Evidence map›Paper›PMID 34492394›Full record

ArticleInternational journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases2021

Facial nerve palsy following the administration of COVID-19 mRNA vaccines: analysis of a self-reporting database.

Kenichiro Sato, Tatsuo Mano, Yoshiki Niimi, Tatsushi Toda, Atsushi Iwata, Takeshi Iwatsubo

Abstract read
In one paragraph

Article in International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
–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

30 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
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  6. Article
  7. Review
  8. Neurological sequelae of vaccines.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2023
    Review
  9. Co-VAN study: COVID-19 vaccine associated neurological diseases- an experience from an apex neurosciences centre and review of the literature.Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia · 2023
    Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Vocal fold palsy after vaccination against SARS-CoV-2.Medicina clinica (English ed.) · 2022
    Article
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Kenichiro SatoDepartment of Neurology, Graduate School of Medicine, University of Tokyo; Department of Neuropathology, Graduate School of Medicine, University of Tokyo; Unit for Early and Exploratory Clinical Development, University of Tokyo Hospital.
Tatsuo ManoDepartment of Neurology, Graduate School of Medicine, University of Tokyo.
Yoshiki NiimiUnit for Early and Exploratory Clinical Development, University of Tokyo Hospital.
Tatsushi TodaDepartment of Neurology, Graduate School of Medicine, University of Tokyo.
Atsushi IwataDepartment of Neurology, Tokyo Metropolitan Geriatric Medical Center Hospital. Electronic address: iwata-tky@umin.ac.jp.
Takeshi IwatsuboDepartment of Neuropathology, Graduate School of Medicine, University of Tokyo; Unit for Early and Exploratory Clinical Development, University of Tokyo Hospital.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesFacial nerve palsy (or Bell's palsy) has occasionally been reported following the administration of coronavirus disease 2019 (COVID-19) mRNA vaccines (BNT162b2 and mRNA-1273). Our study investigated such cases using a large self-reporting database from the USA (Vaccine Adverse Event Reporting System [VAERS]).

methodsA disproportionality analysis, adjusted for age and sex, was conducted for VAERS reports from individuals who were vaccinated at the age of 18 years or over, between January 2010 and April 2021.

resultsThe analysis revealed that the adverse events following immunization (AEFI) of facial nerve palsy, after administration of COVID-19 mRNA vaccines, was significantly highly reported, both for BNT162b2 (reporting odds ratio [ROR] 1.84; 95% confidence interval [CI] 1.65-2.06) and mRNA-1273 (ROR 1.54; 95% CI 1.39-1.70). These levels were comparable to that following influenza vaccination reported before the COVID-19 pandemic (ROR 2.04; 95% CI 1.76-2.36).

conclusionsOur pharmacovigilance study results suggest that the incidence of facial nerve palsy as a non-serious AEFI may be lower than, or equivalent to, that for influenza vaccines. This information might be of value in the context of promoting worldwide vaccination, but needs to be validated in future observational studies.

Indexed as

Bell PalsyCOVID-19Influenza VaccinesAdolescentAdultAdverse Drug Reaction Reporting SystemsBNT162 VaccineCOVID-19 VaccinesFacial NerveHumansPandemicsParalysisRNA, MessengerSARS-CoV-2Young AdultBNT162 VaccineCOVID-19 VaccinesInfluenza VaccinesRNA, MessengerBell's palsyCOVID-19facial nerve palsymRNA vaccinepharmacovigilanceVAERS

Identifiers

PMID34492394
PMCPMC8418051

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.