Progress in research of safety, efficiency and vaccination status of influenza vaccine in populations at high risk / 中华流行病学杂志

This paper reviews the domestic and foreign studies published in 2020 on the application of influenza vaccine in populations at high risk. The importance of influenza vaccination in population at high risk has been proved by larger sample, multicentre, high-quality evidence-based studies. Influenza vaccination is the most cost-effective measure to prevent influenza. However, the coverage rate of influenza vaccine is very low in China, it is necessary to strengthen the health education to promote influenza vaccination in different populations. It is recommended to give influenza vaccination to the population in whom influenza vaccination has been proven safe and effective before influenza season. Research of the safety, efficiency and cost-effectiveness of influenza vaccine should be accelerated for the populations in whom such data are lacking or insufficient.

Eventos adversos pós-vacinação em idosos no Estado de São Paulo, Brasil, de 2015 a 2017 / Post-vaccination adverse events in the elderly in the State of São Paulo, Brazil, 2015 to 2017 / Eventos adversos posvacunación en ancianos del Estado de São Paulo, Brasil, de 2015 a 2017

A vacinação é uma das ações de saúde pública que tem colaborado com a diminuição da incidência das doenças imunopreveníveis. No entanto, as vacinas podem acarretar eventos adversos pós-vacinação. Assim, este estudo teve como objetivos: analisar a prevalência dos eventos adversos pós-vacinação em pessoas idosas; levantar os eventos notificados; identificar as vacinas que causaram eventos e verificar os eventos adversos pós-vacinação e as vacinas administradas que acarretaram internações no Estado de São Paulo, Brasil, nos anos de 2015 a 2017. Estudo descritivo, transversal, de abordagem quantitativa com base nas notificações de eventos adversos pós-vacinação registradas no Sistema de Informações do Programa Nacional de Imunizações. Os resultados mostraram que dentre as 15.196.080 pessoas idosas imunizadas, ocorreram 207 notificações de eventos adversos pós-vacinação, sendo 187 (89%) devido a evento adverso não grave e 15 (8%) por erro de imunização. A maioria dos acometidos era: do sexo feminino (86%); raça branca (49%); com idades de 60 a 69 anos (70%). Dentre as manifestações clínicas destacamos as reações nos locais das aplicações (84%). Constatou-se que 131 casos (64%) evoluíram para cura sem sequelas. Em relação às internações, verificou-se que duas pessoas (2%) foram hospitalizadas devido a efeito adverso grave, a primeira recebeu as vacinas: difteria/tétano adulto (dT), pneumocócica (Pn23) e influenza, e a segunda recebeu Pn23. Observaram-se informações incompletas nas notificações de eventos adversos pós-vacinação. Conclui-se que a notificação do eventos adversos pós-vacinação é essencial. Faz-se necessário o comprometimento dos profissionais no preenchimento adequado da notificação, e ainda, a supervisão da vigilância sanitária visando à qualidade da assistência prestada à pessoa idosa acometida por eventos adversos pós-vacinação.

Vaccination is one of the public health measures that has most contributed to decreasing the incidence of vaccine-preventable diseases. However, vaccines can lead to post-vaccination adverse events. This study thus aimed to analyze the prevalence of post-vaccination adverse events in elderly persons, determine the reported post-vaccination adverse events, identify the vaccines that cause post-vaccination adverse events, and verify the post-vaccination adverse events and vaccines that lead to hospitalizations in the State of São Paulo, Brazil, from 2015 to 2017. This was a descriptive cross-sectional study with a quantitative approach based on notifications of post-vaccination adverse events recorded in the Information System of the National Immunization Program. The results showed that of the 15,196,080 elderly persons that were immunized, there were 207 reports of post-vaccination adverse events, of which 187 (89%) were non-serious adverse events and 15 (8%) due to immunization errors (IE). The majority of the patients were female (86%), white (49%), and from 60 to 69 years of age (70%). Clinical manifestations featured local reactions at the injection site (84%). There were 131 cases (64%) that evolved to cure without sequelae. Two individuals (2%) were hospitalized due to serious adverse events. The first had received adult diphtheria/tetanus (dT), pneumococcal (Pn23), and influenza vaccines, and the second had received Pn23. The post-vaccination adverse events notifications showed incomplete information. In conclusion, notification of post-vaccination adverse events is essential. Health professionals need to be committed to adequate completion of the notification forms, with health surveillance supervision aimed at quality of care for elderly persons with post-vaccination adverse events.

La vacunación es una de las acciones de salud pública que ha colaborado a la disminución de la incidencia de enfermedades inmunoprevenibles. No obstante, las vacunas pueden acarrear eventos adversos de posvacunación. Por ello, este estudio tuvo como objetivos: analizar la prevalencia de los eventos adversos de posvacunación en personas ancianas; recoger los eventos adversos de posvacunación notificados; identificar las vacunas que causaron eventos eventos adversos de posvacunación y verificar los eventos eventos adversos de posvacunación y las vacunas administradas que provocaron internamientos en el Estado de São Paulo, Brasil, durante los años de 2015 a 2017. Estudio descriptivo, transversal, de abordaje cuantitativo basado en las notificaciones de eventos adversos de posvacunación, registradas en el Sistema de Información del Programa Nacional de Inmunizaciones. Los resultados mostraron que, entre las 15.196.080 personas ancianas inmunizadas, ocurrieron 207 notificaciones de eventos adversos de posvacunación, siendo 187 (89%) debidas a un evento adverso no grave y 15 (8%) por error de inmunización. La mayoría de los afectados era del sexo femenino (86%); raza blanca (49%); con edad de 60 a 69 años (70%). Entre las manifestaciones clínicas se destacaron las reacciones en los lugares de la aplicación de la vacuna (84%). Se constató que 131 casos (64%) evolucionaron a una cura sin secuelas. En relación con los internamientos se verificó que dos personas (2%) fueron hospitalizadas, debido a un efecto adverso grave, la primera recibió las vacunas: difteria/tétano adulto (dT), neumocócica (Pn23) y gripe y la segunda recibió Pn23. Se observó información incompleta en las notificaciones de eventos adversos de posvacunación. Se concluye que la notificación del eventos adversos de posvacunación es esencial. Es necesario el compromiso de los profesionales en la cumplimentación adecuada de la notificación e incluso, la supervisión de la vigilancia sanitaria, con el fin de analizar la calidad de la asistencia prestada a la persona anciana afectada por eventos adversos pós- vacinação.

