{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,24]],"date-time":"2026-03-24T09:04:40Z","timestamp":1774343080442,"version":"3.50.1"},"reference-count":55,"publisher":"MDPI AG","issue":"10","license":[{"start":{"date-parts":[[2023,10,21]],"date-time":"2023-10-21T00:00:00Z","timestamp":1697846400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>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-Barr\u00e8 syndrome, Bell\u2019s 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\u20137.48); insomnia (vs. mRNA-1273, OR: 1.87, 95% CI: 1.02\u20133.39); muscle spasms (vs. BNT162b2, OR: 1.62, 95% CI: 1.08\u20132.46); and headaches (vs. BNT162b2, OR: 1.49, 95% CI: 0.96\u20131.57). For mRNA-1273, there were increased risks of parethesia (vs. ChAdOx1nCov-19, OR: 2.37, 95% CI: 1.48\u20133.79); vertigo (vs. ChAdOx1nCov-19, OR: 1.68, 95% CI: 1.20\u20132.35); diplopia (vs. ChAdOx1nCov-19, OR: 1.55, 95% CI: 0.67\u20133.57); and sleepiness (vs. ChAdOx1nCov-19, OR: 1.28, 95% CI: 0.98\u20131.67). 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.<\/jats:p>","DOI":"10.3390\/vaccines11101621","type":"journal-article","created":{"date-parts":[[2023,10,21]],"date-time":"2023-10-21T12:59:01Z","timestamp":1697893141000},"page":"1621","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["NEURO-COVAX: An Italian Population-Based Study of Neurological Complications after COVID-19 Vaccinations"],"prefix":"10.3390","volume":"11","author":[{"given":"Maria","family":"Salsone","sequence":"first","affiliation":[{"name":"Institute of Molecular Bioimaging and Physiology, National Research Council, 20125 Milan, Italy"},{"name":"Sleep Disorders Center, Division of Neuroscience, San Raffaele Scientific Institute, 20127 Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carlo","family":"Signorelli","sequence":"additional","affiliation":[{"name":"School of Medicine, Vita-Salute San Raffaele University, 20132 Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alessandro","family":"Oldani","sequence":"additional","affiliation":[{"name":"Sleep Disorders Center, Division of Neuroscience, San Raffaele Scientific Institute, 20127 Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Valerio Fabio","family":"Alberti","sequence":"additional","affiliation":[{"name":"Sovrintendenza Sanitaria del Gruppo San Donato, 20122 Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vincenza","family":"Castronovo","sequence":"additional","affiliation":[{"name":"Sleep Disorders Center, Division of Neuroscience, San Raffaele Scientific Institute, 20127 Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Salvatore","family":"Mazzitelli","sequence":"additional","affiliation":[{"name":"Direzione Sanitaria, San Raffaele Scientific Institute, 20127 Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Massimo","family":"Minerva","sequence":"additional","affiliation":[{"name":"School of Medicine, Vita-Salute San Raffaele University, 20132 Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luigi","family":"Ferini-Strambi","sequence":"additional","affiliation":[{"name":"Sleep Disorders Center, Division of Neuroscience, San Raffaele Scientific Institute, 20127 Milan, Italy"},{"name":"Sleep Disorders Center, Division of Neuroscience, Vita-Salute San Raffaele University, 20132 Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2023,10,21]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"389","DOI":"10.1136\/postgradmedj-2021-140654","article-title":"Review of COVID-19 vaccine subtypes, efficacy and geographical","volume":"98","author":"Francis","year":"2022","journal-title":"Postgrad. 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