CDC Finally Releases VAERS Safety Monitoring Analyses For COVID Vaccines

Authors: Authored by Professor Josh Guetzkow via Jackanapes Junction  January 9, 2023

  • CDC’s VAERS safety signal analysis based on reports from Dec. 14, 2020 – July 29, 2022 for mRNA COVID-19 vaccines shows clear safety signals for death and a range of highly concerning thrombo-embolic, cardiac, neurological, hemorrhagic, hematological, immune-system and menstrual adverse events (AEs) among U.S. adults.
  • There were 770 different types of adverse events that showed safety signals in ages 18+, of which over 500 (or 2/3) had a larger safety signal than myocarditis/pericarditis.
  • The CDC analysis shows that the number of serious adverse events reported in less than two years for mRNA COVID-19 vaccines is 5.5 times larger than all serious reports for vaccines given to adults in the US since 2009 (~73,000 vs. ~13,000).
  • Twice as many mRNA COVID-19 vaccine reports were classified as serious compared to all other vaccines given to adults (11% vs. 5.5%). This meets the CDC definition of a safety signal.
  • There are 96 safety signals for 12-17 year-olds, which include: myocarditis, pericarditis, Bell’s Palsy, genital ulcerations, high blood pressure and heartrate, menstrual irregularities, cardiac valve incompetencies, pulmonary embolism, cardiac arrhythmias, thromboses, pericardial and pleural effusion, appendicitis and perforated appendix, immune thrombocytopenia, chest pain, increased troponin levels, being in intensive care, and having anticoagulant therapy.
  • There are 66 safety signals for 5-11 year-olds, which include: myocarditis, pericarditis, ventricular dysfunction and cardiac valve incompetencies, pericardial and pleural effusion, chest pain, appendicitis & appendectomies, Kawasaki’s disease, menstrual irregularities, vitiligo, and vaccine breakthrough infection.
  • The safety signals cannot be dismissed as due to “stimulated,” exaggerated, fraudulent or otherwise artificially inflated reporting, nor can they be dismissed due to the huge number of COVID vaccines administered. There are several reasons why, but the simplest one is this: the safety signal analysis does not depend on the number of reports, but whether or not some AEs are reported at a higher rate for these vaccines than for other non-COVID vaccines. Other reasons are discussed in the full post below.
  • In August, 2022, the CDC told the Epoch Times that the results of their safety signal analysis “were generally consistent with EB [Empirical Bayesian] data mining [conducted by the FDA], revealing no additional unexpected safety signals.” So either the FDA’s data mining was consistent with the CDC’s method—meaning they “generally” found the same large number of highly alarming safety signals—or the signals they did find were expected. Or they were lying. We may never know because the FDA has refused to release their data mining results.

INTRODUCTION

Finally! Zachary Stieber at the Epoch Times managed to get the CDC to release the results of its VAERS safety signal monitoring for COVID-19 vaccines, and they paint a very alarming picture (see his reporting and the data files here, or if that is behind a paywall then here). The analyses cover VAERS reports for mRNA COVID vaccines from the period from the vaccine rollout on December 14, 2020 through to the end of July, 2022. The CDC admitted to only having started its safety signal analysis on March 25, 2022 (coincidentally 3 days after a lawyer at Children’s Health Defense wrote to them reminding them about our FOIA request for it).

[UPDATE: T Coddington left a link in comments to a website where he made the data in the Excel files more accessible.]

Like me, you might be wondering why the CDC waited over 15 months before doing its first safety signal analysis of VAERS, despite having said in a document posted to its website that it would begin in early 2021—especially since VAERS is touted as our early warning vaccine safety system. You might also wonder how they could insist all the while that the COVID-19 vaccines are being subjected to the most rigorous safety monitoring the world has ever known. I’ll come back to that later. First I’m going to give a little background information on the analysis they did (which you can skip if you’re up to speed) and then describe what they found.

BACKGROUND ON SAFETY SIGNAL ANALYSIS

Back in June 2022, the CDC replied to a Freedom of Information Act (FOIA) request for the safety signal monitoring of the Vaccine Adverse Events Reporting System (VAERS)—the one it had said it was going to do weekly beginning in early 2021. Their response was: we never did it. Then a little later they said they had been doing it from early on. But by August, 2022, they had finally gotten their story straight, saying that they actually did do it, but only from March 25, 2022 through end of July. You can get up to speed on that here.

The analysis they were supposed to do uses what’s called proportional reporting ratios (PRRs). This is a type of disproportionality analysis commonly used in pharmacovigilance (meaning the monitoring of adverse events after drugs/vaccines go to market). The basic idea of disproportionality analysis is to take a new drug and compare it to one or more existing drugs generally considered safe. We look for disproportionality in the number of adverse events (AEs) reported for a specific AE out of the total number of AEs reported (since we generally don’t know how many people take a given drug). We then compare to existing drugs considered safe to see if there is a higher proportion of particular adverse events reported for the new drug compared to existing ones. (In this case they are looking at vaccines, but they still use PRR even though they generally have a much better sense of how many vaccines were administered.)

There are many ways to do disproportionality analysis. The PRR is one of the oldest. Empirical Bayesian data mining, which was supposed to be done on VAERS by the FDA, is another. The PRR is calculated by taking the number of reports for a given adverse event divided by the total number of events reported for the new vaccine or the total number of reports. It then divides that by the same ratio for one or more existing drugs/vaccines considered safe. Here is a simple formula:

So for example, if half of all adverse events reported for COVID-19 vaccines and the comparator vaccine(s) are for myocarditis, then the PRR is 0.5/0.5 = 1. If one quarter of all AEs for the comparator vaccine are for myocarditis, then the PRR is 0.5/0.25 = 2.

Traditionally, for a PRR to count as a safety signal, the PRR has to be 2 or greater, have a Chi-square value of 4 or greater (meaning it is statistically significant) and there has to be at least 3 events reported for a given AE. (This also means that if there are tons of different AEs reported for COVID vaccines that have never been reported for any other vaccine, it will not count as a safety signal. I found over 6,000 of those in my safety signal analysis from 2021.

Of course a safety signal does not necessarily mean there is a problem or that the vaccine caused the adverse event. But it is supposed to set off alarm bells to prompt closer inspection, as in this CDC pamphlet:

Ah yes, shared with the public — after first refusing to share the results and months of foot-dragging following repeated FOIA requests! We will see that the CDC has not done a more focused study on almost any of adverse events with “new patterns” (AKA safety signals).

SO WHAT DID THE CDC ACTUALLY DO?

The Epoch Times obtained 3 weeks of safety signal analyses from the CDC for VAERS data updated on July 15, 22 and 29, 2022. Here I will focus on the last one, since there is very little difference between them and it is more complete. The safety signal analysis compares adverse events1 reported to VAERS for mRNA COVID-19 vaccines from Dec. 14, 2020 through July 29, 2022 to reports for all non-COVID vaccines from Jan 1, 2009 through July 29, 2022.

PRRs are calculated separately for 5-11 year-olds, 12-15 year-olds and 18+ separately. For each age group, there are separate tables for AEs from all reports, AEs from reports marked serious and AEs from reports not marked as serious.2 Recall that a serious report is one that involves death, a life-threatening event, new or prolonged hospitalization, disability or permanent damage, or a congenital anomaly. I will focus on the reports for all AE’s.

