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.
Highlights
Emerging reports of rare neurological complications associated with COVID-19 infection and vaccinations are leading to regulatory, clinical and public health concerns
32,552,534 people received their first dose of COVID19 vaccine (ChAdOx1nCoV-19, n = 20,417,752; BNT162b2, n = 12,134,782) in England between 1 December 2020 and 31 May 2021
This large population-based study of more than 32 million people investigated the neurological adverse events associated with the ChAdOx1nCoV-19 and BNT162b2 vaccines as well as SARS-CoV-2 infection
Summary
In the [1–28] days post-exposure period we did not observe any association with ChAdOx1nCoV-19 (IRR, 1.23; 95% CI: 0.94–1.62) or BNT162b2 (IRR, 1.18; 95% CI: 0.88–1.59), but an increased risk after a SARS-CoV-2-positive test was identified (IRR, 3.01; 95% CI: 1.70–5.36). For SARS-CoV-2 infection, in the [1–28] days period after a positive test there were an estimated 123 extra events of encephalitis meningitis and myelitis and 145 of Guillain–Barré syndrome per 10 million people with a positive test. The main findings were not sensitive to censoring due to death (with the exception of hemorrhagic stroke), removal of patients who had a second dose of the vaccine or adjustment for potential delays in recording The results did not change from the main analysis for both vaccine exposures (Supplementary Table 7d)
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