Reações de hipersensibilidade a vacinas / Hypersensitivity reactions to vaccines

O desenvolvimento e a ampliação do uso das vacinas durante décadas contribuíram para o controle e erradicação de doenças infecciosas, causando um grande impacto na saúde pública no mundo. A análise de segurança das vacinas percorre criteriosos processos e fases dos estudos clínicos, um dos pilares essenciais para aprovação regulatória e utilização do produto na população. O evento supostamente atribuído à vacinação e imunização (ESAVI), terminologia atual, é definido como qualquer ocorrência médica indesejada após a vacinação que possui, ou não, uma relação causal com o uso de uma vacina ou outro imunobiológico. Cabe ressaltar que eventos adversos mais raros ou inesperados, incluindo os eventos de hipersensibilidade, poderão ocorrer na fase pós-comercialização, quando as vacinas são aplicadas em milhões de pessoas. Neste artigo, serão discutidos os principais aspectos relacionados aos eventos adversos de hipersensibilidade pós-vacinais de interesse do especialista, e os desafios frente ao reconhecimento do agente causal e conduta a ser adotada. Além disso, serão revisados os potenciais alérgenos presentes nas vacinas de uso rotineiro para auxiliar o profissional de saúde na identificação de pacientes com potencial de risco de ESAVI por tais componentes. A atualização do conhecimento acerca da segurança e dos benefícios das vacinas pelos profissionais de saúde, sobretudo em populações especiais, contribui para condutas em imunização mais apropriadas, reduzindo o risco de exposição a um possível alérgeno em pessoas comprovadamente alérgicas às vacinas ou a alguns dos seus componentes, além de evitar contraindicações desnecessárias em eventos coincidentes ou não graves.

The expansion of vaccine use and development in recent decades has contributed to the control and eradication of infectious diseases, causing a major impact on public health worldwide. Vaccine safety analysis, which involves careful processes and clinical study, is one of the essential pillars of regulatory approval and use in the population. In current terminology, events supposedly attributable to vaccination and immunization (ESAVI) are defined as any unwanted medical occurrence after vaccination that may or may not have a causal relationship with vaccines or other immunobiologicals. It is noteworthy that rare or unexpected adverse events, including hypersensitivity, can occur during the post-marketing phase, when vaccines are administered to millions of people. In this article, we will discuss the main aspects of post-vaccine hypersensitivity events of interest to specialists and challenges to recognizing the causal agent and appropriate clinical practice. Potential allergens in routine vaccines will also be reviewed to help health professionals identify patients with a potential risk of ESAVI due to such components. Updating health professionals' knowledge about the safety and benefits of vaccines, particularly in special populations, can contribute to more appropriate clinical practice regarding immunization, reducing the risk of exposure to possible allergens in people with allergies to vaccines or their components, avoiding unnecessary contraindications in coincidental or non-serious events.

A review of the current diphtheria outbreaks

Corynebacterium diphtheriae is responsible for both endemic and epidemic diphtheria. The predisposing factor for this disease is the failure to immunize during childhood. Humans are the only hosts of the organism and is present in the upper respiratory tract. The organism is transmitted via airborne route and can cause respiratory obstruction and heart failure because of the exotoxin it produces. There is presently a resurgence of diphtheria outbreaks in Nigeria. The Nigeria Center for Disease Control (NCDC) was notified of suspected diphtheria outbreaks in Lagos and Kano States, Nigeria, in December 2022 and has been issuing monthly reports since that time. This review of the diphtheria outbreaks following online database searches on PubMed and Google Scholar as well as the NCDC/WHO websites and grey literatures, describes the current trend of the outbreaks globally, elucidated the different strains of Corynebacterium responsible for the outbreaks, identified the recent vaccine formulation developed to tackle the outbreaks, and provide information on vaccine delivery and efficacy studies in the country and globally.

Comunicação de risco: caso suspeito de difteria / Risk communication: suspected case of diphtheria

A comunicação de risco tem como objetivo apoiar na divulgação rápida e eficaz de conhecimento às populações, parceiros e partes intervenientes possibilitando o acesso às informações fidedignas que possam apoiar nos diálogos para tomada de medidas de proteção e controle em situações de emergência em saúde pública. Em Goiás na SE 16/2022, foi notificado 01 caso suspeito de difteria, sexo feminino, 16 anos, do município de Santa Helena de Goiás, com histórico de 03 doses da vacina DTP+HIB (08/2010), não foi identificada doses de reforço, conforme preconizados pelo PNI

Risk communication aims to support the rapid and effective dissemination of knowledge to populations, partners and stakeholders, enabling access to reliable information that can support dialogues for taking protection and control measures in emergency situations in public health. In Goiás on SE 16/2022, 01 suspected case of diphtheria was reported, female, 16 years old, from the municipality of Santa Helena de Goiás, with a history of 03 doses of the DTP+HIB vaccine (08/2010), no doses were identified reinforcement, as recommended by the PNI

Atraso na vacina tetravalente (DTP+Hib) em crianças de 12 a 23 meses de idade: Pesquisa Nacional de Saúde, 2013 / Delay in quadrivalent vaccine (DTP+Hib) in children 12 to 23 months of age: Brazilian National Health Survey, 2013 / Retraso en la vacuna tetravalente (DTP+Hib) en niños de 12 a 23 meses de edad: Encuesta Nacional de Salud, 2013

Resumo: O objetivo foi estimar a prevalência do atraso nas três doses da vacina tetravalente (DTP+Hib) em crianças de 12 a 23 meses de idade, no Brasil, por meio dos dados da Pesquisa Nacional de Saúde (PNS) de 2013 e descrever o atraso em cada uma das doses segundo variáveis sociodemográficas, utilização de serviços e intervenções públicas de saúde. Foram utilizados dados da PNS, estudo transversal realizado em 2013. O desfecho foi o atraso pelo menos em uma das três doses da vacina tetravalente. Considerou-se como atraso a dose recebida pelo menos 30 dias após a data preconizada, segundo informação da caderneta de vacinação. A prevalência do atraso foi descrita segundo variáveis sociodemográficas e utilização de serviços de saúde. Realizou-se análise descritiva obtendo-se frequências absolutas e relativas e seus respectivos intervalos de 95% de confiança. Das 2.016 crianças com informações coletadas, 1.843 foram analisadas. A prevalência de atraso de pelo menos uma dose da vacina foi de 44%. Observou-se atraso de 14,8% na primeira, 28,8% na segunda e 45,4% na terceira dose, sendo que 10% das crianças tiveram atraso nas três doses. Maiores prevalências de atraso foram encontradas em crianças do sexo masculino, de cor da pele parda, pertencentes ao quintil mais pobre de riqueza, moradores da zona rural e da Região Norte do Brasil. Evidenciou-se alta prevalência de atraso na vacina tetravalente (DTP+Hib) em crianças de 12 a 23 meses do Brasil, sendo maior na terceira dose.