They also have a table that calculates PRRs by comparing reports for the Pfizer COVID-19 vaccine to reports for the Moderna vaccine and vice versa, again for all reports, serious reports only and non-serious reports. There were no remarkable findings in those tables, so I will not discuss them. [Edit: I forgot what Norman Fenton noted in his analysis: the overall proportion of reports with serious adverse events is 9.6% for Modern compared to 12.6% for Pfizer.] This isn’t that surprising since both vaccines are very similar and so should present relatively similar adverse events when compared to each other, and any differences are likely not large enough to be picked up by a PRR analysis. [Though the difference in the overall rate of serious adverse events, which are not specific to a particular type of event only how serious it is, was significant.]

The CDC seems to have calculated PRRs for every different type of adverse event reported for all the COVID vaccines examined – though it’s possible they only analyzed a subset. What seems clear is that, among the AEs they examined, the only ones included in the tables satisfy at least one of two conditions: a PRR value of at least 2 and a Chi-square value of at least 4 (Chi is the Greek letter χ and is pronounced like ‘kai’). When both conditions were met, they highlighted the adverse event in yellow, which appears to indicate a safety signal. There were no COVID vaccine AEs listed with fewer than 3 reported events, though for non-COVID vaccines there were many AEs listed that had only 1 or 2 reported since 2009. The CDC tables still include these and highlight them in yellow when the PRR is greater than 2 and the Chi-square value is great than 4, indicating these events are counted as safety signals.

WHAT SAFETY SIGNALS DID THE CDC FIND?

I’m going to divide this up by age groups and the Pfizer v. Moderna comparison. Let’s start with the 18+ group.

There are 772 AEs that appear on the list. Of these, 770 are marked in yellow and have PRR and Chi-square values that qualify them as safety signals. Some of these are new COVID-19 related codes, and we would expect those to trigger a signal since they didn’t exist in prior years to be reported by other vaccines. So if we take those off, we are left with 758 different types of non-COVID adverse events that showed safety signals.

I grouped these 758 safety signals into different categories. The figure below shows the total number of AEs reported for each of the major categories of safety signals:

Let’s dig into some of these categories to look at what types of AEs generated the most number of reports:3

Let’s dig into some of these categories to look at what types of AEs generated the most number of reports:3

You can peruse the adverse events using the Excel tables provided by the CDC, which were posted by The Epoch Times and Children’s Health Defense at the links at the top of this post.

What about The Children?

If there is anything that looks remotely like a bright spot in all of this is that the list of safety signals for 12-17 and 5-11 year-olds is much shorter than for 18+. There are 96 AEs that qualify as a safety signal for the 12-17 group and 67 for the 5-11. When we take out the new COVID-era AEs, there are 92 safety signals for 12-17 year-olds and 65 for 5-11 year-olds. Here are the most alarming ones:

I don’t know why the list of AE’s is so much shorter for these age groups. It could be that the list of AE’s for other vaccines for these age groups is much shorter, so in a case where AEs have been reported for the mRNA COVID vaccines but not for other vaccines, it will not be counted as a safety signal by definition.

COMPARISONS TO MYOCARDITIS & PERICARDITIS

We are told that the existence of a safety signal doesn’t necessarily mean the AE is caused by the vaccine, and I accept that premise. But the current practice seems to be to ignore safety signals, dismiss them as noise without any evidence, and stall any investigation into them as long as possible. The precautionary principle, however, dictates we should presume that a safety signal indicates causality, until proven otherwise. Since, it has been acknowledged that the mRNA COVID vaccines can cause myocarditis and pericarditis (often referred to as myo-pericarditis), we can take those AEs as a kind of benchmark, and propose that, at minimum, any AE with a signal of equal or greater size should be considered potentially causal and investigated more thoroughly.4

After dropping the new COVID-era AEs, there are 503 AEs with PRRs larger than myocarditis (PRR=3.09) and 552 with PRRs larger than pericarditis (PRR=2.82).5 This means that 66.4% of the AEs had a bigger safety signal than myocarditis and 77.3% were larger than pericarditis. You can see what those were by use this Excel file provided by the CDC and sorting the 18+ tab by the 12/14-07/29 PRR column (Column E). Then just look at which AEs have PRRs larger than the ones for pericarditis and myocarditis.

For 12-17 year-olds, there is 1 safety signal larger than myocarditis (it’s ‘troponin increased’) and 14 safety signals larger than pericarditis (excluding myocarditis), which include: mitral valve incompetence, bell’s palsy, heavy menstrual bleeding, genital ulceration, vaccine breakthrough infection, and a range of indicators of cardiac abnormalities.

For 5-11 year-olds, the comparison to myo/pericarditis is less germane, as they seem to suffer less from this side effect. But we can still make the comparison: there are 7 safety signals larger than pericarditis, including bell’s palsy, left ventricular dysfunction, mitral valve incompetence, and ‘drug ineffective’ (presumably meaning they still got COVID). There are 16 safety signals larger than myocarditis (excluding pericarditis), which in addition to those listed above also include: pericardial effusion, diastolic blood pressure increase, tricuspid valve incompetence, and vitiligo. Sinus tachycardia (high heart rate), appendicitis, and menstrual disorder come in just below myocarditis.

Now if we think of a safety signal as having both strength and clarity, then the PRR can be thought of as an indicator of how strong the signal is, while the Chi-square is a measure of how clear or unambiguous the signal is, because it gives us a sense of how likely the signal is due to chance alone: the larger the Chi-square value, the less likely the signal is due to chance. A Chi-square of 4 means there is only a 5% chance the observed signal is due to chance. A Chi-square of 8 means there is only a 0.5% chance of it being due to chance.6

For the 18+ group, there are 57 AEs with a Chi-square larger than myocarditis (Chi-square=303.8) and 68 with a Chi-square larger than pericarditis (Chi-square=229.5). Again, you can see what these are by going the Excel file linked above and sorting on Column D.

For the 12-17 group, there are 4 AEs with a larger Chi-square than myocarditis (Chi-square=681.5) and 6 larger than pericarditis (Chi-square=175.4).

For the 5-11 group, there are 22 AEs with a Chi-square larger than myocarditis (Chi-square=30.42) and 34 AEs with a Chi-square larger than pericarditis (Chi-square=18.86).

RESPONDING TO OBJECTIONS

Let’s dispense with some of the criticisms used to dismiss VAERS data, which will undoubtedly be raised if you try to bring the CDC’s analysis to people’s attention.

