As of March, 2021, 262,383 of the 904,534 cases of Covid vaccination adverse side effects were severe

Update 3.9 .: EMA database: 262,383 of the 904,534 suspected cases of Covid vaccination side effects are severe

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The reported suspected side effects for the four Covid vaccines, which are conditionally approved in the EU, are record-breaking after just 8 months. Serious side effects and first deaths have also been reported in children who have not yet been vaccinated. 

The European Medicines Agency EMA currently lists 904,534 personal suspected cases with a total of 3,478,979 individual side effects to the Covid vaccines (as of 03.09.21).

Almost a third of them are categorized as difficult.

The four Covid vaccines have only been approved to a limited extent in the EU to this day. Approval phase 4 is currently running. The final evaluation reports are not expected until the end of 2022 or 2023.

In the EMA EudraVigilance database, the data for the following vaccines are listed together with the medicinal products:

Covid-19 mRNA Vaccine Pfizer-Biontech (Tozinameran)

Covid-19 Vaccine Astrazeneca (Chadoxi NCoV-19)

Covid-19 mRNA Vaccine Moderna (CX-024414)

Covid-19 Vaccine Janssen (AD26.CoV2.S)

For the significance of EMA suspected side effects, we refer to our EMA database report .

Reported suspected cases in the EMA EudraVigilance database

On 09/03/21 the following were listed in the EudraVigilance database:

EMA EudraVigilance: Suspected cases of side effects Covid vaccines, 03.09.21

Transparency test, raw data EMA EudraVigilance: Suspected cases of side effects Covid vaccines, 03.09.21

In total, the EudraVigilance database shows 904,534 personal suspected cases (ADR report). These include all cases from mild to life threatening.

 
Transparency test Archi.medes, EMA Increase in suspected side effects, 29.05.-03.09.21

Transparency test Archi.medes, EMA Increase in suspected cases of side effects, 29.05.-03.09.21

The total number of all suspected cases reported to the EMA increased by over 80 percent in the period 29.05.21 – 03.09.21.

Percentage of suspected side effects reported by doctors, clinical staff, Biontech 9/11/21

EMA EudraVigilance Reporting Group Suspected Side Effects, Biontech Covid Vaccine 09/03/21

EMA EudraVigilance reporting group for suspected cases of side effects, Biontech Covid vaccine 11.09.21

Contrary to some representations, the majority of the reports are made by staff from the health sector such as clinics or medical practices. At Biontech it is around 46% that are reported by EU medical practices / clinics.

This speaks for a solid database. Added to this are the control and monitoring mechanisms of the EMA, which have been tried and tested over many years, in order to secure the best possible data sets.

The reports are usually first sent to the national competent authorities (Germany PEI). These cases are often filtered and then reported to the EMA.

What proportion do the reported suspected Covid vaccination cases make up in the EMA database?

If you follow the information in the 2020 annual report, the 904,534 suspected Covid vaccination cases in the period of just 8 months from 2021 account for almost exactly 50% of the 1,821,211 suspected side effects of all 5,042 substances listed there for drugs / vaccinations in 2020 .

That is incredibly high.

Overview Serious Side Effects Biontech / Pfizer Vaccine

EMA EudraVigilance Suspected Serious Side Effects, Biontech Covid Vaccine 09/11/21

EMA EudraVigilance suspected cases Serious side effects, Biontech Covid vaccine 09/11/21.

The “Serious Side Effects” category excludes deaths.

Serious side effects, which are so categorized by the EMA, are also severe. The EMA defines this in its interpretation instruction as follows:

“Most important is the spontaneous reporting of serious or previously unknown suspected side effects. A side effect is considered serious if it

  • is life-threatening or has a fatal outcome ;

  • a stationary receiving in the hospital or a prolongation of an existing hospitalization makes necessary;

  • leads to persistent or significant disability or incapacity for work; or

  • represents a congenital abnormality / birth defect. ”

It is therefore frightening how high the proportion is even in the large groups. Over 80,000 serious side effects that are temporally related to the Biontech / Pfizer vaccination are already listed in the general diseases category. In categories like heart disease or immune system disorders, serious illnesses make up the vast majority of cases.

In the heart disease category currently being discussed in the media, there are three quarters: myocardial infarction, cardiac arrest, myocarditis, angina pectoris … the list of reported heart diseases is long. The effects can sometimes last a lifetime or lead to premature death.

In terms of serious side effects, most of the suspected cases of all 4 Covid vaccines occurred in the nervous system organ class. Unlike heart disease, for example, this has not yet been addressed by the media.

The following figures and graphics refer to the daily report of September 3rd, 21st of the group vaccine side effects net, which compiled the cases on the basis of the EMA raw data and ADR reports.

