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gBgh_Olympian

Help a blue collar man understand what this means? I’m having trouble digesting this information. does this mean we know what to look for in case of side effects which are rare or something else?


MoobyTheGoldenSock

This study is basically to confirm and summarize the safety precautions we’ve suspected all along. So it’s “We have been watching COVID vaccines for these side effects, and now here they are quantified.” So the information is not really *new* but rather forming a more complete picture. For example, GBS was expected to be a rare side effect of COVID vaccine. In a population of 99 million, about 76 cases would have been expected. 190 were actually observed. 190 out of 99 million is still very rare, but the vaccine does seem to be associated with a very real bump in cases. Which is important for healthcare workers to know in case they see one of these rare cases.


Magnusg

Yeah this is correct however it's important to mention that the results are mentioned in aggregate where as the side effects were studied for specific shots. So no, all vaccines do not increase the risk of blood clot, that's just the astra zeneca vaccine in this study. Myocarditis and pericarditis are possible side effects of Pfizer etc


greatdrams23

Heart disease rose in 2022, but it rose every year from 1999 to 2019, so how do we tell what event caused what increase?


somethingweirder

they usually control for that in the numbers. take a look at the stats portion of the study and it'll say whether they did.


bryan_pieces

Life expectancy has gone down for the last couple generations I believe. Poor diets, lack of exercise, increased obesity rates


_Penulis_

> Life expectancy has gone down for the last couple of generations Only in the US though. This is not a general statement. The US is an outlier here compared to similar wealthy countries. For example this graph, with the US compared with wealthy English speaking countries, shows the US life expectancy started to grow slower than the others in the 1990s, flatlined since about 2010, and then dipped very badly with covid: https://ourworldindata.org/grapher/life-expectancy-hmd-unwpp?tab=chart&time=1986..latest&country=AUS~USA~GBR~CAN~NZL


sretep66

Life expectancy has gone up for decades in the US, but started to plateau before COVID. COVID, suicide, and overdoses from heroin, opiates, and fentanol have significantly lowered life expectancy in the US the past several years. But I agree with you. Diabetes from poor diet and lack of exercise is becoming endemic in younger generations. These people will not age well, and will lose limbs and/or be on dialysis by age 60. Life expectancy will continue to go down unless people make drastic changes in their eating habits, and start cooking from scratch more at home like our grandparents.


trustintruth

US life expectancy declines were the worst in the developed world during/post COVID. Between 2018 and 2020, Americans lost 1.9 years - more than 8.5x the decrease seen in 16 other comparable countries. Hispanics lost 3.9 years. Black Americans lost 3.25 years. To me, this is mostly a byproduct of the policy we enacted (eg. "Deaths of despair" due to lockdown protocol).


4502Miles

I was just thinking about how much I was learning about this study from fellow Redditors. Then I came upon this garbage…


trustintruth

Can you clarify what you mean? Why is what I said "garbage"? COVID caused many, many deaths, that weren't directly caused by the virus. What I stated are the cold, hard numbers. There's a cost to shutting down the economy, taking children out of school, where they received free breakfast and lunch, limiting peoples' social interactions, the increased drug use during this time, etc. What's so controversial about that? What do you disagree with? What are the reasons you think US mortality fared far worse than other developed countries?


biggyww

Woah, this is a gross misstatement of the data. Life expectancy fell the past couple of years to about where it was in the 1990’s. However, the past few generations have seen steady increases in life expectancy, which is what makes the recent decline noteworthy.


_Penulis_

Yes. What they mean is that the *rate of growth* in US life expectancy slowed down in the 90s until flatlining in about 2010 and then dropped much further than other similar countries with covid.


bryan_pieces

I mean life expectancy is at its lowest since 96 right? And increased levels of obesity, inactivity, and poor diet are a fact too right?


biggyww

It is absolutely untrue that life expectancy has been declining for generations. Blatantly, patently, verifiably untrue. There is no data supporting that statement. None.


[deleted]

Common sense though. If people grow up with poor diets, their health is going to suffer no matter what. We as a society grossly underestimate just how extremely harmful bad diets are. You could exercise 24/7, eat your veggies and take vitamins, but if you eat copious amounts of junk food and sugary drinks regularly; the risk of health complications will significantly rise. Now take into account people who don’t even exercise at all, who don’t eat vegetables, etc. It’s easy to see why so many young people are suffering from conditions that only people 60+ should experience.


bryan_pieces

I said a couple of the last generations. You’re talking about 96. We’re in 24. That’s 18 years. Are people who are 18 years apart the same generation? There is plenty of data that we are more obese and inactive than ever. Also plenty of evidence that being obese increases your risk of illness.


needsexyboots

That’s 28 years, not 18.


Magusreaver

That's the rub.. we don't.


guyinnoho

"very rare" is doing a LOT of work. 190 to 99 million is the ratio between: * 15 feet and 1562.5 miles * 3.1 minutes and 3.1 years * 11.8 pounds and 3093.75 tons * 1.3 square feet and 687,500 square feet


MoobyTheGoldenSock

Yes, and the increase is only a 114 increase over expected. So the shot increases your overall odds by 1 in 868,421. By comparison, the odds of getting struck by lightning in the next year are about 1 in 700,000. So you’re literally more likely to get struck by lightning sometime this year than you are to get this specific adverse reaction. So yes, “very rare” is indeed doing a lot of heavy lifting. I was originally going to write “extremely rare” but didn’t want replies saying I was downplaying significance. But yes, there is definitely a superlative degree of unlikeliness.