  1. Objection: Anybody can report to VAERS. The reports are unreliable. Anti-vaxxers made lots of fraudulent reports. Nobody was aware of VAERS in the past, but now they are. So many people were afraid of the vaccine so they blamed all their health problems on it. Health workers were required by law to report certain adverse events, like deaths and anaphylaxis. Etc. Etc.All of these objections ultimately rely on the notion that VAERS reports for COVID-19 vaccines have been artificially inflated over previous years for one reason or another. The thing of it is, though, that the CDC has a method for distinguishing between artificial inflation and real signal. The idea is simple: if adverse events are artificially inflated, they should be artificially inflated to the same degree. Meaning, the PRRs for all of these safety signals should be about the same. But even a casual glance at the PRRs in the Excel file show they vary widely, from as low at 2 to as high as 105 for vaccine breakthrough infection or 74 for cerebral thrombosis. This method does not on the number of reports, but the rate of reporting for certain events out of all events reported. If anything, this method would tend to hide safety signals in a situation where a new vaccine generates a very large number of reports.The CDC has even done us the favor of calculating upper and lower confidence intervals, meaning that we can be at least 95% confident that two PRRs are truly different if their confidence intervals don’t overlap. So for example the lower confidence interval for pulmonary thrombosis is 19.7, which is higher than the upper confidence interval for 543 other signals. Artificially inflated reporting cannot explain why so many different adverse events have large PRRs that are statistically distinct from one another.
  2. Objection: The safety signals are due to the huge number of COVID vaccines given out. Never before have we given out so many vaccine doses. By the end of July, the US had administered something like 600 million vaccine doses to people aged 18+. But the CDC analysis compares VAERS reports for these doses to all doses for all other vaccines for this age group since Jan. 1, 2009. But from 2015-2020 there were over 100 million flu doses administered annually to this age group alone. In previous work, I estimated 538 million doses of flu given to people 18+ from July 2015-June 2020. The number of flu and other non-COVID vaccines for this age group administered from Jan 1., 2009 through July 29, 2022 must be well over double this number, meaning VAERS reports for COVID vaccines are being compared to reports for at least double the number of doses for other vaccines. In addition to this, as already noted, the PRR methodology does not depend, strictly speaking, on the number of doses, but rather the rate of reporting of a specific AE out of all AEs for that vaccine.
  3. Objection: the vaccines are mainly being given to older people who tend to have health problems, whereas other vaccines are given to younger people. This objection is dealt with, since the analyses are stratified by age groups. It might be still be somewhat valid for the 18+ group, except that in the safety signal analysis I did in the fall of 2021I stratified by smaller age bands and still found safety signals. In any case, this objection is not enough to dismiss the safety signal analysis out of hand, but rather calls for better and more refined research.
  4. Objection: The VAERS data is not verified and cannot be trusted. I’ll be the first person to agree that VAERS is not high quality data, but if it is completely untrustworthy, then how is it that the CDC uses these data to publish in the best medical journals such as JAMA and The Lancet? If the data were worthless, then these journals shouldn’t accept these papers. In that JAMA paper, they reported that 80% of the myocarditis reports met their definition of myocarditis and were included in the analysis. Many other reports simply needed more details for validation. Furthermore, the CDC has the ability and budget to follow-up on every report VAERS receives to get more details and even medical records to verify the report.So if myocarditis shows a clear signal in the CDC’s analysis, and 80% of those reports were apparently high quality enough to be included in a paper published in one of the world’s top medical journals, how is it possible that all the rest of the reports are junk? That all of the other safety signals are meaningless? Answer: it isn’t.And since we’re on the topic of safety signals that turned out to be real, it’s instructive to find appendicitis turn up as a safety signal in all 3 age groups, since a study published in NEJM based on medical records of over a million adult Israelis found an increased risk of appendicitis in the 42 days following Pfizer vaccination (but not following a positive SARS-CoV-2 PCR test). That study also found an increase in lymphadenopathy (swollen lymph nodes) after vaccination, but not after positive COVID test. Lymphadenopathy was another safety signal.
  5. And that brings us to our last objection to be dispensed with: all of these AEs were due to COVID. There was an epidemic and so people were falling ill due to COVID and having all of these problems that were then blamed on the vaccine. Well to begin with, as we just saw, at least two of them (appendicitis and lymphadenopathy) do not appear to have increased risk ratios following a positive SARS-CoV-2 test, and we know that the mRNA vaccines increase risk of myo/pericarditis independent of infections. So how can we assume the rest of these are and dismiss them with the wave of a hand? We can’t. At minimum, they need further investigation. Furthermore, in the safety signal analysis I did in 2021, I dropped all VAERS reports where any sign of a SARS-CoV-2 exposure or infection was indicated on the report, and I still found large, significant safety signals.

PUTTING IT ALL INTO PERSPECTIVE

The Epoch Times article quotes my esteemed colleague and friend, Norman Fenton, Professor of Risk Management and an world renowned expert in Bayesian statistical analysis: “from a Bayesian perspective, the probability that the true rate of the AE of the COVID-19 vaccines is not higher than that of the non-COVID-19 vaccines is essentially zero…. The onus is on the regulators to come up with some other causal explanation for this difference if they wish to claim that the probability a COVID vaccine AE results in death is not significantly higher than that of other vaccines.” (See his post on the CDC analysis here.) The same is true for all the safety signals they found.

The CDC’s VAERS SOP analysis document lists 18 Adverse Events of Special Interest says they are going to pay close attention to. In their 2021 JAMA paper (and similar presentations to ACIP), the researchers responsible for analyzing the millions of medical records in the CDC’s Vaccine Safety Datalink (VSD) using the ‘Rapid Cycle Analysis’ only studied 23 outcomes. A Similar analysis in NEJM from Israeli researchers focused on only 25 outcomes. Compare this to over 700 safety signals found by the CDC when they finally decided to look—and that’s not even counting all the adverse events that have never been reported for other vaccines so cannot ever show a safety signal by definition. How can the CDC say that these safety signals are meaningless if almost none of them have been studied any further? And yet we are assured that these vaccines have undergone the most intensive safety monitoring effort in history. It’s complete and utter hogwash!

*  *  *

Josh Guetzkow is a senior lecturer at The Hebrew University of Jerusalem. Subscribe to his Substack here.

1) To be precise, the ‘adverse events’ are for ‘preferred terms’ (PTs) which is a type/level of classification used in the Medical Dictionary for Regulatory Activities (MedDRA), which is the classification system used by VAERS and in other pharmacovigilance systems and clinical research for coding reported adverse events. Not all preferred terms are a symptom or adverse event per se. Some refer to a specific diagnostic test that was done or a treatment that was given.

2) It’s not entirely clear how they divided these up, since there are clearly AEs that should be considered serious that don’t show up in the serious Excel table — though maybe they don’t come up simply because they are looking within serious reports. I believe that they just filtered the reports to include only serious reports or non-serious reports, then did the safety signal analysis on all the AE’s coded in those reports. The reason I think this is that I used the MedAlerts Wayback Machine, selected just the serious COVID-19 vaccine reports, and the numbers of total reports was very close to the one in the table provided by the CDC (MedAlerts actually had a bit less). The files obtained by the Epoch Times do not include much in the way of a description as to how the analyses were done, so I had to infer some details, which might be incorrect. I will try to note when I am drawing an inference about how the analysis was done.

3) Generally speaking, these figures show the top ten AEs in each category. In some cases I combined AEs that indicated the same thing, such as combining ‘heart rate irregular’ with ‘arrythmia.’ [UPDATE: Note that the charts of all categories, cardiac and thrombo-embolic events were updated on Jan 7, 2023. The reason is that I had previously categorized acute myocardial infarction as a cardiac issue and myocardial infarction as thrombo-embolic. To be consistent, I have now combined myocardial infarction and acute myocardial infarction into one AE category in the thrombo-embolic events (which made the total AEs reported for that category larger than for pulmonary ones) and then added a different cardiac AE to the cardiovascular AE category, ventricular extrasystoles, AKA premature ventricular contraction (PVC), which dependent on frequency and the presence of other cardiomyopathies is associated with sudden cardiac arrest.]

