Received Feb 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | 5N2AN | — |
Third dose given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 8-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 5N2AN) for prophylaxis. Previously administered products included Rotarix (received first dose of Rotarix on an unknown date) and Rotarix (received second dose of Rotarix on an unknown date). On 18-FEB-2025, the patient received the 3rd dose of Rotarix lyophilized formulation. On 18-FEB-2025, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: Third dose given). The outcome of the extra dose 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: 20-FEB-2025 The other health professional reported that third vaccines dose in an 8 month old patient which led to extra dose administered. The Vaccine Administration Facility was the same as Primary Reporter.