[Analysis of the Vaccine Adverse Event Reporting System in Brazil, 2014 to 2016Análisis del Sistema de Información de Vigilancia de Eventos Adversos Posvacunación en Brasil, 2014 a 2016]. / Análise do Sistema de Informação da Vigilância de Eventos Adversos Pós-Vacinação no Brasil, 2014 a 2016.

OBJECTIVE: To describe the characteristics of vaccine adverse events (VAE) reports in the online VAE Reporting System (VAE-RS) after 2 years of operation. METHOD: A descriptive analysis of VAE reports entered into the VAE-RS between July 2014 and June 2016 was performed. RESULTS: During the study period, 24 732 VAE were reported. Of 5 570 Brazilian municipalities, 2 571 (46.2%) reported at least one VAE; however, only 1 622 (6.6%) reports had been completed/closed at the end of the study period. Of these, 89.9% referred to mild VAE. Among the completed reports, 19.7% did not provide information on "type of medical care provided," and 98.7% had no information regarding laboratory tests. Systemic neurological symptoms were the most frequent serious VAE among closed reports (59.5% of serious signs/symptoms). Concerning age, the highest VAE reporting coefficients were recorded for children aged ≤ 4 years. CONCLUSION: The VAE-RS is useful to monitor immunization safety. However, municipal services must increase adherence to the system and perform the required investigation and reporting of VAE, with timely and adequate completion of the VAE-RS form. Knowledge regarding VAE can be used in the daily routine of surveillance services, improving the safety of immunobiological agents.

OBJETIVO: Describir las características de las notificaciones de eventos adversos posvacunación (EAPV) en el Sistema de Información de Vigilancia de EAPV (SI-EAPV, un sistema en línea, durante los primeros 2 años de ejecución del sistema. MÉTODO: Se realizó un estudio descriptivo de los registros de EAPV notificados en el SI-EAPV entre julio de 2014 y junio de 2016. RESULTADOS: Durante el período del estudio, se registraron 24 732 notificaciones. De 5 570 municipios brasileños, 2 571 (46,2%) notificaron algún EAPV. Sin embargo, solamente 1 622 (6,6%) notificaciones estaban cerradas al momento del estudio; de ellas, el 89,9% no presentó gravedad. Respecto a las notificaciones cerradas, en el 19,7% no fue anotada la variable "atención médica" y el 98,7% no presentó registro de exámenes de laboratorio. Entre los eventos adversos graves cerrados, las manifestaciones clínicas sistémicas neurológicas fueron las más frecuentes, representado el 59,5% de los signos y síntomas. En cuanto a la edad, los mayores coeficientes de notificación se registraron entre los menores de 4 años. CONCLUSIÓN: El SI-EAPV es útil para el monitoreo de la seguridad de las vacunas. Sin embargo, los municipios necesitan ampliar la adhesión al sistema, así como realizar las investigaciones y notificaciones de los EAPV, llenando la ficha de notificación de forma adecuada y oportuna. El conocimiento sobre EAPV puede ser aplicado en la práctica de los servicios de vigilancia en salud, mejorando la seguridad en la utilización de los productos inmunobiológicos.

Human papillomavirus vaccination coverage in Northeast Brazil, 2013-2021: a descriptive study.

OBJECTIVE: to describe human papillomavirus (HPV) vaccination coverage in the Northeast region of Brazil, in the period from 2013 to 2021. METHODS: this was a descriptive study conducted with data obtained from the National Immunization Program, which sets a goal of 80% coverage of HPV vaccination in girls aged between 9 and 14 years and boys aged between 11 and 14 years. RESULTS: HPV vaccination coverage in girls was 73.9%, regarding the first dose, and 54.3% regarding the second dose, and for boys, the coverage of each dose was 49.7% and 32.6%, respectively; with the exception of the states of Ceará and Paraíba, which reached coverage above 80% regarding the first dose in girls, none of the states reached the goal for both doses. CONCLUSIONS: between 2013 and 2021, HPV vaccination coverage was below the target for both sexes, with the exception of the states of Ceará and Paraíba, which reached the goal for the first dose in the girls.