4) Note that using the myo-pericarditis signal as a yardstick doesn’t mean that these are the only signals that matter. To give one example, anaphylactic reactions don’t even show up in the list of safety signals, even though that was one of the very first risk of the vaccine that became apparent from day one of the vaccine rollout.

One potential objection to this benchmark is that it is too low of a bar, since myo-pericarditis appears to disproportionately affect younger men and so a proper safety signal should be stratified by age and gender then compared with myocarditis similarly stratified. I agree, and it is the CDC’s job to do that. But the fact is that any adverse reaction might disproportionately affect some subgroup of people, in which case the safety signal for that group would be similarly faint or diluted when we look at everyone together. So objection overruled.

5) In their Standard Operation Procedures document, the CDC said they would combine these and related codes together to assess a safety signal, but never mind – at least they finally got around to doing something.

6) In this context, the Chi-square is largely driven by the sheer number of adverse events: the more adverse events reported, including for the comparator vaccine, the larger the Chi-square. For example, the PRR for pericarditis and subdural haematoma is the same (2.82), but there were 1,701 incidents of pericarditis reported for mRNA COVID vaccines versus 221for the comparator vaccines, with Chi-square of 229.5. For subdural haematoma, these numbers are 162 verus 21, for a Chi-square of 21.2.

You’re MORE likely to get Covid again within weeks if you take Pfizer’s Paxlovid drug, early study indicates

  • Covid patients who use Paxlovid are twice as likely to suffer an infection rebound
  • In a study, a third of patients who used the drug had their Covid return 
  • It is yet another setback for the drug President Biden backed in March
  • The CDC warned about these Covid rebounds when reports emerged in May 

Authors: MANSUR SHAHEEN DEPUTY HEALTH EDITOR FOR DAILYMAIL.COM PUBLISHED: 12:32 EST, 17 November 2022

People appear to be more likely to suffer a Covid rebound if they use Pfizer‘s antiviral drug Paxlovid, a study suggests.

In the past few months, President Joe Biden, Dr Anthony Fauci and CDC director Dr Rochelle Walensky have all tested positive again quickly after they stopped taking the drug.

Scientists from Scripps Research Translational Institute in La Jolla, California, compared 127 infected people who used Paxlovid to 43 others who beat the virus without the drug.

They found that 14 per cent of Paxlovid users tested positive for the virus in the weeks after recovering. Meanwhile, only nine per cent tested positive again in the group that didn’t use the antiviral. 

The study was small and the researchers don’t feel confident that the results weren’t chance, but they aim to stand it up in a future trial involving 800 people.

The exact causes of the rebound are unknown, but doctors suspect it is because of the how the drug functions. Rather than killing the virus outright, Paxlovid stop its replication within the body. 

Experts theorize that, having been suppressed by Paxlovid, Covid bounces back when the drug vanishes from the body, leading to high viral levels and potent immune responses that can cause symptoms to reappear. 

Notable examples of the Covid rebounds include President Joe Biden, who suffered a rebound after being infected with the virus in June and receiving Paxlovid

Two of America’s leading health officials, Dr Fauci, the nation’s top infectious disease expert, and Dr Walensky, director of the Centers for Disease Control and Prevention (CDC), were also affected.

The drug was heralded by President Biden as one of the silver bullets to fight the pandemic at his 2022 State of the Union address.

Paxlovid was central to his ‘test to treat’ Covid program launched earlier this year that offered it to Americans who tested positive for the virus at select pharmacies.

It is prescribed as three pills taken twice a day for five days 

The study, which is available in pre-print and still pending peer review, gathered data from 170 patients.

Each of the patients were offered Paxlovid after testing positive for the virus. Among them, 127 accepted to offer while 43 chose not to use the drug.

Patients were also given 12 at-home COVID-19 tests and instructed to test themselves every other day. 

They reported test results and daily symptoms to researchers.

In the weeks following completion of the course, 18 people in the Paxlovid group, or 14 per cent, once again tested positive for the virus.

Another 22, or 19 per cent of the study group, reported that their Covid symptoms had returned but did not record a positive test.

In the control group, only four testes positive again – nine per cent – while three had symptoms return despite negative swabs – or seven per cent.

In total, 33 per cent of Paxlovid users and 16 per cent of non-users experienced either a symptom bounce back or positive test after recovering from virus. 

Dr Michael Charness, chief of staff at the Veterans Affairs Boston Healthcare System, told CNN: ‘There is an indication that symptomatic rebound is more frequent in Paxlovid-treated participants than in untreated controls, but larger numbers are needed to draw confident conclusions.’

This study is another setback for Paxlovid, which was billed as a pandemic ‘game-changer’ when it first hit the market in late 2021.

Clinical trials showed it reduced the likelihood of hospitalization or death caused by the virus 90 per cent. 

Vaccinated people now make majority of COVID deaths in US: Report

Authors: Reported By: IANSNew YorkPublished on: November 24, 2022 INdia

For the first time since the beginning of the pandemic in early 2020, a majority of Americans dying from Covid were at least partially vaccinated, according to the new analysis of federal and state data.

In a startling revelation, a Washington Post analysis has found that more vaccinated people are now dying of the Covid disease and 58 per cent of coronavirus deaths in August in the US “were people who were vaccinated or boosted”.

For the first time since the beginning of the pandemic in early 2020, a majority of Americans dying from Covid were at least partially vaccinated, according to the new analysis of federal and state data.

“In September 2021, vaccinated people made up just 23 per cent of coronavirus fatalities. In January and February this year, it was up to 42 per cent,” the report mentioned.

The death among vaccinated people is increasing due to the waning efficacy of Covid vaccines and “increasingly contagious strains of the virus being spread to elderly and immunocompromised people” among those who have taken at least one vaccine dose.

“We can no longer say this is a pandemic of the unvaccinated,” said Kaiser Family Foundation vice president Cynthia Cox, who conducted the analysis on behalf of the Washington Post.

Outgoing White House Chief Medical Adviser, Anthony Fauci has emphasised the safety and efficacy of the approved Covid vaccines in preventing severe illness and deaths, encouraging people to get vaccinated and boosted as soon as possible.

He said that coronavirus vaccine effectiveness wanes over time and the disease shouldn’t be compared to other vaccine-treatable illnesses because of new emerging variants.

“My message, and my final message, maybe the final message I give you from this podium, is that please, for your own safety, for that of your family, get your updated Covid-19 shot as soon as you’re eligible to protect yourself, your family and your community,” Fauci said.

“I urge you to visit vaccine.gov to find a location where you can easily get an updated vaccine, and please do it as soon as possible.”

Older people were always especially vulnerable and now make up a higher proportion of Covid fatalities than ever before in the pandemic, reports Scientific American.

Today in the US, about 335 people will die from Covid — a disease for which there are highly effective vaccines, treatments and precautions, it added.

“Covid deaths among people age 65 and older more than doubled between April and July this year, rising by 125 per cent,” according to the Kaiser Family Foundation.

