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Ocorrência de eventos adversos após o uso da vacina adsorvida difteria, tétano e pertussis (acelular) – dTpa –, São Paulo, SP, 2015-2016 *

2020; MINISTÉRIO DA SAÚDE; Volume: 29; Issue: 2 Linguagem: Inglês

10.5123/s1679-49742020000200027

ISSN

2237-9622

Autores

Vera Lúcia Gattás, Expedito José Albuquerque Luna, Ana Paula Sayuri Sato, Eder Gatti Fernandes, Lourdes R.A. Vaz-de-Lima, Helena Keiko Sato, Euclides Ayres de Castilho,

Tópico(s)

Intramuscular injections and effects

Resumo

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.

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