Prevalence of oral HPV infection in unvaccinated young adults in Brazil.

OBJECTIVES: This study aimed to report the national prevalence of oral HPV infection among unvaccinated women and men aged 16-25 years who utilized the public primary care services. METHODS: POP-Brazil is a cross-sectional, multicentric, nationwide survey conducted between September 2016 and November 2017. Recruitment was based in 119 public primary care practices in 26 state capitals and the Federal District of Brazil. Trained health professionals conducted face-to-face interviews. Oral samples were collected with mouthwash and gargle cycles. Genotyping was performed using the Roche PCR-based linear array genotyping test. Sampling weights by sex and age were applied. RESULTS: Valid oral HPV samples were collected from 5071 (96.88%) participants; 4005 women and 1066 men. Mean participant age was 21.63 years. Overall HPV prevalence was 1.69% (n = 73, 95% CI 1.05-2.32). Thirty individuals presented at least one high-risk HPV type [0.57% (95% CI, 0.29-0.85)]. There were no associations between age, sex, sociodemographic characteristics, drug use or sexual behavior and oral HPV prevalence. CONCLUSION: The prevalence of oral HPV infection in Brazilian teenagers and young adults is low, with no sociodemographic or behavioral correlates.

Effectiveness of a universal vaccination program with an HPV quadrivalent vaccine in young Brazilian women.

We examined human papillomavirus (HPV) vaccine effectiveness in a nationwide sample of women aged 16 to 25 years who utilized the public health system in Brazil. This was a cross-sectional, multicentric survey conducted between September 2016 and November 2017 (POP-Brazil Study). A total of 5,945 young adult women were recruited from 119 public primary care units from all 27 federative units of Brazil by trained health professionals. The participants participated in a face-to-face interview and provided biological samples for genital HPV analysis. HPV genotyping was performed using a Linear Array HPV genotyping test in a central laboratory. Sampling weights were applied to the data. Overall, 11.92% (95% CI 10.65, 13.20) of the participants reported having been vaccinated. The frequency of vaccination was highest in 16- to 17-year-old women, with a decreasing vaccination rate with increasing age, and vaccinated women were more likely to belong to the high socioeconomic status group. The use of a quadrivalent vaccine decreased the HPV types 6, 11, 16, and 18 by 56.78%, from 15.64% in unvaccinated women to 6.76% in vaccinated women (P < 0.01), even after adjustment for age. Those who received the vaccine had lower HPV 16 (2.34% in vaccinated vs 8.91% in unvaccinated, P < 0.01) and 6 rates (2.06% vs 5.77%, P < 0.01). Additionally, a higher rate of high-risk HPV types other than HPV 16 and 18 (40.47% in vaccinated vs 32.63% in unvaccinated, P < 0.01) was observed. In conclusion, the results of this study support the effectiveness of HPV vaccination in Brazil. Continuous surveillance must be assured to monitor the HPV infection rate in the vaccination era.

Immunization stress-related responses presenting as psychogenic non-epileptic seizures following HPV vaccination in Rio Branco, Brazil.

IMPORTANCE: The absence of a positive diagnosis of psychogenic non-epileptic seizures (PNES) in immunization stress-related response (ISRR) clusters may have not only a direct impact on affected patients' health but may also reduce compliance to national vaccination programs. It is therefore crucial to develop efficient diagnostic tools and a feasible proposal for proper communication and treatment of ISRR. PURPOSE: To explore the psychogenic nature of patients' convulsive seizures in a suspected outbreak of an ISRR cluster following human papillomavirus vaccination in Rio Branco, Brazil. METHODS: Twelve patients with convulsive seizures were submitted to prolonged intensive video-electroencephalography monitoring, brain magnetic resonance imaging, cerebrospinal fluid diagnostic testing, laboratory subsidiary examinations, and complete neurological and psychiatric evaluations. RESULTS: Ten patients received the positive diagnosis of PNES, and two patients received the diagnosis of idiopathic generalized epilepsy. No biological association was found between the HPV vaccine and the clinical problems presented by the patients. CONCLUSIONS: Prolonged VEEG monitoring can contribute significantly to the positive diagnosis of PNES in ISRR clusters and to avoid hesitancy to vaccinate.

