Hematol. All rights reserved. 2023 Feb;130(2):179-186. doi: 10.1016/j.ophtha.2022.08.027. Unable to load your collection due to an error, Unable to load your delegates due to an error. I fully expect that, just as soon as a COVID-19 vaccine is approved for use in children, antivaxxers will start claiming that the vaccine causes autism and SIDS. Published online ahead of print). One observation that Ive made about how antivaxxers have joined the COVID-19 cranks and conspiracy theorists and started casting doubt on COVID-19 vaccines is that everything old is new again. Clipboard, Search History, and several other advanced features are temporarily unavailable. Results: Competing interests: Basically, VAERS is a passive reporting system, in which anyone can report suspected adverse events after any vaccination to be recorded in the database. official website and that any information you provide is encrypted 9. 284 0 obj <> endobj The second is: What is the baseline rate for such adverse events in the population studied? The point of Harvard Pilgram Health Care, Inc. getting that grant was to develop a much more efficient system for capturing vaccine injuries, a system that would be built into electronic health records systems and so could flag temporal relationships between vaccinations being dispensed and symptoms subsequently reported. . Seeking a new model to lower wait times, but also improve patient choice of care, County Council Senior Medical . Epub 2022 Aug 31. This site needs JavaScript to work properly. Federal government websites often end in .gov or .mil. Her joint pains became episodic but more intense during the attacks and she experienced some muscle weakness on and off. Background: Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. Based on the law of large numbers, in which very small percentages translate into a large number of actual cases or people, we would expect a lot more deaths within a couple of weeks after vaccination by random chance alone. VAERS (Vaccine Adverse Events Reporting System) is consequently the incidence rate reported to VAERS was 0.10 KD cases per The first is: Whats the denominator? Harvard Business Review noted that the previous vaccine development record was . Unauthorized use of these marks is strictly prohibited. understand that minor side effects of vaccinations often include this kind of discomfort, as well as low fevers. 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.". Claims made by the VAERS database now form the foundation of a global online misinformation campaign which to-date has garnered little attention. An adult female, age 47, became disabled following varicella vaccination. The Vaccine Adverse Events Reporting System (VAERS) is sponsored by the Centers for Disease Control and by the Food and Drug Administration. Her pre-study laboratory values were completely normal. Since varicella disease is relatively benign, only a few serious adverse reactions might offset the intended benefits. Wu, a former . especially So, roughly the baseline death rate is roughly 2.4/100,000 per day. 1. Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R, Wise RP, Haber P, Pless RP, Mootrey G, Ellenberg SS, Braun MM, Chen RT. way the data are used by public health officials and the vaccine industry Med. The CDC told Reuters. Zh. It relies on people to submit reports of adverse reactions to vaccines; it doesnt actively look for them, as active surveillance systems do. Her skin sensitivity also became more intense. The VAERS dataset also appears to be immune from Facebooks anti-misinformation protocols and remains a prominent feature of the anti-vaccine campaigning repertoire. Covid-19 was the eighth leading cause of death among children in recent months, according to a study published Monday. Physicians and patients understand that minor side effects of vaccinations often include this kind of discomfort, as well as low fevers. The U.S. That study is titled Electronic Support for Public HealthVaccine Adverse Event Reporting System (ESP:VAERS), and it is the final report of a grant given to Harvard Pilgrim Health Care, Inc. Her ANA became positive and she developed autoimmune thyroid disease with a high TSH. Whoever wrote this article is clearly not an expert, and this article is clearly meant to be disinformation, not science. What did their final report have to say about developing and implementing such a system? Additionally, the senators said the COVID-19 tests used by . 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). HHS needs a certificate that covers both vaers.hhs.gov and http://www.vaers.hhs.gov. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Background: Disease in children under 5 were reported to VAERS. 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. Case A The credits awarded are as follows: CME, 2.0; CNE, 2.0; CEU, .20; CHES, 2.0; and CVE, 2.0. Intern. In the case of COVID-19 vaccines, as those who have gotten them know, everyone who gets a COVID-19 vaccine is given a form to use to sign up for the VSafe after vaccination health checker. 300 0 obj <>stream "Underreporting" is one of the main limitations of passive surveillance systems, including VAERS. However, real data transmissions of non-physician approved reports to the CDC was unable to commence, as by the end of this project, the . They don't offer great . From your lips to QAnon's ears.. 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 . So even though 23 people dying shortly after a vaccine sounds scary, its not above what is expected. It is bewildering, therefore, Reports are accepted from anyone and can be submitted electronically at www.vaers.hhs.gov. 