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VAERS ID:478983 (history)  Vaccinated:2007-11-07
Age:  Onset:2007-11-07, Days after vaccination: 0
Gender:Unknown  Submitted:2012-12-20, Days after onset: 1870
Location:Unknown  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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1212USA007067
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report was received from a doctor in pharmacy concerning to a patient of unknown age and gender. On 07-JUN-2007, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot reported). On 21-AUG-2012, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot not reported). On 07-NOV-2012, the patient was vaccinated with the third dose of GARDASIL (dose, route and lot not reported). No other co-suspects were reported. No concomitant medications were reported. The patient received a compressed schedule for GARDASIL. No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.

VAERS ID:478984 (history)  Vaccinated:2012-10-11
Age:  Onset:2012-10-11, Days after vaccination: 0
Gender:Male  Submitted:2012-11-30, Days after onset: 50
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: WAES1211USA011061
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 11-OCT-2012 11:37, 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 reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, 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:478985 (history)  Vaccinated:2012-10-13
Age:  Onset:2012-10-13, Days after vaccination: 0
Gender:Female  Submitted:2012-11-30, Days after onset: 48
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: WAES1211USA011064
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, Unevaluable event
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 13-OCT-2012 12:07, 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 reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, 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:478986 (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: WAES1211USA011112
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 21:29, 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 0385AE, 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:478987 (history)  Vaccinated:2012-10-08
Age:  Onset:2012-10-08, Days after vaccination: 0
Gender:Male  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: WAES1211USA011101
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  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 08-OCT-2012 12:42, 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 reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, 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:478988 (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: WAES1211USA011109
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 13:10, 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:478989 (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: WAES1211USA011108
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 12:56, 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:478990 (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: WAES1211USA011105
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 03:13, 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: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.

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