Serious Case Safety Reports

Post #815

In the European Economic Area (EEA), there were 729 million COVID shots given out by the end of 2021:

But when looking at the number of serious individual case safety reports (ICSRs) to the EudraVigilance system (Europe’s version of drug and vaccine surveillance), then you find an astonishing increase in reports for 2021:

The left column refers to only Euro Area reports, and 2020 only had 812,784 total reports, or an average of 2,227 reports per calendar day in 2020. COVID-related reports weren’t itemized back then, because under 300,000 total COVID shots went out prior to 1 Jan 2021.

The itemized numbers for 2021 and 2022 at bottom-left show that serious ICSRs for COVID shots (484,307) ran higher than all serious ICSRs for all of the 6,000 or so medical substances approved in the EU for the years of 2019 and 2020. That’s one type of thing being higher than 6,000 other types of things put together.

While COVID shot uptake reduced dramatically in 2022, serious ICSRs did not.

This suggests that COVID shots were “becoming more dangerous” over time. When CDC examined VAERS data for an 11-year span, the rate of serious adverse event reports (serious AERs) turned out to be only 9.6 per million net doses distributed. But in 2021 in the EU, the reporting rate was 362 serious ICSRs per million doses.

That suggests that COVID shots are 38 times more dangerous than typical vaccines. But the story gets worse. In 2022, only 182 million COVID shots were given in the EU. But that didn’t stop, or appreciably slow down, the influx of serious ICSRs. The 2022 rate of serious ICSRs for COVID shots was 1,408 per million doses.

That’s 147 times more dangerous than typical vaccines. Even if event capture rates rose, so that a much greater share of all underlying reports were getting reported, you cannot explain away a 147-fold increase in the reporting rate for serious reactions.

Reference

European Medical Agency (EMA) report. https://www.ema.europa.eu/en/documents/report/report-pharmacovigilance-tasks-eu-member-states-and-european-medicines-agency-ema-2019-2022_en.pdf

CDC report on 11-years of VAERS data. https://www.cdc.gov/mmwr/preview/mmwrhtml/ss5201a1.htm

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