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Is the US's vaccine adverse event reporting system broken?
- fwungy 3y ago[flagged]
- TurkishPoptart 3y agoIt's sad that you have to claim that you're "not anti-vax" in order to criticize a broken system these days.
- carlosft 3y ago[dead]
- biomcgary 3y agoYour link demonstrates that vaccines get special treatment rather than being treated like regular pharmaceuticals.
- mgkimsal 3y agoIt 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.
- cempaka 3y agoThe 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.
- mgkimsal 3y agoThat 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.
- fwungy 3y ago> "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? [0] https://www.justice.gov/civil/vicp https://www.justice.gov/civil/vicp
- Analemma_ 3y ago> 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.
- masks_masked 3y ago[flagged]
- Analemma_ 3y agoHaven't masked in over 18 months, but yeah I think I've gotten 5 boosters at this point. I feel great.
- junofan 3y agoWell 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.
- omginternets 3y ago> 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.
- smegsicle 3y ago[flagged]
- aredox 3y agoFor 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.
- krrrh 3y agoCounterpoint: 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/vsd/index.html https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/...
- deleted 3y ago[deleted]
- gadders 3y agoThe UK version has issues as well https://appgpandemic.org/news/yellow-card https://appgpandemic.org/news/yellow-card
- dadjoker 3y ago[flagged]
- fooker 3y ago“The Party told you to reject the evidence of your eyes and ears. It was their final, most essential command.” ― George Orwell, 1984
- kiltedpanda 3y ago
- slackfan 3y ago[flagged]
- belltaco 3y agoThere was a concerted mass campaign on social media to misreport serious side effects, I wonder if that was factored in.
- derbOac 3y agoDo 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.
- longbrass 3y agohttps://www.npr.org/sections/health-shots/2021/06/14/1004757554/anti-vaccine-activists-use-a-federal-database-to-spread-fear-about-covid-vaccine https://www.npr.org/sections/health-shots/2021/06/14/1004757... https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9670676/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9670676/ https://www.who.int/europe/news/item/01-09-2022-infodemics-and-misinformation-negatively-affect-people-s-health-behaviours--new-who-review-finds https://www.who.int/europe/news/item/01-09-2022-infodemics-a...
- eli 3y agoNone of those seem to be about intentionally reporting false reactions?
- neilv 3y agoThat sounds like sociopathic/imbecilic behavior, and arguably a national security threat. Do we know whether and how it was investigated?
- itishappy 3y ago"That's not even the tragedy of the commons anymore. That's the tragedy of you're a dick." https://xkcd.com/958/ https://xkcd.com/958/
- decremental 3y ago
- omginternets 3y ago[flagged]
- deleted 3y ago[deleted]
- erichanson 3y agoReporting to it is entirely voluntary, so that's a broken premise.
- giantg2 3y agoNot 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.
- bruce511 3y agoThe 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.
- shadowgovt 3y agoIndeed. 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.
- nradov 3y agoWhat'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.
- nradov 3y agoThat 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.
- timr 3y ago> 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.
- gadders 3y agoThe UK version doesn't work either. https://appgpandemic.org/news/yellow-card https://appgpandemic.org/news/yellow-card
- shadowgovt 3y agoFascinating 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.
- toast0 3y ago> 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.
- Gibbon1 3y agoYou'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.
- kiltedpanda 3y agoI 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!
- giantg2 3y agoPatients 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).
- kiltedpanda 3y agoI'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.
- cempaka 3y agoAn 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).
- disambiguation 3y agoVAERS is as good as a suggestion box on top of a trash bin.
- bigtex 3y agoIt'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.
- egberts1 3y ago> 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.