Age: 11.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP reported PROQUAD & VARIVAX were administered to multiple patients during a temperature excursion. See request case #02541105. Dates of administration unknown. Patient demographic information was not provided. No additional information provided. N; This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. For all patients, the concurrent conditions, medical history and concomitant medications were not provided.    On multiple an unknown dates, the patients were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (strength, dose, route, frequency, were not provided) for prophylaxis; Lot No. X019300 has been verified to be a valid lot number, expiration date reported as 14-JAN-2025, and upon internal validation established as the same; and with Lot No. X022924 has been verified to be a valid lot number, expiration date reported as 12-MAR-2025, and upon internal validation established as the same.   And they were also vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, route, frequency, were not provided) for prophylaxis; Lot No. X017487 has been verified to be a valid lot number for [varicella virus vaccine live (Oka/Merck)], expiration date reported as 25-JUN-2025, and upon internal validation established as the same.   The nurse reported that these vaccines doses were administered during a temperature excursion on multiple unspecified dates to multiple patients and the vaccines were improperly stored (incorrect product storage). They presented a temperature excursion with a temperature of -12.9 Celsius degrees for a time frame of 0 Hours 13 Minutes 0 Seconds. There were no previous temperature excursions. Moreover, no information was reported regarding the sterile diluent that was used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX), but it was not an hazardous product. No additional adverse events (AE) were reported (No adverse event).  This is a non-valid report due to the lack of patients' identifiers.  Follow-up information was received from the nurse on 05-MAR-2024.  This spontaneous report was referring a 11-year-old male patient who was only vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and hepatitis a vaccine, inactivated (VAQTA) which were involved in temperature excursion reported in the previous version.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  Temperature excursion that occurred on 29-DEC-2023 was discovered that had gone unnoticed, the vaccine (product) remained liable after the excursion. Temperature excursion occurred as a result of a reading from a digital data logger.  On 09-JAN-2024 (11 days after excursion), the patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, therapy type (rHA), lot #X019300, expiration date: 14-JAN-2025, anatomical location: left arm, administered subcutaneously for prophylaxis (strength and exact dose was not provided) and second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #X015720, expiration date: 05-DEC-2024, anatomical location: right deltoid, administered intramuscularly for prophylaxis (strength and exact dose was not provided) (Product storage error). No adverse events were reported by patient (No adverse event).   Patient's exact number and identifiers and specified suspect product were missed in previous version and completed per the follow-up information, case was a valid case.  This is one of reports received from the same reporter.  ; Sender's Comments:  US-009507513-2403USA002922:same reporter link