The Vaccine Adverse Event Reporting System (VAERS) is a United States program for
vaccine
A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifie ...
safety, co-managed by the U.S.
Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention (CDC) is the national public health agency of the United States. It is a United States federal agency, under the Department of Health and Human Services, and is headquartered in Atlanta, Georgi ...
(CDC) and the
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA). VAERS is a
postmarketing surveillance Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmac ...
program, collecting information about
adverse events (possible harmful
side effects) that occur after administration of vaccines to ascertain whether the
risk–benefit ratio is high enough to justify continued use of any particular vaccine.
VAERS, the
Vaccine Safety Datalink, and the Clinical Immunization Safety Assessment (CISA) Network are tools by which the CDC and FDA
monitor
Monitor or monitor may refer to:
Places
* Monitor, Alberta
* Monitor, Indiana, town in the United States
* Monitor, Kentucky
* Monitor, Oregon, unincorporated community in the United States
* Monitor, Washington
* Monitor, Logan County, West Vir ...
vaccine safety
to fulfill their duty as
regulatory agencies charged with protecting the public.
As it is based on submissions by the public, VAERS is susceptible to unverified reports, misattribution,
underreporting Under-reporting usually refers to some issue, incident, statistic, etc., that individuals, responsible agencies, or news media have not reported, or have reported as less than the actual level or amount. Under-reporting of crimes, for example, makes ...
, and inconsistent
data quality
Data quality refers to the state of qualitative or quantitative pieces of information. There are many definitions of data quality, but data is generally considered high quality if it is "fit for tsintended uses in operations, decision making and ...
.
Raw, unverified data from VAERS has often been used by the
anti-vaccine community to justify misinformation regarding the safety of vaccines; it is generally not possible to find out from VAERS data if a vaccine caused an adverse event, or how common the event might be.
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).
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
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. Data mining techniques such as empirical Bayes
Empirical Bayes methods are procedures for statistical inference in which the prior probability distribution is estimated from the data. This approach stands in contrast to standard Bayesian methods, for which the prior distribution is fixed be ...
methods can be used to improve the quality of data analysis. The system was used in 1999 to identify a rotavirus vaccine that had an increased risk of a bowel obstruction condition, and confirmatory research led to the vaccine's use being suspended.
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, raw 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 ( also spelled ''paediatrics'' or ''pædiatrics'') is the branch of medicine that involves the medical care of infants, children, adolescents, and young adults. In the United Kingdom, paediatrics covers many of their youth until th ...
'' found that most VAERS reports related to thimerosal, and many related to autism
The autism spectrum, often referred to as just autism or in the context of a professional diagnosis autism spectrum disorder (ASD) or autism spectrum condition (ASC), is a neurodevelopmental condition (or conditions) characterized by difficulti ...
, 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 n vaccine-related adverse eventsthat are based on litigation, not health research." Paul Offit, chief of infectious disease at Children's Hospital of Philadelphia, 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.
Limitations and abuse
Like other spontaneous reporting systems, VAERS has several limitations, including underreporting, unverified reports, inconsistent data quality, and inadequate data about the number of people vaccinated.[Rizk JG, Barr CE, Rizk Y, Lewin JC. The next frontier in vaccine safety and VAERS: Lessons from COVID-19 and ten recommendations for action. Vaccine. 2021;39(41):6017-6018. doi:10.1016/j.vaccine.2021.08.006] Due to the program's open and accessible design and its allowance of unverified reports, incomplete VAERS data is often used in false claims regarding vaccine safety. The Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention (CDC) is the national public health agency of the United States. It is a United States federal agency, under the Department of Health and Human Services, and is headquartered in Atlanta, Georgi ...
(CDC) has warned that raw data from VAERS is not enough to determine whether a vaccine can cause a particular adverse event.
For instance, Jim Laidler
James R. Laidler is an American anesthesiologist in Portland, Oregon, who is known both for his activism for, and later his opposition to, alternative autism therapies.
Education
Laidler obtained his bachelor's degree from Pacific Lutheran Univer ...
once reported to VAERS that a vaccine had turned him into The Incredible Hulk. The report was accepted and entered into the database, but the dubious nature of the report prompted a VAERS representative to contact Mr. Laidler, who then gave his consent to delete it from the database.
During the COVID-19 pandemic
The COVID-19 pandemic, also known as the coronavirus pandemic, is an ongoing global pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The novel virus was first identif ...
, raw VAERS data has often been disseminated by anti-vaccine groups in order to justify inaccurate safety claims related to COVID-19 vaccine
A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 ( COVID19).
Prior to the COVID19 pandemic, an e ...
s, including adverse reactions and alleged fatalities claimed to have been caused by vaccines. Websites such as Medalerts (published by the anti-vaccine group National Vaccine Information Center
The National Vaccine Information Center (NVIC), founded under the name Dissatisfied Parents Together (DPT) in 1982, is an American 501(c)(3) organization that has been widely criticized as a leading source of fearmongering and misinformation a ...
) and OpenVAERS (which published a tally of vaccine adverse events and fatalities allegedly linked to COVID-19 vaccines based on VAERS data), have been linked to this misinformation. Comparative studies of VAERS, which look at relative reporting rates, have found that the data does not support these claims.
See also
*FDA Adverse Event Reporting System
The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biol ...
(FAERS)
*Yellow Card Scheme
The Yellow Card Scheme is the United Kingdom's system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored.
History ...
(UK reporting system)
References
External links
vaers.hhs.gov
– Vaccine Adverse Event Reporting System (official website). This also contains instructions for downloading the VAERS data.
FDA
for searching the database
*Galindo, Belkys M., et a
"Vaccine-Related Adverse Events in Cuban Children"
1999–2008. ''MEDICC Review''. 2012;14(1):38–43.
{{Vaccines
Food and Drug Administration
Centers for Disease Control and Prevention
Public safety
Drug safety
Vaccination in the United States