The new american links to this url, which it claims is an FDA document that (even though it's not an FDA URL):
https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf
Within this document to which the new american links, it says the following:
AE= adverse event
[begin quote]
• Reports are submitted voluntarily, and the magnitude of underreporting is unknown. Some of the factors that may influence whether an event is reported include: length of time since marketing, market share of the drug, publicity about a drug or an AE, seriousness of the reaction, regulatory actions, awareness by health professionals and consumers of adverse drug event reporting, and litigation.
• Because many external factors influence whether or not an AE is reported, the spontaneous reporting system yields reporting proportions not incidence rates. As a result, it is generally not appropriate to make between-drug comparisons using these proportions; the spontaneous reporting system should be used for signal detection rather than hypothesis testing.
• In some reports, clinical information (such as medical history, validation of diagnosis, time from drug use to onset of illness, dose, and use of concomitant drugs) is missing or incomplete, and follow-up information may not be available.
• An accumulation of adverse event reports (AERs) does not necessarily indicate that a particular AE was caused by the drug; rather, the event may be due to an underlying disease or some other factor(s) such as past medical history or concomitant medication.
[end quote]
Foxy did you read this before you posted it? It doesn't seem to fit your narrative.