Abstract: The study aimed to estimate the prevalence of delay in the three doses of quadrivalent vaccine (DTP+Hib) in children 12 to 23 months of age in Brazil, based on data from the Brazilian National Health Survey (PNS) of 2013 and to analyze the delay in each of the doses according to sociodemographic variables and use of health services and public health interventions. The data are from the PNS a cross-sectional study performed in 2013. The outcome was delay in at least one of the three doses of the quadrivalent vaccine. Delay was defined as a dose received at least 30 days after the recommended date according to information on the child's vaccination card. Prevalence of delay was analyzed according to sociodemographic variables and use of health services. A descriptive analysis was performed to obtain absolute and relative frequencies and their respective 95% confidence intervals. Of the 2,016 children with information collected, 1,843 were analyzed. The prevalence of delay in at least one dose of the vaccine was 44%. There was a delay of 14.8% in the first dose, 28.8% in the second, and 45.4% in the third, and 10% of the children had delays in all three doses. Higher prevalence of delay was associated with male gender, brown skin color, the poorest income quintile, and residence in rural areas and the North of Brazil. The study revealed high prevalence of delay with the quadrivalent vaccine (DTP+Hib) in children 12 to 23 months of age in Brazil, with the highest delay in the third dose.

Resumen: El objetivo fue estimar la prevalencia del atraso en las tres dosis de la vacuna tetravalente (DTP+Hib) en niños de 12 a 23 meses de edad, en Brasil, mediante los datos de la Encuesta Nacional de Salud (PNS) de 2013 y describir el retraso en cada una de las dosis, según variables sociodemográficas, utilización de servicios e intervenciones públicas de salud. Se trata de un estudio transversal, realizado en 2013, con datos de la PNS. El resultado fue el retraso por lo menos en una de las tres dosis de la vacuna tetravalente. Se consideró como un atraso la dosis recibida por lo menos 30 días tras la fecha prefijada, según la información de la cartilla de vacunación. La prevalencia del atraso fue descrita según variables sociodemográficas y utilización de servicios de salud. Se realizó un análisis descriptivo, obteniéndose frecuencias absolutas y relativas, así como sus respectivos intervalos de 95% de confianza. De los 2016 niños con información recogida, se analizaron 1843. La prevalencia de atraso de por lo menos una dosis de la vacuna fue de un 44%. Se observó un retraso de 14,8% en la primera, un 28,8% en la segunda y un 45,4% en la tercera dosis, siendo que un 10% de los niños sufrieron atraso en las tres dosis. Las mayores prevalencias de atraso se encontraron en niños de sexo masculino, mestizos, pertenecientes al quintil más pobre de riqueza, habitantes de la zona rural y de la Región Norte de Brasil. Se evidenció una alta prevalencia de atraso en la vacuna tetravalente (DTP+Hib) en niños de 12 a 23 meses de Brasil, siendo mayor en la tercera dosis.

Análisis económico de las vacunas del primer año de vida con componente pertussis en el contexto de la ini-ciativa mundial de erradicación de la poliomielitis en Argentina / Vaccination in children under 1 year with pertussis component in the context of the global initiative for the eradication of poliomyelitis in Argentina: economic analysis

INTRODUCCIÓN: La Iniciativa Mundial de Erradicación de la Polio promueve la introducción de vacuna de polio inactivada (IPV) en sus programas, con la posterior retirada de Sabin (bOPV). OBJETIVO: Construir un modelo de económico que compare diferentes esquemas de vacunación para la prevención de polio y tosferina en el primer año de vida. Material y MÉTODOS: Análisis de cuatro escenarios de vacunación del esquema primario para Argentina, en base a los precios de las vacunas, costos del programa y reactogenicidad de vacuna celular o acelular para Bordetella pertussis: - Escenario 1 (caso base): dos dosis de IPV, una dosis de bOPV y tres dosis de vacuna pentavalente (DTwP-HB-Hib); - Escenario 2: tres dosis IPV y de pentavalente; - Escenario 3: tres dosis de hexavalente (DTaP-HepB-IPV-Hib); - Escenario 4: dos dosis de hexavalente más una dosis de pentavalente más IPV. RESULTADOS: El costo incremental en base al escenario 1 fue de USD 3.716.671; 19.696.668 y 14.383.341 para los escenarios 2, 3 y 4, respectivamente. Para la reactogenicidad, la diferencia fue de USD -14.178.240 comparado el caso base con el escenario 3. DISCUSIÓN: La inversión de incorporación de full IPV y costos asociados se modifica según tipo de vacuna y reactogenicidad asociada al componente B. pertussis.

BACKGROUND: Global Polio Eradication Initiative promotes the introduction of inactivated polio vaccine (IPV) in its programs, with withdrawal of Sabin (bOPV). There is no an economic analysis of the investment related to the incorporation of IPV vaccines together with a whole cell Bordetella pertussis vaccine or combined with acellular hexavalent. AIM: An economic model that compares different vaccination schemes for the prevention of polio and pertussis in the first year of life was carried out. METHODS: Four vaccination scenarios for the primary scheme based on Argentina demographic and costs data were developed: - Scenario 1 (base case): two doses of IPV, one dose of bOPV and three doses of pentavalent (DTwP-HepB-Hib) vaccine; - Scenario 2: three doses of IPV plus three doses of pentavalent; - Scenario 3: three doses of hexavalent; - Scenario 4: two doses of hexavalent plus one dose of pentavalent plus IPV. RESULTS: The incremental cost based on scenario 1 was USD 3.716.671; 19.696.668 and 14.383.341 for scenarios 2, 3 and 4 respectively. In terms of reactogenicity savings was -14.178.240 compared base case with scenario 3. DISCUSSION: Full IPV introduction investment and costs associated were modified according to the type of vaccine and reactogenicity related with the B. pertussis component.

