Adverse events following immunization in Brazil : age of child and vaccine-associated risk analysis using logistic regression

Objective: Vaccines are effective in controlling and eradicating infectious diseases. However, adverse events following immunization (AEFI) can occur in susceptible individuals. The objective of this study was to analyze the Brazilian AEFI database and compare eight vaccines in order to profile risk...

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Detalles Bibliográficos
Autores: Lopes, Silvia Regina Costa, Perin, João Lucas da Rosa, Prass, Taiane Schaedler, Carvalho, Sandra Maria Deotti, Lessa, Sérgio de Castro, Dorea, Jose Garrofe
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2018
País:Brasil
Institución:Universidade Federal do Rio Grande do Sul (UFRGS)
Repositorio:Repositório Institucional da UFRGS
Idioma:inglés
OAI Identifier:oai:www.lume.ufrgs.br:10183/184135
Acceso en línea:http://hdl.handle.net/10183/184135
Access Level:acceso abierto
Palabra clave:Vacinas
Efeitos colaterais e reações adversas relacionados a medicamentos
Imunização
Vigilância em saúde pública
Estatística médica
Brasil
Vaccine
Adverse event
Immunization
AEFI
Passive surveillance
Descripción
Sumario:Objective: Vaccines are effective in controlling and eradicating infectious diseases. However, adverse events following immunization (AEFI) can occur in susceptible individuals. The objective of this study was to analyze the Brazilian AEFI database and compare eight vaccines in order to profile risks of AEFIs related to the mandated pediatric schedule of immunization, considering the age and sex of the child, type of vaccine, and reported adverse events. Methods: We analyzed the Brazilian AEFI database integrating reports between 2005 and 2010 for children less than 10-years old immunized with eight mandated vaccines: diphtheria, pertussis, tetanus, Haemophilus influenzae type b (TETRA); diphtheria, tetanus, and pertussis (DTP); Bacillus Calmette–Guerin (BCG); oral poliovirus vaccine (OPV); measles, mumps, and rubella (MMR); oral rotavirus vaccine (ORV); hepatitis B (HB); and yellow fever (YF). We compared the children’s age regarding types of AEFI, evaluated AEFI factors associated with the chance of hospitalization of the child, and estimated the chance of notification of an AEFI as a function of the type of vaccine. In total, 47,105 AEFIs were observed for the mandated vaccines. Results: The highest AEFI rate was for the TETRA vaccine and the lowest was for the OPV vaccine, with 60.1 and 2.3 events per 100,000 inoculations, respectively. The TETRA vaccine showed the highest rate of hypotonic hyporesponsive episode, followed by convulsion and fever. The MMR and YF vaccines were associated with generalized rash. BCG was associated with enlarged lymph glands but showed the largest negative (protective) association with hyporesponsive events and seizures. Compared with children aged 5–9-years old, young children (<1 year) showed significantly higher odds of hospitalization. Conclusions: The Brazilian AEFI registry is useful to compare the magnitude and certain characteristics of adverse events associated with mandated pediatric vaccines.