Users are claiming that the U.S. Centers for Disease Control and Prevention deleted reports of 6,000 deaths from the U.S. (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. Universal Varicella Vaccination program assumptions that (1) a single dose offered long-term immunity, and (2) there is no immunologically-mediated link between varicella incidence and herpes-zoster incidence are seriously flawed. Harvard Business Review noted that the previous vaccine development record was . The VAERS system keeps track of any unusual or unexpected adverse events that occur after vaccine administration. Published online ahead of print). Jpn. Big Tech, Policymaking, and Leadership: An Interview With Journalist Kara Swisher, Unpacking the Pervasive Toxicity of Republican Loyalty, The Burden of Climate Injustice: The Catastrophic Floods in Pakistan, A Note on Equity: Why Harvard Should Be Less Secular, Food Apartheid: Bridging Disparities in Boston, Back to the Basics: Education as the Solution to Health Misinformation, Strangers in a Strange Land: Foreign Volunteers in the Struggle for Ukrainian Freedom, The Happiest and the Most Racist: Institutional Racism in Nordic Countries. She remains disabled and out of work and the event has been reported to VAERS. Careers. How can public Likewise, fewer than 1% of vaccine adverse events are reported.. He had moderate pain and the lesions were tender and sensitive to clothing. Baton Rouge Louisiana RN Whistleblower on Underreporting of Serious Adverse Effects of Covid Vaccines; Letter to US Senator Johnson: . VAERS reports associated with Varicella, DTaP, Hep B, Hib, and MMR vaccines through December, 2003. The first is: Whats the denominator? 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. SAKAGUCHI M, YAMANAKA T, IKEDA K, SANO Y, FUJITA H, MIURA T, INOUYE S: IgE-mediated systemic reactions to gelatin included in the varicella vaccine. 10. 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 . Nevertheless, VAERS rates have been estimated to represent 5% to 10% of the true figure of adverse reactions. The average age of those who died was 76.5. it varies but in the past 4 weeks, about 0.9-1 per 100k *per day* pic.twitter.com/NVz2MXmFIx. 300 0 obj
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Her symptoms worsened at the age of 6. The sorts of tactics antivaxxers are using now have surprised and befuddled a lot of pro-science advocates, mainly because so many of them have not been paying attention to the antivaccine movement, in particular its longstanding tactics and its basis in conspiracy theories. in young children. If youve been reading this blog a while, you can probably guess. He remains permanently disabled. _RD0rt. to The Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system, meaning it relies on individuals to send in reports of their experiences. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. Her joint pains became episodic but more intense during the attacks and she experienced some muscle weakness on and off. Usefulness of Vaccine Adverse Event Reporting System for Machine-Learning Based Vaccine Research: A Case Study for COVID-19 Vaccines. Claims made by the VAERS database now form the foundation of a global online misinformation campaign which to-date has garnered little attention. Keywords: 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. It would be a dramatic improvement over the current health-care-worker-initiated reports. "@MonicaGandhi9 How underreported are these side effects? Thats not to say that only severe or serious adverse reactions should be reported. With the authority of the CDC, whose official seal adorns the webpage, VAERS packs a shock. Luo C, Jiang Y, Du J, Tong J, Huang J, Lo Re V 3rd, Ellenberg SS, Poland GA, Tao C, Chen Y. Pharmacoepidemiol Drug Saf. Table 1. event underreporting. The estimated underreporting factor for COVID jab . What about the US and VAERS? Additionally, the senators said the COVID-19 tests used by . Nevropatol. Online ahead of print. Physicians and patients understand that minor side effects of vaccinations often include this kind of discomfort, as well as low fevers. She was seen by her physician because of an irregular heart rate and an ECG revealed supra ventricular extra systoles and left ventricular hypertrophy. Facebook and Instagram announced earlier this year they would take steps to ban the spreading of vaccine misinformation on their platforms. They often lack details and sometimes can have information that contains errors. To reach such a critical mass, the federal government is in a race against time. The U.S. (2003) 135(3):415-417. sharing sensitive information, make sure youre on a federal EMRs available from all ambulatory care encounters in a large multi-specialty practice were used. 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: Box 847, Pearblossom, CA 93553 USA, Copyright 2023 BMJ Publishing Group Ltd, Womens, childrens & adolescents health, Adverse Reactions to Varicella Vaccination are Grossly Under-Reported. 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. 290 0 obj
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A Progressive Facade: Comparing the U.S. and Canadas Treatment of Indigenous Peoples, Bringing Down the Worlds Largest Heist: Interview with Clare Rewcastle Brown, Australian PM Details Trump Relationship, Says Obama Called Him a Lunatic. Maybe only 10% are being reported. VAERS accepts all reports without judging whether the event was caused by the vaccine. Hearing disorder following COVID-19 vaccination: A pharmacovigilance analysis using the Vaccine Adverse Event Reporting System. S. S. Korsakova. background rates were 23.1 (2000) and 24.6 (2006); fewer than 1 in 200 KD First, one should note how CHD does note that a VAERS entry does not demonstrate causation. 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. cases were reported to VAERS. Before Her skin sensitivity also became more intense. FOIA She noticed some bruises and had aching in her knees, hands and feet. Case C Case B 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. 284 0 obj