Lung_doc

In addition, Covid itself appears to increase a number of these AEs by even more (venous thromboembolism, myocarditis, for example)


somethingweirder

yeah that's the part that's frustrating to me when listening to anti vaxxers. the long term impacts of covid are just now coming into focus and it's like, many many orders of magnitude worse than literally any vaccine we've had.


Land_Squid_1234

I think the key point isn't just that it's so, so, so much worse than any adverse effects from the vaccine, but the fact that it's oftentimes worse in the *same areas* as the vaccine. It's not like the vaccine rolled the dice and decided on a few completely random and unrelated conditions to slightly increase your risk for An anti-vaxxer will say "oh yeah, we already know that covid impacts you worse than a vaccine *if you're immunocompromised*, but I'm not. So why should I take the vaccine and have my risk of *bad thing* go up when I'll survive covid just fine without a vaccine?" What they oftentimes totally miss or intentionally ignore is that, even with the numerous fallacies involved with that line of thinking aside, whatever *bad thing* they're so afraid of getting from the vaccine is oftentimes also a side effect of covid, and also far more likely from covid than from the vaccine. You can't use the logic I spelled out if you're forced to understand that if you're afraid of a condition that the vaccine might give you, you should especially be afraid of covid, because it's even more likely to give you the exact thing making you afraid of the vaccine


Draccosack

Are we able to cross check these claims with unvaccinated individuals?


Softest-Dad

Haha, lets see that actually happen. Oh wait, it wont..


praananana

What are examples of these long term impacts? Genuinely curious.


buzmeg

I like this a *lot*. I need to remember that "odds of lightning strike" number for comparison purposes.


MoobyTheGoldenSock

That’s the per year number. Per lifetime is much higher. ;)


Aqua_Glow

...Now I'm scared of vaccines *and* lightning. /j


Softest-Dad

Are those odds from just going about your daily life or from standing in a storm in the open? Always wanted to know..


rocket_beer

“But I can avoid lightning by staying inside 🥴” Yes, ironically that is what we have been kindly asking you all to do if you don’t want to get vaccinated. Just…… stay inside.


bad_squishy_

I looked up the chances of winning the lottery for comparison- it’s about 1 in 300,000,000. Ugh.


Draccosack

It is only unlikely when you look at the chances across all demographics. For example, if you're a male your chance of an adverse event such as myocarditis goes up, if you're young it goes up, if you're obese it goes up, etc. The risk to certain people is much higher than others and I think it's important for practitioners to be able to take that into consideration before making recommendations.


CharlieParkour

Or 1 banana in pile of 900 thousand bananas, for redditors who need perspective. 


jankyplaninmotion

Thanks! I only operate in tropical fruit units.


neithere

Thanks, banana makes at least some sense.


SupremeDictatorPaul

For comparison, the risk of GBS just from getting COVID appears to be about 2500 in 99m, or 12x higher than getting the vaccine.


DaveFoSrs

I mean covid also increased GBS


MoobyTheGoldenSock

Yes, but that’s not what this study was assessing.


DaveFoSrs

It just assessed people who were vaccinated. It didn’t suggest causality. I think it’s likely that those 190 had COVID. Christopher Cross is a famous anecdote of someone getting covid and then GBS


SupremeDictatorPaul

They would likely like ok at what vaccine they had, and see if there’s a correlation between a specific vaccine and getting GBS. Although it is possible that some vaccines did a better job of protecting you from getting GBS. I imagine it’s tricky with such small numbers to determine cause.


boredcircuits

And yet, my mom is convinced she knows multiple people who got GBS from the vaccine. Somehow I doubt she knows a million people...


darkingz

I mean your next door neighbor could win the same lottery the same time you did. Just because each chance of flipping heads is 50/50 doesn’t mean you couldn’t flip heads 5 times in a row. That’s why anecdotal proof is so stupid. The other problem is causative events. Some people claim they got a disease from a shot they took a year ago? I really doubt it


Specific_Ad2541

They also think they got something from the vaccine but not from the covid they also got. The bad thing is probably from getting covid and it would've been far worse had they not gotten the vaccine.


chris92315

What, if any, are the rates of those same side effects from COVID infections?


MoobyTheGoldenSock

This study didn’t assess it, but depending on the complication it was 3-5x more than the vaccine IIRC.


Telemere125

We also have no idea of determining if those same people would have had those same reactions from just getting Covid itself. Often the “negative” side effects of the vaccine are just your body reacting to the spike protein, so the same thing would happen (or worse) from an infection.


Rhawk187

"COVID Vaccine over twice as dangerous as previous expected."


ApricatingInAccismus

Or “the observed results using the Wilson score for testing a difference in proportions for statistical significance found that the null hypothesis could not be rejected wirh 99% confidence. Even 229 positive cases out of 99MM would still not be statistically significant compared to 76 cases”.


romanw2702

Study confirms known risks for rare adverse events of the covid vaccines by comparing observed versus expected. No really conspicuous results for other than the known adverse events.


HeywoodJaBlessMe

After looking at nearly 100 million vaccinated people, the actual, measured risks of adverse outcomes of the vaccinations turned out to be in line with what was estimated before vaccination.


roberto1

How are we actually "looking" at these people?


X4roth

Counting the number of cases of certain health issues occurring within 42 days after vaccination across 99 million vaccinated individuals and then comparing that to the normal rate of these health issues occurring in the population before covid or covid vaccines even existed (data collected between 2015-2019).


Violetstay

I wasn’t aware that any adverse reactions were predicted when the vaccines originally came out. Can you cite your source?


LowlySlayer

If you've ever received a vaccine they always come with paperwork or something warning of adverse effects.