Análisis de las Campañas de Vacunación Antigripal destinadas al personal de salud del HIBA: período 2016-2018 / Analysis of Influenza Vaccination Campaigns for HIBA health personnel: 2016-2018 period

Introducción: la vacunación antigripal es la forma más eficaz para prevenir la enfermedad por virus Influenza y sus complicaciones. La cobertura en los profesionales sanitarios es un indicador de calidad hospitalaria. Material y métodos: estudio descriptivo de corte transversal. A partir de registros vacunales, se calculó la cobertura para las campañas 2013 a 2018. Se compararon las coberturas por trienios. Se describieron características generales de las campañas de 2016 a 2018. Resultados: en 2016 se alcanzó la mayor tasa del período (59,79%, IC 95%:58,75-60,81); en 2017, la menor (34,46%, IC 95%:33,48-35,46). La campaña 2018 obtuvo una cobertura de 54,90% (IC 95%: 53,88-55,92) y se inició más tempranamente que otras. Al comparar las tasas trienales del período se observó una diferencia de proporción de -1,3% (IC 95%: -2.84-0.24). Durante los tres últimos años, el personal vacunado correspondió mayormente al sexo femenino, a la Sede Central y tenía relación contractual directa. Las mayores coberturas específicas correspondieron a la sede de San Justo y a los profesionales de enfermería. El puesto ambulante fue el que aplicó más vacunas. Conclusión: si bien hubo variaciones en las coberturas alcanzadas a lo largo de los años, siendo la del año 2016 la más elevada y la del año 2017 la más baja, no se observaron diferencias estadísticamente significativas en las coberturas alcanzadas al comparar trienios. Resulta necesario continuar realizando intervenciones adaptadas al contexto local que permitan alcanzar los objetivos de cobertura esperados. Discusión: se reconocieron varios obstáculos para alcanzar las coberturas esperadas. La educación al personal de salud, la evaluación sistematizada de los ESAVI (Eventos supuestamente atribuibles a vacunación e inmunización) y la descripción de los elementos que facilitaron las coberturas específicas elevadas de algunas subpoblaciones podrían contribuir para mejorar los resultados. (AU)

Introduction: influenza vaccination is the most effective way to prevent influenza virus disease and its complications. Coverage in health professionals measurement is an indicator of hospital quality. Material and methods: descriptive cross-sectional study. From vaccination records, the coverage was calculated for the 2013 to 2018 campaigns. The coverage for three years was compared. General characteristics of the campaigns from 2016 to 2018 were described. Results: in 2016, the highest was achieved during the period (59.79%, IC 95%: 58.75 -60.81). In 2017, the lowest (34.46%, IC 95%: 33.48-35,46). The 2018 campaign achieved a coverage of 54.90% (IC 95%: 53.88-55.92) and started earlier than others. When comparing the triennial rates of the period, a difference of proportion of -1.3% was observed (IC 95%: -2.84-0.24). During the last three years, the vaccinated staff corresponded mostly to the female sex, to the headquarters and had a direct contractual relationship. The largest specific coverage corresponded to the San Justo headquarters and to nursing professionals. The ambulatory position was the post that applied the most vaccines. Conclusion: although there were variations in the coverage achieved over the years, with 2016 being the highest and 2017 being the lowest, there were no statistically significant differences in the coverage achieved when comparing trienniums. It is necessary to continue carrying out interventions adapted to the local context to achieve the expected coverage objectives. Discussion: several obstacles were recognized to reach the expected coverage. The education of health personnel, the systematic evaluation of the ESAVIs and the description of the elements that facilitated the high specific coverage of some subpopulations could contribute to improve the results. (AU)

Eventos adversos pós-vacinação contra influenza em idosos no Brasil / Adverse events following immunization against influenza the in elderly in Brazil / Eventos adversos post-vacunación contra la influenza en ancianos en Brasil

