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1.
Epidemiol. serv. saúde ; 29(2): e2019280, 2020. tab, graf
Article in English, Portuguese | LILACS | ID: biblio-1101130

ABSTRACT

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


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


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


Subject(s)
Humans , Female , Pregnancy , Adult , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Immunization Programs/statistics & numerical data , Diphtheria-Tetanus-acellular Pertussis Vaccines/adverse effects , Drug-Related Side Effects and Adverse Reactions , Immunogenicity, Vaccine/immunology , Prenatal Care , Tetanus/immunology , Tetanus/prevention & control , Brazil , Whooping Cough/immunology , Whooping Cough/prevention & control , Pregnant Women , Diphtheria/immunology , Diphtheria/prevention & control
2.
Rev. bras. neurol ; 54(1): 39-45, jan.-mar. 2018. tab
Article in Portuguese | LILACS | ID: biblio-882453

ABSTRACT

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


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


Subject(s)
Humans , Male , Female , Infant , Child , Adult , Vaccines/adverse effects , Immunization Programs , Guillain-Barre Syndrome/diagnosis , Guillain-Barre Syndrome/etiology , Disease Prevention , Autoimmune Diseases/etiology , Brazil , Review Literature as Topic , Influenza Vaccines/adverse effects , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects
3.
Rev. chil. pediatr ; 88(6): 771-775, dic. 2017. tab
Article in Spanish | LILACS | ID: biblio-900050

ABSTRACT

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


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


Subject(s)
Humans , Male , Infant , Pallor/etiology , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Hepatitis B Vaccines/adverse effects , Haemophilus Vaccines/adverse effects , Consciousness Disorders/etiology , Muscle Hypotonia/etiology
4.
Rev. cuba. med. trop ; 67(3): 0-0, dic. 2015. ilus, tab
Article in Spanish | LILACS, CUMED | ID: lil-777072

ABSTRACT

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


Subject(s)
Humans , Infant , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Muscle Hypotonia/diagnosis , Health Surveillance System
5.
Ciênc. Saúde Colet. (Impr.) ; Ciênc. Saúde Colet. (Impr.);20(2): 441-448, fev. 2015. tab
Article in Portuguese | LILACS | ID: lil-742219

ABSTRACT

Objetivou-se analisar as internações por condições sensíveis à atenção primária (ICSAP) específicas em mulheres e os fatores que determinam ou influenciam a ocorrência dessas internações (fatores socioeconômicos, sociodemográficos e controle de saúde) por meio de um inquérito de morbidade hospitalar realizado com amostra de 429 mulheres internadas em hospitais conveniados ao Sistema Único de Saúde. O percentual de ICSAP foi 49,42% (n = 212), com destaque para as internações específicas do sexo feminino 19,35% (n = 83). Associaram ao risco de internar por CSAP: idade superior a 60 anos, baixa escolaridade, internação prévia, realização de controle regular de saúde, falta de vínculo com a Estratégia Saúde da Família (ESF) e ser gestante. As causas evidentes foram as condições relacionadas à gravidez, ao parto e ao puerpério e às inflamações nos órgãos pélvicos femininos. Os resultados sugerem falhas no atendimento ambulatorial que deveria ser oportuno e resolutivo no contexto da saúde da mulher.


The scope of this paper was to analyze female-specific sensitive hospitalization occurring in primary care conditions and factors that determine or affect the occurrence of such hospitalizations (social, economic and demographic factors; health control). Analysis was performed by surveys on hospital morbidity with a sample of 429 females attended in Unified Health System (SUS) contracted hospitals. The sensitive hospitalizations percentage in primary care reached 49.42% (n = 212), highlighting female-specific hospitalization at 19.35% (n = 83). Hospitalization risks comprised elderly people over sixty, low schooling, previous hospitalizations, normal health control, lack of association with the Family Health Strategy and pregnancy. Evident causes were related to conditions of pregnancy, childbirth, post-partum and inflammations of the female pelvic organs. Results suggested flaws in outpatient attendance that should be adequate and provide solutions in women’s health.


