The Vaccine Adverse Event Reporting System ( VAERS ) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a postmarketing surveillance 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.
27-677: VAERS, the Vaccine Safety Datalink , and the Clinical Immunization Safety Assessment (CISA) Network are tools by which the CDC and FDA monitor 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 , and inconsistent data quality . Raw, unverified data from VAERS has often been used by
54-562: A book, DPT: A Shot in the Dark , which asserted an association between the whole cell pertussis (whooping cough) vaccine in the DPT shot and autism . The Centers for Disease Control and Prevention now recommend the newer acellular pertussis vaccines (DTaP and Tdap), and whole cell pertussis vaccines are no longer used in the US. because of adverse effects unrelated to autism. In the early 1980s,
81-549: A small growth of their social media base, while other anti-vaccination groups such as Children's Health Defense saw their impact increase considerably on systems such as Instagram during the COVID-19 pandemic. In April 2020, the organization was identified as one of the greatest disseminators of COVID-19 misinformation on Facebook. Although the NVIC claims to be supported primarily by small donations, 40% of its funding came from
108-404: Is often used in false claims regarding vaccine safety. The Centers for Disease Control and Prevention (CDC) has warned that raw data from VAERS is not enough to determine whether a vaccine can cause a particular adverse event. For instance, noted anesthesiologist Jim Laidler once reported to VAERS that a vaccine had turned him into The Incredible Hulk . The report was accepted and entered into
135-459: Is willfully cautious, containing extensive and important warnings such as "Reports of death to VAERS following vaccination do not necessarily mean the vaccine caused the death" and others. The website states : HHS's VAERS data replicated by Medalerts is known to be frequently misrepresented by anti-vaccines sources. The journalist Michael Specter described the NVIC as: The NVIC falsely asserts that there has been inadequate research into
162-673: The American Academy of Pediatrics stated, "By providing advertising space to an organization like the NVIC... you are putting thousands of lives of children at risk." A controversial ad produced by NVIC regarding preventive measures for influenza was aired on some Delta Air Lines flights, prompting the president of the American Academy of Pediatrics to write a letter to the CEO of Delta on November 4, 2011, urging Delta to "remove these harmful messages." An online petition
189-645: The COVID-19 vaccines . The organization was co-founded in 1982 by Jeff Schwartz, Barbara Loe Fisher, and Kathi Williams under the name Dissatisfied Parents Together (DPT). Each of them had observed the health of one of their children deteriorate at some point after receiving a dose of the DPT vaccine and had watched a television broadcast of the film DPT: Vaccine Roulette , which drew an erroneous causal link between DPT vaccines and illnesses of some children who received them. In 1985, Fisher and Harris Coulter co-authored
216-505: The Paycheck Protection Program , even though it had opposed federal vaccination campaigns and spread misinformation about vaccines. Because of the latter behavior, in early 2021 Facebook disallowed the group from purchasing advertising on its networks. On October 16–18, NVIC hosted the 2020 International Public Conference on Vaccination, which aimed to coordinate messaging between the main anti-vaccination groups in
243-415: 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. The program is an outgrowth of the 1986 National Childhood Vaccine Injury Act (NCVIA), which requires health care providers to report: VAERS was established in 1990 and is managed jointly by
270-525: The "litany of effects is interesting, given that to the best of my knowledge (and I've looked) none of them has actually been linked to vaccines in real medical studies." The NVIC received criticism in April 2011 for ads that it placed on a jumbotron in Times Square . The ads criticized childhood immunization and promoted an alternative medicine website. In a letter to CBS , which owned the jumbotron,
297-487: The "oldest and largest consumer-led organization advocating for the institution of vaccine safety and informed consent protections", it promotes false and misleading information including the discredited claim that vaccines cause autism, and its campaigns portray vaccination as risky, encouraging people to consider "alternatives." In April 2020, the organization was identified as one of the greatest disseminators of COVID-19 misinformation on Facebook. Despite its name,
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#1732783265901324-636: 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. 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 methods can be used to improve
351-704: The National Vaccine Information Center bears no relation to the National Vaccine Advisory Committee, an advisory body of the United States Department of Health and Human Services . Since 2003, the NVIC has maintained a website named Medalerts.org, which republishes the CDC's Vaccine Adverse Event Reporting System data without its appropriate methodological transparency and warnings. This has led to misleading attributions of deaths to
