trial that found a 5-fold KD risk associated with RotaTeq--RR=4.9; 95% CI hbbd``b`$Oo@UHYWY 0 I SUNAGA Y, HIKIMA A, OSTUKA T, MORIKAWA A: Acute cerebellar ataxia with abnormal MRI lesions after varicella vaccination. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 113% of serious events are reported to the Food and Drug Administration (FDA). The literature contains a surprising number of adverse reactions following varicella vaccination [3-12] including vaccine strain HZ in children and adults [13,14]. Baton Rouge Louisiana RN Whistleblower on Underreporting of Serious Adverse Effects of Covid Vaccines; Letter to US Senator Johnson: . VAERS reports vary in quality and completeness and under-reporting, especially of mild and self-limiting AEs, appears common. Unsurprisingly, RFK Jr. and CHD are full ofwell, a brown stinky substance. The CDC describes VAERS as a passive reporting system. Pre-dating the internet, the VAERS database has virtually no guards against its potential role as a source of fake news and is credulous of even the most fanciful claims of COVID-19 vaccine side-effects. Quite the vaccine. It just states it as fact. S. S. Korsakova. Objectives: To determine the sensitivity of VAERS in capturing AE reports of anaphylaxis and Guillain-Barr syndrome (GBS) following vaccination and whether this is consistent with previous estimates for other severe AEs. 7. Image by Mat Napo is licensed under the Unsplash License. hXmk6+B%Yo Izr wnb} >{r= [3%bk2+3J azwyynG0m7oC._s/VuVK_]hBuZ,:E*rpOv1v6[_-n]EPP7g~%~jhq/8Sn?tdg/j]Wdl-7 MGa8[>UgffM,fCM~kWQ?u^\?;5VX)I$@jxF![{L0hQcI 4tIg[,N:wcAx6cLjS?q/]}`.ubb7GKjqvm;+4 F0:i`@1K0V#t|-r$4qKf\~C9vxvp>yQCL\'dJHB^Hh= tBK:rFH|'WdAc-H{2sM:w. She and other immune employees were recruited as healthy controls for a manufacturer-sponsored vaccine study aimed at detecting the boosting effect of the vaccine. Thanks to Dear Pandemic, who did similar back-of-the-envelope calculations, as did Mark Hoofnagle on Twitter, we can make a reasonable estimate for Norway: What does that mean? %%EOF Reports of all possible associations between vaccines and adverse events (possible side Underreporting and Post-Vaccine Deaths in the Vaccine Adverse Event Reporting System (VAERS) Explained | by Shin Jie Yong | Microbial Instincts | Medium Write Sign up Sign In 500 Apologies,. Her skin sensitivity also became more intense. If you look at the CHD scientific advisory board, youll soon see that its a whos-who of antivaccine cranks, including Richard Deth (what a blast from the past!) HHS needs a certificate that covers both vaers.hhs.gov and http://www.vaers.hhs.gov. VAERS, Underreporting, and the Mysterious 1% A CDC database that was mostly unknown except to a small segment of the population is now regularly in the news. Prior research has shown that only a fraction of adverse events are. It is bewildering, therefore, Basically, VAERS is a passive reporting system, in which anyone can report suspected adverse events after any vaccination to be recorded in the database. After the investigations that lead to the licensing of a vaccine, the mainstay of post-marketing surveillance is the mandated reporting of adverse events following vaccines, a reporting system jointly overseen by CDC and FDA was created, the Vaccine Adverse Event Reporting System (VAERS). Covid-19 was the eighth leading cause of death among children in recent months, according to a study published Monday. She received a first dose of the vaccine in March and the second in May 2001. So I suppose I shouldnt be surprised that antivaxxers are now weaponizing the Vaccine Adverse Events Reporting System (VAERS) database to try to blame all manner of adverse events on vaccines, whether there is evidence of causation or not. (1995) 37(5):648-650. This time around, theyve resurrected the old antivaccine trick of deceptively misusing the VAERS database to imply causation from VAERS reports. The VAERS dataset was created to manage reports of vaccine-associated side effects. We had initially planned to evaluate the system by comparing adverse event findings to those in the Vaccine Safety Datalink project however, due to restructuring at CDC and consequent delays in terms of decision making, it became impossible to move forward with discussions regarding the evaluation of ESP:VAERS performance in a randomized trial, and compare ESP:VAERS performance to existing VAERS and Vaccine Safety Datalink data. It might be true that such a small percentage of adverse events is reported for self-limited minor events, such as sore arms, fever, nausea, and the like. Still, its limitations aside, VAERS has its place if you understand its intended purpose. 