Received Mar 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y015108 | — |
no reports of medical concerns or symptoms; improperly stored and administered VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 03-JAN-2025, the patient was administered a dose of improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (0.5 mL, two dose series, lot # Y015108, expiration date: 06-SEP-2026; dose number, route and anatomical site were unknown) for prophylaxis (product storage error), which was reconstituted with sterile diluent (BAXTER Sterile Diluent) (dose, strength, batch/lot#, expiration date, routed and indication were unknown). The vaccine was involved in multiple temperature excursions beginning on 05-DEC-2024. No reports of medical concerns or symptoms from the patient involved (no adverse event). The outcome of the events was unknown.
Sterile diluent