Received Aug 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z004455 | OT |
No additional AE/no PQC reported; VARIVAX involved in temperature excursion has been administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 10-Jul-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE) (lot #Z004455, expiration date: 13-Feb-2027) 1 dosage form (1 dose), administered by unknown route as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (no details provided). The vaccine was administered after being involved in the temperature excursion (Product storage error). No additional adverse events. At the reporting time, the outcome of the events was unknown. The action taken with the suspect vaccine was not reported but established as not applicable.
sterile diluent