I had the same experience as the guy in this BMJ article in terms of trouble filing a report. The process was extremely cumbersome and had to be lodged through my physician. The physician had no idea what paperwork was required or how to fill it out once I found it for him. I don't know whether the report was actually registered in the national database.
My mother-in-law was bedridden for days after each booster (without filing a VAERS report) until her doctor eventually said she maybe shouldn't take any more (god forbid she risk her practicing license by uttering the heresy that the vaccine may not be 100% safe).
A better measure of the prevalence of adverse events are the randomized phone surveys done by countries like Israel. They called 2000 people after their second dose, and magically 4% of men and 7% of women experienced chest pain soon afterwards. What a coincidence!
I had the AstraZeneca vaccine and I was very sick for a week (I couldn't get out of bed and had 39+ Celsius fever) and for a month it was hard for me to walk to the nearby grocery store. The Pfizer vaccine, the second for me, was only slightly better.
Half a year after the vaccines, I had irregular heart beats, at one point more than thousand a day. It's a horrible experience, because even when I had only tens of irregular heart beats a day, I could feel most of them. Now imagine that a thousand times a day, especially knowing that cardiovascular issues are a common side effect.
And I still didn't report anything (Germany) as I don't believe anyone would come out of it. Not to be too cynical, but the Russia-Ukraine war "cured" COVID in Europe, so apart from staying alive and not taking anymore vaccines myself, I didn't care about the issue as I was no longer forced to take further "vaccines" to be a free man.
In the end, there are arguments both for these systems under reporting (cases like mine and many variations of it) and over reporting (in a comment someone mentioned that people maliciously report things or just in general people noticing small things and reporting that as side effect), and it's hard to come up with a sound estimation as to which one is the reality.
Brutal, sorry to hear that. Hope you're feeling better!
I personally don't believe the suggestion of over-reporting is an issue at all. I recall reading that in the VAERS back end they can see which entries are made by individuals vs a doctor or doctor's office, so this could be easily verified.
I also recall reading that the majority of entries made in VAERS are by medical professionals but I can't locate the source for that.
Patients can self report without the provider being involved. You might not have some info like lot numbers, but you can still submit. It was a bit of an ordeal to submit, although I've heard it got easier after they made updates during covid (not sure if that's true).
I'm in Canada. I used the term VAERS, but I meant the Canadian equivalent reporting system. In Canada self-reporting isn't permitted - it has to go through a doctor. Then you're subject to doctor's biases as well. In my case, with first onset of chest pain a couple of days after the second dose, his bias led him to hypothesize that it could have been from a latent Covid infection (with zero covid symptoms). That theory was squashed when I caught Covid a few weeks later.
An American friend of mine in his mid thirties developed cardiac issues after 3 doses of Moderna, but his doctors doggedly attribute it to his mild COVID case (and he is of course happy to believe that rather than that the damage may have been self-inflicted).
Would a peer reviewed study in the European Journal of Heart Failure finding 1 in 35 people suffered heart damage after a Moderna booster shot change his mind?
That's a major problem. Anything that could possibly be caused by the vaccine, or has an unknown cause, should be reported. You want the raw data without the biases of doctors guessing if something is related or not. Then the data scientists and researchers can clean the data.
Indeed. The extreme version would be to collect data about "all problems, period", and compare the rates of "people who got the vaccine in the last N weeks" against a control group. Like looking at "excess deaths" to estimate the deaths caused by COVID. Picking the right control group might be tricky, though...
Yeah, I looked at doing some analysis for a vaccine related injury. There aren't really any control groups for the mandatory vaccines. The best you can do is try to time box it like you're talking about. Even using groups that may not vaccinate (certain religious sects usually) may have issues with the sampling not being random due to genetics and demographics in those communities.
I wanted to do the time boxing like you suggest, but access to anonymous records with that level of detail and with a sufficient size is not easy to come by (as a lay person for free at least).
You might be surprised. I've heard a doctor I know personally who is so pro vaccine that they have stated they are absolutely safe (not generally safe) and they wish they could secretly give the vaccine (specifically covid) to kids who's parents decline.
Have you tried prompting them differently? People are a bit like chatGPT and anchor weirdly.
