Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 5DH4A | IM |
Rotarix vaccine administered IM instead of oral; Rotarix vaccine administered IM instead of oral; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate route of vaccination in a 6-month-old male patient who received Rota (Rotarix liquid formulation) (batch number 5DH4A, expiry date 11-DEC-2026) for prophylaxis. On 15-OCT-2025, the patient received Rotarix liquid formulation (intramuscular). On 15-OCT-2025, an unknown time after receiving Rotarix liquid formulation, the patient experienced inappropriate route of vaccination (Verbatim: Rotarix vaccine administered IM instead of oral) and wrong vaccine administered (Verbatim: Rotarix vaccine administered IM instead of oral). The outcome of the inappropriate route of vaccination and wrong vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 16-OCT-2025 The Licensed Practical Nurse (LPN) requested data regarding a Rotarix vaccine that had been administered intramuscularly (IM) to a 6-month-old patient. It was later identified that the wrong vaccine had been administered to the patient.