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covid-19_vaccines:safety_of_covid-19_vaccines [2022/01/14 03:59]
mathew 		covid-19_vaccines:safety_of_covid-19_vaccines [2022/10/06 09:03] (current)
mathew
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 ====== Safety (Pharmacovigilance) of COVID-19 Vaccines ====== ====== Safety (Pharmacovigilance) of COVID-19 Vaccines ======
 +Safety has been at the center of a heated debate during the mass experimental campaign employing the [[:COVID-19 vaccines]].
  
-===== Ability for COVID-19 Vaccines to Cause COVID-19 =====+See also, 
 +  * [[covid-19_vaccines:batch_analysis|COVID-19 Vaccine Batch Analysis]] 
 +  * [[covid-19_vaccines:whistleblowers|COVID-19 Vaccine Whistleblowers]] 
 + 
 +===== Pharmacovigilance Resources ===== 
 +  * Jan 19, 2022 - 1000 Peer Reviewed Studies Questioning Covid-19 Vaccine Safety((January 19, 2022 | [[Informed Choice Australia]] | [[https://www.informedchoiceaustralia.com/post/1000-peer-reviewed-studies-questioning-covid-19-vaccine-safety|1000 Peer Reviewed Studies Questioning Covid-19 Vaccine Safety]])) 
 + 
 +==== VAERS Data on COVID-19 Vaccines ==== 
 + 
 +==== V-safe Data ==== 
 +On October 3, 2022, the CDC released COVID-19 Vaccine V-safe data pursuant to court order after the [[:Informed Consent Action Network]] filed suit.((October 3, 2022 | prnewswire.com | [[prnewswire.com/news-releases/cdcs-covid-19-vaccine-v-safe-data-released-pursuant-to-court-order-301639584.html|CDC's Covid-19 Vaccine v-safe Data Released Pursuant to Court Order]])) 
 + 
 +===== Biological Plausibility for COVID-19 Vaccines to Cause COVID-19 and Other Disease ===== 
 + 
 +==== VAIDS ==== 
 +Research published in August, 2022 shows that mRNA vaccines exposed altent [[:HIV]] to at least some T-cells.((August 19, 2022 | Stevenson et al | Nature Communications | SARS CoV-2 mRNA vaccination exposes latent HIV to Nef-specific CD8+ T-cells | [[https://www.nature.com/articles/s41467-022-32376-z|DOI 
 +https://doi.org/10.1038/s41467-022-32376-z]])) 
 + 
 +==== Causing COVID-19 ====
 Whether or not due to the spike protein or other factors that a COVID-19 vaccine can cause the COVID-19 condition is up for debate. Even weeks after mass vaccination programs began, researches had not yet determined whether or not vaccination could result in cytokine storming.((January 20, 2021 | [[:Health Desk]] | [[https://health-desk.org/articles/what-do-we-know-about-the-mrna-vaccine-and-cytokine-storm|What do we know about the mRNA vaccine and cytokine storm?]])) Whether or not due to the spike protein or other factors that a COVID-19 vaccine can cause the COVID-19 condition is up for debate. Even weeks after mass vaccination programs began, researches had not yet determined whether or not vaccination could result in cytokine storming.((January 20, 2021 | [[:Health Desk]] | [[https://health-desk.org/articles/what-do-we-know-about-the-mrna-vaccine-and-cytokine-storm|What do we know about the mRNA vaccine and cytokine storm?]]))
 +
 +Aside from spike protein, the [[:lipid nanoparticles]] in many of the vaccines
  
