Received Feb 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Guillain-Barre Syndrome; This serious case was reported by a nurse via call center representative and described the occurrence of guillain barre syndrome in a 60-year-old female 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 guillain barre syndrome (Verbatim: Guillain-Barre Syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to Arexvy. The company considered the guillain barre syndrome to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 12-FEB-2025 The reporter was a GlaxoSmithKline representative who was reporting on behalf of an healthcare professional (nurse practitioner). The reporter had asked the representative if Arexvy could caused Guillain-Barre Syndrome. The reporter had a 60 year old female patient who developed Guillain-Barre Syndrome after receiving unknown vaccines. It was uncertain if the vaccine had been Arexvy.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which, due to the following criteria (missing medical history, concurrent conditions, laboratory data, clinical details) is considered unrelated to GSK vaccine Arexvy.