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Comment by beefman | Hacker News Reader

This is based on VAERS data. I encourage the curious to look at this data. I did. I would characterize its quality as so poor that probably no conclusions at all can be drawn from it. And I usually find myself defending the use of noisy and/or small data in similar situations.

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> Shimabukuro also said the Vaccine Safety Datalink (VSD) - another safety monitoring system - showed an increased incidence of heart inflammation in 16 to 39 year olds after their second shot when compared to the rate observed after the first dose.

https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/...

> The Vaccine Safety Datalink (VSD) is a collaborative project between CDC’s Immunization Safety Office and nine health care organizations. The VSD started in 1990 and continues today in order to monitor safety of vaccines and conduct studies about rare and serious adverse events following immunization.

The nine HMOs are:

  Kaiser Permanente Washington, Seattle, WA
  Harvard Pilgrim Health Care Institute, Boston, MA
  HealthPartners Institute, Minneapolis, MN
  Kaiser Permanente Northwest, Portland, OR
  Kaiser Permanente Northern CA
  Kaiser Permanente CO
  Denver Health, CO
  Marshfield Clinic Research Institute, WI
  Kaiser Permanente Southern CA

I've heard less than 1% of adverse reactions are actually reported to VAERS.

Yeah, how many people actually bother to report their symptoms if they’re not serious enough to warrant a trip to the doctor (who might report on their behalf)?

Mild myo can go undetected quite easily. In fact, it’s known well as being a cause of death in young athletes who only learn of the condition when their heart gives out during intense physical exertion.

I am curious: Who reports that dude that died of a heart attack laying in a ditch somewhere.

Anecdotally, my girlfriend got the moderna vaccine and got pretty bad skin rashes from it. She went to report it through a link her provider sent her, but the website would not allow her to report any side effects because it had been longer than 48 hours since her shot.

I’ve heard this too, from anti-vaxxers mostly. VAERS is the medical equivalent of Yelp. Anyone can post anything there and looking at the unverified data is not a reliable indication of anything. And, anti-vaxxers have been known to go report things in order to bolster their arguments.

Not to mention, people who parrot that extrapolation don't give the same sort of consideration in the other direction.

Every assumption goes towards their preferred conspiracy.

VAERS is a clearinghouse. It's a vital tool for finding evidence of possible unexpected interactions that should be investigated, but it's basically textbook "correlations that do not imply causation" data.

The most a correlation in VAERS, by itself, should ever generate is a "huh, that's interesting" reaction and possibly a controlled follow-up study. HHS has a very large disclaimer on the dataset's description (https://vaers.hhs.gov/data.html).

The data is also, at this phase of collection, unfiltered and unverified. Self-reporting biases and simple mistakes are a known concern. There's a relatively famous story of someone, as a sanity-check on the process, reporting that a flu vaccine had turned them into the Incredible Hulk. https://web.archive.org/web/20130419004549/http://neurodiver...

The...stunning mediocrity of VAERS data is in the "it is known" category, and has been since well before I started graduate school. It's important because it's useful for emergent self-reported issues, but there's a reason the concept of post-licensure trials exist.

What is the right way to collect this data, given that the frontline practitioners are actively discouraging any patients from making a connection for adverse reactions with the vaccine?

Put another way: Isn’t VAERS a necessary solution to ensure that the healthcare system does not misrepresent the safety of the vaccines? Transparency should be a first principle requirement for science.

After both doses of my vaccine I was given a link and instructions how to report adverse reactions.

By the looks of it, you should keep that handy.

I’m a few weeks past the most likely time period for this to show up, and I can Google so not too worried about keeping it handy. If you do have symptoms I’d contact my regular doctor first anyway.

given that the frontline practitioners are actively discouraging any patients from making a connection for adverse reactions with the vaccine?

Do you have a source for this? As another poster replied, I was encouraged to report symptoms and given a packet with information on what to look out for, what to report and a website to do so.

Same with my wife and two adult children.

I was also encouraged to report symptoms (or lack thereof) through a website. Unfortunately the website was thoroughly broken and I was unable to do so.

I'll admit I did not even attempt to report anything. I didn't have any meaningful symptoms after my first shot (Moderna) and the symptoms I had after the second were pretty bad but also everything I expected based on what I heard from others. Chills, muscle aches, typical flu-like symptoms that lasted just about 24 hours.

So I can't speak to the quality of any websites. But I do not recall anyone before the parent comment saying they were actively discouraged by health workers to not report symptoms.

Sources are first hand- sorry. Don’t have documentation to point to. Know of a two healthy people who were diagnosed with diabetes within a couple days of the second shot.

Apparently this phenomenon is known for actual covid sufferers.

https://wexnermedical.osu.edu/blog/why-are-people-developing...

The answer is a Phase IV clinical trial, which a number of vaccines have undergone post-approval and I suspect the COVID-19 vaccines will as well.

Does the fact that the major vaccine vendors are encouraging placebo recipients to be notified about their receipt of a placebo, plus encouragement that they go get the vaccine affect your confidence in the trial process for this vaccine?

https://www.npr.org/sections/health-shots/2021/02/19/9691430...

“According to Pfizer-BioNTech and Moderna, interim analyses after approximately 2 months of follow-up suggest their vaccines are 90% to 95% effective at preventing SARS-CoV-2 infection, although no peer review of the data has been conducted to date. Both companies now claim they have an “ethical obligation” to offer vaccine as soon as possible to all participants who received placebo, considering the strong results and participants’ contribution to the research.“

Honestly? No. In the face of a major pandemic, and with the size of the clinical trials and the effectiveness of the vaccines, the ethical obligations to the patients in the trial to unblind the results to get the participants vaccinated is pretty paramount.

There are somewhat more exotic studies designs that can be used for post-unblinding monitoring work that meet the ethical obligations to the participants.

But it's a good question.

Israel had the same findings though.

So instead of wanting to look into a possible major issue with the safety of the Covid vaccines, you'd rather insult the data without providing any substantiating source, then put your hands over your ears and say "LA LA LA LA I CAN'T HEAR YOUUUUU LA LA LA LA"

Covid-19 is meticulously measured and tracked in every human being, but no one is interested in adverse vaccine effects. Things that make you think...

No one's interested in adverse vaccine side effects?

That seems rather counter to my impression which is based on the number of adults who're hesitant and the fact that FDA halted use of Johnson and Johnson vaccines once already and Europe has had it's own fair share of hand wringing about the Astro-Zeneca vaccine.

Agreed with your observation. Every news source has been brimming with stories on potential adverse reactions as they are discovered, including ones that I'm sure GP would dismiss as "MSM" or "the radical left." The reality is that all current evidence suggests the virus is still far worse than any vaccine side effects.

I mean, look at the guy's hyperbolic rhetoric. He's not interested in any discussion in which he might have to confront the fact that he is wrong.

Working with data from monitoring vaccine side effects were two of my early projects in graduate school. They are intensely monitored - vaccine data is some of the best quality data in the infectious disease world.

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