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. Seeking a new model to lower wait times, but also improve patient choice of care, County Council Senior Medical . Local Australian health authorities blasted the spreading of the false reports telling residents to take-off their tin-foil hats.. VAERS is the primary government-funded system for reporting adverse reactions to . The U.S. Epub 2020 Jul 21. A Harvard Vaccine Injury Study conducted from 2007 to 2010, reveals on page 6 a fewer than 1 % report rate in VAERS. It simply contains whatever people have voluntarily reported. Symptoms represent the medical condition (s) in the adverse event description and lab data from the VAERS Report Form. VAERS reports vary in quality and completeness and under-reporting, especially of mild and self-limiting AEs, appears common. 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. It is primarily a hypothesis-generating, not hypothesis-testing, system when it comes to questions related to vaccine safety. 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. Consider this part 2 of my post from two weeks ago, the VAERS edition. 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.. 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. My topic here is not VAERS generally, but a number that recurs often in discussions about the vaccine injury reports VAERS contains. of underreporting varies widely. Accessibility That claim is based on an old study about drug reactions and was not specific to vaccines. 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. "Underreporting" is one of the main limitations of passive surveillance systems, including VAERS. 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. Zh. 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. Im referring, of course, to antivaxxers resurrecting old antivaccine tropes, dusting them off, and updating them for the age of COVID. Deaths definitely get ones attention and are far more likely to be reported than any other AE. Those of you whove been reading this blog and my not-so-super-secret other blog should be familiar with VAERS, as its been discussed many times on both. It relies on people to submit reports of adverse reactions to vaccines; it doesnt actively look for them, as active surveillance systems do. 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. LEE SY, KOMP DM, ANDIMAN W: Thrombocytopenic Purpura following varicella-zoster vaccination. What I want readers to understand is that, when it comes to the antivaccine movement, there is nothing new under the sun. MMWR Surveill Summ. He took Acyclovir Oral Suspension (200mg/5ml): Two teaspoons 4 times a day for 5 days. If Laidler hadnt been honest, he could have insisted that the report remain, and it would have. 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 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. 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 . The reason he is concerned is that this is in contrast to the last five flu seasons, over the course of which there have been 119 reports of deaths to VAERS among people who received a seasonal flu vaccine. RR-3. Flora J, Khan W, Jin J, Jin D, Hussain A, Dajani K, Khan B. Int J Mol Sci. ) and transmitted securely. Pediatr. Acta. VAERS accepts all reports without judging whether the event was caused by the vaccine. anti-covid. (Pediatr Infect Dis J 28:943, 2009) From 1988 to According to the VAERS website, only a "small fraction" of vaccine injuries are reported (2). The Vaccine Adverse Event Reporting System (VAERS) database contains information on unverified reports of adverse events (illnesses, health problems and/or symptoms) following immunization with US-licensed vaccines. Misinformation about the coronavirus vaccine abounds on the web, but no site established by an anti-vaccine activist could hope to have the reach and recognisability of the CDC website. National Library of Medicine He was treated again with Acyclovir. Jpn. Careers. A VAERS report was filed January 30, 2000. * Two-year-old boy with staggering gait and difficulty speaking. Children's deaths of any kind are rare, researchers noted. (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. by the vaccine is required in order for VAERS to accept the report. Her older brother reacted to all vaccinations and developed late-onset autism following his MMR. Case A 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. 300 0 obj <>stream During the same A quote from the in-question Harvard Pilgrim Health Care, Inc. study: "Adverse events from drugs and vaccines are common, but underreported. 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. Reports vary in quality and completeness. So, the actual number of serious injuries and deaths is likely 10 to 100 times higher. hXmk6+B%Yo Izr wnb} >{r= [3%bk2+3J azwyynG0m7oC._s/VuVK_]hBuZ,:E*rpOv1v6[_-n]EPP7g~%~jhq/8Sn?tdg/j]Wdl-7 MGa8[>UgffM,fCM~kWQ?u^\?;5VX)I$@jxF![{L0hQcI 4tIg[,N:wcAx6cLjS?q/]}`.ubb7GKjqvm;+4 F0:i`@1K0V#t|-r$4qKf\~C9vxvp>yQCL\'dJHB^Hh= tBK:rFH|'WdAc-H{2sM:w. SUNAGA Y, HIKIMA A, OSTUKA T, MORIKAWA A: Acute cerebellar ataxia with abnormal MRI lesions after varicella vaccination. It is worth pointing out that Harvard Pilgrim Health Care, Inc., has no affiliation with Harvard University. The reason, to reiterate, is that VAERS is unique among US vaccine safety reporting systems in that it is a passive surveillance system. VAERS is a passive surveillance system that relies on the willingness of individuals and professionals to submit reports voluntarily. Table 1. It's a shame because VAERS plays a vital role in detecting important but rare reactions caused by vaccines. Reports vary in quality and completeness. During the same period about 88 million U.S. children passed through the 0-5 age group; Vaccine Adverse Event Reporting System (VAERS), was to construct the below flow of data in order to support the first two Aims: Figure 1. Moreover, the CDC and FDA do not restrict what people can report, as long as it happened at some point following a vaccination. Vulnerability Disclosure Policy - HHS.gov, Centers for Disease Control and Prevention, U.S. Department of Health & Human Services. ones, especially when they occur soon after vaccination, even if they may be coincidental and related to other causes. 