Appendicitis as a possible safety signal for the COVID-19 vaccines

This study reviewed cases of appendicitis following administration of COVID-19 vaccines reported to VigiBase, the WHO database of individual case safety reports (ICSRs). Three hundred fifty-eight cases were identified, and disproportionate reporting was noted, with 329 calculated expected cases. Upo...

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Autores principales:	Joseph Mitchell, Qun-Ying Yue
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	COVID-19 vaccine Appendicitis Safety signal Pharmacovigilance Immunologic diseases. Allergy RC581-607
Acceso en línea:	https://doaj.org/article/06da8d0558d44b9db86f852c50d4321c
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spelling	oai:doaj.org-article:06da8d0558d44b9db86f852c50d4321c2021-11-12T04:46:42ZAppendicitis as a possible safety signal for the COVID-19 vaccines2590-136210.1016/j.jvacx.2021.100122https://doaj.org/article/06da8d0558d44b9db86f852c50d4321c2021-12-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2590136221000395https://doaj.org/toc/2590-1362This study reviewed cases of appendicitis following administration of COVID-19 vaccines reported to VigiBase, the WHO database of individual case safety reports (ICSRs). Three hundred fifty-eight cases were identified, and disproportionate reporting was noted, with 329 calculated expected cases. Upon review, 24 ICSRs were excluded, so 334 unique ICSRs underwent clinical review from 19 countries. Forty-eight percent of ICSRs reported imaging and 69% noted surgical intervention. The cases were clinically coherent, with an apparent increase in reporting in the four days post-vaccination and a possible dose–response relationship. Appendicitis has been suggested as an adverse event of special interest post-vaccination against COVID-19 after a numerical increase in the vaccine arm of a clinical trial. The case series may be affected by differences in global patterns of reporting, and it is not possible to prove nor disprove causality from this case series. Global longitudinal studies are required to clarify any possible relationship.Joseph MitchellQun-Ying YueElsevierarticleCOVID-19 vaccineAppendicitisSafety signalPharmacovigilanceImmunologic diseases. AllergyRC581-607ENVaccine: X, Vol 9, Iss , Pp 100122- (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	COVID-19 vaccine Appendicitis Safety signal Pharmacovigilance Immunologic diseases. Allergy RC581-607
spellingShingle	COVID-19 vaccine Appendicitis Safety signal Pharmacovigilance Immunologic diseases. Allergy RC581-607 Joseph Mitchell Qun-Ying Yue Appendicitis as a possible safety signal for the COVID-19 vaccines
description	This study reviewed cases of appendicitis following administration of COVID-19 vaccines reported to VigiBase, the WHO database of individual case safety reports (ICSRs). Three hundred fifty-eight cases were identified, and disproportionate reporting was noted, with 329 calculated expected cases. Upon review, 24 ICSRs were excluded, so 334 unique ICSRs underwent clinical review from 19 countries. Forty-eight percent of ICSRs reported imaging and 69% noted surgical intervention. The cases were clinically coherent, with an apparent increase in reporting in the four days post-vaccination and a possible dose–response relationship. Appendicitis has been suggested as an adverse event of special interest post-vaccination against COVID-19 after a numerical increase in the vaccine arm of a clinical trial. The case series may be affected by differences in global patterns of reporting, and it is not possible to prove nor disprove causality from this case series. Global longitudinal studies are required to clarify any possible relationship.
format	article
author	Joseph Mitchell Qun-Ying Yue
author_facet	Joseph Mitchell Qun-Ying Yue
author_sort	Joseph Mitchell
title	Appendicitis as a possible safety signal for the COVID-19 vaccines
title_short	Appendicitis as a possible safety signal for the COVID-19 vaccines
title_full	Appendicitis as a possible safety signal for the COVID-19 vaccines
title_fullStr	Appendicitis as a possible safety signal for the COVID-19 vaccines
title_full_unstemmed	Appendicitis as a possible safety signal for the COVID-19 vaccines
title_sort	appendicitis as a possible safety signal for the covid-19 vaccines
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/06da8d0558d44b9db86f852c50d4321c
work_keys_str_mv	AT josephmitchell appendicitisasapossiblesafetysignalforthecovid19vaccines AT qunyingyue appendicitisasapossiblesafetysignalforthecovid19vaccines
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Appendicitis as a possible safety signal for the COVID-19 vaccines

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