Her skin sensitivity also became more intense. The reason, to reiterate, is that VAERS is unique among US vaccine safety reporting systems in that it is a passive surveillance system. For instance, in todays Mercola.com newsletter there is an article summarizing Dr. Mercolas interview with Dr. Vladimir Zelenko. Im. 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. Ophthalmology. 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. Nevropatol. J. Infect. 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. VAERS Data includes information about the patients demographics, and data related to their adverse event. VAERS (Vaccine Adverse Events Reporting System) is the voluntary system used in the U.S. to signal vaccine side effects. Neurol. (1997) 99(2):263-264. All narrative text taken from original VAERS reports are classified with Medical Dictionary for Regulatory Activities (MedDRA) concepts. It is the Vaccine Adverse Event Reporting System, commonly known as VAERS. Maybe only 10% are being reported. Background Users can access data pertaining to clinically significant medical events that occur after vaccination in the United States. First, lets get back to the question of the denominator. Of course, whenever you see these sorts of numbers, two questions should come straight to you mind right away. It is bewildering, therefore, Disease in children under 5 were reported to VAERS. Psikhiatr. Data is also available through the CDC wonder interface by clicking on the CDC wonder link at the top of the page. Indeed, antivaxxers have long loved to portray VAERS as the be-all and end-all of the databases monitoring vaccine safety. Based on the law of large numbers, in which very small percentages translate into a large number of actual cases or people, we would expect a lot more deaths within a couple of weeks after vaccination by random chance alone. Clipboard, Search History, and several other advanced features are temporarily unavailable. 13. Sadly, those over 80, especially those already frail enough to be a nursing home, already have high BASELINE mortality. He received a third course of Acyclovir and the rash resolved after a month. The patient's nausea decreased and her fever subsided. How can public I know that this discussion began with According to the VAERS website, only a "small fraction" of vaccine injuries are reported (2). 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. 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. Additionally, the senators said the COVID-19 tests used by . The lot number associated with each vaccine is recorded in the VAERS data base. Case A Patients, parents and caregivers are encouraged to report "any clinically important medical event or health problem that. Reference to the Harvard study regarding the 1% figure adds legitimacy it doesnt deserve. This may sound similar to another argument that many COVID-19 deaths in older adults are deaths that would have happened anyway. hbbd``b`$Oo@UHYWY 0 I These symptoms along with dizziness persisted for weeks and she had difficulty going from her bed to the bathroom without assistance. Links to VAERS are included. Epub 2016 Jul 19. ones, especially when they occur soon after vaccination, even if they may be coincidental and related to other causes. Whats 285 divided by 22 million? The report of an adverse event to VAERS is not documentation that a vaccine caused the event. %%EOF (Pediatr Infect Dis J 28:943, 2009) From 1988 to Image by Mat Napo is licensed under the Unsplash License. Methods: We estimated VAERS reporting rates following vaccination for anaphylaxis and GBS. She was told that her collagenous colitis was autoimmune in nature. Am. A quote from the in-question Harvard Pilgrim Health Care, Inc. study: "Adverse events from drugs and vaccines are common, but underreported. JAMA. J. . Federal government websites often end in .gov or .mil. : Vaccine-associated uveitis following COVID-19 vaccination: vaccine adverse event reporting system database analysis. Maintained/created by: Centers for Disease Control, Food and Drug AdministrationWebsite: http://vaers.hhs.gov/data/indexGeographic unit of data: U.S National, U.S. State, Keywords: adverse event, CDC, FDA, Reporting, side effects, vaccination, vaccine, Users can access data pertaining to clinically significant medical events that occur after vaccination in the United States. 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. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. This time around, theyve resurrected the old antivaccine trick of deceptively misusing the VAERS database to imply causation from VAERS reports. Healthcare providers are required by law to report to VAERS: VAERS, Report an Adverse Event, accessed April 9, 2021. 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. 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. It is the Vaccine Adverse Event. MMWR Surveill Summ. adverse He was listless and had some rhinorhea but remained afebrile. As for that last part about VAERS having been an abject failure, to support that claim RFK Jr. cites this: A critic familiar with VAERS shortcomings bluntly condemned VAERS in The BMJ as nothing more than window dressing, and a part of U.S. authorities systematic effort to reassure/deceive us about vaccine safety.. Harvard Business Review noted that the previous vaccine development record was . Im referring, of course, to antivaxxers resurrecting old antivaccine tropes, dusting them off, and updating them for the age of COVID. Ann. BRAUN MM, MOOTREY GT, SEWARD JF, RIDER LG, KRAUSE PR: Postlicensure safety surveillance for varicella vaccine. This site needs JavaScript to work properly. * Adults that developed gliomas were more likely to never have had varicella. 