Evidence map›Paper›PMID 35715350›Full record

ArticleVaccine2022

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 and 27 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Review
  6. Core Concepts: Self-Controlled Designs in Pharmacoepidemiology.Pharmacoepidemiology and drug safety · 2025
    Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Rare cases of Guillain-Barré syndrome after COVID-19 vaccination, Germany, December 2020 to August 2021.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2023
    Article
  16. Review
  17. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

37 authors.

Jemma L WalkerOpenSAFELY 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.
Anna SchultzeOpenSAFELY Collaborative, UK; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
John TazareOpenSAFELY Collaborative, UK; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
Arina TamborskaNIHR 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.
Bhagteshwar SinghNIHR 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.
Katherine DoneganMedicines and Healthcare products Regulatory Agency (MHRA), 10 South Colonnade, Canary Wharf, London E14 4PU, UK.
Julia StoweUK Health Security Agency, 61 Colindale Ave, London NW9 5EQ, UK.
Caroline E MortonOpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
William J HulmeOpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
Helen J CurtisOpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
Elizabeth J WilliamsonOpenSAFELY Collaborative, UK; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
Amir MehrkarOpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
Rosalind M EggoOpenSAFELY Collaborative, UK; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
Christopher T RentschOpenSAFELY Collaborative, UK; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
Rohini MathurOpenSAFELY Collaborative, UK; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
Sebastian BaconOpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
Alex J WalkerOpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
Simon DavyOpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
David EvansOpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
Peter InglesbyOpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
George HickmanOpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
Brian MacKennaOpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
Laurie TomlinsonOpenSAFELY Collaborative, UK; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
Amelia Ca GreenOpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
Louis FisherOpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
Jonathan CockburnOpenSAFELY Collaborative, UK; TPP, TPP House, 129 Low Lane, Horsforth, Leeds LS18 5PX, UK.
John ParryOpenSAFELY Collaborative, UK; TPP, TPP House, 129 Low Lane, Horsforth, Leeds LS18 5PX, UK.
Frank HesterOpenSAFELY Collaborative, UK; TPP, TPP House, 129 Low Lane, Horsforth, Leeds LS18 5PX, UK.
Sam HarperOpenSAFELY Collaborative, UK; TPP, TPP House, 129 Low Lane, Horsforth, Leeds LS18 5PX, UK.
Christopher BatesOpenSAFELY Collaborative, UK; TPP, TPP House, 129 Low Lane, Horsforth, Leeds LS18 5PX, UK.
Stephen Jw EvansOpenSAFELY Collaborative, UK; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
Tom SolomonNIHR 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.
Nick J AndrewsLondon 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.
Ian J DouglasOpenSAFELY Collaborative, UK; London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
Ben GoldacreOpenSAFELY Collaborative, UK; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, OX26GG, UK.
Liam SmeethOpenSAFELY 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.
Helen I McDonaldOpenSAFELY 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.

Funding

Department of Health 17/63/110Department of Health NIHR200907Department of Health NIHR200929Medical Research Council MC_PC_20058Medical Research Council MC_PC_20059Medical Research Council MR/S003975/1Medical Research Council MR/V033441/1Wellcome Trust 220283/Z/20/Z
6 · The paper itself

Abstract

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

methodsWith 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.

resultsAmong 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).

conclusionsCOVID-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.

Indexed as

Bell PalsyCOVID-19COVID-19 VaccinesFacial ParalysisGuillain-Barre SyndromeMyelitis, Transverse2019-nCoV Vaccine mRNA-1273BNT162 VaccineChAdOx1 nCoV-19EnglandHumansVaccination2019-nCoV Vaccine mRNA-1273BNT162 VaccineChAdOx1 nCoV-19COVID-19 VaccinesBell’s palsyCOVID-19 vaccinesGuillain-Barré syndromeSelf-controlled case seriesTransverse myelitisVaccine safety

Identifiers

PMID35715350
PMCPMC9170533

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.