Received Jan 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | 2155252 | — |
No Additional AE; Customer called to report TE. ROTATEQ was administered to 2 patients; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's medical history, past medications, and concomitant medications were not reported. On 03-Jan-2026, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq) oral solution (reported as vial) (batch/lot number reported as Z155252 but upon internal validation established as 2155252 has been verified to be a valid batch/lot number for Rotavirus Vaccine, Live, Oral, Pentavalent, expiration date reported and confirmed as 07-Dec-2026) administered as prophylaxis (route and strength were not reported). The vaccine administered underwent a temperature excursion (35.6F for 0 hours 2 minutes and 0 seconds); no previous temperature excursion (Product storage error). No additional AE (adverse event) was reported. This is one of two reports received from the same reporter (Linked Case: Same Reporter: US-009507513-2369223).