Estrutura e localização dos serviços de vacinação influenciam a disponibilidade da tríplice viral no Brasil / La estructura y ubicación de los servicios de vacunación influyen en la disponibilidad de la vacuna triple viral en Brasil / Structure and location of vaccination services influence the availability of the triple viral in Brazil

RESUMO OBJETIVO: analisar a associação de fatores estruturais e diferenças geográficas na disponibilidade da vacina tríplice viral nos serviços de atenção básica no Brasil. MÉTODOS: estudo transversal, com dados secundários do segundo ciclo das avaliações externas do Programa de Melhoria da Qualidade da Atenção Básica (PMAQ-AB) coletados em 19.752 serviços de vacinação de todo o país entre os anos de 2013 e 2014. Razões de prevalência (RP) ajustadas e seus respectivos intervalos de confiança de 95% (IC 95%) foram estimados com a técnica de regressão multivariada de Poisson com variâncias robustas. RESULTADOS: a vacina tríplice viral estava sempre disponível em 93% dos serviços estudados, mas com diferenças regionais, sendo a menor frequência observada na região Norte (87,4%; p<0,001). Os seguintes fatores estruturais dos serviços associaramse positivamente à maior frequência de vacina tríplice viral sempre disponível: possuir sala de vacinação (RP: 1,05; IC 95%: 1,01-1,09), sala de vacinação exclusiva para imunização (RP: 1,04; IC 95% 1,02-1,05), geladeira exclusiva para vacinas (RP: 1,13; IC 95%: 1,10-1,16); cartões de vacinação impressos sempre disponíveis (RP: 1,12 IC 95%: 1,09-1,16) e caixas térmicas para vacinas sempre disponíveis (RP: 1,18 IC 95%: 1,14-1,21). CONCLUSÃO: a localização e a estrutura dos serviços de atenção básica influenciaram na disponibilidade da vacina tríplice viral no Brasil. Serviços da região Norte e com estrutura deficiente para as ações de imunização apresentaram menor frequência da disponibilidade da vacina.

RESUMEN OBJETIVO: analizar la asociación entre los factores estructurales y las diferencias geográficas en la disponibilidad de la vacuna triple viral en los servicios de atención primaria de Brasil. MÉTODO: estudio transversal con datos secundarios del segundo ciclo de evaluaciones externas del Programa de mejora de la calidad de la atención primaria recogidos en 19.752 servicios de vacunación de todo el país entre 2013 y 2014.Las razones de prevalencia ajustadas (PR) y sus respectivos intervalos de confianza del 95% (IC del 95%) se estimaron utilizando la técnica de regresión multivariante de Poisson con varianzas robustas. RESULTADOS: la vacuna triple viral siempre estuvo disponible en el 93% de los servicios estudiados, pero con diferencias regionales, con la menor frecuencia observada en el norte (87,4%; p <0,001). Los siguientes factores estructurales de los servicios se asociaron positivamente con la mayor frecuencia de vacuna triple viral siempre disponible: tener una sala de vacunación (RP: 1.05; IC 95%: 1.01-1.09), sala de vacunación exclusiva para inmunización (RP: 1,04; IC del 95%: 1,02-1,05), refrigerador exclusivamente para vacunas (RP: 1,13; IC del 95%: 1,10-1,16); tarjetas de vacunación impresas siempre disponibles (RP: 1,12 IC 95%: 1,09-1,16) y cajas térmicas para vacunas siempre disponibles (RP: 1,18 IC 95%: 1,14-1,21). CONCLUSIÓN: la ubicación y estructura de los servicios de atención primaria influyó en la disponibilidad de la vacuna triple viral en Brasil. Los servicios de la región norte con estructura deficiente para las acciones de inmunización mostraron menor frecuencia de disponibilidad de vacunas.

ABSTRACT OBJECTIVE: to analyze the association of structural factors and geographical differences in the availability of the measle, mumps, and rubella vaccine in primary care services in Brazil. METHODS: this is a cross-sectional study, with secondary data from the second cycle of external evaluations of the Primary Care Quality Improvement Program (Programa de Melhoria da Qualidade da Atenção Básica - PMAQ-AB) collected from 19,752 vaccination services across the country between 2013 and 2014. We estimated the prevalence ratio (PR) and their respective 95% confidence intervals (CI 95%) using the Poisson multivariate regression technique with robust variances. RESULTS: the MMR vaccine was always available in 93% of the services studied, but with regional differences, with the lowest frequency observed in the North (87.4%; p <0.001). The following structural factors of the services were positively associated with the higher frequency of MMR vaccine always available: having a vaccination room (PR: 1.05; 95% CI: 1.01-1.09), exclusive vaccination room for immunization (PR: 1.04; 95% CI 1.02-1.05), refrigerator exclusively for vaccines (PR: 1.13; 95% CI: 1.10-1.16); printed vaccination cards always available (PR: 1.12 95% CI: 1.09-1.16) and coolers for vaccines always available (PR: 1.18 95% CI: 1.14-1.21). CONCLUSION: the location and structure of primary care services influenced the availability of the MMR vaccine in Brazil. Services in the North region and with a poor structure for immunization actions showed less frequency of vaccine availability.

Ocorrência de eventos adversos após o uso da vacina adsorvida difteria, tétano e pertussis (acelular) - dTpa -, São Paulo, SP, 2015-2016 / Aparecimiento de eventos adversos después del uso de la vacuna adsorbida difteria, tétanos y tosferina (acelular) - dTpa -, São Paulo, SP, Brasil, 2015-2016 / Adverse event occurrence following use of tetanus, diphtheria and acellular pertussis adsorbed vaccine - Tdap -, São Paulo, SP, Brazil, 2015-2016

Objetivo: descrever a ocorrência de eventos adversos pós-vacinação (EAPV) com a vacina dTpa durante a gestação. Métodos: estudo descritivo, com dados de relatos das participantes de estudo de efetividade e imunogenicidade realizado em dois hospitais de São Paulo, SP, Brasil, entre 2015 e 2016. Resultados: das 201 mães incluídas no estudo, 48 (23,9%) apresentaram pelo menos um EAPV; foram identificados 60 sintomas relacionados ao uso da dTpa - dor (22,4%), inchaço (2,5%), febre (1,5%), sono (1,0%), vermelhidão (0,5%), vômito (0,5%), dor de cabeça (0,5%), reação local (0,5%) e cansaço (0,5%); não foram registrados eventos adversos raros, muito raros ou extremamente raros; todos os eventos foram considerados esperados e estão descritos em bula; todos tiveram desfecho para cura sem sequelas. Conclusão: a dTpa, na forma adotada pelo Programa Nacional de Imunizações (PNI), é segura; não foram identificados eventos adversos inesperados entre as gestantes imunizadas com a vacina.

