[mdj930]

Originally Posted by LEAKYSEALS951

FAQS:Also report any additional select AEs and/or any revised safety reporting requirements per FDA’s conditions of authorized use of vaccine(s) throughout the duration of any COVID-19 Vaccine being authorized under an Emergency Use Authorization (EUA).

AE defined as:
Serious AEs regardless of causality. Serious AEs per FDA are defined as:
Death;
A life-threatening AE;
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.

Goodnight folks. I'm out.

Works perfect
Just ask Hank Aaron

Mike