Guillain-Barré Syndrome After Covid-19 Vaccination in US Vaccine Safety Datalink [pdf]
medrxiv.org
medrxiv.org
> The incidence of GBS in the 21 days after Ad.26.COV2.S was 34.6 per 100,000 person-years, which was substantially greater than the expected background rate of 1-2 per 100,000 person-years.
I've tried googling for this a few times recently and find an overwhelming amount of discussion from the anti-vax or anti-anti-vax perspectives, but hard to find a solid accounting based on hard facts.
In my view, the CDC site seems to be designed to promote confidence and authority, and hide any reason for doubt.
https://www.cdc.gov/vaccines/covid-19/info-by-product/jansse...
As per the paper though, the FDA does have a warning about this potential side effect.
In a perfect world we'd have productive discussions where nuanced topics like this can be explored in depth, but morale narcissism is rampant and everyone believes they know best.
[0] https://youtu.be/Y0sg9G5BBVU
[1] https://www.forbes.com/sites/startswithabang/2020/07/30/you-...
There is public centralized data you can analyse for US, EU and others. Data that has clear limitations, and takes skill and knowledge to interpret and actually extract information out of. There are reports that are provided by various national agencies. But these can also be misinterpreted and take careful reading.
Unfortunately, I do not know of a centralised aggregated summary for someone seaking a one stop resource.
When I go to her website I haven't been able to re-find the "doctors don't want you know about this cancer cure" link, but I have seen "A Teaspoon On An Empty Stomach Burns 4 Lbs Of Fat A Week Safely". Sounds like BS to me, but I'm not an expert
>VAERS is a voluntary reporting system, it does not include any deaths by bus
You're right that it's a voluntary system where anyone can report a negative outcome. If you look at VAERS, it includes a ton of reports like "I saw on Facebook that someone died". For example, look at VAERS report 1429304-1 it says "This spontaneous report received from a consumer via social media concerned multiple patients of unspecified ages with unknown ethnicity and race. The patient's weight, height, and medical history were not reported.". Literally, shitposting on the Johnson & Johnson facebook page leads to a VAERS report. There's quite a few from Pfizer's facebook page as well.
I couldn't find any deaths by bus, but I did find a death from a car crash (1180840-1). There's also a VAERS report (1082804-1) for someone who stepped in front of a semi truck on the highway.
VAERS also includes multiple people who died after being vaccinated while they were already in hospice. I think if someone was already in hospice for their terminal condition, it's unlikely that the vaccine is the cause of death (e.g. VAERS IDs 0921880-1, a 96 man who was vaccinated while in hospice and died the following day)
When I last checked the data, the risks of Covid-19, particularly the risk of severe infection and/or "long hauler" symptoms, seemed to outweigh the risks of vaccination by ~10:1. But that was several months ago, and I am wondering if/how things have changed when it comes to booster shots and omicron variant.
If you're looking at VAERS then this statement is objectively wrong.
VAERS records every medical event that happens within 6 weeks of any vaccination and does not establish causation.
It didn’t seem worth the trouble or expense to try to do anything about it.
That is the kind of underreporting.
A second kind of underreporting is having only very mild symptoms which would only be caught with a timely test.
This statement is also objectively wrong. VAERS has no data for unreported medical events.
There's a legal penalty for incorrect/false reporting, i.e. reporting = risk.
In the current contested environment, there can be institutional pressure against reporting.
Some people don't associate symptoms with the previous vaccination, don't go to the hospital because symptoms recede, etc. Sometimes health care workers are overworked and can't be bothered, or assume someone else reported, etc.
Databases like VAERS and EudraVigilence do indeed suffer from both under-reporting (due to patient apathy, and other reasons) and over-reporting (by design, even events with unrelated caused are included). Therefore analysis of such data takes a lot of care, skill, knowledge and effort.
There are ways we could actually increase the trust of the public in such databases.
By allowing selfreporting but separating reports into validated by a physician and not validated, by default only displaying validated. And grouping reports based on patient so that a selfreported incident and a report made by a physician are not counted twice when referring to the same incident.
By allowing patients to verify that a report made on their behalf by an intermediary (physician, national agency for EU) was included into the publicly accessible anonymised dataset.
By improving the UI/UX of the publicly available dataset (for EU, the Oracle made interface, while serviceable, is suboptimal).
By improving granularity for the age variable. (when investigating the under/over 30 difference in heart issues risk for mRNA vaccines, I found the granularity of EudraVigilence unsatisfactory)
By tracking/allowing public access to extra variables. (I found no way to investigate the theory that heart issues caused mRNA were linked to improper administration. A way to filter/categorise based on facility, date and time of vaccine dose would have been helpful)
There are options we can pursue, but these being state institutions, improvements take a lot of time. We are not a pull request away from doing better.
