Received Aug 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (VAQTA) | MERCK & CO. INC. | UNK | Z27PB | — |
No additional AE; Clinical Manager called regarding a possible temp. excursion for VAQTA; This spontaneous report has been received from a consumer, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 23-JUN-2025, the patient was vaccinated with an improperly stored dose of Hepatitis A Vaccine, inactivated (VAQTA) at a dose of 1 milliliter (ml), once (lot #Z27PB (invalid) expiration date: 27-Aug-2026) as prophylaxis (anatomical site of injection and route of administration was not provided). Administered doses were stored at a temperature of 50 degrees Fahrenheit (F), during a time frame of 148 hour (product storage error). There was not a previous temperature excursion reported. No additional adverse events were reported in the patient. This case was determined to be non-valid due to the lack of patient's identifiers.