Overview of reported suspected serious side effects and deaths

 Vaccination side effects net EMA raw data, serious side effects and deaths, 03.09.21

Transparency test, vaccine side effects net EMA raw data, serious side effects and deaths, 03.09.21

Up to September 3rd, 21st the EMA database contained 262,383 suspected cases (ADR reports) of serious side effects. Of these, 19,761 are classified as life-threatening, 77,842 cases required hospitalization, and 18,329 result in ongoing secondary illnesses. There are 14,167 deaths.

Serious suspected side effects mRNA Covid vaccines by number

Transparency test Archi.medes, EMA reported suspected cases of serious side effects mRNA Covid vaccines, 09/03/21

Transparency test Archi.medes, EMA reported suspected cases of serious side effects mRNA Covid vaccines, 09/03/21

Serious suspected side effects mRNA Covid vaccines

every 1,000,000 people vaccinated with at least one vaccination dose

Transparency test Archi.medes, EMA reported suspected cases of severe side effects mRNA Covid vaccines per 1,000,000 vaccinations, 09/03/21

Transparency test Archi.medes, EMA reported suspected cases of serious side effects mRNA Covid vaccines per 1,000,000 vaccinations, 09/03/21

 
 
Vaccine side effects net, deaths according to clinical picture, daily report 03.09.21

Vaccine side effects net, deaths according to clinical picture, daily report 03.09.21

 

If one analyzes the deaths not according to organ class, but according to clinical picture, it becomes apparent that a particularly large number of suspected cases can be assigned to clinical pictures with rapid or abrupt consequences of death: Unexpected death, heart attack, dyspnoea, thrombosis & embolism, stroke speak a clear language here.

 

This fits in with the side effects of the Covid mRNA vaccinations that were forecast by critics at the turn of the year. They suspected that the continuously formed spikes in the bloodstream could lead to severe vascular problems – similar to severe Covid courses. The warning from the PEI in autumn 2020 regarding the spike problem in severe Covid diseases also pointed in the same direction. Even if the PEI warning was actually aimed at Covid diseases.

 

It is empirically conspicuous that these numbers have not yet occurred in any drug group or in vaccines. In the case of vaccines, this applies to both the absolute and the relative numbers in cases per 1,000,000 vaccinations.

 
Vaccination side effects net, serious cases according to age, daily report 09/03/21

Vaccination side effects net, serious cases according to age, daily report 09/03/21

 

It is noticeable here that, unlike Covid diseases, there is a dominant accumulation in the age group of 18-64 years. Unfortunately, the EMA does not provide differentiation for this large age group. A division into several age groups would be good. It would also be transparent if the relative risk or suspected cases per 1,000,000 vaccinations for different age groups were indicated by the EMA at the same time.

 

180,153 of 262,383 cases – two thirds – happen in this young to middle group, who are normally not often affected by Covid diseases. This aspect must definitely be included in the risk-benefit assessment.

 
Vaccination side effects net, life-threatening cases according to age, daily report 03.09.21

Vaccination side effects net, life-threatening cases according to age, daily report 03.09.21

 

The same applies to life-threatening incidents. Here, too, the young middle age group is particularly affected.

 
Vaccination side effects net, serious side effects in children / adolescents, daily report 03.09.21

Vaccination side effects net, serious side effects in children / adolescents, daily report 03.09.21

 

EMA suspected serious side effects of vaccination in children:

 

Around 320 children’s myocarditis,

140 children with acute heart disease,

70 children paralysis,

50 children thrombosis embolism

20 children each with stroke, lung disease, kidney damage.

 

And that in this short time and although so far only small parts of the children / adolescents have been vaccinated with the mRNA.

 

It should also be borne in mind that the number of unreported cases is estimated at between 94% -97% according to meta-studies.

 

Comparison with pediatric intensive care patients due to Covid disease

 

According to the RWI Annual Report 2020 on behalf of the Federal Ministry of Health, in 2020 exactly 120 children were in German intensive care units because of Covid. That is 0.33%. The remaining 99.66% intensive care patients were thus adults.

 

The 120 children were also only PCR positive confirmed cases. It is unknown whether there were also typical symptoms of Covid, as this is not collected and documented as standard. Furthermore, it is clearly indicated in the RWI annual report that multiple counts can occur, e.g. when moving from one station to another.

 
Vaccination side effects net, deaths in children / adolescents, daily report 03.09.21

Vaccine side effects net, deaths in children / adolescents, daily report 03.09.21

So far there have been 35 deaths in children up to 17 years of age.

 

As a reminder: Since children and adolescents have not yet been vaccinated, the number of cases cannot yet be as high as in adults.

