copenlu/druid huggingface dataset:
Claim: "Autopsies performed by the Italian pathologists [have] shown that [COVID-19] is not pneumonia but it is disseminated intravascular coagulation" (Chinonyerem Emmanuella, Facebook users, 2020-05-01)
Evidence (2021-08-06): Results: Extensive coagulopathic changes are seen throughout the bodies of diseased patients. Diffuse alveolar damage is pathognomonic of COVID-19 viral pneumonia, and is the leading cause of lethal outcome in younger patients. Extrapulmonary pathology is predominantly seen in the liver and spleen. Intravascular thrombosis is often widespread and signs of septic shock are often present. [...] 35. Lillicrap, D. Disseminated intravascular coagulation in patients with 2019‐nCoV pneumonia. J Thromb Haemost (2020) 18(4):786–7. doi:10.1111/jth.14781 36. Yao, XH, Li, TY, He, ZC, Ping, YF, Liu, HW, Yu, SC, et al. [A pathological report of three COVID-19 cases by minimal invasive autopsies]. Zhonghua Bing Li Xue Za Zhi (2020) 49(0):411–7. doi:10.3760/cma.j.cn112151-20200312-00193 37. Tian, S, Xiong, Y, Liu, H, and Niu, L. Pathological study of the 2019 novel coronavirus disease (COVID-19) through post-mortem core biopsies. Mod Pathol (2020) 33:1007–1014.
Claim: "Autopsies performed by the Italian pathologists [have] shown that [COVID-19] is not pneumonia but it is disseminated intravascular coagulation" (Chinonyerem Emmanuella, Facebook users, 2020-05-01)
Evidence (2020-07-30): Reports of widespread thromboses and disseminated intravascular coagulation (DIC) in patients with coronavirus disease 19 (COVID-19) have been rapidly increasing in number. Key features of this disorder include a lack of bleeding risk, only mildly low platelet counts, elevated plasma fibrinogen levels, and detection of both severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and complement components in regions of thrombotic microangiopathy (TMA). This disorder is not typical DIC. Rather, it might be more similar to complement-mediated TMA syndromes, which are well known to rheumatologists who care for patients with severe systemic lupus erythematosus or catastrophic antiphospholipid syndrome. This perspective has critical implications for treatment. Anticoagulation and antiviral agents are standard treatments for DIC but are gravely insufficient for any of the TMA disorders that involve disorders of complement. Mediators of TMA syndromes overlap with those released in cytokine storm, suggesting close connections between ineffective immune responses to SARS-CoV-2, severe pneumonia and life-threatening microangiopathy. [...] Lillicrap, D. Disseminated intravascular coagulation in patients with 2019-nCoV pneumonia. J. Thromb. Haemost.18, 786–787 (2020).
Claim: "Autopsies performed by the Italian pathologists [have] shown that [COVID-19] is not pneumonia but it is disseminated intravascular coagulation" (Chinonyerem Emmanuella, Facebook users, 2020-05-01)
Evidence (2021-04-06): McGonagle, D., O’Donnell, J. S., Sharif, K., Emery, P. & Bridgewood, C. Immune mechanisms of pulmonary intravascular coagulopathy in COVID-19 pneumonia. Lancet Rheumatol.2, e437–e445 (2020). [...] Goshua, G. et al. Endotheliopathy in COVID-19-associated coagulopathy: evidence from a single-centre, cross-sectional study. Lancet Haematol.7, e575–e582 (2020). [...] Disseminated intravascular coagulation (DIC). An acquired syndrome characterized by the intravascular activation of coagulation without a precise localization in response to microvascular injury, leading to organ dysfunction when sufficiently severe. DIC involves large production of thrombin accompanied by platelet activation and consumption, altered fibrinolysis and microvascular thrombosis. It can occur in critically ill patients with overwhelming infection, fulminant sepsis, extensive tissue damage or malignancy.
