Received May 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | 2088619 | OT |
No additional AE reported.; patient was administered ROTATEQ during a temperature excursion.; This spontaneous report was received from an office manager concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 25-Apr-2025, during a temperature excursion of 0 degrees Celsius (C) for 1 hour 0 minutes and 0 seconds, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #2088619 has been verified to be a valid batch lot number for Rotavirus Vaccine, Live, Oral, Pentavalent, expiration reported and confirmed as 09-Mar-2026) 1 dosage form (dosage regimen not reported) administered by oral route as prophylaxis (product storage error.) There were no additional adverse events (AE) reported (no adverse event). There were no additional details reported.