3 ms·
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 t
by pseudalopex 6y ago
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.
- timr 5y agoI 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 https://www.fda.gov/media/144413/download
- pseudalopex 5y agoYou 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"