chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an office manager referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates in January and February 2017, the patients received improperly stored doses of M-M-R II lot # M007277, expiration date: 09-FEB-2018; lot #M034857, expiration date: 27-JUL-2018 (dose and route of administration were not reported) for prophylaxis. The reporter had not been informed of an adverse experience. Administered doses of M-M-R II were exposed to temperature excursions as follows: In January 2017, between 5°F and 14°F for 4640 minutes (806 minutes highest 32°F); in February 2017, between 5°F and 14°F for 5164 minutes (560 minutes highest 36°F). Data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA008835: US-009507513-1703USA009922: US-009507513-1703USA009923: US-009507513-1703USA009924: US-009507513-1703USA009925: US-009507513-1703USA009926: US-009507513-1704USA001629: US-009507513-1704USA001630: US-009507513-1704USA001631:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, or concomitant medications. On unspecified dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (lot number M036059, expiration date 03-JUN-2019) for prophylaxis (dose and route of administration were not reported). The administered doses of the vaccine experienced a temperature excursion 57 degrees Farenheit for 15 minutes. A previous temperature excursion of 48 degrees Farenheit for 15 minutes was also reported. The temperature excursion were recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports from the same reported (MARRS No. 1704USA001638, 1704USA001639 and 1704USA001640). Additional information has been requested. Sender's Comments: US-009507513-1704USA001638: US-009507513-1704USA001639: US-009507513-1704USA001640.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 02-FEB-2017 at 15:50, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441:  US-009507513-1704USA000389:  US-009507513-1704USA000390:  US-009507513-1704USA000391:  US-009507513-1704USA000392:  US-009507513-1704USA000393:  US-009507513-1704USA000394:  US-009507513-1704USA000395:  US-009507513-1704USA000396:  US-009507513-1704USA000397:  US-009507513-1704USA000398:  US-009507513-1704USA000399:  US-009507513-1704USA000400:  US-009507513-1704USA000401:  US-009507513-1704USA000402:  US-009507513-1704USA000403:  US-009507513-1704USA000404:  US-009507513-1704USA000405:  US-009507513-1704USA000406:  US-009507513-1704USA000407:  US-009507513-1704USA000408:  US-009507513-1704USA000409:  US-009507513-1704USA000410:  US-009507513-1704USA000412:  US-009507513-1704USA000413:  US-009507513-1704USA000414:  US-009507513-1704USA000415:  US-009507513-1704USA000416:  US-009507513-1704USA000417:  US-009507513-1704USA000418:  US-009507513-1704USA000419:  US-009507513-1704USA000420:  US-009507513-1704USA000421:  US-009507513-1704USA000422:  US-009507513-1704USA000423:  US-009507513-1704USA000424:  US-009507513-1704USA000425:  US-009507513-1704USA000426:  US-009507513-1704USA000427:  US-009507513-1704USA000428:  US-009507513-1704USA000429:  US-009507513-1704USA000430:  US-009507513-1704USA000431:  US-009507513-1704USA000432:  US-009507513-1704USA000433:  US-009507513-1704USA000434:  US-009507513-1704USA000435:  US-009507513-1704USA000436:  US-009507513-1704USA000437:  US-009507513-1704USA000438:  US-009507513-1704USA000439:  US-009507513-1704USA000440:  US-009507513-1704USA000441:  US-009507513-1704USA000442:  US-009507513-1704USA000443:  US-009507513-1704USA000444:  US-009507513-1704USA000445:  US-009507513-1704USA000446:  US-009507513-1704USA000447:  US-009507513-1704USA000448:  US-009507513-1704USA000449:  US-009507513-1704USA000450:  US-009507513-1704USA000451:  US-009507513-1704USA000452:  US-009507513-1704USA000453:  US-009507513-1704USA000454:  US-009507513-1704U
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 24-JAN-2017  at 11:02, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 24-JAN-2017 at 13:56, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441:  US-009507513-1704USA000389:  US-009507513-1704USA000390:  US-009507513-1704USA000391:  US-009507513-1704USA000392:  US-009507513-1704USA000393:  US-009507513-1704USA000394:  US-009507513-1704USA000395:  US-009507513-1704USA000396:  US-009507513-1704USA000397:  US-009507513-1704USA000398:  US-009507513-1704USA000399:  US-009507513-1704USA000400:  US-009507513-1704USA000401:  US-009507513-1704USA000402:  US-009507513-1704USA000403:  US-009507513-1704USA000404:  US-009507513-1704USA000405:  US-009507513-1704USA000406:  US-009507513-1704USA000407:  US-009507513-1704USA000408:  US-009507513-1704USA000409:  US-009507513-1704USA000410:  US-009507513-1704USA000411:  US-009507513-1704USA000412:  US-009507513-1704USA000414:  US-009507513-1704USA000415:  US-009507513-1704USA000416:  US-009507513-1704USA000417:  US-009507513-1704USA000418:  US-009507513-1704USA000419:  US-009507513-1704USA000420:  