Safety Signals before March 2021

Post #659

Edit: Date errors have been fixed.

Harpaz et al. looked at VAERS data for evidence of safety signals from the COVID shots. They used many methods but the official one in use in the USA is the proportional reporting ratio, or PRR. Its the share of all reports made up by a single adverse effect, such as the share of all reports which are for pericarditis.

When the share of all reports for an adverse effect on an individual vaccine is at least twice the corresponding share of all reports for that particular adverse effect for all other vaccines, it makes for a safety signal. But another method is to set up confidence intervals around the proportions, and to look for “non-overlap”.

When repeatedly sampling from the same population, 95% confidence intervals from those samples will overlap each other more than 99% of the time. To become extremely confident in a safety signal, you can check 99% confidence intervals for non-overlap.

Pulmonary Embolism

To get the overall proportion of all mRNA shots, the Moderna reports were combined with the Pfizer reports below (a weighted proportion). Here are the shares of all reports made up by pulmonary embolism in Week 3 of 2021 (January 2021) — comparing mRNA shots to all others:

In terms easier to comprehend, for mRNA shots, 1 in every 27 (3.8%) of the adverse event reports to VAERS in Week 3 of 2021 were for pulmonary embolism, but for all other injections, only 1 in every 165 reports were for pulmonary embolism (0.6%).

To make sure the signal is robust, here are the 99% confidence limits (lower limit for mRNA, upper limit for all other shots):

Even though 99% confidence intervals on the proportion of all reports comprised by pulmonary embolism shows such high significance, pulmonary embolism was still not mentioned in the warning section of the product labels for mRNA shots, even as late as June 2022.

In other words, high significance existed in January 2021, but 1.5 years later, it was still not being recognized. Talk about an abject failure of pharmaco-vigilance!

Pericarditis

Here are the results for “pericarditis” in Week 7 of 2021 (February 2021):

And here are the 99% confidence limits on those proportions:

Evidence suggests that, before March 2021, two strong safety signals were present in the data, but were overlooked by regulatory authorities for months-to-years.

Reference

[proportional reporting in VAERS] — Harpaz R, DuMouchel W, Van Manen R, Nip A, Bright S, Szarfman A, Tonning J, Lerch M. Signaling COVID-19 Vaccine Adverse Events. Drug Saf. 2022 Jul;45(7):765-780. doi: 10.1007/s40264-022-01186-z. Epub 2022 Jun 23. PMID: 35737293; PMCID: PMC9219360. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9219360/