{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T01:12:20Z","timestamp":1760058740997,"version":"build-2065373602"},"reference-count":40,"publisher":"MDPI AG","issue":"5","license":[{"start":{"date-parts":[[2025,4,27]],"date-time":"2025-04-27T00:00:00Z","timestamp":1745712000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>Background\/Objectives: Post-market surveillance of COVID-19 vaccines is vital. This study analyzed EudraVigilance data (Jan 2021\u2013Dec 2023) to detect potential safety signals linking COVID-19 vaccines and specific neurological adverse events (aseptic meningitis, Guillain\u2013Barr\u00e9 syndrome, polyradiculoneuropathies, multiple sclerosis, transverse myelitis, neuromyelitis optica). It also explored the impact of non-healthcare professional reports on disproportionality analysis. Methods: EudraVigilance reports were analyzed to quantify neurological events for 5 COVID-19 vaccines and 47 comparators. Disproportionality was assessed using the Proportional Reporting Ratio (PRR). Spearman\u2019s correlation (SCC) was used to examine the impact of non-healthcare professional reports on PRR. Results: An analysis of 4,159,820 COVID-19 vaccine and 114,025 comparator reports showed a reporting decline over time. A higher proportion of adverse drug event reports were submitted by non-healthcare professionals for COVID-19 vaccines compared to control vaccines, a trend observed consistently across 2021 (57.3% vs. 33%, p &lt; 0.001), 2022 (59.4% vs. 36.5%, p = 0.001), and 2023 (42% vs. 24.36%, p = 0.006). In 2023, significant signals (PRR \u2265 2) were found between Jcovden\u00a9 and polyradiculoneuropathy (PRR 5.4, IC 95% 3.98\u20137.32), multiple sclerosis (PRR 2.72, IC 95% (1.08\u20136.87), transverse myelitis (PRR 4.68, IC 95% 1.02\u201321.35) and neuromyelitis optica (PRR 7.79, IC 95% 3.5\u201317.37). In addition, both Spikevax\u00a9 and Comirnaty\u00a9 showed significant signals with multiple sclerosis (PRR 2.50, IC 95% 1.70\u20133.68, and PRR 2.33, IC 95% 1.68\u20133.24) and transverse myelitis (PRR 3.50, IC 95% 1.66\u20137.50 and PRR 3.58, IC 95% 1.85\u20136.93). A significant negative correlation between the proportion of reports from non-healthcare professionals and the case\/no-case ratio was found (SCC = \u22120.4683, p = 0.009). Conclusions: While some significant signals emerged in 2023, the combined three-year data showed no vaccine exceeding the PRR threshold of 2. High-quality data and bias mitigation strategies are crucial for accurate PRR estimation in pharmacovigilance and public health.<\/jats:p>","DOI":"10.3390\/ph18050636","type":"journal-article","created":{"date-parts":[[2025,5,2]],"date-time":"2025-05-02T11:35:13Z","timestamp":1746185713000},"page":"636","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Disproportionality Analysis of the Five Most Widespread Neurological Effects of COVID-19 Vaccines from 2021 to 2023: Insights from EudraVigilance"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5729-7728","authenticated-orcid":false,"given":"Arturo G\u00f3mez","family":"L\u00f3pez de las Huertas","sequence":"first","affiliation":[{"name":"Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefan","family":"Stewart","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6951-5518","authenticated-orcid":false,"given":"Mikel Urroz","family":"Elizalde","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Javier","family":"Guijarro-Eguinoa","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Enrique","family":"Seco-Meseguer","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elena","family":"Diago-Sempere","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mar\u00eda Jim\u00e9nez","family":"Gonz\u00e1lez","sequence":"additional","affiliation":[{"name":"Clinical Trials Unit, La Paz University Hospital-IdiPAZ, 28046 Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1823-4174","authenticated-orcid":false,"given":"Antonio J.","family":"Carcas-Sansuan","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8584-3263","authenticated-orcid":false,"given":"Alberto M. Borobia","family":"P\u00e9rez","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4052-8876","authenticated-orcid":false,"given":"Elena","family":"Ram\u00edrez","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2025,4,27]]},"reference":[{"key":"ref_1","unstructured":"European Medicines Agency (2024, April 25). Statement from Emer Cooke on the End of the COVID-19 Public Health Emergency. 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