chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown gender and age. The patients' concurrent condition, medical history and concomitant therapy were not reported. On multiple unspecified dates multiple unspecified patients were vaccinated with improperly stored PROQUAD (dose, route , lot# and expiration date unknown) which was reconstituted with properly stored sterile diluent for prophylaxis. The vaccine was improperly stored at 15 to 46 degrees Fahrenheit for 1 hour and 6 degrees Fahrenheit to 14 degrees Fahrenheit for 2 hours 30 minutes. The vaccine also had a previous temperature excursion at 15 to 46 degrees Fahrenheit for 1 hour. No adverse effects were reported. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1708USA008431: US-009507513-1708USA010012:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown gender and age. The patients' concurrent condition, medical history and concomitant therapy were not reported. On multiple unspecified dates multiple unspecified patients were vaccinated with improperly stored ZOSTAVAX (dose, route, lot# and expiration date unknown) which was reconstituted with properly stored sterile diluent for prophylaxis. The vaccine was improperly stored at 15 to 46 degrees Fahrenheit for 1 hour and 6 degrees Fahrenheit to 14 degrees Fahrenheit for 2 hours 30 minutes. The vaccine also had a previous temperature excursion at 15 to 46 degrees Fahrenheit for 1 hour. No adverse effects were reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA010011: US-009507513-1708USA008431.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to 7 unspecified patients of unknown ages and genders. On unknown date in August-2017, the patients were vaccinated with PROQUAD (lot # N013270, expiry date: 25-OCT-2018, lot # N014947 expiry date: 11-NOV-2018) (route: subcutaneous). The vaccine was stored at a temperature of 32 F (foreign heat) for unknown period of time (reported as "ongoing excursion"). The previous temperature excursion included multiple 6F to 14 F for total 6.5 hours. The call was because of the data logger. No adverse effects were reported.  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA000128:
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a nurse referring to a 20 year old female patient. The patient's medical history included gallbladder removal and headache. Drug reactions/allergies was reported as none. Concomitant therapy included oral contraceptive. The patient was vaccinated with two doses of VARIVAX (dose, route, lot# and expiration date were unknown) one dose on 14-JAN-1999 and one dose on 28-JUN-2007. A varicella titer was drawn on 12-AUG-2017 and the results showed there was no immunity to varicella. One booster dose of VARIVAX (lot # N000682, expiration date 06-JAN-2019) was administered to patient on 18-AUG-2017. No treatment was given. The outcome of the event was reported as not recovered. The patient visited physician to seek medical attention. The causality assessment was not provided. This is one of two reports regarding to the same patient. Sender's Comments: US-009507513-1709USA000121.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a unspecified patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL 9 lot number M040412 oral for prophylaxis. On an unknown date, the vaccine was incorrectly storage.; Sender's Comments: US-009507513-1708USA005527: US-009507513-1708USA012512:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 lot # M044717 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9.    Additional information has been requested.; Sender's Comments: US-009507513-1709USA000094:
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60-year-old (also reported as 61-year-old) female patient, who was hospitalized due to bowel obstruction on 25-AUG-2017 and was allergic to dextroamphetamine and penicillin. The patient's medical history included kidney stones. The patient's historical drugs included dextroamphetamine and penicillin. On 26-AUG-2017 (also reported as 28-AUG-2017), the patient was vaccinated with PNEUMOVAX 23 injection, 0.5 ml intramuscularly, lot # N014188 with expiration date of 22-JAN-2019 for prevention of pneumococcal disease. Concomitant therapies included TYLENOL, azithromycin, ceftriaxone, PEPCID, heparin, ZOFRAN and PERCOCET. On 28-AUG-2017, the patient experienced redness and swelling of skin and pain at injection site, which extended to her neck and face. The patient received treatment but no laboratory diagnostics were performed. The outcome of the adverse events was reported as recovering/resolving. The relatedness between the adverse event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA, HIBV, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544: US-009507513-1708USA013537.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB lot # M032649 and lot # reported as M002914 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB. Lot number M002914 is an invalid lot number for RECOMBIVAX HB. Sender's Comments: US-009507513-1708USA012995: US-009507513-1708USA012994.
