Headache as the most prevalent post-vaccination adverse event after Covid-19 vaccination / Dor de cabeça como evento adverso pós-vacinação mais prevalente após a vacinação contra Covid-19

BACKGROUND: In 2020, the first vaccines were approved, according to the WHO. However, speculations arose regarding their efficacy and post-vaccination adverse events (AEFV). OBJECTIVE: To evaluate the prevalence of headache as AEFI from the SARSCoV-2 vaccine in Piauí, Brazil. METHODS: This is a quantitative, observational, cross-sectional, and prevalence study. Data were provided by the Post-Vaccination Adverse Event Information System (SI-AEFV), from reported cases from January to September 2021. Data were analyzed, and the research was approved by the UFPI Research Ethics Committee. RESULTS: A total of 2,008 cases were analyzed. Headache was reported in 752 cases (27.99%) as an AEFV after vaccination against SARS-CoV-2. In most cases, patients were from Teresina (67.62%), of brown race/ethnicity (52.67%), female (79.00%), and the majority were not healthcare professionals (54.27%). The most common age of patients, with the original data, was 33 years. After data correction, the most common age was 28 years. The majority of these cases were not severe (96.44%), and the majority of cases were associated with the first dose of the Covid-19-Covishield-Oxford/AstraZeneca vaccine (43.18%).CONCLUSION: Thus, it is concluded from the partial analysis of the results that headache is the most common adverse event after vaccination against SARS-CoV-2. The profile of patients with the most notifications was brown women aged 30 to 40 years who received the first dose of the Covid-19-Covishield-Oxford/AstraZeneca vaccine. Regarding the severity of events, the vast majority were considered non-severe, and no deaths were mentioned, demonstrating the safety of immunobiologicals.

FUNDAMENTO: Em 2020, foram aprovadas as primeiras vacinas, segundo a OMS. No entanto, surgiram especulações quanto à sua eficácia e eventos adversos pós-vacinais (EAPV). OBJETIVO: Avaliar a prevalência de cefaleia como EAPV da vacina SARSCoV-2 no Piauí, Brasil. MÉTODOS: Trata-se de um estudo quantitativo, observacional, transversal e de prevalência. Os dados foram fornecidos pelo Sistema de Informação de Eventos Adversos Pós-Vacinação (SI-AEFV), dos casos notificados no período de janeiro a setembro de 2021. Os dados foram analisados ​​e a pesquisa foi aprovada pelo Comitê de Ética em Pesquisa da UFPI. RESULTADOS: Foram analisados ​​2.008 casos. Cefaleia foi relatada em 752 casos (27,99%) como EAPV após vacinação contra SARS-CoV-2. Na maioria dos casos, os pacientes eram procedentes de Teresina (67,62%), de raça/etnia parda (52,67%), do sexo feminino (79,00%) e a maioria não era profissional de saúde (54,27%). A idade mais comum dos pacientes, com os dados originais, era de 33 anos. Após correção dos dados, a idade mais comum foi 28 anos. A maioria desses casos não foi grave (96,44%), e a maioria dos casos esteve associada à primeira dose da vacina Covid-19-Covishield-Oxford/AstraZeneca (43,18%).CONCLUSÃO: Assim, conclui-se a partir da análise parcial dos resultados de que cefaleia é o evento adverso mais comum após vacinação contra SARS-CoV-2. O perfil dos pacientes com mais notificações foi de mulheres pardas com idade entre 30 e 40 anos que receberam a primeira dose da vacina Covid-19-Covishield-Oxford/AstraZeneca. Quanto à gravidade dos eventos, a grande maioria foi considerada não grave e não foram mencionados óbitos, demonstrando a segurança dos imunobiológicos.