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 . Thats 1.3/100,000. So, the actual number of serious injuries and deaths is likely 10 to 100 times higher. 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 degree of underreporting varies widely. J. Ophthalmol. the 18-year period from 1990 through 2007 just 88 cases of Kawasaki health VAERS accepts all reports of suspected adverse events, in all age groups. Paediatr. ** The author writes concerning neurological complications, "There is no way of predicting who will have an adverse reaction to vaccination. Methods: Competing interests: Basically, in the age of the COVID-19 pandemic, everything old is new again, and antivaxxers have used the same old playbook to misuse VAERS reports in the age of COVID-19. POSER CM: Neurological Complications of Vaccinations. He was treated again with Acyclovir. endstream endobj 285 0 obj <>/Metadata 22 0 R/Outlines 32 0 R/PageLayout/OneColumn/Pages 282 0 R/StructTreeRoot 49 0 R/Type/Catalog/ViewerPreferences<>>> endobj 286 0 obj <>/Font<>>>/Rotate 0/StructParents 0/Type/Page>> endobj 287 0 obj <>stream While the VAERS database numbers are sobering, according to a U.S. Department of Health and Human Services study, the actual number of adverse events is likely significantly higher. The problem is that the natural human tendency to seek patterns, coupled with the way antivaccine lawyers game VAERS by having their clients report all sorts of spurious adverse events to the database after vaccination, means that VAERS is a very noisy, distorted, and unreliable database. 2022 Harvard Political Review. Online ahead of print. * Two-year-old boy with staggering gait and difficulty speaking. As of today, the online database alleges 1349 U.S. deaths attributable to COVID-19 vaccines. 300 0 obj <>stream The Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system, meaning it relies on individuals to send in reports of their experiences. They also allow users to verify that they are connected to the real web site, rather than a hackers web site. That one earned a much belated Godzilla facepalm: When Godzilla gives you the facepalm, you know the failure is monstrous. Acta. It should therefore be no surprise that antivaxxers are now using VAERS to try to portray COVID-19 vaccines as harmful or even deadly. The site is secure. 290 0 obj <>/Filter/FlateDecode/ID[<2DFFE8CD87B0A54688B7A1A0039905EB>]/Index[284 17]/Info 283 0 R/Length 53/Prev 85940/Root 285 0 R/Size 301/Type/XRef/W[1 2 1]>>stream VAERS (Vaccine Adverse Events Reporting System) is the voluntary system used in the U.S. to signal vaccine side effects. It is primarily a hypothesis-generating, not hypothesis-testing, system when it comes to questions related to vaccine safety. The average age of those who died was 76.5. For GBS, VAERS captured 12% of cases after the 2012-13 inactivated seasonal influenza vaccine, 15-55% of cases after the 2009 H1N1 inactivated pandemic influenza vaccine, and 64% of cases after 4vHPV vaccine. Its basically against public health and any collective action to protect public health. Even VAERS cautions people about how to interpret its data: When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. Background: Twenty-eight months following varicella vaccination (October 29, 2002), he developed breakthrough chickenpox with an estimated 30 to 40 lesions that were intensely itchy. Additionally, the senators said the COVID-19 tests used by . The Harvard Pilgraim study is here for all to see: https://digital.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report-2011.pdf, Naturopathic physician, licensed acupuncturist, medical researcher. 