Is the US's vaccine adverse event reporting system broken? | Hacker News Reader

Is the US's vaccine adverse event reporting system broken?

bmj.com

60 pointscempaka92 comments

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!

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).

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).

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?

https://farmersforum.com/one-in-35-people-suffered-heart-dam...

https://onlinelibrary.wiley.com/doi/10.1002/ejhf.2978

Vaccines are safer than water!

I doubt any medical doctor has claimed that.

Heck, I doubt any have even said that an injection of saline solution is as safe as normal water consumption.

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.

True, this was unprompted and offered up voluntarily.

Yeah this whole thing really brought out the inner SS in some people.

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!"

> the vaccines didn't prevent transmission

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.

> CDC's Provincetown study

Tell me you don't know Baysean statistics etc.

https://www.usatoday.com/story/news/nation/2021/08/08/cdc-re...

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."

Gosh I wonder where they got that idea

"When people are vaccinated, they're not going to get infected" - Fauci

"You're not going to get Covid if you get these vaccinations" - Biden

"Vaccinated people do not carry the virus and don't get sick" - Walensky (Head of CDC)

"There is no variant that escapes the protection of our vaccines" - Bourla (Pfizer CEO)

"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.

> "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.

To put that another way: https://www.ideatovalue.com/insp/nickskillicorn/2021/04/dont...

> "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.

Here you go:

https://www.cnbc.com/2021/05/04/cnbc-exclusive-cnbc-transcri...

https://twitter.com/i/status/1555369351238537216

"I have no idea why you think this quote is supposed to support your point."

Because it says "authorized to prevent COVID-19 in ages 5+". It does no such thing obviously.

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.

> just as good as the ones that are 99% effective

How many vaccines do you think are 99% effective? Or even 90%?

The covid vaccine researchers would've been happy if it had only been 50% effective.

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%.

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.

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.

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.

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.

> 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.

"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.

Any individual observation is an anecdote.

Enough anecdotes become data.

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.

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.

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.

> Not sure how we fell into this erroneous belief that we need tell others that they shouldn't or should be vaccinated.

If you'd like the answer, the belief originally stems from watching hundreds of millions of people die of smallpox

https://historyofvaccines.org/blog/timeline-of-vaccination-m...

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.

If anything, vaccine is a misnomer for the Covid shots. Maybe prophylactic is more accurate?

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.

Thank you for sharing.

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.

The problem is that it wasn't a personal choice for a lot of people who were effectively coerced.

Agreed.

>The problem with articles of this nature is that anecdotes are not data.

If enough anecdotes differ from data, you need a different way to measure the data.

Reporting to it is entirely voluntary, so that's a broken premise.

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.

VAERS is as good as a suggestion box on top of a trash bin.

> VAERS is a voluntary reporting system. It's right there, in the name.

Can’t do science until there are sufficient data collected, even if it is merely supplied by layman.

And I too filled one out for my total hearing loss after taking Zyban.

Cumbersome data entry, yes; useless, no.

There was a concerted mass campaign on social media to misreport serious side effects, I wonder if that was factored in.

Do you have any links to stories on this? Not meaning to question the truth of what you're saying, I'm just interested in reading more about it.

https://www.npr.org/sections/health-shots/2021/06/14/1004757...

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9670676/

https://www.who.int/europe/news/item/01-09-2022-infodemics-a...

None of those seem to be about intentionally reporting false reactions?

That sounds like sociopathic/imbecilic behavior, and arguably a national security threat. Do we know whether and how it was investigated?

"That's not even the tragedy of the commons anymore. That's the tragedy of you're a dick."

https://xkcd.com/958/

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’s not going to get any better either.

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 UK version doesn't work either. https://appgpandemic.org/news/yellow-card

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.

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

The UK version has issues as well https://appgpandemic.org/news/yellow-card

“The Party told you to reject the evidence of your eyes and ears. It was their final, most essential command.”

― George Orwell, 1984

The Canadian system had issues as well. Extremely difficult to lodge a report.

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.

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