Reações adversas graves das vacinas COVID-19 em Portugal até julho de 2021 : síndrome de trombose com trombocitopenia, miocardite/pericardite e síndrome de Guillain-Barré
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2022
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Edições Universitárias Lusófonas
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As reações adversas graves a medicamentos (RAM) das vacinas COVID-19 podem estar relacionadas com morte ou outras
situações clínicas graves. Objetivo do estudo: descrever e analisar o perfil de gravidade das Reações Adversas Medicamentosas
(RAM) e a ocorrência de algumas RAM graves e raras das vacinas COVID-19 em Portugal até 22 de julho de 2021. Os dados
foram recolhidos a partir de relatórios públicos do INFARMED, I.P. (agência portuguesa do medicamento). Até 22 de julho
de 2021, foram administradas 11.002.983 vacinas contra a COVID-19 em Portugal, com 11.314 RAM notificadas: 36%
graves e 64% não graves. Globalmente, foram reportadas 1 RAM e 0,4 RAM graves por cada 1.000 vacinas administradas,
respetivamente. Entre as RAM graves, verificaram-se 2 casos confirmados de síndrome de trombose com trombocitopenia
(TTS), 3 casos prováveis de síndrome de Guillain-Barré (SGB) e 2 casos definitivos de miocardite/pericardite. Em conclusão,
como esperado, o número de casos notificados de TTS, SBG e miocardite/pericardite foram raros, o que suporta a manutenção
do perfil de segurança das vacinas COVID-19 a nível nacional e internacional.
Palavras-chave: vacinas COVID-19; síndrome de trombose com trombocitopenia; síndrome de Guillain-Barré; miocardite;
pericardite
Serious adverse reactions to COVID-19 vaccines may be related to death or other serious clinical events. The aim of this study was to describe and to analyze the profile of serious notified Adverse Drug Reactions (ADRs) and the occurrence of some rare and serious adverse reactions to COVID-19 vaccines in Portugal up to 22 July 2021. Data was collected from public reports of INFARMED, I.P. (the Portuguese medicine agency). Up to 22 July 2021, there were 11,002,983 administered COVID-19 vaccines in Portugal, with 11,314 notified ADRs: 36% serious and 64% non-serious. Overall, 1 ADR and 0.4 serious ADRs were reported per each 1,000 administered vaccines, respectively. There were 2 confirmed cases of thrombosis with thrombocytopenia syndrome (TTS), 3 probable cases of Guillain-Barré syndrome (GBS), and 2 definitive cases of myocarditis/pericarditis, among the studied rare serious ADRs. In conclusion, as expected, rare cases of TTS, GBS and myocarditis/pericarditis were reported, which contribute to the maintenance of a safety profile of COVID-19 vaccines at national and international levels. Keywords: COVID-19 vaccines; thrombosis with thrombocytopenia syndrome; Guillain-Barré syndrome; myocarditis; pericarditis
Serious adverse reactions to COVID-19 vaccines may be related to death or other serious clinical events. The aim of this study was to describe and to analyze the profile of serious notified Adverse Drug Reactions (ADRs) and the occurrence of some rare and serious adverse reactions to COVID-19 vaccines in Portugal up to 22 July 2021. Data was collected from public reports of INFARMED, I.P. (the Portuguese medicine agency). Up to 22 July 2021, there were 11,002,983 administered COVID-19 vaccines in Portugal, with 11,314 notified ADRs: 36% serious and 64% non-serious. Overall, 1 ADR and 0.4 serious ADRs were reported per each 1,000 administered vaccines, respectively. There were 2 confirmed cases of thrombosis with thrombocytopenia syndrome (TTS), 3 probable cases of Guillain-Barré syndrome (GBS), and 2 definitive cases of myocarditis/pericarditis, among the studied rare serious ADRs. In conclusion, as expected, rare cases of TTS, GBS and myocarditis/pericarditis were reported, which contribute to the maintenance of a safety profile of COVID-19 vaccines at national and international levels. Keywords: COVID-19 vaccines; thrombosis with thrombocytopenia syndrome; Guillain-Barré syndrome; myocarditis; pericarditis
Descrição
Biomedical and biopharmaceutical research : jornal de investigação biomédica e biofarmacêutica
Palavras-chave
CIÊNCIAS FARMACÊUTICAS, TROMBOSE, TROMBOCITOPENIA, SINDROME DE GUILLAIN-BARRÉ, PERICARDITE, VACINAS, PHARMACEUTICAL SCIENCES, THROMBOCYTOPENIA, THROMBOSIS, GUILLAIN-BARRE SYNDROME, PERICARDITIS, VACCINES, COVID-19, MIOCARDITE