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. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 113% of serious events are reported to the Food and Drug Administration (FDA). 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. 12. He remains permanently disabled. Dr. Gorski's full information can be found here, along with information for patients. cases were reported to VAERS. These statistics are, of course, patently false. Raw data is available from 1990- May 14, 2013 and can be downloaded using ZIP files or Comma-Separated Value (CSV) files. 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. There were nearly 3,800 anti-Asian hate incidents in the U.S. between March 19, 2020 and Feb. 28, 2021, according to data from the Stop AAPI Hate coalition released this week. Ds mother was initially fearful and refused the varicella vaccine for her daughter. Practically no one is going to report an adverse reaction like a sore arm or transient fever to VAERS, but you know damned well theyll report more serious ones, such as a seizure. They also allow users to verify that they are connected to the real web site, rather than a hackers web site. Med. To test the correlations found in VAERS requires different systems, systems such as the Vaccine Safety Datalink (VSD) or others, which are active safety monitoring databases in which investigators actively scan real medical records and insurance claims data to seek increases in frequencies of adverse events after vaccination and try to determine if there is a real association. A report to VAERS generally does not prove that the identified vaccine(s) caused the adverse event described. Am. 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*. The second is: What is the baseline rate for such adverse events in the population studied? 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). 13. That purpose, contrary to what antivaxxers would have you believe, is not as the be-all and end-all of vaccine safety surveillance. Whos Really Responsible for Climate Change? 2016 Aug 17;34(37):4406-14. doi: 10.1016/j.vaccine.2016.07.019. InDepthNH.org - The New Hampshire Center for Public Interest . 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. She was admitted to a hospital for rehydration after losing 12 lbs or more than 10% of her previous healthy weight. The true figure is likely to be significantly higher as Keyhole excludes Instagram and private Facebook groups from its analytics. 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. SUNAGA Y, HIKIMA A, OSTUKA T, MORIKAWA A: Acute cerebellar ataxia with abnormal MRI lesions after varicella vaccination. VAERS is a government database managed by the Centers for Disease. by the vaccine is required in order for VAERS to accept the report. 10. 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 had moderate pain and the lesions were tender and sensitive to clothing. official website and that any information you provide is encrypted The shock of Covid-19 hit in different ways for Xiao Wu, a 27-year-old Ph.D. student in Harvard's public health school, and his academic adviser, biostatistician Francesca Dominici. After the investigations that lead to the licensing of a vaccine, the mainstay of post-marketing surveillance is the mandated reporting of adverse events following vaccines, a reporting system jointly overseen by CDC and FDA was created, the Vaccine Adverse Event Reporting System (VAERS). Given that anyone can report any suspected adverse event, VAERS is intended to be an early warning system. VAERS is a passive surveillance system that relies on the willingness of individuals and professionals to submit reports voluntarily. health LEE SY, KOMP DM, ANDIMAN W: Thrombocytopenic Purpura following varicella-zoster vaccination. The CDC blocked both the data collection by the Harvard Pilgrim group, and also any implementation that could have followed from their findings. (1986) 8(1):78-80. Nevropatol. A man who was vaccinated against varicella in 1995 developed encephalomyloneuritis and required hospitalization for months. Table 1. How can there possibly be over 16,000 reported in VAERS if nothing is going on? Case B 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]. Her physician was of the opinion that a virus probably triggered her autoimmune response. 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. A VAERS report was filed January 30, 2000. and Nobel Prize winner turned homeopathy believer, antivaxxer, autism quack, and now COVID-19 crank, Luc Montagnier. This time around, theyve resurrected the old antivaccine trick of deceptively misusing the VAERS database to imply causation from VAERS reports. sharing sensitive information, make sure youre on a federal Studies have found reporting rates on VAERS of 47% for cases of intussusception cases after the rotavirus vaccine and 68% for paralytic polio after the oral polio vaccine, while rates ranged from. Keywords: It is primarily a hypothesis-generating, not hypothesis-testing, system when it comes to questions related to vaccine safety. (Pediatr Infect Dis J 28:943, 2009. Disclaimer Immonol. Unauthorized use of these marks is strictly prohibited. Her physician reassured her by saying: Do you think I would give the vaccination to my own children if I thought it wasn't safe? Her physician also informed her that state law mandates chickenpox vaccination but never told her that she could withhold her consent. (1995) 37(5):648-650. 6. Ophthalmology. 112:495, 2003. RR-3. 2022 Harvard Political Review. She received a first dose of the vaccine in March and the second in May 2001. . The VAERS system keeps track of any unusual or unexpected adverse events that occur after vaccine administration. A Harvard Vaccine Injury Study conducted from 2007 to 2010, reveals on page 6 a fewer than 1 % report rate in VAERS. Would you like email updates of new search results? This, of course, is intended to increase reporting of adverse events to VAERS. VAERS is a postmarketing surveillance program, collecting information about adverse events (possible harmful side effects) that occur after administration of vaccines to ascertain . Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001. 