Serious vs. Severe Challenge

Master the critical distinction between severity and seriousness

Role: Drug Safety Case Processor

Context: Your QC reviewer has flagged several cases where previous processors made seriousness determination errors. This is a common problem area.

Task: Correctly classify each case and understand the reasoning.

Step 1 of 3

Case 1: The Severe Headache

case

A 34-year-old female reports SEVERE headache lasting 3 days after starting Study Drug. She rated pain as 9/10 and was unable to work for 2 days. She took OTC ibuprofen at home and the headache eventually resolved. She did not seek any medical attention.

Is this case SERIOUS per regulatory criteria?