Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Autoimmune disorder, C-reactive protein increased, Erythema, Inflammation, Insomnia
Clinical narrative: Autoimmune disorder; C reactive protein elevated; sedimentation rate elevated; Cramps leg; Swelling arm; Inflammation; Redness; Polymyalgia; Pain/ pain is in random places; Insomnia; This serious case was reported by a nurse via call center representative and described the occurrence of autoimmune disorder in a 70-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included shoulder replacement (Patient has a titanium left shoulder replacement.). Concurrent medical conditions included atrial fibrillation and hypertension. Concomitant products included propafenone, apixaban (Eliquis) and carvedilol (Coreg).   On 29-JAN-2025, the patient received Arexvy (right arm). In JAN-2025, less than a week after receiving Arexvy, the patient experienced c-reactive protein increased (Verbatim: C reactive protein elevated) and elevated sedimentation rate (Verbatim: sedimentation rate elevated). On 31-JAN-2025, the patient experienced leg cramps (Verbatim: Cramps leg), swelling arm (Verbatim: Swelling arm), inflammation (Verbatim: Inflammation), redness (Verbatim: Redness), polymyalgia (Verbatim: Polymyalgia), pain (Verbatim: Pain/ pain is in random places) and insomnia (Verbatim: Insomnia). On an unknown date, the patient experienced autoimmune disorder (Verbatim: Autoimmune disorder) (serious criteria GSK medically significant). The patient was treated with prednisone and methotrexate. The outcome of the autoimmune disorder, leg cramps, swelling arm, inflammation, redness, polymyalgia, pain, insomnia, c-reactive protein increased and elevated sedimentation rate were not resolved.   It was unknown if the reporter considered the autoimmune disorder, leg cramps, swelling arm, inflammation, redness, polymyalgia, pain, insomnia, c-reactive protein increased and elevated sedimentation rate to be related to Arexvy.     It was unknown if the company considered the autoimmune disorder, leg cramps, swelling arm, inflammation, redness, polymyalgia, pain, insomnia, c-reactive protein increased and elevated sedimentation rate to be related to Arexvy.   Additional Information: GSK receipt date: 03-JUN-2025 The reporter was the wife of the patient and a nurse called as a consumer. The reporter stated that her husband received the Arexvy vaccine on 19th January 2025 in his right arm. The reporter stated that 5 days after receiving the vaccine all his symptoms started and are concentrated on his left side. The patient's pain was in random places. All symptoms were persisting. The reporter stated that the patient's physician reported this AE on VAERS in February 2025 and diagnosed patient with an autoimmune response. The patient currently had abnormal labs, CRP and SED rate was elevated. Currently the physician was titrating Prednisone down and had started Methotrexate. The reporter stated that the doctor tried to titrate the Prednisone down before with negative results. The reporter had no information concerning the vaccine and stated that the doctor had all of the information about the vaccine because he did all of the previous reporting in VEARS.; Sender's Comments: Autoimmune disorder is an unlisted event which is considered unrelated to GSK vaccine Arexvy.