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

Sharifa Nasreen; Yannan Jiang; Han Lu; Arier Lee; Clare L. Cutland; Angela Gentile; Norberto Giglio; Kristine Macartney; Lucy Deng; Bette Liu; Nicole Sonneveld; Karen Bellamy; Hazel J. Clothier; Gonzalo Sepulveda Kattan; Monika Naus; Zaeema Naveed; Naveed Z. Janjua; Lena Nguyen; Anders Hviid; Eero Poukka; Jori Perälä; Tuija Leino; Lukman Ade Chandra; Jarir At Thobari; Byung Joo Park; Nam Kyong Choi; Na Young Jeong; Shabir A. Madhi; Felipe Villalobos; Martín Solórzano; Carlo Alberto Bissacco; Juan José Carreras-Martínez; Elisa Correcher-Martínez; Arantxa Urchueguía-Fornes; Debabrata Roy; Alison Yeomans; Taylor Aurelius; Kathryn Morton; Gianmarco Di Mauro; Miriam CJM Sturkenboom; James J. Sejvar; Karina A. Top; Karin Batty; Luam Ghebreab; Jennifer B. Griffin; Helen Petousis-Harris; Jim Buttery; Steven Black; Jeffrey C. Kwong

doi:10.1016/j.vaccine.2025.127291

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

Sharifa Nasreen, Yannan Jiang, Han Lu, Arier Lee, Clare L. Cutland, Angela Gentile, Norberto Giglio, Kristine Macartney, Lucy Deng, Bette Liu, Nicole Sonneveld, Karen Bellamy, Hazel J. Clothier, Gonzalo Sepulveda Kattan, Monika Naus, Zaeema Naveed, Naveed Z. Janjua, Lena Nguyen, Anders Hviid, Eero PoukkaJori Perälä, Tuija Leino, Lukman Ade Chandra, Jarir At Thobari, Byung Joo Park, Nam Kyong Choi, Na Young Jeong, Shabir A. Madhi, Felipe Villalobos, Martín Solórzano, Carlo Alberto Bissacco, Juan José Carreras-Martínez, Elisa Correcher-Martínez, Arantxa Urchueguía-Fornes, Debabrata Roy, Alison Yeomans, Taylor Aurelius, Kathryn Morton, Gianmarco Di Mauro, Miriam CJM Sturkenboom, James J. Sejvar, Karina A. Top, Karin Batty, Luam Ghebreab, Jennifer B. Griffin, Helen Petousis-Harris, Jim Buttery, Steven Black, Jeffrey C. Kwong^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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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.

Original language	English
Article number	127291
Journal	Vaccine
Volume	60
DOIs	https://doi.org/10.1016/j.vaccine.2025.127291
Publication status	Published - 11 Jul 2025

Keywords

COVID-19
Guillain-Barré syndrome
Pharmacovigilance
Self-controlled case series
Vaccine safety surveillance

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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., ... 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, 60, Article 127291. https://doi.org/10.1016/j.vaccine.2025.127291

@article{6f083b5642864728b0603c6ff68825a0,

title = "Risk of Guillain-Barr{\'e} syndrome after COVID-19 vaccination or SARS-CoV-2 infection: A multinational self-controlled case series study",

abstract = "Background: The association between Guillain-Barr{\'e} 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{\texttrademark} (GVDN{\textregistered}). 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-Barr{\'e} syndrome, Pharmacovigilance, Self-controlled case series, Vaccine safety surveillance",

author = "Sharifa Nasreen and Yannan Jiang and Han Lu and Arier Lee and Cutland, {Clare L.} and Angela Gentile and Norberto Giglio and Kristine Macartney and Lucy Deng and Bette Liu and Nicole Sonneveld and Karen Bellamy and Clothier, {Hazel J.} and {Sepulveda Kattan}, Gonzalo and Monika Naus and Zaeema Naveed and Janjua, {Naveed Z.} and Lena Nguyen and Anders Hviid and Eero Poukka and Jori Per{\"a}l{\"a} and Tuija Leino and Chandra, {Lukman Ade} and Thobari, {Jarir At} and Park, {Byung Joo} and Choi, {Nam Kyong} and Jeong, {Na Young} and Madhi, {Shabir A.} and Felipe Villalobos and Mart{\'i}n Sol{\'o}rzano and Bissacco, {Carlo Alberto} and Carreras-Mart{\'i}nez, {Juan Jos{\'e}} and Elisa Correcher-Mart{\'i}nez and Arantxa Urchuegu{\'i}a-Fornes and Debabrata Roy and Alison Yeomans and Taylor Aurelius and Kathryn Morton and {Di Mauro}, Gianmarco and Sturkenboom, {Miriam CJM} and Sejvar, {James J.} and Top, {Karina A.} and Karin Batty and Luam Ghebreab and Griffin, {Jennifer B.} and Helen Petousis-Harris and Jim Buttery and Steven Black and Kwong, {Jeffrey C.}",