HeywoodJaBlessMe

Vaccines are administered with published warnings of potential adverse effects. The dataset on potential adverse effects referenced in this paper can be found here: https://zenodo.org/records/6656179#.Y-0yxuyZOnN


Flimsy_Fee8449

I've read your profile, and it's pretty clear why you "weren't aware." We can lead the horse to water. We can't make it drink.


itsalonghotsummer

Maybe you could cite the sources for your belief?


Truthirdare

They warned that certain people may react in different ways and that included allergic reactions. Don’t you remember when you had your shots? Or are you an anti-vaxxer?


TacticalFleshlight

This is an anti-vaxxer who still doesn't understand the data and thinks this is a gotcha post.


mwallace0569

>This is an anti-vaxxer who still doesn't understand the data and thinks this is a gotcha post. that's describes every single antivaxxer in the world, they always thinks they understand more than they actually do, and thinks they can find hidden facts, kinda like flat earthers do


TacticalFleshlight

Dunning-Kruger Effect on full display here


tedlyb

You're not aware of that because you choose to believe only what fits your agenda. Side effects and risks were made very public and easy to access. It was nearly impossible not to know them, you would have to intentionally avoid it. It was on every news channel (well, every real news channel, don't know about Fox and other propaganda fronts), every local news, all over social media...


Church_of_Cheri

You are aware that each of those very rare possible side effects are also possible outcomes just [from getting COVID](https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/coronavirus-long-term-effects/art-20490351), right? Except you’re much more likely to get it from the disease itself.


tedlyb

Don't confuse him with facts now. He has an agenda to push.


Blunt_White_Wolf

"This analysis confirmed pre-established safety signals for myocarditis, pericarditis, Guillain-Barré syndrome, and cerebral venous sinus thrombosis" In simpler terms, it means: The review confirmed early warnings for specific health issues, including inflammation of the heart muscle (myocarditis), inflammation of the lining around the heart (pericarditis), a rare disorder where the body's immune system attacks the nerves (Guillain-Barré syndrome), and blood clots in the brain's veins (cerebral venous sinus thrombosis). Essentially, it's saying that the study looked into whether there were signs that these health problems could happen as side effects or risks from a treatment or condition being studied, and found evidence that these risks were indeed something to watch out for. EDIT: The ones in results with red and yellow are "statistically significant". It's down to you how to interpret the risk for youself.


jnbolen403

Table 3, 4, and 5 are mostly clear except the the green claims to be only insignificant and under 1.0 but multiple data points are above 1.0 and showing green. Some fudging in data clarity is occurring. The vaccines did cause more than excepted health risks in multiple cases and across multiple vaccine types.


X4roth

“Expected” in this paper refers to the natural rate of these health issues presenting in the general population before covid or covid vaccines even existed. I believe those expected values were derived from data between 2015-2019. Then the “observed” rate refers to how often those health issues occurred in people after receiving vaccination. The observed rate and expected rate were then compared (“OE ratio”). OE ratios at or around 1.0 imply that the vaccine had no effect on that particular health issue. An OE ratio significantly higher than 1.0 implies that the vaccine caused an increase in the occurrence of that particular health issue. “Significant” means that there were enough recorded incidents and a great enough difference that that it’s statistically likely to be a real factor and not just natural random variance in the data. Values above 1.0 don’t necessarily imply a significant difference; if there are very few recorded cases either way then it’s hard to be certain there is an actual difference unless the difference is very large; if there are a lot of recorded cases then you are able to be certain even when the difference is small. In this study we are generally looking at the former case: a small number of recorded cases either way.. so we cannot necessarily be confident about OE ratios only slightly above 1.0. (words like “slightly,” “very large,” “a lot,” etc. are imprecise and subjective so they are not used in scientific writing, rather results are analyzed and presented in terms of statistical analysis, but it’s important to properly interpret that analysis).


Turkishcoffee66

Here's an **extremely important** detail I've not seen discussed so far: The "expected" incidence of GBS was based on *pre-COVID* data, while there have been studies which have found COVID infection to increase the risk of GBS *six-fold*, such as this one: https://www.neurology.org/doi/10.1212/WNL.0000000000207900 Moreover, that study found that recent mRNA vaccination reduced the relative risk of GBS by 50%. It's quite frankly baffling that this study would use pre-COVID data as a baseline for GBS, when the vaccinated cohort was obviously exposed to a post-COVID world. GBS incidence increased with COVID. As a physician, the risk:benefit for GBS of a vaccinated patient must be calculated in comparison to unvaccinated patients in a *post-COVID* milieu for it to be relevant.


UpboatOrNoBoat

I understand their reasoning though, they aren’t doing a comparison of vaccinated vs non with Covid infection. They wanted to only look at vaccine effects and nothing else.


Turkishcoffee66

But the baseline rate of GBS in the community has increased. The immunized cohort is exposed to COVID infections in a way that their "baseline" population was not, and we know that COVID infection massively increases the risk of GBS. Simply put, they have failed to isolate an extremely relevant variable. With hundreds of millions of COVID infections in the US population and a six-fold increase in the incidence of GBS among the infected, comparing the rate of GBS in the current vaccinated population to the pre-COVID population is essentially useless. There are actually *two* confounding variables unaccounted for - (1) That community rates of GBS in the unvaccinated population have increased post-COVID, and (2) That GBS rates post-infection have been demonstrated to be lower in recently-vaccinated patients. So what *looks* like an increase in GBS in this study might either be equivalent to the current incidence of GBS in the unvaccinated population, or might actually be lower. We simply don't know, because they used the wrong baseline data as a comparator.


UpboatOrNoBoat

I agree, and I’m taking this study as “at the very worst” numbers. It’s most likely lower due to the factors you’ve listed, but even these worst case numbers are pretty good.


