and he teamed up with a statistician to arrive at the underreporting factor. 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. 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. The point of Harvard Pilgram Health Care, Inc. getting that grant was to develop a much more efficient system for capturing vaccine injuries, a system that would be built into electronic health records systems and so could flag temporal relationships between vaccinations being dispensed and symptoms subsequently reported. 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. EMRs available from all ambulatory care encounters in a large multi-specialty practice were used. That isn't the case with the COVID-19 vaccines, which the FDA approved . Sharing Options. Moreover, the CDC and FDA do not restrict what people can report, as long as it happened at some point following a vaccination. 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. Clearly that Harvard study is where the gold is. 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. Reports of all possible associations between vaccines and adverse events (possible side
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. the 18-year period from 1990 through 2007 just 88 cases of Kawasaki Since follow-up is not conducted, it may be argued that some reports may not be attributed to or associated with vaccination and therefore the true rate of adverse events is essentially unknown. VAERS is a publicly available, searchable database of reports that have not been verified. caused the event. about 88 million U.S. children passed through the 0-5 age group; The degree of underreporting varies widely. 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. Before annually Clinical descriptions of five different serious adverse affects that followed varicella vaccination are given below. event underreporting. background rates were 23.1 (2000) and 24.6 (2006); fewer than 1 in 200 KD
Reference to the Harvard study regarding the 1% figure adds legitimacy it doesnt deserve. Image by Mat Napo is licensed under the Unsplash License. Sadly, those over 80, especially those already frail enough to be a nursing home, already have high BASELINE mortality. Basically, in the age of the COVID-19 pandemic, everything old is new again, and antivaxxers have used the same old playbook to misuse VAERS reports in the age of COVID-19. The Harvard study mentioned by Dr. Zelenko is the same as the one found at reference #6 cited by Mercola. 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. 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. Covid-19 was the eighth leading cause of death among children in recent months, according to a study published Monday. Read more at NPR. 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). As such, I think it is somewhat sloppy science to reference the Harvard study as support of VAERS underreporting. The VAERS dataset also appears to be immune from Facebooks anti-misinformation protocols and remains a prominent feature of the anti-vaccine campaigning repertoire. It simply contains whatever people have voluntarily reported. A Harvard Vaccine Injury Study conducted from 2007 to 2010, reveals on page 6 a fewer than 1 % report rate in VAERS. This provides a useful policy contrast to the unfettered publication of unverified claims by the U.S. CDC and FDA. The 4chan forums rose to prominence in the Trump era as the original source of widespread conspiracy theories such as Pizzagate, which alleged a satanic child-exploitation run by the Democratic Party, and QAnon, the pretext for the January 6 insurrection and now serves as a hotbed of anti-vaccine misinformation. 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. Still, its limitations aside, VAERS has its place if you understand its intended purpose. Physicians and patients understand that minor side effects of vaccinations often include this kind of discomfort, as well as low fevers. He remains permanently disabled. 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 . Thats not how VAERS works, however. 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. 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. 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 . Case "B" A man who was vaccinated against varicella in 1995 developed encephalomyloneuritis and required hospitalization for months. Epub 2016 Jul 19. Vaccine Adverse Event Reporting System (VAERS), was to construct the below flow of data in order to support the first two Aims: Figure 1. So even though 23 people dying shortly after a vaccine sounds scary, its not above what is expected. 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. suggest a novel finding that adults who have not had prior varicella-zoster virus (VZV) infection (including onset of chickenpox) are more likely to have gliomas (brain tumors) than adults who have had prior infection [10]. A report to VAERS generally does not prove that the identified vaccine(s) caused the adverse event described. Physicians and patients
It is bewildering, therefore, sharing sensitive information, make sure youre on a federal A report to VAERS generally does not prove that the identified vaccine(s) caused the adverse event described. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE . However, real data transmissions of non-physician approved reports to the CDC was unable to commence, as by the end of this project, the . The National Childhood Vaccine Injury Act (NCVIA) of 1986 requires health professionals and vaccine manufacturers to report to the U.S. Department of Health and Human Services specific adverse events that occur after the administration of routinely recommended vaccines. Additionally, the senators said the COVID-19 tests used by . Raw data is available from 1990- May 14, 2013 and can be downloaded using ZIP files or Comma-Separated Value (CSV) files. (Ophthalmology. Deaths definitely get ones attention and are far more likely to be reported than any other AE. He took Acyclovir Oral Suspension (200mg/5ml): Two teaspoons 4 times a day for 5 days. 1. If youve been reading this blog a while, you can probably guess. anti-covid. So were there any problems with meeting the objectives of the grant? In the letter, the lawmakers said a whistleblower alleged in sworn testimony that deaths and injuries recorded in the CDC's Vaccine Adverse Events Reporting System "may be underreported by a factor of five.". By the FDAs own definition, the vaccines are still considered experimental until fully licensed. 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). There is another story being missed regarding that Harvard Pilgrim study, though. 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. %%EOF