My reason for phrasing the earlier comment that way, and also my guess for that doctors thought process, is that asking the relative risks per million of a saline injection and only when you get that answer following up by asking if any other injection is safer, would get you there, unless they were currently thinking about all the antivax conspiracies, and there's still a chance that just asking about saline injection would cause that thought process directly.
Only in the parallel reality where the SS was famous for trying to prevent a transmissible illness. Given our reality is one where the SS were racist paramilitaries that industrialised homicide, you seem to be regurgitating from the "everyone I disagree with is literally hitler" school of rhetoric.
There was no "trying to prevent a transmissible illness" once the CDC's Provincetown study made it clear in late July 2021 that the vaccines didn't prevent transmission. After that point, it was purely enforcing a purity ritual and loyalty test on people, and was even couched in those terms: "we're not accepting the refusal of this undertested therapeutic from those anti-social anti-vaxxers!"
Tell me you don't know how vaccines work without telling me you don't know how vaccines work.
Preventing transmission is a nice to have, not a must have. Less serious symptoms (which can include, but are absolutely not limited to, death, not for Covid not for anything else) are the requirement for them to be useful.
Comments like yours are why I wrote the other day:
"I think people expect cancer cures to be as effective as vaccines really are, while also expecting vaccines (and antibiotics) to be as effective as a Potion of Cure Disease in Skyrim."
What was the justification for firing people from their jobs or excluding them from public accommodations for not taking a non-sterilizing vaccine?
The USA Today article you link is just a lot of the usual verbal gymnastics that was rolled out at the time: they still work against severe outcomes, sure lots of vaccinated people are getting infected but you have to use Bayesian analysis and compare against the proportion of the base population that was vaccinated, no vaccine is 100% effective so let's pretend these ones are just as good as the ones that are 99% effective, etc.
> "When people are vaccinated, they're not going to get infected"
> "There is no variant that escapes the protection of our vaccines"
I googled these two then stopped, because you know what results I see? Conspiracy theorists quoting each other. I don't actually see a single reference to any source material to verify the original statements.
> "Emergency uses of the vaccine have not been approved or licensed by US FDA but have been authorized to prevent COVID-19 in ages 5+." - Pfizer Inc.
This I can believe (it's close enough to the docs I can find even though it's not actually a quotation from any of them), but I have no idea why you think this quote is supposed to support your point.
Unless you have the overall incidence of self-reported chest pain or that of those who didn’t get the vaccine in the same period, those aren’t particularly meaningful numbers.
2000 people is a pretty good sample size. It is true though that I'm hazarding a guess that the background rate of chest pain in any given timeframe is slightly lower than ~5%.
Fascinating write-up. I have some experience with log monitoring and alerting systems on cloud infrastructure, and there seem to be some fascinating parallels. Some of the issues described, including especially "Good at catching known-pattern issues, but not great for discovering novel issues."
Large distributed system logs, in the raw, are straight noise. None of the data has meaning until you add a layer of interpretation on top of it, and that interpretation often involves actual software creativity. Is a load spike indicative of a bug in your handler services or your key demographic all logging on at once (because you're, say, a football-focused service and Halftime at the Superbowl just started)? Are spikes in 400 queries on a Monday morning indicative of some kind of cyclical error in your infrastructure or did a client build a broken automated job that fires once a week and tries to feed your system copies of the old query schema? Oh no, a surge in 404s... Did a whole chunk of your site stop serving, or did someone kick off the world's most poorly-tuned web crawler and point an army of instances of it at your domain?
You can query the data for these things, but in general that is the flow of information: the data doesn't tell you anything, you ask it. You come up with queries against the aggregated data, identify and discard obvious noise, and decide whether the data supports a hypothesis that something is actually wrong in the world.
> Large distributed system logs, in the raw, are straight noise. None of the data has meaning until you add a layer of interpretation on top of it, and that interpretation often involves actual software creativity.
Additionally, I find that when people add logs/metrics 'just in case', they're often not sufficient to satisfy the queries that are developed later. You often need to know what you want to query about so that you can log the right things. The same thing happens with medical statistics: you can't prove or disprove a hypothesis from data unless the data collection was designed with that hypothesis in mind.
