Sex: U
Vaccine: HEP, HEPA, HPV9, MMR, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a nurse practitioner, concerning an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. The nurse informed that on unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 for prophylaxis, lot #N001533 and expiration date 16-OCT-2019; lot #N004798 and expiration date 31-OCT-2019; lot #N009801 and expiration date 20-NOV-2019; lot #N010497 and expiration date 15-JAN-2020; lot #N004799; lot #N20352 and expiration date 10-APR-2020; lot #N007931 and expiration date 07-NOV-2019; and lot #N0013276 and expiration date 21-JAN-2020 (strength, dose, frequency and route of administration were not reported); with improperly stored M-M-R II one single injection, for prophylaxis, lot #N001007 and expiration date 13-JAN-2019; lot #N009171 and expiration date 20-MAR-2019; lot #N001532 and expiration date 13-JAN-2019; lot #N020352 and expiration date 04-MAY-2019; lot #M045395 and expiration date 04-NOV-2018; lot #N001531 and expiration date 13-JAN-2019 and a non-valid lot #M045396 and expiration date 14-NOV-2018 (strength, dose and route of administration were not reported); with improperly stored VAQTA for prophylaxis, lot #N005605 and expiration date 13-JAN-2018 and lot #N012324 and expiration date 05-APR-2018 (strength, dose, frequency and route of administration were not reported); with improperly stored PNEUMOVAX 23 for prophylaxis, lot #N001007 and expiration date 09-SEP-2018; lot #N014946 and expiration date 01-FEB-2019; lot #N011867 and expiration date 08-NOV-2018; lot #N011491 and expiration date 04-NOV-2018; and lot #M047519 and expiration date 04-AUG-2018 (strength, dose, frequency and route of administration were not reported) and with improperly stored RECOMBIVAX HB for prophylaxis, lot #M046373 and expiration date 04-NOV-2018; non-valid lot #N000321 and expiration date 08-NOV-2019 and lot #N006321 and expiration date 08-NOV-2018 (strength, dose, frequency and route of administration were not reported). The vaccines were reconstitued with an improperly stored sterile diluent (MERCK STERILE DILUENT) for prophylaxis (strenght, dose, lot number and expiration date were not reported). The reporter denied any adverse effect reported by the patients. The nurse reported that the time frames and temperatures of excursions were as follows: 47°F to 77°F (48.5°F) during a time frame of 3 hours and 30 minutes; below 32°F / 0°C (31.8°F) during a time frame of 126 hours; bellow 32°F / 0°C (17.3°F) during a time frame of 6 hours and 30 minutes; 47 °F to 77°F (49.8°F) during a time frame of 66 hours and 30 minutes; 47°F to 77°F (52.7°F) during a time frame of 3 hours and 30 minutes: 47 °F to 77 °F (52.3°F) duing a time frame of 160 hours and below 32°F / 0°C (31.5°F) during a time frame of 16 hours. There was no previous temperature of excursion reported. There was a digital data logger involved. As of 19-FEB-2018, all telephone attempts to obtain follow-up information were unsuccessful.