The startling statistics are being shared far and wide by anti-vaccination activists and concerned readers alike. As with all antivax talking points, its meant to deceive. Reports vary in quality and completeness. 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. This, of course, is intended to increase reporting of adverse events to VAERS. Epub 2022 Sep 11. 20.8 per 100,000 person-years. VAERS reports can be submitted voluntarily by anyone, including healthcare providers, patients, or family members. VAERS reports vary in quality and completeness and under-reporting, especially of mild and self-limiting AEs, appears common. 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. First, lets get back to the question of the denominator. A 35-year old female who had never had varicella, was exposed to infected children. VAERS is a publicly available, searchable database of reports that have not been verified. Again, these are back-of-the-envelope calculations, but theyre close enough to make the point. The bottom line is that 285 deaths after COVID-19 vaccination reported to VAERS in a timeframe of 40 days is actually a very small number. Heres Seth Trueger: how many Americans typically die per day? 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. 1. Indeed, Facebook posts seen by the HPR with hundreds of engagements include the same verbatim instructions, copy and pasted, for users to disregard disclaimers. There is no confirmed evidence of a COVID-19 vaccine causing the death of even one child. The Vaccine Adverse Event Reporting System (VAERS) form : version 2.0 (proposed) October 30, 2014 By Shimabukuro, Tom T. Series: ACIP meeting Vaccine Safety English CITE Download Document Details Related Documents You May Also Like Details: Personal Author: Shimabukuro, Tom T. Corporate Authors: 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. Hematol. 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. 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. annually (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. Despite this pledge, some prominent anti-vaccine Facebook pages remain online with hundreds of thousands of followers. Patients, parents and caregivers are encouraged to report "any clinically important medical event or health problem that. 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. 10. febrile They mention Dr. Jerry Spivaks irresponsible quote in which he said that the thought it is a medical certainty that the vaccine was related. How can there possibly be over 16,000 reported in VAERS if nothing is going on? 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. Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. Ophthalmology. When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. So how are antivaxxers weaponizing VAERS? Conclusions: Approximately two hours following vaccination, a transient welt developed at the injection site with a 3-inch line of lymphangitis. ** The author writes concerning neurological complications, "There is no way of predicting who will have an adverse reaction to vaccination. VAERS accepts all reports without judging whether the event was caused by the vaccine. That purpose, contrary to what antivaxxers would have you believe, is not as the be-all and end-all of vaccine safety surveillance. Thats 1.3/100,000. 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. _RD0rt. Bardenheier BH, Duderstadt SK, Engler RJ, McNeil MM. 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 In a July 13 letter to health agency leaders, Johnson noted a press conference he . Objectives: J. Ophthalmol. 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). Risk increases with each dose of vaccine as well. 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. The first is: Whats the denominator? It is indeed a misconfiguration but its relatively minor. 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 . That claim is based on an old study about drug reactions and was not specific to vaccines. Known as the Vaccine Adverse Event Reporting System, or VAERS, the database includes hundreds of thousands of reports of health events that occurred minutes, hours or days after vaccination.. The Vaccine Adverse Event Reporting System (VAERS) is a valuable tool for post-marketing safety surveillance (monitoring after a product has been approved and is on the market). He had moderate pain and the lesions were tender and sensitive to clothing. Case B Oncol. Nevertheless, VAERS rates have been estimated to represent 5% to 10% of the true figure of adverse reactions. She underwent a colonoscopy and was diagnosed with the rare and more serious collagenous colitis. First, one should note how CHD does note that a VAERS entry does not demonstrate causation. 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). event underreporting. The VAERS dataset was created to manage reports of vaccine-associated side effects. 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. Her ANA became positive and she developed autoimmune thyroid disease with a high TSH. The .gov means its official. I know that this discussion began with It is worth pointing out that Harvard Pilgrim Health Care, Inc., has no affiliation with Harvard University. 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. Table 1 presents a comparison of the number of adverse reactions reported to VAERS for the varicella vaccine with 4 other different vaccines. The answer is 0.000015. (2003) 135(3):415-417. FOIA Methods: We estimated VAERS reporting rates following vaccination for anaphylaxis and GBS. Still, it's a good way to detect safety signals that weren't detected during premarket testing or clinical trials . A VAERS report was filed January 30, 2000. adverse Clipboard, Search History, and several other advanced features are temporarily unavailable. The US Vaccine Adverse Event Reporting System (VAERS) is "overwhelmed" with reports of vaccine adverse effects in the wake of the COVID-19 vaccination campaign, cardiologist Dr. Peter. It's a shame because VAERS plays a vital role in detecting important but rare reactions caused by vaccines. A federal agency seeking to disabuse citizens of the expectation that government health databases are accurate should be an indicator for the CDC that VAERS has a serious problem. GERECITANO J, FRIEDMAN-KIEN A, CHAZEN GD: Allergic reaction to varicella vaccine. All rights reserved. Results: The https:// ensures that you are connecting to the 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. The Harvard study mentioned by Dr. Zelenko is the same as the one found at reference #6 cited by Mercola. An adult female, age 47, became disabled following varicella vaccination. But thats Norway. 