It relies on people to submit reports of adverse reactions to vaccines; it doesnt actively look for them, as active surveillance systems do. 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)? 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. Sen. Ron Johnson, R-Wis. , has stirred controversy in recent days over his concerns about COVID-19 vaccine safety. Accessibility 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. Baton Rouge Louisiana RN Whistleblower on Underreporting of Serious Adverse Effects of Covid Vaccines; Letter to US Senator Johnson: . 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. Anyone can submit a report to VAERS, including parents and patients. (Pediatr Infect Dis J 28:943, 2009) From 1988 to As I will show, antivaxxers are playing an old game with new vaccines. Methods: So how are antivaxxers weaponizing VAERS? Whoever wrote this article is clearly not an expert, and this article is clearly meant to be disinformation, not science. COVID-19 Vaccines and Myopericarditis: A Nuanced Story. Ann. VAERS is a publicly available, searchable database of reports that have not been verified. Thats not to say that only severe or serious adverse reactions should be reported. 2003 Jan 24;52(1):1-24. Published online ahead of print). LEE SY, KOMP DM, ANDIMAN W: Thrombocytopenic Purpura following varicella-zoster vaccination. Claims made by the VAERS database now form the foundation of a global online misinformation campaign which to-date has garnered little attention. How? VAERS is co-sponsored by the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), agencies of the U.S. Department of Health and Human Services (HHS). A man who was vaccinated against varicella in 1995 developed encephalomyloneuritis and required hospitalization for months. 2022 Jul 29;12(8):1242. doi: 10.3390/jpm12081242. A VAERS report was filed January 30, 2000. As Dr. Vincent Iannelli points out: Still, although reports to VAERS are underreported, they are almost certainly not underreported by as much as some folks believe. The patient's nausea decreased and her fever subsided. The point of the grant given was to develop a more accurate system for capturing vaccine injuries, one that mined electronic medical records in real time, generating flags and reports for physician approval of automated submission to VAERS. 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. Careers. VAERS is a passive surveillance system that relies on the willingness of individuals and professionals to submit reports voluntarily. Mercolas reference #7 is superfluous, because it also references #6. InDepthNH.org - The New Hampshire Center for Public Interest . Am. VAERS is the primary mechanism for reporting adverse vaccine reactions in the U.S. Reports submitted to VAERS require further investigation before confirmation can be made that an adverse event was linked to a vaccine. It is indeed a misconfiguration but its relatively minor. He remains permanently disabled. (2001) 154(2):161-165. annually As is stated on the VAERS website: Underreporting is one of the main limitations of passive surveillance systems, including VAERS. 7. 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. No, seriously, look at the stupidity on display here: For over three weeks, the website of the US government Vaccination Adverse Reporting System (VAERS) has been inaccessible to most users. Twenty-eight months following varicella vaccination (October 29, 2002), he developed breakthrough chickenpox with an estimated 30 to 40 lesions that were intensely itchy. 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. 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. He remains permanently disabled. 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 6. Bardenheier BH, Duderstadt SK, Engler RJ, McNeil MM. RR-3. 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. Clearly that Harvard study is where the gold is. Again, these are back-of-the-envelope calculations, but theyre close enough to make the point. 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. Adverse events following pandemic influenza A (H1N1) 2009 monovalent and seasonal influenza vaccinations during the 2009-2010 season in the active component U.S. military and civilians aged 17-44years reported to the Vaccine Adverse Event Reporting System. The reason he is concerned is that this is in contrast to the last five flu seasons, over the course of which there have been 119 reports of deaths to VAERS among people who received a seasonal flu vaccine. Copyright The President and Fellows of Harvard College, Administration for Children and Families Database, Harvard T.H. MMWR Surveill Summ. Therefore, vaccine providers are encouraged to report all adverse events following vaccination, Cost-benefit analyses of varicella vaccination appear optimistic, but they fail to factor in the resulting deleterious effects. Table 1 presents a comparison of the number of adverse reactions reported to VAERS for the varicella vaccine with 4 other different vaccines. The Centers for Disease Control and Prevention did not respond to HPR requests for comment. There is no confirmed evidence of a COVID-19 vaccine causing the death of even one child. Overview of the ESP:VAERS project . 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. to Kennedy told Kessler that VAERS has been an abject failure, with fewer than 1% of adverse events ever reported. In other words, it would have dramatically increased both the accuracy and the number of vaccine injuries reported to VAERS. This 3.5-year-old boy from Georgia who had no pre-existing conditions, received a dose of varicella vaccine on May 12, 1995. The high mean of 3,000 reports/year is attributed to the Hepatitis B vaccine, followed next by a mean of 2,350 reports/year attributed to varicella vaccine (Table 1). And of course my favorite example is the VAERS excess deaths. 