Eventos adversos após a vacina papilomavírus humano em adolescentes no estado de Minas Gerais / Eventos adversos después de la vacunación contra el virus del papiloma humano, en adolescentes en el estado de Minas Gerais / Adverse events following human papillomavirus vaccine in adolescents in the state of Minas Gerais

RESUMO Objetivo: investigar as notificações dos eventos adversos pós-vacinação papilomavírus humano no estado de Minas Gerais, de acordo com a localidade de notificação, a causalidade, a gravidade e a evolução dos casos. Métodos: estudo epidemiológico realizado com os dados de 2015-2019, notificados no Sistema de Informação de Vigilância de Eventos Adversos. Os dados foram analisados e apresentados em proporções, segundo as macrorregiões de saúde e os anos do estudo. Resultados: em 2015, foram notificados 26,41% eventos adversos, sendo o ano com maior notificação. Na análise das macrorregiões de saúde, Vale do Jequitinhonha apresentou a menor prevalência de registro (0,43%), e a Centro a maior prevalência de notificação (30,95%). Os eventos adversos locais mais prevalentes foram: dor (56,48%) e edema (38,89%). Já quanto aos eventos sistêmicos, a cefaleia (29,69%) e a gastroenterite (29,69%) tiveram os maiores registros de casos. Os eventos classificados como adversos não graves (59,82%) foram os mais prevalentes, e quanto à causa, 35,94% deles foram atribuídos aos erros de imunização. Conclusão: este estudo reforça que os eventos adversos pós-vacina de HPV foram, em sua maioria, eventos não graves, demonstrando, portanto, a segurança da vacina HPV para o público adolescente, contribuindo para o aumento das taxas de cobertura vacinal.

RESUMEN Objetivo: investigar las notificaciones de eventos adversos de papilomavirus humano en el Estado de Minas Gerais, según la localidad de notificación, la causalidad, la gravedad y la evolución de los casos. Métodos: estudio epidemiológico realizado con datos de 2015-2019, notificados en el Sistema de Información de Vigilancia de Eventos Adversos. Los datos fueron analizados y presentados en proporciones, según las macrorregiones sanitarias y los años del estudio. Resultados: en 2015 se notificaron un 26,41% de eventos adversos, siendo el año con mayor notificación. Al analizar las macrorregiones sanitarias, el Valle de Jequitinhonha tuvo la menor prevalencia de registro, con un 0,43%, y el Centro tuvo la mayor prevalencia de notificación (30,95%). Los efectos adversos locales más frecuentes fueron el dolor (56,48%) y el edema (38,89%). En cuanto a los eventos sistémicos, la cefalea (29,69%) y la gastroenteritis (29,69%) presentaron el mayor número de casos. Los eventos clasificados como adversos no graves (59,82%) fueron los más prevalentes y, en cuanto a la causa, el 35,94% de ellos se atribuyeron a los errores de inmunización. Conclusión: este estudio refuerza que los eventos adversos posteriores a la vacuna contra el VPH fueron en su mayoría eventos no graves, demostrando así la seguridad de la vacuna contra el VPH para el público adolescente y contribuyendo al aumento de las tasas de cobertura de vacunación.

ABSTRACT Objective: to investigate reports of adverse events following human papillomavirus vaccination in the state of Minas Gerais, according to the location of notification, causality, severity, and evolution of cases. Methods: epidemiological study carried out with data from 2015-2019, reported in the Adverse Event Surveillance Information System. Data were analyzed and presented in proportions, according to health macro-regions and years of study. Results: in 2015, 26.41% of adverse events were reported, being the year with the highest number of notifications. In the analysis of health macro-regions, Vale do Jequitinhonha had the lowest prevalence of registration (0.43%), and the Center had the highest prevalence of notification (30.95%). The most prevalent local adverse events were pain (56.48%) and edema (38.89%). As for systemic events, headache (29.69%) and gastroenteritis (29.69%) had the highest number of cases. Events classified as non-serious adverse events (59.82%) were the most prevalent, and regarding the cause, 35.94% of them were attributed to immunization errors. Conclusion: this study reinforces that adverse events following HPV vaccination were, for the most part, non-serious events, thus demonstrating the safety of the HPV vaccine for the adolescent public, contributing to the increase in vaccine coverage rates.

Eventos adversos supuestamente atribuibles a la vacunación e inmunización asociados a la vacuna anti-COVID-19 Sputnik V en el personbal del hospital Juan P. Garrahan / Adverse events allegedly attributable to vaccination and immunization with the anti-COVID-19 Sputnik V vaccine in the staff of the Hospital Juan P. Garrahan

Introducción: Debido a la emergencia provocada por la pandemia por el virus SARS-CoV-2 se ha producido una crisis sanitaria global. Una vez disponibles las vacunas, se espera que jueguen un rol decisivo para el control de la enfermedad. Dichas vacunas fueron desarrolladas en tiempo récord por lo que es esencial monitorear su seguridad. Durante la Campaña de Vacunación contra COVID-19, todos los Eventos supuestamente atribuibles a vacunación e inmunización (ESAVI) debieron ser notificados al Ministerio de Salud de la Nación a través del Sistema Integrado de Información Sanitaria de Argentina (SIISA). Materiales y métodos: Se realizó un estudio observacional prospectivo desde el 04/01/2021 al 05/05/2021 en el personal del Hospital Garrahan. Se utilizaron dos métodos de vigilancia de ESAVI. La vigilancia pasiva incluyó las notificaciones voluntarias recibidas de forma telefónica y a través de un cuestionario publicado en intranet. La vigilancia activa se realizó sobre los primeros 947 trabajadores inmunizados, enviando el mismo cuestionario por WhatsApp. Resultados: Hasta el día 05/05/2021 fueron inmunizados 5056 agentes, 4865 con las dos dosis. Se notificaron 473 ESAVI. De ellos, 304 correspondían a la primera dosis y 169 a la segunda. La cantidad de notificaciones según su origen fue de 136 para la vigilancia pasiva, y 333 para la vigilancia activa. Se registraron 5 ESAVI graves; tres anafilaxias, un escotoma secundario a la hipertermia generada por la vacuna y una reacción alérgica grave. Los síntomas locales más frecuentes fueron: dolor, enrojecimiento, hinchazón e induración. Los síntomas sistémicos más frecuentes fueron: fiebre, febrícula, astenia, cefalea, mialgia, artralgia y síntomas gastrointestinales. Como tratamiento en la mayoría de los casos se utilizó paracetamol. Discusión: El presente trabajo logró recolectar un número significativo de notificaciones, brindando información útil al tratarse de una vacuna recientemente aprobada en nuestro país y el mundo. (AU)

Introduction: Due to the SARS-CoV-2 pandemic emergency, a global health crisis has occurred. Once vaccines become available, they are expected to play a decisive role in controlling the disease. These vaccines were developed in record time, and therefore it is essential to monitor their safety. During the COVID-19 Vaccination Campaign, all Events Suspected to be Attributable to Vaccination and Immunization (ESAVI) had to be notified to the National Ministry of Health through the Integrated Health Information System of Argentina (SIISA). Material and methods: A prospective observational study was conducted from 04/01/2021 to 05/05/2021 in the staff of Garrahan Hospital. Two methods of ESAVI surveillance were used. Passive surveillance included voluntary notifications received by telephone and through a questionnaire posted on intranet. Active surveillance was conducted on the first 947 immunized workers, sending the same questionnaire by WhatsApp. Results: Up to 05/05/2021, 5056 workers were immunized, of whom 4865 with two doses. A total of 473 ESAVI were reported. Of these, 304 corresponded to the first dose and 169 to the second. The number of notifications was 136 for passive surveillance and 333 for active surveillance. Five severe ESAVIs were recorded; three anaphylaxis, one scotoma secondary to vaccine-generated hyperthermia, and one severe allergic reaction. The most frequent local symptoms were: pain, redness, swelling, and induration. The most frequent systemic symptoms were: mild fever or fever, asthenia, headache, myalgia, arthralgia, and gastrointestinal symptoms. Paracetamol was used as treatment in most cases. Discussion: In the present study a significant number of notifications was collected, providing useful information on a vaccine recently approved in our country and in the world (AU)

Guía de vigilancia de eventos supuestamente atribuibles a la vacunación e inmunización: Bolivia 2021 / Surveillance guide for events supposedly attributable to vaccination and immunization: Bolivia 2021

El presente documento establece los lineamientos técnicos para la vigilancia integrada de los Eventos Supuestamente Atribuibles a la Vacunación e Inmunización (ESAVI) El documento se estructura en seis capítulos: en el Capítulo I se enfatiza el impacto de las vacunas en el perfil epidemiológico de la salud infantil y se establecen los objetivos del manual y de la vigilancia integrada de los Eventos Supuestamente Atribuibles a la Vacunación e Inmunización, ESAVI. En el Capítulo II se describen los componentes de la vacunación segura como la Calidad e inocuidad, Transporte y almacenamiento seguro, Inyecciones seguras, Disposición final y la Vigilancia de ESAVI como elemento importante en la vacunación segura. En el Capítulo III se describe el marco conceptual de los ESAVI y los parámetros de clasificación final de los mismos. En el Capítulo IV se describen cada uno de los pasos de la vigilancia epidemiológica de los ESAVI desde la detección, la evaluación inicial, notificación, investigación, reporte, plan de acción, seguimiento y retroalimentación. Además, se establece las responsabilidades compartidas entre el personal operativo, el Programa Ampliado de Inmunización (PAI) y la Agencia Estatal de Medicamentos y Tecnología en salud, (AGEMED). En el capítulo V se expone el protocolo de investigación de los ESAVI desde la definición de que se va a investigar, como recolectar la información, el análisis de la información, planificar, ejecutar, evaluar acciones y el Informe de investigación del ESAVI. En el Capítulo VI se describe todos los elementos de la gestión de crisis que incluye líneas de acción estratégica que se deben adoptar al interior del Programa para evitar, prevenir o contener la aparición y desarrollo de amenazas que puedan poner en riesgo la implementación adecuada y oportuna de sus procesos

Adverse events following immunization in pregnant women from Minas Gerais / Eventos adversos pós-vacinação em gestantes de Minas Gerais

ABSTRACT OBJECTIVE: To analyze the distribution of adverse events following immunization (AEFI) in pregnant women in the state of Minas Gerais, between 2015 and 2019. METHODS: This is an epidemiological, descriptive study conducted with AEFI data from 2015 to 2019, recorded in the Adverse Events Surveillance Information System, in the state of Minas Gerais (MG), Brazil. A total of 670 AEFI were analyzed in pregnant women. The estimates were presented in proportions, according to the year of occurrence, health macro-region of Minas Gerais and immunobiological administered. RESULTS: The year in which there were the most records was 2017 (36.8%). Among the 14 macro-regions, the ones with the lowest and highest number of records were the Vale do Jequitinhonha (0.5%) and Center (31.8%), respectively. The vaccines contraindicated during pregnancy represented 27.6% of the total notifications. The total of 69.5% of the cases were considered immunization errors. In 75.9% of the records, the variable of medical care was ignored, and in 73.7% of the cases no information on the evolution was presented. CONCLUSION: This study shows the need for continuing education for the multidisciplinary team, in order to reduce cases of AEFI and ensure the adequate completion of notifications by health professionals.

