Objective: To characterize adverse events following immunization in children under one year old. Methods: Cross-sectional study conducted with data from the Brazilian Notification System on Adverse Events Following Immunization between 2009 and 2013. Results: A total of 810 cases were analyzed, with a rate of 6.76 adverse events per 100,000 doses. Adverse events were related to the tetravalent (45.1%) and pentavalent (37.4%) vaccines, and associated with age, dosage, time elapsed from immunization, and adopted course. Hypotonic-hyporesponsive episode (27.0%) was the most prevalent event (p<0.001). Conclusion: Adverse events were more frequent in children younger than three months that received the first dose of the tetravalent and pentavalent vaccines; they occurred within the first twenty-four hours following immunization, and the prevalent course consisted in changing the immunization schedule.
ResumoObjetivo: Caracterizar os eventos adversos pós-vacinação ocorridos em crianças menores de um ano. Métodos: Estudo transversal, realizado com dados do Sistema de Informação de Eventos Adversos Pós-vacinação, no período de 2009 a 2013. Resultados: Foram analisados 810 casos, com uma taxa de 6,76 eventos adversos por 100.000 doses. Os eventos adversos foram mais relacionados com as vacinas tetravalente (45,1%) e pentavalente (37,4%) e associados com a idade, dose, tempo decorrido da vacinação e a conduta adotada. O episódio hipotônico hiporresponsivo (27,0%) foi o evento mais prevalente (p<0,001). Conclusão: Os eventos adversos foram mais frequentes em crianças menores de três meses, que tomaram a primeira dose das vacinas tetravalente e pentavalente, ocorreram nas primeiras vinte e quatro horas pós-vacinação e a conduta mais prevalente foi a troca do esquema vacinal.
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