Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
suspected vaccination failure; months after his first RSV vaccination, he came down with a diagnosed case of RSV; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included multiple myeloma (treatment every 2 weeks). On an unknown date, the patient received the 1st dose of Arexvy. On an unknown date, several months after receiving Arexvy, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: months after his first RSV vaccination, he came down with a diagnosed case of RSV). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection 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 to be related to Arexvy. Additional Information: GSK Receipt Date: 02-OCT-2025 The patient received a Respiratory syncytial virus (RSV) vaccination 2 years ago. A couple of months after his first RSV vaccination, he came down with a diagnosed case of respiratory syncytial virus infection. His oncologist off. The patient's hematologist had recommended to get a second RSV immunization because of his multiple myeloma. The reporter asking was this considered safe to have another one. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding respiratory syncytial virus were unknown at the time of reporting. Batch number "UNK" and follow-up cannot be performed: The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, several months after receiving Arexvy, in a 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.
Multiple myeloma (treatment every 2 weeks)