Objetivo: describir el aparecimiento de eventos adversos posvacunación (EAPV) con la vacuna dTpa durante el embarazo. Métodos: estudio descriptivo con datos de relatos de las participantes del estudio de efectividad e inmunogenicidad realizado en dos hospitales de São Paulo, SP, Brasil, entre 2015 y 2106. Resultados: de las 201 madres del estudio, 48 (23,9%) tuvieron al menos un EAPV; se identificaron 60 síntomas relacionados al uso de dTpa - dolor (22.4%), hinchazón (2.5%), fiebre (1.5%), somnolencia (1.0%), enrojecimiento (0.5%), vómitos (0.5 %), dolor de cabeza (0.5%), reacción local (0.5%) y cansancio (0.5%) -; no se informaron eventos adversos raros, muy raros o extremadamente raros; todos los eventos se consideraron esperados y se describen en el prospecto; todos tuvieron resultados curativos sin secuelas. Conclusión: el estudio mostró que la vacuna dTpa utilizada por el Programa Nacional de Inmunización (PNI) es segura y no se identificaron eventos adversos inesperados entre las mujeres embarazadas vacunadas.

Objective: to describe occurrence of adverse events following immunization (AEFI) with Tdap vaccine during pregnancy. Methods: this was a descriptive study using data from reports by participants in an effectiveness and immunogenicity study conducted in two hospitals in São Paulo, SP, Brazil, from 2015 to 2016. Results: of the 201 mothers included in the study, 48 (23.9%) had at least one AEFI; 60 symptoms related to Tdap use were identified - pain (22.4%), swelling (2.5%), fever (1.5%), somnolence (1.0%), redness (0.5%), vomiting (0.5%), headache (0.5%), local reaction (0.5%), and fatigue (0.5%); no rare, very rare, or extremely rare adverse events were reported; all events were considered to be expected, as they are described in the vaccine package insert; outcome of all events was recovery without sequelae. Conclusion: Tdap vaccine in the form adopted by the National Immunization Program is safe; no unexpected adverse events were identified among vaccinated pregnant women.

Vigilancia activa de convulsiones febriles vinculadas a vacuna pentavalente en un hospital centinela en Uruguay / Active surveillance of febrile seizures associated to DPT vaccines in a sentinel hospital in Uruguay

Resumen Introducción: Las convulsiones febriles son eventos supuestamente atribuidos a la vacunación e inmunización (ESAVI) frecuentemente asociados a vacuna difteria - tétanos- pertussis a células completas. Objetivo: Analizar la asociación de convulsiones febriles con la administración de la vacuna pentavalente en niños bajo 2 años de edad asistidos en el Centro Hospitalario Pereira Rossell durante el año 2014. Material y Métodos: Estudio de series de casos auto-controlados. Se incluyeron niños procedentes de Montevideo con 2 a 24 meses de edad con diagnóstico de convulsión febril. Se estimó el riesgo relativo (RR) de los períodos de riesgo (0 a 3 días) y de lavado (4a 14 días), en comparación con el período de no riesgo (más de 14 días). Resultados: Se registraron 135 convulsiones febriles, que ocurrieron en 114 niños; 16 niños presentaron dos o más episodios. El total de eventos ocurridos en el período de riesgo fueron 7 (5,2%) y 8 (5,9%) en el período de lavado. El período de riesgo mostró un RR significativo de 4,14 (IC 95%: 1,73; 8,36). Conclusiones: Este trabajo permitió establecer una línea de base nacional sobre el riesgo de convulsiones febriles asociadas con la vacunación pentavalente al utilizar por primera vez en el país una metodología específica para tal fin.

Background: Febrile seizures are VAERS often associated with whole-cells Diphtheria-Pertussis-Tetanus vaccines. Aim: To analyze the association of febrile seizures with the administration of pentavalent vaccine in children under two-years-old assisted in the Centro Hospitalario Pereira Rossell (CHPR), in Montevideo during 2014. Methods: Self-controlled case series study. We included children from Montevideo from two to 24-month-old at the time of admission, with diagnosis of febrile seizure at the time of discharge. We estimated the relative risk in three time periods: 0 to 3 days (risk period), 4 to 14 days (wash-out) and more than 14 days after vaccination (no-risk). Results: We recorded 135 febrile seizures in 114 children, 16 of whom presented two or more events. The total number of events was 7 (5.2%) in risk periods and 8 (5.9%) in wash-out periods. The risk period showed a significantly increased risk (RR = 4.14, CI 95% = [1.73; 8.36]). Conclusions: This work allowed us to establish a national base line for the risk of febrile seizures associated with pentavalent vaccination, by using for the first time in the country a methodology specifically designed for this goal.

An investigation of vaccination in children with human immunodeficiency virus infection / 中国当代儿科杂志

OBJECTIVE@#To investigate the status of vaccination in children with human immunodeficiency virus (HIV) infection.@*METHODS@#A questionnaire survey was performed in 148 children in Hunan province, China who were registered in China's Acquired Immune Deficiency Syndrome Comprehensive Response Information Management System up to December 31, 2016 and were aged <15 years at the time of confirmed diagnosis of HIV infection. The information on vaccination, diagnosis of HIV infection, and diagnosis and treatment of related diseases was collected.@*RESULTS@#Of the 148 children with HIV infection, there were 70 boys (47.3%) and 78 girls (52.7%); 140 children had an age of 3.8 (0.2-14.8) years at the time of confirmed diagnosis, and 8 children refused to answer this question. Mother-to-child transmission was found in 133 children (91.7%), blood transmission in 1 child (0.7%), and unknown in 14 children (9.5%). Of the 148 children, 129 (87.2%) received antiviral therapy and 19 (12.8%) did not receive such treatment. The vaccination rates of hepatitis B vaccine, bacille Calmette-Guérin vaccine, poliomyelitis live attenuated vaccine and diphtheria-pertussis-tetanus vaccine ranged from 70.9% to 77.7%, which was significantly lower than the national level (≥97%); the vaccination rates of the other vaccines in the National Immunization Program gradually decreased with age. No severe adverse effects were reported after vaccination.@*CONCLUSIONS@#Mother-to-child transmission is the main route of HIV infection in Chinese children. The diagnosis of children with HIV infection is significantly delayed, with low vaccination rates. Efforts should be made to strengthen early diagnosis, early treatment and vaccination in children with HIV infection, in order to improve their quality of life.

