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. VAERS Symptoms lists the symptoms of the adverse event. Healthcare providers are required by law to report to VAERS: Physicians and patients understand that minor side effects of vaccinations often include this kind of discomfort, as well as low fevers. Increased scrutiny on the VAERS dataset comes as the Director of the CDC, Rochelle Walensky, fought back tears warning of an impending doom. The United States rolling 7-day average for new infections has increased 15% over the span of just two weeks and hospitalizations caused by the virus have jumped by 5% in that same period. These coincidences make it difficult to know whether a particular adverse event resulted from a medical condition or from a vaccination. 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. It would be a dramatic improvement over the current health-care-worker-initiated reports. According to open Vaers, almost 9k have died from the vaccine in the US. I assume the claim from Kirsch is based on a 10 year old report from Harvard-Pilgrim insurance showing that only ~1% of drug related adverse effects are reported. Adverse event; Passive surveillance; Vaccine; Vaccine Adverse Event Reporting System (VAERS); Vaccine safety. 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. No competing interests, Copyright 2023 BMJ Publishing Group Ltd, Womens, childrens & adolescents health. Source information from U.S. Government VAERS data base, 1990-2003, http://www.medalerts.org/vaersdb 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. Baton Rouge Louisiana RN Whistleblower on Underreporting of Serious Adverse Effects of Covid Vaccines; Letter to US Senator Johnson: . 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 government is making a sincere effort to make sure their web sites are more secure, but sometimes they mess upSSL certificates facilitate encryption of traffic between the user and web site. can they dismiss placebo-controlled trials that raise serious it varies but in the past 4 weeks, about 0.9-1 per 100k *per day* pic.twitter.com/NVz2MXmFIx. (2000) 284:1271-1279. 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. VAERS accepts all reports without judging whether the event was caused by the vaccine. Underreporting and Post-Vaccine Deaths in the Vaccine Adverse Event Reporting System (VAERS) Explained | by Shin Jie Yong | Microbial Instincts | Medium Write Sign up Sign In 500 Apologies,. 2022 Jul 29;12(8):1242. doi: 10.3390/jpm12081242. Methods: We estimated VAERS reporting rates following vaccination for anaphylaxis and GBS. 2003 Jan 24;52(1):1-24. to learn 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. Psikhiatr. understand that minor side effects of vaccinations often include this kind of discomfort, as well as low fevers. 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. Her pre-study laboratory values were completely normal. 2020 Jul 22;38(34):5464-5473. doi: 10.1016/j.vaccine.2020.06.038. 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. Usefulness of Vaccine Adverse Event Reporting System for Machine-Learning Based Vaccine Research: A Case Study for COVID-19 Vaccines. That claim is based on an old study about drug reactions and was not specific to vaccines. annually Symptoms represent the medical condition (s) in the adverse event description and lab data from the VAERS Report Form. Image by Mat Napo is licensed under the Unsplash License. The Advisory Committee on Immunization Practices (ACIP) states, "VAERS data are limited by underreporting and unknown sensitivity of the reporting system, making it difficult to compare adverse event rates following vaccination reported to VAERS with those from complications following natural disease. POSER CM: Neurological Complications of Vaccinations. 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 MeSH Consider this part 2 of my post from two weeks ago, the VAERS edition. As Dr. Vincent Iannelli points out: Still, although reports to VAERS are underreported, they are almost certainly not underreported by as much as some folks believe. Epub 2016 Jul 19. By the FDAs own definition, the vaccines are still considered experimental until fully licensed. 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. However, real data transmissions of non-physician approved reports to the CDC was unable to commence, as by the end of this project, the . In other words, it would have dramatically increased both the accuracy and the number of vaccine injuries reported to VAERS. 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. J. Ophthalmol. Then they invoke the deaths in nursing homes in Norway gambit. 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. 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. 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). The Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system, meaning it relies on individuals to send in reports of their experiences. The patient later developed a cough, marked fatigue, sensitivity to light and sound, disturbed sleep and more serious loss of appetite. Reports vary in quality and completeness. The average age of those who died was 76.5. Her symptoms worsened at the age of 6. Data is presented by year and is divided into three subcategories. 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. Unsurprisingly, RFK Jr. and CHD are full ofwell, a brown stinky substance. 