Associations of Guillain-Barré syndrome with coronavirus disease 2019 vaccination: Disproportionality analysis using the World Health Organization pharmacovigilance database

Jee Eun Kim, Jin Park, Young Gi Min, Yoon Ho Hong, Tae Jin Song

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

Abstract

Vaccinations against the severe acute respiratory syndrome coronavirus 2 which causes COVID-19 have been administered worldwide. We aimed to investigate associations of COVID-19 vaccination with the occurrence of Guillain-Barré syndrome (GBS). We explored potential safety signals regarding the development of GBS using disproportionality analyses to compare COVID-19 vaccination with all adverse drug reaction (ADR) reports and influenza vaccines reported to VigiBase. As of October 15, 2021, a total of 2163 cases (0.13%) of GBS and its variants (including 46 cases of Miller-Fisher syndrome and 13 cases of Bickerstaff's encephalitis) were identified in entire ADR database after vaccination with the ChAdOx1 nCoV-19 (AstraZeneca, Cambridge, UK) or the two messenger RNA-based COVID-19 (BNT162b2; Pfizer and BioNTech) or mRNA-1273; Moderna) vaccines. The median time to onset of GBS after vaccination was around 2 weeks. The ChAdOx1 nCoV-19 and two messenger RNA-based COVID-19 vaccines demonstrated a higher risk for GBS against entire database (information component [IC]025 = 1.73 reporting odds ratio [ROR]025 = 3.51; IC025 = 1.07, ROR025 = 2.22, respectively). When compared with influenza vaccines, neither the ChAdOx1 nCoV-19 nor mRNA-based vaccines were found to be associated with greater risks of GBS (IC025 = −1.84, ROR025 = 0.11; IC025 = −1.86, ROR025 = 0.06, respectively). Although potential safety signals associated with GBS COVID-19 vaccines have been identified, the risk of GBS from COVID-19 vaccines were low and did not surpass those of influenza vaccines; however, because of the heterogeneity of the sources of information in the WHO pharmacovigilance database, further epidemiological studies are warranted to confirm these observations.

Original languageEnglish
Pages (from-to)206-214
Number of pages9
JournalJournal of the Peripheral Nervous System
Volume27
Issue number3
DOIs
StatePublished - Sep 2022
Externally publishedYes

Keywords

  • COVID-19
  • Guillain-Barré syndrome
  • Guillain-Barré syndrome variants
  • SARS-CoV-2
  • vaccination

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