Mortality on the first day of life: trends, causes of death and avoidability in eight Brazilian Federative Units, between 2010 and 2015. / Mortalidade no primeiro dia de vida: tendências, causas de óbito e evitabilidade em oito Unidades da Federação brasileira, entre 2010 e 2015.

OBJECTIVE: to calculate mortality rates on the first day of life from 2010 to 2015 in eight Brazilian Federative Units providing better quality information, to assess associated factors and to classify deaths by underlying causes and avoidability. METHODS: this was a descriptive study; mortality rates were compared according to maternal and child characteristics; avoidability analysis used the 'Brazilian list of avoidable causes of death'. RESULTS: 21.6% (n=20,791) of all infant deaths occurred on the first day of life; the mortality rate reduced from 2.7 to 2.3 deaths/1,000 live births; rates were higher in live births with low birthweight and preterm births, and among babies born to mothers with no schooling; main causes of death were respiratory distress syndrome (8.9%) and extreme immaturity (5.2%); 66.3% of causes of death were avoidable. CONCLUSION: 2/3 of deaths on the first day of life could have been avoided with adequate care for women during pregnancy and delivery and adequate care for live births.

Evaluating sexual health in sex workers and men who have sex with men: the SMESH cross-sectional protocol study.

INTRODUCTION: Human papillomavirus (HPV) infection is transmitted through skin-to-skin contact, and vaginal and anal sex are the most common transmission routes. Sex workers and men who have sex with men (MSM) are more exposed to the virus, and therefore, a higher frequency of this infection would be expected. The prevalence of HPV infection types and the forms and factors of transmission must be investigated to control infection-related outcomes. This protocol study will be the first nationwide study with a uniform methodology to evaluate HPV prevalence of and infection types among sex workers and MSM in Brazil. METHODS AND ANALYSIS: This multicentre cross-sectional study will be conducted with a respondent-driven sampling method to recruit 1174 sex workers and 1198 MSM from all regions of Brazil. The study will consist of preliminary interviews to verify the eligibility criteria and characterise the network size as well as a second questionnaire to obtain sociodemographic, behavioural and sexual information. Specimens from the oral cavity and anal and cervical or penile/scrotal sites will be collected. All HPV samples will be processed in a certified central laboratory. Other sexually transmitted infections will be evaluated by interview and by rapid testing for HIV and syphilis. Strict quality control will be conducted using different procedures, including the training and certification of the health professionals responsible for acquiring data and monitoring visits. ETHICS AND DISSEMINATION: The project was approved by the research ethics committee of the main institution and the corresponding ethics committees of the recruitment sites. Due to the literature gap on the sexual health of sex workers and MSM and the intense stigma surrounding these populations, a critical analysis of the study results will contribute to epidemiological knowledge and will be useful for the development of strategies against virus morbidities.

Factors associated with HPV and other self-reported STI coinfections among sexually active Brazilian young adults: cross-sectional nationwide study.

OBJECTIVES: To analyse factors associated with genital human papillomavirus (HPV) and other self-reported sexually transmitted infection (STI) coinfections among women and men aged 16-25 years from Brazil. DESIGN: A cross-sectional, nationwide, multicentre study. SETTING: 119 primary healthcare centres between September 2016 and November 2017. PARTICIPANTS: 6388 sexually active young adults were enrolled by trained health professionals. PRIMARY OUTCOME MEASURE: Genital HPV and other self-reported STI coinfections. RESULTS: Of 3512 participants with valid data for genital HPV and (STI)-positive status, 276 (9.60%, 95% CI 7.82% to 11.36%) had HPV/STI coinfection. Among men, HPV/STI coinfection was more prevalent than HPV infection alone. Among HPV-positive participants, the percentage of subjects who reported having another STI was highest for gonorrhoea at 4.24% (95% CI 2.67% to 5.81%), followed by syphilis, herpes and HIV. Smoking, drug use and ever having a same-sex sexual experience were risk factors that were uniquely associated with HPV/STI coinfection compared with HPV infection alone. CONCLUSIONS: The results identified a low prevalence of self-reported STIs, but in participants with at least one STI, the prevalence of HPV was high. These results reinforce the importance of implementing strategies to prevent risky behaviours among Brazilian young adults.

