Use of electronic immunization registry in the surveillance of adverse events following immunization

Author(s)

Ana Paula Sayuri Sato ^[1] ; Vinícius Leati de Rossi Ferreira ^[2] ; Márcia de Cantuária Tauil ^[3] ; Laura Cunha Rodrigues ^[4] ; Mariana Bernardes Barros ^[1] ; Edmar Martineli ^[5] ; Ângela Aparecida Costa ^[7] ; Marta Inenami ^[7] ; Eliseu Alves Waldman ^[1]

Affiliation

^[1] Univ Sao Paulo, Fac Saude Publ, Dept Epidemiol, Av Dr Arnaldo 715, BR-01246904 Sao Paulo, SP - Brazil

^[2] Universidade de São Paulo. Faculdade de Saúde Pública. Departamento de Epidemiologia - Brasil

^[3] Universidade de São Paulo. Faculdade de Saúde Pública. Departamento de Epidemiologia - Brasil

^[4] London Sch Hyg & Trop Med, Fac Epidemiol & Populat Hlth, London - England

^[5] Univ Sao Paulo, Ctr Tecnol Informacao Sao Carlos, Sao Carlos, SP - Brazil

^[6] Universidade de São Paulo. Faculdade de Saúde Pública. Serviço Especial de Saúde de Araraquara - Brasil

^[7] Univ Sao Paulo, Fac Saude Publ, Serv Especial Saude Araraquara, Araraquara, SP - Brazil

• Document type: Journal article
• Source: Revista de Saúde Pública; v. 52, 2018-02-05.

Abstract

ABSTRACT OBJECTIVE To describe adverse events following vaccination (AEFV) of children under two years old and analyze trend of this events from 2000 to 2013, in the city of Araraquara (SP), Brazil. METHODS This is a descriptive study conducted with data of the passive surveillance system of AEFV that is available in the electronic immunization registry (EIR) of the computerized medical record of the municipal health service (Juarez System). The study variables were: age, gender, vaccine, dose, clinical manifestations and hospitalization. We estimated rates using AEFV as numerator and administered doses of vaccines as denominator. The surveillance sensitivity was estimated by applying the method proposed by the Centers for Disease Control and Prevention. We used Prais-Winsten regression with a significance level of 5.0%. RESULTS The average annual rate of AEFV was 11.3/10,000 administered doses, however without a trend in the study period (p=0.491). Most cases occurred after the first dose (41.7%) and among children under one year of age (72.6%). Vaccines with pertussis component, yellow fever and measles-mumps-rubella were the most reactogenic. We highlighted the rates of hypotonic-hyporesponsive episodes and convulsion that were 4.1/10,000 and 1.5/10,000 doses of vaccines with pertussis component, respectively, most frequently in the first dose; 60,0% of cases presented symptoms in the first 24 hours after vaccination, however, 18.6% showed after 96 hours. The sensitivity of surveillance was 71.9% and 78.9% for hypotonic-hyporesponsive episodes and convulsion, respectively. CONCLUSIONS The EIR-based AEFV surveillance system proved to be useful and highly sensitive to describe the safety profile of vaccines in a medium-sized city. It was also shown that the significant increase of the vaccines included in the basic vaccination schedule in childhood in the last decade did not alter the high safety standard of the National Immunization Program. (AU)

• FAPESP's process: 14/11714-7 - Vaccination coverage and factors associated with incomplete vaccination in a medium-sized city, São Paulo State, Brazil
• Grantee: Márcia de Cantuária Tauil
• Support Opportunities: Scholarships in Brazil - Doctorate
• FAPESP's process: 14/05183-9 - Evaluation of a nominal immunization information system: Sistema Juarez, Araraquara, SP
• Grantee: Ana Paula Sayuri Sato
• Support Opportunities: Regular Research Grants