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. The term underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. 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. 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. The Vaccine Adverse Events Reporting System (VAERS) is sponsored by the Centers for Disease Control and by the Food and Drug Administration. Sharing Options. She underwent a colonoscopy and was diagnosed with the rare and more serious collagenous colitis. In addition, even vaccine manufacturers have calculated at least a "fifty-fold underreporting of adverse events" on this system. cases were reported to VAERS. In a July 13 letter to health agency leaders, Johnson noted a press conference he . Thats not to say that only severe or serious adverse reactions should be reported. Her nausea and vomiting persisted for the next three months despite use of anti-nausea medication. 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. JAMA. They don't offer great . Before 7. the 18-year period from 1990 through 2007 just 88 cases of Kawasaki Accessibility 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. hXmk6+B%Yo Izr wnb} >{r= [3%bk2+3J azwyynG0m7oC._s/VuVK_]hBuZ,:E*rpOv1v6[_-n]EPP7g~%~jhq/8Sn?tdg/j]Wdl-7 MGa8[>UgffM,fCM~kWQ?u^\?;5VX)I$@jxF![{L0hQcI 4tIg[,N:wcAx6cLjS?q/]}`.ubb7GKjqvm;+4 F0:i`@1K0V#t|-r$4qKf\~C9vxvp>yQCL\'dJHB^Hh= tBK:rFH|'WdAc-H{2sM:w. 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. Methods: 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). endstream endobj startxref Basically, VAERS is a passive reporting system, in which anyone can report suspected adverse events after any vaccination to be recorded in the database. Because of this mismatch, the browser is rejecting it. By the FDAs own definition, the vaccines are still considered experimental until fully licensed. Table 1. On the other hand, more serious and unexpected medical events are probably more likely to be reported than minor J. Pediatr. Two months later on May 13, 2004 he had still another recurrence with moderate pain, in the same location as previously mentioned. Usefulness of Vaccine Adverse Event Reporting System for Machine-Learning Based Vaccine Research: A Case Study for COVID-19 Vaccines. _RD0rt. 4. 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. (1986) 8(1):78-80. She was seen by her physician because of an irregular heart rate and an ECG revealed supra ventricular extra systoles and left ventricular hypertrophy. He took Acyclovir Oral Suspension (200mg/5ml): Two teaspoons 4 times a day for 5 days. By the sixth month post-vaccination, she was seen by a neurologist and a physiatrist. The startling statistics are being shared far and wide by anti-vaccination activists and concerned readers alike. This is a system that sends regular text messages to those whove been vaccinated to ask them about side effects and in general how they feel. 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. effects) are filed in VAERS. The report of an adverse event to VAERS is not documentation that a vaccine Likewise, fewer than 1% of vaccine adverse events are reported.. 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.. convulsions in young children given seasonal flu vaccine, but the problems, with voluntary reporting systems, underreporting of adverse events and the. Synthetic and real test data was been generated and transmitted between Harvard and Constella. Case B FOIA 2023 Feb;130(2):179-186. doi: 10.1016/j.ophtha.2022.08.027. The Harvard study mentioned by Dr. Zelenko is the same as the one found at reference #6 cited by Mercola. and sudden infant death syndrome (SIDS). J. Ophthalmol. She developed diarrhea shortly after the second dose and by November 2001, she was quite ill and had serious intestinal difficulties. Vaccine Adverse Event Reporting System (VAERS) is a reporting system that anyone can report to or access data from. 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]. 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 . Flora J, Khan W, Jin J, Jin D, Hussain A, Dajani K, Khan B. Int J Mol Sci. 2022 Harvard Political Review. The department then gives the example of injection-site soreness,. But death? It is worth pointing out that Harvard Pilgrim Health Care, Inc., has no affiliation with Harvard University. It relies on people to submit reports of adverse reactions to vaccines; it doesnt actively look for them, as active surveillance systems do. They also dont understand how the antivaccine movement has always been about more than just vaccines. In the time since the CDC was approached for comment by the HPR, the shareable buttons have been removed from the site. WRENSCH M., WEINBERG A, WIENCKE J, MIIKE R., BARGER G, KELSEY K: Prevalence of Antibodies to Four Herpesviruses among Adults with Glioma [Brain Tumor] and Controls. As of today, the online database alleges 1349 U.S. deaths attributable to COVID-19 vaccines. Data are updated on a monthly basis. We also know that underreporting is less common for more severe adverse reactions than for those that are more mild. 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. Careers. Users are claiming that the U.S. Centers for Disease Control and Prevention deleted reports of 6,000 deaths from the U.S. ** The author writes concerning neurological complications, "There is no way of predicting who will have an adverse reaction to vaccination. 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. Consider this part 2 of my post from two weeks ago, the VAERS edition. 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. Peter Collignon and his colleagues do not exaggerate the problem of Competing interests: * Authors report that a healthy 5-year-old girl developed HZ in the dermatome supplied by the ophthalmic branch of the fifth cranial nerve 40 months after varicella vaccination. Whoever wrote this article is clearly not an expert, and this article is clearly meant to be disinformation, not science. 300 0 obj <>stream VAERS is a national vaccine safety surveillance program that helps to detect unusual or unexpected reporting patterns of adverse events for vaccines. 100,000 person-years. It is the Vaccine Adverse Event Reporting System, commonly known as VAERS. As such, I think it is somewhat sloppy science to reference the Harvard study as support of VAERS underreporting. An EMG revealed involvement in an ulnar distribution. Links to VAERS are included. 