Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PPV | PNEUMO (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Suspected vaccination Failure; pneumonia; RSV infection; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included Pneumococcal vaccine for prophylaxis. On an unknown date, the patient received Arexvy and Pneumococcal vaccine. On an unknown date, an unknown time after receiving Arexvy and not applicable after receiving Pneumococcal vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination Failure) (serious criteria GSK medically significant), pneumonia (Verbatim: pneumonia) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: RSV infection). The outcome of the vaccination failure was not reported and the outcome of the pneumonia and respiratory syncytial virus infection were not resolved. The reporter considered the vaccination failure, pneumonia and respiratory syncytial virus infection to be related to Arexvy. It was unknown if the reporter considered the pneumonia and respiratory syncytial virus infection to be related to Pneumococcal vaccine. The company considered the vaccination failure and pneumonia to be unrelated to Arexvy. The company considered the respiratory syncytial virus infection to be related to Arexvy. It was unknown if the company considered the pneumonia and respiratory syncytial virus infection to be related to Pneumococcal vaccine. Additional Information: GSK Receipt Date: 23-JUL-2025 This case was reported by a patient via interactive digital media. The patient mentioned she been vaccinated for Respiratory syncytial virus and Pneumonia but still got both. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for Respiratory syncytial virus and laboratory confirmation regarding Respiratory syncytial virus were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Pneumonia, unknown time after receiving Arexvy in a female patient. Based on the available information a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.