1. 1 Review of the Vaccine Adverse Event Reporting System (VAERS) Beth Hibbs RN, MPH; Elaine Miller RN, MPH Immunization Safety Office (ISO) Division of Healthcare Quality Promotion (DHQP) Centers for Disease Control and Prevention National Immunization Conference April 21, 2010

2. 2 By the end of this presentation viewers should be able to describe the following about the Vaccine Adverse Event Reporting System (VAERS): –Role in vaccine safety surveillance –Strengths and limitations –Which adverse events should be reported to VAERS –How to report to VAERS –How to perform a search of the VAERS data Identify resources for vaccine safety Educational Objectives

3. 3 Vaccine Adverse Event Definition Adverse events are defined as health effects that occur after immunization that may or may not be causally related to the vaccine.

4. 4 Vaccine Adverse Event Reporting System (VAERS) National spontaneous reporting system for adverse events after US-licensed vaccines –Received over 38,000 reports in 2009, (2005-2009 average per year ~29,000) –Requires a report be filed; accepts reports from healthcare providers, manufacturers and others Jointly administered CDC and FDA, Authorized by National Childhood Vaccine Injury Act of 1986 –First reports accepted in 1990 VAERS data publicly available on VAERS web site or CDC Wide-ranging Online Data for Epidemiologic Research (WONDER)

5. 5 Purpose of VAERS VAERS is used to: Identify new and/or rare adverse events following immunization Monitor trends of known adverse events Identify potential patient risk factors for particular types of adverse events Generate hypotheses Provide information for public health policies on vaccine safety Monitor vaccine lot safety

6. 6 VAERS Strengths Can detect very rare adverse events that may not be detected before licensure Generates hypotheses –Helps identify new and/or rare adverse events following immunization –Helps determine if further investigations are needed Monitors trends of already known adverse events Monitors vaccine lot safety

7. 7 VAERS Limitations Underreporting Stimulated reporting due to media attention and other factors Possibly incomplete and inaccurate data on report form Lack of availability of denominator data –No information on number of persons vaccinated –No information on background rates of adverse events in the population VAERS generally cannot determine if an adverse event report was coincidental or caused by a vaccine

8. 8 VAERS Uses (Examples) –General Safety of Vaccines H1N1 influenza vaccines Safety of Influenza A (H1N1) 2009 Monovalent Vaccines-US., Oct.1- Nov. 24, 2009. MMWR 2009 Dec 11;58(48): 1351-1356. –New signal, rare adverse events Intussusception after rotashield vaccine Withdrawal of Rotavirus Vaccine Recommendation. MMWR 1999 Nov 5; 48(43): 1007. Myopericarditis after smallpox vaccine Update: Cardiac and Other Adverse Events Following Civilian Smallpox Vaccination --- United States, 2003. MMWR 2003 July 11; 52 (27): 639-642. Syncope following Vaccination Syncope After Vaccination --- United States, January 2005--July 2007. MMWR 2008 May 2; 57(17): 457-60.

9. 9 VAERS Uses (Examples) continued –Reassuring Evidence Supporting Vaccine Safety Guillain-Barre Syndrome risk identified following 1976 influenza vaccine since then VAERS has not identified a clear increase in risk Prevention and Control of seasonal Influenza with vaccines- Recommendations of the ACIP, MMWR 2009 July 31;58(RR08): 1-52. Decreased risk of fever and seizures after acellular compared to whole cell pertussis vaccines Infant Immunization with Acellular Pertussis Vaccines in the US: Assessment of the First Two Years’ Data from the Vaccine Adverse Event Reporting System (VAERS). Braun et al. Pediatrics 2000 Oct;106(4): E51.

10. 10 What to Report to VAERS Report any clinically significant adverse event following immunization ( www.vaers.hhs.gov) –Even if you are not certain the vaccine caused the event The National Childhood Vaccine Injury Act of 1986 mandates that healthcare providers also report specific adverse events that occur after vaccination –Events listed in the Table of Reportable Events https://kids.phila.gov/Docs/VAERS_Reportable EventsTable.pdf –Events listed in the vaccine package insert as a contraindication to further doses of vaccine

11. 11 What to Report to VAERS (continued) The report asks for information about pt, provider and reporter demographics, adverse event, vaccines received and any preexisting conditions. Include as much information as possible in the report (e.g., vaccination location, date, vaccine type, lot number and dose number) –Reports with incomplete information accepted Report as soon as possible but no time limit on reporting demographics AE vax

12. 12 How to Submit a VAERS Report: One of Several Methods May Be Used 1)Online via a secure website at https://vaers.hhs.gov 2) Download a reporting form: http://vaers.hhs.gov/resources/vaers_for m.pdf Fax a completed form: 877-721-0366 Mail a completed VAERS form to VAERS, P.O. Box 1100, Rockville, MD, 20849 To request a reporting form or for other VAERS assistance: call 800-822-7967 or email: info@vaers.org

13. 13 VAERS Follow-up VAERS staff follow up with health care providers on serious reports and certain selected reports of interest by phone to obtain: –Medical records –Autopsy reports Letter sent to reporters to check recovery status for all reports with “no” or “unknown” recovery listed on initial VAERS form (60 days and 1 year)

14. 14 How Does VAERS Define a “Serious” Report?*  Death  Life-threatening illness  Hospitalization  Prolongation of hospitalization  Persistent or significant disability  Certain other medically important conditions *Code of Federal Regulations Title 21 Box 8 of VAERS form