US-009507513-1704USA000421:  US-009507513-1704USA000422:  US-009507513-1704USA000423:  US-009507513-1704USA000424:  US-009507513-1704USA000425:  US-009507513-1704USA000426:  US-009507513-1704USA000427:  US-009507513-1704USA000428:  US-009507513-1704USA000429:  US-009507513-1704USA000430:  US-009507513-1704USA000431:  US-009507513-1704USA000432:  US-009507513-1704USA000433:  US-009507513-1704USA000434:  US-009507513-1704USA000435:  US-009507513-1704USA000436:  US-009507513-1704USA000437:  US-009507513-1704USA000438:  US-009507513-1704USA000439:  US-009507513-1704USA000440:  US-009507513-1704USA000441:  US-009507513-1704USA000442:  US-009507513-1704USA000443:  US-009507513-1704USA000444:  US-009507513-1704USA000445:  US-009507513-1704USA000446:  US-009507513-1704USA000447:  US-009507513-1704USA000448:  US-009507513-1704USA000449:  US-009507513-1704USA000450:  US-009507513-1704USA000451:  US-009507513-1704USA000452:  US-009507513-1704USA000453:  US-009507513-1704USA000454:  US-009507513-1704U
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 06-JAN-2017 at 14:00, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA00045
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 26-JAN-2017 at 16:35, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457: US-009507513-1704USA000458.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 01-FEB-2017  at 13:22, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA00047: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 03-FEB-2017 at 10:42, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441:  US-009507513-1704USA000389:  US-009507513-1704USA000390:  US-009507513-1704USA000391:  US-009507513-1704USA000392:  US-009507513-1704USA000393:  US-009507513-1704USA000394:  US-009507513-1704USA000395:  US-009507513-1704USA000396:  US-009507513-1704USA000397:  US-009507513-1704USA000398:  US-009507513-1704USA000399:  US-009507513-1704USA000400:  US-009507513-1704USA000401:  US-009507513-1704USA000402:  US-009507513-1704USA000403:  US-009507513-1704USA000404:  US-009507513-1704USA000405:  US-009507513-1704USA000406:  US-009507513-1704USA000407:  US-009507513-1704USA000408:  US-009507513-1704USA000409:  US-009507513-1704USA000410:  US-009507513-1704USA000411:  US-009507513-1704USA000412:  US-009507513-1704USA000413:  US-009507513-1704USA000414:  US-009507513-1704USA000415:  US-009507513-1704USA000416:  US-009507513-1704USA000458:  US-009507513-1704USA000418:  US-009507513-1704USA000419:  US-009507513-1704USA000420:  US-009507513-1704USA000421:  US-009507513-1704USA000422:  US-009507513-1704USA000423:  US-009507513-1704USA000424:  US-009507513-1704USA000425:  US-009507513-1704USA000426: US-009507513-1704USA000427:  US-009507513-1704USA000428: US-009507513-1704USA000429:  US-009507513-1704USA000430:  US-009507513-1704USA000431:  US-009507513-1704USA000432:  US-009507513-1704USA000433:  US-009507513-1704USA000434:  US-009507513-1704USA000435:  US-009507513-1704USA000436:  US-009507513-1704USA000437:  US-009507513-1704USA000438:  US-009507513-1704USA000439:  US-009507513-1704USA000440:  US-009507513-1704USA000441:  US-009507513-1704USA000442:  US-009507513-1704USA000443:  US-009507513-1704USA000444:  US-009507513-1704USA000445:  US-009507513-1704USA000446:  US-009507513-1704USA000447:  US-009507513-1704USA000448:  US-009507513-1704USA000449:  US-009507513-1704USA000450:  US-009507513-1704USA000451:  US-009507513-1704USA000452:  US-009507513-1704USA000453:  US-009507513-1704U.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 20-MAR-2017 at 12:44, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse refers to her daughter, a 15 year old female patient. No concomitant medications, pertinent medical history, drug reactions or allergies were reported. On an unspecified day in October 2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot #, expiration date, dose and route of administration were not provided) for immunisation. It was reported that the next morning, the patient broke out in hives from head to toe. The nurse gave her daughter a dose of BENADRYL and took her to pediatrician. The patient was prescribed prednisone (manufacturer unknown). No diagnostic laboratory tests were performed. The outcome of the event was reported as recovered/resolved. Hives resolved within 48 hours from the start of prednisone (manufacturer unknown). Causality was not provided. Additional information is not expected as the reporter did not wish to be contacted.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness unilateral, Diplopia, Eye movement disorder, Hypertension, IIIrd nerve paralysis