Cobertura da vacinação contra papilomavírus humano no Nordeste do Brasil, 2013-2021: estudo descritivo / Human papillomavirus vaccination coverage in Northeast Brazil, 2013-2021: a descriptive study / Cobertura de vacunación contra el virus del papiloma humano en el Nordeste de Brasil, 2013-2021: un estudio descriptivo

Objetivo: descrever a cobertura da vacina contra papilomavírus humano (HPV) na região Nordeste do Brasil, no período de 2013 a 2021. Métodos: estudo descritivo conduzido com dados obtidos do Programa Nacional de Imunizações, que estabelece a meta de 80% para a vacina contra o HPV para meninas entre 9 e 14 anos e meninos entre 11 e 14 anos. Resultados: as coberturas para as meninas foram de 73,9%, na primeira, e de 54,3% na segunda dose, e para meninos, as coberturas de cada dose foram de 49,7% e 32,6%, respectivamente; excetuando-se Ceará e Paraíba, que alcançaram coberturas acima de 80% na primeira dose para as meninas, nenhum estado alcançou a meta para as duas doses. Conclusões: entre 2013 e 2021, as coberturas da vacina contra HPV estiveram abaixo da meta para ambos os sexos, com exceção de Ceará e Paraíba, que atingiram a meta para a primeira dose no grupo de meninas.

Objective: to describe human papillomavirus (HPV) vaccination coverage in the Northeast region of Brazil, in the period from 2013 to 2021. Methods: this was a descriptive study conducted with data obtained from the National Immunization Program, which sets a goal of 80% coverage of HPV vaccination in girls aged between 9 and 14 years and boys aged between 11 and 14 years. Results: HPV vaccination coverage in girls was 73.9%, regarding the first dose, and 54.3% regarding the second dose, and for boys, the coverage of each dose was 49.7% and 32.6%, respectively; with the exception of the states of Ceará and Paraíba, which reached coverage above 80% regarding the first dose in girls, none of the states reached the goal for both doses. Conclusions: between 2013 and 2021, HPV vaccination coverage was below the target for both sexes, with the exception of the states of Ceará and Paraíba, which reached the goal for the first dose in the girls.

Objetivo: describir las coberturas de la vacuna contra el papilomavirus humano en la Región Nordeste de Brasil y sus estados, de 2013 a 2021. Métodos: se trata de un estudio descriptivo realizado con datos de cobertura vacunal obtenidos del Programa Nacional de Immunizaciones, que establece la meta del 80% para la vacuna. Los datos de población se obtuvieron del Departamento de Informática del Ministerio de Salud. Resultados: la cobertura de vacunación en niñas fue del 73,9% en la primera y del 54,3% en la segunda dosis; en niños la cobertura de cada dosis fue del 49,7% y 32,6%; Ceará y Paraíba alcanzaron una cobertura superior al 80% para la primera dosis en niñas, y ningún estado alcanzó la meta para las dos dosis. Conclusiones: la cobertura de la vacuna está por debajo de la meta para ambos sexos, con excepción de la primera dosis en niñas en Ceará y Paraíba.

Sexual behavior across the transition to adulthood and sexually transmitted infections: Findings from the national survey of human papillomavirus prevalence (POP-Brazil).

