Received Dec 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 1 | 2096661 | OT |
ROTATEQ which underwent a temperature excursion were administered; No additional AE/no PQC reported.; This spontaneous report was received from a medical assistant and refers to a 7-months-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 17-NOV-2025, the patient was vaccinated with an improper storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), (lot #2096661 who had been verified to be a valid lot number, expiration date reported and validated as 07-MAR-2026), dose number 1, administered by Oral route (exact dose was not reported) for prophylaxis. The vaccine experienced temperature of 9.1C for 0 hours 47 minutes 0 seconds. There was no previous temperature excursion reported (product storage error). No adverse event reported. This is one of several reports received from the same reporter.