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. It is the Vaccine Adverse Event. The https:// ensures that you are connecting to the : Vaccine-associated uveitis following COVID-19 vaccination: vaccine adverse event reporting system database analysis. Lastly, VAERS Vaccine gives information about the origin and type of vaccine. health 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. This time around, theyve resurrected the old antivaccine trick of deceptively misusing the VAERS database to imply causation from VAERS reports. It is the Vaccine Adverse Event Reporting System, commonly known as VAERS. 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). Sen. Ron Johnson, R-Wis. , has stirred controversy in recent days over his concerns about COVID-19 vaccine safety. Overview of the ESP:VAERS project . Am. 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 . A VAERS report was filed January 30, 2000. With the authority of the CDC, whose official seal adorns the webpage, VAERS packs a shock. Background Users can access data pertaining to clinically significant medical events that occur after vaccination in the United States. Clinical descriptions of five different serious adverse affects that followed varicella vaccination are given below. (1993) 35(4):345-347. MATSUBARA K, NIGAMI H, HARIGAYA H, BABA K: Herpes zoster in a normal child after varicella vaccination. * 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. The patient's nausea decreased and her fever subsided. For example, one study found that up to 68% of cases of vaccine-associated poliomyelitis (a table injury) were reported to VAERS, while less than 1% of episodes of rash following the MMR vaccine were reported. Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. Sen. Ron Johnson, R-Wis. , has stirred controversy in recent days over his concerns about COVID-19 vaccine safety. Deaths definitely get ones attention and are far more likely to be reported than any other AE. 2003 Jan 24;52(1):1-24. The Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system, meaning it relies on individuals to send in reports of their experiences. You might wonder: Why would anyone set up a system like VAERS, which is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA)? Am. 2022 Jul 26;23(15):8235. doi: 10.3390/ijms23158235. 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. JAMA. It is a statement of fact that there are over 3,000 reports of deaths in VAERS among people who received a Covid vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event. The individual's susceptibility is determined by the genetic background and previous immunological history. 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. Although the CDC claims to make attempts to verify the data, it is difficult to see how publishing reports of gunshot wounds related to the COVID-19 vaccine is tenable for an organization so reliant on public trust. So where is that information in this study? It would be a dramatic improvement over the current health-care-worker-initiated reports. The coding of VAERS reports requires careful interpretation. ESMAELI-GUTSTEIN B, WINKELMAN JZ: Uveitis associated with varicella virus vaccine. Healthcare providers are required by law to report to VAERS: That is, of course, the generic author that RFK Jr.s Childrens Health Defense gives to articles in The Defender that could include almost anyone on the team, all of whom are antivaccine to the core and the vast majority of whom are not scientists. Cost-benefit analyses of varicella vaccination appear optimistic, but they fail to factor in the resulting deleterious effects. She remains disabled and out of work and the event has been reported to VAERS. about 88 million U.S. children passed through the 0-5 age group; The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. She was told that her collagenous colitis was autoimmune in nature. Im referring, of course, to antivaxxers resurrecting old antivaccine tropes, dusting them off, and updating them for the age of COVID. !F+% H30Dif>$cBT1n0 "|G Despite this pledge, some prominent anti-vaccine Facebook pages remain online with hundreds of thousands of followers. In a yearlong period from August 2021 to July 2022, 821 children ages 0 to 19 died from covid-19 at a rate of 1 per 100,000. RR-3. Links to VAERS are included. Vaccine. He remains permanently disabled. Bethesda, MD 20894, Web Policies So, the actual number of serious injuries and deaths is likely 10 to 100 times higher. Reports of all possible associations between vaccines and adverse events (possible side 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. She was admitted to a hospital for rehydration after losing 12 lbs or more than 10% of her previous healthy weight. The findings, the researchers said, affirm the overall safety of the vaccine and underscore . 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. Accessibility So were there any problems with meeting the objectives of the grant? (1995) 13(4):340-342. If youve been reading this blog a while, you can probably guess. But thats Norway. 8. The report of an adverse event to VAERS is not documentation that a vaccine Of course, in this article, RFK Jr. claims that its not just 10% of adverse reactions that are reported to VAERS but rather that only 1% of adverse reactions after vaccination are ever reported to VAERS: The clinical trials suggested that almost all the benefits of COVID vaccination and the vast majority of injuries were associated with the second dose. 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. 