The World Health Organization reported a nearly 90 per cent drop in recent Covid-19 deaths globally compared to nine months ago, but still urged vigilance against the pandemic as new variants continue to rise.

Overall, the WHO has reported 629 million cases and 6.5 million deaths linked to the pandemic.

Current state of knowledge on the excretion of mRNA and spike produced by anti-COVID-19 mRNA vaccines; possibility of contamination of the entourage of those vaccinated by these products

Authors: Helene Banoun November 2022 DOI:10.53388/IDR2022112502 Project : Immunology and theory of evolution

Abstract

Abstract The massive COVID-19 vaccination campaign is the first time that mRNA vaccines have been used on a global scale. The mRNA vaccines correspond exactly to the definition of gene therapy of the American and European regulatory agencies. The regulations require excretion studies of these drugs and their products (the translated proteins). These studies have not been done for mRNA vaccines (nor for adenovirus vaccines). There are numerous reports of symptoms and pathologies identical to the adverse effects of mRNA vaccines in unvaccinated persons in contact with freshly vaccinated persons. It is therefore important to review the state of knowledge on the possible excretion of vaccine nanoparticles as well as mRNA and its product, the spike protein. Vaccine mRNA-carrying lipid nanoparticles spread after injection throughout the body according to available animal studies and vaccine mRNA (naked or in nanoparticles or in natural exosomes) is found in the bloodstream as well as vaccine spike in free form or encapsulated in exosomes (shown in human studies). Lipid nanoparticles (or their natural equivalent, exosomes or extracellular vesicles (EVs)) have been shown to be able to be excreted through body fluids (sweat, sputum, breast milk) and to pass the transplacental barrier. These EVs are also able to penetrate by inhalation and through the skin (healthy or injured) as well as orally through breast milk (and why not during sexual intercourse through semen, as this has not been studied). It is urgent to enforce the legislation on gene therapy that applies to mRNA vaccines and to carry out studies on this subject while the generalization of mRNA vaccines is being considered

Another Study Finds Heart Inflammation Higher After Moderna Vaccination Versus Pfizer

Cases of heart inflammation after COVID-19 vaccination were more common among Moderna recipients than those who received Pfizer’s shot, according to a new study.

Canadian researchers analyzed a database and identified 141 cases of myocarditis, a form of heart inflammation, within 21 days of a dose of the Pfizer or Moderna vaccine, both of which utilize messenger RNA (mRNA) technology.

That was compared with an expected number of just 20 cases.

Cases were much higher for young males, as previous studies have found, but were elevated even higher following receipt of a second dose of the Moderna vaccine compared with a second dose of the Pfizer shot.

The incidence, though, was higher after receipt of a third dose of the Pfizer vaccine.

“In this population-based cohort study, observed rates of hospital admissions or emergency department visits for myocarditis after mRNA vaccination for SARS-CoV-2 were higher than expected based on historical background rates, particularly after the second dose, among those who received the mRNA-1273 (Moderna) vaccine, among males and among younger patients (18–29 yr),” Dr. Zaeema Naveed and other researchers with the University of British Columbia and British Columbia Centre for Disease Control wrote.

The paper was published in the Canadian Medical Association Journal on Nov. 21.

Moderna and Pfizer did not respond to requests for comment.

Latest to Find Moderna Higher

Research dating back to mid-2021 shows that the incidence of heart inflammation is higher following a Moderna second dose for young males when compared to a Pfizer second dose.

Both vaccines are recommended as two-dose primary series.

Dr. Anish Koka, a cardiologist based in the United States, said on Twitter that the new study highlights the lack of action by the U.S. Centers for Disease Control and Prevention (CDC), which continues to recommend that young males receive either vaccine.

The rates of Moderna are really much higher for dose 2 in young men,” Dr. Walid Gellad, a professor of medicine at the University of Pittsburgh, said. “I remain perplexed why US never acted on this information, which has been known for a year.”

Some other countries have suspended administration of Moderna’s vaccine—or both vaccines—for young people based on the vaccine side effects and the fact that healthy youth face little risk from COVID-19.

The CDC has also detected more cases of myocarditis (pdf) after receipt of a Moderna second dose in the highest-risk populations, using surveillance data.

U.S. authorities added myocarditis as a possible side effect for both vaccines in 2021, but have not changed their recommendations, which call for virtually all people to receive not only a primary series, but at least one booster shot.

U.S. authorities have said the benefits of the vaccines—primarily protection against severe illness—outweighs the risks.

The Canadian researchers said as much, though their only citation was to a non-peer-reviewed CDC paper from June 2021.

Other studies since then have concluded that the risks outweigh the benefits for one or more populations, particularly young males. The calculus has tilted because of the growing evidence of side effects like myocarditis and the worse performance of the vaccines against the Omicron virus variant and its subvariants, some experts say.

More on New Paper

The Canadian researchers analyzed information from a British Columbia surveillance platform that has data such as laboratory tests and hospital admissions. They examined data from Dec. 15, 2020, to March 10, 2022.

They found that 105 males and 36 females experienced myocarditis and went to a hospital or emergency room within 21 days of a shot.

Approximately 60 percent of the cases happened after a Pfizer jab, but the overall dataset included a higher level of Pfizer administration than Moderna administration.

Researchers calculated an overall rate of 1.37 cases of myocarditis per 100,000 mRNA vaccine doses, above the expected rate of 0.39 cases per 100,000 population. The expected rate was drawn from the incidence of myocarditis in the general population from before the pandemic.

The rates were far higher after a second dose and among young males.

For males aged 18 to 29 after a second dose, the rate was 23 per 100,000 after a Moderna shot and 5.8 per 100,000 after a Pfizer shot.

For males aged 30 to 39 after a second dose, the rate was 7 per 100,000 after a Moderna shot and 1.3 per 100,000 after a Pfizer shot.

COVID-19 Vaccine Triggered Rejection in Lung Transplant Recipients

Authors: The Journal of Heart and Lung Transplant November 18. 2022

Purpose: Anti-severe acute respiratory syndrome corona virus 2 (SARS- CoV-2) vaccination is recommended by AST, ISHLT, and CDC in all transplant recipients. Lung transplant recipients (LTR) are at a higher risk of developing severe symptoms due to higher immunosuppression (IS) an baseline compromised graft function. Limited antibody response to messenger RNA (mRNA) vaccines has been reported in LTR, with the majority mounting a response after the 2nd dose. In this series, 3 patients developed new and significant respiratory compromise after their 2nd vaccine dose consistent with antibody mediated rejection (AMR). To our knowledge, this is the first published case series of vaccine induced rejection in LTR.

