What Do We Know About the Rare COVID-19 Vaccine Complications?

Marshall: So more COVID vaccines have now been distributed in such a short period of time, to such a generalized population, than any time in our history. And yet there's still substantial concern and a substantial amount of information that people are questioning. And perhaps for those who are reluctant to get the vaccine, concern about safety. So the FDA and CDC have a reporting system where some of these events are reported either by themselves or by their doctors. So, what are we seeing from that reporting system?

Marks: Well, I think what we're seeing is robust reporting of adverse events that are occurring. And in some ways that robust reporting is good enough that some are actually even misinterpreting what happens because under the Emergency Use Authorization provisions that are there, there is mandated reporting in some cases, and that is irrespective of whether the event is related or not.

And so a lot of what the public sees from the front-facing part of the Vaccine Adverse Event Reporting System is just a collection of raw data. And then it's our epidemiologists that go and our medical officers that review the data and make sense out of it, in terms of figuring out if there are signals that merit further follow-up.

Marshall: Okay. So what does that data look like? What are you seeing people report and which ones are you following up on?

Marks: So, things that we have followed up on depends on the vaccine, right? So let's talk about the mRNA vaccines. There have been a variety of things that have come up that we've looked into.

Probably the one that has come through that we've continued to look into is that of myocarditis as a signal. Particularly in males ages 16 to 30 as something occurring with somewhat more frequency in those who get the mRNA vaccines than one might expect at baseline. Remember, we're dealing with the fact that there is an elevated incidence of myocarditis because that goes along with COVID-19. But, this is what we're dealing with ...

Marshall: But that population is younger men who aren't as likely to get COVID-19. So, the fact that they're getting myocarditis reported as an adverse event is something that's piqued your interest there?

Marks: Well, it's something that because we have large databases and we have millions of vaccines that have been administered, we're able to use those databases to see whether there's an increased risk. And ... I think that with both of the mRNA vaccines, there has been an increased risk noted, but it's important to caveat that with two things.

First of all, the increased risk, still, even in the group that's at highest risk, those of males in the 16 to 30 age range, the risk is about one in 5,000, roughly, because these aren't hard numbers. But the other piece of that is that there are different kinds of myocarditis. There are certain medical products or even vaccines that are associated with myocarditis that puts one in the hospital, in an ICU.

And then there is this myocarditis, which is occurring, which is a very mild issue, where it's generally been either chest pain and/or ECG changes or troponin levels where within a day people are home if they go to the hospital. And, to the best of CDC's follow-up to date, by and large these cases do not appear to be associated with any lasting effects.

So, from the CDC databases, looking at the Vaccine Adverse Event Reporting System and its other data, it looks like about 98% of the cases that show up are exactly as I've described. It is true that 2% seem to be somewhat more significant, but those are hard to tease out sometimes from other sources of myocarditis.

Marshall: Okay. So that's men with mRNA. What about women? What are you seeing women showing symptoms of with the mRNA vaccine? We know women are more likely to report to VAERS, but what's that data look like?

Marks: So, right now there's not a clear signal. There's a lot of things that people have been concerned about that have been brought up. But so far there's nothing that I would call out here as a particular issue with the mRNA vaccines.

Obviously, if we jump over to the adenoviral vector vaccine or the Johnson & Johnson vaccine, there's this issue of this kind of very unusual, but still striking, thrombosis and thrombocytopenia syndrome, which was seen a number of months ago, more common in 18- to 50-year-old women with this vaccine, still relatively uncommon, a few cases per million.

But something that is of concern because that really is serious, as opposed to myocarditis, which, by and large, has been a mild adverse event. This thrombosis thrombocytopenia syndrome is very significant ... these are serious cases that put people in the hospital and that can result in disability.

So, that is one where we do feel like it's important to warn people, that this is a rare but known complication and that way people can choose their vaccine accordingly.

Marshall: Now, Dr. Marks, that was the one that caused the pause on the J&J vaccine, correct?

