Received Jul 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y006523 | — |
No additional AE; Pharmacist calling to report inadvertently administering VARIVAX to patients after a temperature excursion. Caller stated VARIVAX vaccine was "issued" to the facility on 8/9/2024 and was inadvertently stored in the refrigerated throughout administrat; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 13-Nov-2024, the patient was inadvertently vaccinated with improper stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), lot #Y006523, expiration date: 25-Mar-2026 (formulation, exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). It was reported that Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) vaccine was "issued" to the facility on 09-Aug-2024 and was inadvertently stored in the refrigerated throughout administrations. Administered dose of vaccine was exposed to the temperature excursion from 2 to 8 degrees Celsius (product storage error). No additional adverse event reported (no adverse event).
Sterile diluent