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Safety of COVID-19 vaccination and acute neurological events: A self-controlled case series in England using the OpenSAFELY platform.
Walker, Jemma L; Schultze, Anna; Tazare, John; Tamborska, Arina; Singh, Bhagteshwar; Donegan, Katherine; Stowe, Julia; Morton, Caroline E; Hulme, William J; Curtis, Helen J; Williamson, Elizabeth J; Mehrkar, Amir; Eggo, Rosalind M; Rentsch, Christopher T; Mathur, Rohini; Bacon, Sebastian; Walker, Alex J; Davy, Simon; Evans, David; Inglesby, Peter; Hickman, George; MacKenna, Brian; Tomlinson, Laurie; Ca Green, Amelia; Fisher, Louis; Cockburn, Jonathan; Parry, John; Hester, Frank; Harper, Sam; Bates, Christopher; Evans, Stephen Jw; Solomon, Tom; Andrews, Nick J; Douglas, Ian J; Goldacre, Ben; Smeeth, Liam; McDonald, Helen I.
  • Walker JL; OpenSAFELY Collaborative, UK; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK; NIHR Health Protection Research Unit (HPRU) in Vaccines and Immunisation; UK Health Security Agency, 61 Colindale Ave, London NW9 5EQ, UK.
  • Schultze A; OpenSAFELY Collaborative, UK; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
  • Tazare J; OpenSAFELY Collaborative, UK; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
  • Tamborska A; NIHR Health Protection Research Unit (HPRU) in Emerging and Zoonotic Infections, Institute of Infection, Veterinary and Ecological Science, University of Liverpool, UK; Department of Neurology, Walton Centre NHS Foundation Trust, Liverpool L9 7LJ, UK.
  • Singh B; NIHR Health Protection Research Unit (HPRU) in Emerging and Zoonotic Infections, Institute of Infection, Veterinary and Ecological Science, University of Liverpool, UK; Tropical and Infectious Diseases Unit, Royal Liverpool University Hospital, Liverpool L7 8XP, UK.
  • Donegan K; Medicines and Healthcare products Regulatory Agency (MHRA), 10 South Colonnade, Canary Wharf, London E14 4PU, UK.
  • Stowe J; UK Health Security Agency, 61 Colindale Ave, London NW9 5EQ, UK.
  • Morton CE; OpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
  • Hulme WJ; OpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
  • Curtis HJ; OpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
  • Williamson EJ; OpenSAFELY Collaborative, UK; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
  • Mehrkar A; OpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
  • Eggo RM; OpenSAFELY Collaborative, UK; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
  • Rentsch CT; OpenSAFELY Collaborative, UK; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
  • Mathur R; OpenSAFELY Collaborative, UK; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
  • Bacon S; OpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
  • Walker AJ; OpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
  • Davy S; OpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
  • Evans D; OpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
  • Inglesby P; OpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
  • Hickman G; OpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
  • MacKenna B; OpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
  • Tomlinson L; OpenSAFELY Collaborative, UK; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
  • Ca Green A; OpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
  • Fisher L; OpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
  • Cockburn J; OpenSAFELY Collaborative, UK; TPP, TPP House, 129 Low Lane, Horsforth, Leeds LS18 5PX, UK.
  • Parry J; OpenSAFELY Collaborative, UK; TPP, TPP House, 129 Low Lane, Horsforth, Leeds LS18 5PX, UK.
  • Hester F; OpenSAFELY Collaborative, UK; TPP, TPP House, 129 Low Lane, Horsforth, Leeds LS18 5PX, UK.
  • Harper S; OpenSAFELY Collaborative, UK; TPP, TPP House, 129 Low Lane, Horsforth, Leeds LS18 5PX, UK.
  • Bates C; OpenSAFELY Collaborative, UK; TPP, TPP House, 129 Low Lane, Horsforth, Leeds LS18 5PX, UK.
  • Evans SJ; OpenSAFELY Collaborative, UK; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
  • Solomon T; NIHR Health Protection Research Unit (HPRU) in Emerging and Zoonotic Infections, Institute of Infection, Veterinary and Ecological Science, University of Liverpool, UK; Department of Neurology, Walton Centre NHS Foundation Trust, Liverpool L9 7LJ, UK.
  • Andrews NJ; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK; NIHR Health Protection Research Unit (HPRU) in Vaccines and Immunisation; UK Health Security Agency, 61 Colindale Ave, London NW9 5EQ, UK.
  • Douglas IJ; OpenSAFELY Collaborative, UK; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
  • Goldacre B; OpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
  • Smeeth L; OpenSAFELY Collaborative, UK; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK; NIHR Health Protection Research Unit (HPRU) in Vaccines and Immunisation.
  • McDonald HI; OpenSAFELY Collaborative, UK; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK; NIHR Health Protection Research Unit (HPRU) in Vaccines and Immunisation. Electronic address: helen.mcdonald@lshtm.ac.uk.
Vaccine ; 40(32): 4479-4487, 2022 07 30.
Article in English | MEDLINE | ID: covidwho-1882615
ABSTRACT