Marshall: So the Adverse Event Reporting System has shown for men, they have the myocarditis, and for women and the J&J vaccine, you have the thrombosis. And both of those are considered extremely rare events, correct?

Marks: They're considered, yes, when we say extremely rare, what we're talking about is on the order of about five per million ... in the target age.

There's one other, obviously that I neglected to mention that I probably should have with adenovirus vector vaccine, and that's a somewhat or slightly elevated risk of another very uncommon side effect, which is Guillain-Barré syndrome, which is something that can be seen with other vaccines occasionally. And there is a slight increased risk there, as well. Now, I've kind of told you the group of these that have come up to date.

Marshall: And VAERS is responsible for catching those adverse events, or was this coming out of other medical research?

Marks: So, this is coming out of an overlap of our various safety systems. And that's something that I also want to just leave you with. After all, safety is really important to us for vaccines that are given to healthy individuals, right? Or they're given not just to healthy individuals, they're given to a wide swath of individuals.

Marks: Exactly. So safety is really important. In general, in life, when something's really important, even our own bodies generally have more than one way of doing things. It's redundancy. And so we have redundant safety systems. We have the Vaccine Adverse Event Reporting System that anyone can report to. We have the V-safe text monitoring system that you could opt into to get queried by CDC. We have the Vaccine Safety Datalink, which is more of an active monitoring system for about 14 million people that CDC has. And then we have, the FDA uses large databases, such as the Centers for Medicare and Medicaid Services database.

We also have another confederated database called the BEST, or Biologics Effectiveness Safety System, which is able to look at millions and millions of medical records or claims databases, to see if an adverse event is occurring at a higher frequency. And we're looking and combing that for about 16 different adverse events that are potentially associated with vaccines, so these are overlapping.

Marks: Yeah, that's right. And then of course we don't stop there because we talk with our international colleagues and that's how we actually ... it was very helpful, for instance, with the thrombosis thrombocytopenia syndrome because we had been speaking to international colleagues who had seen something similar with a vaccine that's deployed in Europe and outside of the United States. We were able to be aware that that could happen.

So, I think this global focus also assists us. Lots of overlap and also global dialogue on this. There is barely a week that doesn't go by where we don't have a global safety meeting or safety symposium on these vaccines.

Marshall: So, Doctor, that study I mentioned at the start here in medRxiv, 300 million mRNA vaccines they looked at. All the data and the vast majority of [adverse events] reported were relatively mild, not talking about those extremely rare events that you mentioned earlier. And so, those chills, fever, fatigue, those are things people expect to get from this vaccine. Why are they being reported?

Marks: Because people are allowed to report whatever they'd like, and that's just fine. And we'll sort it all out on the back end because things might be labeled, things might not be labeled, and it's totally fine.

The idea here is it's better to have more under the tent and sort it out than to have somebody who might have some rare adverse event that is real and associated but not report that. So that's, that's the idea here. No one is trying to cover over everything.

By being all inclusive, we're trying to get rid of some of the conspiracy theories and all sorts of craziness that's gone around these vaccine rollouts. That's actually preventing us from getting the population vaccinated in a manner that we really need to see it vaccinated in. There's no conspiracy here. There's no desire to bury adverse events. The idea is to actually find them and do something about them.

Marshall: An important point there. And I want to ask you about it. Because skeptics like to point to the VAERS database as a reason to not get the vaccine. They say, "hey, look, there are all these people that died." So, can you explain why we're seeing that death and what those death numbers are?

Marks: Right. Because these are part of the mandatory reporting. You know, people get vaccines and things happen to them. People get into car accidents. People who are in their 80s, they just pass away from natural causes. And it has to be reported. And so you end up with a database that has deaths in it that we sort through.

And, in fact, when they sort through this they don't find that there is an excess in deaths with the vaccine. Although the people who don't want to get the vaccine are the people who think there's a conspiracy and really like to point at this as the vaccine is causing these things. That's just not the case. And it's hard for some people to see because they're not seeing the back end that we are seeing; they're seeing the front end of all the reporting.

