Received Aug 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z004455 | — |
No additional AE; VARIVAX involved in temperature excursion has been administered; This spontaneous report was received from other health professional and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 10-JUL-2025, the patient was vaccinated with dose of varicella virus vaccine live (Oka-Merck) (VARIVAX) (1 dose, lot # Z004455, expiration date: 13-FEB-2027; dose number, strength, formulation, route and anatomical site were unknown) for prophylaxis, which was involved in temperature excursion and was reconstituted with sterile diluent (MERCK STERILE DILUENT) (expiration date and lot # were not reported) (product storage error). No additional adverse event (no adverse event). The storage temperature of the vaccine was reported as 36.5 degrees Fahrenheit (F) for a time frame of 2 hours and 21 minutes. There was no previous temperature excursion. This is one of the reports from the same reporter (link# 2309177, 2309273, 2309187, 2308972, 2309098, 2309074, 2308927, 2309681).
sterile diluent