COVID-19 vaccines: safety profile after one year of follow-up

Abstract

Introduction: After declaring the global pandemic due to the coronavirus COVID-19, measures were established to combat it, highlighting the existence of COVID-19 vaccines: two messenger RNA [mRNA] and two non-replicating viral vector [VVNR].

Our objective was to contribute to expanding the safety profile of these vaccines through the detection and notification of adverse reactions (ARs) in a health area with 174,398 health cards during the year 2021.

Method: Retrospective descriptive observational study carried out in a second level hospital. The sources of detection of the ADRs were: Coding System of the Center at the Discharge of the Admitted Patient [SIAC] and spontaneous notification. The data used were extracted from the electronic medical record and collected in a Microsoft Excell document.

Results: Of the 654 ARs detected, 36 belonged to COVID-19 vaccines, 72 % being detected by spontaneous notification and 91.67 % being serious. They occurred in 29 patients (median age: 61 years; 51.72 % women), two of them with previous COVID-19 infection. 50 % of the ARs occurred after the second dose. They highlighted: deep vein thrombosis (DVT), pulmonary thromboembolism (PTE) and myopericarditis with mRNA vaccines; and vasculitis and myocarditis in VVNR.

Conclusions: Although the available bibliography indicates that the frequency of serious ARs with these vaccines is usually rare, their follow-up is important. The high percentage of ADRs detected by spontaneous notification reflects the involvement of healthcare professionals to expanding the safety profile.