RESUMO Objetivo Identificar e analisar a ocorrência de eventos adversos pós vacinação contra Influenza em idosos brasileiros. Método Pesquisa descritiva, analítica, retrospectiva e quantitativa. Participaram desta pesquisa 98 idosos identificados por meio das fichas de notificação de eventos adversos pós vacinação disponibilizados pelo Sistema de Informação de Eventos Adversos Pós Vacinação de Minas Gerias - BR, entre 2014 e 2016. Os dados foram duplamente digitados e transportados para os programas Ri386 versão 3.4.3 3 IBM SPSS Statics versão 25. Realizou-se estatísticas descritivas, frequência e percentual para as variáveis qualitativas e medidas de tendência central (média e mediana) e dispersão (desvio padrão) para as variáveis numéricas. Para verificar a associação entre os tipos de eventos (não grave, grave e erro de imunização) e as manifestações sistêmicas com as variáveis de caracterização dos idosos e das vacinas, utilizou-se o teste Exato de Fisher e Qui-quadrado; o nível de significância utilizado foi p<=0,05. Resultados Dos idosos estudados, 75,5% eram do sexo feminino com predominância da raça branca (55,1%) cuja idade variou entre 60 e 97 anos; 84,7% dos eventos adversos foram descritos como Evento Adverso Não Grave, com 64,3% de manifestações locais e 27,6% de manifestações sistêmicas. Conclusão Proporcionar informações específicas aos enfermeiros no que tange os cuidados pré e pós vacinação contra Influenza é de fundamental importância para o estabelecimento de atendimento adequado livre de danos aos idosos e que não incorra em eventos adversos evitáveis.(AU)

ABSTRACT Objective To identify and analyze the occurrence of adverse events after vaccination against influenza in Brazilian elderly. Materials and Methods Descriptive, analytical, retrospective and quantitative research on 98 elderly people identified through post-vaccination adverse event reporting forms provided by the Post-Vaccination Adverse Events Information System of Minas Gerias, Brazil, between 2014 and 2016. Data were double-entered and transferred to the software Ri386 version 3.4.3 3 IBM SPSS Statics version 25. Descriptive statistics, frequency and percentages were used for qualitative variables, and measures of central tendency (mean and median) and dispersion (standard deviation) were used for numerical variables. In order to verify the association between the types of events (non-severe, severe and immunization error) and systemic manifestations with elderly and vaccine characterization variables, Fisher's exact and Chi-square tests were used; the significance level was p <0.05. Results Of the elderly studied, 75.5% were female, predominantly Caucasian (55.1%), whose age ranged from 60 to 97 years; 84.7% of adverse events were described as non-adverse events, with local manifestations in 64.3% and systemic manifestations in 27.6%. Conclusion Providing specific information to nurses regarding pre- and post-vaccination care against influenza is highly relevant for establishing adequate care that is harmless to the elderly and that lead to avoidable adverse events.(AU)

RESUMEN Objetivo identificar y analizar la ocurrencia de eventos adversos después de la vacunación contra la influenza en adultos mayores de Brasil. Método Investigación descriptiva, analítica, retrospectiva y cuantitativa. Un total de 98 personas mayores identificadas a través de los formularios de notificación de eventos adversos posteriores a la vacunación proporcionados por el Sistema de información de eventos adversos posteriores a la vacunación de Minas Gerias - BR entre 2014 y 2016. Los datos fueron de doble digestión y se transportaron a los programas Ri386 3.4.3 3 IBM SPSS Statics versión 25. Estadística descriptiva, frecuencia y porcentaje para variables cualitativas y medidas de tendencia central (media y mediana) y dispersión (desviación estándar) se usaron para las variables numéricas. Para verificar la asociación entre los tipos de eventos (no grave, grave y error de inmunización) y las manifestaciones sistémicas con las variables de caracterización de ancianos y vacunas, se utilizaron la prueba de Fisher Exact y Chi cuadrado; El nivel de significancia fue p <=0.05. Resultados De los ancianos estudiados, el 75,5% eran mujeres, predominantemente caucásicas (55,1%), cuya edad oscilaba entre los 60 y los 97 años; El 84,7% de los eventos adversos se describieron como eventos no adversos, con un 64,3% de las manifestaciones locales y el 27,6% de las manifestaciones sistémicas. Conclusión Proporcionar información específica a las enfermeras sobre la atención antes y después de la vacunación contra la influenza es De importancia fundamental para el establecimiento de una atención adecuada sin daños para los ancianos y que no incurra en eventos adversos evitables.(AU)

Efectos adversos de la vacuna antigripal en el personal de enfermería del Instituto de Cardiología "Juana Francisca Cabral" de la Ciudad de Co / Adverse effects of the influenza vaccine on the nursing staff of the "Juana Francisca Cabral" Cardiology Institute of the City of Corrientes Capital in the period August-September 2018

La vacunación antigripal está recomendada en el personal sanitario de forma anual, constituye un elemento esencial en los programas de prevención de infecciones asociadas a los cuidados de salud, las mismas no están exentas a efectos adversos. Objetivo: El objetivo de este trabajo fue describir la frecuencia de los efectos adversos de la vacuna antigripal en el personal de enfermería del Instituto de Cardiología "Juana Francisca Cabral" de la Ciudad de Corrientes Capital en el periodo 2018. Material y Método: Se realizó un estudio cuantitativo, descriptivo, transversal y observacional, con una muestra probabilística aleatoria simple de 122 unidades de análisis perteneciente a una población de 210 enfermeros. Para la recolección de datos se utilizó un cuestionario de elaboración propia, la tabulación se llevó acabo en una matriz de datos y para sus análisis se utilizaron los programas Excel y SPSS. Resultados: Se analizaron 122 enfermeros en los cuales, los efectos adversos locales se presentaron con una mayor frecuencia (34%) en el sexo masculino, de estos, el dolor es el más frecuente con un 26%. Así, los efectos adversos sistémicos se presentaron en un 12%, donde la cefalea fue el más frecuente con un 11%. Conclusión: Los efectos adversos de la vacuna antigripal que se presentaron con más frecuencia fueron los efectos locales. Por otra parte el tiempo de aparición de los efectos adversos se presentó entre las 16-24 hs.

