# Presentation: 318154

## Figure 1 - Frequency Distribution of All VAERS LYMErix® Reports by Age at Onset of Adverse Event 

- Age not available for 171 (16%) reports

- Interpretation of VAERS data is subject to important limitations - see text for details

## Figure 2- Frequency Distribution of All VAERS LYMErix® Reports by Time to Onset of Adverse Event

- Time to onset not available for 309 (29%) reports

- Interpretation of VAERS data is subject to important limitations - see text for details

## Figure 3 - Frequency Distribution of All VAERS LYMErix® Reports by Dose

- Dose not available for 41 (3.9%) reports

- Interpretation of VAERS data is subject to important limitations - see text for details

## Table 1 - Ten Most Common VAERS LYMErix® Adverse Event Coding Terms

**Arthralgia** (322)
**Myalgia **(227)
- Pain (196)
- Asthenia (167)
- Headache (151)
**Fever **(126)
**Flu syndrome** (124)
**Injection site pain** (117)
**Rash **(85)
**	****	****Bold = event associated with vaccine in pre-licensure trial**
- 		Interpretation of VAERS data is subject to important limitations - see text for details

## Table 2 - Summary of Serious Reports after LYMErix® Reported to VAERS

- 44 reports of musculoskeletal events
- 12 arthritis or arthrosis
- 6 rheumatoid arthritis
- 24 reports of  a variety of neurological events
- 5 reports of cerebral ischemia
- 5 reports of demyelinating disease
- 3 reports of hypersensitivity events
- 13 miscellaneous events
- 5 multiple systemic complaints including dizziness, nausea, fever, photophobia, headache, fatigue, sore throat
- 2 chest pain (1 pericarditis)
- 2 syncope
- 2 chronic or recurrent sinusitis (1 with depression)
- 1 aseptic meningitis
- 1 Lyme disease
- 	Interpretation of VAERS data is subject to important limitations - see text for details

## Figure 4 - Frequency Distribution of VAERS LYMErix® Rheumatoid Arthritis Reports by Time to Onset and Dose 

- Time to onset or dose not available for 5 (38%) reports

- Interpretation of VAERS data is subject to important limitations - see text for details

## Figure 5 - Frequency Distribution of VAERS LYMErix® Arthritis Reports by Time to Onset and Dose

- Time to onset or dose not available for 34 (46%) reports

- Interpretation of adverse event reports is subject to limitations - see text for details

## Table 3 - Clinical Characteristics of VAERS LYMErix® Reports Coded Arthritis, Arthrosis, and Rheumatoid Arthritis (RA)

- Interpretation of VAERS data is subject to important limitations - see text for details

## Figure 6 - Frequency Distribution of VAERS LYMErix® “Arthritis” Reports Indicating Joint Swelling by Time to Onset and Dose

- 58 reports with joint swelling,  time to onset or
- dose not available for 28 (48%) reports

- Interpretation of VAERS data is subject to important limitations - see text for details

##  Figure 7 - Frequency Distribution of VAERS LYMErix® Reports of Facial Paralysis by Time to Onset

- Time to onset  not available for 2 (15%) reports

- Interpretation of VAERS data is subject to important limitations - see text for details

##  Figure 8 - Frequency Distribution of VAERS LYMErix® Reports of Hypersensitivity by Time to Onset

- Time to onset  not available for 3 (13%) reports

- Interpretation of VAERS data is subject to important limitations - see text for details

## Table 4 - Ten Most Common VAERS Coding Terms Following LYMErix® for People with a Self-Reported History of Lyme Disease

- Arthralgia			25
- Asthenia			19
- Myalgia			19
- Headache			18
- Pain				16
- Pain Inject Site		12
- Fever			10
- Hysn Inject Site		8
- Chills			7
- Rash				7

- Interpretation of VAERS data is subject to important limitations - see text for details