LYMErix® Safety Data Reported to the Vaccine Adverse Event Reporting System (VAERS)

2/15/01


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Table of Contents

LYMErix® Safety Data Reported to the Vaccine Adverse Event Reporting System (VAERS)

What is the Vaccine Adverse Event Reporting System (VAERS)?

Uses of VAERS

Limitations of VAERS

Analysis of VAERS Data

Coding of VAERS Reports

LYMErix® Safety Surveillance Through VAERS

LYMErix® Safety Surveillance Through VAERS Results Overview

PPT Slide

Frequency Distribution of All VAERS LYMErix® Reports (n=878) by Calendar Quarter

Frequency Distribution of All VAERS LYMErix® Reports (n=877) by Age at Onset of Adverse Event

Frequency Distribution of All VAERS LYMErix® Reports (n=739) by Time to Onset of Adverse Event

Frequency Distribution of All VAERS LYMErix® Reports (n=1,007) by Dose

Ten Most Common VAERS LYMErix® Adverse Event Coding Terms

Summary of Deaths (n=4) after LYMErix® Reported to VAERS

Summary of Serious Reports (n=85) Following LYMErix® Reported to VAERS

Summary of Serious Reports Following LYMErix® (n=85) Reported to VAERS (cont)

Frequency Distribution of VAERS LYMErix® Reports (n=21) of Hypersensitivity by Time to Onset

Frequency Distribution of Reports of Arthritis, Arthrosis, and Rheumatoid Arthritis (n=132) by Calendar Quarter

Reports of Arthritis (n=74), Arthrosis (n=46), and Rheumatoid Arthritis (RA) (n=13) Following LYMErix®

Frequency Distribution of VAERS LYMErix® Rheumatoid Arthritis Reports (n=8) by Time to Onset and Dose

Frequency Distribution of VAERS LYMErix® Arthritis Reports (n=40) by Time to Onset and Dose

Clinical Characteristics of VAERS LYMErix® Reports Coded Arthritis, Arthrosis, and Rheumatoid Arthritis (RA)

Frequency Distribution of VAERS LYMErix® “Arthritis” Reports Indicating Joint Swelling (n=30) by Time to Onset and Dose

Reports of Facial Paralysis Following LYMErix®

Frequency Distribution of VAERS LYMErix® Reports of Facial Paralysis (n=11) by Time to Onset

Reports of Adverse Events Following LYMErix® for People with a Self-Reported HLA Type

Ten Most Common VAERS Coding Terms Following LYMErix® for People with a Self-Reported History of Lyme Disease (n=76)

Ten Most Common VAERS Coding Terms Following LYMErix® for People with a Self-Reported History of Lyme Disease

Self-Reported Lyme Disease Following LYMErix®

Summary of VAERS Analysis

Follow-up Study

Planned Follow-up Study

Plans for Continued Safety Evaluation of LYMErix®

Collaborators in Analysis of VAERS Data

Author: CBER