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

Sílvia R.C. Lopes, João L.R. Perin, Taiane S. Prass, Sandra Maria D. Carvalho, Sérgio C. Lessa and José G. Dórea
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Sílvia R.C. Lopes: Institute of Mathematics, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre RS 91509-900, Brazil
João L.R. Perin: Management and Technical Support, StatSoft South America, Porto Alegre RS 90040-190 Brazil
Taiane S. Prass: Statistics Department, Federal University of Santa Maria (UFSM), Santa Maria RS 97105-900, Brazil
Sandra Maria D. Carvalho: National Immunization Program/SVS/MS, Brasília 70058-900, Brazil
Sérgio C. Lessa: National Research Council (CNPq), COAGR/CGAPB, Brasília 71605-001, Brazil
José G. Dórea: Faculty of Health Sciences, University of Brasília, Brasília 70919-970, Brazil

IJERPH, 2018, vol. 15, issue 6, 1-13

Abstract: 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.

Keywords: vaccine; adverse event; immunization; AEFI; passive surveillance (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2018
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