This MedLibrary.org supplementary page on Vaccine Adverse Event Reporting System is provided directly from the open source Wikipedia as a service to our readers. Please see the note below on authorship of this content, as well as the Wikipedia usage guidelines. To search for other content from our encyclopedia supplement, please use the form below:
Related Sponsors
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 |
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:. 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
|
|||||||||||||||||||||||||
Wikipedia content modification information:
- This page was last modified on 21 August 2008, at 02:27.
Wikipedia Authorship and Review
Wikipedia content provided here is not reviewed directly by MedLibrary.org. Wikipedia content is authored by an open community of volunteers and is not produced by or in any way affiliated with MedLibrary.org.
Wikipedia Usage Guidelines
This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article on "Vaccine Adverse Event Reporting System".
The URL for this specific entry is:
All Wikipedia text is available under the terms of the GNU Free Documentation License. (See Copyrights for details). Wikipedia® is a registered trademark of the Wikimedia Foundation, Inc.