Received Apr 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y011712 | OT |
No symptomatic events reported; T/E for VARIVAX on 1/29/2025. reported that vaccines were administered to patients.; This spontaneous report was received from a consumer 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 04-Feb-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) injection, 0.5mL (vaccination site, route of administration, and vaccination scheme were not provided; lot #Y011712 which has been verified to be valid, expiration date reported on 29-Jan-2025, but upon internal review it was established as 02-Jul-2026) as a prophylaxis, along with a sterile diluent for dilution. However, the vaccine experienced a temperature excursion. The vaccine administered was stored at temperature of 14.65 degrees Fahrenheit (F) for a time frame of 3 hours and 15 minutes. There was no previous temperature excursion, and no data logger was used. No symptomatic events reported.
STERILE DILUENT