Claim: "Autopsies performed by the Italian pathologists [have] shown that [COVID-19] is not pneumonia but it is disseminated intravascular coagulation" (Chinonyerem Emmanuella, Facebook users, 2020-05-01)
Evidence (2023-10-24): Disseminated intravascular coagulation (DIC) is characterized by systemic activation of blood coagulation, which results in generation and deposition of fibrin, leading to microvascular thrombi in various organs and contributing to multiple organ dysfunction syndrome (MODS). [1, 2] Consumption of clotting factors and platelets in DIC can result in life-threatening hemorrhage. [3] [...] Table 1. Causes of Acute (Hemorrhagic) Disseminated Intravascular Coagulation (Open Table in a new window) Table 2. Causes of Chronic Disseminated Intravascular Coagulation (Open Table in a new window)
Claim: "Autopsies performed by the Italian pathologists [have] shown that [COVID-19] is not pneumonia but it is disseminated intravascular coagulation" (Chinonyerem Emmanuella, Facebook users, 2020-05-01)
Evidence (2020-04-23): Tang et al [7] described the outcome of 183 patients admitted to the Tongji Hospital in Wuhan with RNA detection confirmed 2019-nCoV pneumonia. The authors observed that disseminated intravascular coagulation (DIC) is a frequent occurrence in worsening of COVID-19 pneumonia. Coagulation abnormalities and marked increase of D-dimer were often associated with increased mortality or concomitant severe thromboembolic complications. Surprisingly, the authors noted that in the Chinese population, the prevalence of thromboembolic events was particularly elevated among patients with severe lung failure. Similar prevalence was observed by Cui et al in 81 patients admitted to intensive care units (ICUs), where the prevalence of major thromboembolism was around 25% [8]. Low molecular weight heparin (LMWH) or unfractionated heparin (UFH) at prophylactic doses are associated with a reduced 28-day mortality in more severe COVID-19 patients [9], displaying a sepsis-induced coagulopathy (SIC) score ≥ 4 (40.0% vs. 64.2%, P = 0.029) or D-dimer levels more than six-fold the upper limit of normal (32.8% vs. 52.4%, P = 0.017). Comparably, but slightly higher records of thromboembolic complications (up to about 30%) were observed in Italian patients admitted in ICU (unpublished data). [...] COVID-19 produces a sort of DIC which is usually characterized by hypercoagulability. The exact pathogenetic mechanism of COVID-19-related DIC is unclear, although inflammatory drive and cytokine release may be responsible for the observed coagulation impairment leading to thromboembolic complications. IL-6 may stimulate up-regulation of fibrinogen synthesis by the liver and the virus may bind directly to endothelial cells causing alveolar damage.
Claim: Blank COVID-19 vaccine safety inserts show there are no safety and effectiveness studies for these vaccines (Social media users, 2023-08-03)
Evidence (2023-08-03): COVID-19 vaccines went through clinical trials to determine their effectiveness and safety before they were authorized for use. The Nuremberg Code is a set of ten principles defining legitimate medical research. However, the Code doesn’t apply to medical interventions that were already tested in clinical trials and shown to be safe and effective, like the COVID-19 vaccines.
Claim: Blank COVID-19 vaccine safety inserts show there are no safety and effectiveness studies for these vaccines (Social media users, 2023-08-03)
Evidence (2023-08-11): A Facebook reel posted on 3 August 2023 showed a person speaking to a CVS pharmacist, asking for COVID-19 vaccine inserts. Upon finding a blank sheet of paper except for text indicating the paper was left "intentionally blank", the person asked "How is it informed consent when all of the […] placebo safety studies are not listed from their manufacturer?" and claimed that it showed people "don’t know what we’re injecting into ourselves". [...] Inaccurate to claim there’s no safety and effectiveness studies on COVID-19 vaccines [...] Earlier fact-checks by Reuters and AFP reported that blank COVID-19 vaccine inserts aren’t evidence that there aren’t any safety or effectiveness studies about the vaccines. FDA spokesperson Alison Hunt told AFP that information for approved vaccines is provided in package inserts. But in the case of the authorized vaccines, the information was communicated via patient Fact Sheets that were posted on the FDA website.
Claim: Blank COVID-19 vaccine safety inserts show there are no safety and effectiveness studies for these vaccines (Social media users, 2023-08-03)
Evidence (2022-02-15): How do we know Covid vaccines are safe? [...] Approval is only given if regulators are happy that a vaccine is safe and effective. [...] The Covid vaccines from Pfizer, Moderna and AstraZeneca do not contain this, or any other animal products.
