VAERS is supposed to be the starting point for differentiating between adverse events and adverse effects. So, what 8s your point?
If VAERS is moderated, it is no longer a self-reporting system.
“VAERS is supposed to be the starting point for differentiating between adverse events and adverse effects. So, what 8s your point?”
That is my point. Starting point.
The author uses adverse effect incorrectly. Adverse event refers to everything. The starting point, as you put it. In a clinical trial anything that happens is an adverse event. This literally includes getting hit by a bus, falling down, breaking an arm etc... Anything and everything must be recorded.
These are adverse events that occur to participants in a trial and to be comprehensive must be recorded and included in trial data.
This is the start, to use your terminology again.
Adverse events are examined to determine if they were test substance related, in other words were they caused by the test substance,mare they an effect of the test substance.
If so they are recorded as adverse effects.
Adverse affects are adverse events that can be attributed to the test substance.
It is dishonest to use adverse event data and present it as adverse effect.