Eventos adversos pós-vacinais em pacientes imunizados contra a COVID-19 em um município do sul de Santa Catarina no ano de 2021 / Post-vaccine adverse events in patients immunized against COVID-19 in a munici-pality in the south of Santa Catarina state in 2021

A disponibilização em massa de vacinas contra o vírus SARS-CoV-2 é resultado de esforços científicos mundiais. Entretanto, a insegurança e a hesitação popular per-meiam os movimentos antivacinais. Objetivo: Analisar o perfil dos Eventos Adver-sos Pós-Vacinais (EAPV) na cidade de Tubarão-SC no ano de 2021. Metodologia: Estudo epidemiológico transversal com dados de todas as fichas de notificação padrão de EAPV no município de Tubarão em 2021. As variáveis analisadas foram o perfil epidemiológico do paciente, imunobiológico administrado, o tipo de evento e a evolução do caso. Calculou-se a taxa de incidência (TI) para 10 mil doses apli-cadas. Resultados: A população em estudo foi de 274 pacientes, sendo 73% do sexo feminino, com média das idades de 39,8±14,5 anos. Foram aplicadas 197.001 doses no ano de 2021, o que resultou em uma TI geral de EAPV de 13,9. Houve 206 reações notificadas em pacientes imunizados com a AstraZeneca (TI=29,1), 43 com a Pfizer (TI=5,1), 18 com a Coronavac (TI=4,8) e sete com a Janssen (TI=13,8). Houve apenas sete casos classificados como graves (TI=0,3) e, destes, um paciente evoluiu com óbito, sem relação causal estabelecida. Conclusão: A incidência geral de eventos graves foi baixa, o que corrobora o perfil de segurança dos imunobiológicos disponíveis contra a COVID-19 (AU).

The mass availability of vaccines against the SARS-CoV-2 virus is the result of worldwide scientific efforts. However, insecurity and popular hesitation permeate the antivaccine movements. Objective: Analyze the profile of Post-Vaccine Adverse Events (PVAE) in the city of Tubarão, SC, Brazil, in 2021. Methodology: Cross-sectional epidemiological study with data from all standard PVAE notification forms in the city of Tubarão-SC in 2021. The variables analyzed were the epidemiological profile of the patient, the immunobiological administered, the type of event and the evolution of the cases. The incidence rate (IR) was calculated for 10,000 doses ap-plied. Results: The study population was 274 patients, 73% were female, with a mean age of 39.8±14.5 years. A total of 197,001 doses were applied in the year 2021, resulting in an overall IR of 13.9. There were 206 reactions reported in pa-tients immunized with AstraZeneca (IR=29.1), 43 with Pfizer (IR=5.1), 18 with Coro-navac (IR=4.8) and seven with Janssen (IR=13.8). There were only seven cases classified as severe (IR=0.3) and, of these, one patient died, with no causal rela-tionship established. Conclusion: The overall incidence of serious events was low, which corroborates the safety profile of available immunobiologicals against COVID-19

Oral and nasal vaccination: current prospects, challenges, and impact of nanotechnology-based delivery systems

Abstract Currently, mucosal vaccine administration has stood out as an easier and non-invasive application method. It can also be used to induce local and systemic immune responses. In the COVID-19 pandemic context, nasal and oral vaccines have been developed based on different technological platforms. This review addressed relevant aspects of mucosal vaccine administration, with emphasis on oral and nasal vaccinations, in addition to the importance of using nanotechnology-based delivery systems to enable these strategies.

Pericarditis and myocarditis after COVID-19 mRNA vaccination in a nationwide setting

INTRODUCTION@#Despite reports suggesting an association between COVID-19 mRNA vaccination and pericarditis and myocarditis, detailed nationwide population-based data are sparsely available. We describe the incidence of pericarditis and myocarditis by age categories and sex after COVID-19 mRNA vaccination from a nationwide mass vaccination programme in Singapore.@*METHODS@#The incidence of adjudicated cases of pericarditis and myocarditis following COVID-19 mRNA vaccination that were reported to the vaccine safety committee between January to July 2021 was compared with the background incidence of myocarditis in Singapore.@*RESULTS@#As of end July 2021, a total of 34 cases were reported (9 pericarditis only, 14 myocarditis only, and 11 concomitant pericarditis and myocarditis) with 7,183,889 doses of COVID-19 mRNA vaccine administered. Of the 9 cases of pericarditis only, all were male except one. The highest incidence of pericarditis was in males aged 12-19 years with an incidence of 1.11 cases per 100,000 doses. Of the 25 cases of myocarditis, 80% (20 cases) were male and the median age was 23 years (range 12-55 years) with 16 cases after the second dose. A higher-than-expected number of cases were seen in males aged 12-19 and 20-29 years, with incidence rates of 3.72 and 0.98 case per 100,000 doses, respectively.@*CONCLUSION@#Data from the national registry in Singapore indicate an increased incidence of pericarditis and myocarditis in younger men after COVID-19 mRNA vaccination.

