In spite of treatment with Acyclovir* the rash lasted for 45 days. How can public Healthcare providers are required by law to report to VAERS: . 2023 Jan 4:S0161-6420(22)00929-0. doi: 10.1016/j.ophtha.2022.11.023. 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. The primary goals of VAERS is to detect new, unusual, or rare adverse events; monitor increases in known adverse events; Identify potential patient risk factors for particular types of adverse events; identify vaccine lots with increased numbers of types of adverse events; and assess the safety of newly licensed vaccines. Sadly, those over 80, especially those already frail enough to be a nursing home, already have high BASELINE mortality. It might be true that such a small percentage of adverse events is reported for self-limited minor events, such as sore arms, fever, nausea, and the like. Monitoring the safety of high-dose, trivalent inactivated influenza vaccine in the vaccine adverse event reporting system (VAERS), 2011 - 2019. 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. Vaccine Adverse Event Reporting System (VAERS) is among the best adverse event data collection systems in the world, but it's antiquated and difficult to use. She was admitted to a hospital for rehydration after losing 12 lbs or more than 10% of her previous healthy weight. 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. about 88 million U.S. children passed through the 0-5 age group; This 3.5-year-old boy from Georgia who had no pre-existing conditions, received a dose of varicella vaccine on May 12, 1995. J. Ophthalmol. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Case "B" A man who was vaccinated against varicella in 1995 developed encephalomyloneuritis and required hospitalization for months. Results: This is the study everyone cites when stating that VAERS captures only 1% of vaccine-related injuries. I know that this discussion began with Patients, parents and caregivers are encouraged to report "any clinically important medical event or health problem that. Clinical descriptions of five different serious adverse affects that followed varicella vaccination are given below. SINGER S, JOHNSON CE, MOHR R, HOLOWECKY C: Urticaria following varicella vaccine associated with gelatin allergy. The estimated underreporting factor for COVID jab . On the other hand, more serious and unexpected medical events are probably more likely to be reported than minor 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. 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. (Pediatr Infect Dis J 28:943, 2009. 5. Bardenheier BH, Duderstadt SK, Engler RJ, McNeil MM. How? If youve been reading this blog a while, you can probably guess. Both thought that she could have Guillian-barre syndrome. The VAERS dataset also appears to be immune from Facebooks anti-misinformation protocols and remains a prominent feature of the anti-vaccine campaigning repertoire. 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. WASHINGTON, Jan. 28, 2021 /PRNewswire/ -- The primary mechanism for reporting adverse vaccine reactions in the U.S., the Vaccine Adverse Event Reporting System (VAERS), reported 181 deaths a . VAERS is a passive surveillance system that relies on the willingness of individuals and professionals to submit reports voluntarily. Her older brother reacted to all vaccinations and developed late-onset autism following his MMR. 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). 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. How can there possibly be over 16,000 reported in VAERS if nothing is going on? This boy was born on June 30, 1998 and received the varicella vaccination on June 29, 2000. During While the CDC and FDA disclaimers go to great lengths to point out that reports within VAERS are not verified causal claims, in a world where users absorb headline information and where small-scale disinformation campaigns have been shown to have calamitous consequences, one must question whether publishing VAERS vaccine data in its current form achieves more harm than good. 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. GERECITANO J, FRIEDMAN-KIEN A, CHAZEN GD: Allergic reaction to varicella vaccine. by the vaccine is required in order for VAERS to accept the report. Table 1. 10. 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. 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. 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. 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Objectives: 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 18-year period from 1990 through 2007 just 88 cases of Kawasaki Physicians and patients A cursory search of social media shows those who are spreading the VAERS data have paid little heed to the agencys disclaimers. VAERS accepts all reports without judging whether the event was caused by the vaccine. Whoever wrote this article is clearly not an expert, and this article is clearly meant to be disinformation, not science. So there is no way to explain the excess deaths which are effectively over 640,000 for a 41 underreporting factor. Im referring, of course, to antivaxxers resurrecting old antivaccine tropes, dusting them off, and updating them for the age of COVID. He remains permanently disabled. Fetterman's Wife Abruptly Fled the Country After He Was Hospitalized. 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. 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. Moreover, the CDC and FDA do not restrict what people can report, as long as it happened at some point following a vaccination. Analyses of the universal varicella vaccination program in the U.S. have also failed to consider the potential effect on the closely related herpes-zoster epidemiology. 2003 Jan 24;52(1):1-24. anti-covid. 