You're on the money. People as a group are constantly having transient health related stuff. Reporting all of those when they occur a few days or weeks after someones been vaccinated is no different than snapping a picture with a camera.
One thing that bothers me is composing health events after vaccination with the base rate of those events. Those are no the same because in the former there is an known event. In the latter we don't capture the triggering events. Like perhaps both vaccination and the flu in young males causes mild heart inflammation. The base rate for flu related heart inflammation will be proportional to the percentage of males that get the flu per unit time. A small fractional number. Where when measuring after vax, 100% were vaxed.
It's by design. Can take 45 minutes to properly fill out but it will timeout at the end meaning EVERYTHING entered previously is gone and has to be re-entered. Most doctors who actually submit reports ( most doctors don't even know the system exists as they are never taught this in med school) will copy and paste from a Word document because the system is so unreliable.
The problem with articles of this nature is that anecdotes are not data.
Clearly if you choose to take a vaccine there's risk. It's easy to get someone to have a story of "I did this. That happened".
Maybe the two things are related. Maybe they're not. Maybe the science data is fudged. Maybe there is short-term gain for long-term pain. Maybe this, maybe that.
Now sure, we have study protocols. We collect data, analyse statistics. All very dry, and easily dismissed ("that's what they -want- you to believe.)
You cannot logic someone out of a position they weren't logicd into. You cannot fight emotion with science. Ultimately we all just make a choice. Whatever choice we make, we live, or die, with the consequences.
At this point I choose to be vaccinated. It's not risk free. My mate chooses not to. That's not risk free either. Honestly right now I'm not interested in arguing about it anymore. We all gotta die of something.
> We collect data, analyse statistics. All very dry, and easily dismissed ("that's what they -want- you to believe.) You cannot logic someone out of a position they weren't logicd into. You cannot fight emotion with science. Ultimately we all just make a choice. Whatever choice we make, we live, or die, with the consequences.
This literally has nothing to do with the reality of the situation as discussed in the article. The article talks how it's so difficult to submit something to VAERS that people are discouraged from doing so. A science-based vaccine event system should probably allow people to submit events.
VAERS is a voluntary reporting system. It's right there, in the name. That, in itself, is not a problem. But you can't do science unless you can -- as you say -- collect data and analyze statistics.
From a population perspective, it’s vital that people get to choose. If it turns out there’s something fatally wrong with the vaccine, at least some of us will survive.
"The problem with articles of this nature is that anecdotes are not data."
That could be an issue with this specific article (doesn't really seem like it to me). However, pubmed is filled with studies about how junky and underreported the data is. Basically, the system is only intended to find gross trends and it still largely does that with the junky data. It won't capture the extremely rare stuff though.
Generally agree, but want to add that it depends on how those anecdotes are tracked. They knight not end up as data, bit rather stereotypes (founded or unfounded) if not recorded properly. Take the experiences and opinions of vaccine injury lawyers.
That is not a problem with the article. The article correctly points out that we lack data exactly because of flaws in VAERS. Funding should be increased and those flaws should be fixed so that we can have higher quality data to inform public policy, medical guidelines, and individual decisions.
Well put. At the end of the day, it's a personal choice—a choice that is up to you and you only. Not sure how we fell into this erroneous belief that we need tell others that they shouldn't or should be vaccinated.
The difference is that the smallpox vaccine is close to providing sterilizing immunity, unlike the Covid 'vaccines'. In fact there is a lot of data to suggest now that the number of vaccine doses a person has is correlated to an increased risk of catching covid (and therefore spreading it).
Statistics agencies have to massage the raw data very significantly in their models to make it look like vaccinated individuals catch covid less often than unvaccinated people.
Vaccines can be prophylactic, or therapeutic (to fight a disease that has already occurred, which also includes some cancer treatments). Only some vaccines offer full sterilising immunity.
I get your premise and it's true for a lot of stuff, but the equivalent is saying that following the rules of the road white driving is a personal choice. When choices start effecting those around you it's a different animal.
No, I don't believe it is. Personal health choices and driving laws are two very different things.
When one drives recklessly, we know the result, bodily harm to themselves and or others. When one takes a new vaccine with limited testing and emergency approval, we don't know the result(s), yet.
