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. Children's deaths of any kind are rare, researchers noted. Kennedy told Kessler that VAERS has been an abject failure, with fewer than 1% of adverse events ever reported. Paediatr. 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. 2022 Jul 29;12(8):1242. doi: 10.3390/jpm12081242. Zh. 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. Wrensch et al. 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.. Re: Singh etal. the 18-year period from 1990 through 2007 just 88 cases of Kawasaki If Laidler hadnt been honest, he could have insisted that the report remain, and it would have. 0.6, 239. But definitely its being underreported.. HAMMERSCHLAG MR, GERSHON AA, STEINBERG SP, CLARKE L, GELB LD: Herpes zoster in an adult recipient of live attenuated varicella vaccine. Im. 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. They mention Dr. Jerry Spivaks irresponsible quote in which he said that the thought it is a medical certainty that the vaccine was related. 2020 Jul 22;38(34):5464-5473. doi: 10.1016/j.vaccine.2020.06.038. Her older brother reacted to all vaccinations and developed late-onset autism following his MMR. It is the Vaccine Adverse Event. Baton Rouge Louisiana RN Whistleblower on Underreporting of Serious Adverse Effects of Covid Vaccines; Letter to US Senator Johnson: . 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. and transmitted securely. Share on Facebook, opens a new window VAERS (Vaccine Adverse Events Reporting System) is Would you like email updates of new search results? A certain number of 80+ year olds die every day. Ds mother was initially fearful and refused the varicella vaccine for her daughter. Med. (Pediatr Infect Dis J 28:943, 2009. possibilities of He took Acyclovir Oral Suspension (200mg/5ml): Two teaspoons 4 times a day for 5 days. "Underreporting" is one of the main limitations of passive surveillance systems, including VAERS. It relies on people to submit reports of adverse reactions to vaccines; it doesnt actively look for them, as active surveillance systems do. VAERS accepts all reports of suspected adverse events, in all age groups. 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. 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. 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. Nine months later on March 10, 2004 he had a recurrence of shingles affecting the left nipple and the left side of the back. 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. Whats 285 divided by 22 million? Flora J, Khan W, Jin J, Jin D, Hussain A, Dajani K, Khan B. Int J Mol Sci. (1986) 8(1):78-80. 14. Many physicians consider vaccination extremely safe and parents or patients are not provided with information regarding potential adverse outcomes. 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. How can there possibly be over 16,000 reported in VAERS if nothing is going on? officials rely on a system that reports fewer than 1% of adverse effects? 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. In a yearlong period from August 2021 to July 2022, 821 children ages 0 to 19 died from covid-19 at a rate of 1 per 100,000. Your connection is not private, it says in large font on my screen (fig 1). Seeking a new model to lower wait times, but also improve patient choice of care, County Council Senior Medical . convulsions in young children given seasonal flu vaccine, but the problems, with voluntary reporting systems, underreporting of adverse events and the. 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. Adverse event; Passive surveillance; Vaccine; Vaccine Adverse Event Reporting System (VAERS); Vaccine safety. But since VAERS watches for unexpected or unusual patterns in adverse event reports, it still works even if each and every side effect isnt reported. 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. 7. The U.S. (2001) 154(2):161-165. 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)? Acta. The .gov means its official. Immonol. Moreover, the CDC and FDA do not restrict what people can report, as long as it happened at some point following a vaccination. Acta. Synthetic and real test data was been generated and transmitted between Harvard and Constella. Users are claiming that the U.S. Centers for Disease Control and Prevention deleted reports of 6,000 deaths from the U.S. First, lets get back to the question of the denominator. A CDC database that was mostly unknown except to a small segment of the population is now regularly in the news. Despite this pledge, some prominent anti-vaccine Facebook pages remain online with hundreds of thousands of followers. Vulnerability Disclosure Policy - HHS.gov, Centers for Disease Control and Prevention, U.S. Department of Health & Human Services. A Harvard Vaccine Injury Study conducted from 2007 to 2010, reveals on page 6 a fewer than 1 % report rate in VAERS. Unauthorized use of these marks is strictly prohibited. Disclaimer They don't offer great . Each of the three occurrences of the shingles rash was on his left side. 9. The degree The coalition formed . J. Infect. He received a third course of Acyclovir and the rash resolved after a month. VAERS accepts reports from anyone, including patients, family members, healthcare providers and vaccine manufacturers. 11. Reference to the Harvard study regarding the 1% figure adds legitimacy it doesnt deserve. VAERS accepts all reports of suspected adverse events, in all age groups. As for that last part about VAERS having been an abject failure, to support that claim RFK Jr. cites this: A critic familiar with VAERS shortcomings bluntly condemned VAERS in The BMJ as nothing more than window dressing, and a part of U.S. authorities systematic effort to reassure/deceive us about vaccine safety.. Reports vary in quality and completeness. Thats not how VAERS works, however. 12. (1997) 126(10):833-834. 6. There is no confirmed evidence of a COVID-19 vaccine causing the death of even one child. Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R, Wise RP, Haber P, Pless RP, Mootrey G, Ellenberg SS, Braun MM, Chen RT. * Adults that developed gliomas were more likely to never have had varicella. That purpose, contrary to what antivaxxers would have you believe, is not as the be-all and end-all of vaccine safety surveillance. Keywords: As I will show, antivaxxers are playing an old game with new vaccines. 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. 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. A quote from the in-question Harvard Pilgrim Health Care, Inc. study: "Adverse events from drugs and vaccines are common, but underreported. For anaphylaxis and GBS, VAERS sensitivity is comparable to previous estimates for detecting important AEs following vaccination. 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. Whos Really Responsible for Climate Change? We used data from VAERS safety reviews as the numerator, and estimated incidence rates of anaphylaxis and GBS following vaccination from the Vaccine Safety Datalink (VSD) studies as the denominator. Some infants will experience these medical events shortly after a vaccination by coincidence. 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. J. Epidem. "'Underreporting' is one of the main limitations of passive surveillance systems, including VAERS," HHS says on its website. Indeed, Facebook posts seen by the HPR with hundreds of engagements include the same verbatim instructions, copy and pasted, for users to disregard disclaimers. The coding of VAERS reports requires careful interpretation. These symptoms along with dizziness persisted for weeks and she had difficulty going from her bed to the bathroom without assistance. Epub 2022 Aug 31. VAERS reports associated with Varicella, DTaP, Hep B, Hib, and MMR vaccines through December, 2003. Harvard Business Review noted that the previous vaccine development record was . VAERS Symptoms lists the symptoms of the adverse event. MeSH 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. But thats Norway. Prior research has shown that only a fraction of adverse events are. 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). 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. Her nausea and vomiting persisted for the next three months despite use of anti-nausea medication. official website and that any information you provide is encrypted Information needs to be . In the U.S. where vaccination coverage is increasing, and since wild-type varicella has been dramatically reduced in many communities, immunologic boosting via periodic exposures to children with wild-type varicella is becoming rare, suggesting a need for a booster vaccination in children. sharing sensitive information, make sure youre on a federal 57, No. The first is: Whats the denominator? In spite of treatment with Acyclovir* the rash lasted for 45 days. An EMG revealed involvement in an ulnar distribution. vaccine-caused illness? The second is: What is the baseline rate for such adverse events in the population studied? 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. True, someone did contact him to question it. 2023;130: S0161-6420(22)00672-8. doi: 10.1016/j.ophtha.2022.08.027. A study about it found less than 1% were reported (3). The VAERS dataset also appears to be immune from Facebooks anti-misinformation protocols and remains a prominent feature of the anti-vaccine campaigning repertoire. 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). 2022 Nov;47(11):1789-1795. doi: 10.1111/jcpt.13767. Varicella vaccination is generally considered safe [1] but there are usually no prescreening tests to determine whether an adverse reaction is likely to occur [2]. Competing interests: 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. Table 1 presents a comparison of the number of adverse reactions reported to VAERS for the varicella vaccine with 4 other different vaccines. 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. 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. We know according to a Harvard study that VAERS is only thought to represent 1% of actual injuries." He's using VAERS data, which is generally accepted as being 10% of actually cases, due to the public lack of knowledge and the medical professions refusal to use the system. Psikhiatr. 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. Gradually she was able to work for a few hours at a time. The lot number associated with each vaccine is recorded in the VAERS data base. No competing interests, Medical Veritas International (MVI), P.O. Thats 40 days, if you count December 14, 2020. so wed expect 96/100,000 deaths during that period. 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. They often lack details and sometimes can have information that contains errors. 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. . Data is also available through the CDC wonder interface by clicking on the CDC wonder link at the top of the page. Nevropatol. In fact, lack of engagement by the CDC rendered the entire project pretty much null. The CDC told Reuters. Clearly that Harvard study is where the gold is. By the FDAs own definition, the vaccines are still considered experimental until fully licensed. Consider this part 2 of my post from two weeks ago, the VAERS edition. Although the CDC claims to make attempts to verify the data, it is difficult to see how publishing reports of gunshot wounds related to the COVID-19 vaccine is tenable for an organization so reliant on public trust. 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. For GBS, VAERS captured 12% of cases after the 2012-13 inactivated seasonal influenza vaccine, 15-55% of cases after the 2009 H1N1 inactivated pandemic influenza vaccine, and 64% of cases after 4vHPV vaccine. Vaccine. The mismatch is causing the browser to think that the user is not going to the genuine site. 2023 Jan 4:S0161-6420(22)00929-0. doi: 10.1016/j.ophtha.2022.11.023. Conclusion Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. As of today, the online database alleges 1349 U.S. deaths attributable to COVID-19 vaccines. Background Users can access data pertaining to clinically significant medical events that occur after vaccination in the United States. 