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

Sen P, Ravichandran N, Nune A, Lilleker JB, Agarwal V, Kardes S, Kim M, Day J, Milchert M, Gheita T, Salim B, Velikova T, Gracia-Ramos AE, Parodis I, O'Callaghan AS, Nikiphorou E, Chatterjee T, Tan AL, Cavagna L, Saavedra MA, Shinjo SK, Ziade N, Knitza J, Kuwana M, Distler O, Chinoy H, Agarwal V, Aggarwal R, Gupta L (2022)

Publication Type: Journal article

Publication year: 2022

Journal

DOI: 10.1093/rheumatology/keac305

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.

Authors with CRIS profile

Involved external institutions

University of Manchester United Kingdom (GB) Mahatma Gandhi Mission Institute of Health Sciences (MGMIHS) India (IN) Autonomous University of Barcelona (UAB) / Universitat Autònoma de Barcelona Spain (ES) University of São Paulo / Universidade de São Paulo (USP) Brazil (BR) Université Saint-Joseph (USJ) / جامعة القديس يوسف / Սուրբ Ժոզեֆի համալսարան Lebanon (LB) Nippon Medical School Japan (JP) Maulana Azad Medical College (MAMC) India (IN) Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGIMS) India (IN) Southport and Ormskirk Hospital NHS Trust United Kingdom (GB) Istanbul University / İstanbul Üniversitesi Turkey (TR) University of Illinois at Urbana-Champaign United States (USA) (US) Royal Melbourne Hospital (RMH) Australia (AU) Pomeranian Medical University / Pomorski Uniwersytet Medyczny w Szczecinie (PMU) Poland (PL) Cairo University Egypt (EG) Fauji Foundation Hospital Pakistan (PK) Hl. Kliment Ochridski-Universität Sofia Bulgaria (BG) Instituto Mexicano del Seguro Social Mexico (MX) Karolinska Institute Sweden (SE) University of Zurich / Universität Zürich (UZH) Switzerland (CH) King’s College London United Kingdom (GB) Leeds Teaching Hospitals NHS Trust United Kingdom (GB) Università degli Studi di Pavia Italy (IT) University of Pittsburgh United States (USA) (US)

How to cite

APA:

Sen, P., Ravichandran, N., Nune, A., Lilleker, J.B., Agarwal, V., Kardes, S.,... Gupta, L. (2022). COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study. Rheumatology. https://doi.org/10.1093/rheumatology/keac305

MLA:

Sen, Parikshit, et al. "COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study." Rheumatology (2022).

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