In my last post I talked about how in pharmacovigilance we have to make sure we have valid reports meaning a identifiable reporter, patient, adverse event and a suspect drug/vaccine/molecule. Once we are clear we have valid report with all 4 criteria meeting the report we can proceed further to look into does the reported event qualify as serious or not. Now I have a severe headache? Does this make it serious adverse event? Do you consider headache as serious event each time?
No, in real world when you are looking at patient we do not quantify headache immediately as serious, in same way in PV(Pharmacovigilance) too we don't label everything as serious if it says severe or mentioned words that denote severity. Now lets look at same example, I have severe headache that i am admitted in hospital for 2 days now. So now we can say this is pretty serious. In PV world too this will be…