Summary: Influenza vaccination is recommended in the workforce on a yearly basis, it constitutes an essential element in the programmes of prevention of infections associated with health care, they are not exempt to adverse effects. The objective of this study was to describe the frequency of the adverse effects of the flu vaccine in nurses of the Institute of Cardiology "Juana Francisca Cabral" in the city of Capital flows in the period 2018. Material and method: a prospective and observational, quantitative, descriptive study with a sample simple random probability of 122 units belonging to a population of 210 registered. A homemade questionnaire was used for data collection, tabulation was conducted in an array of data and Excel and SPSS programs were used for their analysis. Results: Analyzed 122 nurses in which local adverse effects occurred most frequently (34%) in males, of these, pain is the most frequent with 26%. Thus, systemic adverse effects were presented in 12%, where the headache was the most common with 11%. Conclusion: The adverse effects of the flu vaccine which arose more frequently were the local effects. On the other hand the time of occurrence of the adverse effects arose between 16-24 hours.

Resumo: Gripe, a vacinação é recomendada na força de trabalho em uma base anual, é um elemento essencial nos programas de prevenção de infecções associadas a cuidados de saúde, eles não são isentos de efeitos adversos. Objetivo: O objetivo deste estudo foi descrever a frequência dos efeitos adversos da vacina contra a gripe em enfermeiras do Instituto de Cardiologia "Juana Francisca Cabral" na cidade de fluxos de Capital no período de 2018. Material e método: um prospectivo e observacional, estudo quantitativo, descritivo, com uma probabilidade aleatória simples de amostra de 122 unidades pertencentes a uma população de 210 registrado. Utilizou-se um questionário caseiro para coleta de dados, tabulação foi conduzida em uma matriz de dados e programas Excel e SPSS foram usados para sua análise. Resultados: 122 enfermeiros que foram analisados, os efeitos adversos locais ocorreram mais frequentemente (34%) nos machos, destes, a dor é o mais frequente com 26%. Assim, os efeitos adversos sistêmicos foram apresentados em 12%, onde a dor de cabeça foi o mais comum com 11%. Conclusão: Os efeitos adversos da vacina contra a gripe que surgiu com mais frequência foram os efeitos locais. Por outro lado, o tempo de ocorrência dos efeitos adversos surgiu entre 16 a 24 horas.

Eventos adversos pós- vacinação contra Influenza em idosos de Minas Gerais / Adverse events after vaccination against Influenza in the elderly in Minas Gerais

É de grande relevância o conhecimento dos eventos adversos ocorridos após aplicação da vacina contra Influenza em idosos, visando sua identificação e possíveis intervenções preventivas. Considera-se que os idosos são assistidos por equipe de enfermagem que atua em hospitais, Unidades Básicas de Saúde, em domicílios ou em Instituições de Longa Permanência. Eventos adversos ocorridos após aplicação da vacina contra Influenza em idosos institucionalizados foram os motivadores para o desenvolvimento do presente estudo. Objetivos: Identificar e analisar a ocorrência de eventos adversos após vacinação contra Influenza em idosos de Minas Gerais, caracterizar os dados sócio demográficos e suas associações; confeccionar material educativo direcionado aos enfermeiros que atuam no cuidado aos idosos. Método: Pesquisa descritiva-analítica, retrospectiva e quantitativa; a amostra foi composta por 98 idosos de ambos os sexos, que corresponderam a 12,9% da população inicial, identificados por meio das Fichas de Notificação de Eventos Adversos Pós Vacinação, disponibilizados pelo Sistema de Informação de Eventos Adversos Pós Vacinação de Minas Gerias - BR, entre 2014 e 2016. Os dados foram duplamente digitados e transportados para o programa Ri386 versão 3.4.3 3 IBM SPSS Statics versão 25. Realizou-se estatísticas descritivas, frequência e percentual para as variáveis qualitativas e medidas de tendência central (média e mediana) e dispersão (desvio padrão) para as variáveis numéricas. Para verificar a associação entre os tipos de eventos (não grave, grave e erro de imunização) e as manifestações sistêmicas com as variáveis de caracterização dos idosos e das vacinas, utilizou-se o teste Exato de Fisher e Qui-quadrado; o nível de significância utilizado foi p < 0,05. Após a análise e discussão dos dados procedeu-se a confecção do material educativo. Resultados: Os eventos adversos não graves representaram 84,7% das notificações obtidas, eventos adversos graves, 5,1% e erros de imunização, 10,2%. Os testes revelaram significância estatística para eventos adversos não graves e a variável sexo (p=0,042) mais entre as mulheres que apresentaram manifestações locais, ou seja, 70,3% e entre os homens que apresentaram manifestações clínicas sistêmicas (p=0,021) - 45,8%, as quais foram caracterizadas por sintomas neurológicos. Erro de imunização se caracterizou por aplicações duplas do mesmo imunobiológico por falta de informação ou esquecimento do cartão de vacinas. Conclusão: O conhecimento do enfermeiro sobre a temática em estudo é de fundamental importância para um atendimento adequado livre de danos ao idoso para que não incorra em eventos adversos evitáveis. O material educativo se apresenta como ferramenta para orientar o enfermeiro que assiste o idoso seja em uma Instituição de Longa Permanência, seja numa Unidade de Saúde da Família, Unidades Básicas de Saúde, hospitais ou em domicílio. Espera-se que este estudo desperte interesse para futuras pesquisas relacionadas à compreensão do surgimento dos eventos adversos pós vacinação contra Influenza em idosos, visando a prevenção de tais eventos e suas consequências, assim como estimule a adesão às campanhas vacinais