Subject(s)
Humans , Infant , Bacterial Proteins/immunology , Carrier Proteins/immunology , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Diphtheria-Tetanus-Pertussis Vaccine/immunology , Haemophilus Vaccines/adverse effects , Haemophilus Vaccines/immunology , Immunoglobulin D/immunology , Lipoproteins/immunology , Pneumococcal Vaccines/adverse effects , Pneumococcal Vaccines/immunology , Poliovirus Vaccine, Inactivated/adverse effects , Poliovirus Vaccine, Inactivated/immunology , Antibodies, Bacterial/immunology , Antibodies, Viral/immunology , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Haemophilus Vaccines/administration & dosage , Immunization Schedule , Netherlands , Pneumococcal Vaccines/administration & dosage , Poliovirus Vaccine, Inactivated/administration & dosage , Vaccination , Vaccines, Combined/administration & dosage , Vaccines, Combined/adverse effects , Vaccines, Combined/immunology , Vaccines, Conjugate
6.
Rio de Janeiro; s.n; 2011. 69 p. ilus, tab, graf.
Thesis in Portuguese | LILACS | ID: lil-638271

ABSTRACT

Alguns estudos que tem acompanhado a utilização da vacina tetravalente na rotina do PNI desde 2002 observaram uma incidência maior de eventos adversos associados à mesma em comparação com as demais vacinas do calendário vacinal. Este estudo teve como objetivo conhecer a situação vacinal das crianças que apresentaram eventos adversos após vacinação de tetravalente na rede pública do município de Belém no ano de 2008. Foi realizado um estudo transversal. A população estudada foi a de menores de um ano que apresentaram eventos adversos após vacinação tetravalente. Foram analisadas variáveis relacionadas às características sócio-econômicas dos responsáveis, à situação vacinal das crianças participantes e aos eventos adversos após a vacina. Verificou-se que 33,3 por cento das crianças participantes apresentaram algum atraso no esquema vacinal, e os principais motivos do atraso foram o esquecimento por parte da mãe (22,8por cento) e a falta de orientação dos profissionais de saúde (13,7 por cento). Concluiu-se que tais motivos podem indicar falhas na atenção primária em saúde no que se refere ao controle de doenças que, atualmente, são preveníveis por vacinação, assim, presume-se que tenham ocorrido oportunidades perdidas de vacinar estas crianças.


Subject(s)
Infant, Newborn , Infant , Ethics , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Vaccines/adverse effects , Vaccination Coverage
8.
Rev. Inst. Med. Trop. Säo Paulo ; Rev. Inst. Med. Trop. Säo Paulo;51(3): 131-134, May-June 2009. ilus
Article in English | LILACS, SES-SP | ID: lil-517095

ABSTRACT

Objective: to discuss the current PAHO recommendation that does not support the substitution of traditional cellular DTP vaccine by acellular DTP, and the role of mutations, in humans, as the main cause of rare adverse events, such as epileptic-like convulsions, triggered by pertussis vaccine. Data review: the main components related to toxic effects of cellular pertussis vaccines are the lipopolysaccharide of bacterial cell wall and pertussis toxin. The removal of part of lipopolysaccharide layer has allowed the creation of a safer cellular pertussis vaccine, with costs comparable to the traditional cellular vaccine, and which may be a substitute for the acellular vaccine. Conclusion: The new methodology introduced by Instituto Butantan allows for the development of a new safer pertussis vaccine with low LPS content (Plow), and the use of the lipopolysaccharide obtained in the process in the production of monophosphoryl lipid A. This component has shown potent adjuvant effect when administered together with influenza inactivated vaccine, making possible to reduce the antigen dose, enhancing the production capacity and lowering costs.


Objetivo: Discutir as recomendações da WHO-OPAS que não consideram indicada a substituição da vacina DTP celular clássica pela DTP acelular e o papel de mutações, em humanos, como principal causa dos raros eventos de convulsões epileptiformes desencadeadas pela vacina pertussis. Revisão dos dados: Os principais componentes relacionados aos efeitos tóxicos da vacina pertussis celular são o lipopolissacarídio da parede celular da bactéria e a toxina pertussis. A remoção de parte da camada lipopolissacarídica permitiu a criação de uma vacina pertussis celular, mais segura e de custo comparável ao da vacina celular tradicional, podendo substituir a vacina pertussis acelular. Conclusão: A nova vacina pertussis, com baixo teor de LPS (Plow) desenvolvida pelo Instituto Butantan, além de oferecer uma vacina mais segura, permite o aproveitamento do lipopolissacarídeo para a produção de monofosforil lipídeo A. Esse componente mostrou-se potente como adjuvante e altamente eficiente quando administrado com a vacina de influenza, levando à possibilidade de se reduzir a dose de antígeno, aumentando a capacidade de produção e redução dos custos.


