As an example, a great many of the millions of vaccinations administered each year by injection cause soreness, but relatively few of these episodes lead to a VAERS report. Vaccine Adverse Event Reporting System (VAERS). Both thought that she could have Guillian-barre syndrome. 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. The time period for the VAERS report runs from December 14, 2020 (the first day COVID-19 vaccines were generally available) to January 22, 2021. . Case A 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. 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. Pediatr Infect Dis J 29:483, 2010) Even for infants 3-6 Cost-benefit analyses of varicella vaccination appear optimistic, but they fail to factor in the resulting deleterious effects. Med. 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.. Copyright The President and Fellows of Harvard College, Administration for Children and Families Database, Harvard T.H. Chan School of Public Health. 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. (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. He developed convulsions the following day, was hospitalized, and reportedly recovered. 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. Mercolas reference #7 is superfluous, because it also references #6. 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!) No competing interests, Medical Veritas International (MVI), P.O. Paediatr. He was treated again with Acyclovir. The Centers for Disease Control and Prevention did not respond to HPR requests for comment. 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. about 88 million U.S. children passed through the 0-5 age group; Dr. Gorski's full information can be found here, along with information for patients. Maintained/created by: Centers for Disease Control, Food and Drug AdministrationWebsite: http://vaers.hhs.gov/data/indexGeographic unit of data: U.S National, U.S. State, Keywords: adverse event, CDC, FDA, Reporting, side effects, vaccination, vaccine, Users can access data pertaining to clinically significant medical events that occur after vaccination in the United States. She was seen by her physician because of an irregular heart rate and an ECG revealed supra ventricular extra systoles and left ventricular hypertrophy. According to the VAERS data, of the 329 reported deaths, 285 were from the U.S., and 44 were from other countries. consequently the incidence rate reported to VAERS was 0.10 KD cases per Vaccine Adverse Event Reporting System (VAERS) is a reporting system that anyone can report to or access data from. References Wu, a former . 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. Despite this pledge, some prominent anti-vaccine Facebook pages remain online with hundreds of thousands of followers. JAMA. So, the actual number of serious injuries and deaths is likely 10 to 100 times higher. Careers. So, roughly the baseline death rate is roughly 2.4/100,000 per day. A certain number of 80+ year olds die every day. 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. 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). Epub 2022 Sep 11. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The degree Wrensch et al. In a July 13 letter to health agency leaders, Johnson noted a press conference he . Baton Rouge Louisiana RN Whistleblower on Underreporting of Serious Adverse Effects of Covid Vaccines; Letter to US Senator Johnson: . Table 1 presents a comparison of the number of adverse reactions reported to VAERS for the varicella vaccine with 4 other different vaccines. and nurses do not know about VAERS and what is required to be reported. Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. We estimated VAERS reporting rates following vaccination for anaphylaxis and GBS. HHS needs a certificate that covers both vaers.hhs.gov and http://www.vaers.hhs.gov. The true figure is likely to be significantly higher as Keyhole excludes Instagram and private Facebook groups from its analytics. It's a shame because VAERS plays a vital role in detecting important but rare reactions caused by vaccines. When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. Moreover, anyone can submit a report to VAERS, and they do, including parents of autistic children seeking compensation for their childrens autism as being due to vaccine injury. 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. No proof that the event was caused 2022 Jul 29;12(8):1242. doi: 10.3390/jpm12081242. While her lymphocytes decreased from 25 to 14%, her total white count, neutrophils and eosinophils increased. Case D The VAERS system keeps track of any unusual or unexpected adverse events that occur after vaccine administration. She underwent a colonoscopy and was diagnosed with the rare and more serious collagenous colitis. "'Underreporting' is one of the main limitations of passive surveillance systems, including VAERS," HHS says on its website. Objectives: For instance, in todays Mercola.com newsletter there is an article summarizing Dr. Mercolas interview with Dr. Vladimir Zelenko. Case C 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. Neurol. Physicians and patients Singh RB, Parmar UPS, Kahale F, Agarwal A, Tsui E. Ophthalmology. More generally: The chance of dying in an average week for those over 80 is about 0.2% or 1 in 500. 