Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y010184 | — |
No additional AE; HCP reported that one dose of improperly stored VARIVAX was administered to a patient. HCP reported that the product had two current temperature excursions.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 13-Aug-2025, the patient was vaccinated with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #Y010184 with expiration date reported as and upon internal validation established 31-May-2026) 0.5 mL (route of administration and vaccination site were not reported) with sterile diluent (BAXTER STERILE DILUENT) (lot #1950652 with expiration date reported as and upon internal validation established as 27-Jan-2026) (dose, route of administration and vaccination site were not reported) administered for prophylaxis. One dose of improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was administered to the patient (product storage error). The product had two current temperature excursions (temperature 14°F up to 46°F (19.4F) for 0 hours 32 minutes 0 seconds; 6°F up to 14°F (9.3F) for 0 hours 16 minutes 0 seconds). There was no previous temperature excursion. No symptoms were reported. No additional information was provided. No additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event).
DILUENT MRK