Safety of COVID-19 Vaccine in Patients with Rheumatic and Musculoskeletal Diseases

Mediterr J Rheumatol. 2024 Feb 8;35(1):123-133. doi: 10.31138/mjr.140223.sof. eCollection 2024 Mar.

Abstract

Objectives: The main purpose of this study was to determine the frequency of COVID-19 vaccine side effects in patients with rheumatic diseases and to examine any potential associations with medications, disease type, or comorbidities.

Methods: A multicentre cross-sectional study from rheumatology units in different hospitals in Iraq was carried out between 8th of August 2021 and 4th of August 2022. Patients were eligible for inclusion if they have a rheumatic disease and have taken one or more doses of any COVID-19 vaccine.

Results: A total of 661 (57.8% female, mean age 46.51± 12.97 years) patients with rheumatic illnesses who received the "COVID-19" vaccination were included in this study. Rheumatoid arthritis was the most frequent diagnostic group. The Pfizer vaccine was given to the majority of patients (74.6%), followed by Sinopharm (16.2%), and AstraZeneca (9.2%). Side effects were detected in 661(100%) and 528 (100%) patients following the first and second vaccination doses, respectively; among which the most frequent were injection site pain in 57.8% following the first dose and 47.6% after the second dose, followed by fatigue and fever. According to multivariate logistic regression models, age (B=-0.204, p = 0.000), had a significantly inverse correlation coefficient with the experience of greater side effects. Rheumatic disease flares reported in 9.9%, 10.3%, and 8.2% of patients who received the Pfizer, Sinopharm, and AstraZeneca vaccines, respectively.

Conclusion: The "COVID-19" vaccination has a reassuring safety profile with no greater risk of adverse events in any specific illness or pharmacological therapy.

Keywords: COVID-19; flare; rheumatic diseases; safety; vaccine.