ADVERSE EVENTS AFTER VACCINATION FOR SARS-CoV2 IN A CASE SERIES OF FIBROMYALGIA PATIENTS VERSUS HEALTHY CONTROLS

M. L. Aprile, L. Cutore, D. Sambataro, G. Sambataro, M. ColaciUniversity of Catania, Clinical and Experimental Medicine, Catania, Italy Ospedale Cannizzaro, Rheumatology Unit, Catania, Italy Artroreuma S.R.L., Rheumatology Outpatient Clinic, Mascalucia, CT, Italy  Background Fibromyalgia (FM) is a chronic widespread pain syndrome of unknown origin that leads to hypersensitivity for physical, chemical and/or psychic triggers. Vaccination, as an inflammatory stimulus and as a psychologically stressful act, could represent a challenge for these patients. Objectives We aimed to investigate the incidence of adverse reactions after vaccination for Sars-Cov2 in a series of FM patients versus healthy controls. Methods We recruited 65 consecutive FM patients classified according to the 2016 ACR diagnostic criteria¹ (M/F: 5/60; mean age 53.6 +/-12.5 years), without other associated rheumatologic conditions, and 65 age/sex-matched healthy controls. All patients filled a questionnaire in order to investigate eventual adverse events occurring up to 6 months after administration of a Sars-Cov2 vaccine. The questionnaire was divided into two parts: the first part included the patient’s demographic information, the vaccine type performed and the anamnestic data. In the second part, the individuals described all new symptoms or signs occurred after the first, the second or the third dose of Sars-Cov2 vaccine. Results Overall, FM patients reported a higher frequency of adverse events after Sars-Cov2 vaccination in comparison with healthy controls. In particular, 44/65 FM patients vs. 11/65 controls complained of exacerbation of diffuse pain (p<0.001). Fatigue, diarrhea, sweating, tingles, headache, dizziness, transient respiratory discomfort, and paroxysmal vision blurring were also more frequent in FM patients than controls (47/65 vs. 30/65, p=0.004; 6/65 vs. 0/65, p=0.028; 18/65 vs. 8/65, p=0.047; 20/65 vs. 0/65, p<0.001; 22/65 vs. 9/65, p=0.013; 21/65 vs. 5/65, p<0.001; 10/65 vs 1/65, p=0.009; 17/65 vs. 2/65, p< 0.001, respectively). No significant difference between FM and the control group as regards fever was reported (24/65 vs. 30/65; p=0.7). Interestingly, swelling at the injection vaccine site was more commonly reported in controls (9/65 vs. 20/65; p=0.034). Finally, one case of Bell’s palsy was registered in the FM series while one case of myocarditis in the control group. Conclusion FM patients showed an increased frequency of adverse events to Sars-Cov2 vaccination compared to healthy controls. In particular, all the symptoms reported seemed to be associated with the functional hypersensitivity that characterizes FM. Reference [1]Wolfe F, et Al. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec; 46(3):319-329. Acknowledgements: NIL. Disclosure of Interests None Declared. Keywords: Fibromyalgia, Vaccination/immunization, COVID DOI: 10.1136/annrheumdis-2023-eular.4461Citation: , volume 82, supplement 1, year 2023, page 1916Session: Pain in rheumatic diseases, including fibromyalgia (Publication only)