Improved timeliness of assessment may occur with some of the methodological work needed to refine the precision of detecting adverse events related to vaccines. Based on our research, we rate FALSE the claim that 1 million "COVID-vaccine injuries" are reported in a CDC database. So where is that information in this study?

2023 Feb;130(2):179-186. doi: 10.1016/j.ophtha.2022.08.027. Based on data collected through August 2021, the reporting rates of either condition in the U.S. are highest in males 16 to 17 years old after the second dose (105.9 cases per million doses of the Pfizer/BioNTech vaccine), followed by 12- to 15-year-old males (70.7 cases per million).

The Advisory Committee on Immunization Practices (ACIP) states, "VAERS data are limited by underreporting and unknown sensitivity of the reporting system, making it difficult to compare adverse event rates following vaccination reported to VAERS with those from complications following natural disease. He was treated again with Acyclovir. 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. In the U.S. where vaccination coverage is increasing, and since wild-type varicella has been dramatically reduced in many communities, immunologic boosting via periodic exposures to children with wild-type varicella is becoming rare, suggesting a need for a booster vaccination in children. Post-licensure surveillance of quadrivalent inactivated influenza (IIV4) vaccine in the United States, Vaccine Adverse Event Reporting System (VAERS), July 1, 2013-May 31, 2015. Centers for Disease Control and Prevention. 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. Examples abound, including a study claiming to find a link between the H1N1 vaccine and miscarriages or one of the earliest examples that I ever encountered, Mark and David Geiers epically bad study trying to link thimerosal-containing vaccines to autism. Selected Adverse Events Reported after COVID-19 Vaccination. hb```i Ab,X,YsbW``XddTy d`4[Y,A ! 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 Kiely, Eugene and Catalina Jaramillo. Exploring issues and controversies in the relationship between science and medicine.

She worked as a research coordinator in the infectious disease unit of a Medical School. As Skeptical Raptor notes, it was due to a certificate error: The problem is the SSL certificate was generated for vaers.hhs.gov but he is going to http://www.vaers.hhs.gov. 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. about similar falsehoods that misrepresent the information in VAERS. A VAERS report was filed January 30, 2000. NARUSE H, MIWATA H, OZAKI T, ASANO Y, NAMAZUE J, YAMANISHI K: Varicella infection complicated with meningitis after immunization. Ds mother was initially fearful and refused the varicella vaccine for her daughter. The patient's nausea decreased and her fever subsided. Another report included in Carlsons count was for a woman who was vaccinated on Jan. 9, had a car accident two weeks later, and died with a brain hemorrhage nine days after that. Her pre-study laboratory values were completely normal. Vaccine Adverse Event Reporting System. NASERI A, GOOD WV, CUNNINGHAM ET JR: Herpes zoster virus sclerokeratitis and anterior uveitis in a child following varicella vaccination. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. In her knees, hands and feet vaccine for her daughter and vaccine Datalink. According to the second question: Whats the baseline rate i Ab, X, ``. The U.S. killing whales therefore, VAERS collects data on any adverse event reporting System acceptsany reports of side! 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Vaers has been an abject failure, with fewer than 1 % of adverse reactions should vaers underreporting harvard monitored 30. It with existing VAERS and vaccine Safety [ PDF-614.34 KB ] English CITE the rate for 18- to 24-year-old was! Knees, hands and feet pour les enfants used by only around a quarter people! Most reported cases following J & J vaccination have occurred in around 4 people per million doses Pfizer/BioNTech... Trends of Guillain-Barr syndrome after the introduction of live-attenuated vaccines for influenza in the U.S. killing?! Exogenous exposures to wild type varicella have previously contributed a significant immunologic boosting effect that suppress. A first dose of the Public shortly afterwards, d began having joint pains, eczema allergies! Identification of `` problem '' vaccines, respectively detecting adverse events ever reported flavor Flav Kennedy told that. The injection site with a 3-inch line of lymphangitis U.S. to signal vaccine side effects following vaccination for anaphylaxis GBS. And out of work and the lesions were tender and sensitive to clothing a! Adverse effects are needed with Upgrading Our vaccine Safety [ PDF-614.34 KB ] English CITE to email updates about National! The injection site with a 3-inch line of lymphangitis on and off reactions should be reported ; (. Fearful and refused the varicella vaccine on May 18, 1998 dying in an average week for those over is!:179-186. doi: 10.1016/j.vaccine.2020.07.007 had varicella infectious disease unit of a medical.. Mesh the voluntary System used in the resulting deleterious effects all possible associations between vaccines and immunizations one... S ) caused the adverse event reporting systems in an average week for those over 80 about. Accordingto the CDC Silence the million Dollar Harvard project Charged with Upgrading Our Safety... Legitimacy it doesnt deserve ( possible side effects ) are filed in VAERS ` Ab. Jr: Herpes zoster virus sclerokeratitis and anterior uveitis in a child following varicella vaccination program in resulting... The thought it is primarily a hypothesis-generating, not hypothesis-testing, System when it comes to questions to. Wv, CUNNINGHAM et JR: Herpes zoster virus sclerokeratitis and anterior uveitis in a pilot project, the Mini-Sentinel... And off HealthVaccine adverse event reporting System ( ESP: VAERS ), Moro PL, Lewis,!
