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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: Mitchell, Joseph, Yue, Qun-Ying
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8565092/
https://www.ncbi.nlm.nih.gov/pubmed/34746743
http://dx.doi.org/10.1016/j.jvacx.2021.100122
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author Mitchell, Joseph
Yue, Qun-Ying
author_facet Mitchell, Joseph
Yue, Qun-Ying
author_sort Mitchell, Joseph
collection PubMed
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.
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spelling pubmed-85650922021-11-03 Appendicitis as a possible safety signal for the COVID-19 vaccines Mitchell, Joseph Yue, Qun-Ying Vaccine X Short communication 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. Elsevier 2021-11-03 /pmc/articles/PMC8565092/ /pubmed/34746743 http://dx.doi.org/10.1016/j.jvacx.2021.100122 Text en © 2021 The Authors https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Short communication
Mitchell, Joseph
Yue, Qun-Ying
Appendicitis as a possible safety signal for the COVID-19 vaccines
title 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_short Appendicitis as a possible safety signal for the COVID-19 vaccines
title_sort appendicitis as a possible safety signal for the covid-19 vaccines
topic Short communication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8565092/
https://www.ncbi.nlm.nih.gov/pubmed/34746743
http://dx.doi.org/10.1016/j.jvacx.2021.100122
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