Time to Re-Visit Vaers.com
Segment # 026
Last night I listened to NBC’s Nightly News with Kate Snow (@tvkatesnow) and responded in the following manner to her newscast. “I was literally stunned tonight watching your newscast when you stated that the vaccines were fully approved.. all the vaccines available in the US are still under an EUA and second that the vaccines have been proven to be the safest vaccines in history. That's just factually inaccurate if you check CDC's openvaers.com. which currently has a death toll of 22,193 reported covid vaccine deaths. This data is all available of government websites. “
You may have concluded that I have spent a good deal of time researching and trying to understand COVID and the subsequent pandemic. The government is trying to say we have VAERS as an early warning system proving we care about the data… but then on the other hand they say the data is screwed up so its not reliable. That’s not credible when NIH has a proposed budget of 51 billion for 2022. Good people can disagree but they need to disagree by presenting data supporting their argument. Would guess Kate Snow is just reading a script. This is my view below.
https://pubmed.ncbi.nlm.nih.gov/33039207/
Background: Underreporting is a limitation common to passive surveillance systems, including the Vaccine Adverse Event Reporting System (VAERS) that monitors the safety of U.S.-licensed vaccines.
The Harvard Pilgrim (no relation to Harvard ) suggested in 2007 conservatively underreporting could be a factor of 5. It should be noted some experts see this as much greater. https://digital.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report-2011.pdf
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vaers.html
· VAERS is an early warning system used to monitor adverse events that happen after vaccination. VAERS is the frontline system of a comprehensive vaccine safety monitoring program in the United States. It is one of several systemspdf icon CDC and the U.S. Food and Drug Administration (FDA) use to help ensure vaccines used in the United States, including COVID-19 vaccines, are closely monitored for safety.
· VAERS gives vaccine safety experts valuable information so they can assess possible vaccine safety concerns, including the new COVID-19 vaccines. It is especially useful for detecting unusual or unexpected patterns of health problems (also called “adverse events”) that might indicate a possible safety problem with a vaccine.
· If a health problem is reported to VAERS, that doesn’t mean that the vaccine caused the problem. It warns vaccine safety experts of potential problems that they may need to assess, and it alerts them to take further action, as needed.
https://vaers.hhs.gov/about.html
Established in 1990, the Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect possible safety problems in U.S.-licensed vaccines. VAERS is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination. Anyone can report an adverse event to VAERS. Healthcare professionals are required to report certain adverse events and vaccine manufacturers are required to report all adverse events that come to their attention.
VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences to CDC and FDA. VAERS is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine. This way, VAERS can provide CDC and FDA with valuable information that additional work and evaluation is necessary to further assess a possible safety concern.
Welcome to the Office of Budget. FY 2022 President's Budget: In May 2021, President Biden submitted to Congress his FY 2022 Budget encompassing all Federal agencies - including a proposed budget of approximately $51.96 billion for the NIH
https://vaersanalysis.info/2022/01/07/vaers-summary-for-covid-19-vaccines-through-12-31-2021/
Its important to remember that in early 2021 Italy shut down AstraZeneca with 5 deaths. This graph dramatically shows that our standard of what we accept in adverse events has changed dramatically
https://web.sph.harvard.edu/mch-data-connect/results/vaccine-adverse-events-reporting-system-vaers/
Preliminary data were collected from June 2006 through October 2009 on 715,000 patients,
and 1.4 million doses (of 45 different vaccines) were given to 376,452 individuals. Of these
doses, 35,570 possible reactions (2.6 percent of vaccinations) were identified. This is an average
of 890 possible events, an average of 1.3 events per clinician, per month. These data were
presented at the 2009 AMIA conference.
In addition, ESP:VAERS investigators participated on a panel to explore the perspective of
clinicians, electronic health record (EHR) vendors, the pharmaceutical industry, and the FDA
towards systems that use proactive, automated adverse event reporting.
Adverse events from drugs and vaccines are common, but underreported. Although 25% of
ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events
and 1-13% of serious events are reported to the Food and Drug Administration (FDA).
Likewise, fewer than 1% of vaccine adverse events are reported. Low reporting rates preclude or
slow the identification of “problem” drugs and vaccines that endanger public health. New
surveillance methods for drug and vaccine adverse effects are needed. Barriers to reporting
include a lack of clinician awareness, uncertainty about when and what to report, as well as the
burdens of reporting: reporting is not part of clinicians’ usual workflow, takes time, and is
duplicative. Proactive, spontaneous, automated adverse event reporting imbedded within EHRs
and other information systems has the potential to speed the identification of problems with new
drugs and more careful quantification of the risks of older drugs.
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.
Conservatively, medical experts concluded that the under reporting at best is 5 times the actual number reported.
Judge Gives FDA Just Over 8 Months to Produce Pfizer’s Safety Data
A federal judge on Thursday ordered the U.S. Food and Drug Administration to produce, at a rate of 55,000 pages per month, the documents it relied on to license the Pfizer-BioNTech COVID-19 ...
This is what makes folks against these vaccines and mandates crazy. In the initial test studies pregnant women and children were omitted from inclusions.. they are now mandated by a vaccine that was geared to the alpha variant and has proven by the data from Israel which is now about 90% vaccinated and completing shot number 4 in a raging pandemic to not be effective. Ultimately any medical decision is based on informed consent and a careful evaluation of the cost benefit analysis of any considered action. These considerations are very different for a child and a seventy plus patient with co-morbidities. It would be refreshing and a necessary step to restoring credibility in our governmental health system, if we could have some concrete data to support the efficacy of the vaccines and to counter the growing concerns that adverse events are being hidden from the public.