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)

What is the importance of vaccine hesitancy in the drop of vaccination coverage in Brazil? / Qual a importância da hesitação vacinal na queda das coberturas vacinais no Brasil?

ABSTRACT The successful Programa Nacional de Imunizações do Brasil (Brazilian National Immunization Program) has been experiencing a major challenge with regard to vaccination coverage for children, which has been dropping. Several aspects are related, but certainly vaccine hesitancy has been strengthening itself as one of the main concerns of Brazilian public administrators and researchers. Vaccine hesitancy is the delay in acceptance or refusal despite having the recommended vaccines available in health services, being a phenomenon that varies over time, over location and over types of vaccines. Hesitant individuals are between the two poles of total acceptance and refusal of vaccination. Vaccine hesitancy is nothing new in European and North-American countries, and even in Brazil, it has been studied even if under another name. The drop of vaccination coverage observed from 2016 on reiterates the relevance of the theme, which must be better understood through scientific research.

RESUMO O exitoso Programa Nacional de Imunizações do Brasil tem vivenciado grande desafio com relação às coberturas vacinais infantis, que têm apresentado queda. Diversos aspectos estão relacionados, mas certamente a hesitação vacinal vem se fortalecendo como uma das principais preocupações dos gestores e pesquisadores brasileiros. Hesitação vacinal é o atraso em aceitar ou a recusa das vacinas recomendadas quando elas estão disponíveis nos serviços de saúde, sendo um fenômeno que varia ao longo do tempo, do local e dos tipos de vacinas. Indivíduos hesitantes situam-se entre os dois polos de aceitação e recusa total da vacinação. A hesitação vacinal não é novidade em países europeus e norte-americanos e, mesmo no Brasil, ela já vem sendo estudada ainda que sob outra denominação. A queda das coberturas vacinais observadas a partir de 2016 reitera a relevância do tema, que deve ser mais bem compreendido por meio de investigações científicas.

Clinical features and risk factors of pertussis in children / 中国当代儿科杂志

OBJECTIVE@#To study the clinical features and risk factors of pertussis in children.@*METHODS@#A retrospective analysis was performed for the clinical data and laboratory markers for immune function of 253 hospitalized children with pertussis. A total of 314 hospitalized children with cough were used as the control group. Quantitative real-time PCR was used to detect Bordetella pertussis DNA. The clinical data of both groups were collected to analyze the risk factors for pertussis.@*RESULTS@#A total of 23 typical clinical parameters were compared between the pertussis and control groups, and there were significant differences in only 10 clinical parameters between the two groups (P<0.01). As for the complications observed in the two groups, the pertussis group had a significantly lower incidence rate of myocarditis than the control group (P<0.05). The pertussis group had significantly lower levels of serum globulin and IgM than the control group (P<0.05). Compared with the control group, the pertussis group had a significantly higher proportion of children with a lack of diphtheria-pertussis-tetanus immunization or timely immunization and a contact history of suspected pertussis patients (P<0.05). A lack of vaccine immunization or timely immunization and a contact history of suspected pertussis patients were risk factors for pertussis (P<0.05).@*CONCLUSIONS@#The clinical features are not typical in children with pertussis. Quantitative real-time PCR for detecting Bordetella pertussis DNA helps with the early diagnosis of atypical pertussis. Infants/toddlers should be immunized in time and be isolated from suspected pertussis patients to reduce the incidence of pertussis.

Episodio Hipotonía-Hiporreactividad posterior a la inmunización con vacuna combinada con pertussis de células enteras. Reporte de un caso / Hypotonic-Hyporesponsive Episode after immunization with whole-cell pertussis combination vaccine. Clinical Case Report

Resumen Introducción: El Episodio Hipotonía-Hiporreactividad (EHH) es un efecto adverso tras la vacuna ción, asociado principalmente a vacunas anti-pertussis de células enteras. Se caracteriza por un inicio súbito de flacidez muscular, reducida respuesta a estímulos y palidez cutánea o cianosis. Aunque el EHH es infrecuente, está considerado como un efecto adverso severo. Objetivo: Reportar un caso de EHH posterior a la administración de la vacuna combinada pentavalente con: difteria, tétanos, pertussis celular, hepatitis B y Haemophilus influenzae tipo b (DTwP-HB-Hib), que está incluida en el Programa Nacional de Inmunizaciones (PNI) de Chile, con la finalidad de difundir esta infrecuente complicación de evolución benigna, auto-limitada y de carácter no recurrente. Caso clínico: Lactante de 6 meses de edad, 3 h post-vacunación con la tercera dosis de vacuna DTwP-HB-Hib, presentó compromiso del estado de conciencia interpretado como convulsión atónica y que finalmente se consideró como EHH. El lactante evolucionó favorablemente después de 2 h y fue dado de alta tras 24 h de vigilancia clínica; se cambió el esquema de inmunización del lactante con vacunas anti-per tussis acelulares como medida preventiva. Conclusiones: El desconocimiento sobre el EHH puede desalentar la inmunización infantil. Por lo tanto, es importante que el personal médico informe a los padres de los pacientes sobre este evento benigno, autolimitado y no recurrente. En estos casos, se re comienda continuar con el programa de inmunización del lactante con formulaciones que contengan componentes anti-pertussis acelulares.