Clinical narrative: Information was received from attorney regarding a case in litigation concerning a 64 year old female. It is being claimed that on 10-NOV-2014 the patient experienced retinal detachment of the right eye secondary to reaction from ZOSTAVAX, muscular palsy of the right abducens (sic) nerve, ocular nerve and trochlear nerve and hypertension. The patient displays loss of vision in her right eye. The patient is claiming permanent injuries. Post surgery of right retinal reattachment, the patient has remaining double vision with impairment of the movements of the right eye. The nerve damage may be permanent. Medical treatment is continuing and the patient has been treated from 10-NOV-2014 until 28-JAN-2015. The patient has not been hospitalized. As a result of the patient's employment, the patient was required to receive the ZOSTAVAX. The patient has been out of work since November 2014 until the present. The patient has a workers compensation claim for these injuries. Compensation: the judge found that the drug was the cause of her injuries. Her physicians have opined that the drug was directly related to the injuries complained of. Upon internal review, retinal detachment with surgery secondary to reaction from ZOSTAVAX vaccine, loss of vision and muscular palsy of the right abducens nerve, ocular nerve and trochlear nerve were considered medically significant. Retinal detachment with surgery secondary to reaction from ZOSTAVAX vaccine, loss of vision and muscular palsy of the right abducens (sic) nerve, ocular nerve and trochlear nerve  were disabling. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: IVth nerve paralysis, Impaired work ability, Nerve injury, Retinal detachment, Retinopexy
Clinical narrative: Information was received from attorney regarding a case in litigation concerning a 64 year old female. It is being claimed that on 10-NOV-2014 the patient experienced retinal detachment of the right eye secondary to reaction from ZOSTAVAX, muscular palsy of the right abducens (sic) nerve, ocular nerve and trochlear nerve and hypertension. The patient displays loss of vision in her right eye. The patient is claiming permanent injuries. Post surgery of right retinal reattachment, the patient has remaining double vision with impairment of the movements of the right eye. The nerve damage may be permanent. Medical treatment is continuing and the patient has been treated from 10-NOV-2014 until 28-JAN-2015. The patient has not been hospitalized. As a result of the patient's employment, the patient was required to receive the ZOSTAVAX. The patient has been out of work since November 2014 until the present. The patient has a workers compensation claim for these injuries. Compensation: the judge found that the drug was the cause of her injuries. Her physicians have opined that the drug was directly related to the injuries complained of. Upon internal review, retinal detachment with surgery secondary to reaction from ZOSTAVAX vaccine, loss of vision and muscular palsy of the right abducens nerve, ocular nerve and trochlear nerve were considered medically significant. Retinal detachment with surgery secondary to reaction from ZOSTAVAX vaccine, loss of vision and muscular palsy of the right abducens (sic) nerve, ocular nerve and trochlear nerve  were disabling. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: VIth nerve paralysis
Clinical narrative: Information was received from attorney regarding a case in litigation concerning a 64 year old female. It is being claimed that on 10-NOV-2014 the patient experienced retinal detachment of the right eye secondary to reaction from ZOSTAVAX, muscular palsy of the right abducens (sic) nerve, ocular nerve and trochlear nerve and hypertension. The patient displays loss of vision in her right eye. The patient is claiming permanent injuries. Post surgery of right retinal reattachment, the patient has remaining double vision with impairment of the movements of the right eye. The nerve damage may be permanent. Medical treatment is continuing and the patient has been treated from 10-NOV-2014 until 28-JAN-2015. The patient has not been hospitalized. As a result of the patient's employment, the patient was required to receive the ZOSTAVAX. The patient has been out of work since November 2014 until the present. The patient has a workers compensation claim for these injuries. Compensation: the judge found that the drug was the cause of her injuries. Her physicians have opined that the drug was directly related to the injuries complained of. Upon internal review, retinal detachment with surgery secondary to reaction from ZOSTAVAX vaccine, loss of vision and muscular palsy of the right abducens nerve, ocular nerve and trochlear nerve were considered medically significant. Retinal detachment with surgery secondary to reaction from ZOSTAVAX vaccine, loss of vision and muscular palsy of the right abducens (sic) nerve, ocular nerve and trochlear nerve  were disabling. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an office manager referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates in January and February 2017, the patients received improperly stored doses of PROQUAD lot # M015695, expiration date: 26-SEP-2017 (dose and route of administration were not reported) for prophylaxis. The reporter had not been informed of an adverse experience. Administered doses of PROQUAD were exposed to temperature excursions as follows: In January 2017, between 5°F and 14°F for 4640 minutes (806 minutes highest 32°F); in February 2017, between 5°F and 14°F for 5164 minutes (560 minutes highest 36°F). Data logger was involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA008835: US-009507513-1703USA009922: US-009507513-1703USA009923: US-009507513-1703USA009924: US-009507513-1703USA009925: US-009507513-1703USA009926: US-009507513-1703USA012105: US-009507513-1704USA001630: US-009507513-1704USA001631.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an office manager referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates in January and February 2017, the patients received improperly stored doses of VARIVAX lot # M008172, expiration date: 16-FEB-2018; lot # M010482, expiration date: 01-MAR-2018 (dose and route of administration were not reported) for prophylaxis. The reporter had not been informed of an adverse experience. Administered doses of VARIVAX were exposed to temperature excursions as follows: In January 2017, between 5°F and 14°F for 4640 minutes (806 minutes highest 32°F); in February 2017, between 5°F and 14°F for 5164 minutes (560 minutes highest 36°F). Data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA008835: US-009507513-1703USA009922: US-009507513-1703USA009923: US-009507513-1703USA009924: US-009507513-1703USA009925: US-009507513-1703USA009926: US-009507513-1703USA012105: US-009507513-1704USA001629: US-009507513-1704USA001631:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an office manager referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates in January and February 2017, the patients received improperly stored doses of ZOSTAVAX lot # M019646, expiration date: 18-JUL-2017; lot #M035695, expiration date: 07-NOV-2017 (dose and route of administration were not reported) for prophylaxis. The reporter had not been informed of an adverse experience. Administered doses of ZOSTAVAX were exposed to temperature excursions as follows: In January 2017, between 5°F and 14°F for 4640 minutes (806 minutes highest 32°F); in February 2017, between 5°F and 14°F for 5164 minutes (560 minutes highest 36°F). Data logger was involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA008835: US-009507513-1703USA009922: US-009507513-1703USA009923: US-009507513-1703USA009924: US-009507513-1703USA009925: US-009507513-1703USA009926: US-009507513-1703USA012105: US-009507513-1704USA001629: US-009507513-1704USA001630.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, or concomitant medications. On unspecified dates, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (lot number reported as M044031, expiration date 21-FEB-2019 and lot number M031574, expiration date 11-NOV-2018) for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion 57 degrees Farenheit for 15 minutes. A previous temperature excursion of 48 degrees Farenheit for 15 minutes was also reported. The temperature excursions were recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports from the same reported (MARRS No. 1703USA013299, 1704USA001639 and 1704USA001640). Additional information has been requested. Sender's Comments: US-009507513-1704USA001639: US-009507513-1704USA001640: US-009507513-1703USA013299.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, or concomitant medications. On unspecified dates, the patients were vaccinated with an improperly stored dose of ROTATEQ (lot number M035455, expiration date 22-APR-2018) for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion 57 degrees Farenheit for 15 minutes. A previous temperature excursion of 48 degrees Farenheit for 15 minutes was also reported. The temperature excursion were recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports from the same reported (MARRS No. 1703USA013299, 1704USA001638 and 1704USA001640). Additional information has been requested. Sender's Comments: US-009507513-1703USA013299: US-009507513-1704USA001638: US-009507513-1704USA001640.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, or concomitant medications. On unspecified dates, the patients were vaccinated with an improperly stored dose of VAQTA (lot number M033611, expiration date 02-MAR-2018) for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion 57 degrees Farenheit for 15 minutes. A previous temperature excursion of 48 degrees Farenheit for 15 minutes was also reported. The temperature excursions were recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports from the same reported (MARRS No. 1703USA013299, 1704USA001638 and 1704USA001639). Additional information has been requested. Sender's Comments: US-009507513-1704USA001639: US-009507513-1703USA013299: US-009507513-1704USA001638.