I mean, just for comparison with whatever you learn about the vaccine's side effects?
> VigiAccess was launched by the World Health Organization (WHO) in 2015 to provide public access to information in VigiBase, the WHO global database of reported potential side effects of medicinal products. Side effects – known technically as adverse drug reactions (ADRs) and adverse events following immunization (AEFIs) – are reported by national pharmacovigilance centres or national drug regulatory authorities that are members of the WHO Programme for International Drug Monitoring (PIDM). WHO PIDM was created in 1968 to ensure the safer and more effective use of medicinal products.
The US VAERS database has about 50/50 US and foreign reports. It is simultaneously criticized as unverified (i.e. GIGO) and missing data due to disincentives against reporting. If you have a vaccine lot number, replace the last six characters in this sample query URL, for a summary of adverse events. The raw data can be download and imported into a SQL database for deeper analysis: https://medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=...
US Vaccine Safety Datalink (the source for the paper in this article) has data from some HMOs. The raw data is not available to the public. https://pubmed.ncbi.nlm.nih.gov/21502240/
> The Vaccine Safety Datalink (VSD) project is a collaborative project between the Centers for Disease Control and Prevention and 8 managed care organizations (MCOs) in the United States. Established in 1990 to conduct postmarketing evaluations of vaccine safety, the project has created an infrastructure that allows for high-quality research and surveillance. The 8 participating MCOs comprise a large population of 8.8 million members annually (3% of the US population), which enables researchers to conduct studies that assess adverse events after immunization.
I can write a whole paper about how the vaccine turns your skin magnetic and upload it to medRxiv, but that doesn't mean much.
Many of the most worrying news stories about the vaccines have been either disproven or taken out of proportion because of early drafts like these. We'll have to be patient for a bit longer before we can draw any conclusions from this paper.
As their homepage says:
> Caution: Preprints are preliminary reports of work that have not been certified by peer review. They should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
>I can write a whole paper about how the vaccine turns your skin magnetic and upload it to medRxiv, but that doesn't mean much.
Yes you could, and, provided you wrote it in such a way that people didn't think it was a joke, you would get published in Nature for sure. Only later when people try to reproduce your work would they realize you are a fraud, and depending on what country you work in, different disciplinary action might be taken (though probably not).
Do you believe peer review suffers from both false positives and false negatives (type I and II errors, don't remember which is which)?
As a side note, we need better terminology than type I and II or false positive/negative. Type I and II is completely opaque to meaning. False positive and negative is unclear because sometimes the negative is desirable and othertimes the positive is desirable.
Maybe RDO and AUO: rejected desirable option and accepted undesirable option.
I've had GBS twice and decided to get Moderna after doing my own research -- neurologists offices I called locally refused to advise me on what to do at the time (understandably, because they are not necessarily experts with vaccines). I get my booster this weekend, because I fear the effects of covid more than the potential side-effects of the vaccine; even having recovered from GBS twice, at least I know that's something that I could recover from and I'm not sure whether or not the same thing can be said about any long term consequences of getting covid.
> One method to discover the VAERS underreporting analysis can be done using a specific serious adverse event that should always be reported, data from the CDC, and a study published in JAMA. Anaphylaxis after COVID-19 vaccination is rare and occurs in approximately 2 to 5 people per million vaccinated in the United States based on events reported to VAERS according to the CDC report on Selected Adverse Events Reported after COVID-19 Vaccination. Anaphylaxis is a well known side effect and doctors are required to report it. It occurs right after the shot. You can’t miss it. It should always be reported.
Critique/response: https://medium.com/microbial-instincts/debunking-steve-kirsc...
> NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
Peer review is where the journal makes sure the claimed work done is of high enough quality, and that the results are interesting and significant enough to be worthy of publication in that particular journal. If not, the work either needs to be improved or published in a journal that does not have as much "esteem". If anything peer review is the reason that so many fake and fraudulent results are published these days (though I'm not suggesting I know of any better alternative).
This should also require a way to prevent collusion.
All other content would be placed in a pending category.
This would never happen because the current system is about protecting academics' jobs, lest anyone discover that a majority of the work they do is so trivial and down right silly that anyone could do it with no training.
And platforms for distributed networks do exist (1), (2).
The issue is incentives for switching and reaching critical mass.
(1) https://blog.science-octopus.org/
(2) https://osf.io/