Received Mar 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | mg794 | — |
3rd dose Administration after the recommended age at 18 months; 3rd dose Administration after the recommended age at 18 months; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-month-old female patient who received Rotavirus vaccine (batch number mg794, expiry date 15-DEC-2026) 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 05-MAR-2026, the patient received the 3rd dose of Rotavirus vaccine. On 05-MAR-2026, an unknown time after receiving Rotavirus vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: 3rd dose Administration after the recommended age at 18 months ) and extra dose administered (Verbatim: 3rd dose Administration after the recommended age at 18 months ). The outcome of the inappropriate age at vaccine administration and extra dose administered were 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: 06-MAR-2026 A healthcare professional contacted GSK to report that on 05-MAR-2026, an 18 month old accidentally received a third dose of Rotarix. They did state that they wanted to receive recommendations and safety data. Available data was provided but the health care professional tried to push for GSK clinical recommendations, at which point they were offered the CDC contact information, but they declined and said that they would contact them through their own means. The batch number was not provided and request for this information has been made.