Received Dec 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | RA |
Guillain-Barre syndrome; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Additional patient notes included The patient stated that prior to vaccination she was healthy, with no medical conditions and was walking 4 miles daily. On 18-AUG-2025, the patient received Arexvy (right arm). On 28-AUG-2025, 10 days after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barre syndrome) (serious criteria hospitalization and GSK medically significant). The outcome of the guillain barre syndrome was resolving. 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 10-DEC-2025 The patient went to the emergency department and by the end of that night was almost totally paralyzed. The patient was admitted to the hospital, then transferred to rehabilitation services, and subsequently admitted to an assisted living facility for two months. The patient later returned home and was receiving in-home patient services to relearn how to walk. She reported that she was slowly recovering four months after vaccination with Arexvy. The patient could not provide additional information for her primary care provider and was instructed that she could provide further details when contacted by GlaxoSmithKline safety. No additional information was provided. The batch number was not provided and a request for this information has been made.; Sender's Comments: A case of Guillain-Barre syndrome (BCWG Level 4), 10 days after receiving Arexvy, in a 75-year-old female patient. Case lacks further information on medical history, concurrent conditions and relevant laboratory results for confirmation. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Comments: The patient stated that prior to vaccination she was healthy, with no medical conditions and was walking 4 miles daily