Received Dec 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z008197 | — |
No Additional AE; HCP called to report TE where patient received product after it was improperly stored.; This spontaneous report was received from a medical assistant and refers to 1-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-Nov-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (valid lot #Z008197, expiration date: 30-Apr-2027) 0.5 mL as prophylaxis after it was improperly stored in the temperature of 10.5 C for 1 hours 0 minutes 0 seconds, no previous excursions (product storage error). 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.
Sterile diluent