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Ars Pharmaceutica (Internet)

versión On-line ISSN 2340-9894

Resumen

FERNANDEZ-VARELA, Alba María; GRANERO-LOPEZ, Mónica; RODRIGUEZ-RODRIGUEZ, Alejandro  y  RODRIGUEZ-PENIN, Isaura. COVID-19 vaccines: safety profile after one year of follow-up. Ars Pharm [online]. 2024, vol.65, n.1, pp.6-12.  Epub 23-Ago-2024. ISSN 2340-9894.  https://dx.doi.org/10.30827/ars.v65i1.29180.

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.

Palabras clave : vaccines; COVID-19; safety; pharmacovigilance.

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