Adverse Effects Related to SARS-CoV-2 Vaccination in Patients With Rheumatic Diseases and Psoriasis From Argentina

Patients with systemic rheumatic diseases were initially excluded from coronavirus disease 2019 (COVID-19) vaccine trials. Real-world data on vaccine safety in this population remain limited, particularly for non-mRNA vaccines. The aim of this study was to evaluate the safety of COVID-19 vaccines in patients with rheumatic diseases and/or psoriasis.

A longitudinal observational study including vaccinated patients ≥18 years old with rheumatic diseases and/or psoriasis vaccinated against COVID-19 was conducted. Adverse events (AEs) and disease flares were documented. Multivariable logistic regression analysis identified factors associated with AEs.

Among 2160 patients with rheumatic diseases and/or psoriasis vaccinated against COVID-19 (3988 doses), 29.6% reported at least 1 AE, mostly mild/moderate flu-like symptoms and local hypersensitivity. AE incidence was highest for mRNA-1273 (316.7/1000 doses) and lowest for BBIBP-CorV (95.4/1000). Heterologous regimens and ChAdOx1 nCoV-19 as first dose were associated with increased AE risk, whereas BBIBP-CorV showed the opposite effect. Disease flares occurred in 2.5% of patients, predominantly arthritis and arthralgia, without association with any specific vaccines.

COVID-19 vaccines were generally well tolerated, with AE rates comparable to the general population. Heterologous regimens and vector-based and mRNA vaccines had higher AE incidence. These findings provide valuable safety data on vaccines used in Argentina and the region.