ABSTRACT
Background/Purpose: Covid-19 vaccine is one of the most effective strategies to control coronavirus disease 2019 (COVID-19) pandemic. However, safety data of these vaccines among patients with autoimmune diseases is limited. We report case series of patients who developed new-onset or flares of autoimmune disease after COVID-19 vaccination. Method(s): We conducted a retrospective chart review of patients treated by rheumatologists for new-onset or flares of autoimmune diseases after COVID-19 vaccination between March 2021-July 2022. Patients who had COVID-19 infection or other explainable causes were excluded. According to World Health Organization's Adverse Event Following Immunization causality assessment, we use 30-day cut off. Patients were divided into 2 groups. The first group had symptom onset within 30 days after vaccination whereas the second group had symptom onset 31-90 days post-vaccination. Patient's demographics, clinical manifestations and laboratory data were collected. Result(s): We identified 18 (46%) patients with new-onset autoimmune diseases, and 21 (54%) patients with autoimmune disease flares after COVID-19 vaccination. Four patients had recurrent flares following subsequent vaccination. The median age was 45 years and 66.7% were females. The median duration from last vaccination to symptom onset was 16 days. Twenty-two (56.4%) of patients developed symptoms within 30 days post-vaccination. Symptoms occurred mostly after the 2nd (44.2%) dose. The most common diagnosis was systemic lupus erythematosus (SLE) (32.6%) with modified Systemic Lupus Erythematosus Disease Activity Index-2000 ranging from 1-21 at diagnosis. Among patients with disease flares, 4 patients had undiagnosed autoimmune diseases before vaccination, 4 patients stopped immunosuppressive medications months prior to disease flares, 5 patients stopped immunosuppressive medications 1 week after vaccination, and 7 patients continued immunosuppressive medications. Fourteen (35.8%) cases required hospitalization, four of which were treated in intensive care units. The remaining patients were treated at outpatient clinic. Seven patients required initiation or adjustment of biologic disease modifying anti-rheumatic drugs, 19 patients received intravenous cyclophosphamide and/or intravenous methylprednisolone, 3 patients received intravenous immunoglobulin, and 5 patients underwent plasmapheresis. One patient improved without intervention. Three (7.9%) patients with new-onset autoimmune diseases died: 2 patients with SLE, and 1 patient with Hemophagocytic lymphohistiocytosis. Conclusion(s): There are cases of patients with new-onset or flare of autoimmune diseases occurring after COVID-19 vaccination. Although previously undiagnosed autoimmune disease or prior discontinuation of immunosuppressive medications partly contributed to disease flares, some cases occurred without other precipitating factors and were severe. Disease awareness and early detection are needed to improve patient outcomes. (Figure Presented).