These statistics are, of course, patently false. First, you must understand that, as I alluded to above, VAERS isnt intended to give an accurate estimate of the frequency of various adverse events after vaccination. When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. and transmitted securely. 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. Acta. 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. Although the CDC claims to make attempts to verify the data, it is difficult to see how publishing reports of gunshot wounds related to the COVID-19 vaccine is tenable for an organization so reliant on public trust. to other vaccines and other serious clinical problems. A certain number of 80+ year olds die every day. cases were reported to VAERS. 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. trial that found a 5-fold KD risk associated with RotaTeq--RR=4.9; 95% CI The misuse of VAERS to demonize COVID-19 vaccines is just another example of how old antivaccine tactics and tropes have been resurrected, dressed up, and updated to be deployed against COVID-19 vaccines. vaccinedeathreport - Read online for free. The Vaccine Adverse Event Reporting System (VAERS) form : version 2.0 (proposed) October 30, 2014 By Shimabukuro, Tom T. Series: ACIP meeting Vaccine Safety English CITE Download Document Details Related Documents You May Also Like Details: Personal Author: Shimabukuro, Tom T. Corporate Authors: SINGER S, JOHNSON CE, MOHR R, HOLOWECKY C: Urticaria following varicella vaccine associated with gelatin allergy. Synthetic and real test data was been generated and transmitted between Harvard and Constella. In other words, it would have dramatically increased both the accuracy and the number of vaccine injuries reported to VAERS. Disclaimer Competing interests:
During the same According to open Vaers, almost 9k have died from the vaccine in the US. He was treated again with Acyclovir. event underreporting. 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 . . possibilities of This is true, and EXACTLY why scientists prefer to measure EXCESS MORTALITY to assess the true toll of the pandemicwhich counts how many deaths from any cause there have been ABOVE AND BEYOND what is expected. Users are claiming that the U.S. Centers for Disease Control and Prevention deleted reports of 6,000 deaths from the U.S. The patient's nausea decreased and her fever subsided. Neurol. 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. It is worth pointing out that Harvard Pilgrim Health Care, Inc., has no affiliation with Harvard University. ]Jw/d}n?`nGDzh,5crb?|IlO87m:8S.A);B9+k liSC`y2WW0Z=+'kv$n6I,%AMe13em1e63?d[@f=PaVkAV{2"CeU(H3'S?V;5U n3`(*9u&PY)Ug*Q&ObFMRY;Leq,*]&kIegxKw)
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Prior research has shown that only a fraction of adverse events are. (1970) 70(10):1465-1471. More generally: The chance of dying in an average week for those over 80 is about 0.2% or 1 in 500. However, the CDC and FDA have never required the vaccine manufacturers to publicly divulge the number of vaccines contained in a given lot. 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 . Local Australian health authorities blasted the spreading of the false reports telling residents to take-off their tin-foil hats.. Case B Thats 1.3/100,000. The U.S. However, real data transmissions of non-physician approved reports to the CDC was unable to commence, as by the end of this project, the . Psikhiatr. 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. She was admitted to a hospital for rehydration after losing 12 lbs or more than 10% of her previous healthy weight. 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!) It was the waiting that drew the attention of the Stockholm County Council. The site is secure. During the same period about 88 million U.S. children passed through the 0-5 age group; How? So there is no way to explain the excess deaths which are effectively over 640,000 for a 41 underreporting factor. The credits awarded are as follows: CME, 2.0; CNE, 2.0; CEU, .20; CHES, 2.0; and CVE, 2.0. The degree of underreporting varies widely. Paediatr. Harvard Business Review noted that the previous vaccine development record was . It was the waiting that drew the attention of the Stockholm County Council. The combined efforts of communication scientists, health services researchers, and others can enhance the development and implementation of long-term, sustainable plans for gathering reliable real-time data about facilitators of and barriers to vaccine acceptance, translating those data into practical solutions. VAERS reports can be submitted voluntarily by anyone, including healthcare
In a July 13 letter to health agency leaders, Johnson noted a press conference he . 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. 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]. The Vaccine Adverse Event Reporting System (VAERS) database contains information on unverified reports of adverse events (illnesses, health problems and/or symptoms) following immunization with US-licensed vaccines. 0.6, 239. Mercola, just a few paragraphs below that, emphasizes the point: Studies have indicated it could be as low as 1%.6,7. From your lips to QAnon's ears.. 5. adverse Adverse event; Passive surveillance; Vaccine; Vaccine Adverse Event Reporting System (VAERS); Vaccine safety. In a July 13 letter to health agency leaders, Johnson noted a press conference he . Ann. . Bardenheier BH, Duderstadt SK, Engler RJ, McNeil MM. The FDA has established pathways to accelerate vaccine availability before approval, such as Emergency Use Authorization, and to channel resources to high-priority products and allow more. 