Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | 2096665 | — |
No additional AE; a patient was inadvertently administered the first dose of ROTATEQ beyond the recommended age; This spontaneous report was received from a registered nurse (RN) and referred to a 15-week-10-day-old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 25-Nov-2025, the patient was inadvertently vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (2ml/dose, lot #2096665, expiration date: 30-May-2026; strength and route were not reported) for prophylaxis, which was beyond the recommended age (Product administered to patient of inappropriate age). No symptoms or additional adverse event were reported (No adverse event).