Comment by timr | Hacker News Reader

Comment by timr | Hacker News Reader

Parent Full thread

The definition:

"Serious adverse events are defined as: • Death; • A life-threatening adverse event; • Inpatient hospitalization or prolongation of existing hospitalization; • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; • A congenital anomaly/birth defect; • An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above."

So 4 out of the 6 criteria are, in fact, life-threatening, one is "your life is permanently altered, sorry", and the final one is irrelevant.

(and no, despite your link to the other thread, "persistent or significant incapacity" does not include "a sick day")

> And there was no pattern either.

They didn't release the raw data, so there's no way for you to know that.

>"persistent or significant incapacity" does not include "a sick day"

It does, actually. From the UI Medcom link: "symptoms that preclude patient from attending work, school or perform their typical daily activities"

I gave you the definition, from the approval document itself. This is the definitive answer, not some unrelated article about VAERS.

https://www.fda.gov/media/144413/download

https://news.ycombinator.com/item?id=27217737

The question is what substantial means. I believe hvac's credible source over your forceful assertion.

Serious adverse events have to be reported to VAERS. I think the FDA would notice if Pfizer lied about there being no pattern.

I quoted directly from the approval document on the FDA website. The other poster is linking to some unrelated thing about VAERS.

https://www.fda.gov/media/144413/download

You quoted the part of the fact sheet about reporting serious adverse events to VAERS. The University of Iowa page is about the same thing exactly. They quoted the same definition. The only differences were they abbreviated adverse event and gave examples.

"A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; e.g. symptoms that preclude patient from attending work, school or perform their typical daily activities"

Reply on news.ycombinator.com