RESUMO OBJETIVO: Analisar a distribuição dos eventos adversos pós-vacinação (EAPV) em gestantes do estado de Minas Gerais, entre 2015 e 2019. MÉTODOS: Estudo epidemiológico, descritivo, realizado com dados de EAPV, do período de 2015 a 2019, registrados no Sistema de Informação da Vigilância de Eventos Adversos, no estado de Minas Gerais (MG), Brasil. Foram analisados 670 EAPV em gestantes. As estimativas foram apresentadas em proporções, de acordo com o ano de ocorrência, macrorregião de saúde de Minas Gerais e imunobiológico administrado. RESULTADOS: O ano em que mais houve registros foi 2017 (36,8%). Entre as 14 macrorregiões, as com menor e maior número de registros foram o Vale do Jequitinhonha (0,5%) e o Centro (31,8%), respectivamente. As vacinas contraindicadas durante a gestação representaram 27,6% do total de notificações. Foram considerados como erros de imunização 69,5% dos casos. Em 75,9% dos registros, a variável de atendimento médico foi ignorada, e em 73,7% dos casos não foi apresentada informação sobre a evolução. CONCLUSÃO: Este estudo expõe a necessidade da educação continuada para a equipe multidisciplinar, a fim de reduzir casos de EAPV e garantir o preenchimento adequado das notificações pelos profissionais de saúde.

Adverse events following immunization against SARS-CoV-2 (covid-19) in the state of Minas Gerais / Eventos adversos pós-vacinação contra o SARS-CoV-2 (covid-19) no estado de Minas Gerais

ABSTRACT OBJECTIVE To analyze adverse events following immunization (AEFI) against SARS-CoV-2 (covid-19) in the state of Minas Gerais (MG), Brazil. METHODS Epidemiological, descriptive study, with data from e-SUS Notifica (e-SUS Notification) in the state of Minas Gerais from January 20 to March 5, 2021. All suspected cases of AEFI of the covid-19 vaccine in the state were analyzed, totaling 7,305 cases. In this study, we verified the possible correlation between AEFI and the possible immunobiological administered causalities. The variables analyzed for AEFI cases were the immunobiological agent administered (AstraZeneca or Coronavac), the type of event, the evolution of the case, and the time in days since the administration of the immunobiological agent and the onset of symptoms and causality. The incidence rate (IT) was calculated for 100,000 doses applied. RESULTS The occurrence of AEFI as a result of the covid-19 vaccine was frequent (TI: 777.12) in the state. However, only 3% were classified as a severe AEFI, with a 20.85 IT, and 4.71% of them evolved to deaths (8.19 deaths per 100,000 doses applied). Among the deaths analyzed, 84.4% were classified as preexisting conditions caused by factors other than vaccines. Regarding non-serious AEFI, 1.11% occurred by immunization errors (TI: 8.62 EI for every 100 thousand doses applied). CONCLUSION This work encourages the discussion about the importance of recording AEFI related to covid-19 vaccines, demonstrating its safety for the population.

RESUMO OBJETIVO Analisar os eventos adversos pós-vacinação (EAPV) contra o SARS-CoV-2 (covid-19) no estado de Minas Gerais (MG). MÉTODOS Estudo epidemiológico, descritivo, com dados do e-SUS Notifica no estado de Minas Gerais durante o período de 20 de janeiro a 5 de março de 2021. Foram analisados todos os casos suspeitos de EAPV da vacina contra covid-19 no estado, totalizando 7.305 casos. Para este estudo, verificou-se a possível correlação entre os EAPV e a causalidade com o imunobiológico administrado no período estabelecido. As variáveis analisadas para os casos de EAPV foram o imunobiológico administrado (AstraZeneca ou Coronavac), o tipo de evento, a evolução do caso e o tempo em dias da administração do imunobiológico e o início dos sintomas e causalidade. Calculou-se a taxa de incidência (TI) para 100 mil doses aplicadas. RESULTADOS A ocorrência dos EAPV em decorrência da vacina contra covid-19 foi frequente (TI: 777,12) no estado. Entretanto, somente 3% foram classificados como EAPV grave, com TI de 20,85, sendo que 4,71% deles evoluíram para óbitos com TI (8,19 óbitos a cada 100 mil doses aplicadas). Dentre os óbitos analisados, 84,4% foram classificados como condições preexistentes causadas por outros fatores e não por vacinas. Em relação aos EAPV não graves, 1,11% foram em decorrência de erros de imunização (TI: 8,62 EI a cada 100 mil doses aplicadas). CONCLUSÃO Esse trabalho fomenta, portanto, a discussão sobre a importância dos registros dos EAPV decorrentes das vacinas contra covid-19, demonstrando sua segurança para a população.

