1. Medical Analysis Update: VICP Advisory Commission on Childhood Vaccines June 10-11, 2010 Rosemary Johann-Liang, MD Rjohann-liang@hrsa.gov

2. Number of Petitions for Medical Analysis 5 year period: FY 2005-2009

3. Claims filed to VICP Comparing %age-bands 10 years apart

4. FY 2009 Claims Filed to VICP

5. 2010 Medical (MO) Reviews: New Reports FY 2010 8 months so far N=498 reports total N=155 are activated autism reviews

6. 3/10-5/10 MO Reviews: Age

7. 3/10-5/10 MO Reviews: Vaccines Alleged (non-autism) Vaccine Alleged% of totalVaccine Alleged% of total Influenza45%Rotavirus4% HPV13%Meningococcal4% Tetanus8%Varicella2% Hepatitis B6% MMR5%Multiple12.5%

8. 3/10-5/10 MO Reviews: Adverse Events (non-autism) AE% of totalAE% of total GBS30%Death6% Other Demyelinating TM/ADEM/CIDP/NMO/MS 12%Underlying Disorder5% Skin (rash, allergy, fascitis) 7%Immune/Rheum, autoimmune Injuries 5% Shoulder/Arm Injuries (BN, CRPS) 6%Miscellaneous (gastrointestinal, cardiac, hematologic, etc.) 24% Encephalitis, Sz Encepholopathy, 6%

9. HPV Claim: Demographics Total # of claims thus far since 2008 = 54 with 5 death claims Average age = 16.5 years for all female claims with range (12 – 27 yrs) Only one male claim (age over 50 years). 39% had HPV x 1; 32% had HPV x 2 and 29% had HPV x 3 16% of total had other concurrent vaccines (meningococcal, hepatitis A, hepatitis B, and Tetanus-containing)

10. HPV MO Reviews On-going: Injuries Claimed Claimed Injury% of totalClaimed Injury% of total Neurologic (other) Including seizures 24%Syncope “serious sequelae” 6% GBS17%Miscellaneous (GI, cardiac, hematologic) 12% TM/ADEM 7%Death Claims under review (hypercoagulable state, cardiac) some waiting for records those with autopsy – we will request slides for independent pathology review Rheumatologic 19% CTD 6%

11. Shoulder Injury Case Series Bodor M and Montalvo E. Vaccination-related shoulder dysfunction; Vaccine 25 (2007) 585-587 –Case reports of 2 patients; pain within 2 days following vaccination; injection too high on shoulder? Medical Analysis of VICP Claims from 2006-2009; 11 claims identified with significant shoulder pain and dysfunction following vaccine administration

12. Shoulder Series: Initial Analyses 82% female; Mean age = 52 (range 29-83) Vaccine Administered; 64% influenza; 36% tetanus- containing Pain onset is less than 24 hrs in 91% from vaccine administration with 64% recalling immediate symptom onset. Diagnoses: bursitis, rotator cuff injury, adhesive capsulitis Concern: long-term sequelae Concern: where and how administered