Adverse events of six COVID-19 vaccines in patients with autoimmune rheumatic diseases: a cross-sectional study

Esquivel-Valerio, Jorge Antonio; Skinner-Taylor, Cassandra Michele; Moreno-Arquieta, Ilse Andrea; Garza, Jesús Alberto Cárdenas‐de la; García-Arellano, Gisela; Gonzalez-Garcia, Patricia Ludivina; Almaraz-Juarez, Fatima Del Rocio; Galarza-Delgado, D. Á.

doi:10.1007/s00296-021-05017-9

Cited by 45 publications

(44 citation statements)

References 16 publications

(23 reference statements)

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“…To be mentioned, only two of our patients received the Johnson & Johnson vaccine, therefore no definite conclusion can be drawn for this vaccine. In agreement with previously published studies focusing on mRNA vaccines, we found that fatigue and local pain at the site of injection were the most common symptoms for Pfizer vaccine [13,19,20]. In our cohort, fever was the cardinal AE for Astra-Zeneca vaccine, while myalgias and headache were not so commonly reported as in other studies [19].…”

Section: Discussionsupporting

confidence: 92%

“…In agreement with previously published studies focusing on mRNA vaccines, we found that fatigue and local pain at the site of injection were the most common symptoms for Pfizer vaccine [13,19,20]. In our cohort, fever was the cardinal AE for Astra-Zeneca vaccine, while myalgias and headache were not so commonly reported as in other studies [19]. Looking for interactions with clinical, demographic and other characteristics, we are in concert with another study finding that AEs are more common in females [14], reporting also for the first time that the occurrence of COPD is also a risk factor.…”

Section: Discussionsupporting

confidence: 92%

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COVID-19 vaccine safety and nocebo-prone associated hesitancy in patients with systemic rheumatic diseases: a cross-sectional study

et al. 2021

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 92%

COVID-19 vaccine safety and nocebo-prone associated hesitancy in patients with systemic rheumatic diseases: a cross-sectional study

et al. 2021

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“…The frequency and type of early AEs was also similar between vaccines, both for the I-RMD and NI-RMD groups, with the possible exception of a slightly higher proportion of pain at the injection site with the Moderna vaccine (both in the I-RMD and NI-RMD group). Both the flare and AE data are in line with previous smaller studies in patients with I-RMDs (13 to 2860 patients, with the largest cohort being patient reported rather than physician reported) 18–40…”

Section: Discussionsupporting

confidence: 88%

Safety of vaccination against SARS-CoV-2 in people with rheumatic and musculoskeletal diseases: results from the EULAR Coronavirus Vaccine (COVAX) physician-reported registry

et al. 2021

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ObjectivesTo describe the safety of vaccines against SARS-CoV-2 in people with inflammatory/autoimmune rheumatic and musculoskeletal disease (I-RMD).MethodsPhysician-reported registry of I-RMD and non-inflammatory RMD (NI-RMDs) patients vaccinated against SARS-CoV-2. From 5 February 2021 to 27 July 2021, we collected data on demographics, vaccination, RMD diagnosis, disease activity, immunomodulatory/immunosuppressive treatments, flares, adverse events (AEs) and SARS-CoV-2 breakthrough infections. Data were analysed descriptively.ResultsThe study included 5121 participants from 30 countries, 90% with I-RMDs (n=4604, 68% female, mean age 60.5 years) and 10% with NI-RMDs (n=517, 77% female, mean age 71.4). Inflammatory joint diseases (58%), connective tissue diseases (18%) and vasculitis (12%) were the most frequent diagnostic groups; 54% received conventional synthetic disease-modifying antirheumatic drugs (DMARDs), 42% biological DMARDs and 35% immunosuppressants. Most patients received the Pfizer/BioNTech vaccine (70%), 17% AstraZeneca/Oxford and 8% Moderna. In fully vaccinated cases, breakthrough infections were reported in 0.7% of I-RMD patients and 1.1% of NI-RMD patients. I-RMD flares were reported in 4.4% of cases (0.6% severe), 1.5% resulting in medication changes. AEs were reported in 37% of cases (37% I-RMD, 40% NI-RMD), serious AEs in 0.5% (0.4% I-RMD, 1.9% NI-RMD).ConclusionThe safety profiles of SARS-CoV-2 vaccines in patients with I-RMD was reassuring and comparable with patients with NI-RMDs. The majority of patients tolerated their vaccination well with rare reports of I-RMD flare and very rare reports of serious AEs. These findings should provide reassurance to rheumatologists and vaccine recipients and promote confidence in SARS-CoV-2 vaccine safety in I-RMD patients.

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“…fever and/or headache) [15]. Localized pain, fatigue, headache and muscle ache are the most prevalent adverse effects in patients with autoimmune and inflammatory rheumatic diseases following six COVID-19 vaccines [16]. Previous studies indicated that human papillomavirus, hepatitis B and influenza vaccines may trigger the onset or exacerbations of autoimmune diseases by molecular mimicry inducing autoimmunity [17][18][19].…”

Section: Introductionmentioning

confidence: 99%

New‐onset autoimmune phenomena post‐COVID‐19 vaccination

et al. 2022

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Coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to an unprecedented setback for global economy and health. Vaccination is one of the most effective interventions to substantially reduce severe disease and death due to SARS-CoV-2 infection.Vaccination programmes are being rolled out globally, but most of these vaccines have been approved without extensive studies on their side-effects and efficacy.Recently, new-onset autoimmune phenomena after COVID-19 vaccination have been reported increasingly (e.g. immune thrombotic thrombocytopenia, autoimmune liver diseases, Guillain-Barré syndrome, IgA nephropathy, rheumatoid arthritis and systemic lupus erythematosus). Molecular mimicry, the production of particular autoantibodies and the role of certain vaccine adjuvants seem to be substantial contributors to autoimmune phenomena. However, whether the association between COVID-19 vaccine and autoimmune manifestations is coincidental or causal remains to be elucidated. Here, we summarize the emerging evidence about autoimmune manifestations occurring in response to certain COVID-19 vaccines.Although information pertaining to the risk of autoimmune disease as a consequence of vaccination is controversial, we merely propose our current understanding of autoimmune manifestations associated with COVID-19 vaccine. In fact, we do not aim to disavow the overwhelming benefits of mass COVID-19 vaccination in preventing COVID-19 morbidity and mortality. These reports could help guide clinical assessment and management of autoimmune manifestations after COVID-19 vaccination.

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Adverse events of six COVID-19 vaccines in patients with autoimmune rheumatic diseases: a cross-sectional study

Cited by 45 publications

References 16 publications

COVID-19 vaccine safety and nocebo-prone associated hesitancy in patients with systemic rheumatic diseases: a cross-sectional study

COVID-19 vaccine safety and nocebo-prone associated hesitancy in patients with systemic rheumatic diseases: a cross-sectional study

Safety of vaccination against SARS-CoV-2 in people with rheumatic and musculoskeletal diseases: results from the EULAR Coronavirus Vaccine (COVAX) physician-reported registry

New‐onset autoimmune phenomena post‐COVID‐19 vaccination

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