Epileptic Seizure in Epilepsy Patients After SARS-CoV-2 Vaccination

Epileptic Seizure in Epilepsy Patients After First-dose Inactivated SARS-CoV-2 Vaccination: a Self-controlled Case Series Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05341713

Enrollment

240

Registered

2022-04-22

Start date

2022-01-01

Completion date

2022-04-01

Last updated

2022-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epileptic Seizures Related to Drugs, SARS-CoV-2 Acute Respiratory Disease, Vaccine Adverse Reaction

Keywords

epilepsy patient, risk of seizure, SARS-Cov-2 vaccine

Brief summary

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.

Interventions

BIOLOGICALinactive SARS-Cov-2 vaccine

We included epilepsy patients who were vaccinated with inactive SARS-CoV-2 vaccines

Study design

Observational model

CASE_CROSSOVER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female participants * Have a diagnosis of epilepsy by the end of the study * Have received at least one dose of inactive SARS-Cov-2 vaccine (Sinovac Life Sciences and Sinopharm Group)

Exclusion criteria

* Non-epilepsy patients vaccinated with inactive SARS-Cov-2 vaccine * Epilepsy patients administrated with non-inactive vaccine * Unvaccinated epilepsy patients

Design outcomes

Primary

Measure	Time frame	Description
Risk of epileptic seizures within 21 days after first-dose vaccination with inactive SARS-CoV-2 vaccine in epilepsy patients	from 90 days before until 21 days after the first dose of vaccine	Overall relative incidence of epileptic seizures in risk periods compared to control period.
Risk of epileptic seizures in epilepsy patients of different subgroups	from 90 days before until 21 days after the first dose of vaccine	The associations of sex, age or medication status with the relative incidence in risk periods

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026