Abstract Introduction: Hypotonic-Hyporesponsive Episode (HHE) is an adverse event after vaccination, mainly associated with whole-cell pertussis vaccines. It is characterized by a sudden onset of muscle flaccidity, reduced response to stimuli and pallor or cyanosis. Although the HHE is infrequent, it is considered a severe adverse event. Objective: To report a case of HHE following the administration of the whole-cell pertussis combination vaccine (DTwP-HB-Hib), which is included in National Im munization Program (PNI) of Chile, and to contributing to the knowledge of this adverse event in the country. Case report: A 6-month-old infant, 3 hours post-vaccination with the third dose of DTwP-HB-Hib vaccine, presented a decreased level of consciousness that was interpreted as atonic seizure but finally considered as EHH. The infant progressed favorably after 2 hours of clinical observation and was discharged 24 hours later. Parents were suggested to continue the immunization schedule of the infant with acellular pertussis vaccines as a preventive measure. Conclusions: The lack of knowledge about the EHH may discourage childhood immunization. Therefore, it is important for the medical staff to inform parents of the patients about this benign, self-limited and non-recurrent adverse event. In these cases, it is recommended to continue the immunization schedule of the infant with acellular pertussis vaccines.

Vacina de Bordetella pertussis reduz IgE específica, inflamação e remodelamento num modelo animal de alergia respiratória induzida por ácaro / Bordetella pertussis vaccine reduces specific IgE, inflammation, and remodeling in an animal model of respiratory allergy caused by house dust mites

Objetivo: Adjuvantes, como lipopolissacárides bacterianos, vêm sendo estudados para melhorar a eficácia da imunoterapia alérgeno-específica. A vacina de Bordetella pertussis (Pw) mostrou ter papel protetor em modelos de asma induzida por ovalbumina. Porém, seu papel na alergia a ácaros é desconhecido. Avaliamos os efeitos da vacina difteria-tétano-coqueluche (DTPw) em um modelo murino de alergia respiratória induzida por Dermatophagoides pteronyssinus (Derp). Métodos: Num protocolo de 30 dias, camundongos BALB/c foram imunizados por via subcutânea com salina ou Derp, isoladamente ou associados às vacinas de difteria-tétano (DT) ou DTPw (dias 0, 7 e 14). Posteriormente, os animais sofreram desafio intranasal diariamente com salina ou Derp (dias 22 a 28) e foram sacrificados (dia 29). Avaliamos imunoglobulinas séricas específicas, celularidade no lavado bronco-alveolar (BAL), remodelamento das vias aéreas inferiores, densidade de leucócitos polimorfonucleares (PMN) e área de muco ácido no epitélio nasal. Resultados: Os animais sensibilizados com Derp produziram altos níveis de imunoglobulinas específicas, apresentaram aumento da densidade de PMN e da área de muco ácido nasal, elevação da celularidade no BAL e remodelamento. As vacinas levaram à redução dos níveis de IgE, sendo o grupo Derp-DTPw similar aos grupos salina. Os grupos vacinados tiveram redução da celularidade no BAL e do remodelamento, com resultados mais expressivos no grupo Derp-DTPw em relação ao Derp-DT. As vacinas DT e DTPw inibiram o infiltrado PMN nasal e DTPw modulou a produção do muco ácido. Conclusões: A vacina DTPw diminuiu a IgE específica sérica, inflamação nasal e pulmonar e o remodelamento das vias respiratórias inferiores.

Objective: Adjuvant therapies, such as the use of bacterial lipopolysaccharides, have been evaluated as tools to improve the effectiveness of allergen-specific immunotherapy. Bordetella pertussis vaccine (Pw) has been shown to have a protective role in asthma models induced by ovalbumin. Conversely, its role in allergy to dust mites is unknown. We evaluated the effects of diphtheria-tetanus-pertussis vaccine (DTPw) in a murine model of respiratory allergy induced by Dermatophagoides pteronyssinus (Derp). Methods: Over a 30-day protocol, BALB/c mice were immunized subcutaneously with saline or Derp, alone or combined with diphtheria-tetanus vaccine (DT) or DTPw (days 0, 7, and 14). Then, they were subjected to intranasal challenge with saline or Derp daily (days 22 to 28), and sacrificed on day 29. We evaluated serum specific immunoglobulins, bronchoalveolar lavage (BAL) cellularity, lower airway remodeling, density of polymorphonuclear leukocytes (PMN), and acidic mucus area in the nasal epithelium. Results: Animals sensitized to Derp produced high levels of specific immunoglobulins, showed increased PMN density and acidic mucus in the nasal mucosa, and elevated BAL cellularity and remodeling. Vaccines led to the reduction of IgE levels, with the Derp-DTPw group showing similar results to those of the saline groups. Vaccinated groups showed reduced BAL cellularity and airway remodeling, with more expressive results in the Derp-DTPw group compared to Derp-DT. DT and DTPw vaccines inhibited PMN infiltration in nasal mucosa, and DTPw modulated the production of acidic nasal mucus. Conclusions: DTPw vaccine decreased serum specific IgE, nasal and pulmonary inflammation, and lower airway remodeling.

Síndrome de Nicolau por la administración de la vacuna séxtuple intramuscular en un lactante de 6 meses / Nicolau syndrome induced by intramuscular injection of a hexavalent vaccine in a 6-month-old girl

El síndrome de Nicolau, también conocido como embolia cutis medicamentosa o dermatitis livedoide, es una reacción cutánea infrecuente, caracterizada por una necrosis de la piel y los tejidos blandos de aparición súbita luego de la aplicación intramuscular de algunas drogas. Presentamos a un bebé de 6 meses de edad que, al recibir la tercera dosis de la vacuna séxtuple intramuscular, desarrolló una lesión necrótica con reticulado violáceo periférico en el sitio de aplicación. Se destaca la importancia del diagnóstico precoz a fin de instaurar un adecuado tratamiento y seguimiento para evitar complicaciones secundarias a la isquemia.

Nicolau syndrome, also known as embolia cutis medicamentosa or livedo-like dermatitis, is a sudden tissue necrosis, a rare complication of intramuscular injection of some drugs. We report a case of a 6-month-old girl who received intramuscularly the third dose of hexavalent vaccine (DTaP-HVB-IPV/HIb), and immediately presented a livedoid lesion around the injection site, progressing to necrosis. We reinforce the importance of early diagnosis to perform a suitable treatment and clinical follow-up to avoid ischemic secondary complications.