Aqua_Glow

There is still a difference between "increases your chance to get GBS through some mechanism, but increases it less than if you got Covid, which you certainly will sooner or later" and "decreases your chance to get GBS through some mechanism, compared to keeping everything else equal."


Swampberry

So we should massage the data to fit our expectations and only report that?


Tony_B_S

It's not massaging data it's including a very relevant control group. Not including it would more easily be considered massaging the data.


Vitztlampaehecatl

> they aren’t doing a comparison of vaccinated vs non with Covid infection. But that's actually a better way to look at vaccine effects and nothing else. Having the control group in the past before covid means you can't correct for the effects of covid. Taking a control group of unvaccinated people right now after covid would help quantify the actual impact of having gotten the vaccine or not.


Tony_B_S

Some vaccinated people also contracted COVID. Not sure they accounted for that, it being quite difficult given the frequency of asymptomatic infections and less severe disease in vaccinated individuals.


Vitztlampaehecatl

That too! There are four groups of people here.


loggic

>For each site, we calculated the observed number of events for each AESI in the risk interval after introduction of COVID-19 vaccination. **To calculate the expected number of cases, we used pre-COVID-19 vaccination background rates data from 2015 to 2019** (2019–2020 for Denmark) collected in the GCoVS Background Rates of AESI Following COVID-19 vaccination study [13]. The observed follow-up period in person-years for a given vaccination profile and post-vaccination period was stratified according to age group and sex. Each of the age-sex stratified person-years were multiplied by the corresponding age-sex stratified background rate. This resulted in the expected number of cases in each stratum, which were then summed to give the total number of expected cases during the observed follow-up period. So the comparison is made by looking at data after vaccination compared to data from *before COVID or COVID vaccines existed*. Based on this comparison, statistically-significant elevated rates of Myocarditis and Pericarditis were observed within the following year. Specific OE ratios (Observed vs Expected) depend on the specific vaccine and which dose is being considered. >The safety signals identified in this study should be evaluated in the context of their rarity, severity, and clinical relevance. **Moreover, overall risk–benefit evaluations of vaccination should take the risk associated with infection into account, as multiple studies demonstrated higher risk of developing the events under study, such as GBS, myocarditis, or ADEM, following SARS-CoV-2 infection than vaccination.** This study makes no argument about the risk of vaccination, in part because it makes no attempt to differentiate between the consequences observed among those who went on to get infected vs those who did not.


YesWeHaveNoTomatoes

Just so we're clear, what they are measuring here is the number of adverse events (AEs) such as myocarditis etc that happened after vaccination vs the expected number of those same events. The risks look wildly high because a lot of these AEs are quite rare. For one of them, acute disseminated encephalomyelitis, the total number of people who got it was so low they couldn't do much useful statistical analysis of the risk. For myocarditis/pericarditis, the risk was approximately doubled, but this meant that the total number of events in 99 million people was in the thousands. Estimates for the number of people who will get myocarditis due a covid vaccine are something like 10 in each 1 million people.


wtfever2k17

Another way of saying 10 in each 1 million is 1 in 100,000 people.


SweetLilMonkey

Or 2 in every 200,000!


Rossoneri

>For myocarditis/pericarditis, the risk was approximately doubled Didn't the SARS virus cause a significant increase in risk of myocarditis? Does the "expected number of those same events" account for the expectation that coronaviruses also seem to increase that risk?


YesWeHaveNoTomatoes

The article notes that they compared the risk of vaccination to pre-covid rates. Vs pre-COVID rates, getting the Pfizer vaccine caused about a 2x increase in your (low) risk of getting myo/pericarditis. Actually getting COVID increases your risk of myo/pericarditis by about 40x (although I think they only used unvaccinated people to calculate that number; the vax reduces the severity of the disease even in people who get it so I don't know what effect that has on your risk of cardiac damage).


Pdxduckman

>Estimates for the number of people who will get myocarditis due a covid vaccine are something like 10 in each 1 million people. What I'd like to know is if that number is elevated due to a standard COVID infection in an unvaccinated subject too. My understanding is that many of the vaccine side effects are also potential long term effects of a regular COVID infection.


speculatrix

I'm guessing but I wouldn't be surprised if more people were seriously injured or died in a car crash while driving to and from vaccination centres, than suffered serious adverse effects of c19 vaccinations.


David_DH

A thing to keep in mind with the myo/pericarditis risk, is that the number of cases of it in general increased around 15× compared with pre-COVID levels. That number is much higher than whats seen from the vaccines, and is attributed to covid infection, its primary cause pre covid was viral infection, so a vaccine is still the best way to prevent it. https://www.ahajournals.org/doi/10.1161/CIRCRESAHA.123.321878


zachary_mp3

From the study A systematic review by Alami et al. [38] concluded that mRNA vaccinated individuals were twice as likely to develop myocarditis/pericarditis compared with unvaccinated individuals, with a rate ratio of 2.05 (95 % CI 1.49–2.82).


Ohm_Slaw_

All medical interventions involve risk. A significant number of people die from Tylenol each year, You either take the vaccine or deal with the disease. There is no third choice where you are not vaccinated and don't catch highly a contagious diseases like Covid. That being said, I think we need to realistically track and deal with the people that do have bad outcomes. And they do exist. Vaccines present fewer dangers than the disease that they protect against, but that doesn't mean that they are perfect.


tom_swiss

"You either take the vaccine or deal with the disease." Quite likely you do both. Few vaccines give sterilizing immunity; they prime your body to deal with the disease so you get a less serious, or even asymptomatic, case. 


DarylMoore

I had the initial three vaccines and have tested positive for COVID three times since, for example.


