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NEURO-COVAX: An Italian Population-Based Study of Neurological Complications after COVID-19 Vaccinations

Objective: In this Italian population-based study, we aimed to evaluate the neurological complications after the first and/or second dose of COVID-19 vaccines and factors potentially associated with these adverse effects. Methods: Our study included adults aged 18 years and older who received two va...

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Autores principales: Salsone, Maria, Signorelli, Carlo, Oldani, Alessandro, Alberti, Valerio Fabio, Castronovo, Vincenza, Mazzitelli, Salvatore, Minerva, Massimo, Ferini-Strambi, Luigi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10610846/
https://www.ncbi.nlm.nih.gov/pubmed/37897023
http://dx.doi.org/10.3390/vaccines11101621
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author Salsone, Maria
Signorelli, Carlo
Oldani, Alessandro
Alberti, Valerio Fabio
Castronovo, Vincenza
Mazzitelli, Salvatore
Minerva, Massimo
Ferini-Strambi, Luigi
author_facet Salsone, Maria
Signorelli, Carlo
Oldani, Alessandro
Alberti, Valerio Fabio
Castronovo, Vincenza
Mazzitelli, Salvatore
Minerva, Massimo
Ferini-Strambi, Luigi
author_sort Salsone, Maria
collection PubMed
description Objective: In this Italian population-based study, we aimed to evaluate the neurological complications after the first and/or second dose of COVID-19 vaccines and factors potentially associated with these adverse effects. Methods: Our study included adults aged 18 years and older who received two vaccine doses in the vaccination hub of Novegro (Milan, Lombardy) between 7 and 16 July 2021. The NEURO-COVAX questionnaire was able to capture the neurological events, onset and duration. That data that were digitized centrally by the Lombardy region were used to match the demographic/clinical characteristics and identify a vulnerability profile. Associations between vaccine lines and the development of complications were assessed. Digital healthcare system matching was also performed to evaluate severe neurological complications (Guillain-Barrè syndrome, Bell’s palsy, transverse myelitis, encephalitis) and the incidence of hospital admissions and/or the mortality rate after two doses of the vaccines. Results: The NEURO-COVAX-cohort included 19.108 vaccinated people: 15.368 with BNT162b2, 2077 with mRNA-1273, 1651 with ChAdOx1nCov-19, and 12 with Ad26.COV2.S who were subsequently excluded. Approximately 31.2% of our sample developed post-vaccination neurological complications, particularly with ChAdOx1nCov-19. A vulnerable clinical profile emerged, where over 40% of the symptomatic people showed comorbidities in their clinical histories. Defining the neurological risk profile, we found an increased risk for ChAdOx1nCov-19 of tremors (vs. BNT162b2, OR: 5.12, 95% CI: 3.51–7.48); insomnia (vs. mRNA-1273, OR: 1.87, 95% CI: 1.02–3.39); muscle spasms (vs. BNT162b2, OR: 1.62, 95% CI: 1.08–2.46); and headaches (vs. BNT162b2, OR: 1.49, 95% CI: 0.96–1.57). For mRNA-1273, there were increased risks of parethesia (vs. ChAdOx1nCov-19, OR: 2.37, 95% CI: 1.48–3.79); vertigo (vs. ChAdOx1nCov-19, OR: 1.68, 95% CI: 1.20–2.35); diplopia (vs. ChAdOx1nCov-19, OR: 1.55, 95% CI: 0.67–3.57); and sleepiness (vs. ChAdOx1nCov-19, OR: 1.28, 95% CI: 0.98–1.67). In the period that ranged from March to August 2021, no one was hospitalized and/or died of severe complications related to COVID-19 vaccinations. Discussion: This study estimates the prevalence and risk for neurological complications potentially associated with COVID-19 vaccines, thus improving the vaccination guidelines and loading in future personalized preventive medicine.