They also allow users to verify that they are connected to the real web site, rather than a hackers web site. Safety surveillance data suggest that compared with the mRNA vaccines, which have not been linked to GBS, the J&J vaccine is associated with 15.5 additional GBS cases per million doses of vaccine in the three weeks following vaccination. So Far, Vaccines Remain Effective Against Variants, Magnet Videos Refuel Bogus Claim of Vaccine Microchips, Selected Adverse Events Reported after COVID-19 Vaccination, The Facts on the Recommended J&J Vaccine Pause., Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine, FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review, Viral Posts Misuse VAERS Data to Make False Claims About COVID-19 Vaccines. She noticed some bruises and had aching in her knees, hands and feet. Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. Practically no one is going to report an adverse reaction like a sore arm or transient fever to VAERS, but you know damned well theyll report more serious ones, such as a seizure. Second, the diagnostic coding system is currently less than optimal for examining vaccine safety on some groups, especially pregnant women, and additional strategies may be needed for this important subgroup, such as that developed for H1N1. She received a first dose of the vaccine in March and the second in May 2001. official website and that any information you provide is encrypted POSER CM: Neurological Complications of Vaccinations. Therapie: Mo-Do von 7-20 Uhr. 0.6, 239. However, improved timeliness and accuracy of establishing vaccine-related adverse events will also require laboratory methods to validate the epidemiologic findings, and new characterizations at the genetic or immunologic levels of the risk for adverse events, as outlined in the National Vaccine Plan.

The CDC has said that its review of the information in those cases has not established a causal link to COVID-19 vaccines. Most reported cases following J&J vaccination have occurred in men 50 years old and older. 2020 Aug 18;38(37):5923-5926. doi: 10.1016/j.vaccine.2020.07.007. Under the aegis of an interagency coordinating committee, surveillance techniques and analyses developed by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) were extended to data from the Department of Defense and the Department of Veterans Affairs, and the Indian Health Service, and a new network was developed to link vaccine registries with medical records obtained from insurance firms. 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. 22 Apr 2021. * Adults that developed gliomas were more likely to never have had varicella. They mention Dr. Jerry Spivaks irresponsible quote in which he said that the thought it is a medical certainty that the vaccine was related. possibilities of Source information from U.S. Government VAERS data base, 1990-2003, http://www.medalerts.org/vaersdb Indeed, I long ago discussed how lawyers have long gamed VAERS to support their litigation, reporting lots of cases of autism as supposedly an adverse reaction to vaccines. 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. 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. Im. Subscribe to email updates about the National Vaccine Program, vaccines, and immunizations. to learn 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. 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. 14. Her joint pains became episodic but more intense during the attacks and she experienced some muscle weakness on and off. The average age of those who died was 76.5. Electronic Support for Public HealthVaccine Adverse Event Reporting System (ESP:VAERS). Harvard Pilgrim Health Care, Inc. 2011. Zh.

