Received May 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | Unknown | — |
no patient symptoms have been reported; ROTATEQ involved in a temperature excursion was administered to 1 patient; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored 1 dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), (strength, dose, formulation, route and site of administration not provided), lot # 4009341 was established as invalid upon internal validation, expiration date was reported as 24-NOV-2025, administered for prophylaxis (product storage error). The patient had no symptoms, no additional adverse event (AE) (no adverse event). On an unknown date, the suspect vaccine was involved in a temperature excursion of 32.0 degrees Fahrenheit (F) for 1 hour and 30 minutes. No previous excursions reported. Lot # is being requested and will be submitted if received.