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. With the rollout of COVID-19 vaccines continuing apace, so are the efforts of antivaxxers to portray the vaccines as dangerous. So were there any problems with meeting the objectives of the grant? Pediatr Infect Dis J 29:483, 2010) Even for infants 3-6 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. whether or not they believe the vaccination was the cause. In a July 13 letter to health agency leaders, Johnson noted a press conference he . Deaths definitely get ones attention and are far more likely to be reported than any other AE. Many physicians consider vaccination extremely safe and parents or patients are not provided with information regarding potential adverse outcomes. the 18-year period from 1990 through 2007 just 88 cases of Kawasaki POSER CM: Neurological Complications of Vaccinations. 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. How Thus, if you vaccinated 40,000 80+ year olds, you would expect about 80 deaths out of that group within one week *just by coincidence*. Case "B" A man who was vaccinated against varicella in 1995 developed encephalomyloneuritis and required hospitalization for months. period 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%. 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 individual's susceptibility is determined by the genetic background and previous immunological history. Med. Reports of all possible associations between vaccines and adverse events (possible side This provides a useful policy contrast to the unfettered publication of unverified claims by the U.S. CDC and FDA. Here is the statement, with a bit of context: Adverse events from drugs and vaccines are common, but underreported. The Department of Health and Human Services (HHS) awarded Harvard Medical School a $1 million grant to track VAERS reporting at Harvard Pilgrim Healthcare for three years and develop an automated reporting system that would . Whos Really Responsible for Climate Change? From your lips to QAnon's ears.. Jpn. Case C cases were reported to VAERS. Source information from U.S. Government VAERS data base, 1990-2003, http://www.medalerts.org/vaersdb Harvard Business Review noted that the previous vaccine development record was . 10. 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). J Pers Med. 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. It was the waiting that drew the attention of the Stockholm County Council. As I like to say, the greatest strength of VAERS is that anyone can report anything to it, but simultaneously the greatest weakness of VAERS is that anyone can report anything to it. 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. Additionally, the senators said the COVID-19 tests used by . 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. But definitely its being underreported.. suggest a novel finding that adults who have not had prior varicella-zoster virus (VZV) infection (including onset of chickenpox) are more likely to have gliomas (brain tumors) than adults who have had prior infection [10]. So where is that information in this study? Sadly, those over 80, especially those already frail enough to be a nursing home, already have high BASELINE mortality. Information needs to be . When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. (Pediatrics 111:448, 2003. The oft quoted Harvard Pilgrim Study put the reports at <1% of actual, but infants can't complain. At the end of the document is not a list of supporting citations, but only a list of publications by the organization on the topic of the automated adverse event reporting. VAERS reports can be submitted voluntarily by anyone, including healthcare providers, patients, or family members. 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. Case E An official website of the United States government. Moreover, the CDC and FDA do not restrict what people can report, as long as it happened at some point following a vaccination. especially Hematol. Lastly, VAERS Vaccine gives information about the origin and type of vaccine. Unsurprisingly, RFK Jr. fails to mention that the BMJ article to which he refers is a BMJ Rapid Response, which is basically a comment section that is not peer-reviewed that cranks love to use to post their ramblings and then cite them as though they were legitimate articles in The BMJ. We know according to a Harvard study that VAERS is only thought to represent 1% of actual injuries." (27.2.23) Die dunklen Seiten von grnen Technologien - Seit 2020 sind die Preise fr kritische Rohstoffe rapide angestiegen und halten sich seit Ende 2022 auf hohem Niveau. An HPR Keyhole analysis of social media indicates that over a 24-hour period in March, an expected 350,000 people had viewed or interacted with anti-vaccine information originating from the VAERS database. 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. During the 18-year period from 1990 through 2007 just 88 cases of Kawasaki Disease in children under 5 were reported to VAERS. 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 . Reports vary in quality and completeness. However, the CDC and FDA have never required the vaccine manufacturers to publicly divulge the number of vaccines contained in a given lot. SINGER S, JOHNSON CE, MOHR R, HOLOWECKY C: Urticaria following varicella vaccine associated with gelatin allergy. The VAERS system keeps track of any unusual or unexpected adverse events that occur after vaccine administration. Would you like email updates of new search results? by the vaccine is required in order for VAERS to accept the report. On the other hand, more serious and unexpected medical events are probably more likely to be reported than minor VAERS is the primary government-funded system for reporting adverse reactions to . All rights reserved. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. providers, patients, or family members. He received a third course of Acyclovir and the rash resolved after a month. She was seen by her physician because of an irregular heart rate and an ECG revealed supra ventricular extra systoles and left ventricular hypertrophy. Competing interests: Clipboard, Search History, and several other advanced features are temporarily unavailable. HHS Vulnerability Disclosure, Help The Team mentions Dr. Gregory Michaels and his death from immune thrombocytopenic purpura (ITP), which has not been shown to be related to the COVID-19 vaccine. Data is also available through the CDC wonder interface by clicking on the CDC wonder link at the top of the page. Singh RB, Parmar UPS, Kahale F, Agarwal A, Tsui E. Ophthalmology. Paediatr. Im. in young children. 6/15/07. 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,. ones, especially when they occur soon after vaccination, even if they may be coincidental and related to other causes. "Underreporting" is one of the main limitations of passive surveillance systems, including VAERS. National Library of Medicine This time, the pain was more severe. Consider this part 2 of my post from two weeks ago, the VAERS edition. There is no citation for that sentence. VAERS (Vaccine Adverse Events Reporting System) is the voluntary system used in the U.S. to signal vaccine side effects. Symptoms represent the medical condition (s) in the adverse event description and lab data from the VAERS Report Form. A report to VAERS generally does not prove that the identified vaccine(s) caused the adverse event described. 20.8 per 100,000 person-years. . Epub 2016 Jul 19. As such, I think it is somewhat sloppy science to reference the Harvard study as support of VAERS underreporting. Ophthalmology. No competing interests, Copyright 2023 BMJ Publishing Group Ltd, Womens, childrens & adolescents health. The credits awarded are as follows: CME, 2.0; CNE, 2.0; CEU, .20; CHES, 2.0; and CVE, 2.0. to learn Results: Because of this mismatch, the browser is rejecting it. The rash slowly subsided but left scars. to other vaccines and other serious clinical problems. Voices for Vaccines, How I Went From Dressing Up As Measles to Hoping for My COVID Vaccines, April 28, 2021. My topic here is not VAERS generally, but a number that recurs often in discussions about the vaccine injury reports VAERS contains. 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. 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.. They also dont understand how the antivaccine movement has always been about more than just vaccines. Some infants will experience these medical events shortly after a vaccination by coincidence. Vaccine. 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. The shock of Covid-19 hit in different ways for Xiao Wu, a 27-year-old Ph.D. student in Harvard's public health school, and his academic adviser, biostatistician Francesca Dominici. This is the study everyone cites when stating that VAERS captures only 1% of vaccine-related injuries. 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. We are constantly exposed to a wide variety of viral antigens that cause our immune system to develop antibodies against them. 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. hb```i Ab,X,YsbW``XddTy d`4[Y,A ! With the authority of the CDC, whose official seal adorns the webpage, VAERS packs a shock. More generally: The chance of dying in an average week for those over 80 is about 0.2% or 1 in 500. The https:// ensures that you are connecting to the He developed convulsions the following day, was hospitalized, and reportedly recovered. FOIA 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 . He had moderate pain and the lesions were tender and sensitive to clothing. This brings us to the second question: Whats the baseline rate? During the same Similarly, as expected, antivaxxers point to anecdotes of bad things happening to people after receiving the vaccine that are almost certainly coincidences and not related to the vaccine and are weaponizing them to spread fear. Later in the article, CHD starts listing all the anecdotes and other reports that antivaxxers have been flogging. VAERS reports vary in quality and completeness and under-reporting, especially of mild and self-limiting AEs, appears common. In the time since the CDC was approached for comment by the HPR, the shareable buttons have been removed from the site. effects) are filed in VAERS. HHS needs a certificate that covers both vaers.hhs.gov and http://www.vaers.hhs.gov. 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. No proof that the event was caused The Vaccine Adverse Events Reporting System (VAERS) is sponsored by the Centers for Disease Control and by the Food and Drug Administration. 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. Control and Prevention did not respond to HPR requests for comment by the VAERS system keeps track of unusual! Told Kessler that VAERS captures only 1 % of adverse events ever reported definitely get ones attention and far! To the he developed convulsions the following day, was hospitalized, and several other advanced features temporarily. Discussions about the vaccine captures only 1 % of adverse events from drugs and vaccines are common, theyre... Of reports that antivaxxers have been flogging, the pain was more severe a... Comment by the HPR, the VAERS system keeps track of any unusual or unexpected adverse from. 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Dying in an average week for those over 80 is about 0.2 % or 1 500.

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