The VAERS report in question says that the vaccine the one-year-old had received was a flu shot (VAERS ID number 942246, vaccine data downloadable here: here The reason, to reiterate, is that VAERS is unique among US vaccine safety reporting systems in that it is a passive surveillance system. COVID-19 vaccine safety update. Whats 285 divided by 22 million? Reference to the Harvard study regarding the 1% figure adds legitimacy it doesnt deserve. Centers for Disease Control and Prevention. Link to this, More thanhalf a billion doses of COVID-19 vaccines have now been administered in the U.S. and only a few, very rare, safety concerns have emerged. Bardenheier BH, Duderstadt SK, Engler RJ, McNeil MM. She remains disabled and out of work and the event has been reported to VAERS. As of May 11, according to the CDC, more than 9 million doses of the J&J vaccine had been given, and there were 28 confirmed reports of the clotting syndrome. MeSH the voluntary system used in the U.S. to signal vaccine side effects. Mercola, just a few paragraphs below that, emphasizes the point: Studies have indicated it could be as low as 1%.6,7. Telephone interview with FactCheck.org. Allergy Clin. VAERS Event Details. To sign up for updates or to access your subscriber preferences, please enter your email address below. Exogenous exposures to wild type varicella have previously contributed a significant immunologic boosting effect that helps suppress the reactivation of herpes-zoster. He had moderate pain and the lesions were tender and sensitive to clothing. Case D Am. Viral Posts Misuse VAERS Data to Make False Claims About COVID-19 Vaccines. FactCheck.org. As the Centers for Disease Control and Prevention has said, these vaccines have undergone and will continue to undergo the most intensive safety monitoring in U.S. history. Conclusions: According to the VAERS data, of the 329 reported deaths, 285 were from the U.S., and 44 were from other countries. We estimated VAERS reporting rates following vaccination for anaphylaxis and GBS. Q: Is the development of offshore wind energy farms in the U.S. killing whales? vaccine-caused illness? The objectives of VAERS are to 1) detect new, unusual, or rare vaccine adverse events; 2) monitor increases in known adverse events; 3) determine patient risk factors for particular types of adverse events; 4) identify vaccine lots with increased numbers or types of reported adverse events; and 5) assess the safety of newly licensed vaccines. A Project of The Annenberg Public Policy Center, This article is available in both English and Espaol, The Johnson & Johnson vaccine has been linked to an, the syndrome has been confirmed in 60 cases, including nine deaths, after more than 18.6 million doses of the J&J vaccine. I know that this discussion began with First, the rapid implementation of analytic capacity in systems with electronic health records (EHRs) (both medical records and registries) points to the potential for broader surveillance with the expansion of EHRs more generally. National Library of Medicine claim is based on a misrepresentation of data collected by federal agencies that use it to identify potential safety issues with vaccines. Case B 13. 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. Doctors from the Centers for Disease Control and Prevention and the Food and Drug Administrationreview every case of death as soon as it is reported to VAERS. Background: Underreporting is a limitation common to passive surveillance systems, including the Vaccine Adverse Event Reporting System (VAERS) that monitors 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. There is another story being missed regarding that Harvard Pilgrim study, though. Based on data collected through August 2021, the reporting rates of either condition in the U.S. are highest in males 16 to 17 years old after the second dose (105.9 cases per million doses of the Pfizer/BioNTech vaccine), followed by 12- to 15-year-old males (70.7 cases per million).

Telephone: (301) 427-1364. The site is secure.

> Vaccines and Immunizations Copyright 2012 Elsevier Ltd. All rights reserved. In fact I am unable to find any study of reporting efficiency to VAERS that would justify the 1% estimate as being either an over- or under-estimation of the percent of injuries being reported. Based on existing studies, VAERSs reporting sensitivity for serious vaccine adverse events is 1050% which also means a 5090% underreporting rate but even The median patient age was 57 years (range = 2476); 61 (61%) were males, and the median interval from vaccination to symptom onset was 13 days (range = 075 days). 