chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.55
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concomitant conditions were not reported. On 29-JAN-2014, the patient was vaccinated with dose 3 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 2 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 27-JAN-2014, the patient was vaccinated with dose 1 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine does received by patient was a vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 4 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 03-FEB-2014, the patient was vaccinated with dose 2 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.57
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 03-FEB-2014, the patient was vaccinated with dose 2 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 2 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 23-JAN-2014, the patient was vaccinated with dose 1 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 2 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 24-JAN-2014, the patient was vaccinated with dose 1 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 4 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 22-JAN-2014, the patient was vaccinated with dose 2 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 3 months old patient of unknown gender. The nurse reported that on 17-JAN-2014, the patient was vaccinated with the first dose of ROTATEQ, (Lot # J007283), expiration date: 27-SEP-2014. Route and dose were not reported. On 04-MAR-2014, the patient received the second dose of ROTATEQ, (Lot # J007283), expiration date not reported. No other co-suspect or concomitant medications were reported. The nurse reported that both doses received by patient were vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading in the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 24-JAN-2014, the patient was vaccinated with dose 3 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F.  On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.12
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 1 month infant, of unknown gender. Medical history and concurrent conditions were not reported. On 21-JAN-2014, the patient was vaccinated with dose 1 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.32
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 3 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 16-JAN-2014, the patient was vaccinated with ROTATEQ lot # J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 3 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 17-JAN-2014, the patient was vaccinated with dose 1 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F.  On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.52
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 22-JAN-2014, the patient was vaccinated with dose 3 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccines improperly stored as follows: On 13-JAN-2014, oral, ROTATEQ was stored outside of recommended temperatures for 2 hours (2pm-4pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, oral, ROTATEQ was stored outside of recommended temperatures for 2 hours (2pm-4pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, oral, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm- 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, oral, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm- 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, oral, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm- 6 pm) the temperatures recorded was 52.7 degrees F. On 09-MAR-2014, oral, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm- 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, oral, ROTATEQ was stored outside of recommended temperature for 6 hours (8 am- 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, oral, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am-10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, oral, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.15
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 1 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 07-FEB-2014, the patient was vaccinated with first dose of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F.  On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Anxiety, Disturbance in attention, Hearing impaired, Insomnia, Memory impairment
Clinical narrative: This spontaneous report as received from a consumer refers to her 5 year old son. The patient suffered from congenital hyperinsulinism which had no known gene mutation and also could cause the patient to have a protein sensitivity. The patient was allergic to BACTRIM. On 01-AUG-2013, the patient was vaccinated with a dose of PROQUAD (Merck) (lot#, expiration date, strength and route not reported). Concomitant therapies included diazoxide (manufacturer unknown) for treat the hyperinsulinism. The reporter stated that the patient presented with a rash that evening after receiving the PROQUAD (Merck) on 01-AUG-2013. The rash "came and went" for approximately one week. The patient also started to exhibit "explosions of anxiety, obsessive thoughts and violent/autistic features as well as extreme emotional sensitivity" on an unspecified date. The reporter also stated that she considers this a significant disability regarding her son's mental state. The reporter took her son to a physician, on an unspecified date for the change in her son's behavior, "explosions of anxiety, obsessive thoughts and violent/autistic features as well as extreme emotional sensitivity" and no treatment was prescribed. The outcome of explosions of the events was reported as not recovered. It is also mentioned that the reporter herself received an unspecified flu shot (cannot rule out AFLURIA) and an unspecified DTAP vaccine, and was hospitalized for low blood sugar (captured in MARRS# 1404USA013839). Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Obsessive thoughts, Obsessive-compulsive disorder, Psychomotor hyperactivity, Rash erythematous, Rash macular
