The Vaccine Adverse Event Reporting System ( VAERS ) is the United States program for vaccine safety, administered jointly by the US Centers for Disease Control and Prevention (CDC) and Food and Drug Administration FDA). VAERS is a post-marketing surveillance program, collecting information on side effects (possible side effects) that occur after vaccine administration.
VAERS, Vaccine Safety Datalink and Clinical Immunization Safety Assessment (CISA) Network are tools used by the CDC and FDA to measure the safety of vaccines to fulfill their duties as regulatory bodies tasked with protecting the public. Some scientists want to do more scientific work in this regard, noting that the VAERS has some limitations, including unverified reports, unreported, inconsistent data quality, and the absence of unvaccinated control groups.
Video Vaccine Adverse Event Reporting System
Origins
This program is the result of the 1986 National Children's Vaccination Injection Act (NCVIA), which requires healthcare providers to report:
- Any event listed by the vaccine manufacturer as contraindicated for the next dose of vaccine.
- Any event listed in the Announcable Events Table that occurs within a certain time period after vaccination. Data is stored electronically by CDC in Vaccine Safety Datalink (VSD).
VAERS was established in 1990, and jointly managed by the FDA and CDC. It is intended to act as a kind of "early warning system" - a way for physicians and researchers to identify possible unexpected reactions or side effects of vaccination for further research.
Maps Vaccine Adverse Event Reporting System
Operation
Each year the VAERS receives 10,000-20,000 reports of side effects after immunization by more than 10 million vaccines. Higher priority data use includes reports of death and other serious adverse events, recognizing and detecting adverse events, and finding unexpected adverse events involving new vaccines. VAERS data are also used to monitor known reactions to vaccines and for the monitoring of many vaccines. Data mining techniques such as Bayes empirical methods can be used to improve the quality of data analysis.
Limitations
Like other spontaneous reporting systems, the VAERS has several limitations, including unreported, unverified reports, inconsistent data quality, absence of unvaccinated group controls, and inadequate data on the number of people vaccinated. Indeed, an autism activist named Jim Laidler once reported to VAERS that the vaccine has turned it into The Incredible Hulk. The report was received and entered into the database, but the dubious nature prompted the VAERS representative to contact Mr. Laidler, who later gave his consent to remove the report.
Used in research and litigation
Many medical researchers use VAERS to study the effects of vaccination. VAERS warned researchers to use its database that data should not be used separately to draw conclusions about cause and effect. However, data from the VAERS have been used in vaccine litigation to support claims that vaccines cause autism.
Litigation associated with vaccines and autism has led to an increase in VAERS statements filed by plaintiffs' lawyers. A 2006 article in Pediatrics found that most VAERS reports linked to thimerosal, and many related to autism, were filed in relation to litigation, leading the authors to warn that inappropriate dependence on VAERS data may be source bias. The lead author of the study stated: "The lawyers manipulate this system to show an increase [in vaccine-related adverse events] based on litigation, not health research." Paul Offit, head of communicable diseases at Children's Hospital of Philadelphia, writes:
Public health officials are disappointed to learn that the VAIS autism report does not come from parents, doctors, nurses, or nursing practitioners; they come from private-injury lawyers... For lawyers, the VAERS report is not self-fulfilling prophecy; they are self-generated prophecies.
References
External links
- vaers.hhs.gov - Vaccine Adverse Event Reporting System (official website). It also contains instructions for downloading VAERS data.
- Vaccine Adverse Event Report System (VAERS) Overview, FDA
- the VAERS request to search the database
- Galindo, Belkys M., et al. "Vaccine-Related Events in Cuban Children", 1999-2008. MEDICC review . 2012; 14 (1): 38-43.
Source of the article : Wikipedia
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