Subject(s)
Humans , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Diphtheria-Tetanus-acellular Pertussis Vaccines/adverse effects , Lipopolysaccharides/immunology , Mutation , Cost-Benefit Analysis , Diphtheria-Tetanus-Pertussis Vaccine/genetics , Diphtheria-Tetanus-Pertussis Vaccine/immunology , Diphtheria-Tetanus-acellular Pertussis Vaccines/genetics , Diphtheria-Tetanus-acellular Pertussis Vaccines/immunology , Lipopolysaccharides/adverse effects , World Health Organization
9.
Rev. méd. Chile ; 137(1): 10-17, ene. 2009. tab
Article in Spanish | LILACS | ID: lil-511838

ABSTRACT

Background: During 2005, the surveillance system of the Chilean Immunization Program detected an increased number of adverse reaction notifications associated to diphtheria, pertussis and tetanus whole-cell vaccine (DPT), coincidentiy with a change in the vaccine manufacturer. Aim: To compare the reactogenicity of two DPT formulations (vaccines 1 and 2) in 18-month-old infants and 4-year-old children. Material and methods: Severe adverse reactions to DPT were studied at the emergency room of two hospitals of Santiago in a case-control study (110 cases and 171 controls, who consulted for other causes). Simultaneously the incidence of total adverse reactions (mild and severe) for vaccine 1 and 2 was estimated in a cohort of 1,017 children vaccinated in an ambulatory health center of the same área. The formulation of DPT received by all participants was verífied, as well as the temporal relation with consultation or symptoms referred by their caregivers. Results: There was a greater probability of consulting at the emergency rooms for severe adverse reactions among children who received vaccine 1 (odds ratio (OR) =7.1; p <0.001), being greater among 4-year-old children (OR =18.9; p <0.001). Coincidentiy, in the cohort of vaccinated children, those who received vaccine 1 had a higher risk of presenting adverse reactions (RR =2.9; p <0.001), being high fever the commonest. Conclusions: We confirmed that vaccine 1 was associated to a higher risk of adverse reactions, especially among 4-year-old children. These results allowed the sanitary authority to adopt an informed decisión. The usefulness of observational studies in vaccine adverse reactions is confirmed.


Subject(s)
Humans , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Diphtheria/prevention & control , Immunization Programs/standards , Tetanus/prevention & control , Whooping Cough/prevention & control , Adverse Drug Reaction Reporting Systems/standards , Case-Control Studies , Chile , Incidence , Population Surveillance
10.
Rio de Janeiro; s.n; 2009. 71 p. tab, graf, ilus.
Thesis in Portuguese | LILACS | ID: lil-554135

ABSTRACT

Objetivos: Analisar a temperatura axilar no estudo da vacina contra difteria, tétano, o componente pertussis e hemófilo (DTP/Hib), a frequência de febre e a associação dos eventos adversos. Analisar a metodologia para verificação da temperatura corpórea e febre utilizada em diferentes estudos clínicos com a vacina DTP/Hib. Materiais e métodos: Este trabalho é baseado em dados obtidos do “Estudo de imunogenicidade e reatogenicidade de vacina combinada contra difteria, tétano, pertussis e hemófilo tipo b: validação clínica de produto produzido totalmente no Brasil”, com 1000 lactentes, realizado no município do Rio de Janeiro, no ano de 2006. Foi analisada a temperatura axilar nos tempos 3, 6, 12, 24, 48 e 72 horas após a vacinação. Foram analisadas as associações entre os eventos adversos locais e eventos adversos sistêmicos. Resultados: A freqüência de febre foi de 53,4 % após a primeira dose, 39,9 % após a segunda dose e 31,5 % após a terceira dose nas 24 horas após a vacinação. A freqüência de febre foi diminuindo com a aplicação das doses. Não houve padrão de associação entre os eventos adversos locais e sistêmicos. A mediana da distribuição da temperatura axilar foi maior nos tempos 6 e 12 horas após a vacinação. Conclusões: A definição de febre e as metodologias utilizadas nos estudos clínicos para verificar a temperatura corpórea ainda são heterogêneas, o que dificulta a comparabilidade entre eles.