 ===== Safety Monitoring Systems ===== ===== Safety Monitoring Systems =====
 After a vaccine is authorized or approved for use, many vaccine safety monitoring systems watch for adverse events (possible side effects). This continued monitoring can pick up on adverse events that may not have been seen in clinical trials. If an unexpected adverse event is seen, experts quickly study it further to assess whether it is a true safety concern. Experts then decide whether changes are needed in U.S. vaccine recommendations. This monitoring is critical to help ensure that the benefits continue to outweigh the risks for people who receive vaccines. After a vaccine is authorized or approved for use, many vaccine safety monitoring systems watch for adverse events (possible side effects). This continued monitoring can pick up on adverse events that may not have been seen in clinical trials. If an unexpected adverse event is seen, experts quickly study it further to assess whether it is a true safety concern. Experts then decide whether changes are needed in U.S. vaccine recommendations. This monitoring is critical to help ensure that the benefits continue to outweigh the risks for people who receive vaccines.
 +
 +==== Israel ====
 +At the outset of the mass experimental [[:quasi-vaccine]] campaign, Israel had no safety monitoring system in place.
 +  * Leaked video Israeli ministry of health hides a devastating research report on the harms of covid injections((August 20, 2022 | The Fighter | GBN Live | [[https://rumble.com/v1gqgcj-leaked-video-israeli-ministry-of-health-hides-hospital-research-report-on-h.html|Leaked video Israeli ministry of health hides a devastating research report on the harms of covid injections]]))
 +
 +==== United States ====
 +
 +=== VaST ===
 +The Vaccine Safety Technical (VaST) Work Group reports on vaccine safety from a variety of sources.
 +
 +VaST Work Group Reports at the CDC ([[https://www.cdc.gov/vaccines/acip/work-groups-vast/index.html|here]]).
 +
 +== Objectives of VaST ==
 +From the February 4, 2022 VaST Report:((February 4, 2022 | CDC | VaST Work Group Report | [[https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-02-04/05-COVID-Talbot-508.pdf|COVID-19 Vaccine Safety Technical (VaST) Work Group Reports]]))
 +  * Review, evaluate, and interpret post-authorization/approval COVID-19 vaccination safety data
 +  * Serve as the central hub for technical subject matter expertise from federal agencies conducting post-authorization/approval safety monitoring 
 +  * Advise on analyses, interpretation, and presentation of vaccine safety data 
 +  * Provide updates to the ACIP COVID-19 Vaccines Work Group and the entire ACIP on COVID-19 vaccine safety
 +
 +Also from that report: "U.S. safety monitoring systems including Vaccine Adverse Events Reporting System (VAERS), [[:Vaccine Safety Datalink]] (VSD), [[:FDA BEST System]],1 Department of Veterans Affairs (VA), Indian Health Service (IHS), Department of Defense (DoD)"
 +
 +=== Other ===
  
 FDA’s June 2020 guidance document also includes important recommendations for ongoing safety evaluation after any COVID-19 vaccine is made available in the United States. FDA’s June 2020 guidance document also includes important recommendations for ongoing safety evaluation after any COVID-19 vaccine is made available in the United States.
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 Expanded Safety Monitoring Systems Expanded Safety Monitoring Systems
  
-****The following systems and information sources add an additional layer of safety monitoring, giving CDC and FDA the ability to evaluate COVID-19 vaccine safety in real time and make sure COVID-19 vaccines are as safe as possible****+****The following systems and information sources add an additional layer of safety monitoring, giving [[:CDC]] and [[:FDA]] the ability to evaluate [[:COVID-19]] vaccine safety in real time and make sure COVID-19 vaccines are as safe as possible****
  
-CDC [[V-SAFE]] — A new smartphone-based, after-vaccination health checker for people who receive COVID-19 vaccines. V-SAFE will use text messaging and web surveys from CDC to check in with vaccine recipients for health problems following COVID-19 vaccination. The system also will provide telephone follow up to anyone who reports medically significant (important) [[adverse events]].+CDC [[:V-SAFE]] — A new smartphone-based, after-vaccination health checker for people who receive COVID-19 vaccines. V-SAFE will use text messaging and web surveys from CDC to check in with vaccine recipients for health problems following COVID-19 vaccination. The system also will provide telephone follow up to anyone who reports medically significant (important) [[adverse events]].
  
-CDC **National Healthcare Safety Network** [[NHSN]] — An acute care and long-term care facility monitoring system with reporting to the Vaccine Adverse Event Reporting System or [[VAERS]]+CDC **National Healthcare Safety Network** [[:NHSN]] — An acute care and long-term care facility monitoring system with reporting to the Vaccine Adverse Event Reporting System or [[:VAERS]]
  
 FDA **Other large insurer/payer databases** — A system of administrative and claims-based data for surveillance and research FDA **Other large insurer/payer databases** — A system of administrative and claims-based data for surveillance and research
  
-===Existing Safety Monitoring Systems===+=== Existing Safety Monitoring Systems === 
 +As people get vaccinated, CDC, FDA, and other federal partners use the following existing systems and data sources to conduct ongoing safety monitoring.
  
-As people get vaccinated, CDC, FDA, and other federal partners will use the following existing, robust systems and data sources to conduct ongoing safety monitoring: +== Vaccine Adverse Event Reporting System [[:VAERS]] ==
-General public +
- +
-===CDC and FDA: Vaccine Adverse Event Reporting System - VAERS===+
  
 The national system that collects reports from healthcare professionals, vaccine manufacturers, and the public of adverse events that happen after vaccination; reports of adverse events that are unexpected, appear to happen more often than expected, or have unusual patterns are followed up with specific studies. The national system that collects reports from healthcare professionals, vaccine manufacturers, and the public of adverse events that happen after vaccination; reports of adverse events that are unexpected, appear to happen more often than expected, or have unusual patterns are followed up with specific studies.
  