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. 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. This may sound similar to another argument that many COVID-19 deaths in older adults are deaths that would have happened anyway. With the authority of the CDC, whose official seal adorns the webpage, VAERS packs a shock. 112:495, 2003. Sadly, those over 80, especially those already frail enough to be a nursing home, already have high BASELINE mortality. Since varicella disease is relatively benign, only a few serious adverse reactions might offset the intended benefits. VAERS is a government database managed by the Centers for Disease. 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. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. Keep in mind, this system would have extracted probable vaccine injury information from patient charts and fed it directly into the VAERS system. 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." She was told that her collagenous colitis was autoimmune in nature. Therefore, vaccine providers are encouraged to report all adverse events following vaccination, 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. Dis. She noticed some bruises and had aching in her knees, hands and feet. 2, 3 Reasons for clinician under-reporting might include failure to associate an acute health event to recent vaccines, lack of awareness of VAERS, the misperception that only serious events should be reported, or lack of During the same period about 88 million U.S. children passed through the 0-5 age group; Given that anyone can report any suspected adverse event, VAERS is intended to be an early warning system. 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. 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. Methods: We estimated VAERS reporting rates following vaccination for anaphylaxis and GBS. Maybe only 10% are being reported. Intern. Reports are accepted from anyone and can be submitted electronically at www.vaers.hhs.gov. He had moderate pain and the lesions were tender and sensitive to clothing. Bardenheier BH, Duderstadt SK, Engler RJ, McNeil MM. 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. Then, with respect to antivaccine disinformation, truly everything old will be new again. My topic here is not VAERS generally, but a number that recurs often in discussions about the vaccine injury reports VAERS contains. VAERS, of course, is a 30-year-old database to which anyone can literally report anything that might be an adverse event after vaccination. The startling statistics are being shared far and wide by anti-vaccination activists and concerned readers alike. The reason, to reiterate, is that VAERS is unique among US vaccine safety reporting systems in that it is a passive surveillance system. It is a near certainty that scurrilous and outlandish claims around the COVID-19 vaccines will be shared online in any case, but for now, malign actors transmit this information with a veneer of credibility offered by the CDC VAERS database. It is worth pointing out that Harvard Pilgrim Health Care, Inc., has no affiliation with Harvard University. On the other hand, more serious and unexpected medical events are probably more likely to be reported than minor VAERS is a national vaccine safety surveillance program that helps to detect unusual or unexpected reporting patterns of adverse events for vaccines. Case "B" A man who was vaccinated against varicella in 1995 developed encephalomyloneuritis and required hospitalization for months. Does anyone think that deaths after COVID-19 vaccination are going to be underreported by a factor of 100? Signals and trends of Guillain-Barr syndrome after the introduction of live-attenuated vaccines for influenza in the US and South Korean adverse event reporting systems. Her physician was of the opinion that a virus probably triggered her autoimmune response. Vaccine Adverse Event Reporting System (VAERS), was to construct the below flow of data in order to support the first two Aims: Figure 1. This time, the pain was more severe. From your lips to QAnon's ears.. Hematol. She underwent a colonoscopy and was diagnosed with the rare and more serious collagenous colitis. especially However, real data transmissions of non-physician approved reports to the CDC was unable to commence, as by the end of this project, the . Epub 2020 Jun 27. 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). She was admitted to a hospital for rehydration after losing 12 lbs or more than 10% of her previous healthy weight. This boy was born on June 30, 1998 and received the varicella vaccination on June 29, 2000. 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. and nurses do not know about VAERS and what is required to be reported. 13. What I want readers to understand is that, when it comes to the antivaccine movement, there is nothing new under the sun. 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. MMWR Surveill Summ. The high mean of 3,000 reports/year is attributed to the Hepatitis B vaccine, followed next by a mean of 2,350 reports/year attributed to varicella vaccine (Table 1). ) cases were reported to VAERS. And the CDCs role in the dissemination of vaccine misinformation, unwilling though it may be, is attracting increasing scrutiny as it jeopardises what President Biden calls his administrations most important battle: the global coronavirus vaccine rollout. Rather, it was always intended to serve as an early warning system, a canary in the coalmine, so to speak. There is no citation for that sentence. 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