Received Dec 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | Y018582 | — |
no additional AE; improperly stored vaccine administered; This spontaneous report was received from a healthcare professional regarding a 3-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 29-OCT-2025, the patient was vaccinated at a clinic with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) (CVX 83) 0.5 mL administered as the second dose for prophylaxis (lot number reported as Y018582, which has been verified as valid, expiration date reported and validated as 03-JUL-2026) (route and anatomical site of administration were not reported). The administered dose was exposed to multiple temperature excursions starting on 02-OCT-2025 including 34.3 F for 3 hours, 57 minutes and 30 seconds; 34.7 F for 7 hours and 45 minutes; 34.8 F and 35 F for an unknown period (Product storage error). No additional adverse event was reported. This is one of several reports received from the same reporter.