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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. All rights reserved. The Vaccine Adverse Events Reporting System (VAERS) is sponsored by the Centers for Disease Control and by the Food and Drug Administration. Vaccine. J. Ophthalmol. official website and that any information you provide is encrypted Nothing coming before or after even suggests what that number is based upon. He took Acyclovir Oral Suspension (200mg/5ml): Two teaspoons 4 times a day for 5 days. 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. 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!) This boy was born on June 30, 1998 and received the varicella vaccination on June 29, 2000. effects) are filed in VAERS. No competing interests, Medical Veritas International (MVI), P.O. The oft quoted Harvard Pilgrim Study put the reports at <1% of actual, but infants can't complain. Underreporting is a limitation common to passive surveillance systems, including the Vaccine Adverse Event Reporting System (VAERS) that monitors the safety of U.S.-licensed vaccines. A certain number of 80+ year olds die every day. However, real data transmissions of non-physician approved reports to the CDC was unable to commence, as by the end of this project, the . Ds mother was initially fearful and refused the varicella vaccine for her daughter. 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. 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). Vaccine. They also dont understand how the antivaccine movement has always been about more than just vaccines. Risk increases with each dose of vaccine as well. A study about it found less than 1% were reported (3). 100,000 person-years. I dont know. 14. Epub 2020 Jul 21. 1. 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. Since varicella disease is relatively benign, only a few serious adverse reactions might offset the intended benefits. From your lips to QAnon's ears.. It only confirms that the reported event occurred sometime after vaccine was given. 2022 Jul 29;12(8):1242. doi: 10.3390/jpm12081242. Epub 2020 Jun 27. 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. 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. So how are antivaxxers weaponizing VAERS? 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. 2022 Jul 26;23(15):8235. doi: 10.3390/ijms23158235. RAVKINA LI, MATSEVICH GR: Morphological changes in the central nervous system in post-vaccinal encephalomyelitis developing after chickenpox vaccination in children. References Unfortunately, there was never an opportunity to perform system performance assessments because the necessary CDC contacts were no longer available and the CDC consultants responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation. Seeking a new model to lower wait times, but also improve patient choice of care, County Council Senior Medical . "Underreporting" is one of the main limitations of passive surveillance systems, including VAERS. The true figure is likely to be significantly higher as Keyhole excludes Instagram and private Facebook groups from its analytics. . They mention Dr. Jerry Spivaks irresponsible quote in which he said that the thought it is a medical certainty that the vaccine was related. At present, demand for the vaccine is high and supply is constrained, but as the U.S. hurtles toward President Bidens May 1 deadline for universal vaccine eligibility, supply may begin to outpace demand for the injection. to other vaccines and other serious clinical problems. So there is no way to explain the excess deaths which are effectively over 640,000 for a 41 underreporting factor. 3. !F+% H30Dif>$cBT1n0 "|G
(2001) 154(2):161-165. officials rely on a system that reports fewer than 1% of adverse effects? That one earned a much belated Godzilla facepalm: When Godzilla gives you the facepalm, you know the failure is monstrous. Image by Mat Napo is licensed under the Unsplash License. %%EOF
The FDA has established pathways to accelerate vaccine availability before approval, such as Emergency Use Authorization, and to channel resources to high-priority products and allow more. There is another story being missed regarding that Harvard Pilgrim study, though. Her pre-study laboratory values were completely normal. 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. It should therefore be no surprise that antivaxxers are now using VAERS to try to portray COVID-19 vaccines as harmful or even deadly. 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. That isn't the case with the COVID-19 vaccines, which the FDA approved . 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. 112:495, 2003. The term underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. 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. Case A Of the US primary reports received between 2012 and 2016, 0.4% reported death as the outcome; 5% reported a serious nonfatal adverse event (as defined above), and 94.6% reported non-serious events (CDC, unpublished data). These coincidences make it difficult to know whether a particular adverse event resulted from a medical condition or from a vaccination. Med. 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. risk The research, which assessed the safety of the Pfizer/BioNTech BNT162b2 mRNA vaccine, is based on analysis of data from nearly 2 million individuals in Israel and represents one of the largest real-world assessments of COVID-19 vaccine safety to date. Am. Because of this mismatch, the browser is rejecting it. 6/15/07. 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. Her nausea and vomiting persisted for the next three months despite use of anti-nausea medication. Dis. 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. Singh RB, Parmar UPS, Kahale F, Agarwal A, Tsui E. Ophthalmology. This site needs JavaScript to work properly. The true number is likely slightly higher, given that the denominator includes one additional week of vaccinations administered compared to the VAERS figures, which only go until January 22, but, again, this is a back-of-the-envelope calculation, in which the orders of magnitude matter more than the precise figure. Bardenheier BH, Duderstadt SK, Engler RJ, McNeil MM. health J. Ophthalmol. Bethesda, MD 20894, Web Policies So were there any problems with meeting the objectives of the grant? Epub 2016 Jul 19. He was listless and had some rhinorhea but remained afebrile. (1989) 160(3):535-537. Restructuring at CDC and consequent delays in terms of decision making have made it challenging despite best efforts to move forward with discussions regarding the evaluation of ESP:VAERS [the new system] performance in a randomized trial and comparison of ESP:VAERS performance to existing VAERS and Vaccine Safety Datalink data. of underreporting varies widely. 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. In a July 13 letter to health agency leaders, Johnson noted a press conference he . 