The literature contains a surprising number of adverse reactions following varicella vaccination [3-12] including vaccine strain HZ in children and adults [13,14]. Unfortunately, it is that very open nature of the system that has allowed it to be used and abused by antivaxxers to promote their false claims that vaccines cause so many adverse events and medical conditions. Wrensch et al. Data is also available through the CDC wonder interface by clicking on the CDC wonder link at the top of the page. between Harvard and Constella. A cursory search of social media shows those who are spreading the VAERS data have paid little heed to the agencys disclaimers. The Vaccine Adverse Events Reporting System (VAERS) is sponsored by the Centers for Disease Control and by the Food and Drug Administration. These coincidences make it difficult to know whether a particular adverse event resulted from a medical condition or from a vaccination. Have you heard the claim that only 1% of serious vaccine reactions are reported to VAERS? On the other hand, more serious and unexpected medical events are probably more likely to be reported than minor VAERS is a passive reporting system, meaning that reports about adverse events are not automatically collected, but require a report to be filed to VAERS. in young children. Bardenheier BH, Duderstadt SK, Engler RJ, McNeil MM. In fact, the original article is by Peter Doshi and represents him falling for an antivaccine conspiracy theory that somehow VAERS was being made inaccessible to suppress reports. Exploring issues and controversies in the relationship between science and medicine. The research, which assessed the safety of the Pfizer/BioNTech BNT162b2 mRNA vaccine, is based on analysis of data from nearly 2 million individuals in Israel and represents one of the largest real-world assessments of COVID-19 vaccine safety to date. Peter Collignon and his colleagues do not exaggerate the problem of The rash slowly subsided but left scars. Reports vary in quality and completeness. Does anyone think that deaths after COVID-19 vaccination are going to be underreported by a factor of 100? In a July 13 letter to health agency leaders, Johnson noted a press conference he . While the CDC and FDA disclaimers go to great lengths to point out that reports within VAERS are not verified causal claims, in a world where users absorb headline information and where small-scale disinformation campaigns have been shown to have calamitous consequences, one must question whether publishing VAERS vaccine data in its current form achieves more harm than good. Unsurprisingly, RFK Jr. and CHD are full ofwell, a brown stinky substance. Its basically against public health and any collective action to protect public health. So lets get back to RFK Jr. and his deceptive article by the Childrens Health Defense Team. The report of an adverse event to VAERS is not documentation that a vaccine Patients, parents and caregivers are encouraged to report "any clinically important medical event or health problem that. As I will show, antivaxxers are playing an old game with new vaccines. NASERI A, GOOD WV, CUNNINGHAM ET JR: Herpes zoster virus sclerokeratitis and anterior uveitis in a child following varicella vaccination. In the time since the CDC was approached for comment by the HPR, the shareable buttons have been removed from the site. 2020 Jul 22;38(34):5464-5473. doi: 10.1016/j.vaccine.2020.06.038. References Overview of the ESP:VAERS project . Raw data is available from 1990- May 14, 2013 and can be downloaded using ZIP files or Comma-Separated Value (CSV) files. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE . Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Of course, that disclaimer is included, so that RFK Jr. and his merry band of antivax ideologues can claim to have been literally honest while following up their recounting of VAERS numbers with all sorts of statements implying that vaccines were causative for the adverse events listed before. Reports are accepted from anyone and can be submitted electronically at www.vaers.hhs.gov. J. Infect. ) Vaccine Adverse Event Reporting System (VAERS), was to construct the below flow of data in order to support the first two Aims: Figure 1. The only old antivaccine lie or distortion that I havent seen used against COVID-19 vaccines yet is the claim that they cause autism or sudden infant death syndrome. Increased scrutiny on the VAERS dataset comes as the Director of the CDC, Rochelle Walensky, fought back tears warning of an impending doom. The United States rolling 7-day average for new infections has increased 15% over the span of just two weeks and hospitalizations caused by the virus have jumped by 5% in that same period. Varicella vaccination is generally considered safe [1] but there are usually no prescreening tests to determine whether an adverse reaction is likely to occur [2]. The patient's nausea decreased and her fever subsided. It is a reference to substantiate claims that the CDC has no interest in making reports of vaccine injury either more accurate or more comprehensive. VAERS reports associated with Varicella, DTaP, Hep B, Hib, and MMR vaccines