Use of electronic immunization registry in the surveillance of adverse events following immunization / Uso de registro informatizado de imunização na vigilância de eventos adversos pós-vacina

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.

RESUMO OBJETIVO Descrever os eventos adversos pós-vacina ocorridos em crianças com até dois anos de idade e analisar a tendência desses eventos, entre 2000 e 2013, em Araraquara, SP, Brasil. MÉTODOS Estudo descritivo com dados da vigilância passiva de eventos adversos pós-vacina, disponíveis no registro informatizado de imunização do prontuário eletrônico do serviço municipal de saúde (Sistema Juarez). As variáveis de estudo foram: idade, sexo, vacina, dose, manifestações clínicas e hospitalização. As taxas foram estimadas tomando-se os casos de eventos adversos pós-vacina como numerador e as doses aplicadas, como denominador. Estimou-se a sensibilidade da vigilância de eventos adversos pós-vacina aplicando-se o método proposto pelo Centers for Disease Control and Prevention. Para análise de tendência utilizou-se a regressão de Prais-Winsten, considerando o nível de significância de 5,0%. RESULTADOS A taxa anual média de eventos adversos pós-vacina foi de 11,3/10.000 doses aplicadas, porém, sem tendência no período estudado (p = 0,491). Houve predomínio de casos após a primeira dose (41,7%) e entre menores de um ano de idade (72,6%). As vacinas com componente pertussis, de febre amarela e de sarampo-caxumba-rubéola foram as mais reatogênicas. Destacou-se a frequência de episódio hipotônico hiporresponsivo e convulsão, com taxas de 4,1/10.000 e 1,5/10.000 doses de vacinas com componente pertussis, respectivamente, mais elevadas na primeira dose; 60,0% dos casos apresentaram sintomas nas primeiras 24 horas após a vacinação e 18,6% apresentaram-se após 96 horas. A sensibilidade da vigilância foi estimada em 71,9% e 78,9% para episódio hipotônico hiporresponsivo e convulsão, respectivamente. CONCLUSÕES O sistema de vigilância de eventos adversos pós-vacina com base no registro informatizado de imunização mostrou-se útil e dotado de elevada sensibilidade para descrever o perfil de segurança das vacinas em um município de médio porte. Adicionalmente, a expressiva ampliação, na última década, das vacinas incluídas no esquema básico de vacinação na infância não alterou o elevado padrão de segurança do Programa Nacional de Imunizações.

Meningococcal disease before and after the introduction of meningococcal serogroup C conjugate vaccine. Federal District, Brazil

OBJECTIVES: To analyze the behavior of meningococcal disease in the Federal District, Brazil, from 2005 to 2011, and to assess the direct impact of the meningococcal serogroup C conjugate vaccine. METHODS: A descriptive study of cases of meningococcal disease among residents of the Federal District. We included in the study confirmed cases of meningococcal disease reported to the local surveillance. To reduce underreporting we compared data to the Brazilian Mortality Database and the Public Health Laboratory Database. We studied sociodemographic, clinical, and pathogen-related variables. For the assessment of the impact of meningococcal serogroup C conjugate vaccine, which was introduced in 2010 for children under two years of age, we compared the incidence of meningococcal disease before and after vaccine introduction in the recommended age groups for vaccination. RESULTS: We identified 309 cases of meningococcal disease, of which 52.1% were males. The average case fatality rate was 20.7%, the median age was three years and there was a predominance of serogroup C (70.2%) and C:23:P1.14-6 phenotype throughout the study period. In 2005-2009, 2010 and 2011, the incidence rates of meningococcal disease were 2.0, 1.8 and 0.8/100,000 inhabitants/year, while mortality rates were 0.4, 0.4 and 0.2/100,000 inhabitants/year, respectively. In the first and last periods, the incidence in poorer and more affluent areas were, respectively, 2.0 and 0.8, and 0.9 and 0.0/100,000 inhabitants/year. Comparing 2009 (the year prior to the introduction of meningococcal serogroup C conjugate vaccine) and 2011, there was 85% reduction in the incidence of serogroup C meningococcal disease in children under four years of age, from 9.0 to 1.3/100,000 (p < 0.01). CONCLUSIONS: The meningococcal serogroup C conjugate vaccine strategy implemented in Brazil proved highly effective and had a strong direct impact on the target population. However, case ...

Prevalência de sintomáticos respiratórios em regiões do Distrito Federal, Brasil / Prevalence of respiratory symptoms in areas of the Federal District, Brazil

A captação de sintomáticos respiratórios (SR) é importante para a detecção precoce de tuberculose. O objetivo deste estudo foi estimar a prevalência de SR em três regiões administrativas (RA) do Distrito Federal, Brasil. Para tanto, foi utilizada a técnica de amostragem por conglomerados (30 por 7) proposta pela Organização Mundial da Saúde. Foram definidos como SR os indivíduos com 15 anos ou mais residentes nas RAs Estrutural, Itapoã ou Varjão e que apresentassem tosse há pelo menos 3 semanas na data da entrevista. A prevalência de SR em Estrutural e Varjão foi de 5,7 por cento (IC95 por cento: 2,4 a 9,0), e em Itapoã, de 4,8 por cento (IC95 por cento: 1,6 a 7,9), com efeito de desenho próximo de 1,0. Em Estrutural e Itapoã, menos anos de estudo, e em Itapoã e Varjão, menor renda, estiveram associados com ser SR. O tabagismo esteve associado com a presença de sintomas respiratórios em todas as RAs. A prevalência de SR está de acordo com aquela encontrada em outras áreas com perfil socioeconômico semelhante ao das áreas estudadas.

The identification of individuals with respiratory symptoms (RS) is important for the early detection of tuberculosis. The aim of this study was to estimate the prevalence of RS in three administrative regions of the Federal District, Brazil. For this, we used the 30 by 7 cluster sampling technique proposed by the World Health Organization. Individuals with RS were defined as those aged 15 years or older living in the administrative regions of Estrutural, Itapoã, or Varjão and reporting a cough lasting at least 3 weeks at the date of the interview. The prevalence of RS was 5.7 percent in Estrutural and Varjão (95 percent CI: 2.4-9.0) and 4.8 percent in Itapoã (95 percentCI: 1.6-7.9), with a design effect close to 1.0. In Estrutural and Itapoã, fewer years of schooling, and in Itapoã and Varjão, lower income, were associated with RS. Cigarette smoking was associated with the presence of RS in all regions. The prevalence of RS in the three administrative regions investigated is consistent with that of other areas with a similar socioeconomic profile.