COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study

Objectives. COVID-19 vaccines have been proven to be safe in the healthy population. However, gaps remain in the evidence of their safety in patients with systemic autoimmune and inflammatory disorders (SAIDs). COVID-19 vaccination-related adverse events (AEs) in patients with SAIDs and healthy controls (HC) seven days post-vaccination were assessed in the COVAD study, a patient self-reported cross-sectional survey. Methods. The survey was circulated in early 2021 by >110 collaborators (94 countries) to collect SAID details, COVID-19 vaccination details and 7-day vaccine AEs, irrespective of respondent vaccination status. Analysis was performed based on data distribution and variable type. Results. Ten thousand nine hundred respondents [median (interquartile range) age 42 (30–55) years, 74% females and 45% Caucasians] were analysed; 5867 patients (54%) with SAIDs were compared with 5033 HCs. Seventy-nine percent had minor and only 3% had major vaccine AEs requiring urgent medical attention (but not hospital admission) overall. Headache [SAIDs ¼ 26%, HCs ¼ 24%; odds ratio (OR) ¼ 1.1 (95% CI: 1.03, 1.3); P ¼ 0.014], abdominal pain [SAIDs ¼ 2.6%, HCs ¼ 1.4%; OR ¼ 1.5 (95% CI: 1.1, 2.3); P ¼ 0.011], and dizziness [SAIDs ¼ 6%, HCs ¼ 4%; OR ¼ 1.3 (95% CI: 1.07, 1.6); P ¼ 0.011], were slightly more frequent in SAIDs. Overall, major AEs [SAIDs ¼ 4%, HCs ¼ 2%; OR ¼ 1.9 (95% CI: 1.6, 2.2); P < 0.001] and, specifically, throat closure [SAIDs ¼ 0.5%, HCs ¼ 0.3%; OR ¼ 5.7 (95% CI: 2.9, 11); P ¼ 0.010] were more frequent in SAIDs though absolute risk was small (0–4%). Major AEs and hospitalizations (<2%) were comparable across vaccine types in SAIDs. Conclusion. Vaccination against COVID-19 is safe in SAID patients. SAIDs were at a higher risk of major AEs than HCs, though absolute risk was small. There are small differences in minor AEs between vaccine types in SAID patients.