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. 2025 Jul 11:60:127291.
doi: 10.1016/j.vaccine.2025.127291. Epub 2025 May 28.

Risk of Guillain-Barré syndrome after COVID-19 vaccination or SARS-CoV-2 infection: A multinational self-controlled case series study

Sharifa Nasreen  1 , Yannan Jiang  2 , Han Lu  2 , Arier Lee  2 , Clare L Cutland  3 , Angela Gentile  4 , Norberto Giglio  4 , Kristine Macartney  5 , Lucy Deng  5 , Bette Liu  5 , Nicole Sonneveld  5 , Karen Bellamy  6 , Hazel J Clothier  7 , Gonzalo Sepulveda Kattan  7 , Monika Naus  8 , Zaeema Naveed  9 , Naveed Z Janjua  9 , Lena Nguyen  10 , Anders Hviid  11 , Eero Poukka  12 , Jori Perälä  13 , Tuija Leino  13 , Lukman Ade Chandra  14 , Jarir At Thobari  14 , Byung-Joo Park  15 , Nam-Kyong Choi  16 , Na-Young Jeong  17 , Shabir A Madhi  18 , Felipe Villalobos  19 , Martín Solórzano  20 , Carlo Alberto Bissacco  19 , Juan José Carreras-Martínez  21 , Elisa Correcher-Martínez  22 , Arantxa Urchueguía-Fornes  21 , Debabrata Roy  23 , Alison Yeomans  23 , Taylor Aurelius  23 , Kathryn Morton  23 , Gianmarco Di Mauro  24 , Miriam Cjm Sturkenboom  25 , James J Sejvar  26 , Karina A Top  27 , Karin Batty  2 , Luam Ghebreab  2 , Jennifer B Griffin  28 , Helen Petousis-Harris  2 , Jim Buttery  7 , Steven Black  28 , Jeffrey C Kwong  29
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Free article

Risk of Guillain-Barré syndrome after COVID-19 vaccination or SARS-CoV-2 infection: A multinational self-controlled case series study

Sharifa Nasreen et al. Vaccine. .
Free article

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.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Jeffrey C. Kwong reports financial support was provided by Centers for Disease Control and Prevention. Eero Poukka reports a relationship with AstraZeneca Pharmaceuticals LP that includes: equity or stocks. Helen Petousis-Harris reports a relationship with Pfizer Inc that includes: board membership and speaking and lecture fees. Helen Petousis-Harris reports a relationship with GSK plc that includes: board membership and speaking and lecture fees. Karina A Top reports a relationship with Coalition for Epidemic Preparedness Innovations UK Limited that includes: funding grants. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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