By that logic, every set of choices one could have that affects others should be regulated or overseen?
Moreover, that comparison is predicated on the belief that vaccines prevent transmission. There has been no sufficient data (to my knowledge) that backs up the claim of them doing so.
Indeed. There are zero reports in VAERS of people who took no vaccine and died of a preventable disease. There are plenty of reports of people who took a vaccine against a respiratory disease and then caught a different respiratory disease soon after. If one evaluates risk only from the VAERS dataset, vaccines will look quite risky.
What's your point? VAERS was never intended or documented to be used for risk analysis or individual healthcare decisions. If some people are misusing it that is an entirely different issue and off topic from the article.
Not exactly. Specific events are required by law to be reported by medical professionals. Anecdata says this gets missed fairly often as there's no real enforcement.
My favorite were all the fake TikTok tremors videos. Search for it. Like much of TikTok it was people being obnoxious for views.
There's apparently an epidemic if fake medical condition videos on TikTok, including fake Tourette's impressions that are really offensive and harmful to people who actually have the condition.
Or the magnetic shot videos. These were long and involved. Showing people “man on the street” style being asked if they had been vaxxed and then if yes place a magnet on his her arm and it would stick.
There was a lot of propaganda and fake news. A lot of it, to me, appeared to discredit more reliable conscientious objectors by drawing the more feeble minded into this a sort of WWG1WGA q anon BS.
Reading the comments here I see the rhetoric is still simmering on both sides. So much to say on this topic, so little ability to communicate on it. I blame social media and 24/7 news turning us into screaming marionettes warring with each other.
It is a crime to misreport to VAERS. The only people I have seen with "proof" are people who knowingly submitted a false report to "prove" how easy it was to get a report to be accepted. This was done by some who was pro-vaccine as well.
> "The National Childhood Vaccine Injury Act of 1986, as amended, created a unique mechanism for compensating persons injured by vaccinations. The National Vaccine Injury Compensation Program (the "VICP" or the "Program") (42 U.S.C. §§ 300aa-10 et seq.) is an alternative to traditional products liability and medical malpractice litigation for persons injured by their receipt of one or more of the standard childhood vaccines."[0]
NCVIA was passed because of lawsuits over the Pertussis vaccine that were so extensive it threatened the entire vaccine industry. Rather than go back to the industry and say that you need to show that the benefits of the vaccine outweigh the risks with actual data, and not industry funded models, they just decided to hand liability to the taxpayer, through an excise tax. But the same taxpayer pays for healthcare too, don't they have a right to know if a treatment actually works, especially if it's required or requested to attend school/work?
It also demonstrates that they can be held liable.
"should be liable for their products" has an overarching implication that there's no liability. My own anecdata from the last few years is that the majority of anti-vax people parrot the line that "vaccine manufacturers are exempted from all liability"... which is patently false.
The extremely paltry claims paid out by the VICP are funded by an excise tax on all vaccines, it's not any kind of scenario where a manufacturer is on the hook in proportion to their responsibility for causing damages.
That itself might be somewhat politically influence(?) If memory serves, VICP claims used to be on the whole larger and/or more proportional, but that was a couple decades back.
> I've studied VAERS closely. It almost seems purposefully designed to under report adverse reactions, even before Covid.
I'm going to state this bluntly: I think you're lying and/or stupid. I've also looked at VAERS, and the entire system very obviously over-reports every tiny bit of noise. Every cough, hangnail, and sports injury which happens to occur in the 2 weeks after a vaccine gets reported. If there's anything wrong with VAERS, it's that there's so much alerting the system is not useful.
> Vaccine manufacturers should be liable for their products just like regular pharmaceuticals.
You are very misinformed if you think vaccine manufacturers are not liable for their products. They are exempt from normal civil suits because of their mandatory nature (nobody would make a mandatory medical product at the usual rate of medical malpractice suits), but the FDA is authorized to withdraw products and levy fines for defective/harmful vaccines, and has done so many times in the past.
> Good science gets trampled when there's so much money on the table.
Pharmaceutical companies report that they basically break even on most vaccines, since they're pretty much commodities. The new ones like mRNA are the exception, not the norm.