INTRODUCTION:

We investigated the potential association of COVID-19 vaccination with three acute neurological events Guillain-Barré syndrome (GBS), transverse myelitis and Bell's palsy.

METHODS:

With the approval of NHS England we analysed primary care data from >17 million patients in England linked to emergency care, hospital admission and mortality records in the OpenSAFELY platform. Separately for each vaccine brand, we used a self-controlled case series design to estimate the incidence rate ratio for each outcome in the period following vaccination (4-42 days for GBS, 4-28 days for transverse myelitis and Bell's palsy) compared to a within-person baseline, using conditional Poisson regression.

RESULTS:

Among 7,783,441 ChAdOx1 vaccinees, there was an increased rate of GBS (N = 517; incidence rate ratio 2·85; 95% CI2·33-3·47) and Bell's palsy (N = 5,350; 1·39; 1·27-1·53) following a first dose of ChAdOx1 vaccine, corresponding to 11.0 additional cases of GBS and 17.9 cases of Bell's palsy per 1 million vaccinees if causal. For GBS this applied to the first, but not the second, dose. There was no clear evidence of an association of ChAdOx1 vaccination with transverse myelitis (N = 199; 1·51; 0·96-2·37). Among 5,729,152 BNT162b2 vaccinees, there was no evidence of any association with GBS (N = 283; 1·09; 0·75-1·57), transverse myelitis (N = 109; 1·62; 0·86-3·03) or Bell's palsy (N = 3,609; 0·89; 0·76-1·03). Among 255,446 mRNA-1273 vaccine recipients there was no evidence of an association with Bell's palsy (N = 78; 0·88, 0·32-2·42).

CONCLUSIONS:

COVID-19 vaccines save lives, but it is important to understand rare adverse events. We observed a short-term increased rate of Guillain-Barré syndrome and Bell's palsy after first dose of ChAdOx1 vaccine. The absolute risk, assuming a causal effect attributable to vaccination, was low.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Bell Palsy / Guillain-Barre Syndrome / Facial Paralysis / COVID-19 Vaccines / COVID-19 / Myelitis, Transverse Type of study: Experimental Studies / Observational study / Prognostic study Topics: Long Covid / Vaccines Limits: Humans Country/Region as subject: Europa Language: English Journal: Vaccine Year: 2022 Document Type: Article Affiliation country: J.vaccine.2022.06.010

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Bell Palsy / Guillain-Barre Syndrome / Facial Paralysis / COVID-19 Vaccines / COVID-19 / Myelitis, Transverse Type of study: Experimental Studies / Observational study / Prognostic study Topics: Long Covid / Vaccines Limits: Humans Country/Region as subject: Europa Language: English Journal: Vaccine Year: 2022 Document Type: Article Affiliation country: J.vaccine.2022.06.010