Clinical narrative: This spontaneous report as received from a consumer refers to her 5 year old son. The patient suffered from congenital hyperinsulinism which had no known gene mutation and also could cause the patient to have a protein sensitivity. The patient was allergic to BACTRIM. On 01-AUG-2013, the patient was vaccinated with a dose of PROQUAD (Merck) (lot#, expiration date, strength and route not reported). Concomitant therapies included diazoxide (manufacturer unknown) for treat the hyperinsulinism. The reporter stated that the patient presented with a rash that evening after receiving the PROQUAD (Merck) on 01-AUG-2013. The rash "came and went" for approximately one week. The patient also started to exhibit "explosions of anxiety, obsessive thoughts and violent/autistic features as well as extreme emotional sensitivity" on an unspecified date. The reporter also stated that she considers this a significant disability regarding her son's mental state. The reporter took her son to a physician, on an unspecified date for the change in her son's behavior, "explosions of anxiety, obsessive thoughts and violent/autistic features as well as extreme emotional sensitivity" and no treatment was prescribed. The outcome of explosions of the events was reported as not recovered. It is also mentioned that the reporter herself received an unspecified flu shot (cannot rule out AFLURIA) and an unspecified DTAP vaccine, and was hospitalized for low blood sugar (captured in MARRS# 1404USA013839). Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Aggression, Anxiety, Autism, Emotional disorder, Obsessive thoughts
Clinical narrative: This spontaneous report as received from a consumer refers to her 5 year old son. The patient suffered from congenital hyperinsulinism which had no known gene mutation and also could cause the patient to have a protein sensitivity. The patient was allergic to BACTRIM. On 01-AUG-2013, the patient was vaccinated with a dose of PROQUAD (Merck) (lot#, expiration date, strength and route not reported). Concomitant therapies included diazoxide (manufacturer unknown) for treat the hyperinsulinism. The reporter stated that the patient presented with a rash that evening after receiving the PROQUAD (Merck) on 01-AUG-2013. The rash "came and went" for approximately one week. The patient also started to exhibit "explosions of anxiety, obsessive thoughts and violent/autistic features as well as extreme emotional sensitivity" on an unspecified date. The reporter also stated that she considers this a significant disability regarding her son's mental state. The reporter took her son to a physician, on an unspecified date for the change in her son's behavior, "explosions of anxiety, obsessive thoughts and violent/autistic features as well as extreme emotional sensitivity" and no treatment was prescribed. The outcome of explosions of the events was reported as not recovered. It is also mentioned that the reporter herself received an unspecified flu shot (cannot rule out AFLURIA) and an unspecified DTAP vaccine, and was hospitalized for low blood sugar (captured in MARRS# 1404USA013839). Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a consumer refers to her 5 year old son. The patient suffered from congenital hyperinsulinism which had no known gene mutation and also could cause the patient to have a protein sensitivity. The patient was allergic to BACTRIM. On 01-AUG-2013, the patient was vaccinated with a dose of PROQUAD (Merck) (lot#, expiration date, strength and route not reported). Concomitant therapies included diazoxide (manufacturer unknown) for treat the hyperinsulinism. The reporter stated that the patient presented with a rash that evening after receiving the PROQUAD (Merck) on 01-AUG-2013. The rash "came and went" for approximately one week. The patient also started to exhibit "explosions of anxiety, obsessive thoughts and violent/autistic features as well as extreme emotional sensitivity" on an unspecified date. The reporter also stated that she considers this a significant disability regarding her son's mental state. The reporter took her son to a physician, on an unspecified date for the change in her son's behavior, "explosions of anxiety, obsessive thoughts and violent/autistic features as well as extreme emotional sensitivity" and no treatment was prescribed. The outcome of explosions of the events was reported as not recovered. It is also mentioned that the reporter herself received an unspecified flu shot (cannot rule out AFLURIA) and an unspecified DTAP vaccine, and was hospitalized for low blood sugar (captured in MARRS# 1404USA013839). Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Oedema mouth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 69 year old male patient. On 26-MAR-2014, the patient was vaccinated with ZOSTAVAX (dose and frequency were not reported) lot # J011337, subcutaneous. On 27-MAR-2014 (also reported as the next day) the patient experienced mouth swelling and weird sensation going down the side of his face. The outcome of mouth swelling and weird sensation going down the side of his face was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Oedema mouth, Sensory disturbance