You don't seem to know very much about this subject, and I think you should actually bother to learn before making confident statements like this.
Whoa. You can't attack another user like that here, no matter how wrong they are or you feel they are. If you'd please review https://news.ycombinator.com/newsguidelines.html and stick to the rules when posting to HN, we'd appreciate it.
I realize that other comments in this thread were also bad, but this one stands out as particularly personal. That's not cool.
Reporting to VAERS is voluntary. Doctors in your typical HMO practice are extremely busy and highly time managed. They need to be keeping up a high rate
of patient visits and doing all the paperwork for each of them.
They aren't paid to report to VAERS, it's just another thing to do in a very
busy and exhausting day.
If you want to make VAERS into actually usable data doctors should have to report any significant internal change to a patient's health within 72 hours of the vaccine administration, and non-doctor reports should have their own channel because the data quality is likely to be lower. Doctors also need to have some time credit from their employer for handling VAERS reporting.
I'm commenting confidently because I know of what I speak.
Healthcare providers who administer COVID-19 vaccines are required to report the following to VAERS:
Vaccine administration errors whether or not associated with an adverse event (AE).
If the incorrect mRNA COVID-19 vaccine product was inadvertently administered for a second dose in a 2-dose series, VAERS reporting is required.
If a different product from the primary series is inadvertently administered for the additional or booster (third dose), VAERS reporting is required.
VAERS reporting is not required for the following situations:
If a mixed series is given intentionally (e.g., due to hypersensitivity to a vaccine ingredient)
Mixing and matching of booster doses intentionally (as of October 21, 2021, mixing and matching of booster doses is allowed)
Serious AEs regardless of causality. Serious AEs per FDA are defined as:
Death
A life-threatening AE
Inpatient hospitalization or prolongation of existing hospitalization
A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
A congenital anomaly/birth defect
An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above
Cases of myocarditis after a Pfizer-BioNTech, Moderna, Novavax, or Janssen COVID-19 vaccine
Cases of pericarditis after a Pfizer-BioNTech, Moderna, Novavax, or Janssen COVID-19 vaccine
Cases of Multisystem Inflammatory Syndrome in children and adults
Cases of COVID-19 that result in hospitalization or death
Well yeah it’s to identify stuff from the tables that wasn’t well-represented in the study population. You might wanna go back and study it a bit more.
> You are very misinformed if you think vaccine manufacturers are not liable for their products. They are exempt from normal civil suits because of their mandatory nature (nobody would make a mandatory medical product at the usual rate of medical malpractice suits), but the FDA is authorized to withdraw products and levy fines for defective/harmful vaccines, and has done so many times in the past.
I must be severely misinformed as well, because I remember signing a waiver that prevents me from filing a civil suit. I don’t see how such things as negligence and/or willful misrepresentation of benefits and risks can be remedied simply by having the FDA say “whoops, actually you can’t inject this in people anymore.” That’s wildly different from being a able to provide restitution, let alone punish bad behavior.
> I don’t see how such things as negligence and/or willful misrepresentation of benefits and risks can be remedied simply by having the FDA say “whoops, actually you can’t inject this in people anymore.
... because making things to inject in people is their whole business model and if the FDA says that enough they cease to exist as a company? Pretty solid deterrence.
>... because making things to inject in people is their whole business model and if the FDA says that enough they cease to exist as a company?
1. That's a stretch. These companies sell more than just COVID vaccines.
2. How does a patient that was injured by the vaccine, through manufacturer negligence, say, obtain restitution?
I'm glad the FDA is still regulating the vaccine. I wish my constitutional right to bringing civil suit were similarly preserved before I was coerced by my employer into taking the vaccine.
IIUC restitution comes via the vaccine injury compensation program (https://www.hrsa.gov/vaccine-compensation) and is divorced from any preventative or punitive process applied to the manufacturer.
> my constitutional right to bringing civil suit
Um... Is that a Constitutional right? I don't see "civil suit" mentioned anywhere. You could, perhaps, claim it should be considered an always-on right as per common law in due process, except there's already a whole host of possible injuries one can sustain where there is no right to civil suit resulting, so I'm guessing SCOTUS has already at some point ruled that no such universal right exists, or that it's well within the purview of Congress to pass laws modifying / constraining / shaping said right.
