Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y011712 | — |
No symptomatic events reported. MD agrees to be correspondence contact for AE case. No additional AE/No PQC.; Inbound call from HBP regarding T/E for VARIVAX on 1/29/2025. See T/E case #0277601. HBP reported that vaccines were administered to patients. No symptomatic events reported. MD agrees to be correspondence contact for AE case. No additional AE/No PQC; This spontaneous report was received from a consumer or other non-health professional and refers to a(n) 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 21-MAR-2025, the patient was vaccinated with improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection, lot #Y011712 and expiration date: 02-JUL-2026, 0.5 mL for prophylaxis (dose number, route and site of administration were not provided). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The temperature excursion lasted 13 hours 15 minutes 0 seconds in temperature of 14.65F. No previous temperature excursion noted (improper storage of product in use).
Varivax sterile diluent