Evidence map›Paper›PMID 35676452›Full record

ArticleClinical drug investigation2022

Guillain-Barré Syndrome Associated with COVID-19 Vaccines: A Perspective From Spontaneous Report Data.

Marina Atzenhoffer, Marine Auffret, Antoine Pegat, Kamel Masmoudi, Charles Khouri, Blandine Bertin, Thierry Vial

Open access · bronzeAbstract read
In one paragraph

Article in Clinical drug investigation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 11% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
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  7. 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

7 authors at 4 institutions in 1 country.

Marina AtzenhofferPharmacovigilance Center, Hospital University Pharmacotoxicology Department, Hospices civils de Lyon, 162 avenue Lacassagne, 69003, Lyon, France.
Marine AuffretPharmacovigilance Center, Hospital University Pharmacotoxicology Department, Hospices civils de Lyon, 162 avenue Lacassagne, 69003, Lyon, France.
Antoine PegatElectroneuromyography and Neuromuscular Disorders Unit, Pierre Wertheimer Neurological Hospital, Hospices civils de Lyon, Lyon, France.
Kamel MasmoudiClinical Pharmacology Department, Regional Pharmacovigilance Center, Amiens-Picardie University Hospital Center, Amiens, France.
Charles KhouriClinical Pharmacology and Pharmacovigilance Department, Grenoble Alpes University Hospital, Grenoble, France.
Blandine BertinPharmacovigilance Center, Hospital University Pharmacotoxicology Department, Hospices civils de Lyon, 162 avenue Lacassagne, 69003, Lyon, France.
Thierry VialPharmacovigilance Center, Hospital University Pharmacotoxicology Department, Hospices civils de Lyon, 162 avenue Lacassagne, 69003, Lyon, France. thierry.vial@chu-lyon.fr.ORCID http://orcid.org/0000-0003-3786-581X
Hospices Civils de Lyon · FRCentre Hospitalier Universitaire Amiens-Picardie · FRHôpital Pierre Wertheimer · FRUniversité Grenoble Alpes · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveThe concern surrounding the association between Guillain-Barré syndrome (GBS) and vaccination has increased with the widespread use of COVID-19 vaccines. The aim of this study was to assess the potential association of GBS with mRNA-based or adenovirus-vectored COVID-19 vaccines.

methodsReports of GBS associated with mRNA-based or adenovirus-vectored COVID-19 vaccines were extracted from the WHO pharmacovigilance database, exposure data from the Our World in Data website, and the background rates of GBS from published data. For countries contributing to VigiBase and with available data on COVID-19 vaccine exposure, reporting rates were estimated and observed-to-expected (OE) analyses were performed.

resultsA total of 2499 cases were included: 1157 (46.3%) cases with adenovirus-vectored COVID-19 vaccines and 1342 (53.7%) with mRNA-based COVID-19 vaccines. The male-to-female sex ratio was 1.09 and the median (IQR) age was 57 (45-66) years. The reporting rates (95% CI) per 100,000 person-years within the 42-day window were 5.57 (5.13-6.03) for adenovirus-vectored COVID-19 vaccines and 1.39 (1.31-1.47) for mRNA-based COVID-19 vaccines, while the background incidence was 1.2-3.1 per 100,000 person-years. For mRNA-based COVID-19 vaccines, the OE ratio was <1 for both time windows in all European countries and slightly elevated for the 21-day window in the USA. For adenovirus-vectored COVID-19 vaccines, the OE ratio was consistently > 2.0 for all countries. Sensitivity analyses minimally altered these results.

conclusionsThese findings suggest both the absence of safety concern for GBS with mRNA-based COVID-19 vaccines and an increased risk with adenovirus-vectored COVID-19 vaccines. Back to top.

Indexed as

COVID-19COVID-19 VaccinesGuillain-Barre SyndromeAgedFemaleHumansMaleMiddle AgedCOVID-19 Vaccines

Identifiers

PMID35676452
PMCPMC9177406
OpenAlexW4281726511

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.