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Guillain-Barre Syndrome After COVID-19 Vaccination: A Secondary Analysis of Domestic Safety Data by the Japanese Government

Purpose The purpose of this study was to figure out the risk of Guillain-Barre syndrome (GBS) after coronavirus disease 2019 (COVID-19) vaccination, which has been reported as a rare adverse reaction. Methods Elucidating the characteristics, we performed a secondary analysis of the cases from Februa...

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Autores principales: Kaneda, Yudai, Hashimoto, Takanao, Kaneda, Uiri, Higuchi, Yuka, Murakami, Jun, Inada, Masanari, Senoo, Yuki, Fujieda, Takeshi, Murata, Yuki, Tanimoto, Tetsuya
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cureus 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9620737/
https://www.ncbi.nlm.nih.gov/pubmed/36337786
http://dx.doi.org/10.7759/cureus.30905
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author Kaneda, Yudai
Hashimoto, Takanao
Kaneda, Uiri
Higuchi, Yuka
Murakami, Jun
Inada, Masanari
Senoo, Yuki
Fujieda, Takeshi
Murata, Yuki
Tanimoto, Tetsuya
author_facet Kaneda, Yudai
Hashimoto, Takanao
Kaneda, Uiri
Higuchi, Yuka
Murakami, Jun
Inada, Masanari
Senoo, Yuki
Fujieda, Takeshi
Murata, Yuki
Tanimoto, Tetsuya
author_sort Kaneda, Yudai
collection PubMed
description Purpose The purpose of this study was to figure out the risk of Guillain-Barre syndrome (GBS) after coronavirus disease 2019 (COVID-19) vaccination, which has been reported as a rare adverse reaction. Methods Elucidating the characteristics, we performed a secondary analysis of the cases from February 2020 through January 2022, based on the publicly available spontaneous adverse reaction reports in Japan. Results We identified 115 cases, and all were after messenger RNA (mRNA) vaccination. Of all the cases, 69 (60.0%) were female and 44 (38.2%) were older than 65 years old. Severe GBS was reported by 38 males (median age 61.5 years) and 51 females (median age 55 years). The median interval from vaccination to the onset of symptoms was eight days for males and four days for females. Sequelae were reported in 18 patients (7 males, median age 81 years; 11 females, median age 51 years), 11 of whom were older than 65 years old. The estimated incidence was about 0.0001% (0.000058% for the Pfizer vaccine and about 0.000046% for the Moderna vaccine, respectively). Conclusions Spontaneous reports would have various biases, the incidence of GBS after mRNA vaccination was as low as in other existing vaccination programs, and it is important not to interpret that risk expansively.
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spelling pubmed-96207372022-11-04 Guillain-Barre Syndrome After COVID-19 Vaccination: A Secondary Analysis of Domestic Safety Data by the Japanese Government Kaneda, Yudai Hashimoto, Takanao Kaneda, Uiri Higuchi, Yuka Murakami, Jun Inada, Masanari Senoo, Yuki Fujieda, Takeshi Murata, Yuki Tanimoto, Tetsuya Cureus Neurology Purpose The purpose of this study was to figure out the risk of Guillain-Barre syndrome (GBS) after coronavirus disease 2019 (COVID-19) vaccination, which has been reported as a rare adverse reaction. Methods Elucidating the characteristics, we performed a secondary analysis of the cases from February 2020 through January 2022, based on the publicly available spontaneous adverse reaction reports in Japan. Results We identified 115 cases, and all were after messenger RNA (mRNA) vaccination. Of all the cases, 69 (60.0%) were female and 44 (38.2%) were older than 65 years old. Severe GBS was reported by 38 males (median age 61.5 years) and 51 females (median age 55 years). The median interval from vaccination to the onset of symptoms was eight days for males and four days for females. Sequelae were reported in 18 patients (7 males, median age 81 years; 11 females, median age 51 years), 11 of whom were older than 65 years old. The estimated incidence was about 0.0001% (0.000058% for the Pfizer vaccine and about 0.000046% for the Moderna vaccine, respectively). Conclusions Spontaneous reports would have various biases, the incidence of GBS after mRNA vaccination was as low as in other existing vaccination programs, and it is important not to interpret that risk expansively. Cureus 2022-10-31 /pmc/articles/PMC9620737/ /pubmed/36337786 http://dx.doi.org/10.7759/cureus.30905 Text en Copyright © 2022, Kaneda et al. https://creativecommons.org/licenses/by/3.0/This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Neurology
Kaneda, Yudai
Hashimoto, Takanao
Kaneda, Uiri
Higuchi, Yuka
Murakami, Jun
Inada, Masanari
Senoo, Yuki
Fujieda, Takeshi
Murata, Yuki
Tanimoto, Tetsuya
Guillain-Barre Syndrome After COVID-19 Vaccination: A Secondary Analysis of Domestic Safety Data by the Japanese Government
title Guillain-Barre Syndrome After COVID-19 Vaccination: A Secondary Analysis of Domestic Safety Data by the Japanese Government
title_full Guillain-Barre Syndrome After COVID-19 Vaccination: A Secondary Analysis of Domestic Safety Data by the Japanese Government
title_fullStr Guillain-Barre Syndrome After COVID-19 Vaccination: A Secondary Analysis of Domestic Safety Data by the Japanese Government
title_full_unstemmed Guillain-Barre Syndrome After COVID-19 Vaccination: A Secondary Analysis of Domestic Safety Data by the Japanese Government
title_short Guillain-Barre Syndrome After COVID-19 Vaccination: A Secondary Analysis of Domestic Safety Data by the Japanese Government
title_sort guillain-barre syndrome after covid-19 vaccination: a secondary analysis of domestic safety data by the japanese government
topic Neurology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9620737/
https://www.ncbi.nlm.nih.gov/pubmed/36337786
http://dx.doi.org/10.7759/cureus.30905
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