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Int. J. Environ. Res. Public Health 2018, 15(6), 1149;

Adverse Events Following Immunization in Brazil: Age of Child and Vaccine-Associated Risk Analysis Using Logistic Regression

Institute of Mathematics, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre RS 91509-900, Brazil
Management and Technical Support, StatSoft South America, Porto Alegre RS 90040-190 Brazil
Statistics Department, Federal University of Santa Maria (UFSM), Santa Maria RS 97105-900, Brazil
National Immunization Program/SVS/MS, Brasília 70058-900, Brazil
National Research Council (CNPq), COAGR/CGAPB, Brasília 71605-001, Brazil
Faculty of Health Sciences, University of Brasília, Brasília 70919-970, Brazil
Author to whom correspondence should be addressed.
Received: 21 March 2018 / Revised: 25 May 2018 / Accepted: 29 May 2018 / Published: 1 June 2018
(This article belongs to the Special Issue Vaccination and Health Outcomes)
Full-Text   |   PDF [494 KB, uploaded 1 June 2018]   |  


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. View Full-Text
Keywords: vaccine; adverse event; immunization; AEFI; passive surveillance vaccine; adverse event; immunization; AEFI; passive surveillance

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Lopes, S.R.; Perin, J.L.; Prass, T.S.; Carvalho, S.M.D.; Lessa, S.C.; Dórea, J.G. Adverse Events Following Immunization in Brazil: Age of Child and Vaccine-Associated Risk Analysis Using Logistic Regression. Int. J. Environ. Res. Public Health 2018, 15, 1149.

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