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. So were there any problems with meeting the objectives of the grant? VAERS is a publicly available, searchable database of reports that have not been verified. That isn't the case with the COVID-19 vaccines, which the FDA approved . How However, the CDC and FDA have never required the vaccine manufacturers to publicly divulge the number of vaccines contained in a given lot. sharing sensitive information, make sure youre on a federal Epub 2020 Jun 27. vaccine-caused illness? Mercola, just a few paragraphs below that, emphasizes the point: Studies have indicated it could be as low as 1%.6,7. 2023 Feb;130(2):179-186. doi: 10.1016/j.ophtha.2022.08.027. HAMMERSCHLAG MR, GERSHON AA, STEINBERG SP, CLARKE L, GELB LD: Herpes zoster in an adult recipient of live attenuated varicella vaccine. We defined reporting sensitivity as the VAERS reporting rate divided by the VSD incidence rate. But definitely its being underreported.. Raw data is available from 1990- May 14, 2013 and can be downloaded using ZIP files or Comma-Separated Value (CSV) files. Eight days after vaccination, she developed a fever, sore throat, nausea, vomiting, malaise and dizziness. 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. During the 18-year period from 1990 through 2007 just 88 cases of Kawasaki Disease in children under 5 were reported to VAERS. PMC VAERS accepts reports from anyone, including patients, family members, healthcare providers and vaccine manufacturers. When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. The findings, the researchers said, affirm the overall safety of the vaccine and underscore . But thats Norway. VAERS, Report an Adverse Event, accessed April 9, 2021. 2021 May;30(5):602-609. doi: 10.1002/pds.5196. Her joint pains became episodic but more intense during the attacks and she experienced some muscle weakness on and off. Its a specific skill that requires deep knowledge of conspiracy theories and the specific tactic and tropes used by science denialists and conspiracy theorists like antivaxxers, coupled with a deep understanding of the scientific literature on vaccines. A CDC database that was mostly unknown except to a small segment of the population is now regularly in the news. (1997) 126(10):833-834. Twenty-eight months following varicella vaccination (October 29, 2002), he developed breakthrough chickenpox with an estimated 30 to 40 lesions that were intensely itchy. (1986) 8(1):78-80. "'Underreporting' is one of the main limitations of passive surveillance systems, including VAERS," HHS says on its website. 112:495, 2003. J. Ophthalmol. 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 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 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. Heres Seth Trueger: how many Americans typically die per day? He had moderate pain and the lesions were tender and sensitive to clothing. With the rollout of safe and effective vaccines against COVID-19 finally starting to result in tens of millions of people receiving the Moderna and Pfizer/BioNTech vaccines, with newer vaccines likely to be introduced in the coming months, the predictions that I (and many others) made months ago are coming to pass. This, of course, is intended to increase reporting of adverse events to VAERS. Bookshelf According to the VAERS data, of the 329 reported deaths, 285 were from the U.S., and 44 were from other countries. Adverse event; Passive surveillance; Vaccine; Vaccine Adverse Event Reporting System (VAERS); Vaccine safety. Methods: We estimated VAERS reporting rates following vaccination for anaphylaxis and GBS. 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. The VAERS dataset was created to manage reports of vaccine-associated side effects. Her nausea and vomiting persisted for the next three months despite use of anti-nausea medication. In 2008, patients seeking a hip or knee replacement in Stockholm County faced wait times of up to two years of sometimes debilitating pain, intermittent missed work and income, and the trials of disability. Thats 1.3/100,000. (1995) 13(4):340-342. As of today, the online database alleges 1349 U.S. deaths attributable to COVID-19 vaccines. Competing interests: How? VAERS is the primary mechanism for reporting adverse vaccine reactions in the U.S. Reports submitted to VAERS require further investigation before confirmation can be made that an adverse event was linked to a vaccine. . Vaccine Adverse Event Reporting System (VAERS) is a reporting system that anyone can report to or access data 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]." 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. The degree Later in the article, CHD starts listing all the anecdotes and other reports that antivaxxers have been flogging. Nine months later on March 10, 2004 he had a recurrence of shingles affecting the left nipple and the left side of the back. With the rollout of COVID-19 vaccines continuing apace, so are the efforts of antivaxxers to portray the vaccines as dangerous. COVID-19 Vaccines and Myopericarditis: A Nuanced Story. and Nobel Prize winner turned homeopathy believer, antivaxxer, autism quack, and now COVID-19 crank, Luc Montagnier. Her pre-study laboratory values were completely normal. VAERS (Vaccine Adverse Events Reporting System) is 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 only old antivaccine lie or distortion that I havent seen used against COVID-19 vaccines yet is the claim that they cause autism or sudden infant death syndrome. That one earned a much belated Godzilla facepalm: When Godzilla gives you the facepalm, you know the failure is monstrous. She developed diarrhea shortly after the second dose and by November 2001, she was quite ill and had serious intestinal difficulties. In normal times Norway typically sees 45 deaths among nursing residents each week. Covid-19 was the eighth leading cause of death among children in recent months, according to a study published Monday. You might wonder: Why would anyone set up a system like VAERS, which is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA)? She worked as a research coordinator in the infectious disease unit of a Medical School. Unsurprisingly, RFK Jr. fails to mention that the BMJ article to which he refers is a BMJ Rapid Response, which is basically a comment section that is not peer-reviewed that cranks love to use to post their ramblings and then cite them as though they were legitimate articles in The BMJ. On the other hand, more serious and unexpected medical events are probably more likely to be reported than minor %%EOF Between 2000-2020, VAERS received 1,005 reports of death after vaccination, according to a USA TODAY analysis of VAERS data. period 9. 