State of equity: childhood immunization in the World Health Organization African region

Introduction: in 2010, the Global Vaccine Action Plan called on all countries to reach and sustain 90% national coverage and 80% coverage in all districts for the third dose of diphtheria-tetanus-pertussis vaccine (DTP3) by 2015 and for all vaccines in national immunization schedules by 2020. The aims of this study are to analyze recent trends in national vaccination coverage in the World Health Organization African Region and to assess how these trends differ by country income category.Methods: we compared national vaccination coverage estimates for DTP3 and the first dose of measles-containing vaccine (MCV) obtained from the World Health Organization (WHO)/United Nations Children's Fund (UNICEF) joint estimates of national immunization coverage for all African Region countries. Using United Nations (UN) population estimates of surviving infants and country income category for the corresponding year, we calculated population-weighted average vaccination coverage by country income category (i.e., low, lower middle, and upper middle-income) for the years 2000, 2005, 2010 and 2015.Results: DTP3 coverage in the African Region increased from 52% in 2000 to 76% in 2015,and MCV1 coverage increased from 53% to 74% during the same period, but with considerable differences among countries. Thirty-six African Region countries were low income in 2000 with an average DTP3 coverage of 50% while 26 were low income in 2015 with an average coverage of 80%. Five countries were lower middle-income in 2000 with an average DTP3 coverage of 84% while 12 were lower middle-income in 2015 with an average coverage of 69%. Five countries were upper middle-income in 2000 with an average DTP3 coverage of 73% and eight were upper middle-income in 2015 with an average coverage of 76%.Conclusion: disparities in vaccination coverage by country persist in the African Region, with countries that were lower middle-income having the lowest coverage on average in 2015. Monitoring and addressing these disparities is essential for meeting global immunization targets

Missed opportunities and barriers for vaccination: a descriptive analysis of private and public health facilities in four African countries

Introduction: missed opportunities and barriers to vaccination limit progress toward achieving high immunization coverage and other global immunization goals. Little is known about vaccination practices contributing to missed opportunities and barriers among private healthcare providers in Africa.Methods: Service Provision Assessments (SPA) of representative samples of health facilities in four African countries (Kenya, Tanzania, Senegal, Malawi) in 2010-2015 were used to describe missed opportunities and barriers for vaccination in public, private for-profit, private not-for-profit and faith-based facilities. Data included vaccination practices, observations during sick child and antenatal visits, and exit interviews following sick child visits.Results: data from 3,219 health facilities, 11,613 sick child visits and 8,698 antenatal visits were included. A smaller proportion of for-profit facilities offered child vaccination services (country range, 25-37%) than did public facilities (range, 90-96%). The proportion of facilities offering pentavalent vaccine (diphtheria, pertussis, tetanus, hepatitis B and Haemophilus influenza type b antigens) daily ranged 0-77% across countries and facility types. Less than 33% of for-profit facilities in any country offered measles vaccination daily. A minority of public or private providers assessed the child's vaccination status during a sick child visit (range by country and facility type, 14-44%), or offered tetanus toxoid during antenatal visits (range, 19-51%). Very few providers discussed the importance of newborn vaccination. Conclusion: substantial missed opportunities for, and barriers to, vaccination were identified across this representative sample of health facilities in four African countries. Strategies are needed to ensure that private and public providers implement practices to minimize barriers and missed opportunities for vaccination

Análise da cobertura da vacina dupla em adultos em gestantes de santiago de los caballeros republica dominicana / Analisis de la cobertura de vacuna dupla adulto en embarazadas de santiago de los caballeros republica dominicana / Analysis of the coverage of adult double vaccine in pregnant women of santiago de los caballeros republica dominicana

Introdução: A vacinação é um dos passos importantes que devem ser oferecidos durante agravidez para impedir resultados adversos para mulher e o feto através da imunidade ativa eda imunidade passiva, respectivamente; e uma das medidas preventivas do tétano materno eneonatal é através da vacinação de mulheres grávidas ou em idade fértil com o toxóidetetânico (TT) ou com o toxóide tetânico e diftérico (dT). Recentemente, recomenda-seadministrar o tétano e a difteria em combinação com o componente pertussis acelular (dTpa)para todas as mulheres grávidas durante cada gestação independente do estado imunitárioanterior. Objetivo: Analisar a cobertura da dupla adulto (dT) em grávidas de Santiago de loscaballeros/ Republica Dominicana. Metodologia: Trata-se de um estudo epidemiológico,transversal, descritivo e analítico. As puérperas foram convidadas a participar da investigaçãodurante os dias de hospitalização pós-parto. Foram coletados dados sociodemográficos,obstétricos e dados sobre vacinação da grávida, a partir de um questionário estruturado. Paraanálise do estado de vacinação, foi considerado somente o cartão de vacina e para as dosesadministradas durante a gestação foi considerado tanto o cartão de vacina, quanto o relatoverbal da mulher. Para a tabulacão e análise dos dados utilizou-se o programa STATA versão12.0 com dupla entrada para eliminar possíveis erros de digitacão. A análise contemplou ocálculo das distribuições de frequências absolutas e relativas e foi utilizada a RegressãoLogística Simples de Poisson. Razão de Prevalencia (RP) ajustadas e seus respectivosInvervalos de Confiança foram calculados. Para a verificação do ajuste do modelo final,realizou-se o teste de Hosmer & Lemeshow. Para toda a análise, o nivel de significânciaestatística estabelecido foi de 5% (p < 0,05)...

Introduction: Vaccination is one of the important steps that must be taken during pregnancyto prevent adverse outcomes for women and the fetus through active immunity and passiveimmunity, respectively; and one of the preventive measures for maternal tetanus and neonatalis through the vaccination of pregnant or fertile women with tetanus toxoid (TT) or withtetanus and diphtheria toxoid (dT). Recently, it is recommended to administer tetanus anddiphtheria in combination with the acellular pertussis component (dTpa) for all pregnantwomen during each pregnancy regardless of the previous immune status. Objective: Toanalyze the double adult vaccine (dT) in pregnant women from Santiago de los Caballeros /Dominican Republic. Methods: This is an epidemiological, transversal, descriptive andanalytical study. The puerperal were invited to participate in the research during the days oftheir postpartum hospitalization. Sociodemographic, obstetric, health status and data onvaccination of pregnant women were collected from a structured questionnaire. For theanalysis of the variables as vaccinated situation, only the vaccination card was considered andfor the dose administered during pregnancy, both the vaccination card and the verbal report ofthe woman were considered. Epi Data program with double entry was used to tabulate andanalyze the data. The analysis included the calculation of the absolute and relative frequencydistributions and Simple Poisson Regression with robust variances was used. AdjustedPrevalence Ratios (RP) and their respective confidence intervals were calculated. In order toadjust the verification of the final model, the Hosmer & Lemeshow test was performed. Forall analyzes, the level of statistical significance was set at 5% (p <0.05)...

