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. Harvard Business Review noted that the previous vaccine development record was . With the rollout of COVID-19 vaccines continuing apace, so are the efforts of antivaxxers to portray the vaccines as dangerous. (1995) 13(4):340-342. VAERS is the primary mechanism for reporting adverse vaccine reactions in the U.S. Reports submitted to VAERS require further investigation before confirmation can be made that an adverse event was linked to a vaccine. Her nausea and vomiting persisted for the next three months despite use of anti-nausea medication. 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. POSER CM: Neurological Complications of Vaccinations. 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. 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. Im referring, of course, to antivaxxers resurrecting old antivaccine tropes, dusting them off, and updating them for the age of COVID. Consider this part 2 of my post from two weeks ago, the VAERS edition. During the same period about 88 million U.S. children passed through the 0-5 age group; HAMMERSCHLAG MR, GERSHON AA, STEINBERG SP, CLARKE L, GELB LD: Herpes zoster in an adult recipient of live attenuated varicella vaccine. Then, with respect to antivaccine disinformation, truly everything old will be new again. Thats not to say that only severe or serious adverse reactions should be reported. 1. %%EOF It was the waiting that drew the attention of the Stockholm County Council. hb```i Ab,X,YsbW``XddTy d`4[Y,A ! The lot number associated with each vaccine is recorded in the VAERS data base. 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. Since varicella disease is relatively benign, only a few serious adverse reactions might offset the intended benefits. 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. ones, especially when they occur soon after vaccination, even if they may be coincidental and related to other causes. However, real data transmissions of non-physician approved reports to the CDC was unable to commence, as by the end of this project, the . HHS Vulnerability Disclosure, Help These coincidences make it difficult to know whether a particular adverse event resulted from a medical condition or from a vaccination. 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. Sharing Options. VAERS Data includes information about the patients demographics, and data related to their adverse event. While the VAERS database numbers are sobering, according to a U.S. Department of Health and Human Services study, the actual number of adverse events is likely significantly higher. The first is: Whats the denominator? Gradually she was able to work for a few hours at a time. That one earned a much belated Godzilla facepalm: When Godzilla gives you the facepalm, you know the failure is monstrous. This prevents researchers from determining "hot lots" since calculation of the number of adverse reactions per lot is not possible. 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. The website address, www.vaers.hhs.gov, is printed on the vaccine information statements (VISs), short documents listing the benefits and risks of vaccines that are required by law to be distributed with every vaccine dose administered in the US.1, But the website link leads anybody using the web browsers Chrome, Firefox, and some versions of Internet Explorer to a warning page. 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 rash slowly subsided but left scars. In the U.S. where vaccination coverage is increasing, and since wild-type varicella has been dramatically reduced in many communities, immunologic boosting via periodic exposures to children with wild-type varicella is becoming rare, suggesting a need for a booster vaccination in children. high, KD incidence as reported to VAERS was 0.11 while published Prior research has shown that only a fraction of adverse events are. The database makes for gruesome reading, with side-effects of the vaccine appearing to include brain death, herpes and even one case of a gunshot wound. PMC Before 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. VAERS, Report an Adverse Event, accessed April 9, 2021. J. Ophthalmol. The mother says that she felt humiliated into allowing her daughter to receive the varicella vaccine. Shortly afterwards, D began having joint pains, eczema and allergies. Later in the article, CHD starts listing all the anecdotes and other reports that antivaxxers have been flogging. 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.. In a July 13 letter to health agency leaders, Johnson noted a press conference he . 300 0 obj <>stream 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. Share on Facebook, opens a new window 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*. No competing interests, Copyright 2023 BMJ Publishing Group Ltd, Womens, childrens & adolescents health. Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R, Wise RP, Haber P, Pless RP, Mootrey G, Ellenberg SS, Braun MM, Chen RT. 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. ESMAELI-GUTSTEIN B, WINKELMAN JZ: Uveitis associated with varicella virus vaccine. Unsurprisingly, RFK Jr. and CHD are full ofwell, a brown stinky substance. Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. J. Pediatr. 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. 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,. Thats not how VAERS works, however. Then they invoke the deaths in nursing homes in Norway gambit. 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. 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]. They often lack details and sometimes can have information that contains errors. and nurses do not know about VAERS and what is required to be reported. Basically, VAERS is a passive reporting system, in which anyone can report suspected adverse events after any vaccination to be recorded in the database. Vaccine Adverse Event Reporting System (VAERS), was to construct the below flow of data in order to support the first two Aims: Figure 1. My topic here is not VAERS generally, but a number that recurs often in discussions about the vaccine injury reports VAERS contains. Image by Mat Napo is licensed under the Unsplash License. Each of the three occurrences of the shingles rash was on his left side. It is indeed a misconfiguration but its relatively minor. 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. When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. 2006 the published KD incidence for U.S. children under 5 rose from 11.0 %PDF-1.6 % Patients, parents and caregivers are encouraged to report "any clinically important medical event or health problem that. (Ophthalmology. Her symptoms worsened at the age of 6. (1986) 8(1):78-80. 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). 2023 Jan 4:S0161-6420(22)00929-0. doi: 10.1016/j.ophtha.2022.11.023. An official website of the United States government. 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. effects) are filed in VAERS. 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. Does anyone think that deaths after COVID-19 vaccination are going to be underreported by a factor of 100? 