Figure 1 - Frequency Distribution of All VAERS LYMErix® Reports by Age at Onset of Adverse Event Age not available for 171 (16%) reports Interpretation.

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Presentation transcript:

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 Arthralgia25 Asthenia19 Myalgia19 Headache18 Pain16 Pain Inject Site12 Fever10 Hysn Inject Site8 Chills7 Rash7 Interpretation of VAERS data is subject to important limitations - see text for details