VAERS

Vaccine Adverse Event Reporting System

This post has been converted from 1/4/2023 Twitter Thread

You’ve probably noticed that anytime someone brings up the VAERS reports that are off the charts post injection, they are immediately dismissed as fake reports that have not been verified and the usual go to is “correlation doesn’t imply causation”.

It’s a convenient way to dismiss legitimate safety concerns without having to do any critical thinking on the matter. So I wanted to see what iI could find about the VAERS process. Sure anyone can submit a report and that is the point, its a passive pharmacovigilance system designed to alert the CDC and FDA if there is a pattern of safety signals.

My question was, what happens to the reports of Severe Adverse Events?

Skeptics would have you believe that every report submitted is just added to the pile and thats because anyone can submit a report they cannot be trusted, because in theory they could be fake. As if a legion of anti-vax conspiracy theorists are typing up fake reports to inflate the numbers to further their own diabolical agenda, which of course is to bring back every infection disease of the past, because, well, just because.

VAERS (Vaccine Adverse Event Reporting System) was set up in 1990 as a part of the 1986 National Childhood Vaccine Injury Act and is ran jointly by the FDA and CDC. However they do hire contractors to operate the database and review reports.

Whoever files the report is liable for it and if it is found that it has been falsified, it is punishable by imprisonment. This screen shots are right from the website.

So they do review reports submitted and if they look to be obviously fabricated they remove them but it’s more thorough than that. Frederick Varricchio, formerly of the FDA, Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research had this to say about serious reports entered into the system.

“At the FDA, serious reports are reviewed by a physician within 24 hours of data entry. Serious reports are classified by the US Code for Federal Regulations as those which report a death, hospitalization, life-threatening illness, prolongation of hospitalization, permanent disability, or some other event which may reasonably lead to hospitalization, permanent disability or life threatening illness.”

“Based on the judgment of the reviewing physician, any report may be selected for immediate, initial follow up. Reporters of serious adverse events receive a letter (or email now) acknowledging receipt of the report, and follow-up letters are sent 60 days and 1 year after receipt of the initial report. This 60-day letter requests information on the resolution of the adverse event and any key information that was missing from the original report.”

“Most follow-up is carried out by the contractor’s staff of nurses, who request pertinent medical records and administer prepared questionnaires for some predetermined conditions. The FDA physician may sometimes personally conduct further inquiry in a focused manner.”

“Due to the severity of the event, 100% of domestic death reports receive follow-up by the contractor’s staff.”

“Follow-up activities may involve FDA field offices, CDC or other government agencies. State health departments are intimately involved in immunization programs and often receive reports of possible vaccine adverse events. Such reports are then transmitted to VAERS. In exceptional cases, a state health department may have a role in a follow-up activity.”

Source: https://www.tandfonline.com/doi/pdf/10.1586/14760584.4.4.445

So despite the talking points that are constantly trotted out to discredit VAERS, reports of SAE’s are reviewed and a determination is made whether to allow it to remain or remove it based on a clinicians assessment.

Even though, based on what we are seeing now on VAERS, the system has worked as intended in the past.

“Several investigations based on VAERS data have uncovered previously unrecognized problems that may occur in vaccine recipients, including: rare life-threatening thrombocytopenia after measles-mumps-rubella (MMR) vaccination,hair loss after hepatitus B vaccination, serious injuries resulting from vaccine-induced syncope or fainting, and identification of the low risk of convulsions following receipt of DTP and measles-containing vaccines”.

https://biotech.law.lsu.edu/cases/vaccines/vaersce.pdf

Here are a couple slides and a quote from the FDA I found that break down who reports on average and the workflow that generally occurs depending on the classification of the event. These are from 2010 so the reporting demographics may differ somewhat now. I provide this for further insight into the importance placed on VAERS by FDA and CDC.

“The effectiveness of a national post-marketing surveillance program is directly dependent on the active participation of health professionals. Despite the limitations of spontaneous reports,FDA’s program for vaccine surveillance provides vital information of clinical importance.”

