2 ms·

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/144

• pseudalopex 5y ago
  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"