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. The Centers for Disease Control and Prevention (CDC) in Atlanta is recognized as the lead United States agency for protecting the public health and safety of people by providing credible information to enhance health decisions, and promoting health through strong partnerships with state health departments and other organizations. ... Jump to: navigation, search The United States Food and Drug Administration (FDA) is the government agency responsible for regulating food (human and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal), biologics and blood products in the United States. ...

Origins

The program is an outgrowth of the 1986 National Childhood Vaccine Injury Act (NCVIA), which requires health care providers to report: Jump to: navigation, search 1986 is a common year starting on Wednesday of the Gregorian calendar. ... Jump to: navigation, search The National Childhood Vaccine Injury Act (NCVIA) of 1986 (42 U.S.C. §§ 300aa-1 to 300aa-34) was enacted in the United States to reduce the liability of vaccine makers, thereby ensuring a stable market supply. ...

• 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." Jump to: navigation, search 1990 is a common year starting on Monday of the Gregorian calendar. ...

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. For example, Dr. Mark Geier has reported that children exposed to vaccines containing the preservative thimerosal are significantly more likely to develop symptoms of autism. Dr. Thomas Verstraeten, on the other hand, has reported that the data show no statistically significant link between thimerosal-containing vaccines and neurological symptoms. Most scientists agree, the study shows no statistical link between thimerosal and autism, even though an early draft of the study findings - obtained by the advocacy group Safeminds via FOIA - do suggest a relationship between exposure to thimerosal and developmental delays.[1] Mark Geier, M.D., is a vaccine researcher and vocal advocate for vaccine safety, based in Silver Spring, Maryland. ... The structure of Thimerosal Thimerosal (sometimes spelled as thimerosol and thiomersal[1]) is an organometallic compound used commonly since the 1930s as a disinfectant (trade name: Merthiolate) and as a preservative in some vaccines, cosmetics, tattoo inks, eye drops, and contact lens solutions, as a result of the deaths of... Jump to: navigation, search Autism is classified as a neurodevelopmental disorder that manifests itself in markedly abnormal social interaction, communication ability, patterns of interests, and patterns of behavior. ... Thomas Verstraeten, MD, MSc, is a vaccine researcher for GlaxoSmithKline Biologicals. ... The Freedom of Information Act (FOIA) is the implementation of freedom of information legislation in the United States. ...

This type of controversy has prompted VAERS to instruct researchers [2]:

"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."

Based on VAERS data, Geier has also challenged the FDA reported numbers for vaccine complications, citing his own analysis of the CDC database. He asserts that following reports of roughly one billion vaccine doses administered, there were 244,424 'possible reactions', 99,145 emergency room visits, 5,149 life-threatening reactions, 27,925 hospitalizations, 5,775 disabilities, and 5,309 deaths.[3]

See also

• Adverse effect (medicine)
• Controversies in autism
• Iatrogenesis

Adverse effect, in medicine, is an abnormal, harmful, undesired and/or unintended side-effect, although not necessarily unexpected, which is obtained as the result of a therapy or other medical intervention, such as drug/chemotherapy, physical therapy, surgery, medical procedure, use of a medical device, etc. ... There is considerable disagreement over the exact nature of autism, a spectrum or cluster of conditions, of varying severity, which are not well understood. ... An iatrogenic (pronounced , IPA) condition is a state of ill health or adverse effect caused by medical treatment, usually due to mistakes made in treatment. ...

External links

• VAERS.org - Vaccine Adverse Event Reporting System {official website)
• medalerts.org - Online search engine for VAERS data
• AAP.org - 'Study Fails to Show a Connection Between Thimerosal and Autism' (May 16, 2003)
• CQS.com - 'Autism: a Novel Form of Mercury Poisoning', S. Bernard, B.A., A. Enayati, M.S.M.E., L. Redwood, M.S.N., H. Roger, B.A., T. Binstock (April, 2001)
• DrugIntel.com - 'Drugs of Concern: Vaccines' (January 21, 2004)
• FDA.gov - 'Vaccine Adverse Event Report System (VAERS)'
• VaccineTruth.org - 'Neurodevelopmental disorders following thimerosal-containing childhood immunizations: a follow-up analysis' (abstract), Int. Journal of Toxicology, David Geier & Mark Geier, Vol 23, No 6. pp 369-76, Nov-Dec, 2004
• Whale.to - 'Geier, MR and Geier, DA'
• Whale.to - 'VAERS (Vaccine Adverse Event Reporting System)'