The sexual behaviors of 15- to 24-year-olds increase the risk of this population to acquire sexually transmitted infections (STIs). The present study aimed to describe the sexual behavior in the transition to adulthood Brazilian population and its association with STI history.We analyzed cross-sectional data collected from 8562 sexually active women and men who participated in the National Survey of Human Papillomavirus Prevalence (POP-Brazil). This large-scale survey enrolled participants from 26 Brazilian capitals and the Federal District. Professionals from primary care facilities were trained to collect data utilizing a standardized questionnaire with questions on sociodemographic, sexual behavior, and drug use. We constructed a Poisson model with robust variance for both crude and adjusted analysis to investigate the associations between the variables. To adjust the distribution of the sample to the study population, we weighted the measures by the population size in each city and by gender.There were differences in several aspects from sexual behavior between genders. The majority of men reported an early sexual initiation, more sexual partners, and a different practice in sexual positions when compared with women. Women reported use of contraception more frequently than men (P < .001). The use of alcohol and drugs and the use of drugs before sexual intercourse impact in STIs equally between the genders. Exclusive for women, the presence of any STI was associated with the practice of vaginal sex and other types of intercourse (adjusted prevalence ratio [APR] 1.43, 95% CI 1.08-1.88). For men, the number of sexual partners in the last year (APR 1.02, 95% CI 1.01-1.04), not having vaginal sex (APR 3.25, 95% CI 1.78-5.92) and sexual experience with someone of the same sex (APR 4.05, 95% CI, 2.88-5.70) were associated with a higher presence of STIs.This is the first report regarding sexual behavior in a nationally representative population sample in Brazil. This study provides more valid estimates of sexual behavior and associated STIs, identifying important differences in sexual behavior and identifying predictors for referred STIs among females and males.

POP-Brazil study protocol: a nationwide cross-sectional evaluation of the prevalence and genotype distribution of human papillomavirus (HPV) in Brazil.

INTRODUCTION: Human papillomavirus (HPV) is associated with the development of genital warts and different types of cancer, including virtually all cervical cancers and a considerable number of penile, anal and oropharyngeal cancers. Data regarding the prevalence of HPV infection in Brazil are limited and fragmented. We aim to determine HPV prevalence in sexually active women and men aged 16-25 years and to investigate regional differences in virus prevalence and types. METHODS AND ANALYSIS: This is a nationwide, multicentric, cross-sectional, prospective study that will include participants aged 16-25 years from all Brazilian capital cities. Recruitment will occur in primary health units by trained health professionals who will be responsible for collecting biological samples and interviewing the volunteers. After signing informed consent, all participants will answer a questionnaire that will collect sociodemographic and behavioural data. All samples will be processed in a certified central laboratory, and strict quality control will be performed by many different procedures, including double data entry, training and certification of primary care health professionals responsible for data collection, simulation of interviews, and auditing and monitoring of visits. The sample size will be standardised based on the population distribution of each capital using SAS and R statistical software. ETHICS AND DISSEMINATION: The project was approved by the research ethics committee of the main institution and the corresponding ethics committees of the recruitment sites. This will be the first Brazilian nationwide study to determine overall HPV prevalence and to examine regional differences and social, demographic and behavioural factors related to HPV infection. Critical analysis of the study results will contribute to epidemiological knowledge and will set a baseline for future evaluation of the impact of the National HPV Vaccination Program.

Prevalence of papillomavirus in Brazil: a systematic review protocol.

INTRODUCTION: Human papillomavirus (HPV) infection is a cause of premalignant and malignant cancer in the lower genital and digestive tracts. In Brazil, there have been no prevalence studies that included a nationwide sample, and the prevalence of HPV has not been determined in many regions. METHODS: We will search the EMBASE, LILACS, MEDLINE, Web of Science and SciELO databases and previously published review articles to identify original research articles assessing HPV prevalence of the perineal (cervical, penile and anal) and oral areas. No exclusion criteria related to language or publication date will apply. 2 reviewers will independently screen for eligibility and perform data extraction. Discrepancies will be resolved through consensus; the opinion of a third reviewer will be sought as necessary. Relevant measures and data about study and population characteristics will be extracted from the included studies. Where possible, study prevalence will be pooled using a random-effects meta-analysis. The methodological quality of the studies will be assessed using an adapted version of the NIH 'Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies'. The overall quality of evidence will be assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE). ETHICS AND DISSEMINATION: We expect to estimate the prevalence of perineal and oral HPV infection in the general population as well as the prevalence of HPV infection in individuals with premalignant and malignant lesions in Brazil and its 5 geographic regions. This systematic review does not require ethical approval. TRIAL REGISTRATION NUMBER: CRD42016032751.

