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VAERS reported new-onset seizures following use of Covid 19 vaccinations as compared to influenza vaccinations
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  • Jagannadha Avasarala,
  • Christopher McLouth,
  • Luther Pettigrew,
  • Sally Mathias,
  • Sharoon Qaiser,
  • Phenu Zachariah
Jagannadha Avasarala
University of Kentucky Medical Center

Corresponding Author:javasarala@uky.edu

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Christopher McLouth
University of Kentucky Medical Center
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Luther Pettigrew
University of Kentucky Medical Center
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Sally Mathias
University of Kentucky Medical Center
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Sharoon Qaiser
University of Kentucky Medical Center
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Phenu Zachariah
Aurora Medical Center in Kenosha
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Abstract

The incidence of new-onset seizures, which we defined as de novo seizures occurring within four weeks of receiving any of the FDA-approved Covid 19 vaccinations as reported in patient-reported data compiled in the US Centers for Disease Control and Prevention Vaccine Adverse Events Reporting System Data (CDC VAERS) has not been explored. The VAERS database contains de-identified patient-reported adverse events following vaccinations and represents post-marketing surveillance and analysis of vaccine safety. After adjusting for time at risk, this resulted in estimated incidence rates of 3.19 seizures per 100,000 persons per year for either Pfizer, Moderna or Janssen vaccines and 0.090 seizures per 100,000 persons per year for the influenza vaccine. A data-driven, individualized dataset that is comprehensive and coupled with a longitudinal follow-up in larger numbers of vaccinated individuals is needed to expand on our preliminary findings of vaccine-related seizures. The VAERS database helps in the identification of a safety signal detection and is fundamentally a hypothesis-generating system; the data or results cannot be used to analyze cause and effect.
22 Mar 2022Submitted to British Journal of Clinical Pharmacology
23 Mar 2022Submission Checks Completed
23 Mar 2022Assigned to Editor
29 Mar 2022Reviewer(s) Assigned
12 Apr 2022Review(s) Completed, Editorial Evaluation Pending
21 Apr 2022Editorial Decision: Revise Major
07 May 20221st Revision Received
10 May 2022Submission Checks Completed
10 May 2022Assigned to Editor
10 May 2022Review(s) Completed, Editorial Evaluation Pending
11 May 2022Editorial Decision: Revise Minor
11 May 20222nd Revision Received
12 May 2022Submission Checks Completed
12 May 2022Assigned to Editor
12 May 2022Review(s) Completed, Editorial Evaluation Pending
13 May 2022Editorial Decision: Accept
Nov 2022Published in British Journal of Clinical Pharmacology volume 88 issue 11 on pages 4784-4788. 10.1111/bcp.15415