Primeiros casos de rejeição em transplante penetrante após vacina contra COVID-19 / First cases of penetrating corneal transplant rejection after COVID-19 vaccines

RESUMO Este artigo descreve dois casos de reação imunológica de rejeição de transplante penetrante após a aplicação de dois tipos de vacina contra a COVID-19 - CoronaVac (Sinopharm/Butantan) e MRNA BNT162&2 (Pfizer-BioNTech) - com intervalo de 1 e 10 dias, respectivamente. A rejeição se manifestou com hiperemia, edema corneano e embaçamento da visão, que responderam rapidamente ao uso de corticoide tópico e subconjuntival. Até onde sabemos, este é o primeiro relato de rejeição de transplante penetrante de córnea pós-vacina anti-COVID-19. Recomendamos, presentemente, como prevenção, colírio de prednisolona a 1% 4 dias antes e durante 2 semanas após receber qualquer tipo de vacina para a COVID-19.

ABSTRACT This paper describes two cases of allograft corneal transplant rejection after the application of two types of COVID-19 vaccines - Coronavac (Sinopharm/Butantan) and MRNA BNT162&2 (Pfizer-BioNTech) vaccines - with an interval of 1 to 10 days, respectively. The rejection manifested in the form of corneal edema, hyperemia and blurred vision, which responded rapidly to the use of topical and subconjunctival corticosteroid. As far as we know, this is the first published report of immunological rejection of penetrating corneal transplant after COVID-19 vaccination. As a preventative measure, we now recommend the use of 1% prednisolone eye drop 4 days before and during 2 weeks after having received any type of COVID-19 vaccine.

Chest computed tomography findings of 1271 patients with COVID-19 pneumonia and classifications with different age groups: a descriptive study from Istanbul, Turkey

SUMMARY OBJECTIVE: The objectives of this study were to describe lung computed tomography findings of patients with COVID-19 diagnosed by real-time reverse transcription polymerase chain reaction test, investigate whether the findings differ regarding age and gender, and evaluate the diagnostic performance of chest computed tomography based on the duration of symptoms at the time of presentation to the hospital. METHODS: From March 11 to May 11, 2020, 1271 consecutive patients (733 males and 538 females) were included in this retrospective, cross-sectional study. Based on age, patients were divided into five separate subgroups. Then based on the duration of symptoms, patients were divided into five separate phases. The presence of lung lesion(s) and their characteristics, distribution patterns, and the presence of concomitant pleural thickening/effusion and other findings (malignancy, metastasis, chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, bronchiectasis, cardiomegaly, pericardial effusion) were evaluated by five radiologists independently. RESULTS: The "normal lung computed tomography finding" was the most common chest CT finding (37%), followed by ground-glass opacity (31%). Regardless of the shape of the lesion, the distribution features were significant (peripheral, subpleural, and lower lobe distribution) (p<0.05). The presence of pleural thickening posteriorly and adjacent to the lesion was statistically different in groups 1-3 (p<0.05). Other concomitant pathologies, except pulmonary congestion, did not suppress the typical findings of COVID-19. CONCLUSION: Chest computed tomography findings were mostly normal in the early phase (P1). Therefore, it may be appropriate to perform the first computed tomography screening of COVID-19 after 6 days to decrease the radiation exposure.

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)

Lesões de pele diagnosticadas em búfalos (Bubalus bubalis) na região do baixo Amazonas / Skin injuries diagnosed in buffaloes (Bubalus bubalis) in the lower Amazon region

