Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | J757K | — |
given his second dose dose of Rotarix twenty days after his first dose; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 3-month-old patient who received Rota (Rotarix liquid formulation) (batch number J757K, expiry date 05-DEC-2026) for prophylaxis. Concomitant products included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX). On 16-OCT-2025, the patient received the 2nd dose of Rotarix liquid formulation. On 16-OCT-2025, an unknown time after receiving Rotarix liquid formulation, the patient experienced drug dose administration interval too short (Verbatim: given his second dose dose of Rotarix twenty days after his first dose). The outcome of the drug dose administration interval too short 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: 16-OCT-2025 Pediatrician stated that they had a three-month-old who was inadvertently given his second dose dose of Rotarix twenty days after his first dose. Obviously, this was invalid. The reporter asked that they should give a third dose in one month. Vaccination date, vaccine detail and patient demographics were obtained in this call. The vaccine administration facility was the same as primary reporter.