5. 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). However, real data transmissions of non-physician approved reports to the CDC was unable to commence, as by the end of this project, the . Unauthorized use of these marks is strictly prohibited. It is bewildering, therefore, Cost-benefit analyses of varicella vaccination appear optimistic, but they fail to factor in the resulting deleterious effects. As Skeptical Raptor notes, it was due to a certificate error: The problem is the SSL certificate was generated for vaers.hhs.gov but he is going to http://www.vaers.hhs.gov. A CDC database that was mostly unknown except to a small segment of the population is now regularly in the news. Share on Facebook, opens a new window Conclusions: Results: She was admitted to a hospital for rehydration after losing 12 lbs or more than 10% of her previous healthy weight. First, one should note how CHD does note that a VAERS entry does not demonstrate causation. The sorts of tactics antivaxxers are using now have surprised and befuddled a lot of pro-science advocates, mainly because so many of them have not been paying attention to the antivaccine movement, in particular its longstanding tactics and its basis in conspiracy theories. VAERS, Underreporting, and the Mysterious 1% A CDC database that was mostly unknown except to a small segment of the population is now regularly in the news. 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. 8. 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. (2000) 284:1271-1279. 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. Her skin sensitivity also became more intense. S. S. Korsakova. (1995) 37(5):648-650. 8600 Rockville Pike The coalition formed . 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. VAERS is a publicly available, searchable database of reports that have not been verified. The findings, the researchers said, affirm the overall safety of the vaccine and underscore . Unsurprisingly, RFK Jr. and CHD are full ofwell, a brown stinky substance. Each of the three occurrences of the shingles rash was on his left side. Sadly, those over 80, especially those already frail enough to be a nursing home, already have high BASELINE mortality. 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. 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. 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. Fetterman's Wife Abruptly Fled the Country After He Was Hospitalized. ESMAELI-GUTSTEIN B, WINKELMAN JZ: Uveitis associated with varicella virus vaccine. The Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system, meaning it relies on individuals to send in reports of their experiences. (I realize that that 22 million figure includes an additional week of vaccinations and does not break down how many people had received one or both doses, but this is a back-of-the-envelope) calculation. A man who was vaccinated against varicella in 1995 developed encephalomyloneuritis and required hospitalization for months. The VAERS dataset also appears to be immune from Facebooks anti-misinformation protocols and remains a prominent feature of the anti-vaccine campaigning repertoire. Deaths definitely get ones attention and are far more likely to be reported than any other AE. If you look at the CHD scientific advisory board, youll soon see that its a whos-who of antivaccine cranks, including Richard Deth (what a blast from the past!) 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. Clearly that Harvard study is where the gold is. 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. A 17-month-old female toddler received the varicella vaccination on March 20, 1996. Paediatr. (Pediatr Infect Dis J 28:943, 2009. 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). No competing interests, Medical Veritas International (MVI), P.O. So beim Kupfer, dessen Abbau [] Despite this pledge, some prominent anti-vaccine Facebook pages remain online with hundreds of thousands of followers. 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. sharing sensitive information, make sure youre on a federal 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. RAVKINA LI, MATSEVICH GR: Morphological changes in the central nervous system in post-vaccinal encephalomyelitis developing after chickenpox vaccination in children. VAERS reports can be submitted voluntarily by anyone, including healthcare providers, patients, or family members. RR-3. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. 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. At the end of the document is not a list of supporting citations, but only a list of publications by the organization on the topic of the automated adverse event reporting. I know that this discussion began with 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. Vaccine. 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*. Information needs to be . That isn't the case with the COVID-19 vaccines, which the FDA approved . It just states it as fact. He developed convulsions the following day, was hospitalized, and reportedly recovered. Competing interests: So how are antivaxxers weaponizing VAERS? A cursory search of social media shows those who are spreading the VAERS data have paid little heed to the agencys disclaimers. 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. Since varicella disease is relatively benign, only a few serious adverse reactions might offset the intended benefits. 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. In a yearlong period from August 2021 to July 2022, 821 children ages 0 to 19 died from covid-19 at a rate of 1 per 100,000. 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. . Please enable it to take advantage of the complete set of features! In fact, lack of engagement by the CDC rendered the entire project pretty much null. Its not just vaccines and autism, either. The first is: Whats the denominator? Case E 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. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. Lastly, VAERS Vaccine gives information about the origin and type of vaccine. Additionally, the senators said the COVID-19 tests used by . VAERS is the primary government-funded system for reporting adverse reactions to . 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