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. whether or not they believe the vaccination was the cause. The patient's nausea decreased and her fever subsided. The lot number associated with each vaccine is recorded in the VAERS data base. Intern. POSER CM: Neurological Complications of Vaccinations. Some infants will experience these medical events shortly after a vaccination by coincidence. Nevertheless, VAERS rates have been estimated to represent 5% to 10% of the true figure of adverse reactions. He was listless and had some rhinorhea but remained afebrile. The .gov means its official. Risk increases with each dose of vaccine as well. 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. A cursory search of social media shows those who are spreading the VAERS data have paid little heed to the agencys disclaimers. Still, it's a good way to detect safety signals that weren't detected during premarket testing or clinical trials . 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). 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. The CDC told Reuters. As I will show, antivaxxers are playing an old game with new vaccines. 14. The degree of underreporting varies widely. 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). possibilities of Neurol. Many physicians consider vaccination extremely safe and parents or patients are not provided with information regarding potential adverse outcomes. Epub 2021 Feb 23. Source information from U.S. Government VAERS data base, 1990-2003, http://www.medalerts.org/vaersdb Vaccine Adverse Event Reporting System (VAERS). 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). The report of an adverse event to VAERS is not documentation that a vaccine caused the event. 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. Table 1 presents a comparison of the number of adverse reactions reported to VAERS for the varicella vaccine with 4 other different vaccines. Dr. Gorski's full information can be found here, along with information for patients. Acta. In this case, a retired pediatrician named Allan Cunningham rattled off a whole lot of antivaccine tropes about vaccines and autism and cites antivaccine-sympathetic BMJ editor Peter Doshi. (1989) 160(3):535-537. 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. Basically, VAERS is a passive reporting system, in which anyone can report suspected adverse events after any vaccination to be recorded in the database. NARUSE H, MIWATA H, OZAKI T, ASANO Y, NAMAZUE J, YAMANISHI K: Varicella infection complicated with meningitis after immunization. She was seen by her physician because of an irregular heart rate and an ECG revealed supra ventricular extra systoles and left ventricular hypertrophy. Share on Facebook, opens a new window Even VAERS cautions people about how to interpret its data: When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. Physicians and patients Federal government websites often end in .gov or .mil. Case E 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. While her lymphocytes decreased from 25 to 14%, her total white count, neutrophils and eosinophils increased. VAERS is a postmarketing surveillance program, collecting information about adverse events (possible harmful side effects) that occur after administration of vaccines to ascertain . adverse Vaccine. Image by Mat Napo is licensed under the Unsplash License. The newly installed CDC Director urged Americans to not let down their guard, saying she is scared a fourth wave of the coronavirus may batter the country before vaccinations can reach a critical mass. It is the Vaccine Adverse Event. If anyone can find one or several citations that actually seek to quantify VAERS underreporting, please send me a note. 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. Chan School of Public Health. VAERS is a government database managed by the Centers for Disease. Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Her physician recommended prompt vaccination and she received a first dose of varicella vaccine on May 18, 1998. 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. It just states it as fact. health VAERS accepts all reports of suspected adverse events, in all age groups. (2000) 284:1271-1279. 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. 2022 Jul 26;23(15):8235. doi: 10.3390/ijms23158235. For instance, in todays Mercola.com newsletter there is an article summarizing Dr. Mercolas interview with Dr. Vladimir Zelenko. Thanks to Dear Pandemic, who did similar back-of-the-envelope calculations, as did Mark Hoofnagle on Twitter, we can make a reasonable estimate for Norway: What does that mean? Thats not to say that only severe or serious adverse reactions should be reported. Epub 2016 Jul 19. There is no confirmed evidence of a COVID-19 vaccine causing the death of even one child. Whoever wrote this article is clearly not an expert, and this article is clearly meant to be disinformation, not science. They often lack details and sometimes can have information that contains errors. VAERS Symptoms lists the symptoms of the adverse event. 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. 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