So as of 2010, 83% of reports were from either the manufacturer, a health care provider, or a state provider of immunizations. So unless the officials who submitted these are anti-vax zealots I highly doubt the percentage of false reports are anywhere near what skeptics will have you believe. Keep in mind the 20% of SAE’s were all subject to review and follow up so they were deemed legitimate. This doesn’t mean all of them can be directly attribute to the vaccine but it does mean they were taken seriously by CDC and FDA.

So if a given adverse event is being reported more frequently than would be expected according to the background rate, it should trigger an investigation.

Here is the method CDC uses to determine causality of an SAE following immunization, straight from the CDC’s own website.

•The health problem occurs during a plausible time period following vaccination.

•The adverse event corresponds to adverse events previously associated with the vaccine.

•The event is consistent with a specific clinical syndrome where association with vaccination has strong biologic plausibility (e.g., anaphylaxis) or where the syndrome is known to occur following the natural disease.

•A laboratory result confirms the association (e.g., isolation of vaccine-strain varicella virus from skin lesions of a patient with rash).

•The event recurs with re-administration of the vaccine in the same patient.

•A controlled clinical trial or epidemiologic study shows greater risk of a specific adverse event among vaccinated versus unvaccinated groups.

•A finding linking an adverse event to a vaccine has been confirmed by other studies.

CDC and the FDA use four main systems to monitor the safety of vaccines in use: the Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink (VSD), the Post-licensure Rapid Immunization Safety Monitoring System (PRISM), and the Clinical Immunization Safety Assessment (CISA) project.

Again, vaccine manufacturers are required to report all adverse events that come to their attention.

Up until recently the average number of SAE’s was around 30K per year. In late 2020 this began to change dramatically. In the seven-month period from Dec. 14, 2020, to July 9, 2021, VAERS reported 463,457 adverse vaccination events, meaning deaths and injuries.

At 463,457 events, of which 10,991 were deaths, any drug or procedure in the past resulting in this level of harm would by now have been discontinued and banned by the FDA. VAERS reports require patient information, the identity of the person submitting the form, a health provider’s contact information, which vaccine(s) were given, a description of the adverse event, the result or outcome of the event, and any other adverse events the patient might have had from previous vaccines. Again, the reporting party is held legally responsible and both the FDA and the CDC review all VAERS reports and can issue alerts to the public.

In fact the system was already used successfully to identify several safety signals related to COVID-19 vaccines, including Guillain–Barré Syndrome, thrombosis with thrombocytopenia following the Johnson & Johnson/Janssen COVID-19 vaccine, and myocarditis and anaphylaxis following the Pfizer–BioNTech and Moderna COVID-19 vaccines as reported by the FDA. The safety signals garnered little if any serious reporting from the media though.

The 2011 Lazarus Report

The report entitled “Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS)” looked at how good VAERS is at identifying adverse events and found.

“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.”

Fewer than 1%

Researchers followed more than 376,452 vaccinated subjects for three years, and monitored all adverse drug events while recording the frequency of provider reporting. The researchers found that adverse drug events, in general, were common but extremely underreported. So if this is true, you do the math on actual numbers that remain unreported.

As I said VAERS isn’t the only system used to look for safety signals. V-Safe is another database managed and monitored by the CDC. It’s a voluntary “after vaccination health checker” deployed to collect data on those who got the COVID injection.

The CDC created v-safe, a smartphone-based program, to collect health assessments after Covid-19 vaccination. 

Anyone in the United States can enroll in V-Safe, using their smartphone, after receiving any dose of COVID-19 vaccine. During the first week after each dose, V-Safe will send you a daily text message asking for details on your health and well-being. After that, check-ins are sent out on an intermittent basis. It’s a pretty solid system to detect safety signals. If action is taken on said signal.

Unfortunately as you shall see, the CDC for some reason that is beyond me has been sitting on the mountain of data generated via V-Safe post covid injection and to take it a step further has refused to release the data to the public for review. Luckily ICAN, a non-profit doing tremendous work around transparency in our government successfully sue the CDC and they were forced to provide the data to ICAN. Here is what was discovered.