It is highly important to be aware of the adverse events that occur after the elderly are vaccinated against influenza in order to identify them, therefore making preventive measures possible. It is considerable that the elderly are cared for by nursing teams who work in hospitals, Basic Healthcare Units, residences or in Long Stay Institutions. The adverse events in elderly after they were vaccinated against influenza were the motivators so this study could be developed. Objectives: Identify and analyze the occurrence of the adverse events after the elderly from Minas Gerais are vaccinated against influenza, characterize the socio demographic data and their associations, prepare socio educative material addressed to nurses who work in caring for the elderly. Method: Quantitative, retrospective and descriptiveanalytical study. The sample was composed for 98 seniors both sexes, men and women, covering a rate of 12,9% of the initial population, identified from Notification Sheets of Post-Vaccination Adverse Events, available in the Information of Post-Vaccination Adverse Events System from Minas Gerais - Br, between 2016 and 2016. The data were doubleentered and carried foward for the Program Ri386 version 3.4.3 3 IBM SPSS Statics version 25. Percentage, frequency and descriptive statistics were performed for qualitative variables and central tendency measures (mean and median), and dispersion (standard deviation) for numerical variables. In order to make the association among events possible (severe, nonsevere and immunization error) and the systemic manifestations with the elderly and vaccines variable of characterization, the Fisher's Exact and Qui-square tests were used and the significance level that was used was p < 0,05. After the analysis and the discussion of the data, the educative material was prepared. Results: The non-severe adverse events accounted for 84,7% of the obtained notifications, the severe adverse events, 5,1% and the immunization, 10,2%. The tests revealed statistical significance for the non-severe adverse events and the sex variation (p=0,042) better among women who presented local manifestations, that is to say 70,3% and, among men who presented systemic clinical manifestations (p=0,21) - 45,8%, which were characterized by neurological symptoms. The immunization error was characterized by double applications of the same immunobiological, either because of lack of information or vaccination card oversight. Conclusion: The nurse's expertise on the thematic being studied is really important for an appropriate caring free from damage to the elderly just so preventable adverse events can be avoided. The educative material is presented like a tool to guide the nurse who cares for the elderly in a Long-Stay Institution, in a Family Health-Care Unit, in Basic Health-Care Units, in hospitals or in residences. It is expected that this study motivates interest for future studies regarding the understanding of the development of different post-vaccination adverse events against influenza in elderly people, aiming the prevention of such events and their consequences. It is also expected that it motivates the accession to vaccination campaigns

A 19-year old man with IgA vasculitis after vaccination

ABSTRACT A 19-year-old patient who mistakenly received two doses of influenza vaccine 10 days before presentation, was admitted with malaise, weakness, and a purpuric non-blanching rash most prominent on the ankles followed by abdominal pain and hematochezia 72 h later. The diagnosis of influenza vaccine-related Henoch-Schonlein vasculitis was made. This complication, although rare, is the most common vasculitis related to immunization.

Síndrome de Guillain-Barré e sua relação com o calendário vacinal brasileiro: uma revisão de literatura / Guillain-Barré syndrome and its relationship with the brazilian vaccine calendar: a literature review

A síndrome de Guillain-Barré (SGB) é uma polineuropatia inflamatória desmielinizante aguda, geralmente pós-infecciosa e mediada pelo sistema imune, levando a graus variados de fraqueza progressiva e ascendente, podendo atingir os membros superiores e a face. A SGB é a causa mais frequente de paralisia flácida aguda e subaguda desde a erradicação da poliomielite. Estudos mostram a associação de SGB e diversas vacinas do calendário vacinal brasileiro. Este artigo tem por objetivo estabelecer as vacinas como fator desencadeante de SGB que compõem o Programa Nacional de Imunização. Com o emprego em larga escala das vacinas em nosso meio, estudos mostram a associação temporal significante com a SGB. Recomenda-se, portanto, a descrição dos casos suspeitos dessa associação. A vacina continua sendo o método mais efetivo para prevenir doenças graves e morte.(AU)

Guillain-Barré syndrome (GBS) is a post-infectious, immune-mediated, acute inflammatory demyelinating polyneuropathy, leading to varying degrees of progressive and ascending weakness, reaching the upper limbs and a face. GBS is the most frequent cause of acute and subacute flaccid paralysis since poliomyelitis eradication. Studies show an association between GBS and several vaccines of the Brazilian vaccine calendar. This article aims to establish GBS as a triggering factor for some vaccines that make up the National Immunization Program. With the large-scale use of vaccines in our country, studies show a significant temporal association with a GBS, it is therefore recommended a description of the suspected cases of the association. The vaccine continues to be the most effective method to prevent grave diseases and death.(AU)

Immunogenicity and safety of Southern Hemisphere inactivated quadrivalent influenza vaccine: a Phase III, open-label study of adults in Brazil

