Cargando…

Trends in reporting embolic and thrombotic events after COVID-19 vaccination: A retrospective, pharmacovigilance study

With the progression of global vaccination against coronavirus disease 2019 (COVID-19), embolic and thrombotic events (ETEs) following COVID-19 vaccination continue to be reported. To date, most reports on the type of COVID-19 vaccine and ETEs have been based on clinical trials, and other reports in...

Descripción completa

Detalles Bibliográficos
Autores principales: Kan, Yusuke, Asada, Mizuho, Uesawa, Yoshihiro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9342794/
https://www.ncbi.nlm.nih.gov/pubmed/35913955
http://dx.doi.org/10.1371/journal.pone.0269268
_version_ 1784760903295565824
author Kan, Yusuke
Asada, Mizuho
Uesawa, Yoshihiro
author_facet Kan, Yusuke
Asada, Mizuho
Uesawa, Yoshihiro
author_sort Kan, Yusuke
collection PubMed
description With the progression of global vaccination against coronavirus disease 2019 (COVID-19), embolic and thrombotic events (ETEs) following COVID-19 vaccination continue to be reported. To date, most reports on the type of COVID-19 vaccine and ETEs have been based on clinical trials, and other reports include a small number of cases. Further, the relationship between the type of COVID-19 vaccine and ETEs has not been clarified. It is important to elucidate trends in the development of ETEs after vaccination, which is a crucial concern for both prospective patients and healthcare providers. In this retrospective, pharmacovigilance study, we analyzed the Vaccine Adverse Event Reporting System (VAERS) reports from January 1, 2020 to June 18, 2021, and performed signal detection and time-to-onset analysis of adverse events by calculating the reported odds ratio (ROR) to understand ETE trends after COVID-19 vaccination based on the vaccine type. Using VAERS, we could collect data about several ETEs associated with COVID-19 vaccination. Nine adverse events associated with ETEs were reported following the administration of viral vector vaccines. The median time to ETE onset was 6 (interquartile range: 2–17) days for mRNA vaccines and 11 (interquartile range: 4–21) days for viral vector vaccines. This study suggests that VAERS aids in disequilibrium analysis to examine the association between vaccine type and ETEs after COVID-19 vaccination. Additionally, the tendency to develop ETEs and the number of days taken to develop ETEs varied depending on the type of the COVID-19 vaccine. Thus, vaccinators and healthcare providers should consider the primary diseases associated with ETEs while selecting vaccines for administration and carefully monitor patients following vaccination for potential ETEs based on the characteristics of vaccine type-specific onset period.
format Online
Article
Text
id pubmed-9342794
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Public Library of Science
record_format MEDLINE/PubMed
spelling pubmed-93427942022-08-02 Trends in reporting embolic and thrombotic events after COVID-19 vaccination: A retrospective, pharmacovigilance study Kan, Yusuke Asada, Mizuho Uesawa, Yoshihiro PLoS One Research Article With the progression of global vaccination against coronavirus disease 2019 (COVID-19), embolic and thrombotic events (ETEs) following COVID-19 vaccination continue to be reported. To date, most reports on the type of COVID-19 vaccine and ETEs have been based on clinical trials, and other reports include a small number of cases. Further, the relationship between the type of COVID-19 vaccine and ETEs has not been clarified. It is important to elucidate trends in the development of ETEs after vaccination, which is a crucial concern for both prospective patients and healthcare providers. In this retrospective, pharmacovigilance study, we analyzed the Vaccine Adverse Event Reporting System (VAERS) reports from January 1, 2020 to June 18, 2021, and performed signal detection and time-to-onset analysis of adverse events by calculating the reported odds ratio (ROR) to understand ETE trends after COVID-19 vaccination based on the vaccine type. Using VAERS, we could collect data about several ETEs associated with COVID-19 vaccination. Nine adverse events associated with ETEs were reported following the administration of viral vector vaccines. The median time to ETE onset was 6 (interquartile range: 2–17) days for mRNA vaccines and 11 (interquartile range: 4–21) days for viral vector vaccines. This study suggests that VAERS aids in disequilibrium analysis to examine the association between vaccine type and ETEs after COVID-19 vaccination. Additionally, the tendency to develop ETEs and the number of days taken to develop ETEs varied depending on the type of the COVID-19 vaccine. Thus, vaccinators and healthcare providers should consider the primary diseases associated with ETEs while selecting vaccines for administration and carefully monitor patients following vaccination for potential ETEs based on the characteristics of vaccine type-specific onset period. Public Library of Science 2022-08-01 /pmc/articles/PMC9342794/ /pubmed/35913955 http://dx.doi.org/10.1371/journal.pone.0269268 Text en © 2022 Kan et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Kan, Yusuke
Asada, Mizuho
Uesawa, Yoshihiro
Trends in reporting embolic and thrombotic events after COVID-19 vaccination: A retrospective, pharmacovigilance study
title Trends in reporting embolic and thrombotic events after COVID-19 vaccination: A retrospective, pharmacovigilance study
title_full Trends in reporting embolic and thrombotic events after COVID-19 vaccination: A retrospective, pharmacovigilance study
title_fullStr Trends in reporting embolic and thrombotic events after COVID-19 vaccination: A retrospective, pharmacovigilance study
title_full_unstemmed Trends in reporting embolic and thrombotic events after COVID-19 vaccination: A retrospective, pharmacovigilance study
title_short Trends in reporting embolic and thrombotic events after COVID-19 vaccination: A retrospective, pharmacovigilance study
title_sort trends in reporting embolic and thrombotic events after covid-19 vaccination: a retrospective, pharmacovigilance study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9342794/
https://www.ncbi.nlm.nih.gov/pubmed/35913955
http://dx.doi.org/10.1371/journal.pone.0269268
work_keys_str_mv AT kanyusuke trendsinreportingembolicandthromboticeventsaftercovid19vaccinationaretrospectivepharmacovigilancestudy
AT asadamizuho trendsinreportingembolicandthromboticeventsaftercovid19vaccinationaretrospectivepharmacovigilancestudy
AT uesawayoshihiro trendsinreportingembolicandthromboticeventsaftercovid19vaccinationaretrospectivepharmacovigilancestudy