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 69 year old male patient. On 26-MAR-2014, the patient was vaccinated with ZOSTAVAX (dose and frequency were not reported) lot # J011337, subcutaneous. On 27-MAR-2014 (also reported as the next day) the patient experienced mouth swelling and weird sensation going down the side of his face. The outcome of mouth swelling and weird sensation going down the side of his face was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Influenza like illness, Local swelling, Pruritus, Rash generalised, Skin exfoliation
Clinical narrative: This spontaneous report as received from a consumer refers to her 17 year old son. No pertinent medical history or drug reactions/allergies were reported. On an unspecified date the patient was vaccinated with 0.5ml his second dose of GARDASIL (lot# unspecified) Intramuscular. On an unspecified date the patient was vaccinated with 0.5ml his third dose of GARDASIL (lot# unspecified) Intramuscular. The first dose was vaccinated on an unspecified date. On an unspecified date, after receiving the second dose of GARDASIL the patient felt an itchy sensation underneath the skin. The reporter also stated that "after the patient developed skin irritation that was raised, it became scaly and gray in color on his back and chest and developed diarrhea, severe stomach pains, canker sores the size of a quarter and the entire injected arm began to swell". Furthermore, on an unspecified date sometime in March 2013, after third dose of GARDASIL was administered the patient was also prescribed amoxicillin (Dava Pharma/500mg/2 times daily) and oxycycline (dosage/frequency/manufacturer unknown) as reported to treat an ear infection which resulted in the patient having a "swollen throat". The reporter then stated, "After both the second and third doses of GARDSAIL, the patient developed flu like symptoms lasting up to 10 days". The reporter made no mention of any adverse events associated with the first shot of GARDASIL (specified date unknown). The patient had sought medical attention via visited the physician. No treatment was given for the events. Blood work was performed on an unspecified date. At the time of the report, the outcome of the events was not recovered. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Aphthous stomatitis, Blood test, Diarrhoea, Ear infection
Clinical narrative: This spontaneous report as received from a consumer refers to her 17 year old son. No pertinent medical history or drug reactions/allergies were reported. On an unspecified date the patient was vaccinated with 0.5ml his second dose of GARDASIL (lot# unspecified) Intramuscular. On an unspecified date the patient was vaccinated with 0.5ml his third dose of GARDASIL (lot# unspecified) Intramuscular. The first dose was vaccinated on an unspecified date. On an unspecified date, after receiving the second dose of GARDASIL the patient felt an itchy sensation underneath the skin. The reporter also stated that "after the patient developed skin irritation that was raised, it became scaly and gray in color on his back and chest and developed diarrhea, severe stomach pains, canker sores the size of a quarter and the entire injected arm began to swell". Furthermore, on an unspecified date sometime in March 2013, after third dose of GARDASIL was administered the patient was also prescribed amoxicillin (Dava Pharma/500mg/2 times daily) and oxycycline (dosage/frequency/manufacturer unknown) as reported to treat an ear infection which resulted in the patient having a "swollen throat". The reporter then stated, "After both the second and third doses of GARDSAIL, the patient developed flu like symptoms lasting up to 10 days". The reporter made no mention of any adverse events associated with the first shot of GARDASIL (specified date unknown). The patient had sought medical attention via visited the physician. No treatment was given for the events. Blood work was performed on an unspecified date. At the time of the report, the outcome of the events was not recovered. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Influenza like illness, Injection site swelling, Local swelling, Pharyngeal oedema, Pruritus
Clinical narrative: This spontaneous report as received from a consumer refers to her 17 year old son. No pertinent medical history or drug reactions/allergies were reported. On an unspecified date the patient was vaccinated with 0.5ml his second dose of GARDASIL (lot# unspecified) Intramuscular. On an unspecified date the patient was vaccinated with 0.5ml his third dose of GARDASIL (lot# unspecified) Intramuscular. The first dose was vaccinated on an unspecified date. On an unspecified date, after receiving the second dose of GARDASIL the patient felt an itchy sensation underneath the skin. The reporter also stated that "after the patient developed skin irritation that was raised, it became scaly and gray in color on his back and chest and developed diarrhea, severe stomach pains, canker sores the size of a quarter and the entire injected arm began to swell". Furthermore, on an unspecified date sometime in March 2013, after third dose of GARDASIL was administered the patient was also prescribed amoxicillin (Dava Pharma/500mg/2 times daily) and oxycycline (dosage/frequency/manufacturer unknown) as reported to treat an ear infection which resulted in the patient having a "swollen throat". The reporter then stated, "After both the second and third doses of GARDSAIL, the patient developed flu like symptoms lasting up to 10 days". The reporter made no mention of any adverse events associated with the first shot of GARDASIL (specified date unknown). The patient had sought medical attention via visited the physician. No treatment was given for the events. Blood work was performed on an unspecified date. At the time of the report, the outcome of the events was not recovered. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Skin discolouration, Skin exfoliation, Skin irritation