Marshall: Okay. And so some of that front end reporting, as we've said, these numbers are still being crunched, as you mentioned. A recent study from the U.K. found that the AstraZeneca vaccine, which isn't being given here, but a similar one is, the J&J one, actually found a greater risk of developing neurological complications following COVID infection than the vaccine. So, that's really interesting to me because I find that people say, "oh, well, don't get the vaccine because of X, Y, and Z" ... but there's still so much we don't know about the virus itself.

Marks: Right. That's exactly right. And what we do know that's emerging or stuff that really troubles me, like when you start to see studies coming out of Great Britain, that there seems to be long-term effects on the brain in some people, and the fact that we have some people with long COVID, including children, who seem to have long-term side effects that go on for months, where they have either breathing symptoms or heart-related symptoms. That's troubling.

And, so, I think part of this issue is something that we have to deal with as human beings, which is that there is an enormity of this horrible thing of COVID-19 that has taken 700,000 people that were part of families, that were loved, etc. There's that piece. And sometimes rather than actually dealing with what we can do, what we have at hand, a vaccine that can help prevent this and help bring this under control, we focus on things that seem to be peripheral, like small risks, that we can get our hands around. It's kind of like having a major auto accident and namely being concerned about a fingernail when you have multiple broken bones.

We really have kind of lost some of the big picture here that we are very lucky to have a vaccine ... the idea that we have multiple vaccines that are so effective against preventing COVID-19 deaths or hospitalizations, and yet we're still struggling here. It's something that makes me take pause about, you know, what do we need to do differently here?

Marshall: Well, wouldn't some of this reasoning come from the fact that the mRNA ... it's the first time that vaccine has been given in a population, and that perhaps we don't know what the long-term side effects are also from giving that vaccine?

Marks: That's a very reasonable question, but let's just remember that mRNA vaccines have been in clinical investigation for any number of years.

Those people that received these vaccines under these investigative new drug applications were followed and nothing came out of that that was surprising. Also, on first principles, let's just remember that what these mRNA vaccines are, mRNA, which is a relatively labile molecule, which has been stabilized obviously, somewhat, put into a lipid and the product -- it's not like a virus that stays around. It's basically the mRNA gets in, it produces a protein, and that mRNA is degraded and the lipid is metabolized.

And so you get an immune response much the way you get an immune response to other vaccines. Now I can take it that people would be concerned about this and maybe after the first 10, 20, 30, 40, 50 million people, but now we're getting out to a point where we have hundreds of millions of individuals globally who have taken these vaccines.

We have not seen issues. We haven't seen issues in any of the preclinical studies suggesting any adverse events on reproduction, on the integrity of our genomes. And one would not expect that because there's just not a way that these mRNAs can get incorporated into our genomes because we just don't have the right enzymes to make that happen.

And that would be even if you could get them into the nucleus of the cell, because there's a one-way valve that helps prevent that from happening. So there's a lot of things here working against some of the myths that have gotten out there.

Marshall: So, anaphylaxis, for example. If you've had a reaction to a previous vaccine, but you've never received an mRNA vaccine, is that something that people should be worried about?

Marks: That's a great question. Now there we go. There's one that people should be concerned about.

So, if you've had an allergic reaction to a prior vaccine, you need to go to your healthcare provider and have a good discussion about getting one of these vaccines, because there, it could be, really, as they say, about the technicals. It could be that you might have an allergy to one of the contents of one of these vaccines, and you might not want to get one of the vaccines that has a component that you might be allergic to.

On the other hand, what seems to be the case too, is that ... in some cases, people have been able to get these vaccines without any issue, and they've been monitored afterwards. But I do think if you've had a previous allergic reaction to any injected medicine, it's probably a good idea to have a conversation with your healthcare provider.

Marshall: Everything we've talked about so far, Dr. Marks, all the studies we've seen are adults because these vaccines haven't been given in kids. So what should we be watching for now as the vaccination population trends downward in age?

