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I figured it might be worth a shot to pose this question here. We are analyzing adverse event data from openFDA related to a specific product. As an exercise, we looked at specific events over a 10-year period and compared the data from openFDA to the manufacturer's own pharmacovigilance (PV) data. We found that the PV data contains cases that are not in openFDA, and openFDA contains cases that are not in the PV data. We were hoping to see better alignment between the two sources and are struggling to account for the differences since identical criteria were used to query both sources.

Perhaps a long shot; however, would anyone be able to provide a plausible explanation for why discrepancies might exist between the two sources?

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Could it be more accurate if you compare data of both resources by year? For example, in year 2018 what events were reported on both platforms, something like that.

I really don't know for sure but I expected that the adverse events on OpenFDA could be reported directly by pharma companies and consumers of all manufacturers while the data from PV could be reported by their own consumers of a specific manufacture or of specific ingredients of a product.

I've been working on a few heath AI projects including SAEs for disabilities for 2 years now and we're going to try to combine both resources this year, so that our end-users won't get duplication data in the search filtering. During the changes process, I tried a small set of data from both resources for the past recent year. It turns out that 20% of data from both resources are identical events. If I have some time next couple weeks, I can try out 5 to 10 years data to see how big the differences are.

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