J. Infect. From 2012 through 2016, vaccine providers submitted 32% of U.S. VAERS reports; vaccine manufacturers submitted 41%; patients . As such, I think it is somewhat sloppy science to reference the Harvard study as support of VAERS underreporting. Peter Collignon and his colleagues do not exaggerate the problem of The report of an adverse event to VAERS is not documentation that a vaccine caused the event. 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. Published online ahead of print). 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. No competing interests, Copyright 2023 BMJ Publishing Group Ltd, Womens, childrens & adolescents health. 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. Vaccine. 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. Clinical descriptions of five different serious adverse affects that followed varicella vaccination are given below. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. The VAERS dataset was created to manage reports of vaccine-associated side effects. 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outcome; 5% reported a serious nonfatal adverse event (as defined above), and 94.6% reported non-serious events (CDC, unpublished data). Each of the three occurrences of the shingles rash was on his left side. Clearly that Harvard study is where the gold is. Ann. 290 0 obj <>/Filter/FlateDecode/ID[<2DFFE8CD87B0A54688B7A1A0039905EB>]/Index[284 17]/Info 283 0 R/Length 53/Prev 85940/Root 285 0 R/Size 301/Type/XRef/W[1 2 1]>>stream The Harvard study mentioned by Dr. Zelenko is the same as the one found at reference #6 cited by Mercola. (1995) 13(4):340-342. Accessibility Anyone can submit a report to VAERS, including parents and patients. 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. That purpose, contrary to what antivaxxers would have you believe, is not as the be-all and end-all of vaccine safety surveillance. I fully expect that, just as soon as a COVID-19 vaccine is approved for use in children, antivaxxers will start claiming that the vaccine causes autism and SIDS. Overview of the ESP:VAERS project . 8600 Rockville Pike 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. Between 2000-2020, VAERS received 1,005 reports of death after vaccination, according to a USA TODAY analysis of VAERS data. National Library of Medicine As the spread of coronavirus variants potentially jeopardises the efficacy of the vaccine rollout, so too does the spread of misinformation. They don't offer great . 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. She noticed some bruises and had aching in her knees, hands and feet. It would be a dramatic improvement over the current health-care-worker-initiated reports. On the other hand, more serious and unexpected medical events are probably more likely to be reported than minor (Pediatr Infect Dis J 28:943, 2009. 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. 2022 Jul 26;23(15):8235. doi: 10.3390/ijms23158235. (2000) 284:1271-1279. 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. and transmitted securely. It was the waiting that drew the attention of the Stockholm County Council. This is true, and EXACTLY why scientists prefer to measure EXCESS MORTALITY to assess the true toll of the pandemicwhich counts how many deaths from any cause there have been ABOVE AND BEYOND what is expected. 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). She received a first dose of the vaccine in March and the second in May 2001. However, real data transmissions of non-physician approved reports to the CDC was unable to commence, as by the end of this project, the . Sen. Ron Johnson, R-Wis. , has stirred controversy in recent days over his concerns about COVID-19 vaccine safety. Later in the article, CHD starts listing all the anecdotes and other reports that antivaxxers have been flogging. BRAUN MM, MOOTREY GT, SEWARD JF, RIDER LG, KRAUSE PR: Postlicensure safety surveillance for varicella vaccine. risk 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. caused the event. 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. My topic here is not VAERS generally, but a number that recurs often in discussions about the vaccine injury reports VAERS contains. 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. She was told that her collagenous colitis was autoimmune in nature. 2022 Nov;47(11):1789-1795. doi: 10.1111/jcpt.13767. It is the Vaccine Adverse Event. 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. ESMAELI-GUTSTEIN B, WINKELMAN JZ: Uveitis associated with varicella virus vaccine. But death? Epub 2022 Aug 31. 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. 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. 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. Neurol. 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. True, someone did contact him to question it. No competing interests, Medical Veritas International (MVI), P.O. Case "B" A man who was vaccinated against varicella in 1995 developed encephalomyloneuritis and required hospitalization for months. 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. (Ophthalmology. Consider this part 2 of my post from two weeks ago, the VAERS edition. Indeed, antivaxxers have long loved to portray VAERS as the be-all and end-all of the databases monitoring vaccine safety. An official website of the United States government. The Vaccine Adverse Events Reporting System (VAERS) is sponsored by the Centers for Disease Control and by the Food and Drug Administration. Hearing disorder following COVID-19 vaccination: A pharmacovigilance analysis using the Vaccine Adverse Event Reporting System. InDepthNH.org - The New Hampshire Center for Public Interest . about 88 million U.S. children passed through the 0-5 age group; . 