Safety of COVID-19 vaccination and acute neurological events: A self-controlled case series in England using the OpenSAFELY platform

Jemma L Walker, Anna Schultze, John Tazare, Arina Tamborska, Bhagteshwar Singh, Katherine Donegan, Julia Stowe, Caroline E Morton, William J Hulme, Helen J Curtis, Elizabeth J Williamson, Amir Mehrkar, Rosalind M Eggo, Christopher T Rentsch, Rohini Mathur, Sebastian Bacon, Alex J Walker, Simon Davy, David Evans, Peter InglesbyGeorge Hickman, Brian MacKenna, Laurie Tomlinson, Amelia CA Green, Louis Fisher, Jonathan Cockburn, John Parry, Frank Hester, Sam Harper, Christopher Bates, Stephen JW Evans, Tom Solomon, Nick J Andrews, Ian J Douglas, Ben Goldacre, Liam Smeeth, Helen I McDonald

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)4479-4487
Number of pages9
JournalVaccine
Volume40
Issue number32
Early online date15 Jul 2022
DOIs
Publication statusPublished - 30 Jul 2022
Externally publishedYes

Keywords

  • 2019-nCoV Vaccine mRNA-1273
  • BNT162 Vaccine
  • Bell Palsy/chemically induced
  • COVID-19/prevention & control
  • COVID-19 Vaccines/adverse effects
  • ChAdOx1 nCoV-19
  • England
  • Facial Paralysis/chemically induced
  • Guillain-Barre Syndrome/chemically induced
  • Humans
  • Myelitis, Transverse/complications
  • Vaccination/adverse effects

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