note = "Publisher Copyright: {\textcopyright} 2025 The Authors",

year = "2025",

month = jul,

day = "11",

doi = "10.1016/j.vaccine.2025.127291",

language = "English",

volume = "60",

journal = "Vaccine",

issn = "0264-410X",

publisher = "Elsevier",

}

Nasreen, S, Jiang, Y, Lu, H, Lee, A, Cutland, CL, Gentile, A, Giglio, N, Macartney, K, Deng, L, Liu, B, Sonneveld, N, Bellamy, K, Clothier, HJ, Sepulveda Kattan, G, Naus, M, Naveed, Z, Janjua, NZ, Nguyen, L, Hviid, A, Poukka, E, Perälä, J, Leino, T, Chandra, LA, Thobari, JA, Park, BJ, Choi, NK, Jeong, NY, Madhi, SA, Villalobos, F, Solórzano, M, Bissacco, CA, Carreras-Martínez, JJ, Correcher-Martínez, E, Urchueguía-Fornes, A, Roy, D, Yeomans, A, Aurelius, T, Morton, K, Di Mauro, G, Sturkenboom, MCJM, Sejvar, JJ, Top, KA, Batty, K, Ghebreab, L, Griffin, JB, Petousis-Harris, H, Buttery, J, Black, S & Kwong, JC 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

TY - JOUR

T1 - Risk of Guillain-Barré syndrome after COVID-19 vaccination or SARS-CoV-2 infection

T2 - A multinational self-controlled case series study

AU - Nasreen, Sharifa

AU - Jiang, Yannan

AU - Lu, Han

AU - Lee, Arier

AU - Cutland, Clare L.

AU - Gentile, Angela

AU - Giglio, Norberto

AU - Macartney, Kristine

AU - Deng, Lucy

AU - Liu, Bette

AU - Sonneveld, Nicole

AU - Bellamy, Karen

AU - Clothier, Hazel J.

AU - Sepulveda Kattan, Gonzalo

AU - Naus, Monika

AU - Naveed, Zaeema

AU - Janjua, Naveed Z.

AU - Nguyen, Lena

AU - Hviid, Anders

AU - Poukka, Eero

AU - Perälä, Jori

AU - Leino, Tuija

AU - Chandra, Lukman Ade

AU - Thobari, Jarir At

AU - Park, Byung Joo

AU - Choi, Nam Kyong

AU - Jeong, Na Young

AU - Madhi, Shabir A.

AU - Villalobos, Felipe

AU - Solórzano, Martín

AU - Bissacco, Carlo Alberto

AU - Carreras-Martínez, Juan José

AU - Correcher-Martínez, Elisa

AU - Urchueguía-Fornes, Arantxa

AU - Roy, Debabrata

AU - Yeomans, Alison

AU - Aurelius, Taylor

AU - Morton, Kathryn

AU - Di Mauro, Gianmarco

AU - Sturkenboom, Miriam CJM

AU - Sejvar, James J.

AU - Top, Karina A.

AU - Batty, Karin

AU - Ghebreab, Luam

AU - Griffin, Jennifer B.

AU - Petousis-Harris, Helen

AU - Buttery, Jim

AU - Black, Steven

AU - Kwong, Jeffrey C.

PY - 2025/7/11

Y1 - 2025/7/11

N2 - 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.

AB - 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.

KW - COVID-19

KW - Guillain-Barré syndrome

KW - Pharmacovigilance

KW - Self-controlled case series

KW - Vaccine safety surveillance

UR - http://www.scopus.com/inward/record.url?scp=105006663314&partnerID=8YFLogxK

U2 - 10.1016/j.vaccine.2025.127291

DO - 10.1016/j.vaccine.2025.127291

M3 - Article

AN - SCOPUS:105006663314

SN - 0264-410X

VL - 60

JO - Vaccine

JF - Vaccine

M1 - 127291

ER -

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

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