Objectives: To analyze the axillary temperature in the study of the vaccine DTP/Hib (Martins et al., 2008), the frequency of fever and the association of the adverse events. To analyze themethodology for checking of the corporal temperature and fever used in different clinical trial with the vaccine DTP/Hib. Materials and methods: This work is based on obtained data of the “Study of immunogenicity and reactogenicity of vaccine combined against diphtheria, tetanus, pertussisand haemophylus type b: clinical validation of product produced totally in Brazil ”, with 1000 infants, carried out in the local authority of the Rio of January, in the year of 2006. The axillary temperature was analyzed in the times 3, 6, 12, 24, 48 and 72 hours after the vaccination. The associations were analyzed between the adverse local events and adverse systemic events. Results: The frequency of fever was 53.4 % after the first dose, 39.9 % after the second dose and 31.5 % after the third dose in 24 hours after the vaccination. The frequency of feverwas lessening with the application of the doses. There was no standard of association between the adverse local events and systemic adverse events. The medium one of the distribution ofthe axillary temperature was bigger in the times 6 and 12 hours after the vaccination. Conclusions: The definition of fever and the methodologies used in the clinical studies to check the corporal temperature they are still heterogeneous what makes difficult thecomparability between them.


Subject(s)
Humans , Fever/physiopathology , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Diphtheria-Tetanus-Pertussis Vaccine/immunology , Body Temperature
11.
Mem. Inst. Oswaldo Cruz ; 103(7): 711-718, Nov. 2008. ilus, tab
Article in English | LILACS | ID: lil-498381

ABSTRACT

A randomized, double-blinded study evaluating the immunogenicity, safety and consistency of production of a combined diphtheria-tetanus-pertussis-Haemophilus influenzae type b vaccine entirely produced in Brazil by Bio-Manguinhos and Instituto Butantan (DTP/Hib-BM) was undertaken. The reference vaccine had the same DTP vaccine but the Hib component was produced using purified materials supplied by GlaxoSmithKline (DTP/Hib-GSK), which is registered and has supplied the Brazilian National Immunization Program for over more than five years. One thousand infants were recruited for the study and received vaccinations at two, four and six months of age. With respect to immunogenicity, the vaccination protocol was followed in 95.6 percent and 98.4 percent of infants in the DTP/Hib-BM and DTP/Hib-GSK groups, respectively. For the Hib component of the study, there was 100 percent seroprotection (>0.15 µg/mL) with all three lots of DTP/Hib-BM and DTP/Hib-GSK. The geometric mean titer (GMT) was 9.3 µg/mL, 10.3 µg/mL and 10.3 µg/mL for lots 1, 2 and 3 of DTP/Hib-BM, respectively, and the GMT was 11.3 g/mL for DTP/Hib-GSK. For diphtheria, tetanus and pertussis, seroprotection was 99.7 percent, 100 percent and 99.9 percent, respectively, for DTP/Hib-BM, three lots altogether and 99.2 percent, 100 percent and 100 percent for DTP/Hib-GSK. GMTs were similar across all lots and vaccines. Adverse events rates were comparable among the vaccine groups. The Brazilian DTP/Hib vaccine demonstrated an immunogenicity and reactogenicity profile similar to that of the reference vaccine.


Subject(s)
Female , Humans , Infant , Male , Diphtheria-Tetanus-Pertussis Vaccine/immunology , Diphtheria/prevention & control , Haemophilus Infections/prevention & control , Haemophilus Vaccines/immunology , Tetanus/prevention & control , Whooping Cough/prevention & control , Bordetella pertussis/immunology , Clostridium tetani/immunology , Corynebacterium diphtheriae/immunology , Double-Blind Method , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Haemophilus Vaccines/administration & dosage , Haemophilus Vaccines/adverse effects , Haemophilus influenzae type b/immunology , Time Factors
12.
Indian J Dermatol Venereol Leprol ; 2008 May-Jun; 74(3): 251-3
Article in English | IMSEAR | ID: sea-52927

ABSTRACT

Erythema multiforme is a cutaneous reaction pattern precipitated by varied agents, notably herpes simplex and drugs. It predominantly occurs in adolescents and young adults but may be seen at other ages also. While vaccination is rarely a precipitating factor for erythema multiforme, it may occasionally be seen in infants and children. We report here a case of a two month-old infant with lesions of erythema multiforme minor appearing after two weeks following vaccination for DPT, Hepatitis B and influenza.


