[_Microft]

There was one but it was taken off the market. It's a bit of a sad story because it worked but because of unfounded claims that it had side effects, it lost trust of the public:

"In clinical trials involving more than 10,000 people, the vaccine, called LYMErix, was found to confer protective immunity to Borrelia in 76% of adults and 100% of children with only mild or moderate and transient adverse effects. [...] Subsequently, hundreds of vaccine recipients reported they had developed autoimmune and other side effects. Supported by some advocacy groups, a number of class-action lawsuits were filed against GlaxoSmithKline, alleging the vaccine had caused these health problems. These claims were investigated by the FDA and the Centers for Disease Control, which found no connection between the vaccine and the autoimmune complaints.

Despite the lack of evidence that the complaints were caused by the vaccine, sales plummeted and LYMErix was withdrawn from the U.S. market by GlaxoSmithKline in February 2002, in the setting of negative media coverage and fears of vaccine side effects.",

https://en.wikipedia.org/wiki/Lyme_disease#Vaccination

[ad404b8a372f2b9]

Unfounded claims from 100s of people developing imaginary autoimmune disorders? Mind you people are still getting compensated in court for autoimmune disorders arising from the Hep-B vaccine, even though no causal link was found. Just yesterday I had to accompany my sister to the phlebologist, because of severe side-effects from Pfizer, he told us he was seeing troves of patients for similar reasons even though officially no causal-link was established.

At some point you have to wonder if health-policy takes precedence over truthful reporting when it comes to vaccines. (I'm "pro-vax" btw, I was the one who convinced my sister to go take her dose even though she's quite young. Now I feel like a moron.)

[542354234235]

> Just yesterday I had to accompany my sister to the phlebologist, because of severe side-effects from Pfizer, he told us he was seeing troves of patients for similar reasons even though officially no causal-link was established.

This is the issue with correlation vs causation. When you look at sufficiently large group, like tens of millions of people, some percentage of them are going to die for various reasons. Some will have medical emergencies. Some will get cancer. So, you can’t just say “these people got the vaccine and then had this effect”. You have to look at how many were effected and compare that with the “normal” rate.

For instance, venous thromboembolism (VTE) already effects 2 out of every thousand Americans (600,000 cases a year) [1]. So, many people that get a vaccine will also experience some form of VTE because they were going to anyway. However, preliminary information is showing that the mRNA vaccine does cause about a 3 times increase in the risk of VTE, while covid causes about a 15 times increase [2]. For reference, taking hormonal birth control causes a 1.5 to 7 times increase risk of VTE [3]. So just taking birth control can be far more “dangerous” than the vaccine, so I wouldn’t beat yourself up.

[1] https://www.ajpmonline.org/article/S0749-3797(09)00946-5/ful...

[2] https://www.news-medical.net/news/20210801/Risk-of-venous-th...

[3] https://helloclue.com/articles/sex/hormonal-birth-control-an...

[sbsosbdba]

You compare the vaccine to birth control to dismiss the risks of the vaccine, however birth control is taken by sexually active and mature women.

That is people who have a real probability risk and want to avoid getting pregnant. You don't give birth control to 10 year old girls or to boys.

In the OP’s case his sister was in the low risk category (quite young). So its not obvious that a priori the vaccine outweighed the risks. Nor is it obvious that the young have a moral responsibility to to society to take on a personal risk to ameliorate a risk that doesn't affect them (this is unlike a defensive war where, presumably, the defending youth will also suffer devastation if their country is overrun)

[542354234235]

>You compare the vaccine to birth control to dismiss the risks of the vaccine

Or I compare it as a reference to a commonly taken medication to contextualize the risk. I also included a comparison to the disease it is vaccinating against, again, to contextualize. It is also worth noting that the absolute risk amounts to about 4 additional cases of VTE per 100,000 people that are vaccinated.

>In the OP’s case his sister was in the low risk category (quite young). So its not obvious that a priori the vaccine outweighed the risks.

Between 12 and 115 children end up hospitalized with covid per 100,000 total child population, not per 100,000 that catch covid (which is 1,900 per 100,000 infected children) [1]. So the risk of catching covid, and having a case severe enough to end up hospitalized, is far higher than your chance of VTE from the vaccination. So I find it odd that you would describe those odds as “low risk” for covid. And yes, its pretty obvious the vaccine outweighs the risk.

[1] https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19...

[ad404b8a372f2b9]

I'd imagine a phlebologist is in a good position to know the difference between correlation and causation with regards to their practice and their patient population.

Thanks for the links about VTE, that's interesting, I don't know if it's precisely what my sister has. Though I don't remember reading about it on any of the official websites I consulted regarding possible side-effects.

I'm mostly feeling dumb about convincing her using incomplete data at an age at which I'm not sure the vaccine is critical, the doctor having told me these side-effects are common and not being reported.