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. Since varicella disease is relatively benign, only a few serious adverse reactions might offset the intended benefits. If Laidler hadnt been honest, he could have insisted that the report remain, and it would have. Voices for Vaccines, How I Went From Dressing Up As Measles to Hoping for My COVID Vaccines, April 28, 2021. From your lips to QAnon's ears.. For anaphylaxis, VAERS captured 13-27% of cases after the pneumococcal polysaccharide vaccine, 13% of cases after influenza vaccine, 21% of cases after varicella vaccine, 24% of cases after both the live attenuated zoster and quadrivalent human papillomavirus (4vHPV) vaccines, 25% of cases after the combined measles, mumps and rubella (MMR) vaccine, and 76% of cases after the 2009 H1N1 inactivated pandemic influenza vaccine. During the same Analyses of the universal varicella vaccination program in the U.S. have also failed to consider the potential effect on the closely related herpes-zoster epidemiology. 2022 Nov;47(11):1789-1795. doi: 10.1111/jcpt.13767. Copyright The President and Fellows of Harvard College, Administration for Children and Families Database, Harvard T.H. (1986) 8(1):78-80. VAERS is a passive surveillance system that relies on the willingness of individuals and professionals to submit reports voluntarily. J. 100,000 person-years. Unfortunately, there was never an opportunity to perform system performance assessments because the necessary CDC contacts were no longer available and the CDC consultants responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation. The Vaccine Adverse Events Reporting System (VAERS) is sponsored by the Centers for Disease Control and by the Food and Drug Administration. Table 1 presents a comparison of the number of adverse reactions reported to VAERS for the varicella vaccine with 4 other different vaccines. 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]. With the rollout of safe and effective vaccines against COVID-19 finally starting to result in tens of millions of people receiving the Moderna and Pfizer/BioNTech vaccines, with newer vaccines likely to be introduced in the coming months, the predictions that I (and many others) made months ago are coming to pass. associated with RotaTeq would translate to an extra 4000 U.S. cases So where is that information in this study? Unable to load your collection due to an error, Unable to load your delegates due to an error. Between 2000-2020, VAERS received 1,005 reports of death after vaccination, according to a USA TODAY analysis of VAERS data. Competing interests: convulsions in young children given seasonal flu vaccine, but the problems, with voluntary reporting systems, underreporting of adverse events and the. Harvard Business Review noted that the previous vaccine development record was . Your connection is not private, it says in large font on my screen (fig 1). The brain tumor pathogenesis is not fully understood at this time. The CDC blocked both the data collection by the Harvard Pilgrim group, and also any implementation that could have followed from their findings. According to the VAERS website, only a "small fraction" of vaccine injuries are reported (2). 0.6, 239. Users are claiming that the U.S. Centers for Disease Control and Prevention deleted reports of 6,000 deaths from the U.S. Keep in mind, this system would have extracted probable vaccine injury information from patient charts and fed it directly into the VAERS system. The database makes for gruesome reading, with side-effects of the vaccine appearing to include brain death, herpes and even one case of a gunshot wound. 2023;130: S0161-6420(22)00672-8. doi: 10.1016/j.ophtha.2022.08.027. 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. She underwent a colonoscopy and was diagnosed with the rare and more serious collagenous colitis. So how are antivaxxers weaponizing VAERS? It is indeed a misconfiguration but its relatively minor. Heres what I mean: As of Jan. 22, 329 deaths a subset of 9,845 total adverse events had been reported to the Centers for Disease Control and Preventions (CDC) Vaccine Adverse Event Reporting System (VAERS) following COVID-19 vaccinations. JAMA. (2000) 284:1271-1279. Physicians and patients The U.S. Objectives: 6/15/07. The patient's nausea decreased and her fever subsided. Raw data is available from 1990- May 14, 2013 and can be downloaded using ZIP files or Comma-Separated Value (CSV) files. "@MonicaGandhi9 How underreported are these side effects? Exogenous exposures to wild type varicella have previously contributed a significant immunologic boosting effect that helps suppress the reactivation of herpes-zoster. So there is no way to explain the excess deaths which are effectively