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. So there is no way to explain the excess deaths which are effectively over 640,000 for a 41 underreporting factor. The easily-abused nature of VAERS data is one huge reason why those of us whove been following the antivaccine movement a long time like to refer to the bad scientific studies published by antivaccine physicians and scientists that use VAERS as their data source as dumpster diving. It's a shame because VAERS plays a vital role in detecting important but rare reactions caused by vaccines. Facebook and Instagram announced earlier this year they would take steps to ban the spreading of vaccine misinformation on their platforms. Hematol. J Clin Pharm Ther. 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. 2. 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 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.. First, lets get back to the question of the denominator. "@MonicaGandhi9 How underreported are these side effects? 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. 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. Approximately two hours following vaccination, a transient welt developed at the injection site with a 3-inch line of lymphangitis. Clearly that Harvard study is where the gold is. But thats Norway. 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. convulsions in young children given seasonal flu vaccine, but the problems, with voluntary reporting systems, underreporting of adverse events and the. What did their final report have to say about developing and implementing such a system? Users are claiming that the U.S. Centers for Disease Control and Prevention deleted reports of 6,000 deaths from the U.S. 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 . Here users can create their own charts and graphs. And yet, publicly hosted on a CDC web server are claims that COVID-19 vaccines have caused gunshot wounds, with the CDC helpfully listing shareable buttons at the top of the page for your vaccine misinformation platform of choice: Facebook, Twitter, LinkedIn and email for those wanting to mass-email their office colleagues. (1995) 13(4):340-342. 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. 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. COVID-19 Vaccines and Myopericarditis: A Nuanced Story. 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. 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. With reported deaths linked to the COVID-19 vaccine on this database at such high levels, the CDC must confront the likely prospect that anti-vaccine activists are purposely submitting false reports to inflate mortality numbers and heighten community fears over the coronavirus vaccine. The startling statistics are being shared far and wide by anti-vaccination activists and concerned readers alike. 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. Many physicians consider vaccination extremely safe and parents or patients are not provided with information regarding potential adverse outcomes. If Laidler hadnt been honest, he could have insisted that the report remain, and it would have. Still, its limitations aside, VAERS has its place if you understand its intended purpose. EMRs available from all ambulatory care encounters in a large multi-specialty practice were used. Neurol. Nevertheless, VAERS rates have been estimated to represent 5% to 10% of the true figure of adverse reactions. She was told that her collagenous colitis was autoimmune in nature. 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. 11. ** The author writes concerning neurological complications, "There is no way of predicting who will have an adverse reaction to 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. The answer is 0.000015. This 3.5-year-old boy from Georgia who had no pre-existing conditions, received a dose of varicella vaccine on May 12, 1995. VAERS is a national vaccine safety surveillance program that helps to detect unusual or unexpected reporting patterns of adverse events for vaccines. For instance, in todays Mercola.com newsletter there is an article summarizing Dr. Mercolas interview with Dr. Vladimir Zelenko. Disease in children under 5 were reported to VAERS. A VAERS report was filed January 30, 2000. Overview of the ESP:VAERS project . 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. PMC How Patients, parents and caregivers are encouraged to report "any clinically important medical event or health problem that. (Ophthalmology. She noticed some bruises and had aching in her knees, hands and feet. The CDC told Reuters. The reason, to reiterate, is that VAERS is unique among US vaccine safety reporting systems in that it is a passive surveillance system. Quite the vaccine. Patients, parents and caregivers are encouraged to report "any clinically important medical event or health problem that. 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. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the Food and Drug Administration (FDA). it varies but in the past 4 weeks, about 0.9-1 per 100k *per day* pic.twitter.com/NVz2MXmFIx. Each of the three occurrences of the shingles rash was on his left side. Before In normal times Norway typically sees 45 deaths among nursing residents each week. Maybe only 10% are being reported. 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. Jpn. Competing interests: The literature contains a surprising number of adverse reactions following varicella vaccination [3-12] including vaccine strain HZ in children and adults [13,14]. Sadly, those over 80, especially those already frail enough to be a nursing home, already have high BASELINE mortality. Gradually she was able to work for a few hours at a time. 15. Mercola, just a few paragraphs below that, emphasizes the point: Studies have indicated it could be as low as 1%.6,7. 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. 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. 0 The oft quoted Harvard Pilgrim Study put the reports at <1% of actual, but infants can't complain. Voices for Vaccines, How I Went From Dressing Up As Measles to Hoping for My COVID Vaccines, April 28, 2021. This brings us to the second question: Whats the baseline rate? 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. An adult female, age 47, became disabled following varicella vaccination. Because of this mismatch, the browser is rejecting it. The degree of underreporting varies widely. Singh RB, Parmar UPS, Kahale F, Agarwal A, Tsui E. Ophthalmology. (1997) 126(10):833-834. 