Tolerability and safety of Gam-COVID-Vac (Sputnik V) vaccine in adult patients with autoimmune rheumatic diseases

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To evaluate the tolerability and safety profile of GamCOVID-Vak (Sputnik V) vaccine in adult patients with autoimmune inflammatory rheumatic diseases.

Material and methods

In a cross-sectional study, we enrolled adult patients with and without autoimmune inflammatory diseases, e.g. rheumatoid arthritis, systemic vasculitis, diffuse connective tissue diseases, etc, who were immunized with at least one dose of Gam-COVID-Vac vaccine prior to visit to investigational site. Demographic parameters, comorbidity, local and systemic adverse events were evaluated using online questionnaire.


One hundred fifty seven patients with autoimmune rheumatic disease and 168 subjects without inflammatory diseases have completed online questionnaire. Two groups were comparable by age (46 [37; 61] and 48 [30; 60] years, respectively, p=0.523), gender (71.3% and 72.0% females, p=0,903) and comorbidity. Both doses of vaccine were administered to 131 (83.4%) and 159 (94.6%) participants in the two groups, respectively. In patients with autoimmune rheumatic diseases, any adverse event after the first dose of vaccine occurred less frequently than in control subjects (72.0% vs. 82,7%, p=0.024), whereas after the second dose the occurrence of any adverse event was similar in the two groups (64.1% vs. 68,6%, p=0.454). Local pain, fatigue, myalgia, arthralgia, chills, and fever were the most common adverse reactions after vaccination. The incidence of allergic reactions was low and similar in the two grous (p>0.05).


Our findings suggest the acceptable safety profile of Gam-COVID-Vas vaccine in adult patients with autoimmune rheumatic diseases.

Key words

COVID-19, rheumatic diseases, vaccination, Gam-COVID-19, Sputnki V.