Sex: F
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative. This female consumer reported similar events for herself and her husband. This is 1st of 2 reports concerning the wife. A female patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced major stinging after vaccination on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2017142847 same reporter/product/event, diff patients.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Nausea
Clinical narrative: This is a spontaneous report from a contactable pharmacist who reported the same event for 2 patients (husband and wife). This is the 2nd of 2 reports. A 63-year-old male patient received the first dose of PREVNAR 13 (lot R41774, expiry date Apr2018) on 04Mar2017, in left deltoid, at 0.5 ml single, for immunisation. No other vaccines were administered on the same date. The patient medical history was not reported. The patient's concomitant medications were not reported. Within 24 hours, on an unspecified date in Mar2017, the patient experienced nausea. It was mentioned to his doctor and to the pharmacy on 14Mar2017 and when the pharmacist was able to get back in touch with him on 24Mar2017 the nausea had abated. The reporter stated that it sounded as though doctor office was just made aware of the nausea over the phone and that the patient did not receive care or treatment for the nausea. No physician office or emergency room visit were required. The event resolved on an unknown date in Mar2017.  The reporting pharmacist did not believe that the nausea was related to PREVNAR 13. He believed that it sounded more as though the patient picked up a GI bug. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017143838 Same reporter/drug/AE, different patient.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Exposure to vaccinated person, Secondary transmission
Clinical narrative: Smallpox cross inoculation.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, redness to L arm extending down to elbow, whole upper arm swelling, +pain.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Anti-thyroid antibody positive, Antinuclear antibody negative, Blood thyroid stimulating hormone decreased, Encephalitis autoimmune, HIV test negative
Clinical narrative: Possible autoimmune encephalitis. HSV ab negative. TSH 1.24  Thyroglobulin 52,  Thyroid Peroxidase Ab 36, HIV negative, ANA negative.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Herpes simplex test negative, Thyroglobulin present
Clinical narrative: Possible autoimmune encephalitis. HSV ab negative. TSH 1.24  Thyroglobulin 52,  Thyroid Peroxidase Ab 36, HIV negative, ANA negative.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Amnesia, Computerised tomogram head, Foaming at mouth, Full blood count, Headache
Clinical narrative: Foaming at the mouth, rigid, unresponsive for 20 minutes. Memory loss after event and headache the following day.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Metabolic function test, Muscle rigidity, Toxicologic test, Unresponsive to stimuli
Clinical narrative: Foaming at the mouth, rigid, unresponsive for 20 minutes. Memory loss after event and headache the following day.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 14-MAR-2017 from a health care worker concerning an unknown number of unspecified patients. No medical history, concomitant medications or patient demographics were reported. The unspecified patients were each administered improperly stored vaccines on unknown dates, starting after 01-JUN-2015. There were several different sets of excursion conditions with different vaccines involved. The nurse confirmed that while many of the vaccines lots are now expired, all improperly stored doses were not expired at the time of administration. No adverse effects were reported. The lots of GARDASIL involved in the temperature excursions were lot J009788, expired 17-MAR-2016, K003520, expired 20-NOV-2016 and lot K006960, expired 19-FEB-2017. Other vaccines involved in the temperature excursion were PNEUMOVAX23 (MARRS# 1703USA014563), RECOMBIVAX HB (MARRS# 1703USA014564),  GARDASIL9 (MARRS #1703USA014565), PEDVAX HIB (MARRS#1703USA014567) and VARIVAX (MARRS# 1703USA014566). Follow-up information was received on 20-MAR-2017 from the reporter. She reported that GARDASIL doses were administered 22 times; 02-JUL-2015, 13-JUN-2015, 14-JUL-2015, 15-JUL-2015, 11-AUG-2015, 12-AUG-2015, 14-SEP-2015, 15-SEP-2015, 15-SEP-2015, 16-SEP-2015, 13-NOV-2015, 29-DEC-2015, 23-FEB-2016, 19-APR-2016, 26-APR-2016, 06-MAY-2016, 03-JUN-2016, 09-AUG-2016, 23-AUG-2016, 28-AUG-2016, 16-SEP-2016 and 13-JAN-2017 for lot K006960 (out of range 308 hours, 30 minutes) and dose administered on 28-SEP-2015, 15-OCT-2015 and 27-OCT-2015 for lot K003520. Temperature was out of range 303 hours, 30 minutes. No information was provided for lot J009788. No patient identifiers were provided. Additional information has been requested.  