CDC/FDA assessments confirm emergent black-box-worthy safety signals

ICAN PRR data on VAERS - Proportional Reporting Ratios (PRR) are off the scales

First off, thank you to Aaron Siri and Elizabeth Brehm and ICAN for all of their diligence in fighting to get this data to all of us.

BREAKING: ICAN Acquires Critical FDA Safety Reports Concerning COVID-19 Vaccines After Years of Litigation.

Just as a reminder, a PRR>2 means there’s a safety signal. I have written articles on the PRR and related issues here, here, here, here and here, to list a few. Josh Geutzkow wrote this up too and you can read about that here and here.

According to CDC's VAERS Standard Operating Procedures, a “safety signal” is defined as a condition that has a PRR>=2.00, N>=3, and Chi-Square>=4.00.

I decided to focus on the serious 12-17 year old data in the Table5 PRR of PTs for COVID19 mRNA Compared to 2009_2022 NON-COVID19_05.27.2022 from the Weekly PRR Tables 3-5 May 27 2022 file, because I was most interested to see the what signals associated with myocarditis in kids they found. Let’s just say, I am not surprised by what I saw, but very angry that - not only was this was hidden - but I and others have been reporting these exact findings for years now, and been ignored by public health officials.

To this day, I have not received an answer from the CDC as to why they have not done and made transparent causality assessments using VAERS data.

Here’s some of the now viewable signals, that yes, were there all along. This is truly criminal.

Source: Weekly PRR Tables 3-5 May 27 2022; Table 5PRR of PTs for COVID19 mRNA Compared to 2009_2022 NON-COVID19_05.27.2022 - SERIOUS 12 Yrs-17 Yrs. https://icandecide.org/cdc-proportional-reporting-ratio/

As you can see, those PRR numbers for myocarditis and myocarditis-associated symptoms are much higher than 2. These aren’t just safety signals: these products need warning labels and black box ones at that.

Here’s Figure 1 from our paper on Myocarditis from 2021 that got force-withdrawn and republished 3 years later.

Figure 2: Figure 1 extracted from Rose J, Hulscher N, McCullough PA. Determinants of COVID-19 vaccine-induced myocarditis. Therapeutic Advances in Drug Safety. 2024;15. doi:10.1177/20420986241226566.

And here’s where I calculated PRR for death in my 2021 paper. 2021.

Figure 3: Snapshot from Discussion Section. Source: Rose J. Critical Appraisal of VAERS Pharmacovigilance: Is the U.S. Vaccine Adverse Events Reporting System (VAERS) a Functioning Pharmacovigilance System?. Science, Public Health Policy and the Law. 2021 Oct 01; v3.2019-2024

I am so disgusted by this. All this heart damage was preventable.

THM: This is VAERS data (from December 2020- May 2022) and PRR analysis - U.S. government data and analytic means. No interpretation. Why was this not published years ago? How many young hearts have been destroyed since then?

Why are these products so clearly associated with harms still on the market?