1 VAERS Reporting During a Large Scale Vaccination Clinic in Chicago Lessons Learned Chicago Department of Public Health Immunization Program Lorraine Schoenstadt MS, RN, BC Vaccine Safety Coordinator Chicago Department of Public Health

2 City urges parents to get teens vaccinated against meningitis

3 Problem Since 2006, increasing numbers of Group C meningococcal infections in Chicago From January- April, 2008 –Two deaths among teens residing in one neighborhood –Additional cases clustered in a nearby neighborhood Although increasing, numbers not consistent with CDC definition of outbreak

4 Response April 20, CDPH decision –Reinforce ACIP recommendation for adolescents (11-18 years) to receive meningococcal vaccine throughout the city –Administer vaccine to students attending schools in the two affected neighborhoods

5 Partners CDPH staff –Immunization Program –Communicable Disease Program –Emergency Preparedness Program –Other programs School staff Respiratory Health Association Other local health departments

6 “Just-in-time” training Daily review of: Standing medical orders Consent Forms –Parents advised to follow up with their doctor with concerns after vaccination Vaccine Information Statements Vaccine administration guidelines Contraindications Observation area Emergency procedures VAERS forms were included in manual –No specific instructions on use of VAERS

7 Results April 24 –May 8, 2008 –Schools: 53 Number of vaccinees: 6,831 On-site VAERS reports: 28 –Park Districts: 2 Number of vaccinees: 436 On-site VAERS reports: 0

8 Summary of VAERS Reports Number females: 15 (54%) Number males: 13 (46%) Events: –Syncope: 1 (3%) –Dizziness 11 (39%) –Headache 18 (64%) –SOB2 (7%) –Nausea9 (32%) ER visits: 4 (14%)

9 Observations Clustering of adverse events occurred during post-vaccination observation period VAERS documentation lacked uniformity –Completed by vaccinators themselves or site coordinators No systematic collection of off-site adverse events

10 Lessons Learned Review Vaccine Adverse Event Reporting procedures in “Just-in- Time” training VAERS reports should be reviewed by the safety officer on a daily basis Develop a system to organize and analyze Complete some fields on VAERS forms ahead of time

11 Recommendations The Vaccine Safety Coordinator should play a key role in the development of the Pandemic Operations Protocol and Plan –Build a network of key partners –Train partners on how to report and who to report to –Enhance existing plans/policies for reporting –Develop a database for tracking adverse events

12 Contact Information Lorraine Schoenstadt MS, RN, BC Chicago Department of Public Health