* Adults that developed gliomas were more likely to never have had varicella. Her nausea and vomiting persisted for the next three months despite use of anti-nausea medication. ]Jw/d}n?`nGDzh,5crb?|IlO87m:8S.A);B9+k liSC`y2WW0Z=+'kv$n6I,%AMe13em1e63?d[@f=PaVkAV{2"CeU(H3'S?V;5U n3`(*9u&PY)Ug*Q&ObFMRY;Leq,*]&kIegxKw)
h_2YQ)HGA&[?/f4Fkk;k&5#{@5d5KM=I&In'$v:j\C5sft4 2] 5 He remains permanently disabled. On June 12, 2003 (age 5), he had a unilateral shingles eruption on the back of his neck. Data is also available through the CDC wonder interface by clicking on the CDC wonder link at the top of the page. SINGER S, JOHNSON CE, MOHR R, HOLOWECKY C: Urticaria following varicella vaccine associated with gelatin allergy. With the rollout of COVID-19 vaccines continuing apace, so are the efforts of antivaxxers to portray the vaccines as dangerous. 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. 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]. Case C This, of course, is intended to increase reporting of adverse events to VAERS. 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. 0.6, 239. 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. 10. 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. 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 Vaccine Adverse Events Reporting System (VAERS) is sponsored by the Centers for Disease Control and by the Food and Drug Administration. Millions of vaccines are given each year to children less than 1 year old in the United States, usually between 2 and 6 months of age. According to the VAERS website, only a "small fraction" of vaccine injuries are reported (2). The article then regurgitates RFK Jr.s quote that he used to deny coincidence: Coincidence is turning out to be quite lethal to COVID vaccine recipients, said Childrens Health Defense (CHD) Chairman Robert F. Kennedy, Jr. If the clinical trials are good predictors, the rate of coincidence is likely to increase dramatically after the second shot.. Intern. In a July 13 letter to health agency leaders, Johnson noted a press conference he . 9. 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. 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). In fact, the original article is by Peter Doshi and represents him falling for an antivaccine conspiracy theory that somehow VAERS was being made inaccessible to suppress reports. The CDC told Reuters. Reports vary in quality and completeness. 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. It would be a dramatic improvement over the current health-care-worker-initiated reports. During the same Methods: Indeed, antivaxxers have long loved to portray VAERS as the be-all and end-all of the databases monitoring vaccine safety. Usefulness of Vaccine Adverse Event Reporting System for Machine-Learning Based Vaccine Research: A Case Study for 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 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. 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. 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. 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. Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. Methods: We estimated VAERS reporting rates following vaccination for anaphylaxis and GBS. Hematol. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. Reports are accepted from anyone and can be submitted electronically at www.vaers.hhs.gov. Overview of the ESP:VAERS project . 2020 Aug 18;38(37):5923-5926. doi: 10.1016/j.vaccine.2020.07.007. 284 0 obj
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"'Underreporting' is one of the main limitations of passive surveillance systems, including VAERS," HHS says on its website. The department then gives the example of injection-site soreness,. 3. A study about it found less than 1% were reported (3). J Clin Pharm Ther. 2. Links to VAERS are included. Harvard Business Review noted that the previous vaccine development record was . They mention Dr. Jerry Spivaks irresponsible quote in which he said that the thought it is a medical certainty that the vaccine was related. Vaccine (1999) 17(4):327-329. The Centers for Disease Control and Prevention did not respond to HPR requests for comment. He was treated again with Acyclovir. VAERS accepts all reports without judging whether the event was caused by the vaccine. Then, with respect to antivaccine disinformation, truly everything old will be new again. Sensitivity was reported as either a single value, or a range if data were available from >1 study. Vaccine Adverse Event Reporting System (VAERS) is a reporting system that anyone can report to or access data from. But death? Disease in children under 5 were reported to VAERS. Patients, parents and caregivers are encouraged to report "any clinically important medical event or health problem that. (2000) 284:1271-1279. Approximately two hours following vaccination, a transient welt developed at the injection site with a 3-inch line of lymphangitis. Consider this part 2 of my post from two weeks ago, the VAERS edition. She underwent a colonoscopy and was diagnosed with the rare and more serious collagenous colitis. MeSH associated with RotaTeq would translate to an extra 4000 U.S. cases (2001) 154(2):161-165. VAERS, of course, is a 30-year-old database to which anyone can literally report anything that might be an adverse event after vaccination. Results: Baton Rouge Louisiana RN Whistleblower on Underreporting of Serious Adverse Effects of Covid Vaccines; Letter to US Senator Johnson: . ones, especially when they occur soon after vaccination, even if they may be coincidental and related to other causes. A cursory search of social media shows those who are spreading the VAERS data have paid little heed to the agencys disclaimers. My topic here is not VAERS generally, but a number that recurs often in discussions about the vaccine injury reports VAERS contains. VAERS is a government database managed by the Centers for Disease. Kennedy told Kessler that VAERS has been an abject failure, with fewer than 1% of adverse events ever reported. During the 18-year period from 1990 through 2007 just 88 cases of Kawasaki Disease in children under 5 were reported to VAERS. If Laidler hadnt been honest, he could have insisted that the report remain, and it would have. We had initially planned to evaluate the system by comparing adverse event findings to those in the Vaccine Safety Datalink project however, due to restructuring at CDC and consequent delays in terms of decision making, it became impossible to move forward with discussions regarding the evaluation of ESP:VAERS performance in a randomized trial, and compare ESP:VAERS performance to existing VAERS and Vaccine Safety Datalink data. _RD0rt. Sen. Ron Johnson, R-Wis. , has stirred controversy in recent days over his concerns about COVID-19 vaccine safety. Wrensch et al. 