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. the voluntary system used in the U.S. to signal vaccine side effects. Prediction of post-vaccination Guillain-Barr syndrome using data from a passive surveillance system. caused the event. 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,. 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. 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. During the same period about 88 million U.S. children passed through the 0-5 age group; * Two-year-old boy with staggering gait and difficulty speaking. 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. Gradually she was able to work for a few hours at a time. VAERS Symptoms lists the symptoms of the adverse event. Source information from U.S. Government VAERS data base, 1990-2003, http://www.medalerts.org/vaersdb Thats why Im going to take this opportunity to point out how, contrary to how one eminent academic oncologist like to put it, refuting antivaccine disinformation is anything but LeBron James dunking on a 7 hoop. Does anyone think that deaths after COVID-19 vaccination are going to be underreported by a factor of 100? An official website of the United States government. 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. I know that this discussion began with Share on Facebook, opens a new window Psikhiatr. But thats Norway. If anyone can find one or several citations that actually seek to quantify VAERS underreporting, please send me a note. Ann. Facebook has further sought to stem the spread of misinformation by providing public health agencies with free advertising space and by directing users to their local health authorities. Many physicians consider vaccination extremely safe and parents or patients are not provided with information regarding potential adverse outcomes. 8600 Rockville Pike Her CPK was elevated to 676. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. to learn In that intervew Dr. Zelenko states a common refrain about VAERS reporting: If you look at the 2009 Harvard study on the VAERS system, they said only 1% of events are actually reported. Exploring issues and controversies in the relationship between science and medicine. VAERS is a publicly available, searchable database of reports that have not been verified. He was treated again with Acyclovir. NASERI A, GOOD WV, CUNNINGHAM ET JR: Herpes zoster virus sclerokeratitis and anterior uveitis in a child following varicella vaccination. Competing interests:
For instance, in todays Mercola.com newsletter there is an article summarizing Dr. Mercolas interview with Dr. Vladimir Zelenko. 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. We know according to a Harvard study that VAERS is only thought to represent 1% of actual injuries." Of course, that disclaimer is included, so that RFK Jr. and his merry band of antivax ideologues can claim to have been literally honest while following up their recounting of VAERS numbers with all sorts of statements implying that vaccines were causative for the adverse events listed before. Oncol. J. Case E 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 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. 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. VAERS accepts all reports without judging whether the event was caused by the vaccine. 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. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001. 0.6, 239. Nine months later on March 10, 2004 he had a recurrence of shingles affecting the left nipple and the left side of the back. 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." Anyone can submit a report to VAERS, including parents and patients. 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. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. 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. . (Ophthalmology. Heres Seth Trueger: how many Americans typically die per day? 2020 Aug 18;38(37):5923-5926. doi: 10.1016/j.vaccine.2020.07.007. government site. Hematol. For anaphylaxis and GBS, VAERS sensitivity is comparable to previous estimates for detecting important AEs following vaccination. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. 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. Reports vary in quality and completeness. Given that anyone can report any suspected adverse event, VAERS is intended to be an early warning system. These symptoms along with dizziness persisted for weeks and she had difficulty going from her bed to the bathroom without assistance. VAERS, Underreporting, and the Mysterious 1% A CDC database that was mostly unknown except to a small segment of the population is now regularly in the news. Mercolas reference #7 is superfluous, because it also references #6. Data is also available through the CDC wonder interface by clicking on the CDC wonder link at the top of the page. 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. (1995) 13(4):340-342. The brain tumor pathogenesis is not fully understood at this time. During the same 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. Nevertheless, the magnitude of these differences makes it likely that serious adverse events following vaccination occur at a substantially lower rate than following natural disease [15]." VAERS cannot determine if a vaccine was the specific cause of an adverse event. Some infants will experience these medical events shortly after a vaccination by coincidence. Acta. It just states it as fact. Consequently, even though antivaxxers like to harp on how passive surveillance systems generally capture only a small fraction of adverse reactions, one thing VAERS does do is capture severe reactions. 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. Then they invoke the deaths in nursing homes in Norway gambit. Prior research has shown that only a fraction of adverse events are. especially The startling statistics are being shared far and wide by anti-vaccination activists and concerned readers alike. VAERS accepts all reports of suspected adverse events, in all age groups. When the Vaccine Adverse Event Reporting System (VAERS) was established in 1990, its creators at the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) would have scarcely imagined the government program would become a leading vector for vaccine misinformation amidst a global pandemic. 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. 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