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Abstract Background Patients with immune-mediated rheumatic diseases (IMRDs) have been prioritized for COVID-19 vaccination to mitigate the infection severity risks. Patients with rheumatoid arthritis (RA) are at a high risk of severe COVID-19 outcomes, especially those under immunosuppression or with associated comorbidities. However, few studies have assessed the safety of the COVID-19 vaccine in patients with RA. Objective To evaluate the safety of vaccines against SARS-CoV-2 in patients with RA. Methods This data are from the study “Safety and Efficacy on COVID-19 Vaccine in Rheumatic Diseases,” a Brazilian multicentric prospective phase IV study to evaluate COVID-19 vaccine in IMRDs in Brazil. Adverse events (AEs) in patients with RA of all centers were assessed after two doses of ChAdOx1 (Oxford/AstraZeneca) or CoronaVac (Sinovac/Butantan). Stratification of postvaccination AEs was performed using a diary, filled out daily and returned at the end of 28 days for each dose. Results A total of 188 patients with RA were include, 90% female. CoronaVac was used in 109 patients and ChAdOx1 in 79. Only mild AEs were observed, mainly after the first dose. The most common AEs after the first dose were pain at the injection (46,7%), headache (39,4%), arthralgia (39,4%), myalgia (30,5%) and fatigue (26,6%), and ChAdOx1 had a higher frequency of pain at the injection (66% vs 32 %, p < 0.001) arthralgia (62% vs 22%, p < 0.001) and myalgia (45% vs 20%, p < 0.001) compared to CoronaVac. The more common AEs after the second dose were pain at the injection (37%), arthralgia (31%), myalgia (23%), headache (21%) and fatigue (18%). Arthralgia (41,4% vs 25%, p = 0.02) and pain at injection (51,4% vs 27%, p = 0.001) were more common with ChAdOx1. No serious AEs were related. With Regard to RA activity level, no significant difference was observed between the three time periods for both COVID-19 vaccines. Conclusion In the comparison between the two immunizers in patients with RA, local reactions and musculoskeletal symptoms were more frequent with ChAdOx1 than with CoronaVac, especially after the first dose. In summary, the AE occurred mainly after the first dose, and were mild, like previous data from others immunizing agents in patients with rheumatoid arthritis. Vaccination did not worsen the degree of disease activity. immunemediated immune mediated (IMRDs COVID19 COVID 19 COVID-1 risks (RA outcomes comorbidities However SARSCoV2 SARSCoV SARS CoV 2 SARS-CoV- Safety Diseases, Diseases Brazil (AEs ChAdOx Oxford/AstraZeneca OxfordAstraZeneca Oxford AstraZeneca (Oxford/AstraZeneca Sinovac/Butantan. SinovacButantan Sinovac/Butantan . Sinovac Butantan (Sinovac/Butantan) diary 18 include 90 female 10 79 46,7%, 467 46,7% , 46 7 (46,7%) 39,4%, 394 39,4% 39 4 (39,4%) 30,5% 305 30 5 (30,5% 26,6%, 266 26,6% 26 6 (26,6%) 66% 66 (66 3 % 0.001 0001 0 001 62% 62 (62 22 22% 45% 45 (45 20 20% 37%, 37 37% (37%) 31%, 31 31% (31%) 23%, 23 23% (23%) 21% 21 (21% 18%. 18% (18%) 41,4% 414 41 (41,4 25 25% 0.02 002 02 51,4% 514 51 (51,4 27 27% related level summary COVID1 1 COVID- SARS-CoV (Sinovac/Butantan 9 46,7 (46,7% 39,4 (39,4% 30,5 (30,5 26,6 (26,6% (6 0.00 000 00 (4 (37% (31% (23% (21 (18% 41,4 (41, 0.0 51,4 (51, 46, (46,7 39, (39,4 30, (30, 26, (26,6 ( (37 (31 (23 (2 (18 41, (41 0. 51, (51 (46, (39, (30 (26, (3 (1 (5 (46 (39 (26

Index code	Element
ti	article title
au	author
kw	article keywords
subject	subject (title words, abstract and keywords)
ab	abstract
ta	journal short title (e.g. Cad. Saúde Pública)
journal_title	journal full title (e.g. Cadernos de Saúde Pública)
la	publication language code (e.g. pt - Portuguese, es - Spanish)
type	document type
pid	publication identifier
publication_year	publication year of publication
sponsor	sponsor
aff_country	country code of the author's affiliation
aff_institution	author affiliation institution
volume	article volume
issue	article issue
elocation	elocation
doi	DOI number
issn	journal ISSN
in	SciELO colection code (e.g. scl - Brasil, col - Colômbia)
use_license	article usage license code

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