Farmacovigilancia de vacunas y su aplicación en Chile / Vaccine pharmacovigilance and its application in Chile

La inmunización se encuentra entre las intervenciones en salud pública más exitosas y costo efectivas de todas las épocas, siendo su beneficio tan importante como su seguridad. Las vacunas, como cualquier otro medicamento, pueden generar eventos adversos, los que deben ser monitorizados permanentemente por sistemas de vigilancia. Esta disciplina recibe el nombre de Farmacovigilancia de Vacunas (FVV), encargada de estudiar los Eventos Supuestamente Atribuidos a la Vacunación ó Inmunización (ESAVI). El objetivo de este trabajo es revisar la evolución del sistema de farmacovigilancia de vacunas en Chile. El sistema de FVV chileno se basa en la vigilancia pasiva, y contempla la notificación obligatoria al Instituto de Salud Pública (ISP) de todos los ESAVI detectados, por parte de profesionales de la salud, directores de establecimientos y titulares de registro sanitario, priorizando las notificaciones de ESAVI serios e incluyendo la monitorización de todas las vacunas usadas en el país, tanto las que se encuentran incorporadas al Programa Nacional de Inmunización (PNI), como las que se encuentran fuera de este. El sistema de FVV chileno se caracteriza por un trabajo colaborativo permanente entre el ISP y el PNI, y parte de sus desafíos incluyen generar capacidades y alianzas estratégicas con la academia para la realización de estudios post comercialización sobre seguridad de vacunas. Finalmente, es importante destacar que tanto el marco normativo promulgado el año 2010, como la elaboración de procedimientos, el trabajo permanente con el PNI, y la conformación de un comité de expertos de ESAVI, y las diferentes estrategias de retroalimentación, son medidas implementadas que han contribuido a mejorar la tasa de reporte nacional y el análisis de los casos.

Immunization is among the most successful and cost-effective public health interventions of all times, its benefits being as important as its safety. Vaccines, like any other medicine, can generate adverse events, which must be permanently monitored by surveillance systems. Vaccine Pharmacovigilance (VPV) is the discipline responsible for studying Adverse Events Following Immunization (AEFI). The objective of this article is to review the evolution of the pharmacovigilance system of vaccines in Chile. The Chilean VPV system is based on passive surveillance, and establishes the mandatory reporting of all AEFI detected by healthcare workers, directors of healthcare facilities, and Marketing Authorization holders, to the Public Health Institute of Chile (PHI), prioritizing the reporting of serious ESAVI and including the monitoring of all vaccines used in the country, both those that are incorporated into the National Immunization Program (NIP), and those that are outside of it. The Chilean VPV system is characterized by a permanent collaborative work between the PHI and the NIP, and its challenges include generating capacities and strategic alliances with the academy to carry out post-marketing studies on vaccine safety. Finally, it's important to point out that the regulatory framework promulgated in 2010, as well as the elaboration of procedures, the permanent work with the NIP, the formation of an AEFI expert committee, and the different feedback strategies implemented, have contributed in improving case analysis and the national reporting rate.

Respuesta inmune y alergia a vacunas / Immune response and allergies to vaccines

Las vacunas son altamente efectivas en prevenir enfermedades infecciosas a través del desarrollo en el individuo de una respuesta inmune protectora, sin desarrollar la enfermedad. Los distintos tipos de vacunas producen diferentes tipos de respuestas inmunes y variadas estrategias se han desarrollado para mejorar esta respuesta. El sistema inmune sufre cambios con la edad y esta inmunosenecencia altera la capacidad de responder frente a ellas. Por otro lado, si bien el sistema inmune puede reconocer elementos presentes en las vacunas y montar respuestas de hipersensibilidad ante ellos, las alergias a las vacunas son raras, teniendo que distinguirlas adecuadamente de otro tipo de reacciones. En caso que un paciente presente una reacción compatible con alergia, es importante conocer todos los componentes de la vacuna para realizar un estudio adecuado.

Vaccines are highly effective in preventing infectious diseases through the development in the individual a protective immune response, without developing the disease. Different types of vaccines produce different types of immune responses, and varied strategies have been developed to improve this response. The immune system undergoes changes with age, and this inmunosenescence alters the ability to respond to them. On the other hand, although the immune system can recognize elements present in vaccines and establish hypersensitivity responses to them, vaccine allergies are rare, having to properly distinguish them from other types of reactions. In the event that a patient has an allergy-compatible reaction, it is important to know all the components of the vaccine to conduct a proper study.

