Received Apr 21, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Rotavirus; Suspected vaccination failure/ AE Rotarix Lack of efficacy; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 3-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: Suspected vaccination failure/ AE Rotarix Lack of efficacy) (serious criteria GSK medically significant) and rotavirus infection (Verbatim: 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 Oral Applicator Device, Rotarix liquid formulation and Rotarix Oral Applicator Device. The company considered the vaccination failure and rotavirus infection to be unrelated to Rotarix liquid formulation, Rotarix Oral Applicator Device, Rotarix liquid formulation and Rotarix 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 doctor stated at least 4 to 5 cases of patients vaccinated with rotarix as 2 doses were given and patient were hospitalized with Rotavirus. The lasted patient was 3 year old female and was hospitalized. No further details provided. This case was considered as suspected vaccination failure as details regarding time to onset for Rotavirus infection and laboratory confirmation regarding Rotavirus infection were unknown at the time of reporting. The batch number was not provided upon follow- up with the reporter.; Sender's Comments: A case of Vaccination failure and Rotavirus infection, unknown time after receiving 2nd dose and 1st dose of Rotarix liquid formulation and Rotavirus vaccine ORAL APPLICATOR DEVICE in a 3-year-old female patient. Case lacks further information on time to onset, medical history, 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-US2026049714:SAME REPORTER US-GSK-US2026049596:SAME REPORTER