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spelling pubmed-106108462023-10-28 NEURO-COVAX: An Italian Population-Based Study of Neurological Complications after COVID-19 Vaccinations Salsone, Maria Signorelli, Carlo Oldani, Alessandro Alberti, Valerio Fabio Castronovo, Vincenza Mazzitelli, Salvatore Minerva, Massimo Ferini-Strambi, Luigi Vaccines (Basel) Article Objective: In this Italian population-based study, we aimed to evaluate the neurological complications after the first and/or second dose of COVID-19 vaccines and factors potentially associated with these adverse effects. Methods: Our study included adults aged 18 years and older who received two vaccine doses in the vaccination hub of Novegro (Milan, Lombardy) between 7 and 16 July 2021. The NEURO-COVAX questionnaire was able to capture the neurological events, onset and duration. That data that were digitized centrally by the Lombardy region were used to match the demographic/clinical characteristics and identify a vulnerability profile. Associations between vaccine lines and the development of complications were assessed. Digital healthcare system matching was also performed to evaluate severe neurological complications (Guillain-Barrè syndrome, Bell’s palsy, transverse myelitis, encephalitis) and the incidence of hospital admissions and/or the mortality rate after two doses of the vaccines. Results: The NEURO-COVAX-cohort included 19.108 vaccinated people: 15.368 with BNT162b2, 2077 with mRNA-1273, 1651 with ChAdOx1nCov-19, and 12 with Ad26.COV2.S who were subsequently excluded. Approximately 31.2% of our sample developed post-vaccination neurological complications, particularly with ChAdOx1nCov-19. A vulnerable clinical profile emerged, where over 40% of the symptomatic people showed comorbidities in their clinical histories. Defining the neurological risk profile, we found an increased risk for ChAdOx1nCov-19 of tremors (vs. BNT162b2, OR: 5.12, 95% CI: 3.51–7.48); insomnia (vs. mRNA-1273, OR: 1.87, 95% CI: 1.02–3.39); muscle spasms (vs. BNT162b2, OR: 1.62, 95% CI: 1.08–2.46); and headaches (vs. BNT162b2, OR: 1.49, 95% CI: 0.96–1.57). For mRNA-1273, there were increased risks of parethesia (vs. ChAdOx1nCov-19, OR: 2.37, 95% CI: 1.48–3.79); vertigo (vs. ChAdOx1nCov-19, OR: 1.68, 95% CI: 1.20–2.35); diplopia (vs. ChAdOx1nCov-19, OR: 1.55, 95% CI: 0.67–3.57); and sleepiness (vs. ChAdOx1nCov-19, OR: 1.28, 95% CI: 0.98–1.67). In the period that ranged from March to August 2021, no one was hospitalized and/or died of severe complications related to COVID-19 vaccinations. Discussion: This study estimates the prevalence and risk for neurological complications potentially associated with COVID-19 vaccines, thus improving the vaccination guidelines and loading in future personalized preventive medicine. MDPI 2023-10-21 /pmc/articles/PMC10610846/ /pubmed/37897023 http://dx.doi.org/10.3390/vaccines11101621 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Salsone, Maria
Signorelli, Carlo
Oldani, Alessandro
Alberti, Valerio Fabio
Castronovo, Vincenza
Mazzitelli, Salvatore
Minerva, Massimo
Ferini-Strambi, Luigi
NEURO-COVAX: An Italian Population-Based Study of Neurological Complications after COVID-19 Vaccinations
title NEURO-COVAX: An Italian Population-Based Study of Neurological Complications after COVID-19 Vaccinations
title_full NEURO-COVAX: An Italian Population-Based Study of Neurological Complications after COVID-19 Vaccinations
title_fullStr NEURO-COVAX: An Italian Population-Based Study of Neurological Complications after COVID-19 Vaccinations
title_full_unstemmed NEURO-COVAX: An Italian Population-Based Study of Neurological Complications after COVID-19 Vaccinations
title_short NEURO-COVAX: An Italian Population-Based Study of Neurological Complications after COVID-19 Vaccinations
title_sort neuro-covax: an italian population-based study of neurological complications after covid-19 vaccinations
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10610846/
https://www.ncbi.nlm.nih.gov/pubmed/37897023
http://dx.doi.org/10.3390/vaccines11101621
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