripheral, Swelling face
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of anaphylactic shock in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). ACTHIB (non-GSK) and PREVENAR (non-GSK). On 14 December 2012, the subject received an unspecified dose of ROTARIX (1.5 ml, oral, batch number not provided), an unspecified dose of ACTHIB (0.5 ml, subcutaneous, unknown injection site) and an unspecified dose of PREVENAR (subcutaneous, unknown injection site). On 14 December 2012, approximately 30 minutes after vaccination with ACTHIB, PREVENAR and ROTARIX, the subject experienced anaphylactic shock with swelling of face and arms. The subject was hospitalised for 4 days (from 14 December 2012 to 17 December 2012). A test was performed to confirm whether the shock was induced by infection: the result was negative. Consequently, the shock was considered to be related to the vaccine. The subject was treated with an unspecified treatment. On 14 December 2012, the events were resolved. The physician considered the events were related to vaccination with ROTARIX, ACTHIB and PREVENAR.

VAERS ID:479004 (history)  Vaccinated:2012-12-07
Age:0.3  Onset:2012-12-11, Days after vaccination: 4
Gender:Male  Submitted:2012-12-20, Days after onset: 9
Location:Foreign  Entered:2012-12-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UN
CDC Split Type: B0853695A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA568AA0PO 
Administered by: Other     Purchased by: Other
Symptoms: Eating disorder, Intussusception
SMQs:, Gastrointestinal obstruction (narrow)
Write-up: This case was reported by a physician and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 7 December 2012, the subject received 1st dose of ROTARIX (oral). On 11 December 2012, 4 days after vaccination with ROTARIX, the subject was eating poorly. On 13 December 2012, 6 days after vaccination with ROTARIX, intussusception was diagnosed. The physician considered the events were clinically significant (or requiring intervention). The subject was hospitalised for surgery. At the time of reporting, the outcome of the events was unspecified. The physician considered the events were probably related to vaccination with ROTARIX.

VAERS ID:479005 (history)  Vaccinated:2012-11-01
Age:39.0  Onset:2012-11-06, Days after vaccination: 5
Gender:Female  Submitted:2012-12-20, Days after onset: 44
Location:Foreign  Entered:2012-12-20
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: Pregnancy
Diagnostic Lab Data: Blood pressure, Good all the way; Blood pressure, Perfect; Blood test, Perfect; Heart rate, 28Oct2012, Fine; Weight, 11Nov2012, On delivery foet; Growth measure on 28/10/2012 and was fine; Down''s syndrome test - positive
CDC Split Type: B0853512A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test abnormal, Foetal exposure during pregnancy, Foetal hypokinesia, Hypoxia, Stillbirth, Trisomy 21
SMQs:, Asthma/bronchospasm (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Respiratory failure (broad)
Write-up: This retrospective pregnancy case was reported by a consumer, via the foreign regulatory authority, and described the occurrence of stillbirth in a male neonate who was exposed to Influenza vaccine (manufacturer unknown) and (non-gsk) REPEVAX transplacentally when his mother was being treated. On 1 November 2012 the 39-year-old mother of the patient received unspecified doses of Influenza vaccine (batch details unknown) and REPEVAX. The mother''s last menstrual period was on an unknown date and the estimated date of delivery was not provided. The neonate was exposed to Influenza vaccine and REPEVAX at 36.4 weeks. It was reported that the mother was advised by the mid-wife to have the whooping cough vaccination, the midwife informed the mother and father that it had been advised by the government and that it was safe, so to protect the unborn child the parents decided to book an appointment with the nurse. On the same midwife appointment the baby''s growth and heartbeat were also checked, the mother''s blood pressure and pulse were also checked, everything was fine. Two days later the parents attended an appointment for the vaccinations, whilst waiting they had to fill in a form to check that the mother had no allergies. The mother received the jabs and went home. Four days after the vaccination, the mother started to lose pink fluid, so the father called the delivery suite to ask if they should come in. They said it was fine and could be the mucus plug. From that morning the mother also noticed a decrease in the baby''s movements, this was not normal as the baby was always so strong and moved all the time. Over the next days, movements had stopped completely, in the end the parents had to wait for a routine midwife appointment three days later. At this appointment they discovered that the baby had died. The mother gave birth to the baby two days after this. The baby was 47cm long and weighed 3.1kg which was normal for the age 36.5 weeks. This was the mother''s fifth pregnancy, all 4 prior resulted in live births. There had been no history of miscarriages or stillbirths in the family. The only thing that had changed with all 5 pregnancies was the whooping cough vaccination. Looking over the mother''s records everything had been spot on throughout. Throughout the pregnancy his mother''s bloods were perfect and her blood pressures were perfect, at every appointment the baby''s growth, heart and movement were perfect. The mother had a midwife''s appointment a few days before the injections and as usual her health was fine, and baby was very active (he never liked to be prodded) and his heart beat was ''so so strong''. The neonate died on 6 November 2012 from hypoxia and stillbirth. An autopsy was not performed however the parents did agree to all blood tests, his cord, placenta and also tissue to be tested. The results of the tests were positive for Down''s syndrome, but the parents believed ''very slightly as there are no visible signs to this''. They put this to ''out of the blue'' as there was nothing in their bloods that could cause a risk to this. The placenta was in perfect condition and working order. The consumer was in strong belief that the whooping cough vaccination caused the death of the child on and around four days after the vaccination. For details of the mother case please see B0853150A. Verbatim text: I am writing in concern of the above program (Temporary Programme of Pertussis (Whooping Cough) vaccination of pregnancy women). My wife was advised by the midwife to have the whooping cough vaccination, the midwife informed us that it has been advised by the government and that it is safe, so to protect our unborn child we decided to book an appointment with the nurse. On the same midwife appointment the baby''s growth and heartbeat were also checked, my wife''s blood pressure and pulse were also checked, everything was fine. Two days later we attended our appointment for the vaccinations, whilst waiting we had to fill in a form to

