This term corresponds to item 26 in the Vaccine adverse event reporting system (VAERS) form. Serious, unexpected adverse experiences must be submitted to the FDA no later than 15 calendar days of initial receipt of the information by the applicant. Check yes if this report meets criteria specified in the biologic regulations for reports of serious and unexpected adverse events (21 CFR section 600.80).
status
ACTIVE
Fully-Specified Name
component
15 day report
property
Find = Finding
time
Pt = Point in time: To identify measures at a point in time. This is a synonym for “spot” or “random” as applied to urine measurements.
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