Mahatma Gandhi Mission Medical College, Navi Mumbai, Maharashtra, India.
Department of Medical Ecology and Hydroclimatology, Istanbul Faculty of Medicine, Istanbul University, Capa-Fatih, Istanbul, Turkey.
Center for Outcomes Research, Department of Internal Medicine, University of Illinois College of Medicine Peoria, Illinois, USA.
Department of Rheumatology, Royal Melbourne Hospital, Parkville, Australia; Walter and Eliza Hall Institute of Medical Research, Parkville, Australia; Department of Medical Biology, University of Melbourne, Parkville, Australia.
Department of Internal Medicine, Rheumatology, Geriatrics and Clinical Immunology, Pomeranian Medical University in Szczecin, ul Unii Lubelskiej 1, Szczecin, Poland.
Rheumatology Department, Kasr Al Ainy School of Medicine, Cairo University, Cairo, Egypt.
Rheumatology Department, Fauji Foundation Hospital, Rawalpindi, Pakistan.
Department of Clinical Immunology, Medical Faculty, University Hospital "Lozenetz", Sofia University St. Kliment Ohridski, Sofia, Bulgaria.
Department of Internal Medicine, General Hospital, National Medical Center "La Raza", Instituto Mexicano del Seguro Social, Av. Jacaranda S/N, Col. La Raza, Del. Azcapotzalco, C.P., Mexico City, Mexico.
Internal Medicine Department, Vall D'hebron General Hospital, Universitat Autonoma de Barcelona, Barcelona, Spain.
Centre for Rheumatic Diseases, King's College London, London, UK; Rheumatology Department, King's College Hospital, London, UK.
Center for Outcomes Research, Department of Internal Medicine, University of Illinois College of Medicine Peoria, Illinois, USA.
NIHR Leeds Biomedical Research Centre,Leeds Teaching Hospitals Trust, Leeds, UK; Leeds Institute of Rheumatic and Musculoskeletal Medicine,University of Leeds, Leeds, UK.
Rheumatology Unit, Dipartimento di Medicine Interna e Terapia Medica, Università degli studi di Pavia, Pavia, Lombardy, Italy.
Departamento de Reumatología Hospital de Especialidades Dr. Antonio Fraga Mouret, Centro Médico Nacional La Raza, IMSS, Mexico City, Mexico.
Division of Rheumatology, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Rheumatology Department, Saint-Joseph University, Beirut, Lebanon; Rheumatology Department, Hotel-Dieu de France Hospital, Beirut, Lebanon.
Medizinische Klinik 3 - Rheumatologie und Immunologie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Deutschland.
Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan.
Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre,The University of Manchester, Manchester, UK; National Institute for Health Research Manchester Biomedical Research Centre,Manchester University NHS Foundation Trust,The University of Manchester, Manchester, UK; Department of Rheumatology, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK.
Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.
Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India; Department of Rheumatology, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, United Kingdom; Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre,The University of Manchester, Manchester, UK.
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 (ADEs) 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 ADEs, irrespective of respondent vaccination status. Analysis was performed based on data distribution and variable type.
RESULTS: 10900 respondents [42 (30-55) years, 74% females and 45% Caucasians] were analyzed. 5,867 patients (54%) with SAIDs were compared with 5033 HCs.79% had minor and only 3% had major vaccine ADEs requiring urgent medical attention (but not hospital admission) overall. Headache [SAIDs=26%, HCs=24%; OR = 1.1 (1.03-1.3); p = 0.014], abdominal pain [SAIDs=2.6%, HCs=1.4%; OR = 1.5 (1.1-2.3); p = 0.011], and dizziness [SAIDs=6%, HCs=4%; OR = 1.3 (1.07-1.6); p = 0.011], were slightly more frequent in SAIDs. Overall, major ADEs [SAIDs=4%, HCs=2%; OR = 1.9 (1.6-2.2); p < 0.001] and, specifically, throat closure [SAIDs=0.5%, HCs=0.3%; OR = 5.7 (2.9-11); p = 0.010] were more frequent in SAIDs though absolute risk was small (0-4%). Major ADEs and hospitalizations (less than 2%) were comparable across vaccine types in SAIDs.
CONCLUSION: Vaccination against COVID-19 is relatively safe in SAID patients. SAIDs were at a higher risk of major ADEs than HCs, though absolute risk was small. There are small differences in minor ADEs between vaccine types in SAID patients.
Oxford University Press, 2022. Vol. 62, no 1, p. 65-76