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20-September-2008 09:55:52 - Adverse Event Reporting System The Vaccine Adverse Event Reporting System is a United States program for vaccine safety, co-sponsored by the Centers for Disease Control and Prevention CDC and the Food and Drug Administration FDA. VAERS is a post-marketing safety surveillance program, collecting information about adverse events possible side effects that occur after administration of vaccines. Contents 1 Origins 2 Research use 3 Litigation as a source of bias 4 References 5 External links Origins The program is an outgrowth of the 1986 National Childhood Vaccine Injury Act NCVIA, which requires health care providers to report: Any event listed by the vaccine manufacturer as a contraindication to subsequent doses of the vaccine. Any event listed in the Reportable Events Table that occurs within the specified time period after vaccination. The data are stored electronically by the CDC in the Vaccine Safety Datalink VSD. The FDA claims that Very rarely, people experience serious adverse events following immunization. The FDA says 15 percent of the 123,000 adverse events reported since 1990 reflect serious adverse events involving life-threatening conditions, hospitalization, permanent disability, or death, which may or may not have been truly caused by an immunization. VAERS is meant to act as a sort of early warning system-a way for physicians and researchers to identify possible unforeseen reactions or side effects of vaccination for further study. Research use Many medical researchers make use of VAERS to study the effects of vaccination. VAERS instructs researchers using its database:1: Establishing causal relationships between vaccines and adverse events requires additional scientific investigation. The CDC and FDA take into account the complex factors mentioned above, and others, when monitoring vaccine safety and analyzing VAERS reports. The purpose of VAERS is to detect possible signals of adverse events associated with vaccines. Additional scientific investigations are almost always required to properly validate signals from VAERS and establish a cause and effect relationship between a vaccine and an adverse event. Litigation as a source of bias There is a clear increase in VAERS reports related to litigation, and litigation-related reports may skew trends. In 2002, nearly one third of the reports were related to litigation.1 References ^ Goodman MJ, Nordin J 2006. Vaccine adverse event reporting system reporting source: a possible source of bias in longitudinal studies. Pediatrics 117 2: 387-90. doi:10.1542/peds.2004-2687. PMID 16452357. External links vaers.hhs.gov - Vaccine Adverse Event Reporting System official website FDA.gov - 'Vaccine Adverse Event Report System VAERS' VAERS brouchure U.S. Department of Health Human Services v d e Vaccines, Vaccination, Immunization, and Inoculation see also artificial induction of immunity Development Adjuvants Cancer vaccines DNA vaccination HIV Live vector vaccine Models Timeline Trial Administration Global: GAVI Policy Schedule Vaccine injury USA: ACIP VAERS VSD Vaccine court Vaccines live Anthrax BCG tuberculosis Flu MMR MMRV PolioOPV Rotavirus Smallpox Varicella Yellow fever Inactivated/toxoid inactivated virus: Flu HAV PolioIPV inactivated bacteria/toxoid: DTwP conjugate: Hib PCV Other subunit: Anthrax DTaP HPV recombinant DNA: HBV other: Anthrax PPV Controversy General A-CHAMP MMR NCVIA Pox party Safe Minds Thiomersal See also List of vaccine topics Epidemiology Eradication of infectious diseases Retrieved from http://en..org/wiki/Vaccine_Adverse_Event_Reporting_System Categories: Public health | Vaccination-related organizations Views Article Discussion this page History Personal tools Log in / create account Navigation Main page Contents Featured content Current events Random article Search Go Search Interaction Community portal Recent changes Contact Donate to Help Toolbox What links here Related changes Upload file Special pages Printable version Permanent link Cite this page This page was last modified on 21 August 2008, at 02:27
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