article-VaccineAR-data

article-VaccineAR-data

Article: Vaccine AR Data

Re: the under-reporting & risks of covid vaccine injury in Germany

 

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English Translation from CoronaCases of original article: (as reported on achtung.com Feb 19, 2022)


The Revealing Accounting of Vaccine Damage

by Ulrich Adam

Since 1 April 2021, numerous cases of adverse reactions in connection with Covid-19 vaccinations have been documented in Germany and billed to health insurers – the picture painted there testifies to a comparatively poor safety profile. Who doesn’t know the obligatory slogan after every TV or radio advertisement for non-prescription drugs? At the end it always says in unison: “For risks and side effects, read the package leaflet and ask your doctor or pharmacist.”

The package leaflet is rarely seen with Covid 19 vaccines, and enquiries with doctors and pharmacists about possible side effects are often not very meaningful or informative. In view of the fact that the substances have only been on the market for just under 14 months,
longer empirical values are of course not available.

At the same time, there are a large number of articles and reports on side effects on the internet, most of which are anecdotal and suggestive and do not necessarily help to make a sober scientific assessment.

So where can an interested layperson start? One of the official pieces of information from the Federal Ministry of Health already makes one wonder: the risk of myocarditis is given here as 1:5000, an extremely poor value for a vaccine in terms of safety profile – both in
comparison to other classic inactivated vaccines and under medical ethical and regulatory aspects. After all, vaccines are usually administered to healthy persons and must therefore rightly meet the highest safety requirements. The latest report of the Paul Ehrlich Institute on reported suspected side effects is complex, but points in a similar direction: severe side effects are estimated in a similar order of magnitude (2/10,000).

Worrying data

It is good that there is the INEK database, which contains the services documented and billed in German hospitals. Unfortunately, there are no regular reliable summaries regarding the frequency and severity of Covid-19 vaccination reactions registered there. But as long as
you know that since 1 April 2021 the code U12.9 can be used for such adverse event diagnoses, you can do a little research yourself in the publicly accessible database.

The picture that emerges there for the period from 1 April to 31 December 2021 confirms the comparatively poor safety profile, and the full extent of toxicity does not yet seem to be covered.

Even taking into account the high number of Covid-19 vaccine doses administered in total during this period (around 110 million), the frequency and severity of side effects is considerable. 14,367 cases were treated in German hospitals, 1,652 of which involved a stay
in intensive care, and 170 people died.

In addition to the deaths, the intensive care stays are worrying, since it was precisely the avoidance of a potential temporary overload situation in intensive care units in Germany that was cited as the primary justification for the measures – and vaccinations – taken.
The breadth and (in some cases) severity of the adverse events recorded is also worrying.

Many of the primary diagnoses recorded in association with U12.9 as a secondary diagnosis (369 in total) are consistent with those in the emerging scientific literature. For example, the available data show significant adverse events in seven prominent areas (myocarditis,
pericarditis, non-pyogenic thrombosis, Guillain-Barré syndrome, tachycardia, hypoaesthesia/paraesthesia of the skin, pulmonary embolism) – in addition to the numerous others (many of which, however, are also mild and temporary, such as headache).

Urgent data research needed

A comparison with the data for the previous year’s period also indicates a possible under-recording/under-use of the U12.9 code. For myocarditis (codes I40.8, I40.9, I51.4), an 80% increase in total cases compared to the previous year is reported. 4,478 cases in the last 9
months of 2021 were compared to 2,481 cases in the same period in 2020. Of the 4,478 total cases, 618, or about 30 per cent of the increase, were associated with a Covid 19 vaccine adverse event.

Although it cannot be excluded that other factors may have played a role in the massive increase in myocarditis cases in 2021, a possible under-reporting seems plausible. Further data research is urgently needed to clarify the situation in order to prevent possible harm to people.

Slogans and slogans can no longer help to overcome the existing uncertainties. Risks and side effects are not a banality, certainly not in the context of a mass vaccination campaign. A broader discussion and more extensive educational work on risks and side effects appear to be urgently needed.

Ulrich Adam studied history and political science in Tübingen and Cambridge (UK).

He has lived in Belgium for many years and worked, among other things, on EU regulatory issues of prescription drugs and vaccines.


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Keywords

accounting, article, Data, deaths, evaluation, germany, INEK, Insurance, myocarditis, risks, Safety, side effects, Ulrich Adam, underreporting, Vaccination, Vaccine


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Pfizer FOIA Case

Pfizer FOIA Case

Pfizer FOIA Case

Re: the Legality of Pfizer taking 75 years to release the data on its covid vaccine

 

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Facts of the Case

  • Dates: Jan 6, 2022
  • Location: USA
  • Court: US District Court for the Northern District of Texas, Fort Worth Div.
  • Case #: 4:21-cv-1058-P
  • Plaintiff: PHMPT, Plaintiff
  • Defendant: FDA
  • Trial Type: FOIA Request
  • Judge:
  • Status: Dedided
  • Verdict: for the Plaintiff


 

Background

The Firm of Attorney Aaron Siri, on behalf of Public Health and Medical Professionals for Transparency (PHMPT), and an unnamed client made a request : that the FDA produce all the data submitted by Pfizer to license its Covid-19 vaccine. [1]

The FDA asked the Court for permission to only be required to produce at a rate of 500 pages per month, which would have taken over 75 years to produce all the documents. [1]