Mortalidade no primeiro dia de vida: tendências, causas de óbito e evitabilidade em oito Unidades da Federação brasileira, entre 2010 e 2015 / Mortalidad en el primer día de vida: tendencias, causas de muerte y evitabilidad en ocho Unidades de la Federación brasileña, entre 2010 y 2015 / Mortality on the first day of life: trends, causes of death and avoidability in eight Brazilian Federative Units, between 2010 and 2015

Objetivo: calcular taxas de mortalidade no primeiro dia de vida entre 2010 e 2015 em oito Unidades da Federação brasileira com melhor qualidade de informação, avaliar fatores associados e classificar os óbitos segundo causa básica e evitabilidade. Métodos: estudo descritivo; as taxas foram comparadas conforme características maternas e da criança; a análise de evitabilidade usou a 'Lista brasileira de causas de mortes evitáveis'. Resultados: 21,6% (n=20.791) dos óbitos infantis ocorreram no primeiro dia de vida; a taxa de mortalidade reduziu-se de 2,7 para 2,3 óbitos/1.000 nascidos vivos; observaram-se maiores taxas em NV com baixo peso, nascidos pré-termo e filhos de mães sem escolaridade; as principais causas dos óbitos foram síndrome da angústia respiratória (8,9%) e imaturidade extrema (5,2%); 66,3% das causas de óbito foram consideradas evitáveis. Conclusão: dois terços dos óbitos no primeiro dia de vida poderiam ser evitados por atenção adequada à mulher na gestação e no parto, e ao NV.

Objetivo: calcular la mortalidad en el primer día de vida entre 2010 y 2015 en ocho Unidades de la Federación brasileña con mejor calidad de información, analizar factores asociados y clasificar las causas básicas y la evitabilidad de los óbitos. Métodos: estudio descriptivo; las tasas de mortalidad fueron comparadas según las características maternas y del recién nacido (RN); el análisis de evitabilidad utilizó la 'Lista brasileña de causas de muertes evitables'. Resultados: un 21,6% (n=20.791) de los óbitos infantiles ocurrió en el primer día de vida; la tasa de mortalidad se redujo de 2,7 a 2,3 óbitos/1.000 nacidos vivos (NV); las tasas fueron mayores en NV de bajo peso, prematuros e hijos de madres sin escolaridad; las principales causas de óbito fueron síndrome de angustia respiratoria (8,9%) e inmadurez extrema (5,2%); un 66,3% de las causas de óbito fueron consideradas evitables. Conclusión: 2/3 de los óbitos en el primer día de vida podrían haber sido evitados con una atención adecuada a la mujer embarazada, al parto y al NV.

Objective: to calculate mortality rates on the first day of life from 2010 to 2015 in eight Brazilian Federative Units providing better quality information, to assess associated factors and to classify deaths by underlying causes and avoidability. Methods: this was a descriptive study; mortality rates were compared according to maternal and child characteristics; avoidability analysis used the 'Brazilian list of avoidable causes of death'. Results: 21.6% (n=20,791) of all infant deaths occurred on the first day of life; the mortality rate reduced from 2.7 to 2.3 deaths/1,000 live births; rates were higher in live births with low birthweight and preterm births, and among babies born to mothers with no schooling; main causes of death were respiratory distress syndrome (8.9%) and extreme immaturity (5.2%); 66.3% of causes of death were avoidable. Conclusion: 2/3 of deaths on the first day of life could have been avoided with adequate care for women during pregnancy and delivery and adequate care for live births.

Análise do Sistema de Informação da Vigilância de Eventos Adversos Pós-Vacinação no Brasil, 2014 a 2016

