Received Sep 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 7YS93 | PO / MO |
The vaccine was prepared for different patients, and the vaccines were mixed due to a room change, leading to giving the 6-day-old baby the Rotarix orally; received 6-day-old baby the Rotarix orally; This non-serious case was reported by a physician via call center representative and described the occurrence of administered drug to incorrect patient in a 6-day-old female patient who received Rota (Rotarix liquid formulation) (batch number 7YS93, expiry date 15-NOV-2026) for prophylaxis. On 04-AUG-2025, the patient received the 1st dose of Rotarix liquid formulation (oral). On 04-AUG-2025, an unknown time after receiving Rotarix liquid formulation, the patient experienced administered drug to incorrect patient (Verbatim: The vaccine was prepared for different patients, and the vaccines were mixed due to a room change, leading to giving the 6-day-old baby the Rotarix orally) and inappropriate age at vaccine administration (Verbatim: received 6-day-old baby the Rotarix orally). The outcome of the administered drug to incorrect patient and inappropriate age at vaccine administration were not applicable. Additional Information: GSK Receipt Date: 04-AUG-2025 The vaccines had been prepared for different patients, but they were mixed due to a room change. As a result, a 6-day-old baby was mistakenly given Rotarix orally, which led to Inappropriate age at vaccine administration and Administered drug to incorrect patient.