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

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

0

25

50

75

100

125

150

175

0 10 20 30 40 50 60 70 80

Age (years)

Nu

mb

er

less seriousseriousfatal

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

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50

100

150

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300

0 2 4 6 8 10 12 14 16 18 20 >21

Time to Onset (days)

Nu

mb

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Time to onset not available for 309 (29%) reportsInterpretation of VAERS data is subject to important limitations - see text for details

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

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100

200

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1 2 3 4 5

Dose

Nu

mb

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Dose not available for 41 (3.9%) reports


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


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


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

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10

Num

ber

1 2 3 4 5 6 7 8 9 >9

Time to Onset (weeks)

1st Dose2nd Dose

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


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

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1

2

3

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Num

ber

1 2 3 4 5 6 7 8 9 > 9


1st Dose2nd Dose3rd 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)

Arthritis (n=74) Arthrosis (n=46) RA (n=13)

Joint Pain 41 29 10

Limited Motion 9 12 5

Joint Tenderness 3 2 -

Joint Warmth 3 4 2

Joint Swelling 12 40 6


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

Onset and Dose

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1 2 3 4 5 6 7 8 9 >9


1st Dose

2nd Dose

3rd Dose

58 reports with joint swelling, time to onset or

dose not available for 28 (48%) reports


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

0

5

10

1 2 3 4 5 6 >6


Nu

mb

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reported cases

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


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

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5

10

24 48 72 >72

Time to Onset (hours)

Nu

mb

er

urticaria

respiratory symptoms

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


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


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

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