Received Oct 23, 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 an Administrator on 17-Oct-2025 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 26-Sep-2025, the patient was administered improperly stored varicella virus vaccine live (Oka-Merck) (VARIVAX), Injection, lot #Y005922, expiration date: 13-Mar-2026, 0.5 mL (strength, dose number, route and anatomical site of administration were not provided) for Prophylaxis. The vaccine was administered after a temperature excursion at 6°F up to 14°F for 1 hour 30 minutes 0 seconds, 14°F up to 46°F (19.9F) for 1 hour 0 minutes 0 seconds. There were two previous temperature excursions: Prior 1: 6°F up to 14°F (7.5F) for 1 hour 15 minutes 0 seconds; Prior 2: 6°F up to 14°F for 0 hours 30 minutes 0 seconds, 14°F up to 46°F (20.9F) for 0 hours 30 minutes 0 seconds (Product storage error). No additional adverse event (AE)/product quality compliance (PQC) provided (No adverse event).