Received Apr 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
hospitalized with Rotavirus; Suspected vaccination failure/Lack of efficacy; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a 30-month-old female patient who received Rota (Rotarix liquid formulation) for prophylaxis. Co-suspect products included Rota (Rotarix liquid formulation) for prophylaxis. On an unknown date, the patient received the 2nd dose of Rotarix liquid formulation and the 1st dose of Rotarix liquid formulation. On an unknown date, an unknown time after receiving Rotarix liquid formulation and Rotarix liquid formulation, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/Lack of efficacy) (serious criteria GSK medically significant) and rotavirus infection (Verbatim: hospitalized with Rotavirus) (serious criteria hospitalization). The outcome of the vaccination failure was unknown and the outcome of the rotavirus infection was not reported. It was unknown if the reporter considered the vaccination failure and rotavirus infection to be related to Rotarix liquid formulation, Rotarix Pre-Filled Oral Applicator Device, Rotarix liquid formulation and Rotarix Pre-Filled Oral Applicator Device. The company considered the vaccination failure and rotavirus infection to be unrelated to Rotarix liquid formulation, Rotarix Pre-Filled Oral Applicator Device, Rotarix liquid formulation and Rotarix Pre-Filled Oral Applicator Device. 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: 09-APR-2026 The physician stated at least 4 to 5 cases of patients vaccinated with Rotarix 2 doses were hospitalized with Rotavirus. The physician wanted to know if there had been an increase in reported cases. He further said the cases had been over the last 6 months. This case was considered as suspected vaccination failure as details regarding time to onset for rotavirus and laboratory confirmation regarding rotavirus were unknown at the time of reporting. The batch number was not provided upon follow- up with the reporter. This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments: A case of Vaccination failure and Rotavirus infection, on an unknown time after vaccination with 1st and 2nd dose of Rotarix liquid formulation and Rotarix PRE-FILLED ORAL APPLICATOR DEVICE, in a 30-month-old female patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received. US-GSK-US2026050072:SAME REPORTER US-GSK-US2026049714:Same reporter/Different patient