Received Aug 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | Z003883 | — |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | — |
HBP confirmed the patient involved did not experience any medical concerns or symptoms after the administration of the improperly stored VARIVAX.; the VARIVAX was exposed to multiple temperature excursions beginning in May 2025 and stated that a dose of the VARIVAX was administered to the patient involved on 6/9/2025.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In the beginning of May 2025, Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was exposed to multiple temperature excursions. On 09-Jun-2025, the patient was vaccinated with a dose of the Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #Z003883 and expiration date reported as 03-Feb-2027) 0.5 mL (dose frequency reported as: 0.5 mL / two dose series) (route of administration and vaccination site were not reported) administered for prophylaxis (product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). The patient involved did not experience any medical concerns or symptoms after the administration of the improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX). No additional information was provided. No additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event).