Received Apr 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y011712 | — |
no adverse event; improper storage of product in use; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, Concomitant therapies, and drug reactions/allergies were not reported. On 03-Mar-2025, the patient was vaccinated with improperly stored vaccine of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE) injection (lot #Y011712, expiration date: 02-Jul-2026), 0.5 mL, diluted with sterile diluent (MERCK STERILE DILUENT) (expiration date, and lot # were not reported) as prophylaxis (improper storage of product in use). The vaccine was exposed to temperature excursion (Temperature: 14.65 F, Time frame: 13 hours 15 minutes 0 seconds) on 29-Jan-2025. No symptomatic events reported (no adverse event). There was no previous temperature excursion.
Comments: unknown
Sterile diluent