Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (VAQTA) | MERCK & CO. INC. | UNK | Y014585 | — |
No symptoms reported at the time of the call; administration of improperly stored VAQTA to one patient on 2/3/2025; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On unspecified date, doses of Hepatitis A Vaccine, Inactivated (VAQTA) pre-filled syringe, underwent a temperature excursion at 34.6 degrees Fahrenheit (F) during 1 hour, 0 minutes and 0 seconds, without previous temperature excursions. On 03-Feb-2025, the patient was vaccinated by a healthcare professional, with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) pre-filled syringe, lot #Y014585, expiration date reported as 12-Nov-2025 but upon internal verification established as 01-Feb-2026, 0.5 mL administered as prophylaxis (dosage regimen, anatomical location and route of administration were not provided) (product storage error.) There were no symptoms informed at the time of the report (no adverse event.)