Estrategias de enfermería para la prevención de errores programáticos en vacunatorio / Nursing strategies for the prevention of programmatic errors in vaccination

El Programa Nacional de Inmunizaciones (PNI) nace el año 1978 en Chile, considerando dentro de sus objetivos la prevención de la morbilidad, discapacidad y muertes secundarias a enfermedades inmunoprevenibles a lo largo de todo el ciclo vital. Dentro de los eventos asociados al proceso de inmunización y que el PNI contempla desde sus inicios, se encuentran los "Errores Programáticos en vacunación" (EPRO), definidos como eventos relacionados con los aspectos operativos de la vacunación, evitables, que no cumplen con las normas establecidas y que no causaron daño en el paciente. La gestión y prevención de los EPRO son vitales para asegurar la calidad y seguridad en la atención de pacientes durante todo su ciclo vital, debido a que a partir de estos se efectúan medidas correctivas y se puede realizar una evaluación de las razones de su ocurrencia pudiendo así evitar su futura aparición, a través de la elaboración de lineamientos para su prevención. Esta tarea ha sido liderada por los equipos de enfermería desde los inicios del proceso de inmunización en nuestro país y la cual se ha demostrado mediante estrategias como la estandarización de procesos, implementación de pautas de seguridad durante todo el proceso de vacunación, realización de reportes de errores con información detallada y veraz, programas de mejoras continua, evaluación de pautas de calidad de procesos, sistemas de gestión de control de stock, trabajo en equipo y metodologías de comunicación efectivas.

The Expanded Program on Immunization (EPI) in Chile, was born in 1978, considering within its objectives the prevention of morbidity, disability and deaths secondary to immunoprevenible diseases throughout the entire life cycle. Among the risks associated with the immunization process and that the EPI contemplates since its inception, there are the "Programmatic Errors in Vaccination" (EPRO), defined as attitudes or procedures that do not comply with the established norms of vaccination and that alone or in together they can generate serious and fatal adverse events. The management and prevention of events such as EPROs are vital for the assurance of quality and safety in patient care throughout their life cycle, a task that the Nursing team has been responsible for leading since the beginning of the immunization process in our country and which has been demonstrated through strategies such as process standardization, implementation of safety guidelines throughout the vaccination process, reporting of errors with detailed and truthful information, continuous improvement programs, evaluation of quality guidelines of processes, stock control management systems, teamwork and effective communication methodologies.

Prevalence of red blood cell alloimmunization in multiply transfused patients

Introduction: To analyze the prevalence of alloantibodies in multiply transfused patients. Methods: This study was a retrospective, exploratory and descriptive study with a quantitative approach. The study sample comprised 185 patients transfused at a referral service in the city of Passo Fundo, Rio Grande do Sul, from January 2016 to February 2018. Results: Overall, the antibodies identified were as follows: anti-E in 47 patients (18%), anti-D and anti-K in 28 patients each (11%), anti-C in 21 patients (8.1%), and inconclusive antibody results in 23 patients (8.9%). Females were a majority (55.7%), mean age was 48.8 years and mean quantity of blood transfused was 7.2 bags. Cardiovascular disorders were the most common comorbidities, in 39 patients (21.2%), followed by oncological disorders, in 38 patients (18.4%). Conclusion: Alloimmunization is an important and frequent clinical condition that increases the risk of hemolytic reactions and is associated with significant patient morbidity and mortality. (AU)

O panorama da vigilância de eventos adversos pós-vacinação ao fim da década de 2010: importância, ferramentas e desafios / El panorama de la vigilancia de eventos adversos posvacunación al final de la década de 2010: importancia, herramientas y desafíos / Surveillance of adverse events following immunization in the late 2010s: an overview of the importance, tools, and challenges

A vacinação é uma das ações mais efetivas para proteger o indivíduo e a população contra doenças imunopreveníveis. Vacinas são produtos seguros e eficazes, porém, como qualquer outro medicamento, podem causar eventos adversos, que ganham maior visibilidade na medida em que as doenças são controladas, eliminadas ou erradicadas. Este trabalho analisou as ações de vigilância de eventos adversos pós-vacinação (EAPV) com base em dados da literatura científica e sites de programas de imunizações, agências reguladoras e de saúde, além da expertise dos autores nas áreas de imunizações e farmacovigilância. Com o aumento do número de vacinas no calendário básico e a ampliação do acesso da população, tornou-se fundamental o estabelecimento de um sistema eficiente de vigilância de EAPV no Brasil. Entretanto, a subnotificação de casos no Brasil e em outros países dificulta a detecção de EAPV, principalmente os raros. Informações sempre atualizadas sobre o benefício/risco das vacinas permitem que programas de imunizações deem respostas rápidas e claras aos rumores de EAPV. Isso garante a confiabilidade no sistema, ainda mais diante do crescente movimento antivacinista e a influência cada vez maior das mídias sociais na opinião pública.

La vacunación es una de las acciones más efectivas para proteger al individuo y a la población contra enfermedades inmunoprevenibles. Las vacunas son productos seguros y eficaces, sin embargo, como cualquier otro medicamento, pueden causar eventos adversos, que tienen mayor visibilidad según se controlen, eliminen o se erradiquen las enfermedades. Este trabajo analizó las acciones de vigilancia de eventos adversos posvacunación (EAPV), basándose en datos de la literatura científica y sitios web de programas de inmunizaciones, agencias reguladoras y de salud, además de la expertise de los autores en las áreas de inmunizaciones y farmacovigilancia. Con el aumento del número de vacunas en el calendario básico y la ampliación del acceso de la población, se hizo fundamental el estabelecimiento de un sistema eficiente de vigilancia de EAPV en Brasil. Sin embargo, la subnotificación de casos en Brasil y en otros países dificulta la detección de EAPV, principalmente, los raros. Informaciones siempre actualizadas sobre el beneficio/riesgo de las vacunas permiten que programas de inmunizaciones proporcionen respuestas rápidas y claras a los rumores sobre EAPV. Esto garantiza la confianza en el sistema, incluso más aún ante el creciente movimiento antivacunas y la influencia cada vez mayor de los redes sociales en la opinión pública.

