Usually, children with the condition “were the 5- to 9-month olds, not a 2-month-old. “What was odd about that was that they were generally young for intussusception,” he said. “There were like 15 case reports of children who had intestinal blockage called intussusception within two weeks of getting the vaccine,” Offit told PolitiFact. In the late 1990s, RotaShield was given to young children to prevent infection from the rotavirus, which causes vomiting and diarrhea in infants and young children. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, cites the case of a vaccine called RotaShield as an example of the Vaccine Adverse Event Reporting System working at its best. Shimabukuro said one of the strengths is that it allows the CDC and the FDA to quickly detect safety issues or rare reactions that warrant further study.ĭr. The system accepts all of these reports, regardless of the plausibility of the vaccine causing the event or the clinical seriousness of the event. “We depend on people to send reports of their experience after a vaccination to the VAERS system.” Tom Shimabukuro, deputy director of the CDC Immunization Safety Office. It’s also known as a passive surveillance system,” said Dr. “It’s called a spontaneous reporting system. licensed vaccines,” according to the CDC. How is VAERS supposed to work?Įstablished in 1990, the Vaccine Adverse Event Reporting System works as a “national early warning system to detect possible safety problems in U.S. That’s where the Vaccine Adverse Event Reporting System comes in. Manufacturers must compensate those who claim to be injured by vaccines on a “no fault” basis, and must report certain adverse events to the government. It also required health care providers to disclose known risks to the person being vaccinated or their parents. The law established the National Vaccine Program Office to coordinate immunization-related activities among federal agencies. In 1986, Congress passed the National Childhood Vaccine Injury Act to “create a simple, transparent process for dealing with injury claims,” Mnookin wrote. A vaccine shortage resulted and public health officials became concerned about the return of epidemic disease.” “As a result of these decisions, liability and prices soared, and several vaccine manufacturers halted production. “Damages were awarded despite the lack of scientific evidence to support vaccine injury claims,” the CDC says. The CDC says the uncertainty was a disaster for their effort to eradicate diseases. “The lack of comprehensive regulations meant that all the parties involved, from patients and pediatricians to drug manufacturers and the federal government, were unsure of their rights and obligations under existing immunization mandates,” Mnookin wrote. The difficult issue in these cases was trying to prove, or disprove, whether the vaccine caused the harm.Īt the same time, there was no nationwide policy governing drug manufacturers’ ultimate liability, Seth Mnookin wrote in his book The Panic Virus: A True Story of Medicine, Science and Fear, a history of modern vaccine use. The creation of the Vaccine Adverse Event Reporting System was well-intentioned, born out of concerns about the potential health risks posed by vaccines and the potential legal liability surrounding them.įrom the late 1950s into the ’70s, pharmaceutical companies routinely faced lawsuits from families whose children had experienced adverse health events after being vaccinated. So, I now know the difference, but yes, I did believe in the VAERS.” Why does VAERS exist? “Somebody said that their hair dye was messed up from a vaccine. Simpson said she began sharing claims on social media and became an anti-vaccine influencer, sometimes pulling reported quotes directly from the Vaccine Adverse Event Reporting System to use as a source for her posts.

Vaers database