Vaccine Adverse Event Reporting System
Encyclopedia
The Vaccine Adverse Event Reporting System is a United States
program for vaccine safety, co-managed 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. VAERS has several limitations, including unverified reports, underreporting, inconsistent data quality, and absence of an unvaccinated control group.
(NCVIA), which requires health care providers to report:
VAERS was established in 1990, and is managed jointly by the FDA and the CDC. It 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.
techniques such as empirical Bayes methods can be used to improve the quality of data analysis, even with these techniques the VAERS data do not establish whether a vaccine caused an adverse event.
Litigation related to vaccines and autism has led to an increase in VAERS reports filed by plaintiff's attorneys. A 2006 article in Pediatrics
found that most VAERS reports related to thimerosal, and many related to autism
, were filed in connection with litigation, leading the authors to caution that inappropriate reliance on VAERS data may be a source of bias. The study's lead author stated: "Lawyers are manipulating this system to show increases [in vaccine-related adverse events] that are based on litigation, not health research." Paul Offit
, chief of infectious disease at Children's Hospital of Philadelphia
, wrote:
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
program for vaccine safety, co-managed by the Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention are a United States federal agency under the Department of Health and Human Services headquartered in Druid Hills, unincorporated DeKalb County, Georgia, in Greater Atlanta...
(CDC) and the Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA). VAERS is a post-marketing safety surveillance program, collecting information about adverse events (possible side effects) that occur after administration of vaccines. VAERS has several limitations, including unverified reports, underreporting, inconsistent data quality, and absence of an unvaccinated control group.
Origins
The program is an outgrowth of the 1986 National Childhood Vaccine Injury ActNational Childhood Vaccine Injury Act
The National Childhood Vaccine Injury Act of 1986 was enacted in the United States to reduce the potential financial liability of vaccine makers due to vaccine injury claims. The legislation was aimed at ensuring a stable market supply, and to provide cost-effective arbitration for vaccine...
(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 DatalinkVaccine Safety DatalinkThe Vaccine Safety Datalink Project was established in 1990 by the United States Centers for Disease Control and Prevention to study the adverse side effects of vaccines....
(VSD).
VAERS was established in 1990, and is managed jointly by the FDA and the CDC. It 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.
Operation
Each year the VAERS receives 10,000–20,000 reports of adverse events following immunization. Higher-priority uses of the data include reports of death and other serious adverse events, recognizing and detecting adverse effects, and finding unexpected adverse events involving new vaccines. The VAERS data are also used to monitor known reactions to vaccines and for vaccine lot surveillance. Like other spontaneous reporting systems, VAERS has several limitations, including underreporting, unverified reports, inconsistent data quality, absence of a control group that is not vaccinated, and inadequate data about the number of people vaccinated. Although data miningData mining
Data mining , a relatively young and interdisciplinary field of computer science is the process of discovering new patterns from large data sets involving methods at the intersection of artificial intelligence, machine learning, statistics and database systems...
techniques such as empirical Bayes methods can be used to improve the quality of data analysis, even with these techniques the VAERS data do not establish whether a vaccine caused an adverse event.
Use in research and litigation
Many medical researchers make use of VAERS to study the effects of vaccination. VAERS warns researchers using its database that the data should not be used in isolation to draw conclusions about cause and effect. Nonetheless, data from VAERS has been used in vaccine litigation to support the claim that vaccines cause autism.Litigation related to vaccines and autism has led to an increase in VAERS reports filed by plaintiff's attorneys. A 2006 article in Pediatrics
Pediatrics (journal)
Pediatrics is an official peer-reviewed journal of the American Academy of Pediatrics. In the inaugural January 1948 issue, the journal's first editor, Hugh McCulloch, articulated the journal's vision: "The content of the journal is... intended to encompass the needs of the whole child in his...
found that most VAERS reports related to thimerosal, and many related to autism
Autism
Autism is a disorder of neural development characterized by impaired social interaction and communication, and by restricted and repetitive behavior. These signs all begin before a child is three years old. Autism affects information processing in the brain by altering how nerve cells and their...
, were filed in connection with litigation, leading the authors to caution that inappropriate reliance on VAERS data may be a source of bias. The study's lead author stated: "Lawyers are manipulating this system to show increases [in vaccine-related adverse events] that are based on litigation, not health research." Paul Offit
Paul Offit
Paul A. Offit, M.D., is an American pediatrician specializing in infectious diseases and an expert on vaccines, immunology, and virology. He is the co-inventor of a rotavirus vaccine that has been credited with saving hundreds of lives every day. Offit is the Maurice R...
, chief of infectious disease at Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
The Children's Hospital of Philadelphia is one of the largest and oldest children's hospitals in the world. CHOP has been ranked as the best children's hospital in the United States by U.S. News & World Report and Parents Magazine in recent years. As of 2008, it was ranked #1 in the nation for...
, wrote:
Public health officials were disappointed to learn that reports of autism to VAERS weren't coming from parents, doctors, nurses, or nurse practitioners; they were coming from personal-injury lawyers... For the lawyers, VAERS reports hadn't been a self-fulfilling prophecy; they'd been a self-generated prophecy.
External links
- vaers.hhs.gov - Vaccine Adverse Event Reporting System (official website). This also contains instructions for downloading the VAERS data.
- Vaccine Adverse Event Report System (VAERS) Overview, FDA
- VAERS request for searching the database