-CDC **Vaccine Safety Datalink** [[VSD]] — A network of 9 integrated healthcare organizations across the United States that conducts active surveillance and research; the system is also used to help determine whether possible side effects identified using [[VAERS]] are actually related to vaccination+== Vaccine Safety Datalink (VSD) == 
 + 
 +CDC **Vaccine Safety Datalink** [[:VSD]] — A network of 9 integrated healthcare organizations across the United States that conducts active surveillance and research; the system is also used to help determine whether possible side effects identified using [[:VAERS]] are actually related to vaccination. 
 + 
 +  * COVID-19 Vaccination and Non–COVID-19 Mortality Risk — Seven Integrated Health Care Organizations, United States, December 14, 2020–July 31, 2021((October 29, 2021 | Xu et al | [[:CDC]] | [[https://www.cdc.gov/mmwr/volumes/70/wr/mm7043e2.htm|COVID-19 Vaccination and Non–COVID-19 Mortality Risk — Seven Integrated Health Care Organizations, United States, December 14, 2020–July 31, 2021]])) 
 + 
 +== Other ==
          
-CDC **Clinical Immunization Safety Assessment** [[CISA]] — A collaboration between CDC and 7 medical research centers to provide expert consultation on individual cases and conduct clinical research studies about vaccine safety+CDC **Clinical Immunization Safety Assessment** [[:CISA]] — A collaboration between CDC and 7 medical research centers to provide expert consultation on individual cases and conduct clinical research studies about vaccine safety
          
-FDA and the [[Centers for Medicare and Medicaid Services]]: — A claims-based system for active surveillance and research+FDA and the [[:Centers for Medicare and Medicaid Services]] — A claims-based system for active surveillance and research
        
-FDA **Biologics Effectiveness and Safety System** [[BEST]] — A system of electronic health record, administrative, and claims-based data for active surveillance and research+FDA **Biologics Effectiveness and Safety System** [[:BEST]] — A system of electronic health record, administrative, and claims-based data for active surveillance and research
          
 FDA Sentinel Initiative external icon — A system of electronic health record, administrative, and claims-based data for active surveillance and research FDA Sentinel Initiative external icon — A system of electronic health record, administrative, and claims-based data for active surveillance and research
  
-**Members of the military**+=Members of the military=
  
-Department of Defense (DOD): [[DOD VAERS]] — Adverse event reporting to VAERS for the DOD populations+Department of Defense (DOD): [[:DOD VAERS]] — Adverse event reporting to VAERS for the DOD populations
          
-DOD ***Vaccine Adverse Event Clinical System*** [[VAECS]] — A system for case tracking and evaluation of adverse events following immunization in DOD and DOD-affiliated populations+DOD ***Vaccine Adverse Event Clinical System*** [[:VAECS]] — A system for case tracking and evaluation of adverse events following immunization in DOD and DOD-affiliated populations
          
 DOD ***DOD Electronic Health Record and Defense Medical Surveillance System*** — A system of electronic health record and administrative data for active surveillance and research DOD ***DOD Electronic Health Record and Defense Medical Surveillance System*** — A system of electronic health record and administrative data for active surveillance and research
  
-***Veterans***+=Veterans=
  
-Department of Veterans Affairs (VA): **VA Adverse Drug Event Reporting System** VA [[ADERS]] external icon — A national reporting system for adverse events following receipt of drugs and immunizations+Department of Veterans Affairs (VA): **VA Adverse Drug Event Reporting System** VA [[:ADERS]] external icon — A national reporting system for adverse events following receipt of drugs and immunizations
  
 **VA Electronic Health Record and Active Surveillance System** — A system of electronic health record and administrative data for active surveillance and research **VA Electronic Health Record and Active Surveillance System** — A system of electronic health record and administrative data for active surveillance and research
  
-**Tribal nations**+=Tribal nations=
  
-Indian Health Service [[IHS]] IHS [[VAERS]] data external icon — Spontaneous adverse event reporting to VAERS for populations served by IHS and Tribal facilities+Indian Health Service [[:IHS]] IHS [[:VAERS]] data external icon — Spontaneous adverse event reporting to VAERS for populations served by IHS and Tribal facilities
  
 https://web.archive.org/web/20201019021700/https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html https://web.archive.org/web/20201019021700/https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html
 +
 +===== Indications of COVID-19 Vaccine-Associated Mortality =====
 +
 +==== Pathologists and Medical Specialists ====
 +Dr. [[:Sucharit Bhakdi]] and Dr. [[:Arne Burkhardt]] summarized [[:histopathologic]] analyses on 15 persons who died after vaccination and found 14 of those deaths to be associated with vaccination despite none of the coroners recording the appropriate associations.((December 10, 2021 | [[:Sucharit Bhakdi]], MD and [[:Arne Burkhardt]], MD | [[:Doctors for COVID Ethics]] | [[https://doctors4covidethics.org/wp-content/uploads/2021/12/end-covax.pdf|On COVID vaccines: why they cannot work, and irrefutable
 +evidence of their causative role in deaths after vaccination]]))
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