[HN Gopher] Guillain-Barre Syndrome After Covid-19 Vaccination i...
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       Guillain-Barre Syndrome After Covid-19 Vaccination in US Vaccine
       Safety Datalink [pdf]
        
       Author : walterbell
       Score  : 56 points
       Date   : 2021-12-09 20:39 UTC (2 hours ago)
        
 (HTM) web link (www.medrxiv.org)
 (TXT) w3m dump (www.medrxiv.org)
        
       | NikolaeVarius wrote:
       | > Conclusions and Relevance: In this interim analysis of
       | surveillance data of COVID-19 vaccines, the incidence of GBS was
       | elevated after Ad.26.COV2.S. Surveillance is ongoing.
       | 
       | > NOTE: This preprint reports new research that has not been
       | certified by peer review and should not be used to guide clinical
       | practice.
        
         | ianhawes wrote:
         | I'm not sure the preprint matters here, what is being stated is
         | a statistic generated by several fully integrated healthcare
         | providers that have access to the data required to measure such
         | factors as rare side effects of a new vaccine.
        
         | mrjangles wrote:
         | I keep seeing comments like this on the internet and I don't
         | know where this idea comes from the "peer review" is some kind
         | of double checking and reproducing of the scientific research
         | done.
         | 
         | 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).
        
       | neogodless wrote:
       | The short summary of what this paper describes is an increase in
       | GBS specific to the Johnson & Johnson vaccine (Ad.26.COV2.S),
       | with no significant change for recipients of mRNA vaccines.
       | 
       | > 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.
        
       | orangepurple wrote:
       | Meta question: What statistical methods can be used to combat
       | under reporting of a particular event?
        
         | walterbell wrote:
         | Kirsch, Rose, Crawford:
         | https://downloads.regulations.gov/CDC-2021-0089-0024/attachm...
         | & https://www.skirsch.com/covid/Deaths.pdf
         | 
         |  _> 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...
        
       | kokanator wrote:
       | This is a significant and life changing side effect. One that
       | should be getting more coverage than it is. Additionally there
       | appears to be no followup with individuals in the at risk
       | categories post vaccination.
        
         | spullara wrote:
         | Huh. I got a survey every day for weeks and then once a week
         | for a few months. (In the US)
        
         | nerdponx wrote:
         | What are the at-risk categories for GBS? Are the categories
         | different for mRNA vaccines vs. viral-vector vaccines vs. other
         | kinds of vaccines?
        
           | neogodless wrote:
           | In the linked paper, it describes the most common
           | ages/genders, and also specifies that there was _no increase_
           | in GBS incidence for recipients of mRNA vaccines. This is
           | specific to the J &J vaccine.
        
         | jeroenhd wrote:
         | I think it should receive quite a lot of coverage, but not
         | until it's been peer reviewed.
         | 
         | 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.
        
           | mrjangles wrote:
           | You don't know what peer review is.
           | 
           | >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).
        
       | throwaway193727 wrote:
       | The following is not nor should be interpreted as medical advice,
       | talk to your doctor...
       | 
       | 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.
        
       | cwkoss wrote:
       | What is the best source to get a breakdown on covid-19 vaccine
       | side effects?
       | 
       | 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.
        
         | NikolaeVarius wrote:
         | https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer...
        
           | nickff wrote:
           | I tried to find the information on that website, and could
           | not; is it there? If it is there, how do I find it?
        
             | benbayard wrote:
             | It's a list of tables with a breakdown of each side effect.
             | What are you looking for that isn't there?
        
               | nickff wrote:
               | Was hard to find the J&J page (parent commenter linked to
               | Pfizer), and I can't find anything about Guillain-Barre
               | Syndrome.
               | 
               | 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...
        
               | nl wrote:
               | This preprint paper was published 7 days ago. The CDC
               | doesn't move that fast on non-urgent updates with only a
               | single paper published.
               | 
               | As per the paper though, the FDA does have a warning
               | about this potential side effect.
        
         | nerdponx wrote:
         | You can look up data on adverse side effects in the US HHS
         | VAERS database: https://vaers.hhs.gov/data.html but keep in
         | mind that side effects tend to be under-reported. There might
         | be other issues with the VAERS data that I'm not aware of.
         | 
         | 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.
        
           | XorNot wrote:
           | > keep in mind that side effects tend to be under-reported.
           | 
           | 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.
        
             | colechristensen wrote:
             | I had a little inflammation in one of my eyes immediately
             | after my second dose. It went away, I didn't report it to
             | anyone. It might have been an immune reaction, I might have
             | just gotten something in my eye, everything was better in a
             | few days.
             | 
             | 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.
        
             | buffington wrote:
             | > VAERS records every medical event that happens
             | 
             | This statement is also objectively wrong. VAERS has no data
             | for unreported medical events.
        
             | walterbell wrote:
             | There's a requirement to report, but no legal penalty for
             | failure to report.
             | 
             | 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.
        
             | spfzero wrote:
             | You're right in that when someone creates a VAERS report,
             | every type of post-vaccination medical event is to be
             | included. But you're wrong if you are assuming _every_
             | event gets reported by the patient, to a doctor who then
             | _always_ creates a VAERS report.
             | 
             | 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.
        
               | nerdponx wrote:
               | Case in point: having a fatigue, fever, chills, sore arm,
               | etc. is so common after any of the "big 3" vaccines that
               | people come to expect it and take sick days from work in
               | anticipation. How many of those cases ever get reported
               | to anyone? I definitely didn't report mine.
        
         | CamperBob2 wrote:
         | Of course, you've already done a search on the _disease 's_
         | side effects, right?
         | 
         | I mean, just for comparison with whatever you learn about the
         | vaccine's side effects?
        
           | cwkoss wrote:
           | Yep, mostly curious for deciding which vaccine I want to
           | boost with.
        
         | infamouscow wrote:
         | Because of a confluence of institutional capture and heavy-
         | handed censorship by big tech companies, I don't think you'll
         | find much except on fringe "anti-vax" websites, and at that
         | point you'll have to wade through everything yourself.
         | 
         | 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.
        
         | walterbell wrote:
         | For global data, search for "covid-19 vaccine" at
         | http://vigiaccess.org/. Be sure to read the long disclaimer on
         | the page.
         | 
         |  _> 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._
        
         | superfad wrote:
         | https://sharylattkisson.com/2021/10/exclusive-80-of-the-most...
        
           | Rebelgecko wrote:
           | This seems to just be random data from VAERS. So the "deaths"
           | column includes things like people who got hit by a bus 6
           | months after being vaccinated. I think OP is looking for a
           | comparison of side effects _caused by the vaccine_ (for
           | example, comparing death rates b /w vaccinated and the
           | general population, without falling into the common traps you
           | see on websites like this one that is hawking "miracle cures
           | for cancer")
        
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       (page generated 2021-12-09 23:02 UTC)