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Research Article
October 3, 2023
continuing medical education

Risk of Guillain-Barré Syndrome Following COVID-19 Vaccines
A Nationwide Self-Controlled Case Series Study

November 21, 2023 issue
101 (21) e2094-e2102
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Abstract

Background and Objectives

Guillain-Barré syndrome (GBS) has been inconsistently associated with some coronavirus disease 2019 (COVID-19) vaccines. We aimed to quantify the risk of GBS according to the type of COVID-19 vaccine in a large population.

Methods

Using the French National Health Data System linked to the COVID-19 vaccine database, we analyzed all individuals aged 12 years or older admitted for GBS from December 27, 2020, to May 20, 2022. We estimated the relative incidence (RI) of GBS within 1–42 days after vaccination up to the first booster dose compared with baseline periods using a self-controlled case series design. We then derived the number of cases attributable to the vaccination. Analyses were adjusted for the period and stratified by age group, sex, and for the presence of severe acute respiratory syndrome coronavirus 2 or common acute infections.

Results

Of 58,530,770 people aged 12 years or older, 88.8% received at least 1 COVID-19 vaccine dose and 2,229 were hospitalized for GBS during the study period. Patients had a median age of 57 years, and 60% were male patients. The RI of GBS between 1–42 days was 2.5 (95% CI 1.8–3.6) for the first dose of ChAdOx1-S and 2.4 (95% CI 1.2–5.0) for the unique dose of Ad26.COV2.S vaccine. We estimated 6.5 attributable GBS cases per million persons having received a first dose of ChAdOx1-S and 5.7 cases per million for the Ad26.COV2.S vaccine. Except for the age group of 12–49 years after the second dose of the messenger RNA (mRNA)-1273 vaccine (RI 2.6, 95% CI 1.2–5.5), none of the RI estimates were found significantly increased for the mRNA vaccines.

Discussion

In summary, we found increased risks of GBS after the first administration of ChAdOx1-S and Ad26.COV2.S vaccines. In this comprehensive assessment at the French population level, there was no statistically significant increase in the risk of GBS after the administration of mRNA vaccines. This is reassuring in the context of the ongoing and future use of mRNA-based booster vaccination.

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Supplementary Material

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Information & Authors

Information

Published In

Neurology®
Volume 101Number 21November 21, 2023
Pages: e2094-e2102
PubMed: 37788935

Publication History

Received: April 7, 2023
Accepted: August 3, 2023
Published online: October 3, 2023
Published in print: November 21, 2023

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Disclosure

The authors report no relevant disclosures. Go to Neurology.org/N for full disclosures.

Study Funding

No targeted funding reported.

Authors

Affiliations & Disclosures

Stéphane Le Vu, PharmD, PhD https://orcid.org/0000-0002-1303-8281
From the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Marion Bertrand, MSc
From the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Jérémie Botton, PharmD, PhD
From the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Marie-Joelle Jabagi, PharmD, PhD
From the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Jérôme Drouin, MSc
From the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Laura Semenzato, MSc
From the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
From the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Rosemary Dray-Spira, MD, PhD
From the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
From the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE

Notes

Correspondence Dr. Le Vu [email protected]
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Submitted and externally peer reviewed. The handling editor was Associate Editor Anthony Amato, MD, FAAN.

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  1. A nationwide Guillain–Barré syndrome epidemiological study in Spain during the COVID ‐19 years , European Journal of Neurology, 31, 12, (2024).https://doi.org/10.1111/ene.16439
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