 

This case involves the Freedom of Information Act (“FOIA”). Specifically, at issue is Plaintiff’s FOIA request seeking “[a]ll data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Events Reporting System” from the Food and Drug Administration (“FDA”). See ECF No. 1. As has become standard, the Parties failed to agree to a mutually acceptable production schedule; instead, they submitted dueling production schedules for this Court’s consideration. Accordingly, the Court held a conference with the Parties to determine an appropriate production schedule.[1] See ECF Nos. 21, 34. [2]

 

Significance

According to Siri, this case about the importance of transparency and the excessive role of : government federal “health”  authorities have had on the data needed for independent scientists to offer solutions and address serious issues with the current vaccine program – issues which include waning immunity, variants evading vaccine immunity, and, as the CDC has confirmed, that the vaccines do not prevent transmission. [1]

 

Plaintiff’s Argument

The Plaintiff argued that the documents should be made public as it has a right to know what it has bought and paid for.  The issue is about transparency and the ability of scientists and everyone involved in the management of a crisis to have the best information available in order to serve the society as efficiently and usefully as possible. [1]

No person should ever be coerced to engage in an unwanted medical procedure. And while it is bad enough the government violated this basic liberty right by mandating the Covid-19 vaccine, the government also wanted to hide the data by waiting to fully produce what it relied upon to license this product until almost every American alive today is dead. That form of governance is destructive to liberty and antithetical to the openness required in a democratic society. [1]

 

Defendant’s Argument

…More information is needed…

 

Relevant Prior Judgements/ Cases

The Court order discussed the following cases: [2]

  • “[t]he basic purpose of FOIA is to ensure an informed citizenry, [which is] vital to the functioning of a democratic society.” NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214, 242 (1977). “
  • FOIA was [therefore] enacted to ‘pierce the veil of administrative secrecy and to open agency action to the light of public scrutiny.’” Batton v. Evers, 598 F.3d 169, 175 (5th Cir. 2010) (quoting Dep’t of the Air Force v. Rose, 425 U.S. 352, 361 (1976)).
  • And “Congress has long recognized that ‘information is often useful only if it is timely’ and that, therefore ‘excessive delay by the agency in its response is often tantamount to denial.’” Open Soc’y Just. Initiative v. CIA, 399 F. Supp. 3d 161, 165 (S.D.N.Y. 2019) (quoting H.R. REP. NO. 93-876, at 6271 (1974)).
  • When needed, a court “may use its equitable powers to require an agency to process documents according to a court-imposed timeline.” Clemente v. FBI, 71 F. Supp. 3d 262, 269 (D.D.C. 2014).

 

Decision

A federal judge soundly rejected the FDA’s request and ordered the FDA to produce all the data at a clip of 55,000 pages per month! [1]

The Judge recognized that the release of this data is of paramount public importance and should be one of the FDA’s highest priorities. He then aptly quoted James Madison as saying a “popular Government, without popular information, or the means of acquiring it, is but a Prologue to a Farce or a Tragedy” and John F. Kennedy as explaining that a “nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.” [1]

According to the order: [2]

“[t]he basic purpose of FOIA is to ensure an informed citizenry, [which is] vital to the functioning of a democratic society.” NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214, 242 (1977). “FOIA was [therefore] enacted to ‘pierce the veil of administrative secrecy and to open agency action to the light of public scrutiny.’”
there may not be a “more important issue at the Food and Drug Administration . . . than the pandemic, the Pfizer vaccine, getting every American vaccinated, [and] making sure that the American public is assured that this was not [] rush[ed] on behalf of the United States . . . .” ECF No. 34 at 46. Accordingly, the Court concludes that this FOIA request is of paramount public importance. [2]
“[S]tale information is of little value.” Payne Enters., Inc. v. United States, 837 F.2d 486, 494 (D.C. Cir. 1988). The Court, agreeing with this truism, therefore concludes that the expeditious completion of Plaintiff’s request is not only practicable, but necessary.[2]
Accordingly, having considered the Parties’ arguments, filings in support, and the applicable law, the Court ORDERS that:
[2]

  1. The FDA shall produce the “more than 12,000 pages” articulated in its own proposal, see ECF No. 29 at 24, on or before January 31, 2022.
  2. The FDA shall produce the remaining documents at a rate of 55,000 pages every 30 days, with the first production being due on or before March 1, 2022, until production is complete.
  3. To the extent the FDA asserts any privilege, exemption, or exclusion as to any responsive record or portion thereof, FDA shall, concurrent with each production required by this Order, produce a redacted version of the record, redacting only those portions as to which privilege, exemption, or exclusion is asserted.
  4. The Parties shall submit a Joint Status Report detailing the progress of the rolling production by April 1, 2022, and every 90 days thereafter.

Aftermath

…More information is needed…

 


Further Research

Court Documents:
In the news:
  • …More information is needed…

other:

 

Media

……

source: ….

….

source: ….

 

References

  1. Court Orders FDA to Produce Pfizer Covid-19 Data at a rate of 500 pages per month
  2. The Judge’s Ruling / Order

 

Keyword

Aaron, Adverse reactions, CDC, Data, FOIA, Informed Citizenry, JFK, Kennedy, License, Madison, Pfizer, Secrecy, Siri, Transparency, Trial, usa, Vaccine, VAERS


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