Introducción: La vacunación es uno de los pasos importantes que se debe dar durante elembarazo para impedir resultados adversos para la mujer y el feto a través de la inmunidadactiva y de la inmunidad pasiva, respectivamente; y una de las medidas preventivas deltétanos maternal y neonatal es a través de la vacunación de las mujeres embarazadas o enedad fértil con toxoide tetánico (TT) o con toxoide tetánico y diftérico (dT). Recientemente,se recomienda administrar el tétanos y la difteria en combinación con el componente de la tosferina acellular (dTpa) para todas las mujeres embarazadas durante cada embarazoindependientemente del estado inmunitario anterior. Objetivo: Analizar la cobertura duplaadulto (dT) en embarazadas de Santiago de los caballeros/ Republica Dominicana. Métodos:Se trata de un estudio epidemiológico, transversal, descriptivo y analítico. Las puérperasfueron invitadas a participar en la investigación durante los días de su hospitalización delpost- parto. Fueron colectados datos sociodemográficos, obstétrica, el estado de salud y datossobre vacunación de la embarazada, a partir de un cuestionario estructurado. Para el análisisde las variables como estado de vacunación fue considerado solamente la tarjeta de vacuna ypara la dosis administrada durante el embarazo fue considerada tanto la tarjeta de vacunacomo el relato verbal de la mujer. Para la tabulación y el análisis de los datos se utilizó elprograma de Epi Data y STATA versión 12.0 con doble entrada para eliminar posibles erroresde digitación. El análisis contempló el cálculo de las distribuciones de frecuencias absolutas yrelativas y fue utilizada Regresión Simples de Poisson con variancias robustas. Razones dePrevalencia (RP) ajustadas y sus respectivos Invervalos de Confianza fueron calculados. Parala verificación de ajuste del modelo final, se realizó el test de Hosmer & Lemeshow...

Awareness and practices on adult vaccination of obstetrician-gynecologists in the Philippines / Philippine Journal of Obstetrics and Gynecology

BACKGROUND: Adult vaccination is necessary in the prevention of many of the most common infectious diseases because immunity from infant vaccination typically wanes in adulthood In the female population the obstetrician gynecologist is placed at the forefront of health promotion and disease prevention In 2011 the Philippine Obstetrics and Gynecology Society POGS released a Clinical Practice Guideline on Immunization for Filipino Women but no study has been done to determine its impact OBJECTIVE: This study determined the awareness and practices of OB GYN specialists on adult vaccination and their perceived hindrances to routine administration of the recommended vaccines METHODS: A self administered questionnaire was given to the POGS fellows through email phone and personal visits RESULTS: Almost all of the respondents 95 were aware of Clinical Practice Guideline on Immunization but only 4 of the OB GYNs routinely administered all the vaccines The most common vaccinne administered was Human Papilloma Virus HPV vaccine 42 7 followed by Influenza virus vaccine 28 1 and Hepatitis B vaccine 27 3 There is no significant relationship between age of the respondent the number of years in practice place of practice affiliation with a teaching hospital or subspeciality training and vaccine recommendation and administration There is a significant positive relationship between awareness of the guidelines and the frequency of recommending the Tetanus Diphtheria Pertussis Tdap vaccine and the Influenza vaccine Similarly awareness of the guidelines was related to increased frequency of administering the Human Papilloma Virus HPV vaccine and the Influenza vaccine CONCLUSION: Hence adult vaccination coverage may be promoted by increasing the awareness of the obstetrician gynecologists of the POGS Clinical Practice Guidelines on Immunization Although cost remains to be an issue identified by 93 of the respondents increasing awareness among OB GYNs on the importance of adult vaccination through the CPG on Immunization and or through attendance of the Vaccinology 101 Course through vaccinology courses may ultimately help decrease the incidence of some of the most coomon infectious diseases affecting the Filipino women and their children.

Episodio de Hipotonía e Hiporreactividad posterior a la aplicación de vacunas en Cuba durante el período 2012-2013 / Hypotonic-hyporesponsive episodes after the application of vaccines in Cuba during the period 2012-2013

Introducción: la vacuna contra la difteria, la tos ferina (células enteras) y el tétanos que protege contra estas enfermedades, inició su uso en la década de 1940, logró una disminución considerable de estas enfermedades. Pero también, surgieron numerosos eventos asociados a esta vacuna. Uno de ellos es el Episodio de Hipotonía e Hiporreactividad, reportado con menor frecuencia, a las vacunas contra Haemophilus influenzae tipo b y la hepatitis B. Es un evento poco conocido y raro. Objetivo: mejorar el conocimiento sobre esta entidad. Métodos: se realizó un estudio observacional retrospectivo de los Episodio de Hipotonía e Hiporreactividad (según niveles de certeza diagnóstica), reportados durante 2012 y 2013 por el médico de familia al sistema de vigilancia de eventos adversos, procedentes de todas las provincias. Resultados: fueron reportados 27 Episodio de Hipotonía e Hiporreactividad. El 92,6 por ciento correspondió a la vacuna pentavalente, para una tasa de 3,2 x 105 Dosis Aplicadas. El 74 por ciento se notificaron en las primeras 12 horas. Se observó con mayor frecuencia después de la primera dosis, para un 48 por ciento y el 85,4 por ciento ocurrió en los menores de 6 meses. La fiebre, el llanto persistente, los vómitos, el decaimiento y la somnolencia fueron los síntomas asociados con esta entidad. Conclusiones: la vigilancia de este episodio ha permitido conocer el tiempo de aparición después de aplicar la vacuna, dosis, edad y si está asociado con otros síntomas. Constituye un primer acercamiento a este evento, para mejorar su conocimiento, lo cual permitirá continuar con la seguridad y confiabilidad del Programa Nacional de Inmunización en Cuba(AU)