over 640,000 for a 41 underreporting factor. Kennedy told Kessler that VAERS has been an abject failure, with fewer than 1% of adverse events ever reported. Unsurprisingly, its one of the usual suspects responsible, Robert F. Kennedy, Jr. (RFK Jr.), in the form of a post in his antivaccine publication The Defender entitled 329 Deaths + 9,516 Other Injuries Reported Following COVID Vaccine, Latest CDC Data Show. Neurol. If youve been reading this blog a while, you can probably guess. VAERS reports can be submitted voluntarily by anyone, including healthcare providers, patients, or family members. The CDC acknowledges the quality and completeness of reports often lack details and sometimes can have information that contains errors. Beyond that disclaimer, the CDC tries to ensure its readers know the data is inaccurate by offering users terms and conditions, which are presumably mostly unread, and a checkbox to acknowledge their contents. Indeed, antivaxxers have long loved to portray VAERS as the be-all and end-all of the databases monitoring vaccine safety. Here users can create their own charts and graphs. possibilities of Reports vary in quality and completeness. Children's deaths of any kind are rare, researchers noted. Paediatr. In the letter, the lawmakers said a whistleblower alleged in sworn testimony that deaths and injuries recorded in the CDC's Vaccine Adverse Events Reporting System "may be underreported by a factor of five.". Clinical descriptions of five different serious adverse affects that followed varicella vaccination are given below. It is worth pointing out that Harvard Pilgrim Health Care, Inc., has no affiliation with Harvard University. Physicians and patients understand that minor side effects of vaccinations often include this kind of discomfort, as well as low fevers. Share on Facebook, opens a new window It is a near certainty that scurrilous and outlandish claims around the COVID-19 vaccines will be shared online in any case, but for now, malign actors transmit this information with a veneer of credibility offered by the CDC VAERS database. Its a specific skill that requires deep knowledge of conspiracy theories and the specific tactic and tropes used by science denialists and conspiracy theorists like antivaxxers, coupled with a deep understanding of the scientific literature on vaccines. J. Infect. (1970) 70(10):1465-1471. Sen. Ron Johnson, R-Wis. , has stirred controversy in recent days over his concerns about COVID-19 vaccine safety. The first is: Whats the denominator? In December, CHD and Kennedy wrote to former FDA director, Dr. David Kessler, co-chair of the COVID-19 Advisory Board and President Bidens version of Operation Warp Speed. Before 2023 Jan 4:S0161-6420(22)00929-0. doi: 10.1016/j.ophtha.2022.11.023. The findings, the researchers said, affirm the overall safety of the vaccine and underscore . Whats 285 divided by 22 million? Case E The 4chan forums rose to prominence in the Trump era as the original source of widespread conspiracy theories such as Pizzagate, which alleged a satanic child-exploitation run by the Democratic Party, and QAnon, the pretext for the January 6 insurrection and now serves as a hotbed of anti-vaccine misinformation. to learn Reports are accepted from anyone and can be submitted electronically at www.vaers.hhs.gov. This is a system that sends regular text messages to those whove been vaccinated to ask them about side effects and in general how they feel. Certainly, it doesnt help that there is at least one person who proclaims himself so very, very, very pro-vaccine is out there pointing to anecdotes to support his pet hypothesis that its dangerous to vaccinate people who have pre-existing COVID-19 antibodies. To determine the sensitivity of VAERS in capturing AE reports of anaphylaxis and Guillain-Barr syndrome (GBS) following vaccination and whether this is consistent with previous estimates for other severe AEs. Her physician was of the opinion that a virus probably triggered her autoimmune response. J. Pediatr. An official website of the United States government. He took Acyclovir Oral Suspension (200mg/5ml): Two teaspoons 4 times a day for 5 days. 3. It only confirms that the reported event occurred sometime after vaccine was given. ESMAELI-GUTSTEIN B, WINKELMAN JZ: Uveitis associated with varicella virus vaccine. Ophthalmology. Local