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. Table 1 presents a comparison of the number of adverse reactions reported to VAERS for the varicella vaccine with 4 other different vaccines. 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. 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. It is primarily a hypothesis-generating, not hypothesis-testing, system when it comes to questions related to vaccine safety. 4. A study about it found less than 1% were reported (3). My topic here is not VAERS generally, but a number that recurs often in discussions about the vaccine injury reports VAERS contains. The second is: What is the baseline rate for such adverse events in the population studied? Gradually she was able to work for a few hours at a time. J. government site. VAERS reports associated with Varicella, DTaP, Hep B, Hib, and MMR vaccines through December, 2003. They often lack details and sometimes can have information that contains errors. In 2008, patients seeking a hip or knee replacement in Stockholm County faced wait times of up to two years of sometimes debilitating pain, intermittent missed work and income, and the trials of disability. Vaccine Adverse Event Reporting System (VAERS) is among the best adverse event data collection systems in the world, but it's antiquated and difficult to use. J Pers Med. hbbd``b`$Oo@UHYWY 0 I
Careers. The coding of VAERS reports requires careful interpretation. 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. Then they invoke the deaths in nursing homes in Norway gambit. 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. Prediction of post-vaccination Guillain-Barr syndrome using data from a passive surveillance system. A report to VAERS generally does not prove that the identified vaccine(s) caused the adverse event described. Pediatr Infect Dis J 29:483, 2010) Even for infants 3-6 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. That isn't the case with the COVID-19 vaccines, which the FDA approved . If Laidler hadnt been honest, he could have insisted that the report remain, and it would have. We are constantly exposed to a wide variety of viral antigens that cause our immune system to develop antibodies against them. sharing sensitive information, make sure youre on a federal The patient later developed a cough, marked fatigue, sensitivity to light and sound, disturbed sleep and more serious loss of appetite. While her lymphocytes decreased from 25 to 14%, her total white count, neutrophils and eosinophils increased. 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). Objectives: Baton Rouge Louisiana RN Whistleblower on Underreporting of Serious Adverse Effects of Covid Vaccines; Letter to US Senator Johnson: . Healthcare providers are required by law to report to VAERS: can they dismiss placebo-controlled trials that raise serious 14. endstream
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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. National Library of Medicine Clinical descriptions of five different serious adverse affects that followed varicella vaccination are given below. in young children. More than 485 million doses of COVID-19 vaccines were administered in the United States from Dec. 14, 2020 . of underreporting varies widely. providers, patients, or family members. Flora J, Khan W, Jin J, Jin D, Hussain A, Dajani K, Khan B. Int J Mol Sci. VAERS accepts all reports without judging whether the event was caused by the vaccine. This time, the pain was more severe. 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. 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. 9. 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 . 2020 Aug 18;38(37):5923-5926. doi: 10.1016/j.vaccine.2020.07.007. Clearly that Harvard study is where the gold is. Read more at NPR. He was listless and had some rhinorhea but remained afebrile. The VAERS system keeps track of any unusual or unexpected adverse events that occur after vaccine administration. Her physician was of the opinion that a virus probably triggered her autoimmune response. 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. 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. That purpose, contrary to what antivaxxers would have you believe, is not as the be-all and end-all of vaccine safety surveillance. 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. The literature contains a surprising number of adverse reactions following varicella vaccination [3-12] including vaccine strain HZ in children and adults [13,14]. FOIA So, OK whatever the number is, its not 6,000. Again, these are back-of-the-envelope calculations, but theyre close enough to make the point. For instance, in todays Mercola.com newsletter there is an article summarizing Dr. Mercolas interview with Dr. Vladimir Zelenko. Acta. background rates were 23.1 (2000) and 24.6 (2006); fewer than 1 in 200 KD Sen. Ron Johnson, R-Wis. , has stirred controversy in recent days over his concerns about COVID-19 vaccine safety. Patients, parents and caregivers are encouraged to report "any clinically important medical event or health problem that. Exploring issues and controversies in the relationship between science and medicine. RAVKINA LI, MATSEVICH GR: Morphological changes in the central nervous system in post-vaccinal encephalomyelitis developing after chickenpox vaccination in children. 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. 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. The Harvard study mentioned by Dr. Zelenko is the same as the one found at reference #6 cited by Mercola. In 2008, patients seeking a hip or knee replacement in Stockholm County faced wait times of up to two years of sometimes debilitating pain, intermittent missed work and income, and the trials of disability. The rash slowly subsided but left scars. No competing interests, Medical Veritas International (MVI), P.O. That claim is based on an old study about drug reactions and was not specific to vaccines. PMC !F+% H30Dif>$cBT1n0 "|G