Claim: Blank COVID-19 vaccine safety inserts show there are no safety and effectiveness studies for these vaccines (Social media users, 2023-08-03)
Evidence (2023-11-29): COVID-19 Vaccine Safety — What We Know - The Pfizer and Moderna vaccines are strongly recommended as safe and effective at preventing serious illness or death from COVID-19. [...] - Roughly 12 months of data, including data from tens of thousands of participants in clinical trials, show that the vaccines are safe and effective at preventing serious disease or death due to COVID-19. [...] - Careful testing. All vaccines go through clinical trials to test safety and effectiveness. For the COVID-19 vaccine, the FDA set high safety standards for vaccine developers to meet. This graphic from the National Institutes of Health shows the four phases a vaccine goes through before it is released to the public.
Claim: Blank COVID-19 vaccine safety inserts show there are no safety and effectiveness studies for these vaccines (Social media users, 2023-08-03)
Evidence (2024-01-01): It is important that COVID-19 vaccines are safe. Like any other vaccines, COVID-19 vaccines are also subject to strict standards for safety and side effects. A COVID-19 vaccine cannot be used until the application for marketing authorisation has been approved. At the European level, the safety, efficacy and quality of medicinal products – including vaccines – are assessed by the European Medicines Agency (EMA). In the Netherlands, the Dutch government is also involved in assessing medicinal products through the Medicines Evaluation Board (CBG-MEB). Before a vaccine is approved, its benefits (protection against disease) must be assessed in relation to its drawbacks (possible side effects). If a vaccine receives a positive opinion in this initial assessment, a marketing authorisation will be granted by the European Commission which is then valid in all EU (European Union) member states. No vaccines are used that have not been assessed and subsequently approved by the EMA for use in Europe.
Claim: Blank COVID-19 vaccine safety inserts show there are no safety and effectiveness studies for these vaccines (Social media users, 2023-08-03)
Evidence (2020-11-27): COVID-19 Vaccine Safety – Questions and Answers [...] Currently, the Comirnaty (Pfizer) vaccine is the only COVID-19 vaccine available in New Zealand. There is limited data with the use of Comirnaty in pregnant women. Animal studies have not indicated direct or indirect harmful effects in pregnancy, development of the fetus or the newborn. Please refer to the Comirnaty data sheet and Consumer Medicine Information (CMI) for more information. [...] For background information about the investigation process, see the World Health Organization’s COVID-19 Vaccines: Safety Surveillance Manual (see the ‘AEFIs’ and ‘AESIs’ annexes).
Claim: Blank COVID-19 vaccine safety inserts show there are no safety and effectiveness studies for these vaccines (Social media users, 2023-08-03)
Evidence (2024-08-29): Effectiveness of COVID-19 booster vaccines against COVID-19-related symptoms, hospitalization and death in England [...] The long-term follow-up of the COVE study adds evidence that primary vaccination and boosting with mRNA-1273 provided immunogenicity and effectiveness in protection against both COVID-19 and severe COVID-19 with an acceptable safety profile, including during emergent variant waves through April 7, 2023, regardless of prior SARS-CoV-2 infection. These results are consistent with the substantial benefits achieved through global vaccination and booster immunization with safe and effective COVID-19 vaccines in controlling the pandemic and restoring lifestyles to pre-pandemic times7,8,9,10. Continual monitoring of variants and updates of COVID-19 vaccines are essential for limiting the spread of future SARS-CoV-2 infections and ensuring pandemic preparedness. [...] Stowe, J., Andrews, N., Kirsebom, F., Ramsay, M. & Bernal, J. L. Effectiveness of COVID-19 vaccines against omicron and delta hospitalisation, a test negative case-control study. Nat. Commun.13, 5736 (2022).
Claim: Blank COVID-19 vaccine safety inserts show there are no safety and effectiveness studies for these vaccines (Social media users, 2023-08-03)
Evidence (2023-11-20): COVID vaccine package insert is blank because up-to-date information is online CLAIM: The packaging insert with the Johnson & Johnson COVID-19 vaccine is suspiciously blank, containing no information about ingredients and side effects normally found with a vaccine. [...] "A lot of safety and efficacy data — in fact all of the normal information that we would find in a package insert, like the ingredients — that would all be found right here in this package insert," the woman says in the video. "Must be magic. It’s all blank."
