Received Feb 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | — | PO / MO |
Extra Dose; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a female patient who received Rota (Rotarix liquid formulation) for prophylaxis. Previously administered products included Rotarix (received 1st dose of vaccine on unknown date) and Rotarix (received 2nd dose of vaccine on unknown date). On an unknown date, the patient received the 3rd dose of Rotarix liquid formulation (oral). On an unknown date, an unknown time after receiving Rotarix liquid formulation, the patient experienced extra dose administered (Verbatim: Extra Dose). The outcome of the extra dose administered was unknown. 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: 23-JAN-2025 The pediatrician called on the day of reporting and stated that a child was given 3 doses of the vaccine Rotarix by mistake instead of two, which led to extra dose administered.