Received Dec 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 2 | 2142135 | OT |
No additional AE/PQC reported; Customer called to report TE. ROTATEQ was administered to a patient; This spontaneous report was received from a nurse and referred to a/an patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not reported. On 14-Oct-2025, the patient was vaccinated with the second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) Oral solution (1 dosage form total, Lot Number 2142135 with expiration date: 28-May-2026) orally for Prophylaxis. The vaccine was improperly stored under temperature 46.9F for 1 hour. Previous temperature excursion also included 46.9 F for 4 hours (Product storage error). No additional adverse events reported.