Australian health authorities blasted the spreading of the false reports telling residents to take-off their tin-foil hats.. Nonetheless, previous reports demonstrate substantial case capture for clinically severe adverse events (AEs), including 47% of intussusception cases after rotavirus vaccine, and 68% of vaccine associated paralytic polio after oral polio vaccine. Case C 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. cases were reported to VAERS. A certain number of 80+ year olds die every day. VAERS, Report an Adverse Event, accessed April 9, 2021. VAERS is a postmarketing surveillance program, collecting information about adverse events (possible harmful side effects) that occur after administration of vaccines to ascertain . The Harvard study mentioned by Dr. Zelenko is the same as the one found at reference #6 cited by Mercola. The FDA has established pathways to accelerate vaccine availability before approval, such as Emergency Use Authorization, and to channel resources to high-priority products and allow more. febrile Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001. VAERS sensitivity for capturing anaphylaxis after seven different vaccines ranged from 13 to 76%; sensitivity for capturing GBS after three different vaccines ranged from 12 to 64%. Conclusion (Pediatr Infect Dis J 28:943, 2009) From 1988 to It was the waiting that drew the attention of the Stockholm County Council. WASHINGTON, Jan. 28, 2021 /PRNewswire/ -- The primary mechanism for reporting adverse vaccine reactions in the U.S., the Vaccine Adverse Event Reporting System (VAERS), reported 181 deaths a . Vaccine-Associated Uveitis after COVID-19 Vaccination: Vaccine Adverse Event Reporting System Database Analysis. Rather, it was always intended to serve as an early warning system, a canary in the coalmine, so to speak. J. Ophthalmol. 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. But thats Norway. 2016 Aug 17;34(37):4406-14. doi: 10.1016/j.vaccine.2016.07.019. There is another story being missed regarding that Harvard Pilgrim study, though. 20.8 per 100,000 person-years. 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. 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. Now, add this to the mix, for comparison: how many people are dying of COVID in the US per day? providers, patients, or family members. Vaccine Adverse Event Reporting System (VAERS) is a reporting system that anyone can report to or access data from. LEE SY, KOMP DM, ANDIMAN W: Thrombocytopenic Purpura following varicella-zoster vaccination. Table 1. 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. Med. She was told that her collagenous colitis was autoimmune in nature. And the CDCs role in the dissemination of vaccine misinformation, unwilling though it may be, is attracting increasing scrutiny as it jeopardises what President Biden calls his administrations most important battle: the global coronavirus vaccine rollout. Changing the hearts and minds of reticent Americans is set to become more crucial than ever to prevent transmission and limit the potential of new coronavirus variants taking hold. Thats not how VAERS works, however. Lastly, VAERS Vaccine gives information about the origin and type of vaccine. Overview of the ESP:VAERS project . Seeking a new model to lower wait times, but also improve patient choice of care, County Council Senior Medical . The easily-abused nature of VAERS data is one huge reason why those of us whove been following the antivaccine movement a long time like to refer to the bad scientific studies published by antivaccine physicians and scientists that use VAERS as their data source as dumpster diving. Zh. InDepthNH.org - The New Hampshire Center for Public Interest . We also know that underreporting is less common for more severe adverse reactions than for those that are more mild. More generally: The chance of dying in an average week for those over 80 is about 0.2% or 1 in 500. We estimated VAERS reporting rates following vaccination for anaphylaxis and GBS. In a July 13 letter to health agency leaders, Johnson noted a press conference he . Intern. Deaths definitely get ones attention and are far more likely to be reported than any other AE. Sharing Options. hb```i Ab,X,YsbW``XddTy d`4[Y,A ! The true number is likely slightly higher, given that the denominator includes one