Received Oct 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y014939 | — |
No additional AE; Inadvertent administration of VARIVAX to a patient after a temperature excursion. Vaccine was administered on 24OCT2025; 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, historical drugs, and concomitant therapies were not reported. On 24-Oct-2025, the patient was inadvertently vaccinated with a Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) after a temperature excursion of -14.6C for 0 hours 45 minutes 0 seconds; the vaccine did suffered a previous temperature excursion of -13.2C 1 hour 30 minutes 0 seconds; (3.1C) for 2 hours 30 minutes 0 seconds (Product storage error). The Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was administered as prophylaxis, route of administration and anatomical location were not reported, lot #Y014939, expiration date reported as 04-Sep-2029 but upon internal validation was established as 04-Sep-2026. The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot # and expiration date were not reported). No additional adverse event (AE) was reported. Lot # is being requested and will be submitted if received.
Sterile diluent