Received Jul 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y015100 | — |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | — |
No additional AE; inadvertent administration of expired VARIVAX to a patient on 09JUN2025. VARIVAX underwent a temperature excursion on 05MAR2025 which resulted in the vaccine being "supported and viable" until 05JUN2025; This spontaneous report was received from a Pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 09-Jun-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection (valid lot #Y015100, expiration date was provided and confirmed as: 06-Sep-2026) for prophylaxis (exact dose, dose number, anatomical location, and route of administration were not provided). The suspect vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), Solution for injection (expiration date, and lot # were not reported). The patient experienced inadvertent administration of expired Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) on 09-JUN-2025 (conflicting information, expiration date was correct). Suspect vaccine underwent a temperature excursion (on 05-MAR-2025): 36 Fahrenheit (F) to 46F for 286 hours 42 minutes 0 seconds, which resulted in the vaccine being "supported and viable" until 05-JUN-2025 (discrepancy) (product storage error). No additional adverse event (AE) was reported (no adverse event).