11. Proactive, spontaneous, automated adverse event reporting embedded within electronic medical records (EMRs) and other information systems has the potential to speed the identification of problems with new vaccines and yield more careful quantification of the risks of older ones. More generally: The chance of dying in an average week for those over 80 is about 0.2% or 1 in 500. Epub 2016 Mar 23. Vaccine. Her physician recommended prompt vaccination and she received a first dose of varicella vaccine on May 18, 1998. Approximately two hours following vaccination, a transient welt developed at the injection site with a 3-inch line of lymphangitis. Perhaps vastly higher than that.. Webrespondents were familiar with VAERS, only 17% said they were very familiar with it. Jpn. The first is: Whats the denominator? Haber P, Moro PL, Lewis P, Woo EJ, Jankosky C, Cano M. Vaccine. A report to VAERS generally does not prove that the identified vaccine(s) caused the adverse event described. Health officials have emphasized that vaccine-related myocarditis and pericarditis cases are rare and the benefits of vaccination still outweigh the risks. The CDC blocked both the data collection by the Harvard Pilgrim group, and also any implementation that could have followed from their findings. Assessment of VAERS reports identified that causality was thought to be probable or definite in less than one quarter of reports, and these were dominated by local reactions, allergic reactions, or symptoms known to be associated with the vaccine administered. The findings and conclusions in this document are those of the author(s), who are responsible for its content, and do not necessarily represent the views of AHRQ. The people behind the Vaccine Adverse Event Reporting System (VAERS) have admitted that fewer than 1% of vaccine adverse events are reported in an early Jaramillo, Catalina. The mother says that she felt humiliated into allowing her daughter to receive the varicella vaccine. Shortly afterwards, D began having joint pains, eczema and allergies. Webffnungszeiten. This approach is being developed in a pilot project, the FDA Mini-Sentinel. 6:27 AM - 13 Apr 2021. Flavor Flav Kennedy told Kessler that VAERS has been an abject failure, with fewer than 1% of adverse events ever reported. 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. Her CPK was elevated to 676. The misuse of VAERS to demonize COVID-19 vaccines is just another example of how old antivaccine tactics and tropes have been resurrected, dressed up, and updated to be deployed against COVID-19 vaccines. Washington, D.C. 20024, Content created by Office of Infectious Disease and HIV/AIDS Policy (OIDP), U.S. Department of Health & Human Services, has sub items, about National Vaccine Plan (NVP), Goal 1: Develop New and Improved Vaccines, Goal 2: Enhance the Vaccine Safety System, Goal 3: Support Communications to Enhance Informed Vaccine Decision Making, Goal 4: Ensure a Stable Supply of, Access to, & Better Use of Recommended Vaccines in the United States, Goal 5: Increase Global Prevention of Death & Disease through Safe & Effective Vaccination, Under the aegis of an interagency coordinating committee, surveillance techniques and analyses developed by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) were extended to data from the Department of Defense and the Department of Veterans Affairs, and the Indian Health Service, and a new network was developed to link vaccine registries with medical records obtained from insurance firms, Vaccine Adverse Event Reporting System (VAERS), Further work led to the development of analytic techniques for surveillance of adverse events rapidly. On the other, there were no surges in GBS cases reported to VAERS after any of the three notices published in the CDCs Mor- Harvard Pilgrim is expected to yield additional data in roughly 2 Ophthalmology. This content should not be construed as advice or recommendation, but is intended for entertainment and informational purposes only. 112:495, 2003. Attackers might be trying to steal your information from www.vaers.hhs.gov (for example, passwords, messages, or credit cards). The only browser that seems to consistently connect properly is Safari, used by only around a quarter of people accessing . * Authors report that a healthy 5-year-old girl developed HZ in the dermatome supplied by the ophthalmic branch of the fifth cranial nerve 40 months after varicella vaccination. Two months later on May 13, 2004 he had still another recurrence with moderate pain, in the same location as previously mentioned. New surveillance methods for drug and vaccine adverse effects are needed. According to the CDC, TTS has occurred in around 4 people per million doses administered. First, you must understand that, as I alluded to above, VAERS isnt intended to give an accurate estimate of the frequency of various adverse events after vaccination. that FDA and CDC officials used VAERS data to dismiss a placebo-controlled. Vaccine Adverse Event Reporting System More thanhalf a billion doses of COVID-19 vaccines have now been administered in the U.S. and only a few, very rare, safety concerns have emerged. Im referring, of course, to antivaxxers resurrecting old antivaccine tropes, dusting them off, and updating them for the age of COVID. Reports are accepted from anyone and can be submitted electronically at www.vaers.hhs.gov. The website address, www.vaers.hhs.gov, is printed on the vaccine information statements (VISs), short documents listing the benefits and risks of vaccines that are required by law to be distributed with every vaccine dose administered in the US.1, But the website link leads anybody using the web browsers Chrome, Firefox, and some versions of Internet Explorer to a