A pele é o maior órgão do corpo e pode ser acometida por uma série de processos patológicos. As doenças dermatológicas em geral são um aspecto frustrante na clínica de animais de grande porte. Desse modo, o objetivo deste estudo foi relatar lesões de pele diagnosticadas em búfalos na região do Baixo Amazonas, estado do Pará. Foram avaliados 156 búfalos das raças Murrah, Mediterrâneo e seus mestiços; adultos e jovens, com idade variando de oito meses a nove anos. No exame físico constatou-se que 36,5% (57/156) dos animais apresentavam abscessos no local de vacinação. Destes, 12,2% (19/156) eram abscessos com presença de alopecia e 1,3% (2/156) com fistulação Além disso, 1,3% (2/156) dos animais apresentaram ainda no local de vacinação, feridas ulceradas com presença de secreção purulenta. Identificou-se que 3,8% (6/156) dos búfalos possuíam lesões provenientes da marcação a fogo, com queimaduras, de aspecto crostoso, eritematoso e exsudativo, na região da garupa.; A maioria 64,1% (100/156) dos animais apresentaram corte das orelhas, 1,9% (3/156) apresentaram lesões por penetração de corno e em 1,2% (2/156) observou-se lesão de pele no membro posterior direito. Conclui-se que foi possível diagnosticar diversas lesões cutâneas nos búfalos na região do Baixo Amazonas, sendo o erro no manejo dos animais as principais causas das lesões diagnosticadas. Além disso, houve correlação entre dois grupos de animais avaliados (com e sem lesão).

The skin is the largest organ in the body and can be affected by a series of pathological processes. Dermatological diseases in general are a frustrating aspect in the clinic of large animals. Thus, the objective of this study was to report skin lesions diagnosed in buffaloes in the region of Baixo Amazonas, state of Pará. 156 buffaloes of the Murrah, Mediterranean and crossbred breeds were taken; Adults and young people, with ages varying from eight months to nine years. On physical examination, it was found that 36.5% (57/156) of the animals had abscesses at the vaccination site. Of these, 12.2% (19/156) were abscesses with the presence of alopecia and 1.3% (2/156) with fistulation. In addition, 1.3% (2/156) of the animals separated at the vaccination site, ulcerated wounds with the presence of purulent secretion. It was identified that 3.8% (6/156) of the buffaloes had the location of the fire mark, with burns, with a crusted, erythematous and exudative aspect, in the croup region. The majority 64.1% (100/156) of the animals separation of the ears, 1.9% (3/156) dissipation by penetration of the horn and in 1.2% (2/156) a skin lesion was observed in any limb posterior right. It was concluded that it was possible to diagnose several cutaneous lesions in buffaloes in the region of Baixo Amazonas, with the error in handling animals being the main causes of the diagnosed injuries. In addition, there was a correlation between two groups of acquired animals (with and without injury).

Generalized granuloma annulare after pneumococcal vaccination

Abstract Granuloma annulare may be caused by multiple triggers. Among these are vaccinations, which have been described as an infrequent cause of granuloma annulare. The authors report the first case of generalized granuloma annulare associated with pneumococcal vaccination in a 57-year-old woman, who presented cutaneous lesions 12 days after vaccination.

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

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

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

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

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

Vigilância ativa de eventos adversos pós-vacinação na atenção primária à saúde / Observación activa de eventos adversos posvacunación en la Atención Primaria de Salud / Active surveillance of adverse events following immunization in primary health care

Resumo Objetivo Descrever a vigilância ativa dos eventos adversos pós-vacinação, sua incidência e fatores associados, em um município de Minas Gerais, Brasil. Métodos Coorte prospectiva realizada na Atenção Primária à Saúde, entre 2017 e 2018. Foram acompanhados 384 indivíduos que receberam vacinas, excluindo-se aqueles que tiveram eventos adversos prévios. Na linha de base, foram coletadas informações sociodemográficas, de saúde e histórico de vacinação e, no seguimento, as características do evento adverso e das ações de vigilância epidemiológica. Estimou-se taxa de incidência de eventos adversos, e realizaram-se o teste do qui-quadrado, a regressão de Poisson e o teste de Hosmer-Lemeshow. Resultados A incidência de eventos adversos foi de 13,36 casos/100 mil doses de vacinas (intervalo de confiança de 95%: 13,34-13,38), com maior incidência em crianças menores de 5 anos. Os eventos adversos mais frequentes foram dor local, vermelhidão, endurecimento, seguidos de febre e choro persistente. Dentre os fatores associados à ocorrência dos eventos adversos, recebimento da vacina contra tétano e difteria (risco relativo: 7,9; intervalo de confiança de 95%: 2,77-12,46) e administração por meio da via intramuscular foram considerados de risco (risco relativo: 6,1; intervalo de confiança de 95%: 2,55-14,63). A conduta do profissional de enfermagem, diante das orientações sobre as vacinas recebidas, aumentou a notificação de eventos adversos (risco relativo: 3,4; intervalo de confiança de 95%: 1,53-7,68). Conclusão O estudo permitiu conhecer fatores que favorecem a ocorrência de eventos adversos. Há evidências de que condutas adotadas pelos profissionais de enfermagem nas salas de vacinação podem evitar subnotificações de eventos adversos pós-vacinação.

