Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
suspected vaccination failure; RSV; Constantly having mucus issues; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 82-year-old patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: RSV) and nasal mucus increased (Verbatim: Constantly having mucus issues). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection and nasal mucus increased were not resolved. It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and nasal mucus increased to be related to Arexvy. The company considered the vaccination failure to be unrelated to Arexvy. It was unknown if the company considered the respiratory syncytial virus infection and nasal mucus increased to be related to Arexvy. Additional Information: GSK Receipt Date: 02-SEP-2025 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient thought he/she was having RSV (respiratory syncytial virus infection) and constantly having mucus issues. This case was considered as suspected vaccination failure as details regarding time to onset for respiratory syncytial virus infection and laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Arexvy in a 82-year-old 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.