![]() ![]() Well, a lot of things have happened to 80% of people in the last two years that are unrelated to the vaccine.” “Eighty percent of people in this country have gotten at least one dose. “The COVID vaccine especially is where VAERS has gotten so misused,” Talaat says. By following up with other monitoring systems, researchers can determine if, for example, the population of people who report getting arthritis after a vaccine is the same as a control group getting arthritis in the same period, which would rule out the vaccine as the cause. VAERS doesn’t reveal how many people report the same reaction, nor how many in an unvaccinated population report the same thing. That's because medical data for women over 65 or diabetics would include reports from both vaccinated and unvaccinated patients. Importantly, in addition to being verified, this data includes controls, Talaat says. When researchers notice a pattern, such as an uptick in side effects after a particular vaccination or among a particular group of patients, such as women over 65 or people with diabetes, they can follow up by investigating with other safety monitoring systems, such as the Vaccine Safety Datalink, which can connect adverse events to medical records and reports from health care facilities and practitioners. This screening allowed doctors to advise vaccination sites to continue following CDC guidance for administering vaccines as they had been. Ultimately, 10 of those cases turned out to be anaphylaxis, a severe allergic reaction, with nine of the affected people having a history of allergic reactions or allergies-including five of those nine with a history of anaphylaxis specifically. ![]() The CDC and FDA flagged 108 of those cases for further review. Talaat says the best source of research stemming from VAERS is the CDC, because they are able to trace the records backward and verify them.įor example, by January 10, 2021, VAERS logged 1,266 reports of adverse events following the Moderna vaccine. They think it’s things that are vetted and have causal relationships with the vaccine.” ![]() Since it’s so transparent, people don’t really understand what it’s for. “It’s very open and public and searchable. That means events that happen even years later and have no obvious connection to a vaccine, such as feelings of anger, end up reported in the system, says Talaat. Moreover, the CDC and FDA do not restrict what people can report, as long as it happened at some point following a vaccination. It simply contains whatever people have voluntarily reported. VAERS is a publicly available, searchable database of reports that have not been verified. Moreover, additional studies show the risk of myocarditis to be 16 times greater among those infected with COVID-19 than the uninfected, suggesting that full vaccination is helpful in preventing myocarditis and other complications of the disease. After extensive review, scientists determined that the benefits of the vaccine ultimately outweigh the increased risk of myocarditis observed in some of the vaccinated (primarily males ages 12–29). VAERS data also first surfaced reports of myocarditis following the second dose of COVID-19 mRNA vaccine. ![]() That change greatly reduced the rare instances of severe side effects after polio vaccinations. “Some of those signals end up panning out as true safety issues, and some don’t.”įor example, VAERS data helped doctors adjust the childhood polio vaccine schedule in 1997 in response to the 8–10 cases of vaccine-induced paralysis they learned had been occurring annually, according to the CDC’s published reports. VAERS is great at identifying signals of potential concern, says Kawsar Talaat, MD, an associate professor in International Health and co-director of clinical research for the Institute for Vaccine Safety. Often, these problems are so rare that they don’t appear until after clinical trials when a much larger population receives vaccinations. VAERS serves as an early warning system for unforeseen problems with approved vaccinations that might be worth investigating scientifically. Anti-vaccination fringe groups have attempted to spin false stories using VAERS data, adding to misinformation about the safety of COVID-19 vaccinations. Since the emergence of COVID-19 vaccines, however, the database has garnered more dubious notoriety. While VAERS cannot determine whether an adverse event was caused by a vaccination, patterns in reporting may suggest a need for further evaluation to assess potential safety concerns. These could include allergic reactions, intestinal conditions, blood clots, or other problems that may or may not be related to a vaccine. The CDC and FDA jointly established the Vaccine Adverse Events Reporting System, or VAERS, in 1990 as a way for people to report post-vaccination health issues. ![]()
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