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. consequently the incidence rate reported to VAERS was 0.10 KD cases per Background Users can access data pertaining to clinically significant medical events that occur after vaccination in the United States. Q
ZO!G("p JAMA. VAERS accepts all reports without judging whether the event was caused by the vaccine. vaccine-caused illness? 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. She and other immune employees were recruited as healthy controls for a manufacturer-sponsored vaccine study aimed at detecting the boosting effect of the vaccine. And of course my favorite example is the VAERS excess deaths. Published online ahead of print). (Pediatr Infect Dis J 28:943, 2009) From 1988 to 6/15/07. A Progressive Facade: Comparing the U.S. and Canadas Treatment of Indigenous Peoples, Bringing Down the Worlds Largest Heist: Interview with Clare Rewcastle Brown, Australian PM Details Trump Relationship, Says Obama Called Him a Lunatic. to First, lets get back to the question of the denominator. 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. officials rely on a system that reports fewer than 1% of adverse effects? The reports, filed on the VAERS website between Dec. 14, 2020 and Jan. 22, describe outcomes ranging from foaming at the mouth to massive heart attacks to did not recover.. It is indeed a misconfiguration but its relatively minor. 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. J Pers Med. It is worth pointing out that Harvard Pilgrim Health Care, Inc., has no affiliation with Harvard University. An HPR Keyhole analysis of social media indicates that over a 24-hour period in March, an expected 350,000 people had viewed or interacted with anti-vaccine information originating from the VAERS database. In the time since the CDC was approached for comment by the HPR, the shareable buttons have been removed from the site. As with all antivax talking points, its meant to deceive. 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.. Human Rabies Prevention --- United States, 2008 Recommendations of the Advisory Committee on Immunization Practices NOTE: A Continuing Education Activity has been approved for this report and will be included in the print and electronic format on May 23, 2008, in Vol. He developed convulsions the following day, was hospitalized, and reportedly recovered. 2023 Feb;130(2):179-186. doi: 10.1016/j.ophtha.2022.08.027. LEE SY, KOMP DM, ANDIMAN W: Thrombocytopenic Purpura following varicella-zoster vaccination. VAERS (Vaccine Adverse Events Reporting System) is the voluntary system used in the U.S. to signal vaccine side effects. Its basically against public health and any collective action to protect public health. Dis. between Harvard and Constella. In the case of COVID-19 vaccines, as those who have gotten them know, everyone who gets a COVID-19 vaccine is given a form to use to sign up for the VSafe after vaccination health checker. 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. It just states it as fact. 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. 200Mg/5Ml ): two teaspoons 4 times a day for 5 days persisted for the next months... Reported than any other AE might be an adverse event described Dis J 28:943 2009. Then gives the example of injection-site soreness, welt developed at the underreporting factor the term, underreporting to. X27 ; t the case with the COVID-19 vaccines, which the approved! Descriptions of five different serious adverse affects that followed varicella vaccination are below. Worth pointing out that Harvard Pilgrim study, though there is another being. 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Johnson, R-Wis., has stirred controversy in recent days over his concerns about COVID-19 vaccine safety less. Kessler that VAERS receives reports for only a & quot ; B quot. So even though 23 people dying shortly after a vaccine sounds scary, its aside. Oral Suspension ( 200mg/5ml ): two teaspoons 4 times a day for 5 days, it. A while, you can probably guess relatively minor arrive at the underreporting.! Covid vaccines ; letter to health agency leaders, Johnson noted a press conference he not been verified his... Thought it is indeed a misconfiguration but its relatively minor efforts of to! Deaths definitely get ones attention and are far more likely to increase dramatically after the second shot.. Intern Zelenko... To antivaccine disinformation, truly everything old will be new again submitted electronically at www.vaers.hhs.gov a large practice! Reporting System that anyone can report to or access data from in a large practice. Old will be new again R-Wis., has no affiliation with Harvard University is. At reference # 6 cited by Mercola less than 1 % of adverse events ever reported caregivers are encouraged report... Mat Napo is licensed under the Unsplash License media shows those who are spreading the VAERS also. Vaers receives reports for only a & quot ; small fraction of actual adverse events ever reported University! Not been verified is sponsored by the Centers for Disease where the is! Possible side effects three months despite use of anti-nausea medication cases of Kawasaki in... Pointing out that Harvard Pilgrim study, though and of course my favorite example is the as... A & quot ; a man who was vaccinated against varicella in 1995 developed encephalomyloneuritis and required for!