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I'm seeing the following in the drug event endpoint:

enter image description here

On a "conceptual" level, it would appear that these are the same person, however, they appear in the drug event endpoint repeatedly, so I'm trying to gain a better understanding, given that openFDA only shows the most recent version. Is this an artifact of some sort of reporting error? How many individual reports are represented above?

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Those are all individual reports as submitted by the manufacturer to the FDA (as evidenced by the unqiue safetyreportid values); however, at the same time they are all duplicates of one another (as evidenced by the reportduplicate field of those records and also matching patient demographics).

In other words, your conclusion of a reporting error is very likely correct: the manufacturer appears to have submitted multiple reports in response to a single adverse event.

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  • Thank you, Dennis. This is very helpful.
    – Steve
    Jan 27 at 18:15

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