112:495, 2003. Am. With the rollout of COVID-19 vaccines continuing apace, so are the efforts of antivaxxers to portray the vaccines as dangerous. 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. I dont know. In the time since the CDC was approached for comment by the HPR, the shareable buttons have been removed from the site. of underreporting varies widely. 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. 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. 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. She received a first dose of the vaccine in March and the second in May 2001. 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. 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 . All narrative text taken from original VAERS reports are classified with Medical Dictionary for Regulatory Activities (MedDRA) concepts. Conclusions: Her symptoms worsened at the age of 6. health Reports vary in quality and completeness. For anaphylaxis and GBS, VAERS sensitivity is comparable to previous estimates for detecting important AEs following vaccination. ESMAELI-GUTSTEIN B, WINKELMAN JZ: Uveitis associated with varicella virus vaccine. The credits awarded are as follows: CME, 2.0; CNE, 2.0; CEU, .20; CHES, 2.0; and CVE, 2.0. So, OK whatever the number is, its not 6,000. Epub 2022 Aug 31. Unsurprisingly, RFK Jr. and CHD are full ofwell, a brown stinky substance. VAERS is a publicly available, searchable database of reports that have not been verified. The true figure is likely to be significantly higher as Keyhole excludes Instagram and private Facebook groups from its analytics. Disclaimer Whos Really Responsible for Climate Change? Allergy Clin. EMRs available from all ambulatory care encounters in a large multi-specialty practice were used. possibilities of Data is also available through the CDC wonder interface by clicking on the CDC wonder link at the top of the page. 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. 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. Its basically against public health and any collective action to protect public health. Table 1 presents a comparison of the number of adverse reactions reported to VAERS for the varicella vaccine with 4 other different vaccines. 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." (Pediatrics 111:448, 2003. 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. 11. Dr. Gorski's full information can be found here, along with information for patients. However, real data transmissions of non-physician approved reports to the CDC was unable to commence, as by the end of this project, the . Vaccine-Associated Uveitis after COVID-19 Vaccination: Vaccine Adverse Event Reporting System Database Analysis. Vaccine. Epub 2020 Jul 21. Case A Careers. As an amusing aside, whenever I discuss VAERS, I like to recount the tale of how in 2006 Jim Laidler infamously reported to VAERS that the flu vaccine had turned him into The Incredible Hulk and VAERS accepted the report. and he teamed up with a statistician to arrive at the underreporting factor. VAERS (Vaccine Adverse Events Reporting System) is 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. That is, of course, the generic author that RFK Jr.s Childrens Health Defense gives to articles in The Defender that could include almost anyone on the team, all of whom are antivaccine to the core and the vast majority of whom are not scientists. The Harvard Pilgraim study is here for all to see: https://digital.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report-2011.pdf, Naturopathic physician, licensed acupuncturist, medical researcher. effects) are filed in VAERS. Bookshelf He took Acyclovir Oral Suspension (200mg/5ml): Two teaspoons 4 times a day for 5 days. The lot number associated with each vaccine is recorded in the VAERS data base. 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. 6/15/07. The CDC told Reuters. What I want readers to understand is that, when it comes to the antivaccine movement, there is nothing new under the sun. 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 brain tumor pathogenesis is not fully understood at this time. The average age of those who died was 76.5. Sensitivity was reported as either a single value, or a range if data were available from >1 study. Maybe only 10% are being reported. MATSUBARA K, NIGAMI H, HARIGAYA H, BABA K: Herpes zoster in a normal child after varicella vaccination. 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. The problem is that the natural human tendency to seek patterns, coupled with the way antivaccine lawyers game VAERS by having their clients report all sorts of spurious adverse events to the database after vaccination, means that VAERS is a very noisy, distorted, and unreliable database. The second is: What is the baseline rate for such adverse events in the population studied? The individual's susceptibility is determined by the genetic background and previous immunological history. 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. J Clin Pharm Ther. The coding of VAERS reports requires careful interpretation. Again, these are back-of-the-envelope calculations, but theyre close enough to make the point. vaccinedeathreport - Read online for free. A study about it found less than 1% were reported (3). 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. 2022 Jul 29;12(8):1242. doi: 10.3390/jpm12081242. LEE SY, KOMP DM, ANDIMAN W: Thrombocytopenic Purpura following varicella-zoster vaccination. Spoiler alert: Excess mortality during the pandemic has been VERY high. understand that minor side effects of vaccinations often include this kind of discomfort, as well as low fevers. Chan School of Public Health. 