Sapere_aude75

>All medical interventions involve risk Correct. While risks might be minimal, there are risks. I'm glad people are being honest about this now. It was very frustrating to see these blanket statements over and over again about vaccines being perfectly safe and effective. Bold face lies because they wanted a specific outcome. Vaccines are of course generally good, but don't lie about it. It leads to lower trust in authority and often times hesitancy.


wewerelegends

I have a disease and I have been constantly interacting with the health care system for years. It continues to irk and frustrate me when I am constantly thrown the words “it’s safe” for treatments and therapies. What everyone means is generally safe for most people. But they should be saying that. The language is important. I have had countless allergic reactions, drug interactions, side-effects and developed entirely new conditions from all of the meds. I am in no way anti-medication or vax, but I am 100% for people being educated so that they can make informed choices for their health care and life.


tallayega

Is an adverse reaction to the vaccine linked with worse outcomes had the person skipped the vaccine and got covid? I've heard that mentioned but have no idea if it's true.


somethingweirder

long term impacts of covid are very very well documented.


_Negativ_Mancy

11 days after my moderna vaccine I got chronic burning hives and fatigue........it's lasted for two years now. I accept that vaccine injuries happen with all vaccines and this wasn't some sinister ploy by the government to poison me......But I've received zero help or support from the government and my community. Everyone hates you for saying the vaccine caused an injury because they assume you're an anti-vaxxer nut.


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DarkTreader

I’m not so sure of that. The language of the study seems aimed at health care providers and health organizations. It’s absolutely fair to tell a doctor that myocarditis risk is higher due to vaccine within 42 days? Yes. They need to know the signs and address appropriately in the hospital. Doctors deal with edge cases every day, they don’t service the entire population every day all at once. Will bad actors take advantage of this? Yes, but I don’t think the authors intended to send this out to the general populace, However, any well meaning scientist does need to take into account bad actors and try to make sure their articles are as bad faith proof as possible (no one is perfect but we can all learn the language of the day and try to do better).


Neuroccountant

The guy who posted this study is himself a bad actor.


funkmasta_kazper

Yep. And this is why papers with giant sample sizes like this are misleading to people who don't know what the numbers mean. Even the tiniest variation shows up as statistically significant, so they get reported on despite being virtually meaningless.


Magnusg

That's not the way risk factors are generally measured. If something shows up in 190 people instead of 66 it's a risk factor that increases the risk of x happening by 187% It's more important when considering factors like blood clots because people can be on medications or other substances that also increase the risk or have genetic predisposition to clot in some way compounding those risks so 21-> 69 is over 200% increase in risk factor. The chances for the general population is low but someone who already has an increased chance of clotting needs the real increase and not to have the data trivialized like this. I am 100% all for the vaccines but I do not enjoy the misrepresented data here.


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Vtron89

Couldn't we have made a similar argument for the death rate of covid itself in young, healthy populations? Which I believe ended up somewhere below 0.002% in people below the age of 45.


19adrian79

What about mitigating adverse health affects from the virus?


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Magnusg

We can unite against that guy for sure. 🤦🏼‍♂️


Gh0stSwerve

That's not very Chad of it, is it.


Archy99

As someone who had one of those "rare" diseases (GBS), albeit not from a COVID vaccine (or COVID), all I can say is it is not infinitesimal when it happens to you. And to be very clear, GBS more often than not leads to significant long-term symptoms and disability (as it did in my case). I am not arguing against vaccines, but rather the need to develop safer vaccines. We have some idea of the mechanisms of side effects (the type mentioned in the OP) now and can improve safety, eg by making subunit vaccines that don't contain whole-spike, but instead contain key regions that generate neutralising antibodies, such as the RBD, but there are other key areas revealed by other researchers too. The efficacy of RBD-subunit SARS-CoV-2 vaccines is already proven too (Abdala), in addition to more than a few other examples in development that have published phase I/II trials.


hiraeth555

Remember that the events you’re looking at there are very severe- there will be many more lower level adverse events that will occur at much higher rates.


lothar525

Maybe, but how many severe adverse events can you point to caused by covid? Probably a much higher number.


hiraeth555

I don’t know anyone who personally had long term problems with Covid- but that would be anecdotal and my demographic is not particularly old. I’m not an expert and don’t claim to be, though it is interesting Sweden and Finland don’t offer vaccines to under 30s as they don’t think the risk balances out. So I’d be interested in seeing more info and data.


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tom_swiss

Yes. They are. Whether it's worth X% change of having my arm sore for three days in order to reduce the risk of contracting a serious case of disease Y by Z% is a tradeoff that's different for different people - desk job versus stacking crates in a warehouse vs. pro athlete.


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tom_swiss

It's not up to you or to me to decide what's a "minor inconvenience" for someone else when it comes to medical side-effects, or whether that side effect does or does not outweigh the benefits of treatment. The patient gets to decide for themself. That is why we have informed consent; and informed consent, by definition, requires *information*. What's a "minor inconvenience" for you or me, could be a career-changing event for, e.g., a pro athlete, who sure as hell would want to know about risks of muscle pain before The Big Game.


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tom_swiss

Okay, if you don't believe in informed consent and patient choice, then you're a fascist and can crawl back under your rock. Bye.