This is one of several reports by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unknown number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients who were on immunosuppressive therapy with prednisolone (manufacturer unknown) 5 mg once daily, were vaccinated with a dose of ZOSTAVAX and sterile diluent (DILUENT MRK) (dose, route, anatomical location, lot # and expiration date were not reported for both products) for prophylaxis. No adverse effects were reported. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 14-MAR-2017 from a health care worker concerning and unknown number of unspecified patients. No medical history, concomitant medications or patient demographics were reported. The unspecified patients were administered improperly stored vaccines on unknown dates, starting after 01-JUN-2015. There were several different sets of excursion conditions with different vaccine involved. The nurse confirmed that while many of the vaccines lots are now expired, all improperly stored doses were not expired at the time of administration. No adverse effects were reported. The lots of PNEUMOVAX 23 involved in the temperature excursion were lot K015368, exp. 04-MAY-2016; lot L018503, expired 16-MAR-2017; lot K020215, expired 15-MAY-2016; and lot K021577, expired 16-MAR-2017. Other vaccines involved in the temperature excursion were RECOMBIVAX HB (MARRS# 1703USA014564), GARDASIL 9 (MARRS #1703USA014565), PEDVAXHIB (MARRS#1703USA014567), VARIVAX (MARRS# 1703USA014566) and GARDASIL (MARRS# 1703USA007376). Follow-up information was received on 20-MAR-2017 from the reporter. Vaccine PNEUMOVAX 23 Lot K015368, expired 04-MAY-2016, a dose was administered on 10-SEP-2015 (dose not reported) (temperature out of range 24 hours). Lot K020215, expired 15-MAY-2016, doses were administered on 09-JUN-2015, 25-JUN-2015, 09-JUL-2015, 20-JAN-2016, 20-JAN-2016, 22-JAN-2016, 02-FEB-2016 and 02-FEB-2016 (temperature out of range 308 hours, 30 minutes). Lot K021577, expired 22-MAR-2017 (also reported as 16-MAR-2017) doses were administered on 21-JUL-2015, 22-JUL-2015, 11-AUG-2015, 18-AUG-2015, 22-SEP-2015, 22-SEP-2015, 22-SEP-2015 and 20-JAN-2016 (temperature out of range 302 hours 30 minutes). Lot L018503, expired 16-MAR-2017, doses were administered on 22-OCT-2015, 04-NOV-2015, 12-NOV-2015, 19-NOV-2015, 25-NOV-2015, 25-NOV-2015, 11-DEC-2015, 15-DEC-2015, 22-JAN-2016 and 22-JAN-2016 (temperature out of range 265 hours, 30 minutes). Dose and administration sites not reported. No patient identifiers were provided. Additional information has been requested. This is one of several reports by the same reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 14-MAR-2017 from a health care worker concerning and unknown number of unspecified patients. No medical history, concomitant medications or patient demographics were reported. The unspecified patients were administered improperly stored vaccines on unknown dates, starting after 01-JUN-2015. There were several different sets of excursion conditions with different vaccines involved. The nurse confirmed that while many of the vaccines lots are now expired, all improperly stored doses were not expired at the time of administration. No adverse effects were reported. The lot of RECOMBIVAX HB involved in the temperature excursion was lot J009374, expired 11-JUN-2016. Other vaccines involved in the temperature excursion were PNEUMOVAX 23 (MARRS# 1703USA014563), GARDASIL 9 (MARRS# 1703USA014565), PEDVAXHIB (MARRS# 1703USA014567) and VARIVAX (MARRS# 1703USA014566), GARDASIL (MARRS# 1703USA007376). Follow-up information was received on 20-MAR-2017 from the reporter. It was reported that RECOMBIVAX lot J009374, expired 11-JUN-2016 (dose and sites not reported) doses were administered on 29-JUN-2015, 16-JUL-2015, 22-JUL-2015, 27-JUL-2015, 28-JUL-2015, 29-JUL-2015, 30-JUL-2015, 31-JUL-2015, 12-AUG-2015, 13-AUG-2015, 14-AUG-2015, 17-AUG-2015, 02-SEP-2015 and 02-FEB-2016. No patient identifiers provided. Additional information has been requested. This is one of several reports by the same reporter.