Received Dec 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z008197 | — |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | — |
No side effects or symptoms reported. No Additional AE/ No PQC.; HCP called to report TE where patient received product after it was improperly stored; This spontaneous report was received from a healthcare professional regarding a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 21-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 reported as Z008197, which has been verified as valid, expiration date reported and validated as 30-APR-2027) (vaccination scheme, route and anatomical site of administration were not reported). The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot number and expiration date were not reported). The administered dose was exposed to a temperature excursion of -10.5 C for 1 hour (Product storage error). No side effects or symptoms reported. No previous excursions.