Subject(s)
Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Erythema Multiforme/chemically induced , Female , Foot/pathology , Hand/pathology , Hepatitis B Vaccines/adverse effects , Humans , Infant , Influenza Vaccines/adverse effects , Skin/pathology , Vaccines, Combined/adverse effects
13.
Rev. saúde pública ; Rev. saúde pública;41(6): 1032-1041, dez. 2007. tab
Article in English, Portuguese | LILACS | ID: lil-470549

ABSTRACT

OBJETIVO: Avaliar os eventos adversos pós-vacina contra a difteria, coqueluche e tétano (EAPV-DPT) e os fatores associados à sua gravidade. MÉTODOS: Estudo transversal com componente descritivo e analítico, abrangendo os eventos adversos pós-vacina DPT notificados no Estado de São Paulo, de 1984 a 2001, entre crianças menores de sete anos de idade. A definição de caso foi a adotada pela vigilância de EAPV-DPT; os dados obtidos foram originados da vigilância passiva desses eventos. No cálculo das taxas, o numerador foram os EAPV e o denominador o número de doses aplicadas. A associação entre a gravidade dos EAPV-DPT e as exposições de interesse foi investigada pelas estimativas não ajustadas e ajustadas da odds ratio, com os respectivos intervalos de 95 por cento de confiança, usando regressão logística não condicional. RESULTADOS: Identificaram-se 10.059 EAPV-DPT relativos a 6.266 crianças, apresentando um ou mais EAPV, 29,5 por cento foram internadas e em 68,2 por cento houve contra-indicação das doses subseqüentes de DPT. Cerca de 75 por cento dos eventos ocorreram nas primeiras seis horas após a aplicação da vacina. Os eventos mais freqüentes foram: febre<39,5°C, reação local, evento hipotônico hiporresponsivo e convulsão. Mostraram-se independentemente associadas à gravidade: intervalo inferior a uma hora entre a aplicação da vacina e o evento (OR=2,1), primeira dose aplicada (OR=5,8), antecedentes neurológicos pessoais (OR=2,2) e familiares (OR=5,3). CONCLUSÕES: A vigilância passiva de EAPV mostrou-se útil no monitoramento da segurança da vacina DPT, descrevendo as características e a magnitude desses eventos, assim como permitiu identificar possíveis fatores associados às formas graves.


OBJECTIVE: To analyze adverse events following vaccinations against diphtheria, pertussis and tetanus (AEFV-DPT) and to investigate factors associated with event severity. METHODS: A cross-sectional study was carried out with a descriptive and analytical component covering AEFV-DPT that were notified in the State of São Paulo, Brazil, between 1984 and 2001, among children less than seven years old. Cases were defined as used in AEFV-DPT surveillance; the data source was AEFV-DPT passive surveillance. In calculating the rates, the numerator was the number of AEFV-DPT and as denominator was the number of doses applied. The association between severity of AEFV-DPT and the exposures of interest was investigated by means of non-adjusted and adjusted estimates of odds ratios, with their respective 95 percent confidence intervals, using non-conditional logistic regression. RESULTS: A total of 10,059 AEFV-DPT were identified, corresponding to 6,266 children who presented one or more AEFV-DPT, 29.5 percent were hospitalized and 68.2 percent presented contraindications for subsequent DPT doses. Around 75 percent of the events occurred during the first six hours after vaccination. The most frequent AEFV-DPT were: fever < 39.5°C, local reactions, hypotonic-hyporesponsive episodes and convulsion. Time interval of less than one hour between vaccination and the event (OR = 2.1), first dose applied (OR=5.8) and previous personal (OR=2.2) and family (OR=5.3) neurological histories were independently associated with severe events. CONCLUSIONS: Passive surveillance of AEFV-DPT was shown to be useful for monitoring the safety of the DPT vaccine, through describing the characteristics and magnitude of these events, and also enabling identification of possible factors associated with severe forms.


Subject(s)
Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Vaccines , Epidemiological Monitoring , Cross-Sectional Studies
14.
J. pediatr. (Rio J.) ; J. pediatr. (Rio J.);83(6): 523-528, Nov.-Dec. 2007. tab
Article in English, Portuguese | LILACS | ID: lil-472613

ABSTRACT

OBJETIVO: Avaliar a segurança da vacina combinada de difteria-tétano-coqueluche de células inteiras e Haemophilus influenzae tipo b usada no Programa Nacional de Imunizações, e em especial a incidência de episódios hipotônicos-hiporresponsivos. MÉTODO: Acompanhamento de uma coorte de 21.064 lactentes (20.925 ou 99,7 por cento aderiram ao protocolo de estudo), nas 48 horas após a aplicação da vacina de difteria, tétano, coqueluche de células inteiras e Haemophilus influenzae tipo b em centros de saúde na cidade do Rio de Janeiro, para determinar e investigar eventos adversos graves, espontâneos e solicitados. Cada criança foi monitorada durante somente uma dose. RESULTADOS: A incidência de episódios hipotônicos-hiporresponsivos foi de 1:1.744 doses (casos confirmados) e de 1:1.495 doses (casos confirmados mais casos suspeitos). A taxa de incidência de convulsões foi de 1:5.231 doses. Não foram detectados casos de apnéia. Esses resultados são comparáveis àqueles relatados na literatura para a vacina contra difteria-tétano-coqueluche de células inteiras. CONCLUSÃO: A vacina contra difteria, tétano, coqueluche de células inteiras e Haemophilus influenzae tipo b em estudo pode ser usada com segurança no Programa Nacional de Imunizações, de acordo com as precauções e contra-indicações correntes.


