Received May 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
suspected vaccination failure; RSV infection; baby got RSV vaccine; This serious case was reported by a nurse via other manufacturer and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: RSV infection) and inappropriate age at vaccine administration (Verbatim: baby got RSV vaccine). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported and the outcome of the inappropriate age at vaccine administration was not applicable. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 13-MAY-2026 The nurse's daughter's baby got the RSV vaccine and got the RSV. The batch number was not provided and unable to contact the reporter. The case is linked with US2026AMR065916, reported by same reporter. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding RSV were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving RSV vaccine in a 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. Consent for further follow-up has not been received. US-GSK-US2026AMR065916:link case