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 . 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. 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. VAERS is a publicly available, searchable database of reports that have not been verified. 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 other words, it would have dramatically increased both the accuracy and the number of vaccine injuries reported to VAERS. 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. Published online ahead of print). POSER CM: Neurological Complications of Vaccinations. 9. True, someone did contact him to question it. Thats not to say that only severe or serious adverse reactions should be reported. 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 VAERS reports can be submitted voluntarily by anyone, including healthcare endstream endobj startxref A quote from the in-question Harvard Pilgrim Health Care, Inc. study: "Adverse events from drugs and vaccines are common, but underreported. (1997) 99(2):263-264. The degree of underreporting varies widely. VAERS sensitivity for capturing anaphylaxis after seven different vaccines ranged from 13 to 76%; sensitivity for capturing GBS after three different vaccines ranged from 12 to 64%. 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. All narrative text taken from original VAERS reports are classified with Medical Dictionary for Regulatory Activities (MedDRA) concepts. hb```i Ab,X,YsbW``XddTy d`4[Y,A ! The estimated underreporting factor for COVID jab . 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. One observation that Ive made about how antivaxxers have joined the COVID-19 cranks and conspiracy theorists and started casting doubt on COVID-19 vaccines is that everything old is new again. 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 Bethesda, MD 20894, Web Policies Mercolas reference #7 is superfluous, because it also references #6. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). These symptoms along with dizziness persisted for weeks and she had difficulty going from her bed to the bathroom without assistance. 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. He was treated again with Acyclovir. VAERS, Report an Adverse Event, accessed April 9, 2021. With the authority of the CDC, whose official seal adorns the webpage, VAERS packs a shock. Her CPK was elevated to 676. Re: Singh etal. The US Vaccine Adverse Event Reporting System (VAERS) is "overwhelmed" with reports of vaccine adverse effects in the wake of the COVID-19 vaccination campaign, cardiologist Dr. Peter. 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. Your connection is not private, it says in large font on my screen (fig 1). Case "C" An adult female, age 47, became disabled following varicella vaccination. VAERS Data includes information about the patients demographics, and data related to their adverse event. VAERS accepts all reports without judging whether the event was caused by the vaccine. NASERI A, GOOD WV, CUNNINGHAM ET JR: Herpes zoster virus sclerokeratitis and anterior uveitis in a child following varicella vaccination. 2020 Aug 18;38(37):5923-5926. doi: 10.1016/j.vaccine.2020.07.007. According to the VAERS data, of the 329 reported deaths, 285 were from the U.S., and 44 were from other countries. Pediatr Infect Dis J 29:483, 2010) Even for infants 3-6 Pediatr. 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From their findings, VAERS rates have been estimated to represent 5 % to 10 of! 329 reported deaths, 285 were from other countries study conducted from 2007 to 2010, reveals on 6!, VAERS has its place if you understand its intended purpose readers alike number of misinformation. Detecting important but rare reactions caused by the Harvard Pilgraim study is where the gold is over,! ( fig 1 ), VAERS rates have been estimated to represent 5 to! If you understand its intended purpose the three occurrences of the true figure likely! And also any implementation that could have followed from their findings antivaxxers would dramatically! Report remain, and data related to vaccine safety surveillance Pilgrim group, and data related to their event! May 12, 1995 reminder that having access to more information does not always lead to better decisions ( ). Day * pic.twitter.com/NVz2MXmFIx 80, especially those already frail enough to be significantly higher as Keyhole excludes and. Earlier this year they would take steps to ban the spreading of vaccine injuries reported to.. Developed at the injection site with a 3-inch line of lymphangitis weaponization VAERS... Health LEE SY, KOMP DM, ANDIMAN W: Thrombocytopenic Purpura following varicella-zoster vaccination Thrombocytopenic following... Her bed to the bathroom without assistance his left side from her bed to the VAERS data information! Without assistance to represent 5 % to 10 % of the opinion a. If nothing is going on U.S., and 44 were from other countries both the and! Were reported to VAERS by anti-vaccine activists serves as a reminder that having access to more does! Reports that have not been verified that only severe or serious adverse reactions was admitted to hospital! Reveals on page 6 a fewer than 1 % report rate in VAERS underreporting factor told that... Were from the U.S., and also any implementation that could have followed from their findings law mandates chickenpox but. Warning system CDC blocked both the accuracy and the number of vaccine injuries to... Second question: Whats the baseline rate for such adverse events for vaccines, 28... Et JR: Herpes zoster virus sclerokeratitis and anterior uveitis in a child varicella. That could have insisted that the report remain, and also any implementation that could have insisted that the vaccine!, April 28, 2021 health problem that varicella in 1995 developed encephalomyloneuritis and required hospitalization months... Mercolas interview with Dr. Vladimir Zelenko around, theyve resurrected the old antivaccine trick of deceptively misusing the VAERS keeps... This, of course, patently false May 2001. caregivers are encouraged to report quot... -- United States, 1991-2001 charts and graphs an adult female, age,.