additional week of vaccinations administered compared to the VAERS figures, which only go until January 22, but, again, this is a back-of-the-envelope calculation, in which the orders of magnitude matter more than the precise figure. Two months later on May 13, 2004 he had still another recurrence with moderate pain, in the same location as previously mentioned. Moreover, the CDC and FDA do not restrict what people can report, as long as it happened at some point following a vaccination. By the FDAs own definition, the vaccines are still considered experimental until fully licensed. Spoiler alert: Excess mortality during the pandemic has been VERY high. Psikhiatr. VAERS is a government database managed by the Centers for Disease. Mercola, just a few paragraphs below that, emphasizes the point: Studies have indicated it could be as low as 1%.6,7. He remains permanently disabled. Vaccine Adverse Event Reporting System (VAERS). A study about it found less than 1% were reported (3). Then, with respect to antivaccine disinformation, truly everything old will be new again. Her pre-study laboratory values were completely normal. 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. Exploring issues and controversies in the relationship between science and medicine. Both thought that she could have Guillian-barre syndrome. The Vaccine Adverse Event Reporting System or VAERS is being misused by anti-vaxxers to terrify the public. The reason, to reiterate, is that VAERS is unique among US vaccine safety reporting systems in that it is a passive surveillance system. The reports, filed on the VAERS website between Dec. 14, 2020 and Jan. 22, describe outcomes ranging from foaming at the mouth to massive heart attacks to did not recover.. Nevertheless, the magnitude of these differences makes it likely that serious adverse events following vaccination occur at a substantially lower rate than following natural disease [15]." Sensitivity was reported as either a single value, or a range if data were available from >1 study. Big Tech, Policymaking, and Leadership: An Interview With Journalist Kara Swisher, Unpacking the Pervasive Toxicity of Republican Loyalty, The Burden of Climate Injustice: The Catastrophic Floods in Pakistan, A Note on Equity: Why Harvard Should Be Less Secular, Food Apartheid: Bridging Disparities in Boston, Back to the Basics: Education as the Solution to Health Misinformation, Strangers in a Strange Land: Foreign Volunteers in the Struggle for Ukrainian Freedom, The Happiest and the Most Racist: Institutional Racism in Nordic Countries. Time around, theyve resurrected the old antivaccine trick of deceptively misusing the VAERS website, only &. 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Estimated VAERS Reporting rates following vaccination for anaphylaxis and GBS a hypothesis-generating, not hypothesis-testing, When... There is another story being missed regarding that Harvard Pilgrim group, and also any implementation could! Is worth pointing out that Harvard Pilgrim health Care, Inc., has no affiliation with Harvard University users create... Lastly, VAERS received 1,005 reports of vaccine-associated side effects of vaccinations often include kind! Injuries and deaths is likely 10 to 100 times higher April 28, 2021 and... Reports voluntarily completeness of reports often lack details and sometimes can have information that errors... Vaccine development record was can probably guess, especially of mild and self-limiting AEs, appears common implementation could. Wait times, but also improve patient choice of Care, County Council Senior.! The COVID-19 tests used by for 5 days 22 ) 00672-8. doi: 10.1016/j.vaccine.2016.07.019 take-off their tin-foil hats doi! Online database vaers underreporting harvard 1349 U.S. deaths attributable to COVID-19 vaccines as harmful or even deadly was. Old will be new again serious injuries and deaths is likely 10 to 100 higher! Voluntarily by anyone, including healthcare providers, patients, or a range if were. At reference # 6 cited by Mercola author writes concerning neurological complications, `` is... It is primarily a hypothesis-generating, not hypothesis-testing, system When it comes to questions related vaccine.:1789-1795. doi: 10.1016/j.vaccine.2016.07.019 the report remain, and it would have in...
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