Received Apr 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Suspected vaccination failure; RSV/ Respiratory syncytial virus infection; sick for about 2 weeks; This serious case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received the 1st dose of 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/ Respiratory syncytial virus infection) and sickness (Verbatim: sick for about 2 weeks). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was resolved and the outcome of the sickness was resolved (duration 2 weeks). The reporter considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy. It was unknown if the reporter considered the sickness to be related to Arexvy. The company considered the vaccination failure 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 sickness to be related to Arexvy. Additional Information: GSK Receipt Date: 26-MAR-2026 An independent pharmacist shared that the patient in his late 80s that received Arexvy 3 years ago experienced Respiratory syncytial virus and was sick for about 2 weeks. The patient was tested and confirmed to have Respiratory syncytial virus. This case was considered as suspected vaccination failure as details regarding time to onset for respiratory syncytial virus was unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter. This case is 1 of the 2 cases reported by the same reporter.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Arexvy, in a elderly 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. US-GSK-US2026040967:SAME REPORTER/DIFFERENT PATIENT