{"id":84908,"date":"2021-09-20T06:17:35","date_gmt":"2021-09-20T10:17:35","guid":{"rendered":"http:\/\/stateofthenation.co\/?p=84908"},"modified":"2021-09-20T06:23:53","modified_gmt":"2021-09-20T10:23:53","slug":"as-of-march-2021-262383-of-the-904534-cases-of-covid-vaccination-adverse-side-effects-were-severe","status":"publish","type":"post","link":"http:\/\/stateofthenation.co\/?p=84908","title":{"rendered":"

As of March, 2021, 262,383 of the 904,534 cases of Covid vaccination adverse side effects were severe<\/b><\/h2>"},"content":{"rendered":"

Update 3.9 .: EMA database: 262,383 of the 904,534 suspected cases of Covid vaccination side effects are severe<\/h1>\n

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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.<\/span>\u00a0<\/span><\/p>\n

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). <\/span><\/p>\n

Almost a third of them are categorized as difficult.<\/span><\/p>\n

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.<\/span><\/p>\n

In the EMA EudraVigilance database, the data for the following vaccines are listed together with the medicinal products:<\/span><\/p>\n

Covid-19 mRNA Vaccine Pfizer-Biontech (Tozinameran)<\/span><\/p>\n

Covid-19 Vaccine Astrazeneca (Chadoxi NCoV-19)<\/span><\/p>\n

Covid-19 mRNA Vaccine Moderna (CX-024414)<\/span><\/p>\n

Covid-19 Vaccine Janssen (AD26.CoV2.S)<\/span><\/p>\n

For the significance of EMA suspected side effects, we refer to our EMA database report<\/u><\/a> .<\/span><\/p>\n

Reported suspected cases in the EMA EudraVigilance database<\/strong><\/span><\/p>\n

On 09\/03\/21 the following were listed in the EudraVigilance database:<\/span><\/p>\n

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Transparency test, raw data EMA EudraVigilance: Suspected cases of side effects Covid vaccines, 03.09.21<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n

In total, the EudraVigilance database shows 904,534 personal suspected cases (ADR report). These include all cases from mild to life threatening.<\/span><\/p>\n

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Transparency test Archi.medes, EMA Increase in suspected cases of side effects, 29.05.-03.09.21<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n

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.<\/span><\/p>\n

Percentage of suspected side effects reported by doctors, clinical staff, Biontech 9\/11\/21<\/strong><\/span><\/p>\n

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EMA EudraVigilance reporting group for suspected cases of side effects, Biontech Covid vaccine 11.09.21<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n

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.<\/span><\/p>\n

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.<\/span><\/p>\n

The reports are usually first sent to the national competent authorities (Germany PEI). These cases are often filtered and then reported to the EMA.<\/span><\/p>\n

What proportion do the reported suspected Covid vaccination cases make up in the EMA database?<\/strong><\/span><\/p>\n

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<\/strong> almost exactly 50% of the 1,821,211<\/strong> suspected side effects of all 5,042 substances listed there for drugs \/ vaccinations in 2020<\/strong> .<\/span><\/p>\n

That is incredibly high.<\/span><\/p>\n

Overview Serious Side Effects Biontech \/ Pfizer Vaccine<\/strong><\/span><\/p>\n

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EMA EudraVigilance suspected cases Serious side effects, Biontech Covid vaccine 09\/11\/21.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n

The “Serious Side Effects” category excludes deaths.<\/span><\/p>\n

Serious side effects, which are so categorized by the EMA, are also severe. The EMA defines this in its interpretation instruction as follows:<\/span><\/p>\n

“Most important is the spontaneous reporting of serious or previously unknown suspected side effects. A side effect is considered serious if it <\/em><\/span><\/p>\n