That will change dramatically soon. Targeted vaccination for the age group 12-17 years has just started. In Germany, just over 1 million out of 15.2 million children and adolescents under the age of 20 were vaccinated at the beginning of August.

 

Here, too, the reminder: The German Paul Ehrlich Institute PEI in particular has one of the highest reporting delays to the EMA in the EU.

 

We reported on the delays in reporting to the EMA and the Safevac app . Many suspected cases arrive too late or not at the EMA. It is not possible to report directly from those affected or from medical practices / clinics to the EMA from Germany. It’s all about the PEI.

 

Seen in this light, the 35 suspected deaths in children due to mRNA vaccination in this short time are very worrying. This must also be related to the reported Covid deaths in children. Only every 600,000 th child / adolescent up to the age of 20 has died in Germany since the start of the pandemic up to August 31, 21. According to Destatis, that’s 25 cases.

We reported the extremely low Covid death rate among children .

 

A request from the FDP parliamentary group to the federal government on March 15th, 21st resulted in even lower numbers: Only 10 Covid deaths so far under 20 year olds. 8 of them had previous illnesses.

 

Comparison with other vaccines

 

The number of reported Covid vaccination side effects depends on the number of vaccinations. This aspect must not be forgotten. How high the extent is is difficult to estimate without reference. Because these numbers depend on the population of vaccinations. Of course, the number of vaccinations has also increased. We had therefore related the Covid 19 vaccinations to other vaccines, see our article Comparison with other vaccines . These numbers and the following two charts refer to the numbers from the WHO database. 90% of this data comes from America (US VAERS) and Europe (EMA). Europe alone with 52%.

 
 

Comparison of Covid, Polio, TBC suspected vaccination side effects by category per 1,000,000 people vaccinated with at least one vaccination dose.

Transparency test, VigiAccess: Covid, Polio, TBC V side effects acc. To Kat per 1,000,000 vaccinated, 29.8.21

Transparency test, VigiAccess: Covid, Polio, TBC V side effects acc. To Kat per 1,000,000 vaccinated, 29.8.21

 

Blue = Covid mRNA vaccination

Red = polio vaccination

Green = TBC vaccination

 

This graph compares the vaccines in the main categories according to individual side effects. Here, too, based on 1,000,000 people vaccinated with at least one vaccination dose.

 

For the individual side effects, the Covid vaccinations are 17 times higher than for polio . Compared to the tuberculosis vaccination, this increases three-digit by a factor of 103 .

 
 

Comparison of Covid, Polio, TBC Suspected cases of vaccination Deaths in total per 1,000,000 people vaccinated with at least one vaccination dose.

Transparency test, VigiAccess: Covid, Polio, TBC V deaths per 1,000,000 people vaccinated, August 29, 21

Transparency test, VigiAccess: Covid, Polio, TBC V deaths per 1,000,000 people vaccinated, August 29, 21

 

In terms of deaths based on 1,000,000 vaccinations, Covid vaccinations result in 16 times more deaths than polio vaccinations and 108 times more deaths compared to tuberculosis vaccination.

 

This proves that the Covid vaccinations are many times over (two to three-digit factor) compared to previous established vaccinations.

 

When comparing the individual most common categories, the differences are dramatic. The cases for polio can just be shown or seen on this graphic. The suspected cases of side effects for the TB vaccination are so small compared to the Covid vaccinations that they are no longer visible – except in the general diseases category.

 

Transparency test summary

 

The record number of suspected cases of serious side effects with Covid vaccines cannot be dismissed out of hand. Nor can they be glossed over with any arithmetic or argumentation tricks. They speak a clear language: action must be taken immediately. The suspected cases must be examined and clarified in detail.

 

If you want to continue to ignore that, you just keep pushing the growing problem ahead of you. Behind every number is an individual fate and a potentially avoidable tragedy. Each case will have an impact on our health system and cause enormous follow-up costs.

 

The large monitoring systems such as WHO VigiAccess, EMA EudraVigilance or US VAERS still work halfway when reporting. But it can also be stated that the figures can be anything but complete. We have already pointed out enormous differences in the message.

 

At the latest, however, when processing the ADR case reports, it does not seem to be correct. Obviously nothing is happening. Are warning signs being ignored here? Why don’t you react?

  • Why don’t we citizens ask our direct candidates for the state or federal elections to clarify these issues as quickly as possible?

  • Why don’t the members of the state parliament and the Bundestag take action themselves and submit requests for clarification?

  • How long can the big media continue to ignore this imbalance?

  • Why don’t the big media do investigative research on this complex of topics, which affects the health of all citizens worldwide?

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https://www.transparenztest.de/post/update-3-9-ema-datenbank-262383-der-904534-verdachtsfaelle-covid-impf-nebenwirkungen-sind-schwer

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