chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 20-NOV-2015 at time- 00:22, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which was stored were 3.4 and 2.5 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 28-NOV-2015 at time- 00:20, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.3 and 1.8 (units unspecified) for 6 hours 40 minutes respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-OCT-2015 09:32, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5 and 0.7 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 13-OCT-2015 12:52, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5.3 (4hours 8mins) and 1.0 (4hours 8mins) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an adult male patient of mid 50's. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial (dosing details were not reported). No concomitant therapies were reported. On an unknown date, after receiving a dose of ZOSTAVAX vial the patient experienced shingles. The patient sought medical attention, patient was seen by the physician approximately in February 2016 (reported as on an unspecified date last week). The outcome of shingles was unknown. The reporter did not assess the causality between suspect therapy and the adverse event. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 24-NOV-2015 at time- 19:55, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.0 and 1.0 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 07-DEC-2015 at time- 21:31, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.8 and 1.7 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 02-DEC-2015 at time- 17:31, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.5 and 2.4 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 07-DEC-2015 at time- 09:00, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.8 and 1.6 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This is spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient  were not reported. On 12-NOV-2015 at time- 20:17, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L004754 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.6 ad 2.5 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-OCT-2015 12:39, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5.0 and 0.7 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 20-NOV-2015 at time- 12:50, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose#, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.4 and 2.5 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 05-DEC-2015 at time- 08:00, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.8 and 2.4 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 16-NOV-2015 at time- 17:10, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 4.1 and 2.3 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-OCT-2015 12:26, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L004754, expiry date: 10-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5.0 and 0.7 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-OCT-2015 13:43, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5.0 and 0.7 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 25-NOV-2015 at time- 20:10, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.9 and 2.3 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 01-DEC-2015 at time- 23:38, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.6 and 1.7 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 19-NOV-2015 at time- 14:47, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.3 and 2.5 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 16-NOV-2015 at time- 21:39, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 4.1 and 2.3 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 17-NOV-2015 at time- 13:44, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 4.1 and 2.9 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Infantile spitting up, Oral administration complication, Underdose
Clinical narrative: Information has been received from a nurse referring to a female patient of unknown age. Information about medical history and concurrent condition was unspecified. On 03-MAR-2016 the patient was vaccinated with ROTATEQ (lot number, dose and route were unknown). Concomitant medication was unspecified. On the same day, following administration of ROTATEQ, the patient spit up a significant amount of the vaccine (underdose). The outcome of the event was unknown. The causality between the event and ROTATEQ was unspecified. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 02-DEC-2015 at time- 12:31, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.5 and 2.4 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 23-NOC-2015 at time- 13:41, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.3 and 1.9 (units unspecified) respectively. There were not Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 26-NOV-2015 at time- 18:03, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.9 and 2.4 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 14-NOV-2015 at time- 21:42, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.2 and 2.6 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 05-DEC-2015 at time- 15:18, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.8 and 2.4 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of the several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 03-DEC-2015 at time- 11:52, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.4 and 3.1 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 06-DEC-2015 at time- 22:13, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.7 and 2.4 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 04-DEC-2015 at time- 11:29, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.7 and 2.5 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent medical drug allergies of the patient were not reported. On 04-DEC-2015 at time- 02:17, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.7 and 2.5 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received fro a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-OCT_2015 01:15, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L004754, expiry date: 10-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were  and 1.8 (44 mins) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-OCT-2015 00:52, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5 (6hours and 41mins) and 0.7 (6hours 41mins) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 17-NOV-2015 at time- 08:32, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 4.1 and 2.9 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On an unspecified date in June of 2013, the patient was vaccinated with GARDASIL (lot # 0420AE, expiry date 01-DEC-2014) (dose, frequency and route unspecified). On an unspecified date in January of 2016, the patient was administered a dose of GARDASIL 9 (lot # L014415, expiry date 25-JUL-2017) (dose, frequency and route unspecified) (interchange of vaccine products). No adverse effects were reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a currently 22 years old female patient. There was no pertinent medical history, drug reaction or concomitant medication reported. On an unspecified date in 2003 when the patient was 9 years old, the patient was vaccinated with the first dose of GARDASIL (strength, lot number expiration date, dose, route of administration unspecified). On 17-FEB-2016, when the subject was 22 years old, she was vaccinated with her second dose in the HPV vaccine series with GARDASIL 9 (strength, lot number, expiration date, dose, route of administration unspecified) (Interchange of vaccine products and Inappropriate schedule of vaccine administered). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-OCT-2015 16:11, the patient was vaccinated with improperly stored RECOMBIX HB with lot number: L016427, expiry date: 13-APR-2017 9dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 10.0 (1hour 26mins) and 1.2 (3hours 55mins) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 19-NOV-2015 at time- 14:47, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.3 and 2,5 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 17-DEC-2015 at 10:54, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 7.6 and 5.1 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 31-DEC-2015 at 06:43, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 8.6 (1 hour 59 minutes) and 7.4 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 31-DEC-2015 at 14:32, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 8.6 and 7.4 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-JAN-2016 at 01:08, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 8.6 and 8.0 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-DEC-2015 at 14:51 the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 6.2 and 4.7 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 13-NOV-2015 at time- 18:38, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse event were reported. The high temperature and low temperature at which the product was stored were 3.6 and 2.8 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 30-NOV-2015 at time- 06:41, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.8 and 1.9 (units unspecified) for 7 minutes respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 29-DEC-2015 at 08:30, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 8.3 and 5.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-DEC-2015 at 15:36, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 6.8 and 5.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-OCT-2015 12:13, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 7.9 and 1.6 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. Between (reported as "may have been administered between") 24-FEB-2016 and 04-MAR-2016, the patients were vaccinated with the first doses of RECOMBIVAX HB injection, lot # L019298 with expiration date 22-JUN-2017 and L027733 with expiration date 13-SEP-2017 (dose and route of administration were not reported) that were improperly stored. It was not specified which patients received which of the reported lot numbers of RECOMBIVAX HB. The vaccines were exposed to temperature of 33.6 Fahrenheit (F) for 40 minutes and administered. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-DEC-2015 at 22:28, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 6.4 and 5.9 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 17-NOV-2015 at time- 15:08, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 4.1 and 2.9 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 25-NOV-2015 at time- 23:08, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.9 and 2.3 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-DEC-2015 at 05:01, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 5.2 and 4.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 23-NOV-2015 at time- 14:55, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.3 and 1.9 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-DEC-2015 at 16:00, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effect were reported. The high and low temperature were 6.4 and 5.9 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 04-DEC-2015 at time- 14:36, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.7 and 2.5 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-DEC-2015 at 21:16, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 6.8 and 5.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 03-DEC-2015 at time- 08:44, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.4 and 3.1 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.