Adverse Events Related to COVID-19 Vaccines Reported in Pregnant Women in Brazil
Abstract: Regulations for the vaccination of pregnant women in Brazil occurred in March 2021. Despite the absence of robust data in the literature on the coronavirus disease 2019 (COVID-19) vaccinations in pregnant women, it is understood that the benefit-risk ratio tends to be favorable when considering the pandemic and the high burden of the disease. However, it is still important to monitor for Events Supposedly Attributable to Vaccination or Immunization (ESAVI) and to draw safety profiles of the different platforms used in pregnant and postpartum women. The present study aims to describe the main characteristics of ESAVIs related to COVID-19 vaccines occurring in pregnant women in the first months of the vaccination campaign in Brazil. During the evaluation period, 1,674 notifications of ESAVIs in pregnant women were recorded, and 582 notifications were included for the analysis. Of the 582 ESAVIs identified, 481 (82%) were classified as non-serious adverse events and 101 (17%) as serious adverse events. Ten deaths were identified, including one death which was considered to be causally related to the vaccine. The other nine maternal deaths had causality C, that is, without causal relationship with the vaccine, and most were due to complications inherent to pregnancy, such as pregnancy-specific hypertensive disorder (PSHD) in 4 cases and 3 due to COVID-19. Despite some limitations in our study, we believe it brings new insights into COVID-19 vaccines in this group and will add to the available evidence.
- Alternative title
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Eventos adversos pós-vacina contra COVID-19 em gestantes no Brasil
- Location
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Deutsche Nationalbibliothek Frankfurt am Main
- Extent
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Online-Ressource
- Language
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Englisch
- Bibliographic citation
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Adverse Events Related to COVID-19 Vaccines Reported in Pregnant Women in Brazil ; volume:44 ; number:09 ; year:2022 ; pages:821-829
Revista brasileira de ginecologia e obstetrícia ; 44, Heft 09 (2022), 821-829
- Contributor
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Kobayashi, Carla Dinamerica
Porto, Victor Bertollo Gomes
da Nóbrega, Martha Elizabeth Brasil
Cabral, Cibelle Mendes
Barros, Tiago Dahrug
Martins, Cecília Maria Roteli
- DOI
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10.1055/s-0042-1755461
- URN
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urn:nbn:de:101:1-2022120813051616556972
- Rights
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Open Access; Der Zugriff auf das Objekt ist unbeschränkt möglich.
- Last update
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28.11.2022, 4:17 AM CET
Data provider
Deutsche Nationalbibliothek. If you have any questions about the object, please contact the data provider.
Associated
- Kobayashi, Carla Dinamerica
- Porto, Victor Bertollo Gomes
- da Nóbrega, Martha Elizabeth Brasil
- Cabral, Cibelle Mendes
- Barros, Tiago Dahrug
- Martins, Cecília Maria Roteli
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Travelers’ vaccines and their adverse events in Nara, Japan
Hospital deaths and adverse events in Brazil
Adverse events following administration of COVID-19 vaccines in Saudi Arabia
Adverse effects of COVID-19 vaccines and measures to prevent them
Adverse effects of antiretroviral therapy in pregnant women infected with HIV in Brazil from 2000 to 2015: a cohort study
Reported dietary intake in early pregnant compared to non-pregnant women – a cross-sectional study
HIV Prevalence among Pregnant Women in Brazil: A National Survey
Postmarketing Surveillance of Full Spectrum Hemp Extract CBD Products: Reported Adverse Events and Serious Adverse Events
Associations among claims-based care fragmentation, self-reported gaps in care coordination, and self-reported adverse events
A framework to assess patient-reported adverse outcomes arising during hospitalization