Received Dec 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Y018512 | — |
no additional AE; improperly stored vaccine administered; This spontaneous report was received from certified medical assistant (C.M.A) and referred to a 19-month-old patient of unknown gender. The patient's medical history was not reported. The patient's past medications were not reported. The patient's concomitant medications were not reported. On 15-Oct-2025, the patient vaccinated with the improperly stored Hepatitis A Vaccine, Inactivated (VAQTA) (0.5 ml, lot# Y018512, expiration date not reported but upon internal validation established as 03-Jul-2026, frequency, strength and route were unknown) as immunizations at local pediatric clinic (Product storage error). The formulation was reported as adult formulation (CVX code 83). No other adverse event was reported. The stored temperature was 34.3 Fahrenheit (F) for 3 hours and 57 minutes on 02-Oct-2025, 34.8 F for unknown duration on 11-Oct-2025, and 34.7 F for 7 hours and 45 minutes on 15-Oct-2025. There was no previous temperature excursion. This is one of 31 linked cases received from the same reporter.