Received Mar 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | X027423 | OT |
No additional AE reported; ROTATEQ was administered after a temperature excursion; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported. On 17-Mar-2025, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (frequency once, lot # X027423, expiration date: 05-Oct-2025; strength and dose were not reported) administered by oral route for prophylaxis by a health professional, which was administered after a temperature excursion (Product storage error). The excursion temperature was 52.5 Fahrenheit with time frame of 1 hour. There was no previous temperature excursion. No additional adverse event (AE) was reported (No adverse event). This is one of four reports received from the same reporter.