Immunization is one of the most effective measures to protect individuals and the population against vaccine-preventable diseases. Vaccines are safe and effective products, but like any other drug they can cause adverse events, which tend to become more visible as the diseases are controlled, eliminated, or eradicated. This study analyzed activities in the surveillance of adverse events following immunization (AEFI) based on data from the scientific literature, websites of immunization programs and health andregulatory agencies, and the authors' expertise in the areas of immunizations and pharmacovigilance. With the increase in the number of vaccines in the basic immunization schedule and expansion of the population's access, it has become essential to establish an efficient surveillance system for AEFI in Brazil. However, underreporting of cases in Brazil and in other countries hinders the detection of AEFI, especially rare events. Constantly updated information on vaccines' risks and benefits allows immunization programs to provide rapid and clear responses to rumors of AEFI. This ensures the system's reliability, especially in the face of the growing antivaccine movement and the increasing influence of social media in public opinion.

Retrospective study of immunization errors reported in an online Information System / Estudo retrospectivo dos erros de imunização notificados em um Sistema de Informação on-line / Estudio retrospectivo de errores de inmunización reportados en un Sistema de Información en línea

Objective: to analyze the immunization errors reported in an online Information System. Method: retrospective study conducted with data from the Adverse Event Following Immunization Surveillance Information System. Immunization errors were analyzed with respect to demographic characteristics and the vaccination process. Frequencies and error incidence rates have been calculated. Binomial and chi-square tests were used to verify differences in the proportions of the variables. Results: 501 errors were analyzed, the majority involving routine doses (92.6%), without Adverse Event Following Immunization (90.6%) and in children under five years old (55.7%). The most frequent types of errors were inadequacy in the indication of the immunobiological (26.9%), inadequate interval between doses (18.2%) and error in the administration technique (14.2%). The overall error incidence rate was 4.05/100,000 doses applied; the highest incidences of routine vaccines were for human rabies vaccine, human papillomavirus and triple viral; the incidence rate of errors with Adverse Events Following Immunization was 0.45/100,000 doses applied. Conclusion: it was found that immunization errors are a reality to be faced by the health systems, but they are amenable to prevention through interventions such as the adoption of protocols, checklists and permanent education in health.

Objetivo: analisar os erros de imunização notificados em um Sistema de Informação on-line. Método: estudo retrospectivo realizado com dados do Sistema de Informação da Vigilância de Eventos Adversos Pós-Vacinação. Os erros de imunização foram analisados com relação às características demográficas e ao processo de vacinação. Foram calculadas frequências e taxas de incidência dos erros. Os testes binomial e qui-quadrado foram utilizados para verificar diferenças nas proporções das variáveis. Resultados: foram analisados 501 erros, a maioria envolvendo doses de rotina (92,6%), sem Evento Adverso Pós-Vacinação (90,6%) e em crianças menores de cinco anos (55,7%). Os tipos de erros mais frequentes foram inadequação na indicação do imunobiológico (26,9%), intervalo inadequado entre doses (18,2%) e erro na técnica de administração (14,2%). A taxa de incidência global de erros foi de 4,05/100.000 doses aplicadas; as maiores incidências das vacinas de rotina foram para vacina antirrábica humana, papiloma vírus humano e tríplice viral; a taxa de incidência de erros com Eventos Adversos Pós-Vacinação foi de 0,45/100.000 doses aplicadas. Conclusão: verificou-se que erros de imunização são uma realidade a ser enfrentada pelos sistemas de saúde, porém são passíveis de prevenção por meio de intervenções como adoção de protocolos, checklists e educação permanente em saúde.

Objetivo: analizar los errores de inmunización reportados en un Sistema de Información en línea. Método: estudio retrospectivo realizado con datos del Sistema de Información de Vigilancia de Eventos Adversos Posteriores a la Vacunación. Los errores de inmunización se analizaron con respecto a las características demográficas y el proceso de vacunación. Se calcularon las frecuencias y las tasas de incidencia de errores. Se utilizaron pruebas binomiales y de chi-cuadrado para verificar las diferencias en las proporciones de las variables. Resultados: se analizaron 501 errores, la mayoría con dosis de rutina (92,6%), sin evento adverso posterior a la vacunación (90,6%) y en niños menores de cinco años (55,7%). Los tipos de errores más frecuentes fueron la insuficiencia en la indicación del inmunobiológico (26,9%), el intervalo inadecuado entre las dosis (18,2%) y el error en la técnica de administración (14,2%). La tasa de incidencia de error global fue de 4,05/100.000 dosis aplicadas; las mayores incidencias de las vacunas de rutina fueron para la vacuna contra la rabia humana, el virus del papiloma humano y el triple viral; La tasa de incidencia de errores con los eventos adversos posteriores a la vacunación fue de 0,45/100.000 dosis aplicadas. Conclusión: se encontró que los errores de inmunización son una realidad que deben enfrentar los sistemas de salud, pero se pueden prevenir mediante intervenciones como la adopción de protocolos, checklists y educación permanente en salud.

