Evidence map›Paper›PMID 32696320›Full record

ArticleClinical drug investigation2020

Facial Paralysis Following Influenza Vaccination: A Disproportionality Analysis Using the Vaccine Adverse Event Reporting System Database.

Ashwin Kamath, Nivedita Maity, Manel Arjun Nayak

Open access · hybridAbstract read
In one paragraph

Article in Clinical drug investigation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
4.2field-weighted citation impact, top 4% of its field
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

18 citing papers in PubMed, 49 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
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  8. Peripheral facial palsy following COVID-19 vaccination: a practical approach to use the clinical situation as a guide.Acta otorhinolaryngologica Italica : organo ufficiale della Societa italiana di otorinolaringologia e chirurgia cervico-facciale · 2022
    Article
  9. COVID-19 vaccine development: milestones, lessons and prospects.Signal transduction and targeted therapy · 2022
    Review
  10. Response to "Facial nerve palsy following the administration of COVID-19 mRNA vaccines: analysis of a self-reporting database" by Sato et al.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2022
    Article
  11. Article
  12. Article
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  14. Facial nerve palsy following the administration of COVID-19 mRNA vaccines: analysis of a self-reporting database.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2021
    Article
  15. Review
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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

3 authors at 2 institutions in 1 country.

Ashwin KamathDepartment of Pharmacology, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India. ashwin.kamath@manipal.edu.ORCID http://orcid.org/0000-0002-9609-0199
Nivedita MaityDepartment of Pharmacology, M.S. Ramaiah Medical College, Bengaluru, Karnataka, India.ORCID http://orcid.org/0000-0002-1995-5689
Manel Arjun NayakDepartment of General Medicine, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.ORCID http://orcid.org/0000-0001-9193-6864
Manipal Academy of Higher Education · INM.S. Ramaiah Medical College · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveSeveral cases of facial paralysis have been reported following influenza vaccination; however, recent surveillance studies have not shown an increased risk. In this study, we analyzed the vaccine adverse event reporting system (VAERS) data to determine whether the facial paralysis reporting rate is higher in those who received influenza vaccination compared with those who received other vaccines.

methodsWe evaluated reports of facial paralysis in people who received influenza vaccination during January 2015 to October 2019 using Medical Dictionary for Regulatory Activities Preferred Terms. A disproportionality analysis was performed to determine the proportional reporting ratio (PRR), Chi-square statistic, and reporting odds ratio (ROR) with 95% confidence interval (CI). The demographic and clinical characteristics of the cases were also analyzed.

resultsTwo hundred fifty cases of facial paralysis following influenza vaccination were reported during the study period. The median age of the patients was 45 (interquartile range, 30-57) years; 132 (52.8%) patients were females. The majority of the patients received the injected trivalent or quadrivalent seasonal influenza vaccine by intramuscular route. The PRR, Chi-square statistic, and ROR (95% CI) was 2.44, 122.32, and 2.44 (2.08-2.88), respectively; on excluding cases involving concomitant paresis/paralysis of limbs or Guillain-Barre syndrome, the disproportionality statistics were 2.30, 89.37, and 2.30 (1.93-2.75), respectively.

conclusionsOur study shows increased reporting of facial paralysis following influenza vaccination as compared with other vaccines. Considering the inherent limitations of the VAERS database analysis, and the fact that disproportionality measures only indicate the presence of a signal, our study findings need to be explored in well-designed prospective pharmacoepidemiologic studies.

Indexed as

AdultAdverse Drug Reaction Reporting SystemsDatabases, FactualFacial ParalysisFemaleGuillain-Barre SyndromeHumansInfluenza, HumanInfluenza VaccinesMaleMiddle AgedProspective StudiesYoung AdultInfluenza Vaccines

Identifiers

PMID32696320
PMCPMC7371962
OpenAlexW3044032268

What OpenQuestion holds

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LicenceCC BY-NC
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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.