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. They also allow users to verify that they are connected to the real web site, rather than a hackers web site. On June 12, 2003 (age 5), he had a unilateral shingles eruption on the back of his neck. (1995) 37(5):648-650. 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. He had moderate pain and the lesions were tender and sensitive to clothing. Overview of the ESP:VAERS project . 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. VAERS reports associated with Varicella, DTaP, Hep B, Hib, and MMR vaccines through December, 2003. trial that found a 5-fold KD risk associated with RotaTeq--RR=4.9; 95% CI 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. A report to VAERS generally does not prove that the identified vaccine(s) caused the adverse event described. But thats Norway. Fetterman's Wife Abruptly Fled the Country After He Was Hospitalized. to other vaccines and other serious clinical problems. VAERS (Vaccine Adverse Events Reporting System) is She developed diarrhea shortly after the second dose and by November 2001, she was quite ill and had serious intestinal difficulties. 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. Competing interests: 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. Approximately two hours following vaccination, a transient welt developed at the injection site with a 3-inch line of lymphangitis. 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 grant: native advertising "Adverse events from drugs and vaccines are common, but underreported. Vaccine. Prior research has shown that only a fraction of adverse events are. Consider this part 2 of my post from two weeks ago, the VAERS edition. The National Childhood Vaccine Injury Act (NCVIA) of 1986 requires health professionals and vaccine manufacturers to report to the U.S. Department of Health and Human Services specific adverse events that occur after the administration of routinely recommended vaccines. Its basically against public health and any collective action to protect public health. Links to VAERS are included. 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. The department then gives the example of injection-site soreness,. She worked as a research coordinator in the infectious disease unit of a Medical School. annually vaccine-caused illness? 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. He was listless and had some rhinorhea but remained afebrile. 11. Claims made by the VAERS database now form the foundation of a global online misinformation campaign which to-date has garnered little attention. We know according to a Harvard study that VAERS is only thought to represent 1% of actual injuries." 20.8 per 100,000 person-years. Kennedy told Kessler that VAERS has been an abject failure, with fewer than 1% of adverse events ever reported. GERECITANO J, FRIEDMAN-KIEN A, CHAZEN GD: Allergic reaction to varicella vaccine. 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. This may sound similar to another argument that many COVID-19 deaths in older adults are deaths that would have happened anyway. On the other hand, more serious and unexpected medical events are probably more likely to be reported than minor ones, especially when they occur soon after vaccination, even if they may be coincidental and related to other causes. 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. the 18-year period from 1990 through 2007 just 88 cases of Kawasaki The weaponization of VAERS by anti-vaccine activists serves as a reminder that having access to more information does not always lead to better decisions. 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. I assume the claim from Kirsch is based on a 10 year old report from Harvard-Pilgrim insurance showing that only ~1% of drug related adverse effects are reported. * Adults that developed gliomas were more likely to never have had varicella. According to open Vaers, almost 9k have died from the vaccine in the US. %PDF-1.6 % Mercola, just a few paragraphs below that, emphasizes the point: Studies have indicated it could be as low as 1%.6,7. Am. (1995) 13(4):340-342. During 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. This brings us to the second question: Whats the baseline rate? The Vaccine Adverse Events Reporting System (VAERS) is sponsored by the Centers for Disease Control and by the Food and Drug Administration. 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. 2006 the published KD incidence for U.S. children under 5 rose from 11.0 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. An official website of the United States government. (1970) 70(10):1465-1471. Results: 2, 3 Reasons for clinician under-reporting might include failure to associate an acute health event to recent vaccines, lack of awareness of VAERS, the misperception that only serious events should be reported, or lack of This provides a useful policy contrast to the unfettered publication of unverified claims by the U.S. CDC and FDA. VAERS (Vaccine Adverse Events Reporting System) is the voluntary system used in the U.S. to signal vaccine side effects. (Ophthalmology. Vaccine-Associated Uveitis after COVID-19 Vaccination: Vaccine Adverse Event Reporting System Database Analysis. First, lets get back to the question of the denominator. (2000) 284:1271-1279. Keep in mind, this system would have extracted probable vaccine injury information from patient charts and fed it directly into the VAERS system. The answer is 0.000015. VAERS Symptoms lists the symptoms of the adverse event. 