Marks: Yeah, I mean, I think we'll be watching very closely for adverse events of any kind. I think that we've been very careful to look at what we've seen in the clinical trials as they're deployed. We'll be looking to make sure that in the larger population of children that are vaccinated that we don't see anything new. I don't expect that we will, but obviously that's ...

Marks: I don't think we're gonna ... at least with the mRNA vaccines. We will see, we'll continue to see what we saw perhaps in terms of the ... certainly injection site discomfort, the flu-like symptoms, perhaps some fever, but the younger kids, the 5- to 11-year olds, with the Pfizer vaccine, generally had less of that type of reactogenicity, the kind of the flu-like symptoms, than some of the older individuals.

So, we'll just have to see how this goes. And obviously when I say I don't expect, that doesn't mean that we're not looking, because we are. Our job here is to continually look and look for the unexpected because that's what we're trying to do here. We're trying to make sure that we don't miss something that could pop up. I mean, we're not expecting anything, but we will continue to look carefully.

Marshall: Given that people can report to this database anything that they want, you've mentioned some folks were concerned about fertility, and there was a study recently that found there's no evidence a vaccine can cause a miscarriage. But still those questions around fertility percolate.

So, if a parent is looking to get their kid vaccinated and they're hearing these kinds of false narratives, and they're saying, "well, we don't know how long the vaccine trend will go out, of the impact on my child." What do you say to them?

Marks: I think parents -- it's normal to be protective of your child, right? That's a normal thing. I think it's very important to ask your pediatrician, or whoever their healthcare provider is that might be administering the vaccine. Don't hesitate to ask the questions and don't be bashful about asking the ones that you're really concerned about, because sometimes it takes awhile.

And I've heard this from any number of providers. They say, "oh my gosh, it took me half an hour till I finally got to the question that was really making Mrs. Jones really concerned about giving her adolescent the vaccine." And it usually is something like fertility or they think that there might be a tracker or something else in the vaccine.

Those are the things that I think I would just encourage people to ask those questions. There's no evidence whatsoever that these mRNA vaccines will have any effect on fertility or on growth or development, and those were things that were studied. So I think we need to make sure that we answer these questions.

And I also think that it's very important for us to all remain as nonjudgmental as we can when we're answering them. Because, really, people ... when they have some of these questions, it's that they're just trying to do their best by their loved one. And they hear these things on social media or elsewhere, and they're just trying to do their own due diligence.

So we just have to be nonjudgmental. It can be a little exasperating, I know. As somebody who was once a very high-volume care provider, when you have five or six or seven or 10 patients still in the waiting room, it may be hard. But it's just important to be able to answer these questions.

Marshall: An important point, and just one final question for you, Dr. Marks. These multiple systems that you mentioned, how they overlap to help find these adverse rare events. Is that the best we can do or how can it be improved?

Marks: You know, I think we can always improve on things. I think we have a very, very good safety surveillance system. I think hopefully as we move toward the future, if I were to say where I would hope we'll get to would be to have, essentially, a nationally representative integrated safety system. Where we can actually look at safety events from nearly everyone in the country in one fell swoop. That takes a lot of coordinating and it's an aspiration for the future. At the moment, though, I think we're doing a pretty good job by looking at a variety of very large databases and trying to do so in a representative way.

I'm one of the kinds of people who always believes you can always do it better. So that's what I'd say in terms of what I would hope we can do better, but I think what we have now is very good as well.

Side effects from the COVID-19 vaccines -- such as soreness and fever -- are quite common, but the more serious complications are among the top reasons why many may still be hesitant to get vaccinated. Now that hundreds of millions of people have gotten the shots, the FDA and CDC -- through their Vaccine Adverse Event Reporting System (VAERS) -- are getting a clearer picture of how frequently more serious side effects occur.
On this week's episode, Peter Marks, MD, director of the FDA's Center for Biologics Evaluation and Research, joins us to offer insights into the data on adverse events and the questions that still remain.
The following is an abridged transcript of his interview with "Track the Vax" host, Serena Marshall:

Sorry, but 17,000+ deaths for a set of vaccines is not rare.

