Received Feb 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | IM |
Depression; diagnosed with Guillain-Barre Syndrome; acquired a stage III decubitus ulcer on her coccyx; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 88-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. In JAN-2024, the patient received Arexvy (intramuscular). In FEB-2024, 2 weeks after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: diagnosed with Guillain-Barre Syndrome) (serious criteria hospitalization, disability, GSK medically significant and life threatening). On an unknown date, the patient experienced decubitus ulcer (Verbatim: acquired a stage III decubitus ulcer on her coccyx) (serious criteria disability and life threatening) and depression (Verbatim: Depression) (serious criteria hospitalization, disability and life threatening). The outcome of the guillain barre syndrome and depression were not resolved and the outcome of the decubitus ulcer was unknown. The reporter considered the guillain barre syndrome to be related to Arexvy. It was unknown if the reporter considered the decubitus ulcer and depression to be related to Arexvy. The company considered the guillain barre syndrome, decubitus ulcer and depression to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 05-FEB-2025 The reporter was the daughter of the elderly patient. Before this incident, the patient was lived independently, driving, walking, cooking and performing all activities of daily living independently. The patient received her Arexvy vaccination in late January 2024, the daughter stated it was between January 29 and 31, 2024. Beginning 2 to 3 weeks later, she began had weakness in her legs. In mid-March 2024 she was struggled to walk and was struggled at home alone. By 25-MAR-2024 she was used a walker, and her right leg froze up. The report was that one day her legs felt heavy then the followed day one leg was slightly improved, but the other leg could not be moved, no matter how hard she tried. After many weeks of attempted to receive the correct diagnostic testing, she was diagnosed with Guillain-Barre Syndrome. She was hospitalized for several days, receiving IVIG treatment, and then discharged to a nursing home for physical rehabilitation. She was discharged to an Assisted Living Facility after not making progress in rehab. While in rehab, she acquired a stage III decubitus ulcer on her coccyx. The daughter was seeking some sort of financial relief due to this incident. She stated that her mother went from independent living to hospital to nursing home and now assisted living. She had spent half her savings in the past few months. Her monthly rent had gone from 1500 dollar to over 6000 dollars due to the loss of her independence. The incident had completely overturned the patient's life and that of the daughter, who was her primary caregiver and Power of Attorney. This had not yet been reported to VAERS, as the daughter was still gathering documentation needed for that report. She had contacted a friend in a legal office and was awaiting contact from an attorney. At the time of this report, she did not have the handout received from the pharmacy. Under the call note it was reported retiring in June 2025 and please contact before June 2025.; Sender's Comments: Guillain-Barre syndrome, Decubitus ulcer and Depression are unlisted events which are considered unrelated to GSK vaccine Arexvy.