Manual De Vigilância Epidemiológica De Eventos Adversos Pós-Vacinação

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Manual De Vigilância Epidemiológica De Eventos Adversos Pós-Vacinação MINISTÉRIO DA SAÚDE Manual de Vigilância Epidemiológica de Eventos Adversos Pós-Vacinação 3a edição IÇÃO IBU TR IS D DA A PROIBI VEND TA UI Brasília / DF • 2014 GRAT MINISTÉRIO DA SAÚDE Secretaria de Vigilância em Saúde Departamento de Vigilância das Doenças Transmissíveis Manual de Vigilância Epidemiológica de Eventos Adversos Pós-Vacinação 3ª edição Brasília • DF • 2014 1998 Ministério da Saúde. Esta obra é disponibilizada nos termos da Licença Creative Commons – Atribuição – Não Comercial – Compartilhamento pela mesma licença 4.0 Internacional. É permitida a reprodução parcial ou total desta obra, desde que citada a fonte. A coleção institucional do Ministério da Saúde pode ser acessada, na íntegra, na Biblioteca Virtual em Saúde do Ministério da Saúde: <www.saude.gov.br/bvs>. Tiragem: 1ª edição – 1998 – 2ª edição – 2007 – 3ª edição – 2014 – 40.000 exemplares Elaboração, distribuição e informações: MINISTÉRIO DA SAÚDE Secretaria de Vigilância em Saúde Departamento de Vigilância das Doenças Transmissíveis Esplanada dos Ministérios, bloco G, Edifício Sede, sobreloja CEP: 70058-900 – Brasília/DF Site: www.saude.gov.br/svs E-mail: [email protected] Produção e projeto gráfico: Núcleo de Comunicação/SVS Capa: Fred Lobo Editora responsável: MINISTÉRIO DA SAÚDE Secretaria-Executiva Subsecretaria de Assuntos Administrativos Coordenação-Geral de Documentação e Informação Coordenação de Gestão Editorial SIA, Trecho 4, lotes 540/610 CEP: 71200-040 – Brasília/DF Tels.: (61) 3315-7790 / 3315-7794 Fax: (61) 3233-9558 Site: http://editora.saude.gov.br E-mail: [email protected] Equipe editorial: Normalização: Editora MS Revisão: Eveline de Assis e Tatiane Souza Diagramação: Marcelo Rodrigues Impresso no Brasil / Printed in Brazil Ficha Catalográfica Brasil. Ministério da Saúde. Secretaria de Vigilância em Saúde. Departamento de Vigilância das Doenças Transmissíveis. Manual de vigilância epidemiológica de eventos adversos pós-vacinação / Ministério da Saúde, Secretaria de Vigilância em Saúde, Departamento de Vigilância das Doenças Transmissíveis. – 3. ed. – Brasília : Ministério da Saúde, 2014. 250 p. : il. ISBN 1. Vigilância e controle dos eventos adversos pós-vacinação. 2. Vigilância epidemiológica. 3. Saúde pública. I. Título. CDU 616-036.22:614.47(035) Catalogação na fonte – Coordenação-Geral de Documentação e Informação – Editora MS – OS 2014/0015 Títulos para indexação: Em inglês: Handbook of Epidemiological Surveillance of Averse Events After Vaccination Em espanhol: Manual de Vigilancia Epidemiológica de Eventos Adversos Posvacunación Agradecimentos Este Manual, em sua terceira edição, se fundamenta em publicações, documentos, informações e contribuições de muitos profissionais com expertise em vacinologia, em especial no tema específico de “farmacovigilância de vacinas”. Enumerá-las seria impossível e correr-se-ia o risco de omissões, até imperdoáveis. Neste sentido, a Coordenação-Geral do Programa Nacional de Imunizações expressa seu reconhecimento e agradece o empenho e as contribuições de todos os colaboradores desta edição, bem como das edições anteriores, e agradece a toda a equipe técnica desta Coordenação-Geral e a todas as instituições paceiras, acadêmicas ou não, pela anuência da participação desses profissionais. Lista de abreviaturas e siglas ACRV – Áreas com recomendação de vacinação Adem – Encefalomielite disseminada aguda Anvisa – Agência Nacional de Vigilância Sanitária AASM – Academia Americana de Medicina do Sono BCG – Bacilo de Calmette-Guérin (vacina tuberculose) CDC – Centers for Disease Control and Prevention – Centro de Controle de Doenças dos EUA CGPNI – Coordenação-Geral do Programa Nacional de Imunizações CIDP – Chronic Inflammatory Demyelinating Polyneuropathy – Polineuropatia Desmielinizante Inflamatória Crônica Cifavi – Comitê Interinstitucional de Farmacovigilância de Vacinas e outros Imunobiológicos CIOMS – Council for International Organizations of Medical Sciences Conasems – Conselho Nacional de Secretários Municipais de Saúde Conass – Conselho Nacional de Secretários Estaduais de Saúde CRIE – Centro de Referência para Imunobiológicos Especiais DATASUS – Departamento de Informática do SUS DNA – Doença neurológica aguda DRM – Detentores de Registro de Medicamentos DT – Vacina adsorvida difteria e tétano infantil dT ou Td – Vacina adsorvida difteria e tétano adulto DTP – Vacina adsorvida difteria, tétano e pertússis DTPa – Vacina adsorvida difteria, tétano e pertússis (acelular) dTpa – Vacina adsorvida difteria, tétano e pertússis (acelular) adulto DTP, Hib, HB – Vacina adsorvida difteria, tétano, pertússis, Haemophilus influenzae b (conjugada), hepatite B (recombinante) (Pentavalente) DVA – Doença viscerotrópica aguda EAG – Evento adverso grave EANG – Evento adverso não grave EAPV – Evento adverso pós-vacinação EEG – Eletroencefalograma EHH – Episódio hipotônico-hiporresponsivo ENMG – Eletroneuromiografia FAS – Febre amarela silvestre Fiocruz – Fundação Oswaldo Cruz Gfarm – Gerência de Farmacovigilância H1N1 – Influenza A HA – Vacina adsorvida hepatite A HB – Vacina hepatite B (recombinante) HBIG – Imunoglobulina Hepatite B HBsAg – Antígeno de superfície do vírus da hepatite B HDCV – Human diploid cell vaccine – vacina produzida em células diploides HI – Imuno-histoquímica Hib – Vacina Haemophilus influenzae tipo b HIV – Vírus da imunodeficiência humana HPV – Papilomavírus humano ICSD – International Classification of Sleep Disorders IG – Imunoglobulina IGAR – Imunoglobulina antirrábica IGAT – Imunoglobulina antitetânica IGAVZ – Imunoglobulina antivaricela zoster IgG – Imunoglobulina G IGIV – Imunoglobulina intravenosa IgM – Imunoglobulina M IM – Intramuscular IML – Instituto Médico Legal INCQS – Instituto Nacional de Controle de Qualidade em Saúde INF – Vacina influenza (fracionada, inativada) IV – Intravenoso Lacen – Laboratórios Centrais de Saúde Pública LCR – Líquido cefalorraquidiano (liquor) Mn BC – Vacina meningocócica BC Mc CC – Vacina meningocócica C MnCC - Vacina meningocócica C conjugada MS – Ministério da Saúde Notivisa – Sistema de Notificações em Vigilância Sanitária Nuvig – Núcleo de Gestão do Sistema Nacional de Notificação e Investigação em Vigilância Sanitária OCMD – Óbito com causas maldefinidas OMS/WHO – Organização Mundial da Saúde – World Health Organization Opas/PAHO – Organização Pan-Americana da Saúde – Pan American Health Organization PCEV – Purified chick-embryo cell vaccine PDEV – Purified duck embryo vaccine PEESA – Panencefalite esclerosante subaguda Pn 23 – Vacina pneumocócica 23-valente (polissacarídica) PnC 10 – Vacina pneumocócica 10-valente (conjugada) PnC 13 – Vacina pneumocócica 13-valente (conjugada) PNI – Programa Nacional de Imunizações PVCV – Purified vero cell vaccine RB – Soro antirrábico REM – Rapid Eye Moment RNA – Ácido ribonucleico RNM – Ressonância neuromagnética RT-PCR – Reação em cadeia da polimerase (PCR) em tempo real RV – Vacina raiva Vero SAD – Soro antidiftérico SAT – Soro antitetânico SC – Subcutâneo SCR – Vacina sarampo, caxumba e rubéola (atenuada) – Tríplice viral SCRV – Vacina sarampo, caxumba, rubéola e varicela – Tetraviral SGB – Síndrome de Guillain-Barré SIDS – Sudden Infant Death Syndrome SIEAPV – Sistema de Informação da Vigilância de Eventos Adversos Pós-Vacinação SIPNI – Sistema de Informação do Programa Nacional de Imunizações SMSL – Síndrome da morte súbita do latente SNC – Sistema nervoso central SNP – Sistema nervoso periférico SNVEAPV – Sistema Nacional de Vigilância dos Eventos Adversos Pós-Vacinação SNVS – Sistema Nacional de Vigilância Sanitária SUS – Sistema Único de Saúde SVO – Serviço de Verificação de Óbito SVS – Secretaria de Vigilância em Saúde TC – Tomografia computadorizada TCC - Tomografia computadorizada de crânio TLMS – Teste de Latências Múltiplas do Sono UMC – Uppsala Monitoring Center UPA – Unidade de Pronto Atendimento VAERS – Vaccine Adverse Event Reporting System VEAPV – Vigilância de evento adverso pós-vacinação VFA – Vacina febre amarela (atenuada) Vigipos – Sistema de Notificação e Investigação em Vigilância Sanitária VIP/IPV – Vacina poliomielite (inativada) Visas – Centros de Vigilância Sanitária Estaduais, DF e Municipais VOP/OPV – Vacina poliomielite 1, 2, 3 (atenuada) VR - vacina raiva (inativada) VRH – Vacina rotavírus humano G1P1 [8] (atenuada) PAVV – Poliomielite associada ao vírus vacinal VZ – Vacina varicela VZV – Vírus varicela-zoster Lista de ilustrações Figura 1 – Fluxograma de notificação e investigação de eventos adversos 24 Figura 2 – Sistema Nacional de Vigilância de Eventos Adversos Pós-Vacinação 28 Figura 3 – Precauções para administração da vacina influenza em pessoas com alergia a ovo 166 Quadro 1 – Processo de desenvolvimento de novas vacinas 20 Quadro 2 – Classificação segundo causalidade 34 Quadro 3 – Concentrações dos diversos componentes das vacinas dT e dTpa 60 Quadro 4 – Vacinas raiva (inativadas) para uso em humanos, utilizadas pelo PNI 110 Quadro 5 – Cepas que compõem as diversas combinações existentes da tríplice viral 116 Quadro 6 – Principais combinações de cepas nas apresentações disponíveis em nosso meio 116 Quadro 7 – Composição das vacinas varicela monovalente e tetraviral 122 Quadro 8 – Descrição dos produtos 127 Quadro 9 – EHH: níveis de evidência diagnóstica 144 Quadro 10 – Tratamento da reação anafilática 165 Quadro 11 – Elementos para diagnóstico diferencial entre poliomielite, SGB e mielite transversa 171 Quadro 12 – Situações em que se indica a profilaxia com imunoglobulina específica contra a hepatite B (HBIG) em indivíduos não previamente imunizados
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