Received Apr 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
suspcted vaccination failure/ lack of efficacy; rotavirus; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 5-year-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: suspcted vaccination failure/ lack of efficacy) (serious criteria GSK medically significant) and rotavirus infection (Verbatim: rotavirus). 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 to be unrelated to Rotarix liquid formulation, Rotarix Pre-Filled Oral Applicator Device, Rotarix liquid formulation and Rotarix Pre-Filled Oral Applicator Device. It was unknown if the company considered the 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. 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 5-year-old patient who was not hospitalized. 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, unknown time after receiving 2nd dose and 1st dose of Rotarix liquid formulation and Rotavirus vaccine PRE-FILLED ORAL APPLICATOR DEVICE in a 5-year-old female patient. Case lacks further information on time to onset, concurrent conditions and laboratory confirmation. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. US-GSK-US2026050072:Same reporter/Different patient US-GSK-US2026049596:Same reporter/Different patient