[542354234235]

>I'd imagine a phlebologist is in a good position to know the difference between correlation and causation with regards to their practice and their patient population.

Well, you would be wrong. Someone’s intuitive estimation of a section biased sample from an unknown total sample size compared to their memory from years ago is basically guessing. That is exactly why studies need to be conducted, with literally millions of people, and differences measured in a handful of people per 100,000, it is the only way to get any sort of useful data.

>the doctor having told me these side-effects are common and not being reported.

I don’t even understand what they mean. They or you can and should report it to VAERS. Its entire function is to collect data on these things so scientists can look into possible causations.

[1] https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/...

[ad404b8a372f2b9]

> Well, you would be wrong.

You're overly confident for an assertion that relies on your belief that someone with decades of medical experience would be ignorant of these basic statistical pitfalls. Not that all doctors do research but I learned that stuff in my first year in the health industry and I can assure you that doctors are in general very knowledgeable about their patient base and the diseases they treat.

A symptom with a 1 in 100 000 occurrences would result in about 800 cases in my country. Arranged according to demographics, divided by the number of phlebologists in these areas, and the baseline prevalence of these symptoms you can start to make an informed guess as to what amount is "normal".

I don't know if we use VAERS at all being in Europe. I know there was some talk of our reporting system not being interested in non-severe symptoms because of the labour cost of evaluating reports. In truth I don't know exactly what they meant, drugs aren't my domain of expertise and they didn't elaborate. But assuming this doctor is trustworthy in their assessment and intent when they speak of troves of patients with these symptoms and complain of this lack of reporting, it's evidence of a dysfunction somewhere seeing as those side-effects aren't advertised on official channels.

[542354234235]

>A symptom with a 1 in 100 000 occurrences would result in about 800 cases in my country. Arranged according to demographics, divided by the number of phlebologists in these areas, and the baseline prevalence of these symptoms you can start to make an informed guess as to what amount is "normal".

But things aren’t normal. Travel patterns have completely changed due to covid, so less or more people might be visiting a clinic than previously. People have been far more sedentary compared to previous years, a key risk factor for VTE, which could increase individual risk by as much as 30%. Covid itself causes VTE, so people with diagnosed and undiagnosed earlier cases of covid would increase the numbers.

> You're overly confident for an assertion that relies on your belief that someone with decades of medical experience would be ignorant of these basic statistical pitfalls.

Even in well thought out, carefully conducted studies, biases and confounding factors can cause serious issues. These aren’t “basic statistical pitfalls”. These are things that even the smartest people cannot account for without conducting an actual study with actual controls and randomization, actual statistical analysis, actual identification of confounding factors, actual reanalysis accounting for those, and actual peer review to make sure there were not issues you did not think of. I’m confident because I know that we do medical studies because we know that even the smartest people cannot just eyeball changes in incidence rates and cannot know which of many factors is likely causing the change. Even experts have human biases and we require the structure and rigor of studies to help mitigate them. I’m not confident that I am more knowledgeable than a doctor, I’m confident that the people much smarter than me developed evidence based medicine because they understood that no one is above bias, even your doctor.

>I don't know if we use VAERS at all being in Europe.

For Germany, you can report possible side effects here [1] which goes to the Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices) and The Paul-Ehrlich-Institut (Federal Institute for Vaccines and Biomedicines). If I was incorrect and you are in another European country, you can find your reporting agency from the EU website here [2].

[1] https://nebenwirkungen.bund.de/nw/EN/home/home_node.html

[2] https://www.hma.eu/nationalcontacts_hum.html

[sbsosbdba]

What I find interesting in the replies to your comment is that you are not taken at your word. I find we have lost our ability to do that.

You’re point is a strong one: shortly after preforming a very novel and rare action, your sister got ill with a rare disease. Her Dr. also mentioned that he had seen multiple patients who shortly after preforming a novel and novel action they got ill with a rare disease.

instead the replies boil down to:

1. Correlation doesn't imply causation

2. its psychosomatic.

Both annoy me.

1. People forget that the inverse is also true - causation doesn't imply correlation. For example, a quadratic relationship between independent and dependent variable will show zero correlation.

So why bother with correlation at all?

Because we need something to tell us where to start looking

Take the famous ice cream sales vs. robberies example. A lot is learned explaining the strong correlation between the two, even though there is no causation.

Of course, all the AI fanboys have no problem with flaky correlation as long as they predict well and they don't have to explain them.

2. This one really annoys me. While I believe that psychosomatic reactions are real and understudied (my great uncle - head Dr. at the largest hospital in a large city once told my dad that half of all ailments are cured with placeboes) this explanation is far less mechanistic and unscientific than blaming the vaccine itself.

The explanation boils down to “i don't want to believe its something I cherish, so Ill blame your hysterical sister instead”.