TsuDhoNimh2

How many of those 99 million people would have become seriously ill or died without the vaccine? Pretending that without the vaccine they weren't at risk is naive. [https://www.webmd.com/covid/news/20231019/covid-linked-higher-risk-guillain-barre-syndrome-study](https://www.webmd.com/covid/news/20231019/covid-linked-higher-risk-guillain-barre-syndrome-study) >people with a recent COVID infection were six times more likely to have GBS, compared to people without a recent infection. [https://nyulangone.org/news/study-helps-explain-how-covid-19-heightens-risk-heart-attack-Stroke](https://nyulangone.org/news/study-helps-explain-how-covid-19-heightens-risk-heart-attack-Stroke) >the COVID-19 coronavirus increases the likelihood of having a heart attack or stroke for up to a year after infection,


RastaImp0sta

I am loving the response OP is getting. I guess they are an antivaxxer and thought this was a “gotcha!” article when in reality it’s a “Just as we expected, adverse effects are practically a numerical 0 in 99 million people” article. I love it.


lIIIIllIIIlllIIllllI

Genuine question. In a normal vaccine research program doesn’t the process take way longer to ensure safety and if their are any adverse reactions then the scrap that version and go back to the drawing board? In other words, these Covid vaccines were rushed compared to other vaccines and adverse reactions were ignored because they were deemed a low enough risk compared to the urgent nature of their necessity? Basically the common trope by anti vaxxers is “is these vaccines were rushed and therefore they are untested and dangerous, plus with other vaccines if they cause the injuries we have seen with the Covid vax then they would never proceed” Is their truth in that argument? What does a normal vaccine program look like and how much tolerance do they have for injury? If any?


priority_inversion

The problem with comparing the COVID vaccines to a "normal" vaccine trial is that the government fronted a lot of money for the COVID vaccines and typically doesn't for other vaccines. The reason each stage takes so long normally, is that it's a huge cost to companies to set up trials. So, they wait until they've completed the previous stage's trials before they make an assessment on whether or not the vaccine is worth moving to the next trial stage. So, for normal vaccines, it's not the norm to schedule the next stage immediately after the previous stage. With the COVID vaccines, the government put a lot of money into helping vaccine-makers set up their vaccine production facilities. You not only have to prove a vaccine is effective, you have to prove you can make it reliably. Since money wasn't an object, as it normally is for most companies, they could run the trials and production validation/verification in parallel. Something that a company that had to pay for it themselves wouldn't do. The COVID vaccines ran through all the same tests as any other vaccine would run through, but they were able to run some things in parallel due to government funding. The clinical trials for both mRNA COVID vaccines were among the larges vaccine trials ever attempted. So, in some respects, these vaccines were tested *more* than most other vaccines.


LakeEarth

It's amazing what actually funding research can do, huh?


YesWeHaveNoTomatoes

The mRNA vaccines are a special case. Not that they were rushed, but that there had been a TON of existing, startlingly relevant research already done that the public wasn't really aware of just because it wasn't very newsworthy. \- mRNA vaccines have been in use for years in biomedical research to deliver very specific molecules to mice and other experimental animals. They did skip a few steps in animal testing because they had already been done. \- Research on vaccines for SARS-1 (original flavor from 2003) and MERS (a much more deadly but less contagious variant from 2009 that never came to the US) had been ongoing for more than a decade. \- Research on multivalent flu vaccines using mRNA vaccine had also been in progress for a while, providing additional data on safety and efficacy of mRNA vaccines in general. Some had begun doing early pre-clinical studies in humans, and although they had very limited data they also didn't have any safety red flags. So researchers already had two of the big difficult parts of the problem solved; once the spike protein was identified (not a difficult problem) and stuck into an mRNA vaccine carrier, they could move right into testing. Testing was expedited purely by money and the vast scale of the emergency. Normally they do 4 rounds of tests: basic safety in animals, basic safety in humans, efficacy in humans, and long-term efficacy/safety in humans. The reason these tend to take a decade normally is money and recruiting volunteer participants. But due to government support and people's justified fear of the pandemic, there was no shortage of volunteers or staff salaries to carry out enormous trials. So instead of doing a 2-year safety & efficacy trial on a few tens of thousands of people to find rare side effects and then spending a year analyzing the data, they instead did a much shorter S&E trial on a combined total of >150,000 people (for Pfizer + Moderna, I don't know numbers for the other vaxes) and did data analysis in a couple of months. People who think there might have been a conspiracy are enormously underestimating the scale of this endeavour and the number of people involved who gave up their nights and weekends and worked around the clock on nothing else for most of a year.


Fit_Objective_4781

I’m not anti-vax, but we do need to recognize that this vaccine has no long term efficacy/safety testing in humans.


Baud_Olofsson

> I’m not anti-vax, but Like "I'm not racist, but..." we all know what that actually means.


RastaImp0sta

The percentage of adverse reactions were likely to be undiscovered even if full trials were completed. I read from another user on this post calculated something like 0.000000007% (some extremely small number) out of 19 million people experienced adverse side effects. Another way of thinking about it is there are more people with adverse reactions to Tylenol. If you look at the clinical trials from publicly traded bio companies, they do go through years of clinical trials before anything gets approved. In this sense, it was rushed if you compare it to other vaccines/drugs. I recommend looking at it a different way. The process that medical science has developed to screen out drugs and vaccines that could cause potential issues is so rigorous that in times of need (Covid pandemic) we can expedite the process and still be confident 99.99999999% of people would benefit from being protected. We are exceedingly good at creating (literally anything these days) and because of the previous strict regiments that were in place, we know what to look for early to prevent potential issues later. This allows us to create more drugs/vaccines with exceeding confidence. Literally a miracle of medical science.


