Received Sep 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z008196 | — |
No additional AE; HCP called to report a TE for VARIVAX; This spontaneous report has been received from a nurse, regarding to a 26-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 21-AUG-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) at a dose of 0.5 milliliter (ml), lot number Z008196 which had been verified to be a valid number; expiration date reported and upon internal validation established as 30-APR-2027 with sterile diluent (anatomical site of injection was not provided). Administered doses were stored at a temperature of -11.8 degrees Celsius (C) during a time frame of 45 minutes. There was no previous temperature excursion. No additional adverse events were reported in the patient.
Sterile diluent