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. So lets get back to RFK Jr. and his deceptive article by the Childrens Health Defense Team. The coalition formed . If confirmed by a larger trial, the KD Methods: We estimated VAERS reporting rates following vaccination for anaphylaxis and GBS. Reports vary in quality and completeness. Additionally, the senators said the COVID-19 tests used by . The people behind the Vaccine Adverse Event Reporting System (VAERS) have admitted that "fewer than 1% of vaccine adverse events are reported" in an early grant: native advertising "Adverse events from drugs and vaccines are common, but underreported. Jpn. VAERS accepts all reports of suspected adverse events, in all age groups. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. But definitely its being underreported.. Mealeys Litigation Report, Thimerosal & Vaccines (April, 2003) Volume 1, Issue #10. Background: 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 . 2022 Harvard Political Review. J. Pediatr. The Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system, meaning it relies on individuals to send in reports of their experiences. On June 12, 2003 (age 5), he had a unilateral shingles eruption on the back of his neck. The report of an adverse event to VAERS is not documentation that a vaccine caused the event. %%EOF As I like to say, the greatest strength of VAERS is that anyone can report anything to it, but simultaneously the greatest weakness of VAERS is that anyone can report anything to it. Zh. Ophthalmology. VAERS cannot determine if a vaccine was the specific cause of an adverse event. 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. HHS Vulnerability Disclosure, Help 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. 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. The global reach of the CDC VAERS misinformation should not be underestimated, with print copies of the data having been placed into letterboxes as far away as Brisbane, Australia. 2022 Jul 26;23(15):8235. doi: 10.3390/ijms23158235. Likewise, fewer than 1% of vaccine adverse events are reported.. As the spread of coronavirus variants potentially jeopardises the efficacy of the vaccine rollout, so too does the spread of misinformation. In addition, even vaccine manufacturers have calculated at least a "fifty-fold underreporting of adverse events" on this system. 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. This, of course, is intended to increase reporting of adverse events to VAERS. period (Ophthalmology. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. Unable to load your collection due to an error, Unable to load your delegates due to an error. Since varicella disease is relatively benign, only a few serious adverse reactions might offset the intended benefits. With the authority of the CDC, whose official seal adorns the webpage, VAERS packs a shock. 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 VAERS reports associated with Varicella, DTaP, Hep B, Hib, and MMR vaccines through December, 2003. 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. official website and that any information you provide is encrypted An EMG revealed involvement in an ulnar distribution. It's a shame because VAERS plays a vital role in detecting important but rare reactions caused by vaccines. Her physician recommended prompt vaccination and she received a first dose of varicella vaccine on May 18, 1998. Because of this mismatch, the browser is rejecting it. VAERS accepts all reports of suspected adverse events, in all age groups. 2020 Jul 22;38(34):5464-5473. doi: 10.1016/j.vaccine.2020.06.038. Peter Collignon and his colleagues do not exaggerate the problem of Her CPK was elevated to 676. apply The combined efforts of communication scientists, health services researchers, and others can enhance the development and implementation of long-term, sustainable plans for gathering reliable real-time data about facilitators of and barriers to vaccine acceptance, translating those data into practical solutions. The Harvard Pilgrim study is not a reference that substantiates any claims about VAERS underreporting. The findings, the researchers said, affirm the overall safety of the vaccine and underscore . Case D Harvard Business Review noted that the previous vaccine development record was . Her skin sensitivity also became more intense. 0 It is a statement of fact that there are over 3,000 reports of deaths in VAERS among people who received a Covid vaccine. * Adults that developed gliomas were more likely to never have had varicella. This provides a useful policy contrast to the unfettered publication of unverified claims by the U.S. CDC and FDA. to That purpose, contrary to what antivaxxers would have you believe, is not as the be-all and end-all of vaccine safety surveillance. Sen. Ron Johnson, R-Wis. , has stirred controversy in recent days over his concerns about COVID-19 vaccine safety. The degree of underreporting varies widely. 1. In other words, it would have dramatically increased both the accuracy and the number of vaccine injuries reported to VAERS. But thats Norway. Med. Would you like email updates of new search results? The patient later developed a cough, marked fatigue, sensitivity to light and sound, disturbed sleep and more serious loss of appetite. to other vaccines and other serious clinical problems. She was seen by her physician because of an irregular heart rate and an ECG revealed supra ventricular extra systoles and left ventricular hypertrophy. The Harvard study mentioned by Dr. Zelenko is the same as the one found at reference #6 cited by Mercola. Vaccine. VAERS, Report an Adverse Event, accessed April 9, 2021. Vaccine. 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. Data are updated on a monthly basis. As such, I think it is somewhat sloppy science to reference the Harvard study as support of VAERS underreporting. Is nothing new under the sun high BASELINE mortality here, along with information for patients study! 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