Self-Reported Delayed Adverse Events and Flare Following COVID-19 Vaccination Among Patients With Autoimmune Rheumatic Disease (AIRD) in Malaysia: Results From the COVAD-2 Study

Shaharir SS 1 , Nawi AM 2 , Mariamutu TN 1 , Kamaruzaman L 1 , Said MSM 1 , Rajalingham S 1 Show all authors , Parodis I 3 , Sarkar M 4 , Shinjo SK 5 , Kadam E 6 , Ziade N 7 , Tan CL 8 , Gullemin F 9 , Caballero-Uribe CV 10 , Tan AL 11 , Andreoli L 12 , Parihar J 13 , Yaadav P 14 , Saha S 15 , COVAD Study Group , Gupta L 16 , Agarwal V 17

Affiliations 

  • 1 Department of Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Cheras, Kuala Lumpur, Malaysia
  • 2 Department of Public Health, Faculty of Medicine, Universiti Kebangsaan Malaysia, Cheras, Kuala Lumpur, Malaysia
  • 3 Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden
  • 4 MGM Medical College, Navi Mumbai, Maharashtra, India
  • 5 Division of Rheumatology, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, São Paulo, Brazil
  • 6 Seth Gordhandhas Sunderdas Medical College and King Edwards Memorial Hospital, Mumbai, Maharashtra, India
  • 7 Rheumatology Department, Saint-Joseph University, Beirut, Lebanon
  • 8 Rheumatology Unit, Department of Internal Medicine, Hospital Sultanah Bahiyah, Alor Setar, Malaysia
  • 9 EA 4360 Apemac, Université de Lorraine, Nancy, France
  • 10 Department of Medicine, Hospital Universidad del Norte, Barranquilla, Atlantico, Colombia
  • 11 NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust, Leeds, UK
  • 12 Rheumatology and Clinical Immunology Unit, ASST Spedali Civili and University of Brescia, Brescia, Italy
  • 13 All India Institute of Medical Science, New Delhi, India
  • 14 Maharashtra Institute of Medical Sciences and Research, Latur, Maharashtra, India
  • 15 Mymensingh Medical College, Mymensingh, Bangladesh
  • 16 Department of Rheumatology, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK
  • 17 Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
Int J Rheum Dis, 2025 Jan;28(1):e70043.
PMID: 39791506 DOI: 10.1111/1756-185X.70043

Abstract

OBJECTIVES: To determine the prevalence of self-reported delayed adverse events (DAEs), major AEs, and flares following COVID-19 vaccinations among patients with autoimmune rheumatic diseases (AIRDs) in Malaysia.

METHODOLOGY: An electronically validated survey from the COVID-19 vaccination in autoimmune diseases (COVAD) study group was distributed in July 2021 to patients with autoimmune diseases and healthy controls (HCs). The survey collected data on DAEs (any AE that persisted or occurred after 7 days of vaccination), any early or delayed major adverse events (MAEs), and flares following COVID-19 vaccination. Generalized estimating equation (GEE) models were performed to determine the factors associated with repeated events of DAEs, MAEs, and flares.

RESULTS: A total of 556 vaccines were administered to 204 subjects (150 AIRDs and 54 HCs), with 72.1% completing 3 doses. In multivariate GEE analysis, there was a greater frequency of minor DAEs among AIRDs versus HCs (OR 5.65, p = 0.052). The occurrence of MAEs was higher in AIRDs versus HCs (4.9% vs. 1.3%, p = 0.052), but it was no longer significant in the GEE model. In the AIRDs group, the BNT162b2 vaccine increased the risk for minor DAEs (OR4.68, p = 0.02) while patients with autoimmune multimorbidity showed a greater risk for MAEs (OR 8.25, p = 0.007). The rate of flare was 10.6% and multivariate GEE analysis revealed that The rate of flare was 10.6% and multivariate GEE analysis revealed that systemic lupus erythematosus (SLE) (OR0.31, p = 0.03) and hydroxychloroquine (HCQ) (OR 0.16, p 

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