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report as received from a health professional refers to a male patient of unknown age. On 05-AUG-2017 the patient was vaccinated with M-M-R II lot # N004433, 1 DF, subcutaneous for prophylaxis, reconstituted with sodium chloride (manufacturer unknown) lot # U5116AA (product preparation error). No adverse event reported.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Product use issue, Swelling
Clinical narrative: This spontaneous report as received from a other refers to a 2 year old female patient. On 21-AUG-2017 the patient was vaccinated with M-M-R II lot # N009171, subcutaneous in the left thigh for prophylaxis. On an unknown date the patient experienced local swelling and product use issue. The outcome of local swelling was reported as not recovered/not resolved. The outcome of product use issue is unknown. The reporter considered product use issue to be not related to M-M-R II.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to three patients of unknown age and gender. On unknown dates, the patients were vaccinated with incorrectly stored doses of PROQUAD lot # N010247 for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown).; Sender's Comments: US-009507513-1708USA012367:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 16-MAR-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (incorrect product storage) lot # M040141 for prophylaxis. Concomitant therapies included sterile diluent. No adverse event.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 02-AUG-2017 the patient was vaccinated with GARDASIL 9 lot # N010497 for prophylaxis. On 02-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. On an unspecified date in March 2006, the patient was vaccinated with the first dose of VAQTA. The on an unspecified date in April 2011, received the second dose, all of them for prophylaxis. No adverse effects reported.
Sex: U
Vaccine: HEPA, HIBV, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, LIQUID PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent (STERILE DILUENT). On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, LIQUID PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, LIQUID PEDVAXHIB and VAQTA.; Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544:
Sex: U
Vaccine: HEPA, HIBV, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013537: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544.
Sex: U
Vaccine: HEPA, HIBV, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013537: US-009507513- 1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544.
Sex: U
Vaccine: HEPA, HIBV, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013537: US-009507513-1708USA013539: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544.
Sex: U
Vaccine: HEPA, HIBV, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013537: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013543: US-009507513-1708USA013544.
Sex: U
Vaccine: HEPA, HIBV, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013537: US-009507513-1708USA013538: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544.
Sex: U
Vaccine: HEPA, HIBV, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013537: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013544.
Sex: U
Vaccine: HEPA, HIBV, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013537: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543.
Sex: U
Vaccine: HEPA, HIBV, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013537: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544.
Sex: U
Vaccine: HEPA, HIBV, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013537: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544.
Sex: U
Vaccine: HEPA, HIBV, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013537: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544.
Sex: U
Vaccine: HEPA, HIBV, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013537: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544.
Sex: U
Vaccine: HEPA, HIBV, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013537: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544.
Sex: U
Vaccine: HEPA, HIBV, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013539: US-009507513-1708USA013537: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544.
Sex: U
Vaccine: HEPA, HIBV, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013537: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544.
Sex: U
Vaccine: HEPA, HIBV, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013538: US-009507513-1708USA013537: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD lot # N008824 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD. Sender's Comments: US-009507513-1708USA013604: US-009507513-1708USA013605.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX lot # N012615 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1708USA013567.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX lot # M028546 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Sender's Comments: US-009507513-1708USA013567.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, refers to an unknown number of patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates, for the past two years, the patients were vaccinated with improperly stored doses of PROQUAD (strength, dosing details, anatomical location, lot# and expiration date were unknown) for prophylaxis. The vaccine was reconstituted with Sterile Merck Diluent. The Medical assistant refused to provide any additional information including excursion details. No PQC was filed. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000103: US-009507513-1709USA000104.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB lot # M010212 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB. Additional information has been requested. Sender's Comments: US-009507513-1708USA012766.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, refers to an unknown number of patients of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates, for the past two years, the patients were vaccinated with improperly stored doses of VARIVAX (strength, dosing details, anatomical location, lot# and expiration date were unknown) for prophylaxis. The vaccine was reconstituted with Sterile Merck Diluent. The Medical assistant refused to provide any additional information including excursion details. No PQC was filed. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA013798: US-009507513-1709USA000104.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, refers to an unknown number of patients of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates, for the past two years, the patients were vaccinated with improperly stored doses of ZOSTAVAX (strength, dosing details, anatomical location, lot# and expiration date were unknown) for prophylaxis. The vaccine was reconstituted with Sterile Merck Diluent. The Medical assistant refused to provide any additional information including excursion details. No PQC was filed. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000103: US-009507513-1708USA013798.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a nurse referring to a 20 year old female patient. The patient's medical history included gallbladder removal and headache. Drug reactions/allergies was reported as none. Concomitant therapy included oral contraceptive. The patient was vaccinated with three doses of RECOMBIVAX HB (dose, router, lot # and expiration date were unknown) one dose on 16-JAN-1997, one dose on 14-MAY-1997, and one dose on 10-SEP-1997. A hepatitis B titer was drawn on 12-AUG-2017 and the results showed there was no immunity to hepatitis B. One booster dose of RECOMBIVAX HB (lot# N006321, expiration date 08-NOV-2019) was administered to patient on 18-AUG-2017. No treatment was given. The outcome of the event was reported as not recovered. The patient visit physician to seek medical attention. The causality assessment was not provided. This is one of two reports regarding to the same patient. Sender's Comments: US-009507513-1708USA011342.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to 7 unspecified patients of unknown ages and genders. On unknown date in August-2017, the patients were vaccinated with VARIVAX (lot # reported as N014630, expiry date: 11-MAY-2019, lot #L044526 expiry date: 09-NOV-2019, lot #N012618, expiry date: 02-APR-2019 (route: subcutaneous). The vaccine was stored at a temperature of 32 F (foreign heat) for unknown period of time (reported as "ongoing excursion"). The previous temperature excursion included multiple 6 F to 14 F for total 6.5 hours. The call was because of the data logger. No adverse effects were reported. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1708USA010196.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Headache, Injection site discolouration, Injection site rash
Clinical narrative: Initial unsolicited case received from other non-health care professional on 21 Aug 2017. This case involves 17-year-old male patient who was vaccinated with a dose of MENACTRA (Batch number: U5823AA, expiry date, dose, dose in series, route and site of administration were not reported) on 16 Aug 2017 (Wednesday). The patient medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed a rash and black and blue at injection site (skin discoloration and vaccination site reaction) approximately 8" x 4". Patient also had severe headache and dizziness. The patient had no fever. On an unknown date (Saturday) the patient went to Urgent center and was treated with cephalexin. The patient relevant lab tests were not reported. Other corrective treatment was not reported. The outcome of all the events were not reported. List of documents held by sender: none.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of consciousness, Presyncope, Seizure
Clinical narrative: Initial unsolicited report received from physician on 22-Aug-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of ADACEL (Batch number: U5626AA, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, 5-10 minutes following the vaccination, the patient passed out and had a seizure. It was reported that, she had a similar episode that was worked out by neurology and thought to be vasovagal. Lab data and corrective treatment were not reported. The outcome of the event were not reported. Upon internal review, the company decided to consider the event serious because of important medical event passed out and seizure. List of documents held by sender: none.; Sender's Comments: Patient passed out and experienced a seizure after vaccination. Time to onset is compatible with the role of vaccine. Seizure is listed with the vaccine. However, further information including confirmed diagnosis, patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
Age: 0.33
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Injection site discolouration
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pigmentation changes in a 5-month-old female patient who received HIBERIX (batch number T797C, expiry date 8th March 2018). On 29th September 2016, the patient received HIBERIX. On an unknown date, less than a year after receiving HIBERIX, the patient experienced injection site pigmentation changes. On an unknown date, the outcome of the injection site pigmentation changes was unknown. It was unknown if the reporter considered the injection site pigmentation changes to be related to HIBERIX. Additional details were reported as follows: Healthcare professional reported that after administration of HIBERIX, the patient had a block dot appeared at the site of injection. Physician did not want to be contacted further regarding the adverse event. The physician had called regarding the adverse event on several patients prior to these two patients. He stated that they had changed needles and this did not occur anymore. They had needle to send to GSK if their scientists were interested in seeing if they could replicate issue. No further symptoms were stated. This case has been linked with case US2017131736, reported by same reporter.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of passed out in a 16-year-old female patient who received BEXSERO. Concomitant products included MENACTRA. On 28th July 2017, the patient received BEXSERO. On 28th July 2017, less than a day after receiving BEXSERO, the patient experienced passed out (serious criteria GSK medically significant) and syncope. On an unknown date, the outcome of the passed out and syncope were recovered/resolved. It was unknown if the reporter considered the passed out and syncope to be related to BEXSERO. Additional details were reported as follows: The patient received BEXSERO and MENACTRA on the same day and passed out following the administrations. The healthcare professional was not asked to be contacted but did not state they could not be contacted if a follow up was required.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 06-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012723 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 07-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received.     Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012724 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent.  This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments:  US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 8 week old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 07-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012725 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.