Clinical narrative: This spontaneous report as received from a consumer refers to her 17 year old son. No pertinent medical history or drug reactions/allergies were reported. On an unspecified date the patient was vaccinated with 0.5ml his second dose of GARDASIL (lot# unspecified) Intramuscular. On an unspecified date the patient was vaccinated with 0.5ml his third dose of GARDASIL (lot# unspecified) Intramuscular. The first dose was vaccinated on an unspecified date. On an unspecified date, after receiving the second dose of GARDASIL the patient felt an itchy sensation underneath the skin. The reporter also stated that "after the patient developed skin irritation that was raised, it became scaly and gray in color on his back and chest and developed diarrhea, severe stomach pains, canker sores the size of a quarter and the entire injected arm began to swell". Furthermore, on an unspecified date sometime in March 2013, after third dose of GARDASIL was administered the patient was also prescribed amoxicillin (Dava Pharma/500mg/2 times daily) and oxycycline (dosage/frequency/manufacturer unknown) as reported to treat an ear infection which resulted in the patient having a "swollen throat". The reporter then stated, "After both the second and third doses of GARDSAIL, the patient developed flu like symptoms lasting up to 10 days". The reporter made no mention of any adverse events associated with the first shot of GARDASIL (specified date unknown). The patient had sought medical attention via visited the physician. No treatment was given for the events. Blood work was performed on an unspecified date. At the time of the report, the outcome of the events was not recovered. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Injection site pain, Local swelling, Muscular weakness, Paraesthesia
Clinical narrative: Pain and swelling left arm 8 weeks, fatigue weakness left arm 3 PCP appts - physical therapy.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Fatigue, Local swelling, Muscular weakness, Pain in extremity
Clinical narrative: Pain and swelling left arm 8 weeks, fatigue weakness left arm 3 PCP appts - physical therapy.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site inflammation, Nausea, Pain in extremity
Clinical narrative: Onset of headache, nausea & vomiting after eating fruit & drinking hot tea. Laid down when nausea came on, and immediately vomited. By the next day I noted the arm was very sore, with a tennis-ball-size red inflammation around area of shot. For two days I remained in bed, taking only liquids, chicken broth & juice. Sinus headaches came on during night, for which I took aspirin, then Aleve. On April 24 in the evening I took first solid food, and took a Benadryl capsule.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Sinus headache, Vomiting
Clinical narrative: Onset of headache, nausea & vomiting after eating fruit & drinking hot tea. Laid down when nausea came on, and immediately vomited. By the next day I noted the arm was very sore, with a tennis-ball-size red inflammation around area of shot. For two days I remained in bed, taking only liquids, chicken broth & juice. Sinus headaches came on during night, for which I took aspirin, then Aleve. On April 24 in the evening I took first solid food, and took a Benadryl capsule.
Age: 31.0
Sex: M
Vaccine: PPV, TD
Symptoms: Arthralgia, Blood test normal, Diarrhoea, Headache, Injection site erythema
Clinical narrative: Fever, Joint Pain, Nausea, Diarrhea, Headache, Redness Swelling at injection site.
Age: 31.0
Sex: M
Vaccine: PPV, TD
Symptoms: Injection site swelling, Nausea, Pyrexia
Clinical narrative: Fever, Joint Pain, Nausea, Diarrhea, Headache, Redness Swelling at injection site.
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Blood glucose decreased
Clinical narrative: This consumer spontaneous report (initial receipt 23-Apr-2014) concerns a female patient). On an unspecified date, the patient received unspecified influenza virus vaccine (manufacturer and batch number not provided) and unspecified DTAP (manufacturer and batch number not provided). On an unspecified date, the patient was hospitalised for low blood sugar. The outcome was reported as unknown.
Age: 80.0
Sex: U
Vaccine: VARZOS
Symptoms: Abscess limb, Limb operation
Clinical narrative: This spontaneous report as received from a physician, via a company representative, refers to a 80 year old patient. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number and expiry date not provided). On an unknown date, the patient developed an abscess on the arm that was used to administer ZOSTAVAX (hospitalization). The patient required surgery on the affected arm (hospitalization) and was hospitalized in an unspecified hospital on an unspecified date. The outcome of developed an abscess on the arm that was used to administer ZOSTAVAX and surgery on the affected arm was unknown. The physician has had two follow-up appointments with the patient on unspecified dates and stated that the patient was "ok". The reporter did not assess the relationship between the events and ZOSTAVAX. Additional information has been requested.