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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 1 Educational Objectives • 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 2 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. 3 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) 4 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 5 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 6 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 7 VAERS Uses (Examples) – General Safety of Vaccines • H1N1 influenza vaccines Safety of Influenza A (H1N1) 2009 Monovalent Vaccines-US., Oct .1Nov. 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. 8 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 vaccinesRecommendations 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. 9 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 10 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. demographics AE • 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 11 vax 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: [email protected] 12 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) 13 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 14 Box 8 of VAERS form Selected Questions and Answers about VAERS 15 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) 16 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/ 17 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 18 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/vacadmin/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 19 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 20 Example MMR VIS HHS Vaccine Safety Resources • CDC – – – • VAERS -CDC/FDA – – • 800-822-7967 http://vaers.hhs.gov Vaccine Injury Compensation- HRSA – – • Immunization Safety Office Web site www.cdc.gov/vaccinesafety 800-CDC-INFO (232-4636) [email protected] 800-338-2382 www.hrsa.gov/vaccinecompensation/ Food and Drug Administration – www.fda.gov/cber 21 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. 22 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. 23 Questions 24 Flow of a VAERS report Report Submitted Reporters Patients Providers Manufacturers States DOD others Web Mail Fax Serious ID number Data Coded Medical records Acknowledge Request missing info Data sent to CDC/ FDA daily VSD Manf FDA CDC 25 CISA Follow Up letter ACIP 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 (20052009 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 26 VAERS “Non-Serious” Reports* • 92% of VAERS reports are “nonserious” • 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 27 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 28