Received Oct 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (VAQTA) | MERCK & CO. INC. | UNK | Z010429 | — |
No additional AE; Medical assistant reported that VAQTA which underwent a temperature excursion was administered to a patient; This spontaneous report was received from a Physician Assistant (reported as medical assistant) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-OCT-2025, the patient was vaccinated with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) prefilled syringe, 0.5 mL, administered as prophylaxis (lot number Z010429 has been verified to be valid for Hepatitis A Vaccine, Inactivated [VAQTA], expiration date 09-OCT-2026; dose number, route of administration and anatomical site of injection were not reported). The vaccine was administered after undergoing a temperature excursion (TE) at 47.7 degree Fahrenheit (F) for 30 minutes, with not previous TE (Product storage error). No symptoms or additional adverse event was reported for the patient. This is one of several reports from the same reporter.