Claim: Blank COVID-19 vaccine safety inserts show there are no safety and effectiveness studies for these vaccines (Social media users, 2023-08-03)
Evidence (2022-03-01): "It's quite revolting to think that the inserts for these vaccines were blank when they should have contained all these diseases and adverse events," said one video posted on BitChute, a video-hosting platform. "You really have to go through this yourselves, but this is really the bombshell news of the day, of the week, of the year." [...] Safety data for the Pfizer-BioNTech COVID-19 vaccine have been publicly available since 2020. The U.S. Centers for Disease Control and Prevention says that the COVID-19 vaccines are safe and effective for both children and adults. Social media posts claim that the drug labels for the Pfizer COVID-19 vaccine "were blank when they should have contained all these diseases and adverse events" listed in a confidential report.
Claim: Blank COVID-19 vaccine safety inserts show there are no safety and effectiveness studies for these vaccines (Social media users, 2023-08-03)
Evidence (2021-08-10): COVID-19 Vaccines: Verifying Safety and Identifying Misinformation How do we know COVID-19 vaccines are safe? [...] GG: There are different phases of conducting a clinical trial. I referred to these vaccines as being in phase 3 trials. This is the last phase where people are looking at safety and efficacy. The first phase is purely [for] safety. It's [tested on] a small group of people to make sure that the vaccine [is] well tolerated. And in the second phase, they get a little bit more into the safety part and what kind of doses are required.
Claim: Blank COVID-19 vaccine safety inserts show there are no safety and effectiveness studies for these vaccines (Social media users, 2023-08-03)
Evidence (2022-01-24): There are strict precautions in place to help ensure the safety of all COVID-19 vaccines. Before receiving validation from WHO and national regulatory agencies for emergency use, COVID-19 vaccines must undergo rigorous testing in clinical trials to prove that they meet internationally agreed benchmarks for safety and efficacy. [...] The vaccines must be proven safe and effective in large Phase III clinical trials. Some COVID-19 vaccine candidates have already completed their Phase III trials and are being used globally, and many other vaccine candidates are being developed and are still in the trial phase. [...] As with any vaccine, it is essential to closely monitor the safety and effectiveness of COVID-19 vaccines that are used in immunization programmes. If a serious health problem is reported following vaccination, a thorough investigation should take place by the public health programme in the country.
Claim: Blank COVID-19 vaccine safety inserts show there are no safety and effectiveness studies for these vaccines (Social media users, 2023-08-03)
Evidence (2023-12-05): All COVID-19 vaccines, listed by WHO as for emergency use or prequalified, provide protection against severe disease and death resulting from COVID-19 infection. [...] Yes. While COVID-19 vaccines are highly effective against serious disease and death, no vaccine is 100% effective. [...] None of the current COVID-19 vaccines have live virus in them. This means there is no risk of you passing COVID-19 to your baby through your breastmilk. In fact, the antibodies you get after vaccination may go through your breast milk and help to protect your baby.
Claim: Blank COVID-19 vaccine safety inserts show there are no safety and effectiveness studies for these vaccines (Social media users, 2023-08-03)
Evidence (2023-08-02): The document was released by the FDA in response to a Freedom of Information Act request from Public Health and Medical Professionals for Transparency. The group asked the FDA for all of its documents related to the Pfizer/BioNTech COVID-19 vaccine — or around 329,000 pages, plus other files — four days after the agency gave full approval to the vaccine. [...] As MedPage Today has explained, the FDA has already released summaries of the data it has reviewed, and the FOIA documents "may not be material to an overall analysis of the vaccine’s safety and efficacy." Zach Zalewski, a regulatory strategy consultant at Avalere Health, told the outlet, "There’s a risk of cherry picking and taking things out of context." [...] Spencer, Saranac Hale. "Idaho Doctor Makes Baseless Claims About Safety of COVID-19 Vaccines." FactCheck.org. 19 Apr 2021.
Claim: Blank COVID-19 vaccine safety inserts show there are no safety and effectiveness studies for these vaccines (Social media users, 2023-08-03)
Evidence (2021-02-16): COVID vaccines and safety: what the research says It is clear that coronavirus vaccines are safe and effective, but as more are rolled out, researchers are learning about the extent and nature of side effects. [...] Oxford COVID-vaccine paper highlights lingering unknowns about results
Claim: Blank COVID-19 vaccine safety inserts show there are no safety and effectiveness studies for these vaccines (Social media users, 2023-08-03)
Evidence (2023-11-07): More than half a billion doses of COVID-19 vaccines have now been administered in the U.S. and only a few, very rare, safety concerns have emerged. The vast majority of people experience only minor, temporary side effects such as pain at the injection site, fatigue, headache, or muscle pain — or no side effects at all. As the Centers for Disease Control and Prevention has said, these vaccines "have undergone and will continue to undergo the most intensive safety monitoring in U.S. history."
