Risk of Guillain-Barré syndrome after COVID-19 vaccination or SARS-CoV-2 infection: A multinational self-controlled case series study
Publication date
2025-07-11
Authors
Nasreen, Sharifa
Jiang, Yannan
Lu, Han
Lee, Arier
Cutland, Clare L.
Gentile, Angela
Giglio, Norberto
Macartney, Kristine
Deng, Lucy
Liu, Bette
Editors
Advisors
Supervisors
Document Type
Article
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cc_by_nc_nd
Abstract
Background: The association between Guillain-Barré syndrome (GBS) and certain COVID-19 vaccines is inconclusive. We investigated the risk of GBS after COVID-19 vaccination or SARS-CoV-2 infection. Methods: Using a common protocol, we conducted a self-controlled case series study from 1 December 2020 to 9 August 2023 at 20 global sites within the Global Vaccine Data Network™ (GVDN®). Brighton Collaboration case definition criteria were used to determine the level of certainty (LOC) of medical record-reviewed GBS cases at 15 sites. GBS cases following SARS-CoV-2 infection were identified from electronic data sources (EDS) from 11 sites. We estimated the relative incidence (RI) of GBS within 1–42 days following receipt of adenoviral vector, mRNA, or inactivated COVID-19 vaccines or SARS-CoV-2 infection using conditional Poisson regression models, controlling for seasonality. We used random effects meta-analysis to pool the estimates across sites. Results: Of 410 medical record-reviewed post-vaccination GBS cases (out of 2086 EDS-identified cases), 49 were LOC 1 or 2, 187 were LOC 3 or 4, and 174 were LOC 5. These cases received a total of 794 doses of COVID-19 vaccines (160 [20 %] adenoviral vector vaccine doses, 556 [70 %] mRNA vaccine doses, 77 [10 %] inactivated vaccine doses, and 1 [0.1 %] protein-based vaccine dose) during the observation period. We observed an increased risk of confirmed (LOC 1–2) GBS after receiving ChAdOx1-S/nCoV-19 (Vaxzevria/Covishield) (RI = 3.10; 95 % confidence interval [CI], 1.12–8.62). Decreased risks of LOC 1–4 GBS were observed after receiving BNT162b2 (Comirnaty/Tozinameran) (RI = 0.48; 95 %CI, 0.27–0.85) and CoronaVac/Sinovac (RI = 0.04; 95 %CI, 0.00–0.61). For 489 EDS-identified GBS cases after SARS-CoV-2 infection, we found GBS risk to be increased (RI = 3.35; 95 %CI, 1.83–6.11). Conclusion: In this large multinational study, we found increased risks of GBS within 42 days after Vaxzevria/Covishield vaccination or SARS-CoV-2 infection, and decreased risks after receiving Comirnaty/Tozinameran or CoronaVac/Sinovac COVID-19 vaccines.
Keywords
COVID-19, Guillain-Barré syndrome, Pharmacovigilance, Self-controlled case series, Vaccine safety surveillance, Molecular Medicine, General Immunology and Microbiology, General Veterinary, Public Health, Environmental and Occupational Health, Infectious Diseases
Citation
Nasreen, S, Jiang, Y, Lu, H, Lee, A, Cutland, C L, Gentile, A, Giglio, N, Macartney, K, Deng, L, Liu, B, Sonneveld, N, Bellamy, K, Clothier, H J, Sepulveda Kattan, G, Naus, M, Naveed, Z, Janjua, N Z, Nguyen, L, Hviid, A, Poukka, E, Perälä, J, Leino, T, Chandra, L A, Thobari, J A, Park, B J, Choi, N K, Jeong, N Y, Madhi, S A, Villalobos, F, Solórzano, M, Bissacco, C A, Carreras-Martínez, J J, Correcher-Martínez, E, Urchueguía-Fornes, A, Roy, D, Yeomans, A, Aurelius, T, Morton, K, Di Mauro, G, Sturkenboom, M CJM, Sejvar, J J, Top, K A, Batty, K, Ghebreab, L, Griffin, J B, Petousis-Harris, H, Buttery, J, Black, S & Kwong, J C 2025, 'Risk of Guillain-Barré syndrome after COVID-19 vaccination or SARS-CoV-2 infection : A multinational self-controlled case series study', Vaccine, vol. 60, 127291. https://doi.org/10.1016/j.vaccine.2025.127291