Received Mar 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y011712 | OT |
No additional AE; 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 and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-MAR-2025, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka-Merck) (VARIVAX) solution for injection, 0.5 ml, lot #Y011712, expiration date: 02-JUL-2026 (route of administration and anatomical location were not provided), for prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (lot# and expiry date were not reported). On 29-JAN-2025, the vaccine underwent a temperature excursion of 14.65 Fahrenheit (F) degrees for 13 hours and 15 minutes. There was no previous temperature excursion. Data logger was not involved. No symptomatic events, no additional adverse events were reported.
Sterile diluent