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. What has been reported to VAERS is less than the expected baseline death rate in the US for any given day pre-pandemic (the death figures used were for the year 2019). Seeking a new model to lower wait times, but also improve patient choice of care, County Council Senior Medical . 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. Wrensch et al. 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 . 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. As is stated on the VAERS website: Underreporting is one of the main limitations of passive surveillance systems, including VAERS. 8600 Rockville Pike Later in the article, CHD starts listing all the anecdotes and other reports that antivaxxers have been flogging. Case "B" A man who was vaccinated against varicella in 1995 developed encephalomyloneuritis and required hospitalization for months. Accessibility Many physicians consider vaccination extremely safe and parents or patients are not provided with information regarding potential adverse outcomes. 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. Nothing coming before or after even suggests what that number is based upon. Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. There is no citation for that sentence. This, of course, is intended to increase reporting of adverse events to VAERS. and sudden infant death syndrome (SIDS). 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 According to open Vaers, almost 9k have died from the vaccine in the US. Competing interests: You might wonder: Why would anyone set up a system like VAERS, which is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA)? It is a near certainty that scurrilous and outlandish claims around the COVID-19 vaccines will be shared online in any case, but for now, malign actors transmit this information with a veneer of credibility offered by the CDC VAERS database. More generally: The chance of dying in an average week for those over 80 is about 0.2% or 1 in 500. This 3.5-year-old boy from Georgia who had no pre-existing conditions, received a dose of varicella vaccine on May 12, 1995. Careers. 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. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001. Pediatr. 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. Children's deaths of any kind are rare, researchers noted. and nurses do not know about VAERS and what is required to be reported. 112:495, 2003. Jpn. VAERS is a passive surveillance system that relies on the willingness of individuals and professionals to submit reports voluntarily. But definitely its being underreported.. 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. Its not just vaccines and autism, either. Singh RB, Parmar UPS, Kahale F, Agarwal A, Tsui E. Ophthalmology. Unsurprisingly, RFK Jr. and CHD are full ofwell, a brown stinky substance. Mercolas reference #7 is superfluous, because it also references #6. Human Rabies Prevention --- United States, 2008 Recommendations of the Advisory Committee on Immunization Practices NOTE: A Continuing Education Activity has been approved for this report and will be included in the print and electronic format on May 23, 2008, in Vol. 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 18-year period from 1990 through 2007 just 88 cases of Kawasaki The rash slowly subsided but left scars. First, one should note how CHD does note that a VAERS entry does not demonstrate causation. providers, patients, or family members. 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. VAERS accepts all reports without judging whether the event was caused by the vaccine. No proof that the event was caused by the vaccine is required in order for VAERS to accept the report. ** The author writes concerning neurological complications, "There is no way of predicting who will have an adverse reaction to vaccination. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. Since varicella disease is relatively benign, only a few serious adverse reactions might offset the intended benefits. 2022 Harvard Political Review. Disclaimer Two months later on May 13, 2004 he had still another recurrence with moderate pain, in the same location as previously mentioned. These coincidences make it difficult to know whether a particular adverse event resulted from a medical condition or from a vaccination. 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. They often lack details and sometimes can have information that contains errors. 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. It was the waiting that drew the attention of the Stockholm County Council. RAVKINA LI, MATSEVICH GR: Morphological changes in the central nervous system in post-vaccinal encephalomyelitis developing after chickenpox vaccination in children. Prediction of post-vaccination Guillain-Barr syndrome using data from a passive surveillance system. It simply contains whatever people have voluntarily reported. 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