OBJECTIVE:To evaluate the safety of a combined diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine used on the Brazilian National Immunizations Program, chiefly the incidence of hypotonic-hyporesponsive episodes. METHOD: Follow-up of a cohort of 21,064 infants (20,925 or 99.7 percent adhered to the study protocol), within 48 hours of vaccination with diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine in health care units in the City of Rio de Janeiro, to ascertain and investigate spontaneous and solicited severe adverse events. Each child was followed-up for one dose only. RESULTS: The rate of hypotonic-hyporesponsive episodes was 1/1,744 doses (confirmed cases) and 1/1,495 doses (confirmed plus suspect cases). The rate of convulsions was 1/5,231 doses. No cases of apnea were detected. These results are comparable to those found in the literature with diphtheria-tetanus-whole cell pertussis vaccine. CONCLUSION: The diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine under study can be safely used in the National Immunizations Program, according to the current precautions and contraindications.


Subject(s)
Female , Humans , Infant , Male , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Fever/etiology , Haemophilus Vaccines/adverse effects , Immunization Programs/statistics & numerical data , Seizures/etiology , Brazil/epidemiology , Cohort Studies , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Diphtheria/prevention & control , Fever/epidemiology , Haemophilus Infections/prevention & control , Haemophilus Vaccines/administration & dosage , Incidence , Interviews as Topic , Severity of Illness Index , Seizures/epidemiology , Tetanus/prevention & control , Whooping Cough/prevention & control
15.
Rev. bras. enferm ; Rev. bras. enferm;60(4): 444-448, jul.-ago. 2007. graf, tab
Article in Portuguese | LILACS, BDENF | ID: lil-467439

ABSTRACT

Este estudo trata do perfil dos eventos adversos pós-vacinais ocorridos em Teresina em 2006. Os dados foram coletados mediante a aplicação de formulário com 73 participantes em 18 Unidades Básicas de Saúde. Os resultados mostram que as vacinas que mais produziram eventos adversos foram a tetravalente, BCG e DPT. Os eventos mais freqüentes foram: febre, episódio hipotônico hiporresponsivo, irritabilidade e manifestações locais moderadas. Dentre as condutas adotadas pelos profissionais de saúde, aproximadamente 80 por cento foram adequadas. Os menores de ano foram os mais acometidos pelos eventos. Todos os eventos evoluíram para a cura. Conclui-se que a ação de vacinação ainda continua requerendo capacitação constante dos profissionais da área. Sugere-se aprofundar o conhecimento com relação ao manejo, diagnóstico, investigação e tratamento.


This study focuses the profile of the adverse events after-vaccine occurrences in Teresina in 2006. The data had been collected by means of the form application with 73 participants in 18 Basic Units of Health. The results show that the vaccines that had more produced events adverse had been tetravalente, BCG and DPT. The events most frequent had been: fever, hiporresponsivo hipotonic episode, moderate irritability and local manifestations. Amongst the behaviors adopted for the health professionals, 80 percent had been approximately adjusted. The year minors had been accomitted by the events. All the events had evolved for the cure. It was concluded that the action of vaccination still continues requiring constant qualification of the professionals of the area. It is suggested to deepen the knowledge with relation to the handling, diagnosis, inquiry and treatment.


El presente estudio trata del perfil de las ocurrencias adversas de la después-vacuna en Teresina en 2006. Los datos fueron recogidos por medio del uso un formulário a lo cual participaran 73 personas en 18 unidades básicas de salud. Los resultados demuestraran que las vacunas que tenían más ocurrencias adversas fueran la tetravalente, BCG y DPT. Las ocurrencias más frecuentes fueran: fiebre, episodio hipotônico hiporresponsivo, irritabilidad moderada y manifestaciones locales. Entre los comportamientos adoptados por los profesionales de salud, 80 por ciento fueran ajustados aproximadamente. Los menores de edad del año habían sido acometidos por los acontecimientos. Todos los acontecimientos fueran desarrollados para la cura. Se hay concluydo que la acción de la vacunación todavía continúa requiriendo la calificación constante de los profesionales de la área. Se sugiere para profundizar el conocimiento en relación a la dirección, a la diagnosis, a la investigación y al tratamiento.