Abstract The World Health Organization influenza forecast now includes an influenza B strain from each of the influenza B lineages (B/Yamagata and B/Victoria) for inclusion in seasonal influenza vaccines. Traditional trivalent influenza vaccines include an influenza B strain from one lineage, but because two influenza B lineages frequently co-circulate, the effectiveness of trivalent vaccines may be reduced in seasons of influenza B vaccine-mismatch. Thus, quadrivalent vaccines may potentially reduce the burden of influenza compared with trivalent vaccines.In this Phase III, open-label study, we assessed the immunogenicity and safety of Southern Hemisphere inactivated quadrivalent influenza vaccine (Fluarix™ Tetra) in Brazilian adults (NCT02369341). The primary objective was to assess hemagglutination-inhibition antibody responses against each vaccine strain 21 days after vaccination in adults (aged ≥18–60 years) and older adults (aged >60 years). Solicited adverse events for four days post-vaccination, and unsolicited adverse events and serious adverse events for 21 days post-vaccination were also assessed.A total of 63 adults and 57 older adults received one dose of inactivated quadrivalent influenza vaccine at the beginning of the 2015 Southern Hemisphere influenza season. After vaccination, in adults and older adults, the hemagglutination-inhibition titers fulfilled the European licensure criteria for immunogenicity. In adults, the seroprotection rates with HI titer ≥1:40 were 100% (A/H1N1), 98.4% (A/H3N2), 100% (B/Yamagata), and 100% (B/Victoria); in older adults were 94.7% (A/H1N1), 96.5% (A/H3N2), 100% (B/Yamagata), and 100% (B/Victoria). Pain was the most common solicited local adverse events in adults (27/62) and in older adults (13/57), and the most common solicited general adverse events in adults was myalgia (9/62), and in older adults were myalgia and arthralgia (both 2/57). Unsolicited adverse events were reported by 11/63 adults and 10/57 older adults.The study showed that inactivated quadrivalent influenza vaccine was immunogenic and well-tolerated in Brazilian adults and older adults.

Vacinação contra influenza em idosos de Pelotas-RS, 2014: um estudo transversal de base populacional / Vacunación contra la influenza en adultos mayores del Pelotas-RS, 2014: un estudio transversal de base poblacional / Influenza vaccination among elderly in Pelotas-RS, Brazil, 2014: a population-based study

OBJETIVO: descrever a prevalência de vacinados contra influenza e fatores associados à vacinação em idosos, identificar motivos da não adesão e eventos adversos pós-vacinação. MÉTODOS: estudo transversal, realizado na zona urbana de Pelotas-RS, Brasil, em 2014. RESULTADOS: dos 1.451 idosos, 71% se vacinaram; idosos com melhor classificação econômica (RP=1,2 - IC95% 1,1;1,4), que não estavam trabalhando (RP=1,2 - IC95% 1,1;1,3), fisicamente ativos (RP=1,1 - IC95% 1,0;1,2), ex-fumantes (RP=1,3 - IC95% 1,1;1,5), que consultaram com profissional de saúde no último ano (RP=1,2 - IC95% 1,1;1,4) e que relataram dois ou mais problemas de saúde (RP=1,2 - IC95% 1,1;1,4) apresentaram maiores prevalências; entre os não aderentes (n=414), o principal motivo foi 'não quis/não gosta' (45%); os eventos adversos mais relatados foram mal-estar (49/83) e dor muscular (30/83). CONCLUSÃO: a cobertura vacinal não foi universal; abordagens educativas são necessárias para esclarecer controvérsias sobre a eficácia, eventos adversos e benefícios da vacinação contra influenza.

OBJETIVO: describir la prevalencia de vacunación contra influenza y factores asociados EN adultos mayores, identificar causas de la no adherencia y eventos adversos. MÉTODOS: estudio transversal, realizado en el área urbana de Pelotas-RS, Brasil, en 2014. RESULTADOS: de los 1.451 adultos mayores, 71% fueron vacunados. los ancianos con mejor clasificación económica (RP=1,2 - IC95% 1,1;1,4), que no trabajaban (RP=1,2 - IC95% 1,1;1,3), físicamente activos (RP=1,1 - IC95% 1,0;1,2), ex fumadores (RP=1,3 - 1,1;1,5), que consultaron el último año (RP=1,2 - 1,1;1,4), o que informaron dos o más problemas de salud (RP=1,2 - 1,1;1,4) presentaron una mayor prevalencia; entre los no adherentes (n=414) el principal motivo fue 'no quería/disgusta' (45%); los efectos adversos más frecuentes fueron malestar general (49/83) y dolor muscular (30/83). CONCLUSIÓN: la cobertura de vacunación no fue universal; se necesitan enfoques educativos, aclarar las controversias sobre la eficacia, efectos adversos y beneficios de la vacunación.

OBJECTIVE: to describe the prevalence of individuals vaccinated against influenza and associated factors with vaccination among elderly; identify reasons for noncompliance and adverse events. METHODS: this was a cross-sectional study, conducted in the urban area of Pelotas-RS, Brazil, in 2014. RESULTS: out of 1,451 elderly, 71% got vaccinated; the highest prevalences were observed in the elderly with better economic status (PR=1.2 - 95%CI 1.1;1.4), those who were not employed (PR=1.2 - 95%CI 1.1;1.3), those who were physically active (PR=1.1 - 95%CI 1.0;1.2), former smokers (PR=1.3 - 95%CI 1.1;1.5), those who were assisted by a health professional the previous year (PR=1.2 - 95%CI 1.1;1.4) and those who reported two or more health problems (PR=1.2 - 95%CI 1.1;1.4); the main reason for noncompliance (n=414) was 'did not want/do not like' (45%); the most frequently reported adverse events were malaise (49/83) and muscle ache (30/83). CONCLUSION: vaccination coverage was not universal; educational approaches are needed to clarify controversy on the efficacy, adverse events and benefits of vaccination.