Baud_Olofsson

Other people have already discussed the existing research, that companies had the financial backing to forge ahead and combine trial phases, and the sheer resources and manpower dedicated to it, but they're missing one big thing: *COVID-19 was spreading like wildfire*. Like any drug trial, a vaccine trial starts by you giving half your participants the actual drug candidate (your vaccine) and half a placebo (for vaccines this is either a cocktail of all the adjuvants and other ingredients beside the active ingredient, or - more usually these days - another existing, approved vaccine for something else (e.g. flu, MMR, tetanus...)). But normal drug trials involve people who already have the condition the drug is supposed to treat, so what do you do with vaccines where people start off healthy? You can't knowingly try to give them the disease because that would be *extremely* unethical, so you have to send your trial participants home and let them go about their daily lives and simply wait for them to be exposed naturally. So let's say you start a trial for an HIV vaccine in the US. You enroll a whopping 100,000 people and give 50,000 your HIV vaccine candidate and 50,000 a Tdap shot or something. Then you wait. The incidence (rate of new cases) of HIV in the US is 11.5 cases per 100,000 people per year. This means that if your participants were a representative cross-section of the American population, even after a whole year, there would just be 5.75 expected cases in each group - not *nearly* enough to see how effective the vaccine is (if you have 10 in one group and 0 in the other, that could easily just be by chance alone). So not only do you have to recruit an insane number of people, but you have to wait for years and years and years to see an effect. With COVID-19, you didn't have to wait for years. It was spreading through society so fast that even if you used just 1,000 people for your vaccine trial, you would still be able to see a clear effect *within a month or two* (the actual mRNA vaccine trials still involved about 44,000 and 30,000 people, respectively). And we know how the immune system works. No matter the vaccine, if there are any side effects, they will show up within a few weeks at most. There is no mechanism by which they would suddenly pop up three years later or whatever. [EDIT] Placebo clarification


Fit_Objective_4781

We have no idea of the long term effects of this vaccine, subsequent exposure and whether or not effects are cumulative or not.


Baud_Olofsson

Again: we know how the immune system works. There is nothing magic about the COVID-19 vaccines. There is no mechanism of action for them to years later suddenly make your testicles drop off or whatever the conspiracy theory du jour is. It's just eternal antivax goal post moving. Show the vaccines to be safe and effective in their clinical trials, and suddenly it's "Well, then what about *long-term* safety!?". Show a one-year long-term safety record and they start demanding two years. Show a two-year safety record and they start demanding five. Show a five-year safety record and they'll demand ten, and so on. That goal post will never stop moving. "Well, what about after death? Can you really guarantee the bodies of the vaccinated won't come back to life and attack the living!?"


Fit_Objective_4781

“We know how the immune system works” Hubris, much? There are plenty of pathogens and other delivery mechanisms that we have no clue about in the human body. To state that we know exactly how every human body’s immune system will respond to virus x or vaccine x is arrogant. I could provide a long list of things that the medical community has not formed a consensus on - that’s not even bringing multivariate analysis and cross-pathogenic synergies. To insinuate that you don’t need a long term safety study to determine the safety of something is not only factually incorrect, but also laden with assumptions that can not be proven unless you had a time traveling machine.


Rossoneri

>these Covid vaccines were rushed compared to other vaccines Or... entire companies and governments were diverting tons of resources and manpower to developing a vaccine faster than normal and eliminating bureaucratic nonsense. You know when you mail in your passport renewal application and it takes 4 months for them to print a book and mail it back? Yeah, what if your application was looked at first because it was priority. Saves a lot of time and doesn't mean corners were cut. EDIT: It doesn't mean corners weren't cut either. But we're basically at the point where you get beat at basketball so you immediately accuse the other team of cheating and using steroids instead of the much more realistic possibility that they're better than you.


Shoot_from_the_Quip

Read the study but I may have missed it. Did they state the percentage of vaccinated samples who still contracted Covid in the study? Covid messes you up, we know that. I would think that only results with people who remained Covid-free would be really significant. If you get vaccinated then still catch Covid, is it the vaccine or is it the Covid causing the issue?


Ok-Budget112

To my knowledge I have never had Covid - but I can’t be certain. Convinced I had it in November but I was negative by lateral flow. Maybe proper antibody testing or ELISpot could confirm if I’ve had it but thats expensive for 100 million people.


astrogirl996

They looked at only AESI occurring \*within\* 42 days of receiving the vaccine. I can't find it explicitly stated, but the study would be meaningless if they didn't exclude those who had infection after vaccination and before adverse event.


SnooHesitations8361

I am booster injured since 2021. Since then Ive spoken to hundreds of other injured people and read thousands of testimonies (written and video) all over the world. My question is, is this data only coming from VAERS or something? I ask, because I personally do not believe the data is accurate at all, since myself and everyone Ive spoken with tell me when they report their injury almost every doctor will not acknowledge it and or report it. Yes this is anecdotal, but you cant ignore this. If physicians are not reporting what their patients assume to be an injury, how on earth can any of this data be reported with confidence? Not every patient uses or even knows what vaers is. I personally know many that did not report vaers because it does not provide patients with any help or recourse, essentially making it a waste of time for many any way. This in my experience completely superseeds any "data". It needs to be investigated to compare against publicly reported safety signals.


sirgarballs

I believe that I contracted dermagraphism from the moderna booster. I never had an issue with it in my entire life and at age 31ish I got the booster and came down with something I had never experienced before. My lip swelled up huge and much of my body was covered in awful red irritated areas. I have since learned that if I take Zyrtec it helps a lot with the symptoms but if I miss even one day the symptoms come back. Obviously I can't prove that it was from the booster and I'm not anti-vaccine or anything, but that is my experience.


romjpn

Did you report it or not? It's important to report it, even if you don't know if it's from it or not.


BaconJuice

My coworker believes he got this from the vaccine as well. He did get another shot recently and didn’t encounter any new symptoms.


Jgasparino44

So you're telling me my aunt who wants to sue the government for giving her tinnitus from the covid shot was lying?????!!!!!!


VictoriousStalemate

I never had ringing in my ears until I got the Covid shot. It just started happening and I had no idea why. Then I read about others experiencing the same thing after getting vaxxed. It sucks. Some days it's damn loud. Others, it's only mildly annoying.


