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. 2022 Dec 23;62(1):65-76.
doi: 10.1093/rheumatology/keac305.

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

Parikshit Sen  1 , Naveen Ravichandran  2 , Arvind Nune  3 , James B Lilleker  4   5 , Vishwesh Agarwal  6 , Sinan Kardes  7 , Minchul Kim  8 , Jessica Day  9   10   11 , Marcin Milchert  12 , Tamer Gheita  13 , Babur Salim  14 , Tsvetelina Velikova  15 , Abraham Edgar Gracia-Ramos  16 , Ioannis Parodis  17   18 , Albert Selva O'Callaghan  19 , Elena Nikiphorou  20   21 , Tulika Chatterjee  8 , Ai Lyn Tan  22   23 , Lorenzo Cavagna  24 , Miguel A Saavedra  25 , Samuel Katsuyuki Shinjo  26 , Nelly Ziade  27   28 , Johannes Knitza  29 , Masataka Kuwana  30 , Oliver Distler  31 , Hector Chinoy  4   32   33 , Vikas Agarwal  2 , Rohit Aggarwal  34 , Latika Gupta  2   4   35 ; COVAD Study Group
Collaborators, Affiliations

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

Parikshit Sen et al. Rheumatology (Oxford). .

Abstract

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 = 26%, HCs = 24%; odds ratio (OR) = 1.1 (95% CI: 1.03, 1.3); P = 0.014], abdominal pain [SAIDs = 2.6%, HCs = 1.4%; OR = 1.5 (95% CI: 1.1, 2.3); P = 0.011], and dizziness [SAIDs = 6%, HCs = 4%; OR = 1.3 (95% CI: 1.07, 1.6); P = 0.011], were slightly more frequent in SAIDs. Overall, major AEs [SAIDs = 4%, HCs = 2%; OR = 1.9 (95% CI: 1.6, 2.2); P < 0.001] and, specifically, throat closure [SAIDs = 0.5%, HCs = 0.3%; OR = 5.7 (95% CI: 2.9, 11); P = 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.

Keywords: COVID-19; adverse reaction; autoimmune disease; rheumatic disease; vaccine.

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