Received Jun 16, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | — | PO / MO |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | PO / MO |
suspected vaccination failure; Patient contracted rotavirus after being fully immunized; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 1-year-old male patient who received Rotavirus vaccine oral drops for prophylaxis. On an unknown date, the patient received the 2nd dose of Rotavirus vaccine (oral). On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and rotavirus infection (Verbatim: Patient contracted rotavirus after being fully immunized). The outcome of the vaccination failure was not reported and the outcome of the rotavirus infection was resolving. The reporter considered the vaccination failure and rotavirus infection to be related to Rotavirus vaccine. It was unknown if the reporter considered the vaccination failure and rotavirus infection to be related to Rotarix Unspecified Oral Administation Device. The company considered the vaccination failure to be unrelated to Rotavirus vaccine and Rotarix Unspecified Oral Administation Device. The company considered the rotavirus infection to be related to Rotavirus vaccine. 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: 10-JUN-2026 The batch number was not provided upon follow up with the reporter. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for Rotavirus and laboratory confirmation regarding Rotavirus were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving 2nd dose and 1st dose of Rotavirus vaccine and Rotavirus vaccine UNSPECIFIED ORAL ADMINISTRATION DEVICE in a 1-year-old male patient. Case lacks further information on time to onset, medical history, concurrent conditions, completion of primary vaccination schedule and laboratory confirmation. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.