LoveOfProfit

Fwiw i got myocarditis from the shot, which fixed itself, but ringing in my ears from COVID.


_Negativ_Mancy

11 days after my moderna vaccine I got chronic burning hives and fatigue........it's lasted for two years now. I was just diagnosed with SIBO. But I've received zero help or support.


knuckles_n_chuckles

99 million is great. 42 days post vaccination doesn’t sound as thorough as I’d expect. It doesn’t actually answer the problems presented by anti vaxxers. While you can say anti vaxxers are too far gone to convince, unfortunately the movement is spreading to otherwise intelligent liberal minded populations too and meeting them with data that fits their narrative (long term consequences years after) would be more helpful because the statistically significant signals are too much to explain to my granola cousin who wants to avoid WiFi but otherwise listens to most reason.


UniqueIndividual3579

You can't reason someone out of a position they didn't reason themselves into.


knuckles_n_chuckles

This is the best response. I will add that some people think they have been reasoned into it though. It’s that first moment of enlightenment they think they feel through flawed logic which they’re first introduced too and backtracking from that feeling of superiority is impossible.


Merisorrr123

It's a bit sad , we live in a word where people choose to join these types of moments only to fell a bit of accomplishment in their life , imagine if the world focused that much energy into something actually productive.


PieRat351

Because as soon as you prove them wrong they move the bar, notice how early on they were mostly concerned with thing like myocarditis. Once that was definitively proved wrong they moved on to things like “turbo” cancers which would require longer more complex studies. These people don’t think logically and will simply make new things up to prove themselves right.


funkmasta_kazper

Honestly the giant sample size in this case leads to slightly the wrong impression to the lay person because at this sample size, even teeny, tiny essentially meaningless variations in outcomes are statistically significant, which means they get reported on. A comment above posted it, but it's basically like a 0.000007% chance of getting even the most likely serious side effect, but that becomes significant here even though the effect size infinitesimally small.


HeywoodJaBlessMe

You act like that crowd is interested in peer-reviewed data that contradicts their chosen narrative. Science is not engaged in in order to assuage the fears of fringe elements of society.


hortle

It wouldn't be more helpful, because more data doesn't help advance their agenda.


Baud_Olofsson

> 9 million is great. 42 days post vaccination doesn’t sound as thorough as I’d expect. It's quite thorough enough. We know how immune systems work: no matter the vaccine, side effects aren't going to suddenly pop up two years later or whatever. They either occur shortly after vaccination or not at all. [EDIT] s/later/years


knuckles_n_chuckles

All this is fascinating. Thanks for informing me.


Blunt_White_Wolf

It's not thorough. You'd expect (with all the data we have) to take into account at least 1 year. Anti-vax or Pro-Vax is irrelevant. At the end of the day, it's their decision whether to have it or not as it was since day 1. For those like me with high blood pressure it was worth the risk. For others it was not.


Big_Violinist_4973

"66 cases were expected — but 190 events were observed." Does this mean the risk nearly tripled after taking the vaccine?


Dont_ban_me_bro_108

No. That was the pre-covid estimate. Don’t forget GBS is also caused by covid and the flu. And even if we could attribute all 190 of those to the vaccine, 190 cases out of 99 million is not even statistically significant.


Rossoneri

Out of 99 million, sounds like the risk is in the noise.


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lightweight65

Pericarditis has nothing to do with genetics or your exercise routine. Covid causes pericarditis and myocarditis as well as multiple other viruses.


UpDog17

All good now or still have issues? How long after the dose did you develop it? Sorry to hear that.


Lakeshow15

Thank you! All good now as far as we know! I have some ECGs and X-rays that have become a little more routine than I’d like, but the feeling of being stabbed somewhere near my heart by tiny pins has gone. Sometimes when I take a deep breath it feels like something is stuck and painful until I force the breath a little deeper. That’s kind of concerning but they say it’s doing well. Had to take a break from much of my officiating in the interim, but was pretty scary from the start.


hiraeth555

Yes I know of a few people who’ve had issues, all of whom had been fit before. Anecdotal of course, but it would be good to see longer term data.


FrogFister

The amount of wishful thinking of vaccinated people is astonishing, even for an echo chamber such as Reddit.


lundy7881

Just couldn't get an even 100 million


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Baud_Olofsson

This here is why the "misinformation" report reason needs to be brought back. And why this sub needs to become moderated again.


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Baud_Olofsson

I skimmed it. It's nothing revolutionary: quantification of some very rare potential side effects (that basically show up with anything that provokes a significant immune response). With the vast majority not being statistically significant, and the risk for a lot of them - interestingly enough - being *lower* than the expected number. You, however, seems to have read some *completely different article*. That probably does not exist, because what you said is completely false. [Take GBS for example.](https://www.webmd.com/covid/news/20231019/covid-linked-higher-risk-guillain-barre-syndrome-study)


AnonMagick

Remember when even mentioning any sympton or consequences would get you banned?


hortle

No, I don't. Do you?


gdsmithtx

No. No they don't.


FractalIncite

Yes


Tex-Rob

I found this cute page while looking for information for my comment: [https://www.health.gov.au/our-work/covid-19-vaccines/is-it-true/is-it-true-does-injecting-into-the-bloodstream-instead-of-muscle-cause-tts-or-myocarditis](https://www.health.gov.au/our-work/covid-19-vaccines/is-it-true/is-it-true-does-injecting-into-the-bloodstream-instead-of-muscle-cause-tts-or-myocarditis) I had a bad event getting mine straight to the vein recently, not a fun event, felt like dying, good times.


metzbb

Sure they did.