chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 16-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.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 31-OCT-2012 13:03, 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 31-OCT-2012 17:40, 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as receievd from a pharmacist refers to a newborn male patient of unknown age. On 30-OCT-2012 13:53, 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 06-OCT-2012 13:19, 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.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a 67 years old female consumer refers to herself with no pertinent medical history. The patient was vaccinated with ZOSTAVAX (lot number, dose, route not reported) on 30-APR-2012. There were no concomitant medications. The patient experienced a severe red rash, swelling, warmth and pain at the injection site immediately after receiving the ZOSTAVAX vaccination on 30-APR-2012. She was seen by her primary doctor who advised her to expect this sort of reaction. No treatment was given. No laboratory diagnostics studies were performed. The symptoms lasted for about one week and then completely resolved approximately on 07-MAY-2012. Her husband who received the vaccination at the same time also had an adverse experience (captured in MARRS# 1211USA010774). Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 15-OCT-2012 22:19, 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 13-NOV-2012 14:01, 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 the 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.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 27-OCT-2012 11:40, 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.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 31-OCT-2012 08:00, 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.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 06-OCT-2012 13:31, 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.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 27-OCT-2012 11:44, 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 27-OCT-2012 13:38, 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 27-OCT-2012 13:33, 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 29-OCT-2012 22:18, 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 07-OCT-2012 00:33, 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 the 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.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: 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.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: 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.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: 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.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered
Clinical narrative: 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: 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.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash, Vaccination site rash
Clinical narrative: 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: 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.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: 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.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: 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.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: 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.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: 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.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 18-OCT-2012 15:19, 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 18-OCT-2012 15:30, 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 18-OCT-2012 17:40, 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 07-OCT-2012 19:07, 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.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 07-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 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 08-OCT-2012 11:54, 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.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 19-OCT-2012 02:12, 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 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 the 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 19-OCT-2012 09:46, 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.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 19-OCT-2012 11:01, 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 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.
Age: 34.0
Sex: F
Vaccine: DT, TD
Symptoms: Asthenia, Blood test normal, Burning sensation, Chronic inflammatory demyelinating polyradiculoneuropathy, Nerve injury
Clinical narrative: Having nerve pain, numbness, and sensory loss. Falling and not steady on feet. Possible sensory CIPD or just CIPD. Nerve pain in hands, feet, legs, and toes.
Age: 34.0
Sex: F
Vaccine: DT, TD
Symptoms: Neuralgia, Vision blurred
Clinical narrative: Having nerve pain, numbness, and sensory loss. Falling and not steady on feet. Possible sensory CIPD or just CIPD. Nerve pain in hands, feet, legs, and toes.
Age: 34.0
Sex: F
Vaccine: DT, TD
Symptoms: Balance disorder, Fall, Hypoaesthesia, Neuralgia, Sensory loss
Clinical narrative: Having nerve pain, numbness, and sensory loss. Falling and not steady on feet. Possible sensory CIPD or just CIPD. Nerve pain in hands, feet, legs, and toes.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bradycardia, CSF glucose normal, CSF protein increased, Cardiac pacemaker insertion, Cytomegalovirus test negative
