ABSTRACT
Background: Following the introduction of the COVID-19 vaccines, there has been uncertainty as to whether receiving the COVID-19 vaccine will result in overactivation of the immune system and subsequently lead to an autoimmune disease flare.The purpose of this study was to assess whether rheumatoid arthritis (RA) patients who received the mRNA COVID-19 vaccine are at increased risk for disease flare. Methods: We conducted a single-center retrospective and prospective study at the Louis Stokes Cleveland VA Medical Center between 12/2021 and 2/2022. We included 100 patients with rheumatoid arthritis (RA) who were actively on immunosuppressive therapy and received three doses of the Pfizer-BioNTech vaccine. A survey questionnaire was used to collect data about their RA and if they developed symptoms post vaccination. Our primary end point was to determine incidence of flare of RA after COVID-19 vaccine. Secondary end points were to estimate the side effect profile from the vaccine, and to check if patients developed a COVID-19 infection after they received the vaccine. Results: None of the patients reported symptoms of RA flare within two months of receiving the 3 doses of the vaccine. Most common vaccine side effects were soreness over the injection site (n = 14), headache (n = 11), fatigue(n = 7) and myalgias(n = 4). 5 patients developed a COVID-19 infection prior to receiving the vaccine, 8 after being vaccinated, 3 of the 8 within 5 months from the second dose and 5 out of the 8 within 3 months from the third vaccine dose. Conclusion: RA patients receiving the COVID-19 Pfizer mRNA vaccine do not appear to commonly develop major symptoms, flares or side effects following the vaccine. Further research with larger numbers of patients with rheumatoid arthritis as well as those with other autoimmune disease is needed to better understand the safety and effectiveness of COVID-19 vaccine.