It only confirms that the reported event occurred sometime after vaccine was given. For anaphylaxis and GBS, VAERS sensitivity is comparable to previous estimates for detecting important AEs following vaccination. And of course my favorite example is the VAERS excess deaths. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001. How can public They don't offer great . If youve been reading this blog a while, you can probably guess. 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). 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 . A VAERS report was filed January 30, 2000. JAMA. Nonetheless, previous reports demonstrate substantial case capture for clinically severe adverse events (AEs), including 47% of intussusception cases after rotavirus vaccine, and 68% of vaccine associated paralytic polio after oral polio vaccine. The high mean of 3,000 reports/year is attributed to the Hepatitis B vaccine, followed next by a mean of 2,350 reports/year attributed to varicella vaccine (Table 1). On June 12, 2003 (age 5), he had a unilateral shingles eruption on the back of his neck. . 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. Epub 2016 Jul 19. BRAUN MM, MOOTREY GT, SEWARD JF, RIDER LG, KRAUSE PR: Postlicensure safety surveillance for varicella vaccine. 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. Wrensch et al. As the spread of coronavirus variants potentially jeopardises the efficacy of the vaccine rollout, so too does the spread of misinformation. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. Anyone can submit a report to VAERS, including parents and patients. 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. But definitely its being underreported.. All narrative text taken from original VAERS reports are classified with Medical Dictionary for Regulatory Activities (MedDRA) concepts. They also allow users to verify that they are connected to the real web site, rather than a hackers web site. Before anti-covid. 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). 15. The Harvard Pilgrim study is not a reference that substantiates any claims about VAERS underreporting. Spoiler alert: Excess mortality during the pandemic has been VERY high. apply The oft quoted Harvard Pilgrim Study put the reports at <1% of actual, but infants can't complain. * Two-year-old boy with staggering gait and difficulty speaking. Hearing disorder following COVID-19 vaccination: A pharmacovigilance analysis using the Vaccine Adverse Event Reporting System. The .gov means its official. 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.. Published online ahead of print). He took Acyclovir Oral Suspension (200mg/5ml): Two teaspoons 4 times a day for 5 days. These symptoms along with dizziness persisted for weeks and she had difficulty going from her bed to the bathroom without assistance. Kennedy told Kessler that VAERS has been an abject failure, with fewer than 1% of adverse events ever reported. _RD0rt. Physicians and patients
She was seen by her physician because of an irregular heart rate and an ECG revealed supra ventricular extra systoles and left ventricular hypertrophy. The lot number associated with each vaccine is recorded in the VAERS data base. 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 She noticed some bruises and had aching in her knees, hands and feet. Her pre-study laboratory values were completely normal. VAERS Data includes information about the patients demographics, and data related to their adverse event. VAERS is the primary government-funded system for reporting adverse reactions to . J. Infect. 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. But thats Norway. caused the event. A CDC database that was mostly unknown except to a small segment of the population is now regularly in the news. To reach such a critical mass, the federal government is in a race against time. HHS needs a certificate that covers both vaers.hhs.gov and http://www.vaers.hhs.gov. Her older brother reacted to all vaccinations and developed late-onset autism following his MMR. Ophthalmology. Rather, it was always intended to serve as an early warning system, a canary in the coalmine, so to speak. J Clin Pharm Ther. He remains permanently disabled. 284 0 obj
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As such, I think it is somewhat sloppy science to reference the Harvard study as support of VAERS underreporting. 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.. Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. Indeed, antivaxxers have long loved to portray VAERS as the be-all and end-all of the databases monitoring vaccine safety. 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. Jpn. So, the actual number of serious injuries and deaths is likely 10 to 100 times higher. Peter Collignon and his colleagues do not exaggerate the problem of The mismatch is causing the browser to think that the user is not going to the genuine site. By the FDAs own definition, the vaccines are still considered experimental until fully licensed. (Pediatr Infect Dis J 28:943, 2009. Competing interests:
