Received Nov 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y005922 | — |
. No additional AE/no PQC reported.; Administrator reported that VARIVAX which was improperly stored was administered.; This spontaneous report was received from a Consumer or other non-health professional (reported as administrator) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-Sep-2025, the patient was vaccinated with improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) Injection (lot #Y005922, expiration date: 13-Mar-2026) (dose: 0.5 ml, strength and route were unknown) for prophylaxis. The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (Lot number and expiration date were unknown). No additional adverse event. No product quality complaints (PQC) reported. Administered dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) experienced the temperature excursion below 6 Fahrenheit degrees (F) up to 14 F for 1 hour 30 minutes 0 seconds; 14F up to 46F (19.9F) for 1 hour 0 minutes 0 seconds. Previous temperature excursions reported the following: Prior 1: 6F up to 14F (7.5F) for 1 hour 15 minutes 0 seconds; Prior 2: 6F up to 14F for 0 hours 30 minutes 0 seconds, 14F up to 46F (20.9F) for 0 hours 30 minutes 0 seconds.
Sterile Diluent