Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
suspected vaccination failure; Guillain Barre syndrome; RSV; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 63-year-old male 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), guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: RSV). The outcome of the vaccination failure was not reported and the outcome of the guillain barre syndrome and respiratory syncytial virus infection were resolving. It was unknown if the reporter considered the vaccination failure, guillain barre syndrome and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure, guillain barre syndrome and respiratory syncytial virus infection to be unrelated to RSV vaccine. Additional Information: GSK receipt date: 30-SEP-2025 This case was reported by a patient via interactive digital media. Reporter stated that it did not end with RSV as their close family member had it and shortly after ended up with Guillain Barre syndrome and he was recovering in an acute rehab facility. The batch number was not provided, and we are unable to contact the reporter. This case was considered as suspected vaccination failure as details regarding time to onset for RSV infection and laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Guillain-Barre syndrome, unknown time after receiving RSV vaccine, in a 63-year-old male patient. 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.