Disproportionality Analysis of the Five Most Widespread Neurological Effects of COVID-19 Vaccines from 2021 to 2023: Insights from EudraVigilance
<b>Background/Objectives:</b> Post-market surveillance of COVID-19 vaccines is vital. This study analyzed EudraVigilance data (Jan 2021–Dec 2023) to detect potential safety signals linking COVID-19 vaccines and specific neurological adverse events (aseptic meningitis, Guillain–Barré synd...
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MDPI AG
2025-04-01
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| Online Access: | https://www.mdpi.com/1424-8247/18/5/636 |
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| author | Arturo Gómez López de las Huertas Stefan Stewart Mikel Urroz Elizalde Javier Guijarro-Eguinoa Enrique Seco-Meseguer Elena Diago-Sempere María Jiménez González Antonio J. Carcas-Sansuan Alberto M. Borobia Pérez Elena Ramírez |
| author_facet | Arturo Gómez López de las Huertas Stefan Stewart Mikel Urroz Elizalde Javier Guijarro-Eguinoa Enrique Seco-Meseguer Elena Diago-Sempere María Jiménez González Antonio J. Carcas-Sansuan Alberto M. Borobia Pérez Elena Ramírez |
| author_sort | Arturo Gómez López de las Huertas |
| collection | DOAJ |
| description | <b>Background/Objectives:</b> Post-market surveillance of COVID-19 vaccines is vital. This study analyzed EudraVigilance data (Jan 2021–Dec 2023) to detect potential safety signals linking COVID-19 vaccines and specific neurological adverse events (aseptic meningitis, Guillain–Barré syndrome, polyradiculoneuropathies, multiple sclerosis, transverse myelitis, neuromyelitis optica). It also explored the impact of non-healthcare professional reports on disproportionality analysis. <b>Methods:</b> 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’s correlation (SCC) was used to examine the impact of non-healthcare professional reports on PRR. <b>Results:</b> 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%, <i>p</i> < 0.001), 2022 (59.4% vs. 36.5%, <i>p</i> = 0.001), and 2023 (42% vs. 24.36%, <i>p</i> = 0.006). In 2023, significant signals (PRR ≥ 2) were found between Jcovden© and polyradiculoneuropathy (PRR 5.4, IC 95% 3.98–7.32), multiple sclerosis (PRR 2.72, IC 95% (1.08–6.87), transverse myelitis (PRR 4.68, IC 95% 1.02–21.35) and neuromyelitis optica (PRR 7.79, IC 95% 3.5–17.37). In addition, both Spikevax© and Comirnaty© showed significant signals with multiple sclerosis (PRR 2.50, IC 95% 1.70–3.68, and PRR 2.33, IC 95% 1.68–3.24) and transverse myelitis (PRR 3.50, IC 95% 1.66–7.50 and PRR 3.58, IC 95% 1.85–6.93). A significant negative correlation between the proportion of reports from non-healthcare professionals and the case/no-case ratio was found (SCC = −0.4683, <i>p</i> = 0.009). <b>Conclusions:</b> 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. |
| format | Article |
| id | doaj-art-45e2970422dc47f1bb80642e8d404719 |
| institution | Kabale University |
| issn | 1424-8247 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | MDPI AG |
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| series | Pharmaceuticals |
| spelling | doaj-art-45e2970422dc47f1bb80642e8d4047192025-08-20T03:47:58ZengMDPI AGPharmaceuticals1424-82472025-04-0118563610.3390/ph18050636Disproportionality Analysis of the Five Most Widespread Neurological Effects of COVID-19 Vaccines from 2021 to 2023: Insights from EudraVigilanceArturo Gómez López de las Huertas0Stefan Stewart1Mikel Urroz Elizalde2Javier Guijarro-Eguinoa3Enrique Seco-Meseguer4Elena Diago-Sempere5María Jiménez González6Antonio J. Carcas-Sansuan7Alberto M. Borobia Pérez8Elena