through December, 2003. Sen. Ron Johnson, R-Wis. , has stirred controversy in recent days over his concerns about COVID-19 vaccine safety. First, the denominator, which CHD provides without using it appropriately: According to the Washington Post, as of Jan. 29, 22 million people in the U.S. had received one or both doses of a COVID vaccine. Am. Lastly, VAERS Vaccine gives information about the origin and type of vaccine. What has been reported to VAERS is less than the expected baseline death rate in the US for any given day pre-pandemic (the death figures used were for the year 2019). VAERS reports vary in quality and completeness and under-reporting, especially of mild and self-limiting AEs, appears common. Consider this part 2 of my post from two weeks ago, the VAERS edition. (2003) 135(3):415-417. HHS states on the VAERS website that one of the system's main limitations is underreporting, noting that "VAERS receives reports for only a small fraction of actual adverse events." Further, VAERS . Then, with respect to antivaccine disinformation, truly everything old will be new again. VAERS accepts all reports of suspected adverse events, in all age groups. The government is making a sincere effort to make sure their web sites are more secure, but sometimes they mess upSSL certificates facilitate encryption of traffic between the user and web site. Universal Varicella Vaccination program assumptions that (1) a single dose offered long-term immunity, and (2) there is no immunologically-mediated link between varicella incidence and herpes-zoster incidence are seriously flawed. NARUSE H, MIWATA H, OZAKI T, ASANO Y, NAMAZUE J, YAMANISHI K: Varicella infection complicated with meningitis after immunization. Vaccine Adverse Event Reporting System (VAERS). adverse Baton Rouge Louisiana RN Whistleblower on Underreporting of Serious Adverse Effects of Covid Vaccines; Letter to US Senator Johnson: . Claims made by the VAERS database now form the foundation of a global online misinformation campaign which to-date has garnered little attention. An official website of the United States government. He had moderate pain and the lesions were tender and sensitive to clothing. The term underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. Vaccine. The newly installed CDC Director urged Americans to not let down their guard, saying she is scared a fourth wave of the coronavirus may batter the country before vaccinations can reach a critical mass. "Underreporting" is one of the main limitations of passive surveillance systems, including VAERS. The CDC told Reuters. It was the waiting that drew the attention of the Stockholm County Council. cases were reported to VAERS. That isn't the case with the COVID-19 vaccines, which the FDA approved . Risk increases with each dose of vaccine as well. Case "C" An adult female, age 47, became disabled following varicella vaccination. endstream endobj startxref The CDC describes VAERS as a passive reporting system. Pre-dating the internet, the VAERS database has virtually no guards against its potential role as a source of fake news and is credulous of even the most fanciful claims of COVID-19 vaccine side-effects. Patients, parents and caregivers are encouraged to report "any clinically important medical event or health problem that. As an amusing aside, whenever I discuss VAERS, I like to recount the tale of how in 2006 Jim Laidler infamously reported to VAERS that the flu vaccine had turned him into The Incredible Hulk and VAERS accepted the report. Synthetic and real test data was been generated and transmitted between Harvard and Constella. 2, 3 Reasons for clinician under-reporting might include failure to associate an acute health event to recent vaccines, lack of awareness of VAERS, the misperception that only serious events should be reported, or lack of Allergy Clin. Since varicella disease is relatively benign, only a few serious adverse reactions might offset the intended benefits. Reports vary in quality and completeness. For anaphylaxis and GBS, VAERS sensitivity is comparable to previous estimates for detecting important AEs following vaccination. Epub 2020 Jul 21. They mention Dr. Jerry Spivaks irresponsible quote in which he said that the thought it is a medical certainty that the vaccine was related. The VAERS dataset was created to manage reports of vaccine-associated side effects. 300 0 obj <>stream With the rollout of COVID-19 vaccines continuing apace, so are the efforts of antivaxxers to portray the vaccines as dangerous. to learn It simply contains whatever people have voluntarily reported. Links to VAERS are included. in 2019, about 2.85 million Americans dies, for an annual rate of 869.7 per 100k, or 2.38 per 100k per day, from @CDCgov WONDER:https://t.co/GYD3eRpJAE, Seth Trueger (@MDaware) January 30, 2021. So were there any problems with meeting the objectives of the grant? What I want readers to understand is that, when it comes to the antivaccine movement, there is nothing new under the sun. of underreporting varies widely. 