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What are the Foreign Reports and why do we include them?

Published on
06 August 2022

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Wonder has very little to say on the issue of what a nondomestic report is. From their Advisory Guide:

“VAERS occasionally receives case reports from US manufacturers that were reported to their foreign subsidiaries. Under FDA regulations, if a manufacturer is notified of a foreign case report that describes an event that is both serious and unexpected (in other words, it does not appear in the product labeling), they are required to submit it to VAERS. It is important to realize that these case reports are of variable data quality and completeness, due to the many differences in country reporting practices and surveillance system quality.“

The strange thing about this is VAERS implies here that the Foreign Reports are occasional and insignificant. The numbers say otherwise. The Foreign Reports make up close to half of the reports in VAERS and more than half the deaths. For further breakdowns on Foreign Reports you can also look here:

We use the foreign records by default because the VAERS data is the data and we are 'OPENVAERS' not 'OPEN USONLY VAERS'. This is true of the Wonder site as well. You can access all the data not just the US data. One thing to keep in mind is the "US Reports" in the Wonder system include territories and unknowns. It is not a true breakdown of JUST US state data. Additionally, as seen below, the Foreign data contains mistakes of US data marked as "FR".

Here is a breakdown of the distribution of Foreign Reports as of July 29, 2022. Like the Lot Numbers these figures must be taken with a grain of salt due to the really error prone and messy nature of the data in this field*. These numbers are drawn from the data without any cleaning (this is how we do all the numbers). These are the countries with >500 reports per country code.

* These reports are marked as Foreign (come in the Foreign data files) and are marked with type "WA" which normally would be Washington State. No way to know what these are, they are not COVID reports, they are dated from 1990-2016. There are also 200+ reports from the US that are in the Foreign set (not visible on this graph).

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