Yes, it absolutely is a constitutional right [0] and yes, we agree that some of the limitations imposed by the federal tort act are counterproductive. The latter is also irrelevant to the current discussion, which is about filing suit against a private pharmaceutical company.
> and is divorced from any preventative or punitive process applied to the manufacturer.
Yes, this is precisely what feels outrageous to me. I am constitutionally entitled to petitioning for restitution from the private actor, directly, and in a manner that does not a priori exclude punitive damages. I am rather concerned that many of us were coerced into waiving this right.
Aren’t you?
[0] see “right to petition” under first amendment, which includes the right to sue for the redress of grievances. I am surprised someone accusing others of being misinformed would overlook this.
The right to petition for redress of grievances is not abridged by the creation of methods other than a civil suit to redress a grievance. If it were, https://www.law.cornell.edu/uscode/text/10/456 would be Unconstitutional on its face, and it does not seem to be (unless you can find evidence to the contrary in Court interpretation).
And in general: no, it doesn't feel outrageous to me. The law seems to have wide leeway to shape civil suit (statutes of limitations, bars to suit, no ability to sue agents of the government acting in the line of duty for burning one's house down to flush a criminal suspect), and the remedy would therefore be to elect better Congresspeople and state legislators if one is concerned about how civil law has been shaped.
> The right to petition for redress of grievances is not abridged by the creation of methods other than a civil suit to redress a grievance.
What a strange comment. Of course they aren’t. They’re abridged by the de facto obligation to get vaccinated (unless you want to lose your job) and — crucially - the total waiver of liability on the part of pharmaceutical companies.
It’s telling how you went from “you don’t have that right” to “okay, you have that right, but some particular thing isn’t violating it”. Im guessing the next stop is “okay, it was violated, but it’s not a big deal”.
I agree with you that redress of grievances is a Constituational right. Thank you for answering my original "Is that [bringing civil suit] a Constitutional right?" question with a framework in which one can see it as one.
> They’re abridged by the de facto obligation to get vaccinated (unless you want to lose your job)
Ah, here you do run into an issue. There is no Constitutional right to have a job. Kind of an oversight in the construction of the whole thing, really... Quite a bit of the pain in American culture can be traced to "The whole Constitution ultimately does not care if an individual starves to death because they can't participate in capitalism."
And there's plenty of precedent regarding one's health status precluding one from being able to have or maintain a job. Typhoid Mary, famously, was legally precluded from kitchen-work because she was a typhus carrier. Her repeated entry into that field in spite of this stricture placed on her for the health of the citizens of New York (and her entry into other service-sector fields, eventually resulting in the deaths of 3-50 New Yorkers) is how she eventually landed in permanent quarantine.
For all the COVID vaccine truthers that will comment on this story without reading it:
Other countries adverse event reporting system doesn't have the same problems, and reported only a few more rare not-life-threatening adverse effects of vaccines.
Counterpoint: it’s totally embarrassing that the US public had to learn about the serious issues of myocarditis amongst young men and blood clots from J&J from Israeli and European public health, and that it took several months, and arguably more than a year for US public health to fully acknowledge the myocarditis issue with US data from VSD [0] (let’s put to the side what a mess VAERS is).
European countries acted swiftly to increase the time between primary series doses for anyone under 40 (give or take depending on country), and also restricted Moderna for young men as it’s higher dose produced many more myocarditis cases than Pfizer. US regulators for some reason seem to have a parochial view of data provenance and didn’t take these common sense approaches.
Respectfully, there is a vast continuum between “anti-vax” and “vax-maxxie” that a reasonable and prudent person can occupy. I wish you would extend us the courtesy of registering some of the nuance with which the topic of COVID vaccine policy is routinely discussed.
My mother-in-law was bedridden for days after each booster (without filing a VAERS report) until her doctor eventually said she maybe shouldn't take any more (god forbid she risk her practicing license by uttering the heresy that the vaccine may not be 100% safe).
A better measure of the prevalence of adverse events are the randomized phone surveys done by countries like Israel. They called 2000 people after their second dose, and magically 4% of men and 7% of women experienced chest pain soon afterwards. What a coincidence!