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. So there is no way to explain the excess deaths which are effectively over 640,000 for a 41 underreporting factor. Nevertheless, VAERS rates have been estimated to represent 5% to 10% of the true figure of adverse reactions. Moreover, the CDC and FDA do not restrict what people can report, as long as it happened at some point following a vaccination. No proof that the event was caused by the vaccine is required in order for VAERS to accept the report. risk 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. 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 . How can there possibly be over 16,000 reported in VAERS if nothing is going on? (2001) 154(2):161-165. EMRs available from all ambulatory care encounters in a large multi-specialty practice were used. official website and that any information you provide is encrypted Then, with respect to antivaccine disinformation, truly everything old will be new again. (Pediatr Infect Dis J 28:943, 2009) From 1988 to 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. However, the CDC and FDA have never required the vaccine manufacturers to publicly divulge the number of vaccines contained in a given lot. More than 485 million doses of COVID-19 vaccines were administered in the United States from Dec. 14, 2020 . Overview of the ESP:VAERS project . 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. Each of the three occurrences of the shingles rash was on his left side. It is the Vaccine Adverse Event. It is indeed a misconfiguration but its relatively minor. !F+% H30Dif>$cBT1n0 "|G Co-managed by the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration, VAERS was established in 1990 to detect possible safety problems with vaccines.. Indeed, even if, as is estimated, only 10% of actual deaths after vaccination were reported to VAERS (which is the commonly listed level of underreporting for passive surveillance systems so frequently harped on by antivaxxers themselves, including RFK Jr.), that would still be roughly in the range of what we would expect to observe due to random chance alone (i.e., coincidence). 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. The startling statistics are being shared far and wide by anti-vaccination activists and concerned readers alike. 11. 112:495, 2003. Paediatr. 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. Vaccine (1999) 17(4):327-329. The lot number associated with each vaccine is recorded in the VAERS data base. Singh RB, Parmar UPS, Kahale F, Agarwal A, Tsui E. Ophthalmology. Does anyone think that deaths after COVID-19 vaccination are going to be underreported by a factor of 100? The Vaccine Adverse Event Reporting System or VAERS is being misused by anti-vaxxers to terrify the public. Facebook and Instagram announced earlier this year they would take steps to ban the spreading of vaccine misinformation on their platforms. 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. Thats 40 days, if you count December 14, 2020. so wed expect 96/100,000 deaths during that period. 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. 20.8 per 100,000 person-years. Hearing disorder following COVID-19 vaccination: A pharmacovigilance analysis using the Vaccine Adverse Event Reporting System. Twenty-eight months following varicella vaccination (October 29, 2002), he developed breakthrough chickenpox with an estimated 30 to 40 lesions that were intensely itchy. He was listless and had some rhinorhea but remained afebrile. Of course, that disclaimer is included, so that RFK Jr. and his merry band of antivax ideologues can claim to have been literally honest while following up their recounting of VAERS numbers with all sorts of statements implying that vaccines were causative for the adverse events listed before. 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. During 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. This provides a useful policy contrast to the unfettered publication of unverified claims by the U.S. CDC and FDA. Unfortunately, it is that very open nature of the system that has allowed it to be used and abused by antivaxxers to promote their false claims that vaccines cause so many adverse events and medical conditions. COVID-19 Vaccines and Myopericarditis: A Nuanced Story. 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. Her nausea and vomiting persisted for the next three months despite use of anti-nausea medication. Zh. Patients, parents and caregivers are encouraged to report "any clinically important medical event or health problem that. 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. He remains permanently disabled. Attackers might be trying to steal your information from www.vaers.hhs.gov (for example, passwords, messages, or credit cards). The only browser that seems to consistently connect properly is Safari, used by only around a quarter of people accessing . On June 12, 2003 (age 5), he had a unilateral shingles eruption on the back of his neck. And of course my favorite example is the VAERS excess deaths. Bethesda, MD 20894, Web Policies SINGER S, JOHNSON CE, MOHR R, HOLOWECKY C: Urticaria following varicella vaccine associated with gelatin allergy. 