Methods: Retrospective chart review of our cohort showed 46% fully vaccinated and an additional 2.5% partially vaccinated patients. Three fully vaccinated patients with approved mRNA vaccines (2 Moderna, 1 Pfizer-BioNTech) were identified after developing severe respiratory compromise post 2nd vaccine dose. Evaluation revealed AMR as the underlying etiology.
Results: All patients were female, ages 50-70 years old, between 6 months and 2 years post-transplant. No previous rejection episodes. All were on standard IS as per institution protocols. Two were hospitalized with hypoxic respiratory failure within 2 weeks of their 2nd vaccine dose. The 3rdwas seen at clinic for milder similar symptoms, later progressing and requiring supplemental oxygen (O2) and hospitalization. Imaging showed new lung infiltrates, infectious work up was negative. Biopsies did not show any cellular rejection. All developed new DSAs and received treatment for AMR with plasmapheresis, IVIg, and Rituximab. Two recovered their lung function and are off supplemental O2, the 3rd did not and is re-listed for transplant.
Conclusion: While LTR have a diminished response to SARS-CoV-2 vac-cines making them more vulnerable to the disease, their immune system’s response may not always be clear. We report three cases of patients developing severe AMR from new DSAs that appear to be triggered by theCOVID-19 vaccine. This vaccine responses should be collected in a data-base where each case can be investigated to help better understand the mechanism behind them and hopefully identifying LTR at risk. This can then be used to modify vaccination strategies and aid in preventing adverse outcomes in this vulnerable group of patients.(1332)First Report of Daratumumab in Clinical Lung Transplantation
P. Jaksch,1 G. Murak€ozy,2 G. Fischer,3 H. Konrad,4 and A.Benazzo.4 1Department of Thoracic Surgery, Medical University Vienna, Vienna, Austria; 2Medical University Vienna, Wien, Austria; 3Departmentof Blood Group Serology and Transfusion Medicine, Medical University Vienna, Vienna, Austria; and the 4Department of Thoracic Surgery,
Medical University Vienna, Vienna, Austria. Purpose: Antibody mediated rejection (AMR) after lung transplantation is difficult to treat and often results in death or graft loss. Therapies targeting antibodies or B cells are in many cases inadequate for decreasing donor specific antibodies (DSA), particularly when they are directed against MHC class II. Daratumumab (DAR) is a humanized anti-CD38 monoclonal antibody, which induces plasma cell death through multiple mechanisms including complement- dependent cytotoxicity, antibody-dependent phago-cytosis, and apoptosis. Based on these properties it may have the potentialto reduce the amount of DSAs and therefore improve outcome after AMR.
Methods: Retrospective analysis of all patients who received daratumumab as an add on rescue therapy for AMR or for desensitization pre/post-
transplant at our center.

Results: Six patients received daratumumab due to the following reasons:5 patients with de novo DSAs and AMR, 1 patient with pre-transplant DSAs and post-transplant immunoadsorption without clinical AMR. Daratumumab was safely administered with just mild infusion reactions and no severe adverse event. Of not, none of the patients developed and infectious complication. Five of the 6 patients showed a significant
decrease of their DSAs with a reduction of MFI values after 6-8 weeks to<50% of the baseline . Despite this early success, four patients developed CLAD (,two of which required transplantation. The remaining two patients stabilized with their lung function and did not develop CLAD.
Conclusion: Treatment for AMR remains challenging, especially in the presence of class II HLA antibodies. Daratumumab might be a promising addition to the AMR treatment panel, prospective clinical studies are needed. (1333)The Normalized Acute Rejection Score in the First Year Post Transplant and Its Association with CLADN. Belousova,1 R. Gabarin,2 A. Vasileva,1 L. Levy,3 R. Ghany,1 E.Huszti,1 A. Roux,4 C. Chow,1 and T. Martinu.1 1University Health Network, Toronto, ON, Canada; 2University of Toronto, Toronto, ON, Canada; 3Tel-Aviv University, Tel-Aviv, Israel; and the 4Foch Hospital, Suresnes, France. Purpose: The Acute Rejection Score (A-score) is a measure of the burdenof acute cellular rejection (ACR) over time in lung transplant (Ltx) recipients which is often incorporated into multivariate analyses assessing LTx outcomes. We aim to assess the correlation between A-score at 6 and 12months post Ltx and chronic lung allograft dysfunction (CLAD).Methods: We performed a retrospective cohort analysis on adult 1st double
LTx recipients from January 2003 to March 2018, with minimum 6 months of follow-up and 1 or more evaluable transbronchial biopsies (TBBX) in the 1st year post Ltx. A-score was calculated at 6 months (approximated as 10 days) and 1 year (400 days) post-LTx as the sum of all ACR histologic A-grades, divided by the number of TBBX up to that time point. AX grade biopsies were excluded from the calculation. CLAD was determined according to 2019 ISHLT guidelines. Kaplan-Meier curves were compared using the Log-Rank test.
Results: Of 828 1st double lung transplants, 31 were excluded with lessthan 6 months of follow-up and 23 had no evaluable biopsies in the first year post Ltx (final n=774). Mean follow-up was 2102 days to graft failure death or retransplant) or last available pulmonary function test. 345patients (45%) developed CLAD. Mean A-score was 0.37 and 0.32 at 210
and 400 days, respectively; median non-zero A-score was 0.5 and 0.4.Kaplan-Meier curves comparing A-score 0 with scores above and below the median were not significantly different (p=0.08 and 0.78 for 210 and400 days) (Figure A,B). Log-rank comparison of only non-zero groups was not significant (p=0.78 and 0.93 at 210 and 400 days).Conclusion: A-score at 210 and 400 days post Ltx, when setting a cutoff atthe median, is not significantly associated with CLAD. Further study withCox proportional hazard modelling of the A-score as a continuous and time-dependent variable will be conducted to assess the impact on the risk of CLAD.(1334)Unilateral vs Bilateral Lower Lobe surveillance Transbronchial Biopsies in Patients with Bilateral LungTransplantPatientsR.Dandeboyina,1 K. Ausloos,2 T. Grazia,2 K. Vandervest,2 and C.Naik.2 1University of Texas Dallas, Dallas, TX; and the 2Baylor University
Medical Center, Dallas, TX.
Abstracts S533

25% Of People Who Received Covid-19 Vaccination Missed Work Or Reported A “Serious Event” Affecting Their Normal Life Functions, According To CDC Data

Authors: NICOLE DOMINIQUE· Oct 5th 2022

Official data from the CDC has been released due to court orders, as stated by lawyer Aaron Siri. The findings show that 25% of people who got the shot (from a database of 10 million) couldn’t perform normal activities and had to miss work or school afterward.

Lawyer Aaron Siri has successfully obtained reports from the CDC after the Informed Consent Action Network sued the organization twice. The court order required the CDC to release crucial information on the vaccine’s safety. The data is gathered from 10 million individuals who utilized the CDC’s “v-safe” program, a smartphone-based tool where recipients of the Covid-19 vaccine can go for health check-ins. The tool allows people to go on their smartphone and provide information on how they’re feeling post-shot. The newly released data is eye-opening. According to the official CDC data shared by Siri, about 1.2 million people were unable to perform regular activities, 1.3 million had to miss work or school, and another 800,000 people required medical care after getting the vaccine. A total of 3,353,110 recipients were negatively impacted by the jab.

Siri appeared on Fox to talk about the lengthy process of attaining the documents. It took 463 days to receive the data, and Siri believes the CDC could have provided the information in a matter of minutes. “Why did it take numerous legal demands, multiple appeals – two lawsuits in fact – before the CDC finally handed over the v-safe data?” Siri asks.

