Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (VAQTA) | MERCK & CO. INC. | UNK | Z005472 | — |
No symptoms reported. No additional AE/no PQC reported.; a dose of VAQTA which was improperly stored was administered; This spontaneous report was received from a medical assistant on 27-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 27-Oct-2025, the patient was administered a dose of hepatitis A vaccine, inactivated (VAQTA) injection, 25/0.5 (unit not provided), lot #Z005472, expiration date: 08-Jul-2026, 0.5 mL (dose number, route and anatomical site of administration were not provided) for prophylaxis, which was administered after a temperature excursion at 48F for 6 hours 36 minutes 0 seconds, there was no previous temperature excursion (Product storage error). No additional adverse event (AE)/product quality compliance (PQC) provided (No adverse event).