Subject(s)
Humans , Vaccination/adverse effects , BCG Vaccine/adverse effects , Brazil/epidemiology , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Hepatitis B Vaccines/adverse effects , Immunization Programs , Vaccination , Vaccines, Combined/adverse effects , Yellow Fever Vaccine/adverse effects
17.
Rev. peru. med. exp. salud publica ; 23(1): 44-51, ene.-mar. 2006. tab
Article in Spanish | LILACS, INS-PERU | ID: lil-477885

ABSTRACT

Objetivos: Describir las características clínicas, socioeconómicas, y patológicas de nueve casos de lactantes que fallecieron horas después de administrárseles vacunas antipolio y DPT junto con anti Haemophilus influenzae b o asociada con antihepatitis B o BCG. Materiales y métodos: Revisión de la historia clínica, entrevista con el equipo de salud a cargo de la vacunación y con los padres del lactante fallecido. Revisión de los informes del protocolo de autopsia e informes de anatomía patológica y entrevista con los médicos legistas y patólogos. Evaluación de controlde calidad de las vacunas administradas. Realización de exámenes de inmunohistoquímica de tejidos pulmonarespara el diagnóstico de virus. Resultados: Entre agosto y diciembre de 2001 se notificaron en el Perú, nueve casos de fallecimiento de lactantes entre ocho horas y tres días después de la aplicación de vacunas DPT y antipolio. Después de la vacunación, los síntomas iniciaron entre 30 minutos a tres horas y la muerte se produjo entre ocho a 78 horas. Los síntomas más frecuentes fueron irritabilidad 8/9, llanto persistente 6/9, somnolencia 5/9, sangrado por nariz y boca5/9. Todos los casos procedieron de familias pobres o muy pobres. El control de calidad se corroboró que las vacunas cumplieron con los estándares establecidos por la OMS. Las causas de la muerte reportadas en las necropsias fueron neumonía en dos casos y edema pulmonar en cinco casos, los informes de anatomía patológica mostraron una neumonitis intersticial y meningitis linfocitaria. No se observaron efectos citopáticos virales en los tejidos pulmonares y los estudios toxicológicos fueron negativos. Conclusiones: No existe evidencia de una asociación causal entre los eventosfatales y la administración de las vacunas.


Objectives: To describe clinical, socio-economic, and pathological characteristics of nine infants who died hours after receiving anti-polio and DPT vaccines, together with anti-Haemophilus influenzae b or in association to anti-hepatitis B vaccine or BCG. Materials and methods: Review of the clinical record, interview with the healthcare team in charge of immunization, and with parents of the deceased infant. Review the autopsy and pathology reports, as well as an interview with pathologists and forensic physicians. Quality control assessment of vaccines used immunohistochemistry examinations for virus diagnosis. Results: Between August and December 2001, nine cases of infant death were reported in Peru, between 8 hours and 3 days after receiving DPT and anti-polio vaccines. After immunization, symptoms appeared from thirty minutes to three hours, and death occurred between 8 to 78 hours. Most frequently reported symptoms were: irritability (8/9), persistent weeping (6/9), somnolence (5/9), nose and mouth bleeding (5/9). All cases occurred in poor or very poor families. Quality control assessments corroborated that vaccines complied with standards set by the World Health Organization. Causes of death reported in autopsies were pneumonia in 2 cases and pulmonary edema in 5 cases; pathology reports indicated the presence of interstitial pneumonitis and lymphocyte meningitis. No viral cytopathic effects in pulmonary tissues were found, and toxicological studies were reported as negative. Conclusions: There is no evidence of a causal relationship between fatal events and vaccine administration.


Subject(s)
Sudden Infant Death , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Peru
18.
São Paulo; s.n; 2005. [140] p. tab, graf.
Thesis in Portuguese | LILACS | ID: lil-430006

ABSTRACT

Objetivo: Descrever os eventos adversos pós-vacina DPT (EAPV-DPT) notificados no Estado de São Paulo entre 1984 e 2001; identificar preditores de gravidade desses eventos; avaliar o Sistema de Vigilância de Eventos Adversos Pós-Vacina DPT (SVEAVP-DPT). Métodos: Estudo descritivo e exploratório de preditores de gravidade. A definição de caso adotada e do SVEAPV, sendo este também a fonte de dados. A avaliação do SVEAPV-DPT foi efetuada segundo metodologia proposta pelo Center for Disease Control and Prevention. Para identificação dos preditores usou-se a regressão logística não condicional. Resultados: Foram identificados 6266 casos, dos quais 53 por cento eram graves, 29,5 por cento foram hospitalizados; os eventos mais freqüentes foram: febre, episódio hipotônico-hiporresponsivo, reação local e convulsão. Em cerca de 75 por cento dos casos, o evento ocorreu nas primeiras seis horas após a vacinação. Mostraram-se independentemente associadas à gravidade: o intervalo de tempo inferior à uma hora entre a aplicação da vacina e o evento, primeira dose aplicada, antecedentes neurológicos pessoais e familiares. O sistema passivo de EAPV é simples, flexível, de baixa sensibilidade, porém útil, descrevendo diferentes tipos de EAPV, identificando lotes mais reatogênicos e oferecendo subsídios para a elaboração de normas técnicas. Conclusões: Apesar das limitações, os sistemas passivos de VEAPV constituem o principal instrumento para estudar a segurança de vacinas no período pós-licença, sendo, porém, recomendável a incorporação de novas metodologias, entre elas a de municipíos e unidades sentinelas. Além disso, é recomendável a inclusão na pauta de discussão das revisões periódicas do calendário de imunizações, a introdução da vacina DPY acelular.


Subject(s)
Humans , Infant, Newborn , Child, Preschool , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Vaccines/adverse effects , Adverse Drug Reaction Reporting Systems
19.
Article in English | IMSEAR | ID: sea-31655

ABSTRACT

The objective of this study was to assess and compare the reactogenicity of GlaxoSmithKline (GSK) Biologicals' diphtheria-tetanus-tricomponent acellular pertussis vaccine (DTPa) and the locally used combined diphtheria-tetanus-whole-cell pertussis vaccine (DTPw) as a primary vaccination course in healthy infants at the age of 3, 4 and 5 months. A phase IV, single-blinded, randomized comparative clinical study involved one hundred and eighty healthy infants with two study groups in a 2:1 ratio to receive either DTPa or DTPw vaccine which were administered intramuscularly at the right anterior-lateral aspect of the thigh. The incidence and intensity of local solicited symptoms such as pain, redness and swelling at injection site and general solicited symptoms such as fever and fussiness were evaluated. Serious adverse events were followed for one month after each vaccination. The overall incidence of local and general symptoms was significantly higher in the group receiving locally used DTPw vaccine as compared to the group receiving GSK DTPa vaccine. Solicited local symptoms, pain (47.4% vs 15.1%), redness (95.9% vs 84.9%) and swelling (46.2% vs 18.5%), were reported more frequently in the group receiving DTPw vaccine than in the group receiving DTPa vaccine. Fever (> or = 37.5 degrees C) (52% vs 14.6%) and fussiness (60.8% vs 33.6%) were also more commonly reported in the DTPw group. There were six serious adverse events reported (4 with DTPw and 2 with DTPa). None of them related to the study vaccines, as considered by the investigators. Thus it was found that GSK Biologicals' DTPa vaccine was significantly less reactogenic as compared to the locally used DTPw vaccine manufactured by Commonwealth Serum Laboratories when administered as a 3-dose primary vaccination course to healthy infants at the age of 3, 4 and 5 months in Singapore.


Subject(s)
Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Diphtheria-Tetanus-acellular Pertussis Vaccines/adverse effects , Humans , Incidence , Infant , Inflammation/epidemiology , Pain/epidemiology , Singapore/epidemiology , Single-Blind Method
20.
Article in English | IMSEAR | ID: sea-119205

ABSTRACT

Ethics in public health policy is given the least importance and rarely discussed. Resolving ethical issues in public health is often an arduous task as these are complicated and require careful handling. Using four case studies, we discuss issues pertaining to pertussis and brain damage, water fluoridation and dental caries, infection with the human immunodeficiency virus and the right to marriage, and the debate surrounding universal salt iodization. The core issue in all these examples pertains to the relevance of ethics in public health policy.


Subject(s)
Decision Making , Dental Caries/prevention & control , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Ethics, Medical , Fluoridation , HIV Infections/transmission , Health Policy , Humans , India , Iodine/administration & dosage , Marriage , Public Health , Sodium Chloride/chemistry
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