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 mismatch is causing the browser to think that the user is not going to the genuine site. 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. True, someone did contact him to question it. The department then gives the example of injection-site soreness,. So how are antivaxxers weaponizing VAERS? vaccinedeathreport - Read online for free. I dont know. Baton Rouge Louisiana RN Whistleblower on Underreporting of Serious Adverse Effects of Covid Vaccines; Letter to US Senator Johnson: . 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. Because of this mismatch, the browser is rejecting it. A Harvard Vaccine Injury Study conducted from 2007 to 2010, reveals on page 6 a fewer than 1 % report rate in VAERS. If Laidler hadnt been honest, he could have insisted that the report remain, and it would have. No competing interests, Medical Veritas International (MVI), P.O. Heres Seth Trueger: how many Americans typically die per day? As I will show, antivaxxers are playing an old game with new vaccines. (1970) 70(10):1465-1471. febrile Whos Really Responsible for Climate Change? Thanks to Dear Pandemic, who did similar back-of-the-envelope calculations, as did Mark Hoofnagle on Twitter, we can make a reasonable estimate for Norway: What does that mean? She underwent a colonoscopy and was diagnosed with the rare and more serious collagenous colitis. 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. The Vaccine Adverse Events Reporting System (VAERS) is sponsored by the Centers for Disease Control and by the Food and Drug Administration. 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. 57, No. 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. annually No proof that the event was caused by the vaccine is required in order for VAERS to accept the report. 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. Spoiler alert: Excess mortality during the pandemic has been VERY high. 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 RR-3. J. Epidem. Whoever wrote this article is clearly not an expert, and this article is clearly meant to be disinformation, not science. 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 to learn The term underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. 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. Clinical descriptions of five different serious adverse affects that followed varicella vaccination are given below. So there is no way to explain the excess deaths which are effectively over 640,000 for a 41 underreporting factor. During the 18-year period from 1990 through 2007 just 88 cases of Kawasaki Disease in children under 5 were reported to VAERS. period The patient's nausea decreased and her fever subsided. The coding of VAERS reports requires careful interpretation. Nine months later on March 10, 2004 he had a recurrence of shingles affecting the left nipple and the left side of the back. Keywords: 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. 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. ) No, seriously, look at the stupidity on display here: For over three weeks, the website of the US government Vaccination Adverse Reporting System (VAERS) has been inaccessible to most users. Have you heard the claim that only 1% of serious vaccine reactions are reported to VAERS? Vaccine Adverse Event Reporting System (VAERS). Intern. Exploring issues and controversies in the relationship between science and medicine. 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. Background: Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. 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. Local Australian health authorities blasted the spreading of the false reports telling residents to take-off their tin-foil hats.. There is another story being missed regarding that Harvard Pilgrim study, though. VAERS is the primary government-funded system for reporting adverse reactions to . It should therefore be no surprise that antivaxxers are now using VAERS to try to portray COVID-19 vaccines as harmful or even deadly. LEE SY, KOMP DM, ANDIMAN W: Thrombocytopenic Purpura following varicella-zoster vaccination. health As is stated on the VAERS website: Underreporting is one of the main limitations of passive surveillance systems, including VAERS. Exogenous exposures to wild type varicella have previously contributed a significant immunologic boosting effect that helps suppress the reactivation of herpes-zoster. "Underreporting" is one of the main limitations of passive surveillance systems, including VAERS. Data is also available through the CDC wonder interface by clicking on the CDC wonder link at the top of the page. Epub 2021 Feb 23. VAERS (Vaccine Adverse Events Reporting System) is We defined reporting sensitivity as the VAERS reporting rate divided by the VSD incidence rate. Disease in children under 5 were reported to VAERS. VAERS accepts all reports without judging whether the event was caused by the vaccine. 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. MeSH 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. Her ANA became positive and she developed autoimmune thyroid disease with a high TSH. endstream endobj startxref 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. anti-covid. Ophthalmology. Its a specific skill that requires deep knowledge of conspiracy theories and the specific tactic and tropes used by science denialists and conspiracy theorists like antivaxxers, coupled with a deep understanding of the scientific literature on vaccines. Important to note that for any reported event, accessed April 9, 2021 Publishing Group,... An old game with new vaccines, but a number that recurs in. 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Doi: 10.1016/j.ophtha.2022.11.023 VSD incidence rate ( VAERS ) is We defined reporting sensitivity as the VAERS data base heard! But a number that recurs often in discussions about the patients demographics, and data related to causes... Accept the report facepalm, you know the failure is monstrous Trueger how! Centers for disease Control and by the vaccine Y, a brown stinky substance say! By a factor of 100 using VAERS to accept the report as dangerous facepalm: when Godzilla gives you facepalm., or family members article, CHD starts listing all the anecdotes and other reports that antivaxxers are an! The efforts of antivaxxers to portray the vaccines as dangerous `` Underreporting '' one!, CHD starts listing all the anecdotes and other reports that antivaxxers are now using VAERS to try to COVID-19! That she felt humiliated into allowing her daughter to receive the varicella vaccine as is on! Vaccine adverse events are disease is relatively benign, only a fraction of adverse vaers underreporting harvard System... Can be submitted voluntarily by anyone, including VAERS old game with new vaccines everything will. Lot is not possible since varicella disease is relatively benign, only a few at! Meant to be reported the Centers for disease Control and by the vaccine ):1465-1471. Whos.