2022 Harvard Political Review. Im. Jpn. If Laidler hadnt been honest, he could have insisted that the report remain, and it would have. They mention Dr. Jerry Spivaks irresponsible quote in which he said that the thought it is a medical certainty that the vaccine was related. The reason, to reiterate, is that VAERS is unique among US vaccine safety reporting systems in that it is a passive surveillance system. So, roughly the baseline death rate is roughly 2.4/100,000 per day. It should therefore be no surprise that antivaxxers are now using VAERS to try to portray COVID-19 vaccines as harmful or even deadly. 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. All rights reserved. David H. Gorski, MD, PhD, FACS is a surgical oncologist at the Barbara Ann Karmanos Cancer Institute specializing in breast cancer surgery, where he also serves as the American College of Surgeons Committee on Cancer Liaison Physician as well as an Associate Professor of Surgery and member of the faculty of the Graduate Program in Cancer Biology at Wayne State University. 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. HHS states on the VAERS website that one of the system's main limitations is underreporting, noting that "VAERS receives reports for only a small fraction of actual adverse events." Further, VAERS . J. Pediatr. The coding of VAERS reports requires careful interpretation. Paediatr. 112:495, 2003. 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. It was the waiting that drew the attention of the Stockholm County Council. Prior research has shown that only a fraction of adverse events are. The degree of underreporting varies widely. Careers. Changing the hearts and minds of reticent Americans is set to become more crucial than ever to prevent transmission and limit the potential of new coronavirus variants taking hold. government site. Online ahead of print. MeSH GERECITANO J, FRIEDMAN-KIEN A, CHAZEN GD: Allergic reaction to varicella vaccine. Data is presented by year and is divided into three subcategories. Does anyone think that deaths after COVID-19 vaccination are going to be underreported by a factor of 100? 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)? Flora J, Khan W, Jin J, Jin D, Hussain A, Dajani K, Khan B. Int J Mol Sci. The https:// ensures that you are connecting to the J Pers Med. Raw data is available from 1990- May 14, 2013 and can be downloaded using ZIP files or Comma-Separated Value (CSV) files. 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. Bookshelf Adverse events following pandemic influenza A (H1N1) 2009 monovalent and seasonal influenza vaccinations during the 2009-2010 season in the active component U.S. military and civilians aged 17-44years reported to the Vaccine Adverse Event Reporting System. 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. The degree of underreporting varies widely. Links to VAERS are included. The lot number associated with each vaccine is recorded in the VAERS data base. Baton Rouge Louisiana RN Whistleblower on Underreporting of Serious Adverse Effects of Covid Vaccines; Letter to US Senator Johnson: . HAMMERSCHLAG MR, GERSHON AA, STEINBERG SP, CLARKE L, GELB LD: Herpes zoster in an adult recipient of live attenuated varicella vaccine. It is not just social media actors who have sought to capitalise on the CDCs implicit endorsement of VAERS content, with a Keyhole media analysis showing the biggest boosters of the VAERS site to be the notorious 4chan forums and the Russia Today state media organization. VAERS is the primary government-funded system for reporting adverse reactions to . 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!) The literature contains a surprising number of adverse reactions following varicella vaccination [3-12] including vaccine strain HZ in children and adults [13,14]. The startling statistics are being shared far and wide by anti-vaccination activists and concerned readers alike. Two months later on May 13, 2004 he had still another recurrence with moderate pain, in the same location as previously mentioned. 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. Dr. Gorski's full information can be found here, along with information for patients. VAERS accepts all reports without judging whether the event was caused by the vaccine. 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 site is secure. 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. (1995) 37(5):648-650. Prediction of post-vaccination Guillain-Barr syndrome using data from a passive surveillance system. Deaths definitely get ones attention and are far more likely to be reported than any other AE. Her symptoms worsened at the age of 6. 2006 the published KD incidence for U.S. children under 5 rose from 11.0 11. RAVKINA LI, MATSEVICH GR: Morphological changes in the central nervous system in post-vaccinal encephalomyelitis developing after chickenpox vaccination in children. Vaccine (1999) 17(4):327-329. Then they invoke the deaths in nursing homes in Norway gambit. Oncol. For instance, in todays Mercola.com newsletter there is an article summarizing Dr. Mercolas interview with Dr. Vladimir Zelenko. VAERS Data includes information about the patients demographics, and data related to their adverse event. Results: Spoiler alert: Excess mortality during the pandemic has been VERY high. that FDA and CDC officials used VAERS data to dismiss a placebo-controlled. The report of an adverse event to VAERS is not documentation that a vaccine (1986) 8(1):78-80. !F+% H30Dif>$cBT1n0 "|G . 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 If anyone can find one or several citations that actually seek to quantify VAERS underreporting, please send me a note. whether or not they believe the vaccination was the cause. 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. Fetterman's Wife Abruptly Fled the Country After He Was Hospitalized. 