VAERS ID:479006 (history)  Vaccinated:2012-11-15
Age:46.0  Onset:2012-11-16, Days after vaccination: 1
Gender:Male  Submitted:2012-12-21, Days after onset: 35
Location:Massachusetts  Entered:2012-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: COMPLERA; TRICOR; ASA; Fish Oil; MOTRIN
Current Illness:
Preexisting Conditions: Sleep Apnea; HIV positive; Hypertriglyceridemia; Eczema
Diagnostic Lab Data: Hospital
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4462AA0UNLA
Administered by: Private     Purchased by: Public
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (broad)
Write-up: Myocarditis.

VAERS ID:479007 (history)  Vaccinated:2012-12-19
Age:10.0  Onset:2012-12-19, Days after vaccination: 0
Gender:Male  Submitted:2012-12-21, Days after onset: 2
Location:New Mexico  Entered:2012-12-21
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
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH713AB1IMLA
Administered by: Military     Purchased by: Military
Symptoms: Axillary pain, Erythema, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Pt c/o of swelling, pain and pain with movement, redness, and left sided armpit pain.

VAERS ID:479008 (history)  Vaccinated:2012-12-09
Age:29.0  Onset:2012-12-10, Days after vaccination: 1
Gender:Male  Submitted:2012-12-21, Days after onset: 11
Location:Virginia  Entered:2012-12-21
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Chills, Diarrhoea, Dyspnoea, Heart rate decreased, Hyperhidrosis, Hypotension, Joint stiffness
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Chills, sweats, difficulty breathing, joint pain and stiffness, diarrhea. Went to GP on 12/17. BP was low, pulse was low.

VAERS ID:479009 (history)  Vaccinated:2012-03-29
Age:23.0  Onset:2012-04-01, Days after vaccination: 3
Gender:Female  Submitted:2012-12-21, Days after onset: 264
Location:Illinois  Entered:2012-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None- In good health
Preexisting Conditions: No Allergies, no birth defects
Diagnostic Lab Data: EKG, Labs, CPK
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3071SCRA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0OTLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG11240IMLA
Administered by: Military     Purchased by: Military
Symptoms: Blood creatine phosphokinase, Chest pain, Dyspnoea, Electrocardiogram, Laboratory test, Swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: A day after vaccination, I began to have a hard time breathing and chest pain. My parents drove me to the hospital- Emergency Room. I was admitted and given muscle relaxers and pain medication. They drew labs, also. They said the the lining of my chest and lungs has swelled.

VAERS ID:479010 (history)  Vaccinated:2012-12-17
Age:26.0  Onset:2012-12-18, Days after vaccination: 1
Gender:Male  Submitted:2012-12-21, Days after onset: 3
Location:Hawaii  Entered:2012-12-21
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
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3095IMLA
Administered by: Military     Purchased by: Military
Symptoms: Injection site pruritus, Injection site reaction, Injection site urticaria, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: This 26 year old was referred for site reaction after receipt of AVA vaccine and assistance in VAERS filing. Prior AVA vaccines were given 1/11/11, 2/11/11, 7/12/11, and 6/18/12 with soreness to site and arm for 1-2 days. He received AVA #5 to left deltoid on 12/17/12 (AVA FAV 309) - this was given 6 months from previous dose (per AVA schedule). He denied any trauma, exercising or injury to left deltoid. Approximately 24 hours after receipt of AVA vaccine, the vaccine site began to itch. On day 2 (12/19/12) the vaccine site had a "2.5 inch circular red raised rash". He presented to medical and was diagnosed with urticaria lesion to left shoulder. Pt had not been taking any medication for the itching or site redness and advised provider he did not want/require Benadryl or topical steroid cream at this time (does not like to take medication unless needed). Pt advised on 12/20/12 the sited was still red but not as severe as yesterday. (Picture sent by pt...see below). Denied any contact with new clothing, detergents, deodorants, soaps, was not hiking, around animals, no new foods, no recent exercise/trauma to arm.

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