15. 15 Selected Questions and Answers about VAERS

16. 16 How are VAERS Reports Analyzed? CDC and FDA have primary responsibility for analysis Assess for signals for new or unexpected adverse events of concern –Use Medical Dictionary for Regulatory Activities (MedDRA) terms to analyze frequencies of reported adverse events (focus on serious adverse events) –Doses distributed data are commonly used as a proxy for doses administered –Assess and compare reporting rates among vaccines and health events of interest (observed in VAERS versus expected in general population) Review individual reports for serious adverse events and selected other conditions –Additional information available from follow-up medical records and autopsy reports Closely monitor safety of vaccine lots (FDA lead)

17. 17 How Can Public VAERS Data Be Obtained? VAERS data (without identifiable personal information) are accessible to the public through 2 systems: 1.CDC Wide-ranging Online Data for Epidemiologic Research ( WONDER) online search tool: data available about 1 month after VAERS receives the report. http://wonder.cdc.gov/vaers.html 2.Download raw data files for import into a database, spreadsheet, or text editing program; data available about 4 to 6 weeks after VAERS receives the report. http://vaers.hhs.gov/

18. 18 What Are the Best Resources for Vaccine Safety? Publications updated with vaccine safety research findings and recommendations : Manufacturer Vaccine Package Insert –http://www.fda.gov/BiologicsBloodVaccines/Vaccines/Approv edProducts/UCM093833 Advisory Committee on Immunization Practices Statements –http://www.cdc.gov/vaccines/pubs/ACIP-list.htm Vaccine Information Statements –http://www.cdc.gov/vaccines/pubs/vis/default.htm

19. 19 How Can Healthcare and Vaccine Providers Contribute to Vaccine Safety? Properly store and administer vaccine http://www.cdc.gov/vaccines/recs/storage/default.htm Screen for contraindications and precautions http://www.cdc.gov/vaccines/recs/vac- admin/contraindications.htm Educate vaccinee (or caregiver) about risks and benefits of vaccine Evaluate and treat patient if an adverse event occurs Report clinically significant adverse events promptly to VAERS –https://vaers.hhs.gov

20. 20 Continued: How Can Healthcare and Vaccine Providers Contribute to Vaccine Safety? Patient Education Materials CDC Vaccine Information Statements (VIS) http://www.cdc.gov/vaccines/Pubs/vis/ default.htm Contains Vaccine Safety information –Contraindications –VAERS –Vaccine Injury Compensation Public health law requires VIS to be distributed to recipients of recommended childhood vaccines Example MMR VIS

21. 21 HHS Vaccine Safety Resources CDC –Immunization Safety Office Web site www.cdc.gov/vaccinesafety –800-CDC-INFO (232-4636) –CDCinfo@cdc.gov VAERS -CDC/FDA –800-822-7967 –http://vaers.hhs.gov Vaccine Injury Compensation- HRSA –800-338-2382 –www.hrsa.gov/vaccinecompensation/ Food and Drug Administration –www.fda.gov/cber

22. 22 VAERS Selected Bibliography Varricchio F, Iskander J, Destefano F, Ball R, Pless R, Braun MM, Chen RT. Understanding Vaccine Safety Information from the Vaccine Adverse Event Reporting System. Pediatric Infectious Disease Journal 2004;23(4):287-294. Iskander JK, Miller ER, Chen RT. The Role of the Vaccine Adverse Event Reporting System (VAERS) in Monitoring Vaccine Safety. Pediatr Ann. 2004 Sep;33(9):599-606. Iskander J, Pool V, Zhou W, English-Bullard R; The VAERS Team. Data Mining in the US using the Vaccine Adverse Event Reporting System. Drug Safety 2006;29(5):375–384. Zhou W, Pool V, Iskander JK, English-Bullard R, et al. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)—United States, 1991–2001. MMWR 2003;52(1):1–24.

23. 23 Summary VAERS is a front-line mechanism to monitor the safety of US Licensed vaccines The first hint of a potential problem usually originates with the astute clinician and therefore the role of the health professional is essential in identifying vaccine adverse events through reports to VAERS VAERS report data are used to: –inform CDC and FDA and others in vaccine safety surveillance and research, –identify possible rare or new vaccine side effects or changes in known vaccine side effects, –monitor lot safety, –update the manufacturer package insert, Advisory Committee on Immunization Practices (ACIP) vaccine recommendations and Vaccine Information Statements.

24. 24 Questions

25. 25 Flow of a VAERS report Report Submitted ID number Data Coded Serious Medical records Data sent to CDC/ FDA daily FDACDC Follow Up letter VSD CISA Manf ACIP Reporters Patients Providers Manufacturers States DOD others Web Mail Fax Acknowledge Request missing info

26. 26 VAERS Background US post licensure vaccine safety surveillance –Collects voluntary reports of adverse events following immunization –Co-managed by CDC and the Food and Drug Administration (FDA) Healthcare providers are encouraged to report clinically significant adverse events after vaccination* –Anyone can submit a report to VAERS Receives ~23,000 reports per year (2005- 2009 average) Data publicly available *Clinically significant means of concern to the healthcare provider or vaccinee/ care giver or other VAERS reporter; www.vaers.hhs.gov

27. 27 VAERS “Non-Serious” Reports * 92% of VAERS reports are “non- serious” Most frequent adverse events** –Local reactions –Fever –Rashes or itching –Headache –Dizziness or nausea * Data from 91,669 VAERS reports received during 2005 through 2009 **A vaccinee may have had more than one adverse event listed in the report

28. 28 VAERS “Serious” Reports* 8% of VAERS reports are “serious”* (2005-2009)* Most frequent serious adverse events**  Fever  Vomiting  Dyspnea  Headache  Pain  Convulsions  Nausea  Fatigue  Diarrhea * Data from primary, non foreign VAERS reports received during 2005 through 2009 **A vaccinee may have had more than one adverse event listed in the report