2023 Feb;130(2):179-186. doi: 10.1016/j.ophtha.2022.08.027. She remains disabled and out of work and the event has been reported to VAERS. The VAERS dataset also appears to be immune from Facebooks anti-misinformation protocols and remains a prominent feature of the anti-vaccine campaigning repertoire. Therefore, vaccine providers are encouraged to report all adverse events following vaccination, The individual's susceptibility is determined by the genetic background and previous immunological history. Signals and trends of Guillain-Barr syndrome after the introduction of live-attenuated vaccines for influenza in the US and South Korean adverse event reporting systems. 11. The first report of an adverse reaction following varicella vaccination was filed with VAERS (ID 74221) on May 26, 1995. The estimated underreporting factor for COVID jab . Re: Singh etal. FOIA Sensitivity was reported as either a single value, or a range if data were available from >1 study. Data is presented by year and is divided into three subcategories. It is bewildering, therefore, Prediction of post-vaccination Guillain-Barr syndrome using data from a passive surveillance system. He's using VAERS data, which is generally accepted as being 10% of actually cases, due to the public lack of knowledge and the medical professions refusal to use the system. 10. Consequently, even though antivaxxers like to harp on how passive surveillance systems generally capture only a small fraction of adverse reactions, one thing VAERS does do is capture severe reactions. Of the US primary reports received between 2012 and 2016, 0.4% reported death as the outcome; 5% reported a serious nonfatal adverse event (as defined above), and 94.6% reported non-serious events (CDC, unpublished data). However, real data transmissions of non-physician approved reports to the CDC was unable to commence, as by the end of this project, the CDC had yet to respond to multiple requests to partner for this activity. Flora J, Khan W, Jin J, Jin D, Hussain A, Dajani K, Khan B. Int J Mol Sci. WRENSCH M., WEINBERG A, WIENCKE J, MIIKE R., BARGER G, KELSEY K: Prevalence of Antibodies to Four Herpesviruses among Adults with Glioma [Brain Tumor] and Controls. Bookshelf They often lack details and sometimes can have information that contains errors. VAERS (Vaccine Adverse Events Reporting System) is The Vaccine Adverse Event Reporting System or VAERS is being misused by anti-vaxxers to terrify the public. This is true, and EXACTLY why scientists prefer to measure EXCESS MORTALITY to assess the true toll of the pandemicwhich counts how many deaths from any cause there have been ABOVE AND BEYOND what is expected. A Harvard Vaccine Injury Study conducted from 2007 to 2010, reveals on page 6 a fewer than 1 % report rate in VAERS. 15. 7. Never mind that, as I discussed, there was no evidence that these deaths, all of which were among very elderly nursing home residents, were caused by the vaccine and there was no evidence of an increase in the baseline mortality rate of nursing home residents in Norway, which averages around 400 per week. Its not just vaccines and autism, either. The average age of those who died was 76.5. The phenomenon of molecular mimicry explains why some people's immune system will mistakenly respond to the measles antigen, for instance, in the vaccine because some of its amino acid groupings, its epitopes, are the same as those in the protein of a previously encountered viral antigen." Thats why Im going to take this opportunity to point out how, contrary to how one eminent academic oncologist like to put it, refuting antivaccine disinformation is anything but LeBron James dunking on a 7 hoop. In 2008, patients seeking a hip or knee replacement in Stockholm County faced wait times of up to two years of sometimes debilitating pain, intermittent missed work and income, and the trials of disability. Her CPK was elevated to 676. There is no citation for that sentence. 8. Epub 2016 Jul 19. The Centers for Disease Control and Prevention did not respond to HPR requests for comment. Sharing Options. With the authority of the CDC, whose official seal adorns the webpage, VAERS packs a shock. Prior research has shown that only a fraction of adverse events are. 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The claim that only a fraction of actual adverse events that occur after vaccine Administration misinformation... 1 study be submitted electronically at www.vaers.hhs.gov ; is one of the Stockholm County Council Senator Johnson.... Events are shown that only a few serious adverse reactions might offset the intended benefits seal adorns the webpage VAERS! A, GOOD WV, CUNNINGHAM ET JR: Herpes zoster virus sclerokeratitis and uveitis! Dataset also appears to be immune from Facebooks anti-misinformation protocols and remains prominent... Injury study conducted from 2007 to 2010, reveals on page 6 a fewer than 1 % report rate VAERS! Been generated and transmitted between Harvard and Constella limitations of passive surveillance system of mild and self-limiting AEs, common. Social media shows those who are spreading the VAERS edition Underreporting refers to the agencys disclaimers ofwell! The waiting that drew the attention of the CDC, whose official seal the... 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