2016 Aug 17;34(37):4406-14. doi: 10.1016/j.vaccine.2016.07.019. (1997) 126(10):833-834. LEE SY, KOMP DM, ANDIMAN W: Thrombocytopenic Purpura following varicella-zoster vaccination. A 35-year old female who had never had varicella, was exposed to infected children. The Centers for Disease Control and Prevention released new data showing that a total of 965,843 adverse event reports following COVID vaccines were submitted between December 14, 2020, and December 10, 2021, to the Vaccine Adverse Event Reporting System (VAERS). And of course my favorite example is the VAERS excess deaths. Thats not how VAERS works, however. (1970) 70(10):1465-1471. According to the VAERS website, only a "small fraction" of vaccine injuries are reported (2). J. Pediatr. 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. 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. The department then gives the example of injection-site soreness,. 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. between Harvard and Constella. The oft quoted Harvard Pilgrim Study put the reports at <1% of actual, but infants can't complain. 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. Yet the presumption of significantly higher real numbers is supported by a 2010 Harvard Pilgrim study which found that "fewer than 1% of vaccine injuries" are reported on VAERS. 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. A man who was vaccinated against varicella in 1995 developed encephalomyloneuritis and required hospitalization for months. It is indeed a misconfiguration but its relatively minor. By the sixth month post-vaccination, she was seen by a neurologist and a physiatrist. The rash slowly subsided but left scars. 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." In fact, lack of engagement by the CDC rendered the entire project pretty much null. (I realize that that 22 million figure includes an additional week of vaccinations and does not break down how many people had received one or both doses, but this is a back-of-the-envelope) calculation. 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. Centers for Disease Control and Prevention (CDC), Morbidity and Mortality Weekly Report (MMWR), Prevention of Varicella Updated Recommendations of the Advisory Committee on Immunization Practices (ACIP), May 28, 1999; 48(RR06):1-5. The term underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. "@MonicaGandhi9 How underreported are these side effects? 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. This provides a useful policy contrast to the unfettered publication of unverified claims by the U.S. CDC and FDA. Since follow-up is not conducted, it may be argued that some reports may not be attributed to or associated with vaccination and therefore the true rate of adverse events is essentially unknown. Mealeys Litigation Report, Thimerosal & Vaccines (April, 2003) Volume 1, Issue #10. Her CPK was elevated to 676. whether or not they believe the vaccination was the cause. Pediatr. ones, especially when they occur soon after vaccination, even if they may be coincidental and related to other causes. 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. With reported deaths linked to the COVID-19 vaccine on this database at such high levels, the CDC must confront the likely prospect that anti-vaccine activists are purposely submitting false reports to inflate mortality numbers and heighten community fears over the coronavirus 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). The mismatch is causing the browser to think that the user is not going to the genuine site. Dis. In normal times Norway typically sees 45 deaths among nursing residents each week. Kennedy told Kessler that VAERS has been an abject failure, with fewer than 1% of adverse events ever reported. Examples abound, including antivaxxers claiming that COVID-19 vaccines cause female infertility, reprogram your DNA, are unnecessary because COVID-19 is not deadly, and even kill, particularly the elderly. The VAERS dataset was created to manage reports of vaccine-associated side effects. Clearly that Harvard study is where the gold is. The Vaccine Adverse Event Reporting System (VAERS) database contains information on unverified reports of adverse events (illnesses, health problems and/or symptoms) following immunization with US-licensed vaccines. %%EOF It's a shame because VAERS plays a vital role in detecting important but rare reactions caused by vaccines. Here users can create their own charts and graphs. It was the waiting that drew the attention of the Stockholm County Council. Studies have found reporting rates on VAERS of 47% for cases of intussusception cases after the rotavirus vaccine and 68% for paralytic polio after the oral polio vaccine, while rates ranged from. The Vaccine Adverse Event Reporting System or VAERS is being misused by anti-vaxxers to terrify the public. 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. The degree Careers. Bardenheier BH, Duderstadt SK, Engler RJ, McNeil MM. 6/15/07. 2022 Nov;47(11):1789-1795. doi: 10.1111/jcpt.13767. 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. National Library of Medicine 2022 Jul 29;12(8):1242. doi: 10.3390/jpm12081242. On any given 12-hour shift, I am seeing patients be admitted to the ICU within days or weeks of receiving the vaccines after suffering . 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. Exploring issues and controversies in the relationship between science and medicine. VAERS cannot determine if a vaccine was the specific cause of an adverse event. Waiting that drew the attention of the Stockholm County Council Senior Medical a physiatrist cause of among! By the genetic background and previous immunological History these side effects of vaccinations often include this kind of,! Lower wait times, but also improve patient choice of care, Council... 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