There are at least 33 previous vaccines, during the purview of the CDC that were pulled where the number of deaths were ORDERS OF MAGNITUDE LESS.

Add to this the fact that less than 5% of actual Deaths and injuries attributable to Vaccines are actually reported to VAERS, and all of the statements in this article to the contrary are very brightly shown to be pure and utter horseshit Propaganda.

I liked this statement from this Pharma-bought-and-sold “doctor”:

“There’s no evidence whatsoever that these mRNA vaccines will have any effect on fertility or on growth or development, and those were things that were studied.” — Yeah, studied for what, six months?

Reminds me of the Clintons: “There’s no evidence __________ (insert whatever they did here) happened.”

WHO adverse event database: Total number of records retrieved for covid-19 vaccine: 2444292

Blood and lymphatic system disorders (99705)
Cardiac disorders (127943)
Congenital, familial and genetic disorders (1394)
Ear and labyrinth disorders (81442)
Endocrine disorders (3659)
Eye disorders (90194)
Gastrointestinal disorders (493951)
General disorders and administration site conditions (1474428)
Hepatobiliary disorders (5086)
Immune system disorders (37076)
Infections and infestations (179420)
Injury, poisoning and procedural complications (122222)
Metabolism and nutrition disorders (54860)
Musculoskeletal and connective tissue disorders (701669)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) (3873)
Nervous system disorders (1042133)
Pregnancy, puerperium and perinatal conditions (5818)
Product issues (3823)
Psychiatric disorders (115750)
Renal and urinary disorders (20032)
Reproductive system and breast disorders (106018)
Respiratory, thoracic and mediastinal disorders (260792)
Skin and subcutaneous tissue disorders (334647)
Vascular disorders (132036)

Age
Age group Count
0 - 27 days 355 0
28 days to 23 months 1461
2 - 11 years 1750
12 - 17 years 38396
18 - 44 years 968111
45 - 64 years 754768
65 - 74 years 231001
≥ 75 years 155297
Unknown 293153

http://vigiaccess.org/

Big pharma and FAuci/etal are making millions off this stuff.

Reminds me of my primary doctor telling me not to take advil/tylenol/naproxin, or my controversial OTC herbal pain relief. And I asked the doc what I should take for pain. Her answer: hydrocontin.

Wrong. I was addicted to hydro. She makes her money off this kind of stuff, not my OTC herb.

"16 to 30 age range, the risk is about one in 5,000"

If there are 40 million people in that age group (there are probably more), the risk of dying from Covid is about one in 8,700. (There are about 4,500 Covid deaths in that group.) And he is just talking about ONE of the adverse effects. If you add in all the others, the vaccines might adversely effect as many as one in 3,000, if not more, approximately triple the risk of death by Covid.

“We know they’re not rare”

^ THIS ^

A few weeks ago I was with 3 other church friends at our monthly small group meeting and of the four of us TWO had been negatively effected by covid shot side effects.

1) they aren’t that rare, and 2) there is no vaccine as those take 10 YEARS on average to develop and these things took 9 months (aka 111 months short of average). Democrats lie, obviously, and they also cheat. They did it again just this week too and now we know how. I read an article over at 100percentfedup with the details, “NJ ELECTION UPDATE: 56 Voting Machines Were Shut Down, Shipped To Warehouse On Election Night In Dem Stronghold County Where Gov Murphy Got Over 113K Votes”, so give that a look. They also cheated in Virginia but the voter turnout on the Right was larger than they expected so their attempt failed there. Every piece of info the left and MSM give on covid is a lie, including the 6 foot thing (as the virus spreads 30 meters, or 99 feet) and he cloth being magical thing too (smoke particles are larger than ANY virus and those go right through cloth.

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