Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; PROQUAD administered/that were improperly stored; This non-valid spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions or medical histories provided. The patients' concomitant therapies included sterile diluent. Since an unknown day in June 2019, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX)(exact doses, route of administration, lot# and expiration date were not reported) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (exact doses, route of administration, lot# and expiration date were not reported) for prophylaxis. The vaccines underwent temperature excursion of unknown temperature for unknown time frame. There were multiple previous temperature excursion since an unknown day in June 2019. The digital data logger was involved in recording excursion details. Diluent was reported to be stored properly. No adverse effects were reported.  Follow up information has been received from the nurse on 17-JUL-2019. On unknown dates, the patients were also vaccinated with improperly stored doses of Zoster Vaccine Live (ZOSTAVAX). The measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (lot # R004440, expiry date 12-AUG-2019) were exposed to temperature between 47 degrees Fahrenheit (F) to 77 F (between 9 degrees Celsius to 25 degrees Celsius) for 135 hours and was administered to unspecified patients on 17-APR-2019, 18-APR-2019, 22-APR-2019, 23-APR-2019, 24-APR-2019, 30-APR-2019, 07-MAY-2019, 15-MAY-2019, 21-JUN-2019, 24-JUN-2019 and 25- JUN-2019. The varicella virus vaccine live (Oka/Merck)(VARIVAX) (lot # S005080 and expiry date 19-FEB-2019) were exposed to temperature between 47 F to 77 F (between 9 degrees Celsius to 25 degrees Celsius) for 11 hours and 24 minutes. The varicella virus vaccine live (Oka/Merck)(VARIVAX) (lot # R018777 and expiry date 01-JUL-2020) were exposed to temperature between 47 F to 77 F (between 9 degrees Celsius to 25 degrees Celsius) for 135 hours. The measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (lot # R004440, expiry date 12-AUG-2019) were exposed to temperature between 6 F to 14 F (-14 C to -10 C) for 754 minutes and between 15 F to 46 F (-9 C to 8 C) for 41 minutes. The measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (lot # S005074, expiry date 18-AUG-2020) were exposed to temperature between 6 F to 14 F (-14 C to -10 C) for 28 minutes and between 15 F to 46 F (-9 C to 8 C) for 32 minutes. The varicella virus vaccine live (Oka/Merck)(VARIVAX) (lot # R006753 and expiry date 06-MAR-2020) were exposed to temperature between 6 F to 14 F (-14 C to -10 C) for 754 minutes and between 15 F to 46 F (-9 C to 8 C) for 41 minutes. The varicella virus vaccine live (Oka/Merck)(VARIVAX) (lot # R027995 and expiry date 01-OCT-2020) were exposed to temperature between 6 F to 14 F (-14 C to -10 C) for 754 minutes and between 15 F to 46 F (-9 C to 8 C) for 41 minutes. The varicella virus vaccine live (Oka/Merck)(VARIVAX) (lot # S000582 and expiry date 19-FEB-2021) were exposed to temperature between 6 F to 14 F (-14 C to -10 C) for 28 minutes and between 15 F to 46 F (-9 C to 8 C) for 32 minutes.  On 12-AUG-2019, a telephone call was received from the registered nurse. She stated that she was in the process of completing forms with identifiable patients' information. Additional information has been requested.  Upon receipt of follow-up information it was determined that this case is now valid because the patient identifiers were reported. Follow up information from the nurse has been received on 12-AUG-2019, and refers to a 4-year-old female patient. On 24-JUN-2019, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) subcutaneously. There was no prescription drug treatment for the experience required.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1907USA011162: US-009507513-1908USA005023: US-009507513-1908USA004985: US-009507513-1908USA004983: US-009507513-1908USA004922: US-009507513-1908USA004972: US-009507513-1908USA005049: US-009507513-1908USA005063: US-009507513-1908USA004969: