Adverse event occurrence following use of tetanus, diphtheria and acellular pertussis adsorbed vaccine – Tdap –, São Paulo, SP, Brazil, 2015-2016

Translated title
Ocorrência de eventos adversos após o uso da vacina adsorvida difteria, tétano e pertussis (acelular) – dTpa –, São Paulo, SP, 2015-2016;  Aparecimiento de eventos adversos después del uso de la vacuna adsorbida difteria, tétanos y tosferina (acelular) – dTpa –, São Paulo, SP, Brasil, 2015-2016

Publication type
Article
Language
Portuguese;  English
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Open Access
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Abstract
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.
metadata.dc.description.abstractpt
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.
Reference
Gattás VL, Luna EJA, Sato APS, Fernandes EG, Vaz-de-Lima LR.A., Sato HK, et al. Adverse event occurrence following use of tetanus, diphtheria and acellular pertussis adsorbed vaccine - Tdap -, São Paulo, SP, Brazil, 2015-2016. Epidemiol. Serv. Saude. 2020 May;29(2):e2019280. doi:10.5123/s1679-49742020000200027.
Link to cite this reference
https://repositorio.butantan.gov.br/handle/butantan/3284
Issue Date
2020


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