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 2-month-old patient of unknown gender. The patient's medical history, past medications, and concomitant medications were not reported. On 29-Dec-2025, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq) oral solution (reported as vial) (batch 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-009507513-2369260).