Resumen Observación Describir la observación activa de los eventos adversos posvacunación, su incidencia y factores asociados en un municipio del estado de Minas Gerais, Brasil. Métodos Cohorte prospectiva realizada en la Atención Primaria de Salud, entre 2017 y 2018. Se realizó el seguimiento de 384 individuos que recibieron vacunas, excluyendo a aquellos que tuvieron eventos adversos previos. En la línea basal, se recopiló información sociodemográfica, de salud e historial de vacunación y, en el seguimiento, las características del evento adverso y las acciones de observación epidemiológica. Se estimó un índice de incidencia de eventos adversos y se realizó la prueba χ2 de Pearson, la regresión de Poisson y la prueba de Hosmer-Lemeshow. Resultados La incidencia de eventos adversos fue de 13,36 casos/100.000 dosis de vacuna (intervalo de confianza de 95 %: 13,34-13,38), con mayor incidencia en niños menores de 5 años. Los eventos adversos más frecuentes fueron dolor local, enrojecimiento, endurecimiento, seguidos de fiebre y llanto persistente. Entre los factores asociados a la ocurrencia de los eventos adversos, la aplicación de la vacuna contra el tétanos y la difteria (riesgo relativo: 7,9; intervalo de confianza de 95 %: 2,77-12,46) y la administración por medio de la vía intramuscular fueron considerados de riesgo (riesgo relativo: 6,1; intervalo de confianza de 95 %: 2,55-14,63). La conducta del profesional de enfermería ante las instrucciones sobre las vacunas recibidas aumentó la notificación de eventos adversos (riesgo relativo: 3,4; intervalo de confianza de 95 %: 1,53-7,68). Conclusión El estudio permitió conocer factores que favorecen a la ocurrencia de eventos adversos. Hay evidencias de que las conductas adoptadas por los profesionales de enfermería en las salas de vacunación pueden evitar subnotificaciones de eventos adversos posvacunación.

Abstract Objective To describe the active surveillance of adverse events following immunization, their incidence and associated factors in a municipality of Minas Gerais, Brazil. Methods This is a prospective cohort conducted in Primary Health Care between 2017 and 2018. A total of 384 individuals who received vaccines were followed up, excluding those who had previous adverse events. At baseline, sociodemographic, health and vaccination history information and, in follow-up, the characteristics of adverse events and epidemiological surveillance actions were collected. The incidence rate of adverse events was estimated, and the chi-square test, poisson regression and Hosmer-Lemeshow test were performed. Results The incidence of adverse events was 13.36 cases/100,000 doses of vaccines (95% confidence interval: 13.34-13.38), with a higher incidence in children under 5 years of age. The most frequent adverse events were local pain, redness, hardening, followed by fever and persistent crying. Among the factors associated with the occurrence of adverse events, receiving tetanus and diffrhyphria vaccine (relative risk: 7.9; 95% confidence interval: 2.77-12.46) and intramuscular administration were considered at risk (relative risk: 6.1; 95% confidence interval: 2.55-14.63). Nursing professionals' conduct, considering the guidelines on the vaccines received, increased adverse event reporting (relative risk: 3.4; 95% confidence interval: 1.53-7.68). Conclusion The study allowed to know factors that favor the occurrence of adverse events. There is evidence that conducts adopted by nursing professionals in immunization rooms may avoid underreporting of adverse events following immunization.

