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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?

Thanks in advance.

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