Received Apr 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | PO / MO |
Hospitalized for Rotavirus; Suspected vaccination failure; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 2-year-old female patient who received Rota (Rotarix liquid formulation) for prophylaxis. On an unknown date, the patient received Rotarix liquid formulation (oral). On an unknown date, an unknown time after receiving Rotarix liquid formulation, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and rotavirus infection (Verbatim: Hospitalized for Rotavirus) (serious criteria hospitalization). The outcome of the vaccination failure was not reported and the outcome of the rotavirus infection was resolved. It was unknown if the reporter considered the vaccination failure and rotavirus infection to be related to 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 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 hospitalization outcome was reported as recovered. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, 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 Rotarix liquid formulation and Rotarix PRE-FILLED ORAL APPLICATOR DEVICE in a 2-year-old female patient. Case lacks further information on time to onset, medical history, concurrent conditions, completion of primary schedule 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.