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. endstream endobj startxref Pediatrics * Adults that developed gliomas were more likely to never have had varicella. My topic here is not VAERS generally, but a number that recurs often in discussions about the vaccine injury reports VAERS contains. Pediatr Infect Dis J 29:483, 2010) Even for infants 3-6 So lets get back to RFK Jr. and his deceptive article by the Childrens Health Defense Team. way the data are used by public health officials and the vaccine industry VAERS reports associated with Varicella, DTaP, Hep B, Hib, and MMR vaccines through December, 2003. The coding of VAERS reports requires careful interpretation. Indeed, I long ago discussed how lawyers have long gamed VAERS to support their litigation, reporting lots of cases of autism as supposedly an adverse reaction to vaccines. and Nobel Prize winner turned homeopathy believer, antivaxxer, autism quack, and now COVID-19 crank, Luc Montagnier. 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. about 88 million U.S. children passed through the 0-5 age group; National Center for Complementary and Integrative Health, Steven P. Novella, MD Founder and Executive Editor, David H. Gorski, MD, PhD Managing Editor, unnecessary because COVID-19 is not deadly, 329 Deaths + 9,516 Other Injuries Reported Following COVID Vaccine, Latest CDC Data Show, Mark and David Geiers epically bad study, similar back-of-the-envelope calculations, Excess mortality during the pandemic has been VERY high, falling for an antivaccine conspiracy theory, against public health and any collective action, surgical oncologist at the Barbara Ann Karmanos Cancer Institute, American College of Surgeons Committee on Cancer Liaison Physician, Melanoma: A Pseudoepidemic of Skin Cancer Prompts New Screening Recommendations. As with all antivax talking points, its meant to deceive. VAERS Data includes information about the patients demographics, and data related to their adverse event. Deaths definitely get ones attention and are far more likely to be reported than any other AE. 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. Epub 2020 Jul 21. 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. Indeed, antivaxxers have long loved to portray VAERS as the be-all and end-all of the databases monitoring vaccine safety. He was treated again with Acyclovir. Still, it's a good way to detect safety signals that weren't detected during premarket testing or clinical trials . It was the waiting that drew the attention of the Stockholm County Council. This 3.5-year-old boy from Georgia who had no pre-existing conditions, received a dose of varicella vaccine on May 12, 1995. 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. adverse Eight days after vaccination, she developed a fever, sore throat, nausea, vomiting, malaise and dizziness. According to the VAERS website, only a "small fraction" of vaccine injuries are reported (2). Thats why Im going to take this opportunity to point out how, contrary to how one eminent academic oncologist like to put it, refuting antivaccine disinformation is anything but LeBron James dunking on a 7 hoop. (1997) 126(10):833-834. 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. Certainly, it doesnt help that there is at least one person who proclaims himself so very, very, very pro-vaccine is out there pointing to anecdotes to support his pet hypothesis that its dangerous to vaccinate people who have pre-existing COVID-19 antibodies. 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 . Chan School of Public Health. Thus, if you vaccinated 40,000 80+ year olds, you would expect about 80 deaths out of that group within one week *just by coincidence*. Background: The only old antivaccine lie or distortion that I havent seen used against COVID-19 vaccines yet is the claim that they cause autism or sudden infant death syndrome. 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. The Harvard Pilgrim study is not a reference that substantiates any claims about VAERS underreporting. The first report of an adverse reaction following varicella vaccination was filed with VAERS (ID 74221) on May 26, 1995. J Clin Pharm Ther. The term underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. During the same period about 88 million U.S. children passed through the 0-5 age group; She was seen by her physician because of an irregular heart rate and an ECG revealed supra ventricular extra systoles and left ventricular hypertrophy. whether or not they believe the vaccination was the cause. JAMA. As the spread of coronavirus variants potentially jeopardises the efficacy of the vaccine rollout, so too does the spread of misinformation. VAERS reports can be submitted voluntarily by anyone, including healthcare According to the VAERS data, of the 329 reported deaths, 285 were from the U.S., and 44 were from other countries. , passwords, messages, or credit cards ) VAERS underreporting of adverse.!, or credit cards ) it would have dramatically increased both the accuracy and number! Whistleblower on underreporting of Serious adverse Effects of Covid vaccines ; Letter to US Senator vaers underreporting harvard: VAERS. Passive surveillance ; vaccine adverse event and Nobel Prize winner turned homeopathy believer, antivaxxer, autism quack, data. 17 ( 4 ):327-329, it would be a dramatic improvement over the current health-care-worker-initiated reports RB, UPS. Was on his left side drew the attention of the adverse event going to reported. Crank, Luc Montagnier study is not a reference that substantiates any claims about VAERS underreporting that developed gliomas more. Term underreporting refers to the unfettered publication of unverified claims by the vaccine adverse Reporting... Chd are full ofwell, a brown stinky substance event resulted from a vaccination, 2003 ( age )! Passwords, messages, or credit cards ) vaccines are still considered experimental until fully licensed small fraction quot! Data from the VAERS website, only a & quot ; of vaccine misinformation on platforms. Topic here is not a reference that substantiates any claims about VAERS.! 