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). 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). We are constantly exposed to a wide variety of viral antigens that cause our immune system to develop antibodies against them. 3. way the data are used by public health officials and the vaccine industry In addition, even vaccine manufacturers have calculated at least a "fifty-fold underreporting of adverse events" on this system. 14. They don't offer great . 57, No. A spokesperson for the Australian governments Therapeutic Goods Administration told the HPR that the Australian TGA is aware that CDC VAERS data is being used to promulgate anti-vaccination views and noted that the Australian reporting system employs a 90-day delay to allow authorities to verify information before it becomes public. The degree of underreporting varies widely. RAVKINA LI, MATSEVICH GR: Morphological changes in the central nervous system in post-vaccinal encephalomyelitis developing after chickenpox vaccination in children. (Pediatr Infect Dis J 28:943, 2009) From 1988 to Dis. 112:495, 2003. It is the Vaccine Adverse Event Reporting System, commonly known as VAERS. The rash slowly subsided but left scars. 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)? Exogenous exposures to wild type varicella have previously contributed a significant immunologic boosting effect that helps suppress the reactivation of herpes-zoster. He took Acyclovir Oral Suspension (200mg/5ml): Two teaspoons 4 times a day for 5 days. Case "C" An adult female, age 47, became disabled following varicella vaccination. An EMG revealed involvement in an ulnar distribution. National Center for Complementary and Integrative Health, Steven P. Novella, MD Founder and Executive Editor, David H. Gorski, MD, PhD Managing Editor, unnecessary because COVID-19 is not deadly, 329 Deaths + 9,516 Other Injuries Reported Following COVID Vaccine, Latest CDC Data Show, Mark and David Geiers epically bad study, similar back-of-the-envelope calculations, Excess mortality during the pandemic has been VERY high, falling for an antivaccine conspiracy theory, against public health and any collective action, surgical oncologist at the Barbara Ann Karmanos Cancer Institute, American College of Surgeons Committee on Cancer Liaison Physician, Melanoma: A Pseudoepidemic of Skin Cancer Prompts New Screening Recommendations. 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. But definitely its being underreported.. Basically, the 1% gambit with respect to what percentage of adverse reactions are reported to VAERS has entered the realm of antivax talking points, as RFK Jr.s article demonstrates. associated with RotaTeq would translate to an extra 4000 U.S. cases Am. As with all antivax talking points, its meant to deceive. S. S. Korsakova. 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. POSER CM: Neurological Complications of Vaccinations. VAERS accepts reports from anyone, including patients, family members, healthcare providers and vaccine manufacturers. Epub 2020 Jul 21. J. Epidem. Sen. Ron Johnson, R-Wis. , has stirred controversy in recent days over his concerns about COVID-19 vaccine safety. Clipboard, Search History, and several other advanced features are temporarily unavailable. Now, add this to the mix, for comparison: how many people are dying of COVID in the US per day? The report of an adverse event to VAERS is not documentation that a vaccine caused the event. Vaers records 321 cases of myocarditis within five days of receiving a vaccination, falling to almost zero by 10 days. 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. LEE SY, KOMP DM, ANDIMAN W: Thrombocytopenic Purpura following varicella-zoster vaccination. 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. Share on Facebook, opens a new window Local Australian health authorities blasted the spreading of the false reports telling residents to take-off their tin-foil hats.. This type of propaganda is so harmful to our County residents, with The Mountaineer reporting 84 people who have lost their lives and over 3600 who have contracted Covid-19 right here in Haywood. (1989) 160(3):535-537. The findings, the researchers said, affirm the overall safety of the vaccine and underscore . Exploring issues and controversies in the relationship between science and medicine. Given that anyone can report any suspected adverse event, VAERS is intended to be an early warning system. Two months later on May 13, 2004 he had still another recurrence with moderate pain, in the same location as previously mentioned. and transmitted securely. in young children. However, real data transmissions of non-physician approved reports to the CDC was unable to commence, as by the end of this project, the . We defined reporting sensitivity as the VAERS reporting rate divided by the VSD incidence rate. "@MonicaGandhi9 How underreported are these side effects? Methods: A study about it found less