• Of the 10 million people enrolled in V-Safe, 7.7% (770,000 people) required medical care after getting the shot and 25% (2.5 million people) missed work or school or suffered a serious side effect that affected their day-to-day life.

• The V-Safe data also shows a massive immune reaction signal. Four million people — 40% — reported joint pain. Two million, or 20%, reported “moderate” joint pain and 400,000, 4%, classified the pain as “severe”.

ICAN’s legal team sued the CDC twice leading to a court order requiring release of the data. ICAN has taken the CDC’s official raw data and created a dashboard interface which allows users to graphically view the 10 million health entries obtained by ICAN.

You can access an interactive dashboard created by them via the link below. Truly amazing work on their part. Again they had to sue the CDC twice for this data, an agency we pay for that apparently doesn’t believe in transparency.

https://t.co/1yfV6sLdWP

The question that remains, why would they refuse to release this data we have a right to?

You can view a video by a gentleman named Albert Benavides an RCM expert, data analyst and auditor, i which he provides a tour and overview of how to use the dashboard here:

https://t.co/MwR8K66fI5

It should also be noted the CDC also stopped promoting use of V-Safe around May 2021. Now why would that be? The information that could have been collected beyond May 2021 would have been extremely important to assess safety would it not?

The findings in these databases have never been brought forward during any of the CDC’s Advisory Committee on Immunization Practices (ACIP) meetings or the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings, at which members have repeatedly voted to authorize the jabs to people of all ages, including infants and pregnant women.

The CDC uses a type of analysis known as Proportional Reporting Ratio (PRR)

PRR involves comparing the incidence of a specific adverse event after a specific vaccine to the incidence after all other vaccines. A signal is triggered when three thresholds are met, according to the CDC: a PRR of at least two, a chi-squared statistic of at least four, and three or more cases of the event following receipt of the vaccine being analyzed. Chi-squared tests are a form of statistical analysis used to examine data.

“The results obtained by The Epoch Times via a FOIA request show a CDC analysis was conducted on adverse events reported from Dec. 14, 2020, to July 29, 2022 show that there are hundreds of adverse events (AEs) that meet the definition, including serious conditions such as blood clotting in the lungs, intermenstrual bleeding, a lack of oxygen to the heart, and even death. The high numbers, particularly the chi-squared figures, concerned experts.”

Again why aren’t these results made publicly available? A FOIA process shouldn’t have to be undertaken. For many of the events, “the chi-squared is so high that, from a Bayesian perspective, the probability that the true rate of the AE of the COVID vaccines is not higher than that of the non-COVID vaccines is essentially zero.”

Norman Fenton, a professor of risk management at Queen Mary University of London, told The Epoch Times in an email after running the numbers through a Bayesian model.”

CDC analysis was conducted on adverse events reported from Dec. 14, 2020, to July 29, 2022.

“We know that the signal for myocarditis is associated with something that is caused by the mRNA vaccines, so it’s more than reasonable to say that anything with a signal larger than myocarditis/pericarditis should be taken seriously and investigated.”

Josh Guetzkow, an Israeli professor who trained in statistics at Princeton University and has been studying VAERS data during the pandemic, told The Epoch Times”

https://t.co/CcVtUCCKt8

So next time you are gaslit about the dangers of the vaccines or the unreliable nature of VAERS just know, you’re right to be concerned. Some very powerful interests have been aligned and extremely well funded to make you think all is well in OZ but if you look behind the curtain, the wizard is nothing more than a greedy bureaucrat trying desperately trying to fool you with smoke and mirrors.

Finally, here are the VAERS numbers as of today. Each number represents a human being who has either lost their life or has been disabled having their life turned upside because informed consent was never given properly.

I am not saying everything can be correlated to the injection but where are the CDC and FDA on this? Have they conducted follow up as they are mandated to do on all of the following SAE’s reported?

Have they unequivocally determined that none of the 33K deaths reported are attributable? Well, I think you know the answer to those questions don’t you.