Encefalitis recurrente post vacuna influenza anual / Recurrent encephalitis following annual influenza vaccine: case report

Influenza vaccine is rarely associated with neurological adverse effects such as Guillain Barré syndrome, encephalitis or aseptic meningitis. We report the case of a male patient that presented two episodes of acute encephalitis in consecutive years, 16 and 20 days after his annual influenza vaccine shot, respectively. In both instances, patient required ICU admission and evolved with fast recovery and no sequels. The first episode was managed empirically as herpetic encephalitis but an extensive study was performed in the second episode without identifying any microorganism. Neuroimaging studies also discarded acute disseminated encephalomyelitis. Mild pleocytosis of mononuclear predominance was detected in both cases in CSF. Naranjo score punctuated 8 points indicating a probable causal relationship. Acute encephalitis is a rare adverse effect of influenza vaccine and occurs several days after immunization. It has a broad differential diagnosis, and appears to be of self-limited duration and associated with good prognosis.

La vacuna influenza en raras ocasiones se asocia a efectos adversos neurológicos tales como síndrome de Guillain Barré, encefalitis o meningitis aséptica, entre otros. Presentamos el caso clínico de un paciente de sexo masculino de 66 años que presentó dos episodios de encefalitis en años consecutivos, 16 y 20 días después de recibir la vacuna anual de influenza, respectivamente. En ambos casos requirió ingreso a UCI y evolucionó con una rápida recuperación y sin secuelas. El primer episodio fue manejado empíricamente como una encefalitis herpética y en el segundo se hizo un extenso estudio microbiológico que no identificó microorganismos. Los estudios de neuroimágenes descartaron una encefalomielitis aguda diseminada. En ambos casos se pesquisó pleocitosis de predominio mononuclear en el LCR. El score de Naranjo dio 8 puntos indicando una probable relación causal. La encefalitis aguda es un efecto adverso muy infrecuente tras la vacuna influenza y ocurre varios días después de la inmunización. Tiene un amplio diagnóstico diferencial, parece ser autolimitado y de buen pronóstico.

Acute disseminated encephalomyelitis following inactivated influenza vaccination in the Brazilian Amazon: a case report

Here, we describe a case of acute disseminated encephalomyelitis (ADEM) that occurred during a plausible risk interval following inactivated influenza vaccination in a previously healthy 27-year-old man from Manaus, Brazil. He was treated with intravenous methylprednisolone and immunoglobulin. One-month follow-up revealed resolution of the brain lesions, but not of the spinal cord lesions. No recurrence or progression of the main neurological symptoms was observed. After two years of monitoring, the patient continues to experience weak lower limbs and urinary retention. Thus, we recommend that ADEM should be considered in a patient presenting with neurological symptoms after influenza vaccination.

Pityriasis lichenoides et varioliformis acuta after influenza vaccine

The etiology of pityriasis lichenoides is unknown. One of the accepted theories admits that PL is an inflammatory response to extrinsic antigens such as infectious agents, drugs and vaccines. In recent medical literature, only the MMR vaccine (Measles, Mumps and Rubella) was associated with the occurrence of this disease. We present a case of a male, 12 year old healthy patient who, five days after Infl uenza vaccination, developed erythematous papules on the trunk, abdomen and limbs, some with adherent crusts and associated systemic symptoms. This case report is notable for describing the first case of pityriasis lichenoides et varioliformis acuta associated with the vaccine against Influenza.

Peripheral T-cell lymphoma at the injection site of influenza vaccination.

Pseudolymphomas or B‑cell lymphoma at the vaccination site have been reported by several authors. However, onset of cutaneous T‑cell lymphoma with cytotoxic features is a rare complication of vaccination. We report a 27‑year‑old man who developed a nodule and ulcer that arose at the site of injection of influenza vaccine. The neoplastic cells reacted positively for CD56, CD3, CD2, perforin, and granzyme B, but negatively for CD4, CD8, CD10, CD19, CD30, CD34, CD79, and betaF1. Molecular studies showed T‑cell receptor γ (TCR‑γ) chain monoclonal rearrangement. A diagnosis of peripheral T‑cell lymphoma, not otherwise specified (NOS) was established. The patient had high fever, progressive liver dysfunction and a rapid fatal evolution.

Neurological complications after H1N1 influenza vaccination: magnetic resonance imaging findings / Complicações neurológicas após vacinação para H1N1: achados de ressonância magnética.

Objective: To report 4 different neurological complications of H1N1 virus vaccination. Method: Four patients (9, 16, 37 and 69 years of age) had neurological symptoms (intracranial hypertension, ataxia, left peripheral facial palsy of abrupt onset, altered mental status, myelitis) starting 4-15 days after H1N1 vaccination. MRI was obtained during the acute period. Results: One patient with high T2 signal in the cerebellum interpreted as acute cerebellitis; another, with left facial palsy, showed contrast enhancement within both internal auditory canals was present, however it was more important in the right side; one patient showed gyriform hyperintensities on FLAIR with sulcal effacement in the right fronto-parietal region; and the last one showed findings compatible with thoracic myelitis. Conclusion: H1N1 vaccination can result in important neurological complications probably secondary to post-vaccination inflammation. MRI detected abnormalities in all patients. .

