Evidence map›Paper›PMID 38241309›Full record

ArticlePloS one2024

Post-marketing active surveillance of Guillain Barré Syndrome following COVID-19 vaccination in persons aged ≥12 years in Italy: A multi-database self-controlled case series study.

Cristina Morciano, Stefania Spila Alegiani, Francesca Menniti Ippolito, Valeria Belleudi, Gianluca Trifirò, Giovanna Zanoni, Aurora Puccini, Ester Sapigni, Nadia Mores, Olivia Leoni and 7 more

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.6field-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

4 citing papers in PubMed, 7 citations in OpenAlex.

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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

17 authors at 8 institutions in 1 country.

Cristina MorcianoPharmacoepidemiology and Pharmacosurveillance Unit, National Centre for Drug Research and Evaluation, Istituto Superiore di Sanità (National Institute of Health), Rome, Italy.
Stefania Spila AlegianiPharmacoepidemiology and Pharmacosurveillance Unit, National Centre for Drug Research and Evaluation, Istituto Superiore di Sanità (National Institute of Health), Rome, Italy.
Francesca Menniti IppolitoPharmacoepidemiology and Pharmacosurveillance Unit, National Centre for Drug Research and Evaluation, Istituto Superiore di Sanità (National Institute of Health), Rome, Italy.
Valeria BelleudiDepartment of Epidemiology ASL Roma 1, Lazio Regional Health Service, Rome, Italy.
Gianluca TrifiròDepartment of Diagnostics and Public Health, University of Verona, Verona, Italy.
Giovanna ZanoniImmunology Unit, University Hospital, Verona, Italy.
Aurora PucciniHospital Assistance Service, General Directorate for Personal Care, Health and Welfare, Emilia-Romagna Region, Bologna, Italy.
Ester SapigniHospital Assistance Service, General Directorate for Personal Care, Health and Welfare, Emilia-Romagna Region, Bologna, Italy.
Nadia MoresInstitute of Pharmacology, Pharmacovigilance, Policlinico Universitario A. Gemelli, Catholic University of Sacred Heart, Rome, Italy.
Olivia LeoniDepartment of Health of Lombardy Region, Epidemiology Observatory, Milan, Italy.
Giuseppe MonacoDepartment of Health of Lombardy Region, Epidemiology Observatory, Milan, Italy.
Elena ClagnanRegional Health Authority, Friuli Venezia Giulia Region, Udine, Italy.
Cristina ZappettiCentral Directorate for Health, Social Policies, Friuli Venezia Giulia Region, Trieste, Italy.
Emanuela BovoVeneto Tumour Registry, Azienda Zero, Padova, Italy.
Maria CutilloPharmacoepidemiology and Pharmacosurveillance Unit, National Centre for Drug Research and Evaluation, Istituto Superiore di Sanità (National Institute of Health), Rome, Italy.
Roberto Da CasPharmacoepidemiology and Pharmacosurveillance Unit, National Centre for Drug Research and Evaluation, Istituto Superiore di Sanità (National Institute of Health), Rome, Italy.
Marco MassariPharmacoepidemiology and Pharmacosurveillance Unit, National Centre for Drug Research and Evaluation, Istituto Superiore di Sanità (National Institute of Health), Rome, Italy.
Istituto Superiore di Sanità · ITRegione Autonoma Friuli Venezia GiuliaRegione Emilia-RomagnaRegione LombardiaUniversity of Verona · ITAzienda Sanitaria Locale Roma 3 · ITFondazione Progetto Ematologia · ITUniversità Cattolica del Sacro Cuore · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecently published studies have reported association of COVID-19 vaccine ChAdOx1-S (Vaxzevria) with Guillain Barré Syndrome (GBS). Less is known about the safety of other COVID-19 vaccines with respect to GBS outcome. This study investigated the association of COVID-19 vaccines with GBS in more than 15 million persons aged ≥12 years in Italy.

methodsStudy population was all individuals aged ≥12 years who received at least one dose of COVID-19 vaccines, admitted to emergency care/hospital for GBS from 27 December 2020-30 September 2021 in Italy. Identification of GBS cases and receipt of at least one dose of mRNA-1273 (Elasomeran), BNT162b2 (Tozinameran), ChAdOx1-S (Vaxzevria) and Ad26.COV2.S (Janssen) through record linkage between regional health care and vaccination registries. Relative Incidence (RI) was estimated Self-controlled case series method adapted to event-dependent exposure using in the 42-day exposure risk period after each dose compared with other observation periods.

resultsIncreased risk of GBS was found after first (RI = 6.83; 95% CI 2.14-21.85) and second dose (RI = 7.41; 2.35-23.38) of mRNA-1273 and first dose of ChAdOx1-S (RI = 6.52; 2.88-14.77). Analysis by age found an increased risk among those aged≥60 years after first (RI = 8.03; 2.08-31.03) and second dose (RI = 7.71; 2.38-24.97) of mRNA-1273. The first dose of ChAdOx1-S was associated with GBS in those aged 40-59 (RI = 4.50; 1.37-14.79) and in those aged ≥ 60 years (RI = 6.84; 2.56-18.28).

conclusionsmRNA-1273 and ChAdOx1-S vaccines were associated with an increased risk of GBS however this risk resulted in a small number of excess cases. Limitations were loss of GBS outpatient cases and imprecision of the estimates in the subgroup analysis due to a low number of events.

Indexed as

COVID-19COVID-19 VaccinesGuillain-Barre Syndrome2019-nCoV Vaccine mRNA-1273Ad26COVS1BNT162 VaccineChAdOx1 nCoV-19HumansItalyProduct Surveillance, PostmarketingVaccination2019-nCoV Vaccine mRNA-1273Ad26COVS1BNT162 VaccineChAdOx1 nCoV-19COVID-19 Vaccines

Identifiers

PMID38241309
PMCPMC10798452
OpenAlexW4391020505

What OpenQuestion holds

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LicenceCC BY
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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.