Received Mar 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y015108 | — |
No additional AE; Medical Assistant calling with a report of an adverse event regarding improperly stored and administered VARIVAX.; This spontaneous report was received from a physician and refers 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 09-Jan-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), 0.5 mL (lot #Y015108, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 06-Sep-2026) dose description reported as 0.5 mL / Two dose series, administered for prophylaxis; with sterile diluent (BAXTER Sterile Diluent). It was reported that the vaccine was involved in multiple temperature excursions beginning on (05-DEC-2024), and the product was administered to the patient involved on 09-Jan-2025 (Product storage error). The reporter confirmed no reports of medical concerns or symptoms from the patient involved. No additional information provided. There was no additional adverse event (AE) or product quality complaint (PQC) provided.
Sterile Diluent