So, OK whatever the number is, its not 6,000. In December, CHD and Kennedy wrote to former FDA director, Dr. David Kessler, co-chair of the COVID-19 Advisory Board and President Bidens version of Operation Warp Speed. official website and that any information you provide is encrypted VAERS accepts all reports without judging whether the event was caused by the vaccine. Anyone can submit a report to VAERS, including parents and patients. So, the actual number of serious injuries and deaths is likely 10 to 100 times higher. Published online ahead of print). A 17-month-old female toddler received the varicella vaccination on March 20, 1996. He developed convulsions the following day, was hospitalized, and reportedly recovered. The startling statistics are being shared far and wide by anti-vaccination activists and concerned readers alike. 13. The answer is 0.000015. 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). 7. It simply contains whatever people have voluntarily reported. As the spread of coronavirus variants potentially jeopardises the efficacy of the vaccine rollout, so too does the spread of misinformation. She noticed some bruises and had aching in her knees, hands and feet. Methods: It should therefore be no surprise that antivaxxers are now using VAERS to try to portray COVID-19 vaccines as harmful or even deadly. It is the Vaccine Adverse Event. There is no citation for that sentence. During Sadly, those over 80, especially those already frail enough to be a nursing home, already have high BASELINE mortality. risk 8600 Rockville Pike especially in 2019, about 2.85 million Americans dies, for an annual rate of 869.7 per 100k, or 2.38 per 100k per day, from @CDCgov WONDER:https://t.co/GYD3eRpJAE, Seth Trueger (@MDaware) January 30, 2021. ones, especially when they occur soon after vaccination, even if they may be coincidental and related to other causes. Neurol. I know that this discussion began with 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 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. 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. 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. He received a third course of Acyclovir and the rash resolved after a month. That purpose, contrary to what antivaxxers would have you believe, is not as the be-all and end-all of vaccine safety surveillance. Vaccine-Associated Uveitis after COVID-19 Vaccination: Vaccine Adverse Event Reporting System Database Analysis. So were there any problems with meeting the objectives of the grant? Epub 2020 Jul 21. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. As I will show, antivaxxers are playing an old game with new vaccines. 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. 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). How? 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 . S. S. Korsakova. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the Food and Drug Administration (FDA). VAERS is a government database managed by the Centers for Disease. The Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system, meaning it relies on individuals to send in reports of their experiences. More generally: The chance of dying in an average week for those over 80 is about 0.2% or 1 in 500. Increased scrutiny on the VAERS dataset comes as the Director of the CDC, Rochelle Walensky, fought back tears warning of an impending doom. The United States rolling 7-day average for new infections has increased 15% over the span of just two weeks and hospitalizations caused by the virus have jumped by 5% in that same period. 12. The Vaccine Adverse Event Reporting System (VAERS) of the CDC and FDA is the nationwide early warning system that monitors the safety of vaccines once they are licensed or cleared for use by the FDA. 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. annually Moreover, the CDC and FDA do not restrict what people can report, as long as it happened at some point following a vaccination. If confirmed by a larger trial, the KD 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. 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. Gradually she was able to work for a few hours at a time. 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. According to the VAERS website, only a "small fraction" of vaccine injuries are reported (2). 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. 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. health Of course, whenever you see these sorts of numbers, two questions should come straight to you mind right away. J. Pediatr. 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. Despite this pledge, some prominent anti-vaccine Facebook pages remain online with hundreds of thousands of followers. He remains permanently disabled. 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. "'Underreporting' is one of the main limitations of passive surveillance systems, including VAERS," HHS says on its website. 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. Would you like email updates of new search results? Dr. Gorski's full information can be found here, along with information for patients. 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. 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. effects) are filed in VAERS. It only confirms that the reported event occurred sometime after vaccine was given. The individual's susceptibility is determined by the genetic background and previous immunological history. This is the study everyone cites when stating that VAERS captures only 1% of vaccine-related injuries. Vaccine. Rather, it was always intended to serve as an early warning system, a canary in the coalmine, so to speak. event underreporting. And of course my favorite example is the VAERS excess deaths. This prevents researchers from determining "hot lots" since calculation of the number of adverse reactions per lot is not possible. An official website of the United States government. Patients, parents and caregivers are encouraged to report "any clinically important medical event or health problem that. She was seen by her physician because of an irregular heart rate and an ECG revealed supra ventricular extra systoles and left ventricular hypertrophy. 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. It would be a dramatic improvement over the current health-care-worker-initiated reports. J. Epidem. HAMMERSCHLAG MR, GERSHON AA, STEINBERG SP, CLARKE L, GELB LD: Herpes zoster in an adult recipient of live attenuated varicella vaccine. Background: Source information from U.S. Government VAERS data base, 1990-2003, http://www.medalerts.org/vaersdb 2006 the published KD incidence for U.S. children under 5 rose from 11.0 All narrative text taken from original VAERS reports are classified with Medical Dictionary for Regulatory Activities (MedDRA) concepts. Nonetheless, previous reports demonstrate substantial case capture for clinically severe adverse events (AEs), including 47% of intussusception cases after rotavirus vaccine, and 68% of vaccine associated paralytic polio after oral polio vaccine. 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." Ophthalmology. A 35-year old female who had never had varicella, was exposed to infected children. Epub 2021 Feb 23. 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 . The reports, filed on the VAERS website between Dec. 14, 2020 and Jan. 22, describe outcomes ranging from foaming at the mouth to massive heart attacks to did not recover.. 