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VAERS ID: 478821 (history)  
Age: 61.0  
Gender: Female  
Location: Connecticut  
Vaccinated:2012-12-05
Onset:2012-12-06
   Days after vaccination:1
Submitted: 2012-12-09
   Days after onset:3
Entered: 2012-12-19
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. H013024 / 0 LA / SC

Administered by: Other       Purchased by: Private
Symptoms: Cellulitis, Local reaction, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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: Seasonal hay fever; Morphine type product
Diagnostic Lab Data:
CDC Split Type:

Write-up: Thurs noticed large localized reaction, heat, swelling larger than silver dollar, Friday symptoms then intensified, saw dr on Saturday, he prescribed antibiotic which patient started, cellulitis diagnosed.


VAERS ID: 478822 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2012-10-06
Onset:2012-10-06
   Days after vaccination:0
Submitted: 2012-11-29
   Days after onset:54
Entered: 2012-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0385AE / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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: WAES1211USA011095

Write-up: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 06-OCT-2012 21:40, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During the 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 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: 478823 (history)  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:2012-10-27
Onset:2012-10-27
   Days after vaccination:0
Submitted: 2012-11-29
   Days after onset:33
Entered: 2012-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0385AE / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medication
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1211USA011247

Write-up: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 27-OCT-2012 18:58, 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: 478824 (history)  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:2012-10-15
Onset:2012-10-15
   Days after vaccination:0
Submitted: 2012-11-29
   Days after onset:45
Entered: 2012-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0385AE / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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: WAES1211USA011144

Write-up: This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 15-OCT-2012 13:08, 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: 478825 (history)  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:2012-10-30
Onset:2012-10-30
   Days after vaccination:0
Submitted: 2012-11-29
   Days after onset:30
Entered: 2012-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0385AE / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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: WAES1211USA011256

Write-up: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 30-OCT-2012 10:27, 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: 478826 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2012-10-31
Onset:2012-10-31
   Days after vaccination:0
Submitted: 2012-11-29
   Days after onset:29
Entered: 2012-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0385AE / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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: WAES1211USA011260

Write-up: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 31-OCT-2012 10:53, 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: 478827 (history)  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:2012-10-29
Onset:2012-10-29
   Days after vaccination:0
Submitted: 2012-11-29
   Days after onset:31
Entered: 2012-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0385AE / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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: WAES1211USA011252

Write-up: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 29-OCT-2012 14:46, 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: 478828 (history)  
Age: 75.0  
Gender: Male  
Location: Foreign  
Vaccinated:2012-10-27
Onset:2012-10-27
   Days after vaccination:0
Submitted: 2012-12-19
   Days after onset:53
Entered: 2012-12-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Haematuria, Muscular weakness, Platelet count decreased, Urinary tract infection
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic thrombocytopenia (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: ADCAL; Bisoprolol; Lactulose; Miconazole; Omeprazole; Prednisolone; Tamsulosin hydrochloride
Current Illness: Atrial fibrillation; Benign prostatic hyperplasia; Idiopathic thrombocytopenic purpura; Rheumatoid arthritis; Tricuspid valve incompetence
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHFR2012GB006429

Write-up: Case number PHFR2012GB006429 is an initial spontaneous report from a physician via health authority (reference number 21941062) received on 13 Dec 2012. This report refers to a 75-year-old male patient. The patient''s medical history included atrial fibrillation, benign prostatic hyperplasia, idiopathic thrombocytopenic purpura, rheumatoid arthritis and tricuspid insufficiency. Concomitant medications included ADCAL, bisoprolol, lactulose, miconazole, omeprazole, prednisolone tamsulosin hydrochloride and Warfarin sodium. He was vaccinated with influenza virus vaccine (manufacturer, batch number not specified) on 27 Oct 2012. He was vaccinated in the morning and that afternoon after vaccination he had profound weakness in upper and lower limbs such that he had to crawl to get upstairs to bed. He remained very weak over next few days and was confined to bed initially. He was just able to mobilized a short distance. He was seen by his physician and was admitted to a hospital. There was a gradual improvement in his muscle power over last few weeks. On admission, hematuria with urinary tract infection and low platelet count were observed. The outcome of the event weakness in upper and lower limbs was reported as recovering/resolving and the outcome of remaining events was unknown. The event weakness in upper and lower limbs was reported as serious (hospitalization) and remaining events as medically significant. The causality assessment of the events was not reported.


