Received Feb 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
respiratory syncytial virus; bronchitis; pneumonia; suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 85-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: respiratory syncytial virus) (serious criteria hospitalization), bronchitis (Verbatim: bronchitis) (serious criteria hospitalization) and pneumonia (Verbatim: pneumonia) (serious criteria hospitalization and GSK medically significant). The outcome of the vaccination failure, respiratory syncytial virus infection, bronchitis and pneumonia were not reported. It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, bronchitis and pneumonia to be related to Arexvy. It was unknown if the company considered the vaccination failure, respiratory syncytial virus infection, bronchitis and pneumonia to be related to Arexvy. Additional Information: GSK Receipt Date: 20-FEB-2026 This case was reported by a patient via interactive digital media. The batch number was not provided and we and unable to contact the reporter. This case was considered as suspected vaccination failure as details regarding laboratory test confirming Respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, Respiratory syncytial virus infection, Bronchitis and pneumonia, unknown time after receiving Arexvy, in a 85-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.