Received Feb 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
got GB; Unknown cause of death; This serious case was reported by a physician via sales rep and described the occurrence of unknown cause of death in a 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 unknown cause of death (Verbatim: Unknown cause of death) (serious criteria death and GSK medically significant) and guillain barre syndrome (Verbatim: got GB) (serious criteria hospitalization and GSK medically significant). The outcome of the guillain barre syndrome was not reported. The reported cause of death was unknown. It was unknown if the reporter considered the unknown cause of death and guillain barre syndrome to be related to Arexvy. The company considered the unknown cause of death and guillain barre syndrome to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 30-JAN-2025 The physician just stated that one of his patients received a RSV (Arexvy) vaccine and got GB (Guillain Barre syndrome), was admitted to the hospital and died. The GSK representative was not sure about the outcome of death or the patient demographics.; Sender's Comments: Death and Guillain-Barre syndrome are unlisted events which are considered unrelated to GSK vaccine Arexvy.; Reported Cause(s) of Death: Unknown cause of death