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
|