than 1% were reported (3). government site. If you are a potential patient and found this page through a Google search, please check out Dr. Gorski's biographical information, disclaimers regarding his writings, and notice to patients here. In other words, it would have dramatically increased both the accuracy and the number of vaccine injuries reported to VAERS. Jpn. especially 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. ) That one earned a much belated Godzilla facepalm: When Godzilla gives you the facepalm, you know the failure is monstrous. There is no confirmed evidence of a COVID-19 vaccine causing the death of even one child. Maybe only 10% are being reported. To test the correlations found in VAERS requires different systems, systems such as the Vaccine Safety Datalink (VSD) or others, which are active safety monitoring databases in which investigators actively scan real medical records and insurance claims data to seek increases in frequencies of adverse events after vaccination and try to determine if there is a real association. Adverse event; Passive surveillance; Vaccine; Vaccine Adverse Event Reporting System (VAERS); Vaccine safety. My topic here is not VAERS generally, but a number that recurs often in discussions about the vaccine injury reports VAERS contains. Hearing disorder following COVID-19 vaccination: A pharmacovigilance analysis using the Vaccine Adverse Event Reporting System. How? If confirmed by a larger trial, the KD The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. 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." It was the waiting that drew the attention of the Stockholm County Council. 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. Usefulness of Vaccine Adverse Event Reporting System for Machine-Learning Based Vaccine Research: A Case Study for COVID-19 Vaccines. Users are claiming that the U.S. Centers for Disease Control and Prevention deleted reports of 6,000 deaths from the U.S. Would you like email updates of new search results? As an amusing aside, whenever I discuss VAERS, I like to recount the tale of how in 2006 Jim Laidler infamously reported to VAERS that the flu vaccine had turned him into The Incredible Hulk and VAERS accepted the report. 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. The literature contains a surprising number of adverse reactions following varicella vaccination [3-12] including vaccine strain HZ in children and adults [13,14]. VAERS is a government database managed by the Centers for Disease. It should therefore be no surprise that antivaxxers are now using VAERS to try to portray COVID-19 vaccines as harmful or even deadly. VAERS is a national vaccine safety surveillance program that helps to detect unusual or unexpected reporting patterns of adverse events for vaccines. Reports vary in quality and completeness. providers, patients, or family members. Epub 2016 Jul 19. A 35-year old female who had never had varicella, was exposed to infected children. 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. 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. We also know that underreporting is less common for more severe adverse reactions than for those that are more mild. Clearly that Harvard study is where the gold is. Monitoring the safety of high-dose, trivalent inactivated influenza vaccine in the vaccine adverse event reporting system (VAERS), 2011 - 2019. whether or not they believe the vaccination was the cause. J. Infect. Thats 40 days, if you count December 14, 2020. so wed expect 96/100,000 deaths during that 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%. official website and that any information you provide is encrypted (1997) 126(10):833-834. (1997) 99(2):263-264. This site needs JavaScript to work properly. 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. Please enable it to take advantage of the complete set of features! There is no citation for that sentence. Here users can create their own charts and graphs. VAERS is a postmarketing surveillance program, collecting information about adverse events (possible harmful side effects) that occur after administration of vaccines to ascertain . 2020 Jul 22;38(34):5464-5473. doi: 10.1016/j.vaccine.2020.06.038. febrile (2001) 154(2):161-165. 300 0 obj <>stream 15. Reports are accepted from anyone and can be submitted electronically at www.vaers.hhs.gov. Boosting effect that helps to detect unusual or unexpected Reporting patterns of events. My topic here is not documentation that a vaccine affirm the overall safety of Stockholm. Figure is likely to be reported: Thrombocytopenic Purpura following varicella-zoster vaccination hackers web site rather. Vaers ) is vaers underreporting harvard by the Centers for Disease Control and by the VAERS Database now form foundation. Boosting effect that helps to detect unusual or unexpected Reporting patterns of adverse reactions than those! 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When evaluating data from VAERS, almost 9k have died from the vaccine adverse events ever reported figure is 10... Serious collagenous colitis Administration for children and Families Database, Harvard T.H felt humiliated into allowing her daughter receive!

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