[RESUMO]. Objetivo. Descrever as características das notificações de eventos adversos pós-vacinação (EAPV) no Sistema de Informação da Vigilância de EAPV (SI-EAPV) on-line nos primeiros 2 anos de operação do sistema. Método. Foi realizado um estudo descritivo dos registros de EAPV notificados no SI-EAPV entre julho de 2014 e junho de 2016. Resultados. Durante o período do estudo, foram registradas 24 732 notificações. De 5 570 municípios brasileiros, 2 571 (46,2%) realizaram notificação de algum EAPV. Entretanto, somente 1 622 (6,6%) notificações estavam encerradas no momento do estudo; dessas, 89,9% não apresentaram gravidade. Entre as notificações encerradas, 19,7% não tiveram o preenchimento da variável “atendimento médico” e 98,7% não apresentaram registro de exames laboratoriais. As manifestações clínicas sistêmicas neurológicas foram as mais frequentes entre os eventos adversos graves encerrados, correspondendo a 59,5% dos sinais e sintomas. Em relação à idade, os maiores coeficientes de notificação foram registrados entre os menores de 4 anos. Conclusão. O SI-EAPV mostra-se útil no monitoramento da segurança das vacinas. Contudo, os municípios precisam ampliar a adesão ao sistema, bem como realizar as investigações e notificações dos EAPV, preenchendo a ficha de notificação de forma adequada e oportuna. O conhecimento sobre EAPV pode ser aplicado na prática dos serviços de vigilância em saúde, melhorando a segurança de utilização dos imunobiológicos.

[ABSTRACT]. Objective. To describe the characteristics of vaccine adverse events (VAE) reports in the online VAE Reporting System (VAE-RS) after 2 years of operation. Method. A descriptive analysis of VAE reports entered into the VAE-RS between July 2014 and June 2016 was performed. Results. During the study period, 24 732 VAE were reported. Of 5 570 Brazilian municipalities, 2 571 (46.2%) reported at least one VAE; however, only 1 622 (6.6%) reports had been completed/closed at the end of the study period. Of these, 89.9% referred to mild VAE. Among the completed reports, 19.7% did not provide information on “type of medical care provided,” and 98.7% had no information regarding laboratory tests. Systemic neurological symptoms were the most frequent serious VAE among closed reports (59.5% of serious signs/symptoms). Concerning age, the highest VAE reporting coefficients were recorded for children aged ≤ 4 years. Conclusion. The VAE-RS is useful to monitor immunization safety. However, municipal services must increase adherence to the system and perform the required investigation and reporting of VAE, with timely and adequate completion of the VAE-RS form. Knowledge regarding VAE can be used in the daily routine of surveillance services, improving the safety of immunobiological agents.

[RESUMEN]. Objetivo. Describir las características de las notificaciones de eventos adversos posvacunación (EAPV) en el Sistema de Información de Vigilancia de EAPV (SI-EAPV, un sistema en línea, durante los primeros 2 años de ejecución del sistema. Método. Se realizó un estudio descriptivo de los registros de EAPV notificados en el SI-EAPV entre julio de 2014 y junio de 2016. Resultados. Durante el período del estudio, se registraron 24 732 notificaciones. De 5 570 municipios brasileños, 2 571 (46,2%) notificaron algún EAPV. Sin embargo, solamente 1 622 (6,6%) notificaciones estaban cerradas al momento del estudio; de ellas, el 89,9% no presentó gravedad. Respecto a las notificaciones cerradas, en el 19,7% no fue anotada la variable “atención médica” y el 98,7% no presentó registro de exámenes de laboratorio. Entre los eventos adversos graves cerrados, las manifestaciones clínicas sistémicas neurológicas fueron las más frecuentes, representado el 59,5% de los signos y síntomas. En cuanto a la edad, los mayores coeficientes de notificación se registraron entre los menores de 4 años. Conclusión. El SI-EAPV es útil para el monitoreo de la seguridad de las vacunas. Sin embargo, los municipios necesitan ampliar la adhesión al sistema, así como realizar las investigaciones y notificaciones de los EAPV, llenando la ficha de notificación de forma adecuada y oportuna. El conocimiento sobre EAPV puede ser aplicado en la práctica de los servicios de vigilancia en salud, mejorando la seguridad en la utilización de los productos inmunobiológicos.

