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Análise do perfil das notificações de suspeitas de reações adversas às vacinas contra a COVID-19 na Unidade de Farmacovigilância de Lisboa, Setúbal e Santarém
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Resumo(s)
Introdução e objetivos: o rápido desenvolvimento de vacinas contra a COVID-19 levantou várias questões sobre o perfil de segurança das mesmas principalmente em crianças, adolescentes, mulheres grávidas e a amamentar devido à informação limitada proveniente de ensaios clínicos. Assim, considera-se pertinente realizar a análise e caracterização da notificação espontânea de reações adversas às vacinas contra a COVID-19 nestes grupos e efetuar uma comparação dos dados de Portugal com o mundo.
Métodos: estudo descritivo transversal das notificações de suspeitas de reações adversas às vacinas contra a COVID-19 extraídas da base de dados do Portal RAM do Infarmed para o período de 1 de janeiro de 2020 a 31 de março de 2022 e comparação do perfil de notificação no Sistema Nacional de Farmacovigilância com o perfil da notificação rececionada a nível mundial pela OMS.
Resultados: as reações adversas notificadas foram semelhantes para crianças e adolescentes, sendo que no caso das crianças se registaram mais notificações de problemas relacionados com a preparação/administração da vacina enquanto nos adolescentes se verificaram mais falências vacinais. O mesmo se verificou nos dados da VigiLyze havendo, no entanto, uma maior percentagem de reações graves notificadas em Portugal.
Quanto às mulheres grávidas e a amamentar existiu um número muito superior de notificações recebidas no Portal RAM para as mulheres grávidas. No que respeita à gravidade das reações, também as mulheres grávidas apresentaram duas vezes mais reações graves do que as mulheres a amamentar. O mesmo se verificou nos dados da VigiLyze sendo que, no caso das mulheres a amamentar, existiu uma menor percentagem de notificações de reações graves em Portugal.
Conclusão: as crianças e adolescentes apresentaram as alterações no local de administração, ao nível do sistema nervoso e do trato gastrointestinal como as reações mais comuns. As mulheres grávidas e a amamentar apresentaram como reações mais frequentes as alterações no local de administração, alterações a nível muscular e dos tecidos, condições relacionadas com a gravidez e com o procedimento de administração da vacina.
Introduction and objectives: The rapid development of COVID-19 vaccines has raised several questions about their safety profile mainly in children, adolescents, pregnant and breastfeeding women due to limited information from clinical trials. Thus, it is pertinent to analyze and characterize the spontaneous report of adverse reactions to the COVID-19 vaccines in these groups and to compare data from Portugal with the world. Methods: descriptive transversal study of reports of suspected adverse reactions to COVID-19 vaccines extracted from the Infarmed Portal RAM database from January 1, 2020 to March 31, 2022 and comparison of the National Pharmacovigilance System notification profile with the notification profile received worldwide by WHO. Results: Adverse reactions reported were similar for children and adolescents, with children reporting more problems related to vaccine preparation/administration and adolescents reporting more vaccine failures. The same was found in the VigiLyze data, but with a higher percentage of serious reactions reported in Portugal. As for pregnant and breastfeeding women, there was a much higher number of reports received in Portal RAM for pregnant women. Regarding the severity of reactions, also pregnant women had twice as many severe reactions as breastfeeding women. The same was found in the VigiLyze data, with a lower percentage of severe reactions being reported in breastfeeding women in Portugal. Conclusion: Children and adolescents were most commonly reported to have administration site, nervous system and gastrointestinal tract disorders. Pregnant and breastfeeding women had administration site changes, muscle and tissue changes, pregnancy-related conditions, and conditions related to the vaccine administration as the most common reactions.
Introduction and objectives: The rapid development of COVID-19 vaccines has raised several questions about their safety profile mainly in children, adolescents, pregnant and breastfeeding women due to limited information from clinical trials. Thus, it is pertinent to analyze and characterize the spontaneous report of adverse reactions to the COVID-19 vaccines in these groups and to compare data from Portugal with the world. Methods: descriptive transversal study of reports of suspected adverse reactions to COVID-19 vaccines extracted from the Infarmed Portal RAM database from January 1, 2020 to March 31, 2022 and comparison of the National Pharmacovigilance System notification profile with the notification profile received worldwide by WHO. Results: Adverse reactions reported were similar for children and adolescents, with children reporting more problems related to vaccine preparation/administration and adolescents reporting more vaccine failures. The same was found in the VigiLyze data, but with a higher percentage of serious reactions reported in Portugal. As for pregnant and breastfeeding women, there was a much higher number of reports received in Portal RAM for pregnant women. Regarding the severity of reactions, also pregnant women had twice as many severe reactions as breastfeeding women. The same was found in the VigiLyze data, with a lower percentage of severe reactions being reported in breastfeeding women in Portugal. Conclusion: Children and adolescents were most commonly reported to have administration site, nervous system and gastrointestinal tract disorders. Pregnant and breastfeeding women had administration site changes, muscle and tissue changes, pregnancy-related conditions, and conditions related to the vaccine administration as the most common reactions.
Descrição
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, 2022, Universidade de Lisboa, Faculdade de Farmácia.
Palavras-chave
Vacina SARS-CoV-2 Pediatria Gravidez Amamentação Mestrado integrado - 2022