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COVID-19 Vaccine-Associated Transient Global Amnesia: A Disproportionality Analysis of the WHO Safety Database

Coronavirus disease 2019 (COVID-19) spread rapidly, resulting in a global pandemic for which vaccines were quickly developed. As their safety continues to be monitored, cases of transient global amnesia (TGA) following mRNA vaccination with elasomeran have been reported. TGA is characterized by sudd...

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Autores principales: Merino, Diane, Gérard, Alexandre O., Van Obberghen, Elise K., Ben Othman, Nouha, Ettore, Eric, Giordana, Bruno, Viard, Delphine, Rocher, Fanny, Destere, Alexandre, Benoit, Michel, Drici, Milou-Daniel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9164011/
https://www.ncbi.nlm.nih.gov/pubmed/35668936
http://dx.doi.org/10.3389/fphar.2022.909412
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author Merino, Diane
Gérard, Alexandre O.
Van Obberghen, Elise K.
Ben Othman, Nouha
Ettore, Eric
Giordana, Bruno
Viard, Delphine
Rocher, Fanny
Destere, Alexandre
Benoit, Michel
Drici, Milou-Daniel
author_facet Merino, Diane
Gérard, Alexandre O.
Van Obberghen, Elise K.
Ben Othman, Nouha
Ettore, Eric
Giordana, Bruno
Viard, Delphine
Rocher, Fanny
Destere, Alexandre
Benoit, Michel
Drici, Milou-Daniel
author_sort Merino, Diane
collection PubMed
description Coronavirus disease 2019 (COVID-19) spread rapidly, resulting in a global pandemic for which vaccines were quickly developed. As their safety continues to be monitored, cases of transient global amnesia (TGA) following mRNA vaccination with elasomeran have been reported. TGA is characterized by sudden onset of anterograde amnesia with preservation of other cognitive functions and resolution within 24 h. We aimed to investigate the potential link of TGA with COVID-19 vaccines. We queried the World Health Organization VigiBase(®) for all reports of “Transient global amnesia”, up to 6 December 2021. Disproportionality analysis relied on the Reporting Odds Ratio (ROR) with its 95% Confidence Interval (CI) and the Information Component (IC). A positive lower end of the 95% CI of the IC (IC025) is used to statistically detect a signal. Of all TGA cases, 289 were associated with a COVID-19 vaccine, representing the most frequent association. Tozinameran was mostly represented (147, 50.8%), followed by AZD1222 (69, 23,8%), elasomeran (60, 20.8%), and JNJ-78436735 (12, 4.2%). With an IC025 > 0, COVID-19 vaccines showed a significant ROR (5.1; 95%CI 4.4–6.0). Tozinameran reached the strongest ROR (4.6; 95%CI 3.9–5.0), followed by elasomeran (4.4; 95%CI 3.4–6.0), AZD1222 (3.8; 95%CI 3.0–5.0), and JNJ-78436735 (3.7; 95%CI 2.1–6.0). Our analysis of COVID-19 vaccines-related TGA reports shows significant disproportionality. Cerebrovascular, inflammatory, or migrainous mechanisms may underlie this association. Yet, numerous confounding factors cannot be tackled with this approach, and causality cannot be ascertained. The identification of this trigger of TGA may help the clinician in his etiological research.
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spelling pubmed-91640112022-06-05 COVID-19 Vaccine-Associated Transient Global Amnesia: A Disproportionality Analysis of the WHO Safety Database Merino, Diane Gérard, Alexandre O. Van Obberghen, Elise K. Ben Othman, Nouha Ettore, Eric Giordana, Bruno Viard, Delphine Rocher, Fanny Destere, Alexandre Benoit, Michel Drici, Milou-Daniel Front Pharmacol Pharmacology Coronavirus disease 2019 (COVID-19) spread rapidly, resulting in a global pandemic for which vaccines were quickly developed. As their safety continues to be monitored, cases of transient global amnesia (TGA) following mRNA vaccination with elasomeran have been reported. TGA is characterized by sudden onset of anterograde amnesia with preservation of other cognitive functions and resolution within 24 h. We aimed to investigate the potential link of TGA with COVID-19 vaccines. We queried the World Health Organization VigiBase(®) for all reports of “Transient global amnesia”, up to 6 December 2021. Disproportionality analysis relied on the Reporting Odds Ratio (ROR) with its 95% Confidence Interval (CI) and the Information Component (IC). A positive lower end of the 95% CI of the IC (IC025) is used to statistically detect a signal. Of all TGA cases, 289 were associated with a COVID-19 vaccine, representing the most frequent association. Tozinameran was mostly represented (147, 50.8%), followed by AZD1222 (69, 23,8%), elasomeran (60, 20.8%), and JNJ-78436735 (12, 4.2%). With an IC025 > 0, COVID-19 vaccines showed a significant ROR (5.1; 95%CI 4.4–6.0). Tozinameran reached the strongest ROR (4.6; 95%CI 3.9–5.0), followed by elasomeran (4.4; 95%CI 3.4–6.0), AZD1222 (3.8; 95%CI 3.0–5.0), and JNJ-78436735 (3.7; 95%CI 2.1–6.0). Our analysis of COVID-19 vaccines-related TGA reports shows significant disproportionality. Cerebrovascular, inflammatory, or migrainous mechanisms may underlie this association. Yet, numerous confounding factors cannot be tackled with this approach, and causality cannot be ascertained. The identification of this trigger of TGA may help the clinician in his etiological research. Frontiers Media S.A. 2022-05-20 /pmc/articles/PMC9164011/ /pubmed/35668936 http://dx.doi.org/10.3389/fphar.2022.909412 Text en Copyright © 2022 Merino, Gérard, Van Obberghen, Ben Othman, Ettore, Giordana, Viard, Rocher, Destere, Benoit and Drici. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Merino, Diane
Gérard, Alexandre O.
Van Obberghen, Elise K.
Ben Othman, Nouha
Ettore, Eric
Giordana, Bruno
Viard, Delphine
Rocher, Fanny
Destere, Alexandre
Benoit, Michel
Drici, Milou-Daniel
COVID-19 Vaccine-Associated Transient Global Amnesia: A Disproportionality Analysis of the WHO Safety Database
title COVID-19 Vaccine-Associated Transient Global Amnesia: A Disproportionality Analysis of the WHO Safety Database
title_full COVID-19 Vaccine-Associated Transient Global Amnesia: A Disproportionality Analysis of the WHO Safety Database
title_fullStr COVID-19 Vaccine-Associated Transient Global Amnesia: A Disproportionality Analysis of the WHO Safety Database
title_full_unstemmed COVID-19 Vaccine-Associated Transient Global Amnesia: A Disproportionality Analysis of the WHO Safety Database
title_short COVID-19 Vaccine-Associated Transient Global Amnesia: A Disproportionality Analysis of the WHO Safety Database
title_sort covid-19 vaccine-associated transient global amnesia: a disproportionality analysis of the who safety database
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9164011/
https://www.ncbi.nlm.nih.gov/pubmed/35668936
http://dx.doi.org/10.3389/fphar.2022.909412
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