Received Aug 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y006523 | — |
No additional information provided. No additional AE; Pharmacist calling to report inadvertently administering VARIVAX to patients after a temperature excursion.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-APR-2025, the patient was inadvertently vaccinated with an improperly storage dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), lot #Y006523 [which has been verified to be valid lot number for Varicella Virus Vaccine Live (Oka-Merck)], expiration date reported and upon internal validation establish as 25-MAR-2026, administered for prophylaxis (strength, dosage, route and anatomical site or administration were not provided). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The reporter stated that the vaccine was "issued" to the facility on 09-AUG-2024 and was inadvertently stored in the refrigerated throughout administrations (Product storage error). He refused to perform a temperature excursion assessment stating assessment has already been performed. No additional adverse event (No adverse event). This is one of several reports received from the same reporter.
Sterile diluent