Thrombotic Adverse Events Reported for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 Vaccines: Comparison of Occurrence and Clinical Outcomes in the EudraVigilance Database

Vaccination against COVID-19 is the cornerstone of controlling and mitigating the ongoing pandemic. Thrombotic adverse events linked to Moderna, Pfizer and the Oxford-AstraZeneca vaccine have been documented and described as extremely rare. While the Oxford-AstraZeneca vaccine has received much of t...

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Autores principales:	Mansour Tobaiqy, Katie MacLure, Hajer Elkout, Derek Stewart
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	adverse events adverse drug reaction thrombotic COVID-19 vaccine Pfizer Moderna Medicine R
Acceso en línea:	https://doaj.org/article/9e17540dac0c4dc79f696929a27686f9
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spelling	oai:doaj.org-article:9e17540dac0c4dc79f696929a27686f92021-11-25T19:11:20ZThrombotic Adverse Events Reported for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 Vaccines: Comparison of Occurrence and Clinical Outcomes in the EudraVigilance Database10.3390/vaccines91113262076-393Xhttps://doaj.org/article/9e17540dac0c4dc79f696929a27686f92021-11-01T00:00:00Zhttps://www.mdpi.com/2076-393X/9/11/1326https://doaj.org/toc/2076-393XVaccination against COVID-19 is the cornerstone of controlling and mitigating the ongoing pandemic. Thrombotic adverse events linked to Moderna, Pfizer and the Oxford-AstraZeneca vaccine have been documented and described as extremely rare. While the Oxford-AstraZeneca vaccine has received much of the attention, the other vaccines should not go unchallenged. This study aimed to determine the frequency of reported thrombotic adverse events and clinical outcomes for these three COVID-19 vaccines, namely, Moderna, Pfizer and Oxford-AstraZeneca. A retrospective descriptive analysis was conducted of spontaneous reports for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 vaccines submitted to the EudraVigilance database in the period from 17 February to 14 June 2021. There were 729,496 adverse events for the three vaccines, of which 3420 were thrombotic, mainly Oxford-AstraZeneca (n = 1988; 58.1%) followed by Pfizer (n = 1096; 32.0%) and Moderna (n = 336; 9.8%). As serious adverse events, there were 705 reports of pulmonary embolism for the three vaccines, of which 130 reports (18.4%) were for Moderna, 226 reports (32.1%) for Pfizer and 349 (49.5%) for Oxford-AstraZeneca vaccines. The occurrence of pulmonary embolism is significantly associated with a fatal outcome (<i>p</i> ≤ 0.001). Sixty-three fatalities were recorded (n = 63/3420; 1.8%), of which Moderna (n = 6), Pfizer (n = 25) and Oxford-AstraZeneca (n = 32).Mansour TobaiqyKatie MacLureHajer ElkoutDerek StewartMDPI AGarticleadverse eventsadverse drug reactionthromboticCOVID-19 vaccinePfizerModernaMedicineRENVaccines, Vol 9, Iss 1326, p 1326 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	adverse events adverse drug reaction thrombotic COVID-19 vaccine Pfizer Moderna Medicine R
spellingShingle	adverse events adverse drug reaction thrombotic COVID-19 vaccine Pfizer Moderna Medicine R Mansour Tobaiqy Katie MacLure Hajer Elkout Derek Stewart Thrombotic Adverse Events Reported for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 Vaccines: Comparison of Occurrence and Clinical Outcomes in the EudraVigilance Database
description	Vaccination against COVID-19 is the cornerstone of controlling and mitigating the ongoing pandemic. Thrombotic adverse events linked to Moderna, Pfizer and the Oxford-AstraZeneca vaccine have been documented and described as extremely rare. While the Oxford-AstraZeneca vaccine has received much of the attention, the other vaccines should not go unchallenged. This study aimed to determine the frequency of reported thrombotic adverse events and clinical outcomes for these three COVID-19 vaccines, namely, Moderna, Pfizer and Oxford-AstraZeneca. A retrospective descriptive analysis was conducted of spontaneous reports for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 vaccines submitted to the EudraVigilance database in the period from 17 February to 14 June 2021. There were 729,496 adverse events for the three vaccines, of which 3420 were thrombotic, mainly Oxford-AstraZeneca (n = 1988; 58.1%) followed by Pfizer (n = 1096; 32.0%) and Moderna (n = 336; 9.8%). As serious adverse events, there were 705 reports of pulmonary embolism for the three vaccines, of which 130 reports (18.4%) were for Moderna, 226 reports (32.1%) for Pfizer and 349 (49.5%) for Oxford-AstraZeneca vaccines. The occurrence of pulmonary embolism is significantly associated with a fatal outcome (<i>p</i> ≤ 0.001). Sixty-three fatalities were recorded (n = 63/3420; 1.8%), of which Moderna (n = 6), Pfizer (n = 25) and Oxford-AstraZeneca (n = 32).
format	article
author	Mansour Tobaiqy Katie MacLure Hajer Elkout Derek Stewart
author_facet	Mansour Tobaiqy Katie MacLure Hajer Elkout Derek Stewart
author_sort	Mansour Tobaiqy
title	Thrombotic Adverse Events Reported for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 Vaccines: Comparison of Occurrence and Clinical Outcomes in the EudraVigilance Database
title_short	Thrombotic Adverse Events Reported for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 Vaccines: Comparison of Occurrence and Clinical Outcomes in the EudraVigilance Database
title_full	Thrombotic Adverse Events Reported for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 Vaccines: Comparison of Occurrence and Clinical Outcomes in the EudraVigilance Database
title_fullStr	Thrombotic Adverse Events Reported for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 Vaccines: Comparison of Occurrence and Clinical Outcomes in the EudraVigilance Database
title_full_unstemmed	Thrombotic Adverse Events Reported for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 Vaccines: Comparison of Occurrence and Clinical Outcomes in the EudraVigilance Database
title_sort	thrombotic adverse events reported for moderna, pfizer and oxford-astrazeneca covid-19 vaccines: comparison of occurrence and clinical outcomes in the eudravigilance database
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/9e17540dac0c4dc79f696929a27686f9
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Thrombotic Adverse Events Reported for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 Vaccines: Comparison of Occurrence and Clinical Outcomes in the EudraVigilance Database

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