Clinical narrative: Tingling hands, arms, legs. Presented to ER on 12/16 and paralysis set in. Lumbar puncture, CT brain, admitted with Guillain Barre. Paralyzed from eyes to feet. Put on ventilator, trached, pace maker inserted, feeding tube, catheter, abdominal filter. In intensive care on life support for 30 days then transferred to Rehabilitation Hospital on the 36th day. Currently a patient at the Rehab Hosp.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Diplopia, Dysphagia, Fibrin D dimer, Guillain-Barre syndrome, HIV test negative
Clinical narrative: Tingling hands, arms, legs. Presented to ER on 12/16 and paralysis set in. Lumbar puncture, CT brain, admitted with Guillain Barre. Paralyzed from eyes to feet. Put on ventilator, trached, pace maker inserted, feeding tube, catheter, abdominal filter. In intensive care on life support for 30 days then transferred to Rehabilitation Hospital on the 36th day. Currently a patient at the Rehab Hosp.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hepatitis B test negative, Hepatitis C test negative, Mechanical ventilation, Muscular weakness, Pneumonia aspiration
Clinical narrative: Tingling hands, arms, legs. Presented to ER on 12/16 and paralysis set in. Lumbar puncture, CT brain, admitted with Guillain Barre. Paralyzed from eyes to feet. Put on ventilator, trached, pace maker inserted, feeding tube, catheter, abdominal filter. In intensive care on life support for 30 days then transferred to Rehabilitation Hospital on the 36th day. Currently a patient at the Rehab Hosp.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tracheostomy
Clinical narrative: Tingling hands, arms, legs. Presented to ER on 12/16 and paralysis set in. Lumbar puncture, CT brain, admitted with Guillain Barre. Paralyzed from eyes to feet. Put on ventilator, trached, pace maker inserted, feeding tube, catheter, abdominal filter. In intensive care on life support for 30 days then transferred to Rehabilitation Hospital on the 36th day. Currently a patient at the Rehab Hosp.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Cardiac pacemaker insertion, Catheter placement, Computerised tomogram head, Gastrointestinal tube insertion
Clinical narrative: Tingling hands, arms, legs. Presented to ER on 12/16 and paralysis set in. Lumbar puncture, CT brain, admitted with Guillain Barre. Paralyzed from eyes to feet. Put on ventilator, trached, pace maker inserted, feeding tube, catheter, abdominal filter. In intensive care on life support for 30 days then transferred to Rehabilitation Hospital on the 36th day. Currently a patient at the Rehab Hosp.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Intensive care, Life support, Lumbar puncture, Mechanical ventilation
Clinical narrative: Tingling hands, arms, legs. Presented to ER on 12/16 and paralysis set in. Lumbar puncture, CT brain, admitted with Guillain Barre. Paralyzed from eyes to feet. Put on ventilator, trached, pace maker inserted, feeding tube, catheter, abdominal filter. In intensive care on life support for 30 days then transferred to Rehabilitation Hospital on the 36th day. Currently a patient at the Rehab Hosp.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia, Paralysis, Tracheostomy, Vena cava filter insertion
Clinical narrative: Tingling hands, arms, legs. Presented to ER on 12/16 and paralysis set in. Lumbar puncture, CT brain, admitted with Guillain Barre. Paralyzed from eyes to feet. Put on ventilator, trached, pace maker inserted, feeding tube, catheter, abdominal filter. In intensive care on life support for 30 days then transferred to Rehabilitation Hospital on the 36th day. Currently a patient at the Rehab Hosp.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: X-ray
Clinical narrative: Tingling hands, arms, legs. Presented to ER on 12/16 and paralysis set in. Lumbar puncture, CT brain, admitted with Guillain Barre. Paralyzed from eyes to feet. Put on ventilator, trached, pace maker inserted, feeding tube, catheter, abdominal filter. In intensive care on life support for 30 days then transferred to Rehabilitation Hospital on the 36th day. Currently a patient at the Rehab Hosp.
Age: 44.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Pt. claims she was injured by getting a flu shot from us. And MRI showed where the injury occurred according to pt's claim.
Age: 44.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injury, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Pt. claims she was injured by getting a flu shot from us. And MRI showed where the injury occurred according to pt's claim.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest X-ray normal, Chest discomfort, Dysphonia, Electrocardiogram abnormal
Clinical narrative: I experienced numbness and tingling in left arm post injection about 10 minutes after.  About 20 minutes post injection I began to develop tightness in chest, hoarseness in voice, dizziness and weakness.  I then took myself into emergency department.  Arrived at ER at about 11:15am. At this point the tightness in my chest and voice hoarseness had worsened and I had developed a severe headache and neck pain.  I was triaged and immediately taken to a room for IV administration of fluids, Benadryl, Solumedrol, Pepcid.  An EKG was performed and I was found sinus tachycardic.  I was also provided Zofran for my nausea symptoms.  After being monitored for a few hours and my symptoms had improved I was discharged home.  Remaining symptoms were severe headache, neck pain and body weakness.  I was discharged at about 3pm on 11/20/2012.  I returned to ER at about 7:45pm due to return of tightness in chest, hoarseness in voice, increased body weakness and severe head and neck pain as well as neck and upper body stiffness.  