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. 2025 Jan;28(1):e70043.
doi: 10.1111/1756-185X.70043.

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

Syahrul Sazliyana Shaharir  1 , Azmawati Mohammed Nawi  2 , Theepa Nesam Mariamutu  1 , Lydia Kamaruzaman  1 , Mohd Shahrir Mohamed Said  1 , Sakthiswary Rajalingham  1 , Ioannis Parodis  3   4 , Manali Sarkar  5 , Samuel Katsuyuki Shinjo  6 , Esha Kadam  7 , Nelly Ziade  8   9 , Chou Luan Tan  10   11 , Francis Gullemin  12   13 , Carlo Vincio Caballero-Uribe  14 , Ai Lyn Tan  15   16 , Laura Andreoli  17   18 , Jasmine Parihar  19 , Praggya Yaadav  20 , Sreoshy Saha  21 ; COVAD Study Group; Latika Gupta  22   23 , Vikas Agarwal  24
Collaborators, Affiliations

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

Syahrul Sazliyana Shaharir et al. Int J Rheum Dis. 2025 Jan.

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 < 0.001) were protective against flare.

Conclusion: The rates of minor DAEs, major AEs, and flares were comparable with other reported studies. Different types of vaccines, underlying AIRDs, and treatments may influence the symptoms of AEs and flares postvaccination against COVID-19.

Keywords: COVID‐19 vaccine; autoimmunity; flares; quality of life.

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References

    1. J. Cui, F. Li, and Z.‐L. Shi, “Origin and Evolution of Pathogenic Coronaviruses,” Nature Reviews. Microbiology 17, no. 3 (2019): 181–192.
    1. D. Cucinotta and M. Vanelli, “WHO Declares COVID‐19 a Pandemic,” Acta Bio‐Medica 91, no. 1 (2020): 157–160.
    1. S. A. Bono, C. S. Siau, A. L. Samy, et al., “Prevalence and Factors Associated With Anxiety During the COVID‐19 Pandemic Among Malaysians: A Cross‐Sectional Study,” Medicine & Health 18, no. 1 (2023): 80–92.
    1. L. S. Hoff, N. Ravichandran, S. K. Shinjo, et al., “COVID‐19 Severity and Vaccine Breakthrough Infections in Idiopathic Inflammatory Myopathies, Other Systemic Autoimmune and Inflammatory Diseases, and Healthy Controls: A Multicenter Cross‐Sectional Study From the COVID‐19 Vaccination in Autoimmune Diseases (COVAD) Survey,” Rheumatology International 43, no. 1 (2023): 47–58.
    1. S. Akiyama, S. Hamdeh, D. Micic, and A. Sakuraba, “Prevalence and Clinical Outcomes of COVID‐19 in Patients With Autoimmune Diseases: A Systematic Review and Meta‐Analysis,” Annals of the Rheumatic Diseases 80, no. 3 (2021): 384–391.

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