[Comparison the effect of breast feeding with routine clinical procedure on pain relieving during immunization injection]

Pain management is the challenging concepts in health workers. Since neonates have higher pain sensitivity in compare to childhood and adults. The objective of this study was to examine the pain relieving effect of breast feeding during immunization infections in healthy neonates. In this control randomized clinical trial, samples were divided two groups [by age and sex] of 76 healthy 2-4 months old term infants. In breast-fed group, 2 minutes before, during, and 15 seconds after the DPT immunization injection were in mother hug, and in control group as routine of clinic, were lied on the examining table during injection. Appearance of Neonates were observed and assessed by Modified Behavioral Pain Scale[MBPS] during 5 second before immunization to 15 second after it. In breast fed and control group mean of age were 81.53 +/- 41.46 and 81.61 +/- 40.59 day and for weight were 6.65 +/- 1.17 and 6.70 +/- 1.14 kg for height were 64.27 +/- 5.5 and 63.38 +/- 5.06 cm respectively. There were significant differences in Behavioral Pain Scores of two groups include: facial expression [4 items], cry [5 items], and movements [6 items]. [P<0.0001]. There is no statistically significant difference between the 2 groups for age, sex and the time of feeding prior to vaccination. Regarding to significant difference in behavioral of pain responds in two groups, it is suggested, with simple and safe intervention method of straight breast feeding reduce pain during immunization and muscular injections too

Safety and reactogenicity of a low dose diphtheria tetanus acellular pertussis vaccine (Boostrix) in pre-school Indian children.

OBJECTIVE: To evaluate the safety and reactogenicity of a reduced-antigen-content combined Diphtheria Tetanus Acellular Pertussis (dTpa) vaccine in Indian preschool children. METHODS: GlaxoSmithKline Biologicals combination dTpa vaccine was administered as a single booster dose to 347 children aged 46 years in seven centers across India. All children were subsequently followed up for two weeks for safety and reactogenicity assessment. RESULTS: A total of 345 subjects completed the study and two subjects were lost to follow-up. One serious adverse event (head injury) unrelated to vaccination was reported. Otherwise, all subjects were in good health throughout the study period. Three subjects (0.9%) reported transient general symptoms (such as irritability and drowsiness), which prevented normal activity. Pain at injection site, swelling and redness was reported in 31.1%, 18.2% and 8.9% subjects respectively. Five subjects (1.4%) reported severe pain preventing normal movement. This resolved within 48 hours in all cases. There were no other severe local reactions including large injection site reactions. CONCLUSION: The reduced antigen content combined dTpa vaccine is safe and well tolerated in Indian pre-school children.

Antitoxin response to tetanus toxoid [TT] versus combined tetanus -reduced diphtheria [TD] vaccination in pregnant women: clinical trial

Outbreaks of diphtheria in 1990s primarily involved adults. This reflects the decline of immunity with age. It is recommended to use the combined tetanus-diphtheria toxoid [Td] instead of the monovalent tetanus toxoid [TT] whenever tetanus toxoid is indicated. The protective efficacy following the new vaccinations schedule needs to be tested. The present study aimed to compare serum levels of diphtheria and tetanus antitoxin in pregnant women receiving [Td] vaccine and those receiving [TT] tetanus toxoid vaccine. As well as, to compare the frequency of adverse events following immunization between both groups. randomized, double blind controlled trial strategy was adopted. The reference population was pregnant women attending four rural health units in Abu Homos District, Egypt. A simple randomized procedure was used to allocate enrolled subjects [n = 130] to a study group [receiving Td vaccine] and a control group [receiving TT group] in a ratio of 1:1. The study revealed that before the vaccine administration, the mean values of tetanus antitoxin level in the experimental group [who received two doses of Td vaccine] and the control group [who received two doses of TT vaccine] did not differ significantly. After the first dose of vaccination, the mean tetanus antibody level was significantly lower in the Td group than in the TT group [t = 5.51, p < 0.001]. However, after the second dose, the mean tetanus antibody liter for Td group rise to 5.83 +/- 3.99 lU/ml and was still lower than that for the TT group [6.9 +/- 3.27 IU/ml] but this difference was not statistically significant, [t = 1.68, P = 0.096]. There were no significant differences between the two groups as regards the occurrence of systemic adverse events following either the first dose or second dose of Td or TT vaccine. On the other hand, the frequency of local adverse events following the first dose and second dose of Td vaccine were higher than that following TT vaccine. However, the difference was not statistically significant except for occurrence of local pain. The study concluded that tetanus-diphtheria toxoid [Td] can be used instead of single tetanus toxoid [TT] to protect against both tetanus and diphtheria. The local reactions associated with Td are usually self limited and require no therapy

[ effects of breast feeding on pain of injection in newborns]

Pain control in newborns is one of the important tasks, which produced many controversies in pediatric medicine. Nowadays, it is proposed the usage of non-pharmacologic pain control methods. This study has been done to investigate the effect of breast feeding on pain control in newborns. A clinical trial was designed to evaluate analgesic effect of breast-feeding during injection of hepatitis B vaccine. 130 newborns had been referred for hepatitis B vaccination, were selected from Mirza Kochak Khan Hospital, Tehran, Iran. After describing the procedure was described the testimonial was took from parents. They were divided randomly in two groups. In cases group, feeding was begun two minutes before injection and continued for 45 seconds. In the control group injection was made without breast feeding. Pain assessment was performed with Douler Aigue Nouveaune [DAN] scale. In the case group 35.4% of newborns got 4 points and no one got more than 7 points according to DAN scale. In contrast the control group 32.4% got 8 points or more and no one got less than 3 points. The mean of pain severity in case group was 3.5 and in control group was 6.7 and it show significant difference according to Mann-Whitney U test [p<0.0001]. This study shows that breast-feeding can significantly reduce pain in newborns. Therefore, we suggest this simple method generally for all painful procedure to prevent the development of possible permanent psychological effects in newborns

