Received Dec 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | 2155252 | — |
No symptoms reported / No additional AE; ROTATEQ which underwent a temperature excursion was administered; This spontaneous report was received from an administrator and referred to a patient of unknown age and gender. The patient's medical history, past medications, and concomitant medications were not reported. On 18-Dec-2025, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial, 2 mL (batch/lot number 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 (below 36°F [4.5F] for 4 hours 0 minutes and 0 seconds); no previous temperature excursion (Product storage error). No symptoms nor additional AE (adverse event) were reported. This is one of two reports received from the same reporter (Linked case: 2362644).