9. The Electronic Support for Public Health - Vaccine Adverse Event Reporting System (ESP: VAERS) project sought to create a generalizable system to facilitate detection and clinician reporting of vaccine adverse events. 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. period Changing the hearts and minds of reticent Americans is set to become more crucial than ever to prevent transmission and limit the potential of new coronavirus variants taking hold. An official website of the United States government. 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). Disclaimer. Then they invoke the deaths in nursing homes in Norway gambit. BRAUN MM, MOOTREY GT, SEWARD JF, RIDER LG, KRAUSE PR: Postlicensure safety surveillance for varicella vaccine. Given that anyone can report any suspected adverse event, VAERS is intended to be an early warning system. 8600 Rockville Pike Competing interests: vaccinedeathreport - Read online for free. So far, only the Pfizer and Moderna vaccines have been granted Emergency Use Authorization in the U.S. by the U.S. Food and Drug Administration (FDA). The coding of VAERS reports requires careful interpretation. Read more at NPR. There were nearly 3,800 anti-Asian hate incidents in the U.S. between March 19, 2020 and Feb. 28, 2021, according to data from the Stop AAPI Hate coalition released this week. Gradually she was able to work for a few hours at a time. The report of an adverse event to VAERS is not documentation that a vaccine For instance, in todays Mercola.com newsletter there is an article summarizing Dr. Mercolas interview with Dr. Vladimir Zelenko. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 113% of serious events are reported to the Food and Drug Administration (FDA). The 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.. Vulnerability Disclosure Policy - HHS.gov, Centers for Disease Control and Prevention, U.S. Department of Health & Human Services. Vaccine Adverse Event Reporting System (VAERS) is a reporting system that anyone can report to or access data from. As the spread of coronavirus variants potentially jeopardises the efficacy of the vaccine rollout, so too does the spread of misinformation. Disease in children under 5 were reported to VAERS. 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. Additionally, the senators said the COVID-19 tests used by . 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. 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. Neurol. EMRs available from all ambulatory care encounters in a large multi-specialty practice were used. Vaccine-Associated Uveitis after COVID-19 Vaccination: Vaccine Adverse Event Reporting System Database Analysis. understand that minor side effects of vaccinations often include this kind of discomfort, as well as low fevers. 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. 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. Copyright The President and Fellows of Harvard College, Administration for Children and Families Database, Harvard T.H. (1995) 13(4):340-342. This brings us to the second question: Whats the baseline rate? Vaccine. According to open Vaers, almost 9k have died from the vaccine in the US. The degree of underreporting varies widely. We also know that underreporting is less common for more severe adverse reactions than for those that are more mild. 14. There is no citation for that sentence. of underreporting varies widely. Her joint pains became episodic but more intense during the attacks and she experienced some muscle weakness on and off. Facebook and Instagram announced earlier this year they would take steps to ban the spreading of vaccine misinformation on their platforms. With the authority of the CDC, whose official seal adorns the webpage, VAERS packs a shock. Whoever wrote this article is clearly not an expert, and this article is clearly meant to be disinformation, not science. 2016 Aug 17;34(37):4406-14. doi: 10.1016/j.vaccine.2016.07.019. The site is secure. 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. 100,000 person-years. Links to VAERS are included. Dis. Paediatr. The Vaccine Adverse Event Reporting System or VAERS is being misused by anti-vaxxers to terrify the public. However, the CDC and FDA have never required the vaccine manufacturers to publicly divulge the number of vaccines contained in a given lot. Her CPK was elevated to 676. 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. She was told that her collagenous colitis was autoimmune in nature. Sen. Ron Johnson, R-Wis. , has stirred controversy in recent days over his concerns about COVID-19 vaccine safety. providers, patients, or family members. Mercolas reference #7 is superfluous, because it also references #6. If youve been reading this blog a while, you can probably guess. VAERS cannot determine if a vaccine was the specific cause of an adverse event. So there is no way to explain the excess deaths which are effectively over 640,000 for a 41 underreporting factor. What about the US and VAERS? 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. can they dismiss placebo-controlled trials that raise serious People accessing shared far and wide by anti-vaccination activists and concerned readers alike: reaction... Zelenko is the same as the spread of coronavirus variants potentially jeopardises the efficacy of the number of reactions. Comparison of the CDC and FDA have never required the vaccine manufacturers to divulge... 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The true figure of adverse reactions reported to VAERS and caregivers are encouraged to report & quot ; clinically... Not demonstrate causation are effectively over 640,000 for a few hours at a time serious collagenous colitis quality! Than for those that are more mild, Administration for children and Families,.
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