Análise do Sistema de Informação da Vigilância de Eventos Adversos Pós-Vacinação no Brasil, 2014 a 2016 / Analysis of the Vaccine Adverse Event Reporting System in Brazil, 2014 to 2016 / Análisis del Sistema de Información de Vigilancia de Eventos Adversos Posvacunación en Brasil, 2014 a 2016

RESUMO Objetivo Descrever as características das notificações de eventos adversos pós-vacinação (EAPV) no Sistema de Informação da Vigilância de EAPV (SI-EAPV) on-line nos primeiros 2 anos de operação do sistema. Método Foi realizado um estudo descritivo dos registros de EAPV notificados no SI-EAPV entre julho de 2014 e junho de 2016. Resultados Durante o período do estudo, foram registradas 24 732 notificações. De 5 570 municípios brasileiros, 2 571 (46,2%) realizaram notificação de algum EAPV. Entretanto, somente 1 622 (6,6%) notificações estavam encerradas no momento do estudo; dessas, 89,9% não apresentaram gravidade. Entre as notificações encerradas, 19,7% não tiveram o preenchimento da variável "atendimento médico" e 98,7% não apresentaram registro de exames laboratoriais. As manifestações clínicas sistêmicas neurológicas foram as mais frequentes entre os eventos adversos graves encerrados, correspondendo a 59,5% dos sinais e sintomas. Em relação à idade, os maiores coeficientes de notificação foram registrados entre os menores de 4 anos. Conclusão O SI-EAPV mostra-se útil no monitoramento da segurança das vacinas. Contudo, os municípios precisam ampliar a adesão ao sistema, bem como realizar as investigações e notificações dos EAPV, preenchendo a ficha de notificação de forma adequada e oportuna. O conhecimento sobre EAPV pode ser aplicado na prática dos serviços de vigilância em saúde, melhorando a segurança de utilização dos imunobiológicos.

ABSTRACT Objective To describe the characteristics of vaccine adverse events (VAE) reports in the online VAE Reporting System (VAE-RS) after 2 years of operation. Method A descriptive analysis of VAE reports entered into the VAE-RS between July 2014 and June 2016 was performed. Results During the study period, 24 732 VAE were reported. Of 5 570 Brazilian municipalities, 2 571 (46.2%) reported at least one VAE; however, only 1 622 (6.6%) reports had been completed/closed at the end of the study period. Of these, 89.9% referred to mild VAE. Among the completed reports, 19.7% did not provide information on "type of medical care provided," and 98.7% had no information regarding laboratory tests. Systemic neurological symptoms were the most frequent serious VAE among closed reports (59.5% of serious signs/symptoms). Concerning age, the highest VAE reporting coefficients were recorded for children aged ≤ 4 years. Conclusion The VAE-RS is useful to monitor immunization safety. However, municipal services must increase adherence to the system and perform the required investigation and reporting of VAE, with timely and adequate completion of the VAE-RS form. Knowledge regarding VAE can be used in the daily routine of surveillance services, improving the safety of immunobiological agents.

RESUMEN Objetivo Describir las características de las notificaciones de eventos adversos posvacunación (EAPV) en el Sistema de Información de Vigilancia de EAPV (SI-EAPV, un sistema en línea, durante los primeros 2 años de ejecución del sistema. Método Se realizó un estudio descriptivo de los registros de EAPV notificados en el SI-EAPV entre julio de 2014 y junio de 2016. Resultados Durante el período del estudio, se registraron 24 732 notificaciones. De 5 570 municipios brasileños, 2 571 (46,2%) notificaron algún EAPV. Sin embargo, solamente 1 622 (6,6%) notificaciones estaban cerradas al momento del estudio; de ellas, el 89,9% no presentó gravedad. Respecto a las notificaciones cerradas, en el 19,7% no fue anotada la variable "atención médica" y el 98,7% no presentó registro de exámenes de laboratorio. Entre los eventos adversos graves cerrados, las manifestaciones clínicas sistémicas neurológicas fueron las más frecuentes, representado el 59,5% de los signos y síntomas. En cuanto a la edad, los mayores coeficientes de notificación se registraron entre los menores de 4 años. Conclusión El SI-EAPV es útil para el monitoreo de la seguridad de las vacunas. Sin embargo, los municipios necesitan ampliar la adhesión al sistema, así como realizar las investigaciones y notificaciones de los EAPV, llenando la ficha de notificación de forma adecuada y oportuna. El conocimiento sobre EAPV puede ser aplicado en la práctica de los servicios de vigilancia en salud, mejorando la seguridad en la utilización de los productos inmunobiológicos.