378-487: The National Vaccine Information Center in the early 1990s. Like other anti-vaccination groups, NVIC has been investing heavily into its social media presence in the 2010s. In addition to developing their own social media channels, the organization pushes anti-vaccination messages to online gatherings of young parents, anti- GMO activists and wellness enthusiasts. However, due the group's decision to stick to Facebook as their main social media channel, they experienced only
405-654: The United States, including about 500,000 children from birth through age six years (2% of the U.S. population in this age group). The VSD data-sharing program is now being administered by the National Center for Health Statistics Research Data Center. The data sharing guidelines have been revised to include comments from interested groups as well as recommendations from the Institute of Medicine (IOM). The Vaccine Adverse Event Reporting System (VAERS),
432-535: The VSD, and the Clinical Immunization Safety Assessment (CISA) Network are tools by which the CDC and FDA measure vaccine safety to fulfill their duty as regulatory agencies charged with protecting the public. Data from the VSD Project have been used to address a number of vaccine safety concerns; examples include a study clarifying the risk of anaphylaxis after vaccine administration and several studies examining
459-402: The anti-vaccination activist and distributor of vitamin supplements Joseph Mercola , who provided $ 2.9 million between 2009 and 2018. The funds were provided through Mercola's Natural Health Research Foundation. Barry Segal's Focus for Health foundation is also contributing to NVIC, with $ 400,000 between 2011 and 2017. In 2020 the NVIC took and received a federal loan of US$ 136,070 through
486-455: The anti-vaccine group National Vaccine Information Center ) 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. Vaccine Safety Datalink The Vaccine Safety Datalink Project ( VSD )
513-996: 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 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: 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
540-675: The context of the COVID-19 pandemic . The attendees included Robert F. Kennedy Jr. 's Children's Health Defense and Del Bigtree speaking for the Informed Consent Action Network , as well as Joseph Mercola , Andrew Wakefield and Sherri Tenpenny . NVIC's Medalerts republication of Vaccine Adverse Event Reporting System data, done without CDC's detailed warning of the data limitations, had led to incorrect interpretations and misleading reports attributing deaths to COVID-19 vaccines. The original United States Department of Health and Human Services VAERS website
567-474: The database, but the dubious nature of the report prompted a VAERS representative to contact Laidler, who then gave his consent to delete it from the database. During the COVID-19 pandemic , raw VAERS data has often been disseminated by anti-vaccine groups in order to justify inaccurate safety claims related to COVID-19 vaccines , including adverse reactions and alleged fatalities claimed to have been caused by vaccines. Websites such as Medalerts (published by
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#1732783265901594-422: The lawyers, VAERS reports hadn't been a self-fulfilling prophecy; they'd been a self-generated prophecy. 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. Due to the program's open and accessible design and its allowance of unverified reports, incomplete VAERS data
621-493: The link between the rise in the number of children diagnosed with autism and mass vaccination programs. There have been a number of peer-reviewed studies and meta-analyses that have shown no correlation between vaccine administration and autism diagnosis, and there is no biological plausibility for vaccines to cause autism, as autism is not an immune-mediated disease. The skeptic and science blogger Phil Plait notes that while "On their site they take "vaccine injuries" as given,"
648-543: The organization joined with the American Academy of Pediatrics to draft the original legislation for the National Childhood Vaccine Injury Act of 1986, which created a federal vaccine injury compensation program, mandated doctors to give parents vaccine benefit and risk information, and required the recording and reporting of vaccine injuries and deaths (see Vaccine Adverse Event Reporting System ). The organization changed its name to
675-517: 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. 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
702-496: The rejected hypothesis of a link between thimerosal-containing vaccines and autism . The following organizations are members of the project: 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 about vaccines. While NVIC describes itself as
729-527: Was established in 1990 by the United States Centers for Disease Control and Prevention (CDC) to study the adverse effects of vaccines . Four large health maintenance organizations , including Kaiser Permanente , were initially recruited to provide the CDC with medical data on vaccination histories, health outcomes, and subject characteristics. The VSD database contains data compiled from surveillance on more than seven million people in
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