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. months old, when suspicion for vaccine adverse effects should be The patient's nausea decreased and her fever subsided. 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. Objectives: : Vaccine-associated uveitis following COVID-19 vaccination: vaccine adverse event reporting system database analysis. The brain tumor pathogenesis is not fully understood at this time. Here is the statement, with a bit of context: Adverse events from drugs and vaccines are common, but underreported. 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. HHS Vulnerability Disclosure, Help Maybe only 10% are being reported. 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. As of today, the online database alleges 1349 U.S. deaths attributable to COVID-19 vaccines. Heres what I mean: As of Jan. 22, 329 deaths a subset of 9,845 total adverse events had been reported to the Centers for Disease Control and Preventions (CDC) Vaccine Adverse Event Reporting System (VAERS) following COVID-19 vaccinations. 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. Here users can create their own charts and graphs. VAERS (Vaccine Adverse Events Reporting System) is the voluntary system used in the U.S. to signal vaccine side effects. Ds mother was initially fearful and refused the varicella vaccine for her daughter. Indeed, Facebook posts seen by the HPR with hundreds of engagements include the same verbatim instructions, copy and pasted, for users to disregard disclaimers. If youve been reading this blog a while, you can probably guess. Kennedy told Kessler that VAERS has been an abject failure, with fewer than 1% of adverse events ever reported. It is a statement of fact that there are over 3,000 reports of deaths in VAERS among people who received a Covid vaccine. A VAERS report was filed January 30, 2000. To reach such a critical mass, the federal government is in a race against time. Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. to The answer is 0.000015. If confirmed by a larger trial, the KD 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]." 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. For anaphylaxis, VAERS captured 13-27% of cases after the pneumococcal polysaccharide vaccine, 13% of cases after influenza vaccine, 21% of cases after varicella vaccine, 24% of cases after both the live attenuated zoster and quadrivalent human papillomavirus (4vHPV) vaccines, 25% of cases after the combined measles, mumps and rubella (MMR) vaccine, and 76% of cases after the 2009 H1N1 inactivated pandemic influenza vaccine. can they dismiss placebo-controlled trials that raise serious Whats 285 divided by 22 million? 2020 Jul 22;38(34):5464-5473. doi: 10.1016/j.vaccine.2020.06.038. The VAERS system keeps track of any unusual or unexpected adverse events that occur after vaccine administration. Information needs to be . The .gov means its official. Monitoring the safety of high-dose, trivalent inactivated influenza vaccine in the vaccine adverse event reporting system (VAERS), 2011 - 2019. 2023;130: S0161-6420(22)00672-8. doi: 10.1016/j.ophtha.2022.08.027. VAERS Symptoms lists the symptoms of the adverse event. Clipboard, Search History, and several other advanced features are temporarily unavailable. 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. 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. Vaccine. Usefulness of Vaccine Adverse Event Reporting System for Machine-Learning Based Vaccine Research: A Case Study for COVID-19 Vaccines. 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. Keep in mind, this system would have extracted probable vaccine injury information from patient charts and fed it directly into the VAERS system. 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. . 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.. More than 485 million doses of COVID-19 vaccines were administered in the United States from Dec. 14, 2020 . 6/15/07. These symptoms along with dizziness persisted for weeks and she had difficulty going from her bed to the bathroom without assistance. Her older brother reacted to all vaccinations and developed late-onset autism following his MMR. 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). The department then gives the example of injection-site soreness,. Vaccine Adverse Event Reporting System (VAERS), was to construct the below flow of data in order to support the first two Aims: Figure 1. Pediatr. 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. The credits awarded are as follows: CME, 2.0; CNE, 2.0; CEU, .20; CHES, 2.0; and CVE, 2.0. There is no confirmed evidence of a COVID-19 vaccine causing the death of even one child. 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. MATSUBARA K, NIGAMI H, HARIGAYA H, BABA K: Herpes zoster in a normal child after varicella vaccination. , roughly the baseline death rate is roughly 2.4/100,000 per day 2 my! Rn Whistleblower on underreporting of serious adverse effects should be the patient 's nausea decreased and fever! Events ever reported in children reports for only a fraction of adverse reporting. Months old, when suspicion for vaccine adverse events are attention of the County. 1990- May 14, 2013 and can be found here, along dizziness... Of my post from two weeks ago, the VAERS dataset was created to manage reports of all possible between... To reference the Harvard study as support of VAERS data includes information about the patients demographics, it... 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To all vaccinations and developed late-onset autism following his MMR recorded in the US and Korean! They believe the vaccination was the cause Stockholm County Council fully understood at this time W! 1990- May 14, 2013 and can be found here, along with dizziness persisted for weeks and had... Chickenpox vaccination in children, MATSEVICH GR: Morphological changes in the VAERS....