Neuritis óptica por Bartonella Henselae: dos casos: Nº2 / Optic neuritis by Bartonella Henselae: two cases: Nº2

La neuritis óptica es una patología infrecuente en la infancia, pudiendo presentarse de manera primaria o postinfecciosa y, evolutivamente, corresponder a la forma de inicio de una esclerosis múltiple. Sus manifestaciones clínicas incluyen la disminución progresiva de la agudeza visual y la alteración de la percepción de los colores y del campo visual. Sus causas son múltiples, y entre éstas se pueden destacar las patologías desmielinizantes, las vasculitis y las infecciosas. Se muestra el caso de una paciente de 8 años de edad que presentó neuritis óptica bilateral secundaria a la infección por Batonella henselae y se explican la forma de presentación, diagnóstico, tratamiento y evolución de esta patología.

Inibição da migração larval em tecidos de camundongos imunizados com antígenos de / Toxocara vitulorum / Larval migration inhibition in tissues of mice immunized with Toxocara vitulorum antigens

Três grupos de camundongos foram imunizados com os seguintes antígenos de Toxocara vitulorum: fluido perientérico (pe) do parasita adulto, antígenos extrato solúvel bruto (Ex) e excretor/ secretor (ES) de larvas infectantes. Estes três grupos foram comparados com o grupo controle, não imunizado. Todos os grupos foram desafiados uma semana após a imunização com ovos infectantes deste parasita e necropsiados em três períodos diferentes após o desafio: sete horas, quatro dias e 30 dias pós-infecção. Realizou-se a contagem de ovos e de larvas nas fezes dos camundongos e o grupo imunizado com antígeno do fluído perientérico (Pe) foi o que eliminou a maior quantidade de larvas. Após a necropsia, realizou-se a retirada do intestino delgado, intestino grosso, fígado, pulmão, coração, cérebro e músculos (diafragma, língua e quadríceps femoral). Estes tecidos sofrearam digestão péptica e as larvas foram identificadas e contadas em cada um deles. O maior número de larvas foi encontrado no intestino grosso no período de sete horas após o desafio, em todos os grupos examinados, porém, este número foi significativamente inferior nos grupos imunizados. Com quatro dias após o desafio, as larvas concentravam-se, preferencialmente, no fígado e pulmões, e os grupos imunizados apresentaram uma quantidade muito menor de larvas, significativo para o fígado e pulmão em relação ao grupo controle. No período de 30 dias após o desafio, as larvas recuperadas no cérebro e no músculo, mesmo que em pequena quantidade, demonstraram capacidade de alcançar estes tecidos. A efetividade destaimunização baseou-se na redução do número de larvas de T. vitulorum no fígado no quarto dia pós-infecção em relação ao controle, que foi de 86%, 79% e 58% para o antígeno Ex, Pe e ES, respectivamente. O camundongo foi considerado um modelo apropriado para estudar a relação parasita-hospedeiro das infecções por T. vitulorum.

Imunização e reações adversas à vacinação em estudantes de medicina da Universidade Federal de Minas Gerais / Imunization and adverse reactions in medical students of Universidade Federal de Minas Gerais

Este trabalho avaliou os efeitos adversos provocados pela imunização ativa, assim como o nível de cobertura vacinal entre estudantes de Medicina da Universidade Federal de Minas Gerais (UFMG). Esses estudantes representam grupo potencialmente homogêneo quanto ao conhecimento sobre a importância da imunização e atenção para possíveis efeitos colaterais relacionados ao seu uso. As reações adversas foram de baixa prevalência, caracterizadas especialmente por mal-estar (13,7%) e febre (13,5%). A cobertura vacinal apresenta grande variabilidade, desde 2,2% para pneumocócica até 95,8% para BCG.

The adverse effects of active imunization and the level of imunization in medical students of Universidade Federal de Minas Gerais (UFMG) were evaluated. Medical students represent a homogeneous group and are aware of the importance of immunization and of its adverse effects. Adverse reactions had little prevalence and were characterized mainly by fever (13,5%) and malaise (13,7%). The degree of vaccination had a great variability from 2.2% for poliomielitis to 95.8% for BCG.

Manual de normas y procedimientos 2001 / Manual of norms and procedures 2001

El documento presenta El manual de normas y procedimientos 2001 actualizado con el objetivo de proporcionar las bases legales del programa que son de orden público y privado, de interés nacional y que son de estricta obligatoriedad para todos los trabajadores del sector. Además presenta la reseña histórica del PAI en la Región, Conceptos básicos de inmunidad, las vacunas del PAI, las prácticas y aplicación de vacunas, los Procedimientos para las prácticas de vacunación, Las normas nacionales de inmunización, Reacciones adversas en las prácticas de vacunación, la cadena de frio, el sistema de gerencia y suministro del PAI (CLM), Sistema de información del PAI, las Normas básicas de la vigilancia epidemiológica de las enfermedades prevenibles por vacuna, Las normas del laboratorio para la toma y manejo de muestras de las enfermedades prevenibles por vacunas.