Claim: Blank COVID-19 vaccine safety inserts show there are no safety and effectiveness studies for these vaccines (Social media users, 2023-08-03)
Evidence (2023-08-11): Video about blank COVID-19 vaccine insert falsely implies there are no safety data for COVID-19 vaccines [...] Inaccurate to claim there’s no safety and effectiveness studies on COVID-19 vaccines [...] Earlier fact-checks by Reuters and AFP reported that blank COVID-19 vaccine inserts aren’t evidence that there aren’t any safety or effectiveness studies about the vaccines. FDA spokesperson Alison Hunt told AFP that information for approved vaccines is provided in package inserts. But in the case of the authorized vaccines, the information was communicated via patient Fact Sheets that were posted on the FDA website.
Claim: Blank COVID-19 vaccine safety inserts show there are no safety and effectiveness studies for these vaccines (Social media users, 2023-08-03)
Evidence (2022-06-13): The vaccine is safe and effective for all individuals aged 18 and above. In line with the WHO Prioritization Roadmap and and the WHO Values Framework older adults, health workers and immunocompromised persons should be prioritised. [...] The AstraZeneca vaccine is safe and effective at protecting people from the extremely serious risks of COVID-19, including death, hospitalization and severe disease. Read the 16 April 2021 statement of the WHO Global Advisory Committee on Vaccine Safety on AstraZeneca COVID-19 vaccine for reports of very rare side effects. The Council for International Organizations of Medical Sciences classifies rates of adverse events or medicines and vaccines as follows: [...] There will be no further updates to this page. For more information on Covid-19 vaccines.
Claim: Blank COVID-19 vaccine safety inserts show there are no safety and effectiveness studies for these vaccines (Social media users, 2023-08-03)
Evidence (2022-06-29): In addition, the trials follow the FDA's guidance for COVID-19 vaccine development, which reflects the standard clinical trial process: Establish safety and efficacy in adults first, then move to children. Because of the widespread impact of COVID-19, though, many experts say we can’t wait until adult trials are complete. [...] Other COVID-19 vaccine developers, including Johnson & Johnson, Moderna, and AstraZeneca, say they plan to run trials for children in the United States at some point. "Enrollment of children will start once sufficient data are gathered in adults," AstraZeneca stated in reply to an inquiry. Several children’s vaccine trials are underway elsewhere, including the United Kingdom and China; the FDA could approve limited use of those in the United States. [...] If the vaccines prove to be safe and effective, Van Rompay says, "There will be much more confidence and trust [among vaccine developers and regulators] about getting these vaccines into human trials with infants and children."
Claim: Blank COVID-19 vaccine safety inserts show there are no safety and effectiveness studies for these vaccines (Social media users, 2023-08-03)
Evidence (2021-08-30): Yes. The FDA approval process involves careful review of clinical trial data to independently confirm that a vaccine is safe and effective. Two mRNA vaccines have been tested in large-scale clinical trials that included elderly and medically at-risk individuals; 30% of participants in these trials were from racially and ethnically diverse backgrounds. Both vaccines have reported to result in a range of minor side effects, such as flu-like symptoms, that resolve within one or two days. mRNA vaccines do not contain the SARS-CoV-2 virus, so you cannot get COVID-19 from an mRNA vaccine.
Claim: Blank COVID-19 vaccine safety inserts show there are no safety and effectiveness studies for these vaccines (Social media users, 2023-08-03)
Evidence (2024-07-22): Modern vaccines are safe and effective; however, adverse events have been reported after administration of all vaccines (3). More complete information about adverse reactions to a specific vaccine is available in the package insert for each vaccine and from CDC. An adverse event is an untoward event that occurs after a vaccination that might be caused by the vaccine product or vaccination process. These events range from common, minor, local reactions to rare, severe, allergic reactions (e.g., anaphylaxis). Reporting to VAERS helps establish trends, identify clusters of adverse events, or generate hypotheses. However, establishing evidence for cause and effect on the basis of case reports and case series alone is usually not possible, because health problems that have a temporal association with vaccination do not necessarily indicate causality.