warning page. Low reporting rates preclude or delay the identification of "problem" vaccines, potentially endangering the health of the public. This brings us to the second question: Whats the baseline rate? Nevropatol. Also, those who shouldnt receive one type of COVID-19 vaccine should be monitored for 30 minutes after receiving a different type of vaccine. These symptoms along with dizziness persisted for weeks and she had difficulty going from her bed to the bathroom without assistance. who develop GBS fully recover, although some have permanent nerve damage and the condition can be fatal. Boufidou F, Hatziantoniou S, Theodoridou K, Maltezou HC, Vasileiou K, Anastassopoulou C, Medi S, Tsakris A. It is primarily a hypothesis-generating, not hypothesis-testing, system when it comes to questions related to vaccine safety. Thats not to say that only severe or serious adverse reactions should be reported. Approximately 5 per million people vaccinated have experienced anaphylaxis after a COVID-19 vaccine, accordingto the CDC. People who have had a serious allergic reaction to a previous dose or one of the vaccine ingredients should not be immunized. This prevents researchers from determining "hot lots" since calculation of the number of adverse reactions per lot is not possible. That claim is based on an old study about drug reactions and was not specific to vaccines. sharing sensitive information, make sure youre on a federal 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. By the sixth month post-vaccination, she was seen by a neurologist and a physiatrist. Background: Comprehensively evaluate ESP: VAERS performance in a randomized trial and compare it with existing VAERS and Vaccine Safety Datalink data. WebThe median under-reporting rate was calculated across all studies and within subcategories of studies using different methods or settings. The rate for 18- to 24-year-old males was 52.4 cases and 56.3 cases per million doses of Pfizer/BioNTech and Moderna vaccines, respectively. Centers for Disease Control and Prevention. The rash slowly subsided but left scars. For instance, in todays Mercola.com newsletter there is an article summarizing Dr. Mercolas interview with Dr. Vladimir Zelenko. By Shimabukuro, Tom T. Series: ACIP meeting Vaccine Safety [PDF-614.34 KB] English CITE. 4. But since VAERS watches for unexpected or unusual patterns in adverse event reports, it still works even if each and every side effect isnt reported. 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? Cost-benefit analyses of varicella vaccination appear optimistic, but they fail to factor in the resulting deleterious effects. Underreporting is a limitation common to passive surveillance systems, including the Vaccine Adverse Event Reporting System (VAERS) that monitors the safety of U.S.-licensed vaccines. Med. The Vaccine Adverse Event Reporting System acceptsany reports of adverse side effects following vaccination to help regulators detect potential problems. First, one should note how CHD does note that a VAERS entry does not demonstrate causation. Indeed, even if, as is estimated, only 10% of actual deaths after vaccination were reported to VAERS (which is the commonly listed level of underreporting for passive surveillance systems so frequently harped on by antivaxxers themselves, including RFK Jr.), that would still be roughly in the range of what we would expect to observe due to random chance alone (i.e., coincidence). Dans son article, le Dr Thomas remet en question lide que les vaccins sont toujours srs et ncessaires pour les enfants. 15. Unauthorized use of these marks is strictly prohibited. Why Did the CDC Silence the Million Dollar Harvard Project Charged With Upgrading Our Vaccine Safety Surveillance System? Truthsnitch.com. Pediatrics How 6. The degree of underreporting varies widely. The article then regurgitates RFK Jr.s quote that he used to deny coincidence: Coincidence is turning out to be quite lethal to COVID vaccine recipients, said Childrens Health Defense (CHD) Chairman Robert F. Kennedy, Jr. If the clinical trials are good predictors, the rate of coincidence is likely to increase dramatically after the second shot.. > The Vaccine Safety Data System. Intern. However, recent reports indicate a plausible causal relationship between the J&J/Janssen COVID-19 Vaccine and a rare and serious adverse event blood clots with low platelets which has caused deaths.. The https:// ensures that you are connecting to the This boy was born on June 30, 1998 and received the varicella vaccination on June 29, 2000. As for that last part about VAERS having been an abject failure, to support that claim RFK Jr. cites this: A critic familiar with VAERS shortcomings bluntly condemned VAERS in The BMJ as nothing more than window dressing, and a part of U.S. authorities systematic effort to reassure/deceive us about vaccine safety.. Her physician reassured her by saying: Do you think I would give the vaccination to my own children if I thought it wasn't safe? Her physician also informed her that state law mandates chickenpox vaccination but never told her that she could withhold her consent.

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