Received Dec 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z008197 | — |
No side effects or symptoms reported. No Additional AE; patient received product after it was improperly stored: Varivax; This spontaneous report was received from a Physician Assistant (reported as medical assistant) and refers to a 1-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-NOV-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection, 0.5 mL administered as prophylaxis (lot number Z008197 has been verified to be a valid lot number, expiration date 30-APR-2027; route of administration and anatomical site of injection was not provided); which was reconstituted with sterile diluent (HOLLISTER-STIER STERILE DILUENT) (expiration date, and lot # were not reported). The vaccine was administered after being improperly stored at -10.5 degree Celsius (C) for 1 hour with no previous excursions (Product storage error). No additional adverse event was reported for the patient.
Sterile diluent