Neurological complications after first dose of COVID-19 vaccines and SARS-CoV-2 infection

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Patone, Martina and Handunnetthi, Lahiru and Saatci, Defne and Pan, Jiafeng and Katikireddi, Srinivasa Vittal and Razvi, Saif and Hunt, David and Mei, Xue W and Dixon, Sharon and Zaccardi, Francesco and Khunti, Kamlesh and Watkinson, Peter and Coupland, Carol A C and Doidge, James and Harrison, David A and Ravanan, Rommel and Sheikh, Aziz and Robertson, Chris and Hippisley-Cox, Julia (2021) Neurological complications after first dose of COVID-19 vaccines and SARS-CoV-2 infection. Nature Medicine, 27 (12). pp. 2144-2153. ISSN 1078-8956 (https://doi.org/10.1038/s41591-021-01556-7)

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Abstract

Emerging reports of rare neurological complications associated with COVID-19 infection and vaccinations are leading to regulatory, clinical and public health concerns. We undertook a self-controlled case series study to investigate hospital admissions from neurological complications in the 28 days after a first dose of ChAdOx1nCoV-19 (n = 20,417,752) or BNT162b2 (n = 12,134,782), and after a SARS-CoV-2-positive test (n = 2,005,280). There was an increased risk of Guillain–Barré syndrome (incidence rate ratio (IRR), 2.90; 95% confidence interval (CI): 2.15–3.92 at 15–21 days after vaccination) and Bell’s palsy (IRR, 1.29; 95% CI: 1.08–1.56 at 15–21 days) with ChAdOx1nCoV-19. There was an increased risk of hemorrhagic stroke (IRR, 1.38; 95% CI: 1.12–1.71 at 15–21 days) with BNT162b2. An independent Scottish cohort provided further support for the association between ChAdOx1nCoV and Guillain–Barré syndrome (IRR, 2.32; 95% CI: 1.08–5.02 at 1–28 days). There was a substantially higher risk of all neurological outcomes in the 28 days after a positive SARS-CoV-2 test including Guillain–Barré syndrome (IRR, 5.25; 95% CI: 3.00–9.18). Overall, we estimated 38 excess cases of Guillain–Barré syndrome per 10 million people receiving ChAdOx1nCoV-19 and 145 excess cases per 10 million people after a positive SARS-CoV-2 test. In summary, although we find an increased risk of neurological complications in those who received COVID-19 vaccines, the risk of these complications is greater following a positive SARS-CoV-2 test.

ORCID iDs

Patone, Martina, Handunnetthi, Lahiru, Saatci, Defne, Pan, Jiafeng ORCID logoORCID: https://orcid.org/0000-0001-5993-3209, Katikireddi, Srinivasa Vittal, Razvi, Saif, Hunt, David, Mei, Xue W, Dixon, Sharon, Zaccardi, Francesco, Khunti, Kamlesh, Watkinson, Peter, Coupland, Carol A C, Doidge, James, Harrison, David A, Ravanan, Rommel, Sheikh, Aziz, Robertson, Chris and Hippisley-Cox, Julia;
CORE (COnnecting REpositories)