An EKG and chest xray were performed as well as a spinal tap.  I was provided IV fluids, Morphine, Zantac, lorazepam, hydromorphone, diazepam and ketorlac.  I was monitored and when symptoms lessened I was discharged home with medications and instructions to return if symptoms worsened.  I was given prescription for Vicodin, Benadryl, prednisone, Zantac.  I was discharged at about 2:00am on 11/21/2012 with medication allergic reaction and possible viral syndrome due to increased WBC.  I returned again to ER on 11/23/2012 at around 10:00am due to increased head and neck pain, body weakness, nausea, fatigue and neck and upper body stiffness.  I was again provided IV fluids, morphine, Valium and Zofran for nausea symptoms.  I was monitored and discharged home with diagnosis of post medication allergic reaction, and spinal headaches. I was provided prescription for Fioricet and Valium and instructed to follow up with primary doctor and return if worsened symptoms.  Follow up with my primary was performed on 11/28/2012.  I am still experiencing the severe head pain, minor neck pain and over fatigue and malaise.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Haematocrit normal, Haemoglobin normal, Headache, Hypoaesthesia
Clinical narrative: I experienced numbness and tingling in left arm post injection about 10 minutes after.  About 20 minutes post injection I began to develop tightness in chest, hoarseness in voice, dizziness and weakness.  I then took myself into emergency department.  Arrived at ER at about 11:15am. At this point the tightness in my chest and voice hoarseness had worsened and I had developed a severe headache and neck pain.  I was triaged and immediately taken to a room for IV administration of fluids, Benadryl, Solumedrol, Pepcid.  An EKG was performed and I was found sinus tachycardic.  I was also provided Zofran for my nausea symptoms.  After being monitored for a few hours and my symptoms had improved I was discharged home.  Remaining symptoms were severe headache, neck pain and body weakness.  I was discharged at about 3pm on 11/20/2012.  I returned to ER at about 7:45pm due to return of tightness in chest, hoarseness in voice, increased body weakness and severe head and neck pain as well as neck and upper body stiffness.  An EKG and chest xray were performed as well as a spinal tap.  I was provided IV fluids, Morphine, Zantac, lorazepam, hydromorphone, diazepam and ketorlac.  I was monitored and when symptoms lessened I was discharged home with medications and instructions to return if symptoms worsened.  I was given prescription for Vicodin, Benadryl, prednisone, Zantac.  I was discharged at about 2:00am on 11/21/2012 with medication allergic reaction and possible viral syndrome due to increased WBC.  I returned again to ER on 11/23/2012 at around 10:00am due to increased head and neck pain, body weakness, nausea, fatigue and neck and upper body stiffness.  I was again provided IV fluids, morphine, Valium and Zofran for nausea symptoms.  I was monitored and discharged home with diagnosis of post medication allergic reaction, and spinal headaches. I was provided prescription for Fioricet and Valium and instructed to follow up with primary doctor and return if worsened symptoms.  Follow up with my primary was performed on 11/28/2012.  I am still experiencing the severe head pain, minor neck pain and over fatigue and malaise.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture normal, Malaise, Musculoskeletal stiffness, Nausea, Neck pain
Clinical narrative: I experienced numbness and tingling in left arm post injection about 10 minutes after.  About 20 minutes post injection I began to develop tightness in chest, hoarseness in voice, dizziness and weakness.  I then took myself into emergency department.  Arrived at ER at about 11:15am. At this point the tightness in my chest and voice hoarseness had worsened and I had developed a severe headache and neck pain.  I was triaged and immediately taken to a room for IV administration of fluids, Benadryl, Solumedrol, Pepcid.  An EKG was performed and I was found sinus tachycardic.  I was also provided Zofran for my nausea symptoms.  After being monitored for a few hours and my symptoms had improved I was discharged home.  Remaining symptoms were severe headache, neck pain and body weakness.  I was discharged at about 3pm on 11/20/2012.  I returned to ER at about 7:45pm due to return of tightness in chest, hoarseness in voice, increased body weakness and severe head and neck pain as well as neck and upper body stiffness.  An EKG and chest xray were performed as well as a spinal tap.  I was provided IV fluids, Morphine, Zantac, lorazepam, hydromorphone, diazepam and ketorlac.  I was monitored and when symptoms lessened I was discharged home with medications and instructions to return if symptoms worsened.  I was given prescription for Vicodin, Benadryl, prednisone, Zantac.  I was discharged at about 2:00am on 11/21/2012 with medication allergic reaction and possible viral syndrome due to increased WBC.  I returned again to ER on 11/23/2012 at around 10:00am due to increased head and neck pain, body weakness, nausea, fatigue and neck and upper body stiffness.  I was again provided IV fluids, morphine, Valium and Zofran for nausea symptoms.  I was monitored and discharged home with diagnosis of post medication allergic reaction, and spinal headaches. I was provided prescription for Fioricet and Valium and instructed to follow up with primary doctor and return if worsened symptoms.  Follow up with my primary was performed on 11/28/2012.  I am still experiencing the severe head pain, minor neck pain and over fatigue and malaise.