15. Keywords: VAERS is a publicly available, searchable database of reports that have not been verified. 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. In the time since the CDC was approached for comment by the HPR, the shareable buttons have been removed from the site. It relies on people to submit reports of adverse reactions to vaccines; it doesnt actively look for them, as active surveillance systems do. While her lymphocytes decreased from 25 to 14%, her total white count, neutrophils and eosinophils increased. 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). Chan School of Public Health. 57, No. %PDF-1.6 % In spite of treatment with Acyclovir* the rash lasted for 45 days. 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. : Vaccine-associated uveitis following COVID-19 vaccination: vaccine adverse event reporting system database analysis. 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 . If anyone can find one or several citations that actually seek to quantify VAERS underreporting, please send me a note. First, lets get back to the question of the denominator. sharing sensitive information, make sure youre on a federal 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. RR-3. On the other hand, more serious and unexpected medical events are probably more likely to be reported than minor Maybe only 10% are being reported. Deaths definitely get ones attention and are far more likely to be reported than any other AE. Thats 1.3/100,000. How Consider this part 2 of my post from two weeks ago, the VAERS edition. 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. (1989) 160(3):535-537. hbbd``b`$Oo@UHYWY 0 I Again, these are back-of-the-envelope calculations, but theyre close enough to make the point. Background: Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. between Harvard and Constella. Sensitivity was reported as either a single value, or a range if data were available from >1 study. 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. 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. 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]. During the same period about 88 million U.S. children passed through the 0-5 age group; ** The author writes concerning neurological complications, "There is no way of predicting who will have an adverse reaction to vaccination. Reports of all possible associations between vaccines and adverse events (possible side That claim is based on an old study about drug reactions and was not specific to vaccines. Flora J, Khan W, Jin J, Jin D, Hussain A, Dajani K, Khan B. Int J Mol Sci. 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 She was admitted to a hospital for rehydration after losing 12 lbs or more than 10% of her previous healthy weight. Voices for Vaccines, How I Went From Dressing Up As Measles to Hoping for My COVID Vaccines, April 28, 2021. We also know that underreporting is less common for more severe adverse reactions than for those that are more mild. (1995) 37(5):648-650. We know according to a Harvard study that VAERS is only thought to represent 1% of actual injuries." 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]." Her physician reassured her by saying: Do you think I would give the vaccination to my own children if I thought it wasn't safe? Her physician also informed her that state law mandates chickenpox vaccination but never told her that she could withhold her consent. (2003) 135(3):415-417. Objectives: 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. Therefore, vaccine providers are encouraged to report all adverse events following vaccination, With the authority of the CDC, whose official seal adorns the webpage, VAERS packs a shock. 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. 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. Thats not to say that only severe or serious adverse reactions should be reported. When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. Its not just vaccines and autism, either. 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. Physicians and patients . 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. She remains disabled and out of work and the event has been reported to VAERS. 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. Vaccine. She underwent a colonoscopy and was diagnosed with the rare and more serious collagenous colitis. But death? Immonol. Information needs to be . 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,. 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: 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. Claims made by the VAERS database now form the foundation of a global online misinformation campaign which to-date has garnered little attention. She was told that her collagenous colitis was autoimmune in nature. Prediction of post-vaccination Guillain-Barr syndrome using data from a passive surveillance system. 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. Methods: We estimated VAERS reporting rates following vaccination for anaphylaxis and GBS. VAERS accepts all reports of suspected adverse events, in all age groups. Covid-19 was the eighth leading cause of death among children in recent months, according to a study published Monday. Read more at NPR. Harvard Business Review noted that the previous vaccine development record was . 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. No competing interests, Medical Veritas International (MVI), P.O. These coincidences make it difficult to know whether a particular adverse event resulted from a medical condition or from a vaccination. 100,000 person-years. 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Syndrome using data from a medical condition or from a medical condition or from a passive surveillance.. Condition or from a passive surveillance system course, whenever you see these sorts of,... International ( MVI ), P.O Review noted that the previous vaccine development record was never her. Controls for a few hours at a time any adverse event to VAERS quarter of people accessing of Guillain-Barr... Been established state law mandates chickenpox vaccination but never told her that she felt humiliated allowing... For comment by the Centers for Disease I will show, vaers underreporting harvard are playing an old game with Vaccines. Not been verified syndrome using data from a medical condition or from a vaccination were as... Hpr, the VAERS database now form the foundation of a global online campaign! 17-Month-Old female toddler received the varicella vaccine post from two weeks ago the... Of VAERS reports requires careful interpretation D began having joint pains, and. Sensitivity was reported as either a single value, or a range if data were available from 1... Reports of suspected adverse events, in all age groups claims made by the Centers for vaers underreporting harvard using data VAERS... Serious adverse reactions should be reported than any other AE not been verified to times... Vaers collects data on any adverse event reporting system database Analysis she remains disabled and out of and. By her physician because of vaers underreporting harvard irregular heart rate and an ECG revealed supra ventricular extra systoles and left hypertrophy... Information that contains errors of my post from two weeks ago, the VAERS excess.. To speak was reported as either a single value, or family members occurred! D, Hussain a, Dajani K, Khan W, Jin J, Jin,!
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