Post SARS-CoV-2 vaccination Guillain-Barre syndrome in 19 patients

SARS-CoV-2 vaccinations are not free from side effects. Usually, they are mild or moderate but occasionally severe. One of these severe side effects is Guillain-Barré syndrome (GBS). This review summarizes and discusses GBS as a side effect of SARS-CoV-2 vaccinations (SCoVaG) based on recent research reports. Altogether, nine articles reporting 18 patients with SCoVaG were identified and one more report on another patient is under review. The age for the studies ranged between 20-86y. Nine patients were male, and ten were female. In all 19 patients, SCoVaG developed after the first dose of the vaccine. The Astra Zeneca vaccine was used in fourteen patients, the Pfizer vaccine in four patients, and the Johnson & Johnson vaccine was applied in one patient. The latency between vaccination and onset of GBS ranged from 3h to 39d. The treatment of SCoVaG included IVIGs (n=13), steroids (n=3), or no therapy (n=3). Six patients required mechanical ventilation. Only a single patient recovered completely and partial recovery was achieved in nine patients. In conclusion, GBS may develop time-linked to the first dose of a SARS-CoV-2 vaccination. Though a causal relationship between SARS-CoV-2 vaccinations and SCoVaG remains speculative, more evidence is in favour than against it.

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.

Inmunodeficiencia Combinada Severa, reporte de pacientes chilenos diagnosticados durante el período 1999-2020 / Severe combined immunodeficiency, report of Chilean patients diagnosed during the 1999-2020 period

INTRODUCCIÓN: La inmunodeficiencia combinada severa (IDCS) corresponde a una de las formas más graves de inmunodeficiencia primaria, existiendo escasos datos nacionales sobre ésta. OBJETIVO: describir la epidemiología, complicaciones, pronóstico y uso de la vacuna BCG en pacientes chilenos con IDCS. PACIENTES Y MÉTODO: Estudio retrospectivo de pacientes diagnosticados con IDCS entre los años 1999 y 2020 por médicos inmunólogos a lo largo de Chile. El diagnóstico de IDCS se realizó conforme a los criterios propuestos por Shearer: linfocitos T (CD3+) < 300 células/μL y prolife ración 10% del límite de normalidad en respuesta a fitohemaglutinina o presencia de linfocitos T de origen materno. Se obtuvieron de la ficha clínica los datos correspondientes a: sexo, edad al diagnóstico, consanguinidad, región de origen, subpoblaciones linfocitarias, diagnóstico genético, complicaciones infecciosas y no infecciosas, vacunación BCG y sus complicaciones, edad de deriva ción al centro de TPH y causa de mortalidad no relacionada al TPH. RESULTADOS: se diagnosticaron 25 casos de IDCS en 22 familias entre los años 1999-2020. 78% varones, la edad media a la primera manifestación fue 2.3 meses (0-7), mientras que la edad media al diagnóstico fue de 3.4 meses (0 7). Un 16% de los casos tenía un antecedente familiar de IDCS. Un 40% de los casos fueron diag nosticados en la Región Metropolitana. El inmunofenotipo más frecuente fue T-B-NK+ (48%). Se realizaron estudios genéticos en 69,5% de los casos, siendo los defectos genéticos en RAG2 (39%) la causa más frecuente. Un 88% de los casos recibió la vacuna Bacillus Calmette-Guerin (BCG) previo al diagnóstico, incluidos 2 pacientes con historia familiar positiva, 36% de los vacunados experimentó complicaciones de la BCG. La edad media a la derivación a trasplante fue de 7,4 meses (5-16). De los 25 pacientes, 11 fallecieron previo a la derivación a un centro de trasplante. CONCLUSIÓN: En Chile existe un retraso clínicamente significativo entre las primeras manifestaciones y el diagnóstico de IDCS, así como un importante retraso en la derivación a centros de trasplante. La mayoría de los pacientes con IDCS reciben la vacuna BCG, pese a tener antecedentes familiares, y experimentan frecuentemente complicaciones de la vacuna.