VAERS ID: 478829 (history)  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:2012-10-31
Onset:2012-10-31
   Days after vaccination:0
Submitted: 2012-11-29
   Days after onset:29
Entered: 2012-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0385AE / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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: WAES1211USA011259

Write-up: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 31-OCT-2012 09:33, 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 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: 478831 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2012-10-16
Onset:2012-10-16
   Days after vaccination:0
Submitted: 2012-11-29
   Days after onset:44
Entered: 2012-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0385AE / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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: WAES1211USA011146

Write-up: This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 16-OCT-2012 09:48, 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: 478832 (history)  
Age:   
Gender: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-11-29
Entered: 2012-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect dose administered
SMQs:, Medication errors (narrow)

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: Chronic obstructive pulmonary disease
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1211USA010904

Write-up: This spontaneous report as received from a pharmacist refers to unspecified number of patients. The pharmacist reported that she had some patients with certain condition, like COPD, who received PNEUMOVAX23 (lot number, dose, route and injection site were not reported) every year. No other co-suspects were reported. No concomitant medications were reported. Specific number of patients unknown. This is one of several reports received from the same source. Additional information has been requested.


VAERS ID: 478833 (history)  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:2012-10-27
Onset:2012-10-27
   Days after vaccination:0
Submitted: 2012-11-29
   Days after onset:33
Entered: 2012-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0385AE / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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: WAES1211USA011246

Write-up: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 27-OCT-2012 18:26, 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: 478834 (history)  
Age: 69.0  
Gender: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-11-29
Entered: 2012-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site rash, Rash, Vaccination site rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1211USA009918

Write-up: This spontaneous report as received from a Pharmacist refers to a 69 years old male patient. The patient was vaccinated with ZOSTAVAX (dose, route and lot # were unknown) an unspecified date. No other co-suspects were reported. Concomitant medications included: AMOXICILLIN. On an unknown date the patient developed a rash at the injection site of the ZOSTAVAX. The pharmacist indicated that on an unspecified date the rash resolved. The pharmacist indicated the patient had another rash appear on the side of the neck that did not resolve. The patient sought medical attention at their doctor''s office and saw a nurse. It was indicated by the nurse that it wasn''t believed to be caused by the ZOSTAVAX. The pharmacist described the adverse effect as an alligator like crust which subsided in the evening but flared during the daytime and worsened when hot water was applied. Additional information is not expected.


VAERS ID: 478835 (history)  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:2012-10-28
Onset:2012-10-28
   Days after vaccination:0
Submitted: 2012-11-29
   Days after onset:32
Entered: 2012-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0385AE / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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: WAES1211USA011249

Write-up: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 28-OCT-2012 10:40, 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: 478836 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2012-10-27
Onset:2012-10-27
   Days after vaccination:0
Submitted: 2012-11-29
   Days after onset:33
Entered: 2012-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0385E / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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: WAES1211USA011243

Write-up: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 27-OCT-2012 12:24, 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 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 with 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: 478837 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2012-10-28
Onset:2012-10-28
   Days after vaccination:0
Submitted: 2012-11-29
   Days after onset:32
Entered: 2012-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0385AE / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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: WAES1211USA011248

Write-up: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 28-OCT-2012 03:47, 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: 478838 (history)  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:2012-10-29
Onset:2012-10-29
   Days after vaccination:0
Submitted: 2012-11-29
   Days after onset:31
Entered: 2012-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0385AE / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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: WAES1211USA011250

Write-up: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 29-OCT-2012 02:30, 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: 478839 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2012-10-29
Onset:2012-10-29
   Days after vaccination:0
Submitted: 2012-11-20
   Days after onset:22
Entered: 2012-11-29
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0385AE / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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: WAES1211USA011251

Write-up: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 29-OCT-2012 14:19, 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: 478840 (history)  
Age: 0.18  
Gender: Male  
Location: Idaho  
Vaccinated:2012-09-11
Onset:2012-09-12
   Days after vaccination:1
Submitted: 2012-11-29
   Days after onset:78
Entered: 2012-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0182AE / 0 - / PO

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea haemorrhagic
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Hyperbilirubinaemia
Diagnostic Lab Data:
CDC Split Type: WAES1211USA008799

Write-up: This spontaneous report as received from a registered nurse refers to a 9 weeks old male patient with no drug allergy. The patient''s medical history included hyperbilirubinemia at birth, nurse stated child was 38 weeks plus 5 days gestation, no pertinent medical history. The patient was vaccinated with the first dose of live, oral ROTATEQ (lot# reported as 0182AE; expired date: 16-SEP-2013) 0.2 ml orally on 11-SEP-2012 with no concomitant medications. No other co-suspects were reported. The mother of child brought the baby in for a 4 month well check up on 19-NOV-2012("yesterday"). Nurse stated mother reported one day after getting live, oral ROTATEQ on 12-SEP-2012, her child had 1 diaper that had watery diarrhea and some streaks of blood in it. The second diaper after that also had diarrhea but only some specks of blood in it. Child recovered. No treatment was given. No lab tests were performed. Additional information has been requested.


VAERS ID: 478841 (history)  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:2012-10-18
Onset:2012-10-18
   Days after vaccination:0
Submitted: 2012-11-29
   Days after onset:42
Entered: 2012-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0385AE / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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: WAES1211USA011185

Write-up: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 18-OCT-2012 16:47, 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.


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