These findings are very concerning; for years, the vaccine was advertised as “safe” and “effective.” Siri said, “A big reason that they pushed the Covid vaccine is [because] they said, ‘look, not everybody is gonna get – you know – seriously injured by Covid, but for many, it’ll prevent them from having symptoms, being hospitalized, missing work.’ Well, now that we have the data, we could see that getting the vaccine caused 25% of people who got the shot – within this data set of 10 million people – to miss work, to have some serious event affecting their normal life functions.

So far, 68.4% of the U.S. population has been fully vaccinated (as stated by Our World in Data). It’s difficult to determine just how many people have been negatively affected by the vaccine since the information on it seems to be suppressed. The CDC has not yet addressed the released documents, and the information is not available on their website. 

COVID jab’s ‘massive,’ ‘unprecedented’ side effects for pregnant women, babies


Adverse events for expectant mothers and developing children are ‘way off the charts.’

Authors:


Authors” Calvin Freiburger Wed Oct 12, 2022

The mRNA-based COVID-19 vaccines by Pfizer and Moderna carry “massive” side effects for pregnant women, according to 42-year OB/GYN Dr. James Thorp.

Thorp appeared on Dr. Drew Pinsky’s show this week to discuss what he has seen from recent studies into the situation (linked at Pinsky’s website), starting with a “massive” increase in miscarriages, as well as increases in fetal malformation, fetal cardiac abnormalities, fetal cardiac arrhythmias, fetal cardiac arrest, and severe placental problems causing inter-uterine growth restrictions, and even vaccine-acquired immunodeficiency syndrome (VAIDS).  “It’s way off the charts,” he said.

The rates of these maladies, he says, are both far beyond how they correlate to previous vaccines as well as the U.S. Centers for Disease Control’s and Food & Drug Administration’s own criteria for “severe danger signals,” according to the studies.

“I suspect the cause of [the VAIDS cases] is because of the thymus gland,” Thorp said. ‘The thymus gland is under the sternum, and it’s massive in the fetus – very tiny in [adults]. But it’s the organ that’s responsible for seeding all of the t-cell clones. And if you look at that Japanese biodistribution data, it also [shows that it] concentrates in the thymus.

“I think there was a four-fold increase in the thymus, but that’s in an adult […] if you look at a newborn thymus it’s probably more like 120-fold because it’s so vascular and lipophilic,” he surmised, “and these children might have lifelong VAIDS because of that insult to the thymus in utero.”

Back in April, Thorp told The Epoch Times that he sees 6,000-7,000 high-risk pregnant patients per year, and has witnessed “many, many, many complications in pregnant women, in moms and in fetuses, in children, offspring […] what I’ve seen in the last two years is unprecedented.”

Many Americans harbor moral reservations about the use of aborted fetal cells in the COVID vaccines’ development, as well as grave concerns about the necessity and safety of the shots given the superiority of natural immunity, COVID’s low risk to most otherwise-healthy individuals, the vaccines’ failure to prevent infection, their accelerated development under former President Donald Trump’s Operation Warp Speed initiative giving them only a fraction of the evaluation and development time vaccines normally take, the lack of transparency from their manufacturers, and mounting evidence of serious adverse effects.

In March, it was found that 11,289 cases of pericarditis/myocarditis after COVID vaccination were reported to the U.S. government’s federal Vaccine Adverse Event Reporting System (VAERS) between January 1 and February 25, which was already 47% of the 24,177 reports for the same submitted in all of 2021. An April study out of Israel indicates that COVID infection alone cannot account for such cases, despite claims to the contrary.

COVID shot defenders claim that VAERS offers an exaggerated view of a vaccine’s potential risks, as anyone can submit a report without vetting it, but the U.S. Centers for Disease Control & Prevention researchers have acknowledged “high verification rate of reports of myocarditis to VAERS after mRNA-based COVID-19 vaccination,” leading to the conclusion that “under-reporting is more likely” than over-reporting.

Further, VAERS is not the only data source indicating cause for concern. Data from the Pentagon’s Defense Medical Epidemiology Database (DMED) has been similarly alarming, showing that 2021 saw drastic spikes in a variety of diagnoses for serious medical issues over the previous five-year average, including hypertension (2,181%), neurological disorders (1,048%), multiple sclerosis (680%), Guillain-Barre syndrome (551%), breast cancer, (487%), female infertility (472%), pulmonary embolism (468%), migraines (452%), ovarian dysfunction (437%), testicular cancer (369%), and tachycardia (302%).

Case Report of a Pro-Vaccine Researcher Suggests mRNA Vaccine Might Worsen Lymphoma Cancer

Authors:  Jim Hoft Published October 15, 2022 TGP

Evidence of unexpected rapid progression of lymphomatous lesions was detected in a man recently diagnosed with angioimmunoblastic T-cell lymphoma (AITL) a rare, often but not always, aggressive (fast-growing) form of peripheral T-cell lymphoma, according to a case report analyzed by six health experts.

Angioimmunoblastic T-cell lymphoma (AITL) is a type of T-cell lymphoma – non-Hodgkin lymphoma that develops from white blood cells called T cells.

Michael Goldman, a Belgian pro-vaccine doctor and a professor at the Free University of Brussels, Belgium specializing in internal medicine and immunology, was diagnosed with lymphoma, a general term for cancers that start in the lymph system.

Goldman and his colleagues published his case report in Frontiers of Medicine last year, titled “Rapid Progression of Angioimmunoblastic T Cell Lymphoma Following BNT162b2 mRNA Vaccine Booster Shot: A Case Report.

From the case report:

“A 66-year-old man with no significant medical history except for hypertension, hypercholesterolemia and type 2 diabetes presented on September 1, 2021 with cervical lymphadenopathies that became recently apparent during a flu-like syndrome. The two doses of BNT162b2 mRNA vaccine had been administered, respectively, 5 and 6 months earlier in the left deltoid. Besides moderate asthenia, he did not report any constitutional symptom. Blood examination indicated a mild inflammatory syndrome, without anemia or white blood cell changes; Lymphocytes immunophenotyping was unremarkable. Protein electrophoresis and immunoglobulin levels were normal and Coombs test was negative.”

On September 22, 2021, Goldman was eager to receive the mRNA vaccine booster dose. As he was about to undergo chemotherapy that would leave him immunocompromised, he was concerned about not being protected enough from Covid-19.

Within a few days of being boosted, Goldman’s cancer symptoms — including night sweats, tiredness, and enlarged lymph nodes — worsened.

He then took another computed tomography (CT) scan. And the results were horrific.

“The pictures showed a brand-new barrage of cancer lesions — so many spots that it looked like someone had set off fireworks inside [Goldman’s] body,” Khamsi described. “More than that, the lesions were now prominent on both sides of the body, with new clusters blooming in [Goldman’s] right armpit in particular, and along the right side of his neck.”

Such cancer progression within three weeks is uncanny given what we know about the natural course of lymphoma, and Goldman needed steroids as soon as possible. Goldman began to suspect that the booster shot had somehow worsened his lymphoma, making his chance of survival for more than five years at only 30%.

Before getting boosted, the lymphoma was only limited to Goldman’s left armpit and neck. Coincidentally, Goldman received his first and second mRNA vaccine dose on the left arm. But Goldman received the booster on the right arm, and the lymphoma began appearing therein.

