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Background and Objectives: Seizure attack is one of adverse effects of vaccination in epileptic patients, the risk of which after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) inoculation was elucidated in the present study.
Methods: A self-controlled case series study was designed to examine the association between vaccination and epileptic seizure. A total of 240 epilepsy patients were included who were vaccinated with inactive SARS-CoV-2 vaccines (Sinovac Life Sciences and Lanzhou Institute of Biological Products) and admitted to outpatient clinics from July 2021 to December 2021. Poisson analysis was performed to estimate the relative incidence rate of epileptic seizure in risk periods (day 1-7, 8-21 and 1-21 after first-dose vaccination) compared to basal level in control period.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inactive SARS-Cov-2 vaccine | Biological | We included epilepsy patients who were vaccinated with inactive SARS-CoV-2 vaccines |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of epileptic seizures within 21 days after first-dose vaccination with inactive SARS-CoV-2 vaccine in epilepsy patients | Overall relative incidence of epileptic seizures in risk periods compared to control period. | from 90 days before until 21 days after the first dose of vaccine |
| Risk of epileptic seizures in epilepsy patients of different subgroups | The associations of sex, age or medication status with the relative incidence in risk periods | from 90 days before until 21 days after the first dose of vaccine |
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Inclusion Criteria:
Exclusion Criteria:
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We retrospectively enrolled epilepsy patients visiting outpatient clinics of the above two centers from July 2021 to December 2021, who took inactivated vaccines from Sinovac Life Sciences and Sinopharm Group (China). The study included both adults and children aged above 3 years. All the patients were diagnosed with epilepsy according to the International League Against Epilepsy (ILAE) Commission 90 days before till 21 days after the first dose of vaccine. Demographics, clinical manifestations and vaccination records were collected.
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| Name | Affiliation | Role |
|---|---|---|
| Gengyao Hu, doctor | Air Force Military Medical University, China | Principal Investigator |
| Ze Chen, master | Air Force Military Medical University, China | Principal Investigator |
| Kejian Wu, doctor | Air Force Military Medical University, China | Principal Investigator |
| Yuanhang Pan, master | Air Force Military Medical University, China | Principal Investigator |
| Xia Li, master | Xian Children's Hospital | Principal Investigator |
| Junxiang Bao, doctor | Air Force Military Medical University, China | Study Director |
| Yonghong Liu, doctor | Air Force Military Medical University, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Xi'an | Shaanxi | 710000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33020166 | Background | Frontera JA, Sabadia S, Lalchan R, Fang T, Flusty B, Millar-Vernetti P, Snyder T, Berger S, Yang D, Granger A, Morgan N, Patel P, Gutman J, Melmed K, Agarwal S, Bokhari M, Andino A, Valdes E, Omari M, Kvernland A, Lillemoe K, Chou SH, McNett M, Helbok R, Mainali S, Fink EL, Robertson C, Schober M, Suarez JI, Ziai W, Menon D, Friedman D, Friedman D, Holmes M, Huang J, Thawani S, Howard J, Abou-Fayssal N, Krieger P, Lewis A, Lord AS, Zhou T, Kahn DE, Czeisler BM, Torres J, Yaghi S, Ishida K, Scher E, de Havenon A, Placantonakis D, Liu M, Wisniewski T, Troxel AB, Balcer L, Galetta S. A Prospective Study of Neurologic Disorders in Hospitalized Patients With COVID-19 in New York City. Neurology. 2021 Jan 26;96(4):e575-e586. doi: 10.1212/WNL.0000000000010979. Epub 2020 Oct 5. | |
| 32554773 |
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| Background |
| Cabezudo-Garcia P, Ciano-Petersen NL, Mena-Vazquez N, Pons-Pons G, Castro-Sanchez MV, Serrano-Castro PJ. Incidence and case fatality rate of COVID-19 in patients with active epilepsy. Neurology. 2020 Sep 8;95(10):e1417-e1425. doi: 10.1212/WNL.0000000000010033. Epub 2020 Jun 17. |
| 35233819 | Background | Frontera JA, Tamborska AA, Doheim MF, Garcia-Azorin D, Gezegen H, Guekht A, Yusof Khan AHK, Santacatterina M, Sejvar J, Thakur KT, Westenberg E, Winkler AS, Beghi E; contributors from the Global COVID-19 Neuro Research Coalition. Neurological Events Reported after COVID-19 Vaccines: An Analysis of VAERS. Ann Neurol. 2022 Mar 2;91(6):756-71. doi: 10.1002/ana.26339. Online ahead of print. |
| 34391030 | Background | Massoud F, Ahmad SF, Hassan AM, Alexander KJ, Al-Hashel J, Arabi M. Safety and tolerability of the novel 2019 coronavirus disease (COVID-19) vaccines among people with epilepsy (PwE): A cross-sectional study. Seizure. 2021 Nov;92:2-9. doi: 10.1016/j.seizure.2021.08.001. Epub 2021 Aug 6. |
| 23274350 | Background | Arnheim-Dahlstrom L, Hallgren J, Weibull CE, Sparen P. Risk of presentation to hospital with epileptic seizures after vaccination with monovalent AS03 adjuvanted pandemic A/H1N1 2009 influenza vaccine (Pandemrix): self controlled case series study. BMJ. 2012 Dec 18;345:e7594. doi: 10.1136/bmj.e7594. |