Figure 1 - Frequency Distribution of All VAERS LYMErix

1
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
2
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
3
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
4
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

5
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

6
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
7
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
8
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
9
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
10
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
11
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
12
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