Objetivo: Relatar quatro diferentes complicações neurológicas da vacina contra o vírus H1N1. Método: Quatro pacientes (9, 16, 37 e 69 anos) tinham sintomas neurológicos (hipertensão intracraniana, ataxia, paralisia facial esquerda de inicio abrupto, estado mental alterado e mielite) iniciando-se 4 a 15 dias após vacinação contra H1N1. RM foi realizada em quatro pacientes na fase aguda e em um paciente na fase crônica. Resultados: Dos quatro pacientes, um apresentou hipersinal em T2 no cerebelo, interpretado como cerebelite aguda; um, com paralisia facial esquerda, tinha realce dos condutos auditivos internos, maior à direita; um tinha hipersinal em T2 no cortex parieto-occipital direito; um apresentou sinais compatíveis com mielite torácica. Conclusão: A vacinação contra o H1N1 pode resultar em importantes complicações neurológicas, provavelmente secundárias a inflamação pós-vacinal. A RM detectou anormalidades em todos os pacientes. .

¿Hay sesgo en las recomendaciones actuales de vacunación antiinfluenza? / Is there bias in the current recommendations for influenza vaccine?

Contexto: la promoción de la vacuna antiinfluenza es una de las políticas públicas más agresivas y generalizadas en la actualidad siendo recomendada a prácticamente toda la población general, en especial en ciertos países de la Unión Europea y en Estados Unidos. ¿Hay evidencias científicas sólidas como para apoyar esta recomendación? ¿Es esta enfermedad tan seria y agresiva que justifique el inmenso gasto que conlleva la vacunación masiva? Objetivo: este artículo busca analizar si la evidencia disponible en la literatura avala la recomendación prácticamente universal de vacunación contra la influenza. Análisis: el análisis de las evidencias disponibles que apoyan esta recomendación de vacunación masiva, muestra que los estudios están expuestos a múltiples tipos de sesgos. Asimismo, la evidencia disponible demuestra que la vacuna sólo tiene efectos sobre los síntomas de la enfermedad. Por otra parte, se han reportado efectos adversos a la vacuna en Australia (convulsiones febriles en uno por cada 110 vacunados), Canadá (quienes se vacunaron en 2008 presentaron mayor riesgo de adquirir la influenza pandémica H1N1 en 2009), Suecia y Finlandia (un caso de narcolepsia en adolescentes por cada 55.000 vacunados). Conclusión: no existe mayor evidencia que establezca que la influenza represente una amenaza para la salud pública, ni que la vacuna disminuya en forma importante las complicaciones de la infección y la mortalidad.

Context. Influenza vaccine has been aggressively promoted and is currently recommended to practically the whole population, especially in some European Union countries and in the United States of America. Is there sound evidence to support this policy recommendation? Is this disease so serious and aggressive to merit the enormous expenditure associated with mass immunization? Aim. The article seeks to analyze the published evidence that supports the practically generalized recommendation of universal immunization for influenza. Analysis. The analysis of the evidence invoked to support this recommendation of mass flu vaccine shows that there are multiple types of bias present. Likewise, the evidence shows that the vaccine only has effects on flu symptoms. Conversely, adverse effects to the flu vaccine have been reported in Australia (febrile seizures in 1/110), Canada (people who got the flu shot in 2008 had increased risk of contracting H1N1 pandemic influenza in 2009), Sweden and Finland (one case of narcolepsy in 55,000). Conclusion. There is no solid evidence showing that influenza is a threat to public health, nor that the flu shot in any way reduces influenza complications and mortality.

Spontaneous reporting of adverse events following pandemic influenza A (H1N1) immunization in a reference center in the State of Sao Paulo, Brazil

Introduction This paper describes adverse events (AEs) temporally associated to the pandemic influenza A (H1N1) vaccine observed in a reference center in São Paulo, Brazil, during a 2010 mass vaccination campaign. Methods A retrospective study involving persons who sought medical care for AEs following influenza vaccination. Data were retrieved from medical records, vaccine AE notification forms, and a computerized system for immunobiological registration. Results Sixty-six vaccinees sought medical care for AEs after immunization. The most frequent AEs were fever, headache, myalgia, and pain at the injection site. No serious AEs were reported. Conclusions Few vaccinees spontaneously reported AEs to influenza A (H1N1) vaccine at this center. .

Poliarteritis nodosa relacionada con vacuna contra la influenza / Polyarteritis nodosa related with influenza vaccine

Las vasculitis pueden ser secundarias a diferentes procesos, entre ellos infecciones, neoplasias, enfermedades del tejido conectivo o medicamentos, o primarias, generalmente idiopáticas. Se han reportado diversos eventos adversos posvacunales algunos de ellos leves y transitorios y otros más graves tales como enfermedades autoinmunes. Debido a que las vacunas contienes productos virales o bacterianos, o microorganismos vivos atenuados, pueden funcionar como agentes disparadores de enfermedades autoinmunes. Posiblemente el fenómeno autoinmune descrito con mayor frecuencia después de la vacunación contra influenza son las diferentes formas de vasculitis. Reportamos el caso de una paciente que presentó un cuadro de vasculitis clasificada como poliarteritis nodosa, que se inició dos semanas después de recibir una vacuna contra influenza. Revisando de forma crítica la literatura este sería el primer caso claramente documentado como poliarteritis nodosa relacionado con vacunación contra influenza.

Vasculitis can be secondary to various processes, among them infections, malignancies, connective tissue diseases or medications, or primary, generally idiopathic. The reported adverse events after vaccination can be mild and transient or more serious such as autoimmune diseases. Possibly the most frequently described autoimmune phenomena after influenza vaccination are different forms of vasculitis. We report the case of a patient who presented a clinical picture of vasculitis classified as polyarteritis nodosa that began two weeks after receiving the influenza vaccine. After critically reviewing the literature, this would be the first clearly documented case of polyarteritis nodosa associated with vaccination against influenza.