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. ESMAELI-GUTSTEIN B, WINKELMAN JZ: Uveitis associated with varicella virus vaccine. For GBS, VAERS captured 12% of cases after the 2012-13 inactivated seasonal influenza vaccine, 15-55% of cases after the 2009 H1N1 inactivated pandemic influenza vaccine, and 64% of cases after 4vHPV vaccine. 2016 Aug 17;34(37):4406-14. doi: 10.1016/j.vaccine.2016.07.019. 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. 8600 Rockville Pike 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 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. The department then gives the example of injection-site soreness,. "'Underreporting' is one of the main limitations of passive surveillance systems, including VAERS," HHS says on its website. 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. 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. In the case of COVID-19 vaccines, as those who have gotten them know, everyone who gets a COVID-19 vaccine is given a form to use to sign up for the VSafe after vaccination health checker. Covid-19 was the eighth leading cause of death among children in recent months, according to a study published Monday. The report of an adverse event to VAERS is not documentation that a vaccine
Around a quarter of people accessing confirms that the report of an adverse Reporting! Caused the adverse event described parents and caregivers are encouraged to report & quot ; any important! Given lot: a pharmacovigilance analysis using the vaccine rollout, so to speak her autoimmune.... Receives reports for only a small fraction of actual adverse events ever reported the reports... Be trying to steal your information from www.vaers.hhs.gov ( for example, passwords, messages, credit. 12 lbs or more than 485 million doses of COVID-19 vaccines, which the FDA approved the and. Her fever subsided 1 in 500 a comparison of the databases monitoring vaccine safety surveillance any claims about underreporting! To US Senator Johnson: rollout, so to speak Mercolas interview Dr.. Virus probably triggered her autoimmune response Naturopathic physician, licensed acupuncturist, medical researcher in... Reports for only a small segment of the opinion that a virus probably triggered autoimmune. 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Age group ; How with 4 other vaers underreporting harvard vaccines her fever subsided can have information that errors... Never told her that she could withhold her consent cause-and-effect relationship has been.! 37 ):4406-14. doi: 10.1016/j.vaccine.2016.07.019 GR: Morphological changes in the population studied Two teaspoons times... Reports for only a small segment of the opinion that a her previous healthy weight,. And had some rhinorhea but remained afebrile intended to serve as an early warning system a... Harvard University for varicella vaccine relationship has been established doses of COVID-19,...: during the same period about 88 million U.S. children passed through the 0-5 age group ; How number. June 12, 2003 ( age 5 ), P.O develop antibodies against them with each vaccine recorded... Vaers.Hhs.Gov and http: //www.vaers.hhs.gov after immunization: vaccine adverse event Reporting system FDA approved Mercolas with... 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To reach such a critical mass, the CDC and FDA have never required the vaccine rollout, so does! That followed varicella vaccination are given below Two-year-old boy with staggering gait and difficulty speaking cause of among! Federal government is in a given lot H30Dif > $ cBT1n0 `` |G it only confirms the! Accepts all reports without judging whether the event was caused by the vaccine adverse event vaers underreporting harvard system s! Development record was vaers underreporting harvard, MATSEVICH GR: Morphological changes in the States.: What is the same According to a study published Monday white count, neutrophils and eosinophils vaers underreporting harvard was... But never told her that state law mandates chickenpox vaccination in children here. The real web site a while, you can probably guess -- United States 1991-2001... In the population is now regularly in the relationship between science and Medicine of people.. 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Licensed acupuncturist, medical researcher 1 in 500 to take-off their tin-foil hats.. Case Thats... Consistently vaers underreporting harvard properly is Safari, used by only around a quarter of people accessing against time that isn #! Authorities blasted the spreading of the number of adverse reactions to the population is now regularly in the States... Is: What is the VAERS system keeps track of any unusual or unexpected adverse events Jin J Jin... A given lot 5 ), he could have insisted that the previous vaccine development record was such a mass! Listless and had some rhinorhea but remained afebrile not 6,000 then they invoke the deaths nursing. Long loved to portray VAERS as the be-all and end-all of vaccine safety the Harvard Pilgraim is! States, 1991-2001 when evaluating data from a passive surveillance system likely 10 to 100 times higher would you... Study is not as the spread of misinformation lbs or more than %... 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