Newsbreak author Shin Jie Yong, an MSC Biology student reported what he learned from a professor who told him about seven patients with stage IV tumors that were well-controlled for almost five years but suddenly progressed after receiving the Covid-19 vaccination.

He [professor] theorized that vaccination, or any other immune stimulant for that matter, disturbed the delicate balance in the immune surveillance of cancer cells.

Second, lymphadenopathy (swollen lymph nodes) is a common adverse event associated with mRNA vaccines. A nationwide surveillance study from Israel found that the mRNA vaccine (Pfizer-BioNTech) is associated with a 2.4-times increased risk of lymphadenopathy compared to no vaccine, with an excess of 78 cases per 100,000 vaccines.

A meta-analysis of nine studies examining changes in 18F-FDG PET/CT scans after Covid-19 (mainly mRNA) vaccination revealed that 37% of vaccinees developed axillary lymphadenopathy on the same side as the shot due to vaccine-related immune responses. Since such vaccine-related axillary lymphadenopathy is similar to certain cancers, so they may get misdiagnosed as cancer. Patients at risk of cancer spread to axillary lymph nodes — e.g., breast cancer, melanoma, and lymphomas —are thus advised to get vaccinated in the arm opposite to the cancer side.

Third, certain mutations within the lymphomas might make them more sensitive to mRNA vaccines. A 2018 study showed that mice with RHOA G17V and TET2 mutations — which were also present in Goldman’s lymphoma — developed lymphoma upon immunization with sheep red blood cells. And it was the RNA present in the sheep’s red blood cells that was responsible for the immunization. And mRNA is a type of RNA.

Pro-vaccine advocate Michael Goldman, then 66 years old, was challenged whether or not to report the life-threatening adverse event he had after receiving a vaccine, per Shin. In the end, Goldman and his colleagues decided to publish their findings.

A comparison of Goldman’s 18F-FDG PET/CT scans taken before and after he had the mRNA vaccination booster shot is shown below. the black spots, with the exception of the brain, show lymphadenopathies, which are signs of cancer spreading.

The case report suggested that vaccination with the Pfizer mRNA vaccine might induce rapid progression of AITL.

“To the best of our knowledge, this is the first observation suggesting that administration of a SARS-CoV-2 vaccine might induce AITL progression. Several arguments support this possibility. First, the dramatic speed and magnitude of the progression manifested on two 18F-FDG PET-CT performed 22 days apart. Such a rapid evolution would be highly unexpected in the natural course in the disease. Since mRNA vaccination is known to induce enlargement and hypermetabolic activity of draining lymph nodes, it is reasonable to postulate that it was the trigger of the changes observed,” said the experts.

According to a recent study published on the Harvard website, there is a dramatic rise in cancer in people under 50.

“A study by researchers from Brigham and Women’s Hospital reveals that the incidence of early onset cancers — including breast, colon, esophagus, kidney, liver, and pancreas — has dramatically increased around the world.

Florida Surgeon General Recommends Against mRNA COVID-19 Vaccines For Males Aged 18–39

Authors: Mimi Nguyen Ly via The Epoch Times, Ocyobrt 8, 2022

Florida’s Surgeon General, Dr. Joseph A. Ladapo, announced new guidance on messenger RNA (mRNA) vaccines on Friday, specifically recommending against mRNA COVID-19 vaccines for males aged 18 to 39.

Messenger RNA is the technology utilized by both the Pfizer and Moderna COVID-19 vaccines, the most administered vaccines in the United States and a number of other countries.

The new guidance came after the Florida Department of Health carried out an analysis to evaluate vaccine safety, the department said in a bulletin on Friday.

The statewide analysis of vaccinated Florida residents aged 18 years or older (pdf) found an 84 percent increase in the relative incidence of cardiac-related deaths among males aged 18–39, within 28 days of mRNA vaccination.

“Non-mRNA vaccines were not found to have these increased risks,” the Florida Department of Health noted.

Given the high level of global immunity to COVID-19, the benefit of vaccination with mRNA vaccines “is likely outweighed by this abnormally high risk of cardiac-related death among men in this age group,” the department said.

“As such, the State Surgeon General recommends against males aged 18 to 39 from receiving mRNA COVID-19 vaccines,” it said. “Those with preexisting cardiac conditions, such as myocarditis and pericarditis, should take particular caution when making this decision.”

“Far less attention has been paid to safety and the concerns of many individuals have been dismissed—these are important findings that should be communicated to Floridians,” Ladapo said in a statement, referring to the analysis.

In the new guidance (pdf), Florida’s health department said it also “continues to stand by” its guidance for pediatric COVID-19 vaccines it issued in March. That guidance (pdf) recommends against COVID-19 vaccination for healthy children and adolescents aged 5–17. It now also recommends against COVID-19 vaccination among infants and children under five years old.

Statewide Analysis

The analysis from the Florida Health Department that informed Ladapo’s latest recommendation had sought to “evaluate the risks of all-cause and cardiac-related mortality following COVID-19 vaccination.”

Residents in Florida aged 18 years or older who died within 25 weeks of having received a COVID-19 vaccine, since the start of the vaccination roll-out in the state—Dec. 15, 2020—were included. The study end date was June 1, 2022.

People were excluded from the study if they had a documented COVID-19 infection, had a COVID-19 associated death, had received a COVID-19 vaccine booster, or had received their last COVID-19 vaccine after Dec. 8 2021. The last criterion was put in place to make sure that each person was followed up after 25 weeks.

The study found that COVID-19 vaccination “was not associated with an elevated risk for all-cause mortality,” but “was associated with a modestly increased risk for cardiac-related mortality 28 days following vaccination.”

“Results from the stratified analysis for cardiac-related death following vaccination suggests mRNA vaccination may be driving the increased risk in males, especially among males aged 18–39,” according to the analysis.

It also noted that the risk for both all-cause and cardiac-related deaths was “substantially higher 28 days following COVID-19 infection.”

As such, the study concluded that people should weigh the risk associated with mRNA vaccination with the risk associated with COVID-19 infection.

The analysis was a self-controlled case series (SCCS), which is a study design originally developed to evaluate vaccine safety, the department stated. The SCCS method uses individuals as their own control, such that comparisons are made within individuals.

The U.S. Food and Drug Administration’s authorization of the Pfizer-BioNTech and Moderna COVID-19 vaccines for emergency use in 2020 marked the first time it did so for vaccines that use mRNA technology.

According to the FDA, the mRNA vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the distinctive spike protein of the virus. When a person receives the vaccine, their body produces copies of the spike protein which “does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response” against the virus, according to the agency.

The mRNA-based COVID-19 vaccines from Pfizer-BioNTech and from Moderna have both been linked with heart inflammation, including myocarditis and pericarditis, data from around the world have suggested. Younger populations, especially young men, have been observed to experience these conditions at much higher than expected rates, data from the Centers for Disease Control and Prevention (CDC) previously suggested. A small number of deaths from heart inflammation after COVID-19 vaccine have also been reported.

The primary regimens of the vaccines, which are two doses administrated several weeks apart, were insufficient to protect against infection and showed waning efficacy in protecting against hospitalization amid newly-emerging variants. This prompted the governments of many countries to recommend boosters and subsequent boosters throughout the COVID-19 pa