Ramírez9Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, SpainClinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, SpainClinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, SpainClinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, SpainClinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, SpainClinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, SpainClinical Trials Unit, La Paz University Hospital-IdiPAZ, 28046 Madrid, SpainClinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, SpainClinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, SpainClinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, Spain<b>Background/Objectives:</b> Post-market surveillance of COVID-19 vaccines is vital. This study analyzed EudraVigilance data (Jan 2021–Dec 2023) to detect potential safety signals linking COVID-19 vaccines and specific neurological adverse events (aseptic meningitis, Guillain–Barré syndrome, polyradiculoneuropathies, multiple sclerosis, transverse myelitis, neuromyelitis optica). It also explored the impact of non-healthcare professional reports on disproportionality analysis. <b>Methods:</b> 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’s correlation (SCC) was used to examine the impact of non-healthcare professional reports on PRR. <b>Results:</b> 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%, <i>p</i> < 0.001), 2022 (59.4% vs. 36.5%, <i>p</i> = 0.001), and 2023 (42% vs. 24.36%, <i>p</i> = 0.006). In 2023, significant signals (PRR ≥ 2) were found between Jcovden© and polyradiculoneuropathy (PRR 5.4, IC 95% 3.98–7.32), multiple sclerosis (PRR 2.72, IC 95% (1.08–6.87), transverse myelitis (PRR 4.68, IC 95% 1.02–21.35) and neuromyelitis optica (PRR 7.79, IC 95% 3.5–17.37). In addition, both Spikevax© and Comirnaty© showed significant signals with multiple sclerosis (PRR 2.50, IC 95% 1.70–3.68, and PRR 2.33, IC 95% 1.68–3.24) and transverse myelitis (PRR 3.50, IC 95% 1.66–7.50 and PRR 3.58, IC 95% 1.85–6.93). A significant negative correlation between the proportion of reports from non-healthcare professionals and the case/no-case ratio was found (SCC = −0.4683, <i>p</i> = 0.009). <b>Conclusions:</b> 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.https://www.mdpi.com/1424-8247/18/5/636pharmacovigilanceEudraVigilancedisproportionalityvaccinesCOVID-19 |
| spellingShingle | Arturo Gómez López de las Huertas Stefan Stewart Mikel Urroz Elizalde Javier Guijarro-Eguinoa Enrique Seco-Meseguer Elena Diago-Sempere María Jiménez González Antonio J. Carcas-Sansuan Alberto M. Borobia Pérez Elena Ramírez Disproportionality Analysis of the Five Most Widespread Neurological Effects of COVID-19 Vaccines from 2021 to 2023: Insights from EudraVigilance Pharmaceuticals pharmacovigilance EudraVigilance disproportionality vaccines COVID-19 |
| title | Disproportionality Analysis of the Five Most Widespread Neurological Effects of COVID-19 Vaccines from 2021 to 2023: Insights from EudraVigilance |
| title_full | Disproportionality Analysis of the Five Most Widespread Neurological Effects of COVID-19 Vaccines from 2021 to 2023: Insights from EudraVigilance |
| title_fullStr | Disproportionality Analysis of the Five Most Widespread Neurological Effects of COVID-19 Vaccines from 2021 to 2023: Insights from EudraVigilance |
| title_full_unstemmed | Disproportionality Analysis of the Five Most Widespread Neurological Effects of COVID-19 Vaccines from 2021 to 2023: Insights from EudraVigilance |
| title_short | Disproportionality Analysis of the Five Most Widespread Neurological Effects of COVID-19 Vaccines from 2021 to 2023: Insights from EudraVigilance |
| title_sort | disproportionality analysis of the five most widespread neurological effects of covid 19 vaccines from 2021 to 2023 insights from eudravigilance |
| topic | pharmacovigilance EudraVigilance disproportionality vaccines COVID-19 |
| url | https://www.mdpi.com/1424-8247/18/5/636 |
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