Psychosomatic digestive, blood pressure and heart problems are hardly surprising. All those systems are tightly connected and controlled by the mind. But vein issues? What is the mechanistic link between the mind and veins?

[himinlomax]

> Mind you people are still getting compensated in court for autoimmune disorders arising from the Hep-B vaccine, even though no causal link was found.

That's because the standards for being compensated in vaccine court are very, very low, by design, and there is indeed a vaccine court of sorts in the US. It was set up specifically to address the fact herd immunity is so extremely valuable to society as a whole that it's worth having some people be harmed by the vaccine to achieve it because many more people will be saved by it, but not necessarily the same people. Anyone who suffers basically anything that could possibly be linked to a vaccine is then indemnified by that court, even though the vast majority of those who are were probably not indeed suffering because of the vaccine.

Don't take it as a proof that the vaccine is at fault, it's fallacious and is just one in the long list of completely idiotic arguments antivax cultists use. It makes barely more sense than calling ARNm "gene therapy" or complaining about non-existent mercury.

[Vecr]

I wish they had put mercury into the Pfizer-BioNTech vaccine. At least you could use a vial for more than a few hours if they did that. Currently you have to throw away doses because bacteria may have started growing in them. The type of mercury they use in vaccines kills bacteria very well.

[himinlomax]

I don't think it's got anything to do with bacteria, it's the RNA disintegrating.

[sambe]

"These claims were investigated by the FDA and the Centers for Disease Control, which found no connection between the vaccine and the autoimmune complaints."

[ad404b8a372f2b9]

That's already written in the comment I replied to.

[sambe]

Yes, of course, but you then appeared to query the "unfounded" nature of the claims. I thought you had missed the part where they turned out to be indeed unfounded.

[ad404b8a372f2b9]

You should assume the strongest interpretation of the comments you reply to, it leads to better conversations and is part of the site's guidelines.

I disagree about the fact that they're unfounded having read the comment I replied to, therefore it follows I do not believe the results of the FDA's investigation are conclusive. I illustrate this with the Hep-B vaccine for which the health-autorities have not found a causal link, yet the legal system implicitly acknowledges one. There's also my personal experience with the Pfizer vaccine of which some side-effects are not being reported, putting into question any scientific conclusion that'd be reached from the incomplete data that is being gathered.

[Ensorceled]

Wait. You quoting the site's guidelines because the poster assumed you were questioning the unfounded claim but now you are stating you disagree with the unfounded claim?

I'm confused. Can you clarify you stance here?

[jalk]

Curious - what currently unrecognized side-effects are we talking about here?

[ad404b8a372f2b9]

Multiple oedemas and the appearance of enlarged veins far away from where the vaccine was injected.

[andrekandre]

got any links about this?

[ad404b8a372f2b9]

What do you mean? That's some of my sister's symptoms.

[andrekandre]

id like to read up on it, if there were any articles etc i was thinking it would be great to reference (for myself) since ive been googling and haven't really found anything much...

[asah]

I'm sure the FDA is on it, but what about psychosomatic effects?

[darkerside]

What gives you so much confidence it was the vaccine? Correlation does not equal causation, as we all know around here.

[ad404b8a372f2b9]

I'm not confident one way or another. But I'm not ready to take this story at face value as a sad story of a vaccine being recalled because of a few loud-mouthed anti-science idiots just because "no causal-link was established by the FDA".

Health-policy and politics in general have a perverse effect on the science. What was the official stance of the government one day becomes misinformation the next, and vice-versa. I think it's important to recognize that going with the narrative of the government is a political stance rather than a scientific one and that it reflects trust in the system rather than anything else.

Over the years my government has given me many reasons not to trust it blindly when it comes to medical issues. Our legal system recognizes that finding a causal link is not the end-all be-all of medical responsiblity and my personal experience reflects it as well having just done a risk-benefit analysis to convince my sister to get vaccinated, using the information provided by the health-authorities of my country, and discovering afterward that some serious side-effects are not being reported.

[darkerside]

I don't disagree with the principle behind what you say. But the application to where you are acting under the assumption that Pfizer caused your sister's side effects seems unwarranted. It's certainly worth investigating, but it is far from a certainty.

[sbsosbdba]

Very well said.

[bxrxdx]

Yes, it's very easy to see causation when there is only correlation.

[rrrrrrrrrrrryan]

The side effects were real and occurred frequently enough to make vaccinating the entire population a net-negative. Lyme disease is still extremely rare in most areas.

What should have happened is the vaccine should've been made prescribable by doctors to patients who live in areas where Lyme disease is common. Despite its side effects, the vaccine would have been hugely beneficial to specific areas of the U.S., but IIRC there wasn't a regulatory pathway at the time for this sort of limited approval based on geography.