Received Nov 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | LL455 | — |
Expired product used - maladministration of an expired vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired drug administered in a 4-month-old male patient who received Rota (Rotarix liquid formulation) (batch number LL455, expiry date 11-OCT-2025) for prophylaxis. On 07-NOV-2025, the patient received Rotarix liquid formulation. On 07-NOV-2025, an unknown time after receiving Rotarix liquid formulation, the patient experienced expired drug administered (Verbatim: Expired product used - maladministration of an expired vaccine). The outcome of the expired drug administered 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: 11-NOV-2025 The clinical supervisor reported that the maladministration of an expired Rotarix liquid vaccine done by a nurse at their facility. The clinical supervisor needs guidance on this topic. The vaccine administration facility was the same as primary reporter.