Received Jan 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 3Z34X | — |
6-month-old patient was administered with the first dose of ROTARIX; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received Rota (Rotarix liquid formulation) (batch number 3Z34X, expiry date 09-NOV-2026) for prophylaxis. On 07-JAN-2026, the patient received the 1st dose of Rotarix liquid formulation. On 07-JAN-2026, an unknown time after receiving Rotarix liquid formulation, the patient experienced inappropriate age at vaccine administration (Verbatim: 6-month-old patient was administered with the first dose of ROTARIX). The outcome of the inappropriate age at vaccine administration was 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: 07-JAN-2026 The reported that a 6-month-old patient (as of today 07-JAN-2026) was administered with the first dose of ROTARIX. She wanted to know if the second dose could be administered after since the age range limit was 24-weeks of age.