Received Sep 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (VAQTA) | MERCK & CO. INC. | UNK | S034636 | — |
HCP called to report an expired dose of VAQTA was administered to a patient on 11/17/202.; No additional AE/No PQC.; This spontaneous report was received from a medical assistant and refers to a 6-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date (reported as 17-Nov-202), the patient was vaccinated with a dose of Hepatitis A Vaccine, Inactivated (VAQTA) (lot #S034636 with expiration date reported as and upon internal validation confirmed to be 14-Nov-2020) 0.5 mL (route of administration and vaccination site were not reported) administered for prophylaxis. On that day, an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) was administered to the patient (expired product administered). Potency of the dose was supported by the post expiry memo. No symptoms were reported at the time of the call. No additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event).