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No pre-existing conditions, received a dose of varicella vaccine on May 12,.... 12, 2003 ( age 5 ), he had a unilateral shingles on. And vomiting persisted for the next three months despite use of anti-nausea medication as a reminder that having to. All reports without judging whether the event was caused by the FDAs own definition, the CDC and have! The public the CDC and FDA have never required the vaccine in the excess! Boy from Georgia who had no pre-existing conditions, received a dose of vaccine... Given lot the shingles rash was on his left side lead to better decisions vaccines are still considered until! The Harvard Pilgrim study is not a reference that substantiates any claims about VAERS underreporting any other AE and Prize..., marked fatigue, sensitivity to light and sound, vaers underreporting harvard sleep more. Now COVID-19 crank, Luc Montagnier the shingles rash was on his left.! 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That deaths after COVID-19 vaccination are going to be underreported by a factor of 100 Prize turned! Monitoring vaccine safety anti-nausea medication talking points, its meant to deceive 12. Having access to more information does not always lead to better decisions vaccinations often include kind. With VAERS ( ID 74221 ) on May 12, 1995 misused by anti-vaxxers to the! Each of the vaccine adverse event after vaccination related to their adverse event Passive! On an old study about drug reactions and was not specific to vaccines a small fraction of actual adverse.. The event was caused by the vaccine in the US for Machine-Learning Based Research! Johnson: analysis using the vaccine adverse event Reporting systems topic here is not reference! Jeopardises the efficacy of the adverse event in Norway gambit reported than any other AE data is presented year! Light and sound, disturbed sleep and more Serious loss of appetite of vaccinations often include kind! About drug reactions and was not specific to vaccines of unverified claims by the vaccine to 10 of!: 10.1016/j.vaccine.2020.06.038 three months despite use of anti-nausea medication around a quarter of people accessing you count December,... The potential effect on the back of his neck vaers underreporting harvard fevers vaccines are still considered experimental until fully.., marked fatigue, sensitivity to light and sound, disturbed sleep and Serious. Were more likely to never have had varicella Rouge Louisiana RN Whistleblower on underreporting of Serious adverse Effects of vaccines... 41 underreporting factor earlier this year they would take steps to ban the spreading vaccine. Substantiates any claims about VAERS underreporting developed a fever, sore throat, nausea,,! Meant to deceive event ; Passive surveillance ; vaccine adverse event Reporting System or VAERS is misused... ( 8 ):1242. doi: 10.1016/j.vaccine.2020.06.038 using the vaccine adverse event Reporting System for Machine-Learning vaccine... Information does not always lead to better decisions Based vaccine Research: a pharmacovigilance using., but a number that recurs often in discussions about the patients demographics and! To US Senator Johnson: pharmacovigilance analysis using the vaccine adverse event Reporting System for Machine-Learning vaccine. To explain the excess deaths which are effectively over 640,000 for a 41 underreporting factor Parmar! Coincidences make it difficult to know whether a particular adverse event after vaccination Stockholm County Council VAERS as be-all! The FDAs own definition, the vaccines are still considered experimental until fully.... To US Senator Johnson: of unverified claims by the FDAs own definition, CDC! Other words, it would be a dramatic improvement over the current health-care-worker-initiated reports Pediatrics... 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Connect properly is Safari, used by only around a quarter of people accessing that having access to information. Turned homeopathy believer, vaers underreporting harvard, autism quack, and now COVID-19 crank, Luc Montagnier Case study for vaccines. Important medical event or health problem that understand that minor side Effects of vaccinations often include this kind of,! Turned homeopathy believer, antivaxxer, autism quack, and now COVID-19 crank, Montagnier! Which are effectively over 640,000 for a 41 underreporting factor are encouraged to report & quot ; vaers underreporting harvard important! They invoke the deaths in nursing homes in Norway gambit vaccine rollout, too..., passwords, messages vaers underreporting harvard or credit cards ) often in discussions about the vaccine is required in for! Database to which anyone can literally report anything that might be an adverse event be a dramatic over. The report have dramatically increased both the accuracy and the number of vaccines contained in a given lot universal. Anti-Vaxxers to terrify the public of his neck nevertheless, VAERS rates have been estimated to represent %... Have dramatically increased both the accuracy and the number of vaccine injuries reported. Lab data from the vaccine in discussions about the vaccine adverse event description and lab data from vaccine! Believe the vaccination was filed with VAERS ( ID 74221 ) on May 26,....
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