INTRODUCTION: Severe combined immunodeficiency (SCID) is the most severe form of primary immunodeficiency. To date, there is little local information about this disease. OBJECTIVE: To describe the epidemiology, complications, prognosis, and use of the BCG vaccine in Chilean patients with SCID. PATIENTS AND METHOD: Retrospective review of the clinical records of patients diagnosed with SCID by clinical immunologists between 1999 and 2020 throughout Chile. SCID was diagnosed according to the cri teria proposed by Shearer: T lymphocytes (CD3+) < 300 cells/μL and proliferation 10% of the limit of normality in response to phytohemagglutinin or presence of T lymphocytes of maternal origin. Data collected from the clinical records were: sex, age at diagnosis, consanguinity, region of origin, lymphocyte subpopulations, genetic diagnosis, infectious and non-infectious complications, BCG vaccination and its complications, age at referral to the bone marrow transplant (BMT) center, and cause of non-BMT-related mortality. RESULTS: Between 1999 and 2020, 25 patients were diagnosed with SCID. 78% of them were male, mean age at first manifestation of the disease was 2.3 months (0-7), while the mean age at diagnosis was 3.4 months (0-7). 16% of patients had a family history of SCID. 40% of cases were diagnosed within the Metropolitan Region. The most frequent immuno- phenotype was T-B-NK+ SCID (48%). Genetic studies were done in 69.5% of cases, mutations in the RAG2 gene were the most common etiology of SCID (39%). 88% of SCID patients received the Bacillus Calmette-Guerin (BCG) vaccine before diagnosis, including 2 cases with a known family history of SCID. 36% of those who received the vaccine had BCG-related complications. The mean age at referral to a bone marrow transplant center was 7.4 months (5-16). 11/25 patients died before being transferred to a transplant center. DISCUSSION: There is a clinically significant delay between the first manifestations and the diagnosis of SCID in Chilean patients, as well as an important time gap between the diagnosis of SCID and referral to a center for BMT. Most SCID cases in Chile receive the BCG vaccine, despite a known family history of the disease, and frequently develop vaccine-related complications.

Evaluación del sistema de vigilancia de eventos postvacunales en la Isla de la Juventud, Cuba: Una mirada en dos momentos / Evaluation of the system of surveillance of events postvaccination in the Isle of the Youth, Cuba: A look in two moments

La evaluación en la vigilancia en salud es un instrumento útil para analizar resultados en relación con los objetivos, comparar beneficios con costos y orientar objetivos iniciales de los sistemas. El objetivo de ésta investigación fue evaluar el sistema de vigilancia de eventos adversos consecutivos a la vacunación en la Isla de la Juventud, Cuba, entre enero/2018 y marzo/2019. Se llevó a cabo un estudio descriptivo a través del diseño de una investigación evaluativa, que constó de dos fases complementarias para la dimensión Proceso. Se evaluaron los tres componentes del sistema: Estructura, Proceso y Resultado mediante una metodología integral. El alcance del estudio estuvo determinado por todos los médicos y enfermeros de la Atención Primaria de Salud, así como los Vicedirectores de Higiene y Epidemiología y los tutores legales de niños de 2 a 18 meses de edad vacunados. Se emplearon frecuencias absolutas y relativas, así como tasas e Indice de Posición. Se realizó además prueba de comparación de proporciones. La Estructura del sistema se evaluó como definida; el Procesode funcionamiento regular a priori y de buen funcionamiento a posteriori. Con significación estadística en varios atributos vistos como tal y como competencias; mientras que los Resultadosfueron evaluados de muy útiles, marcado por la elevada satisfacción de los usuarios internos y externos. De forma general el sistema fue evaluado de satisfactorio. La evaluación del sistema permitió identificar brechas en su funcionamiento; sin embargo, valoraciones generales hacen suponer una madurez del funcionamiento genérico del Sistema a 20 años de su implementación(AU)

Evaluation in health surveillance is a useful instrument to analyze results in relation to the objectives, compare benefits with costs and guide initial objectives of the systems. The objective of this research was to evaluate the surveillance system for adverse events following vaccination in Isle of Youth, Cuba, between January 2018 and March 2019. A descriptive study was carried out through the design of an evaluative research, which consisted of two complementary phases for the Process dimension. The three components of the system were evaluated: Structure, Process and Results through a comprehensive methodology. The scope of the study was determined by all primary care doctors and nurses, as well as the Deputy Directors of Hygiene and Epidemiology and legal guardians of vaccinated children from 2 to 18 months of age. Absolute and relative frequencies were used, as well as rates and position index. A comparison of proportions test was also performed. The system Structure was evaluated as defined; the regular operation Process a priori and posteriori good functioning; with statistical significance in several attributes seen as such and as competences, while the Results were evaluated as very useful, marked by the high satisfaction of internal and external users. In general, the system was evaluated as satisfactory. The evaluation of the system allowed to identify gaps in its operation, however, general assessment suggests a maturity of the generic functioning of the System 20 years after its implementation(AU)

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.