Received Feb 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | MG794 | — |
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
Inadvertent administration of a third dose of Rotarix/ third dose of Rotarix to a 6 month old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 6-month-old female patient who received Rota (Rotarix liquid formulation) (batch number MG794, expiry date 15-DEC-2026) for prophylaxis. Co-suspect products included Rotavirus vaccine live oral 1v (Rotarix) for prophylaxis. Previously administered products included Rotarix (1st dose on 17-OCT-2025). On 17-FEB-2026, the patient received the 3rd dose of Rotarix liquid formulation. On 17-DEC-2025, the patient received the 2nd dose of Rotarix. On 17-FEB-2026, an unknown time after receiving Rotarix liquid formulation and 62 days after receiving Rotarix, the patient experienced extra dose administered (Verbatim: Inadvertent administration of a third dose of Rotarix/ third dose of Rotarix to a 6 month old patient). The outcome of the extra dose administered was not applicable. Additional Information: GSK receipt date: 18-FEB-2026 The registered nurse sought guidance on possible adverse reactions or what could happen regarding a potential toxic kidney situation.