Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Were administered improperly stored VARIVAX; No adverse effects; This spontaneous report has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' pertinent concurrent conditions, medical history and drug reactions or allergies, if any, were not provided.   The medical assistant reported that, on an unknown date, the unspecified patients were vaccinated with unspecified doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose numbers, route of administration and anatomical locations of administration were not provided; lot number R030606 with expiry date on 23-OCT-2020; lot number reported as R030847 with expiry date on 22-OCT-2020; lot number R026715 with expiry date on 18-SEP-2020; lot number R023504 with expiry date on 16-AUG-2020; lot number R022117 with expiry date on 02-AUG-2020; and lot number R020650 with expiry date 18-JUL-2020) for prophylaxis; and with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) rHA (dose numbers, route of administration and anatomical locations of administration were not provided; lot number S000623 with expiry date on 06-JUL-2020; lot number R030794 with expiry date on 22-APR-2020; lot number R030801 with expiry date on 22-APR-2020; and lot number R021102 with expiry date on 20-JAN-2020) for prophylaxis.   Lot number R030847 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX).   The doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were exposed to a temperature excursion of -14 Celsius degrees to -10 Celsius degrees (-11.5 Celsius degrees) for a time frame of 46 hours and 15 minutes, which was not detected by the Digital Data Logger. There was a previous temperature excursion of -14 Celsius degrees to -10 Celsius degrees (-10.6 Celsius degrees) for 2 hours. No adverse effects were reported.   This case has been considered to be non-valid, since patients' identifiers were not provided.  Follow-up information has been received from the medical assistant on 23-MAY-2019. It was confirmed by the reporter that unspecified 1-year-old patients of unknown gender were vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX).Also, additional lot numbers for varicella virus vaccine live (Oka/Merck) (VARIVAX) were provided: lot # R034394, which was verified to be a valid lot number, with expiration date reported as 27-NOV-2020, but upon internal validation established as 04-DEC-2020; lot #R035222 with expiration date 04-DEC-2020 and lot # R030487 with expiration date 22-OCT-2020. The reporter mentioned that there have been 113 doses of the vaccines administered, however it was not specified how many doses of each vaccination were administered. There have no reports of adverse events following the vaccinations.   Upon receipt of follow-up information it was determined that this case is now valid because patients' identifiers were provided. This is one of two reports received form the same reporter.; Sender's Comments:  US-009507513-1906USA002535: