Exploring regulatory data sets of the Comirnaty vaccine - 12a

What does the FDA package insert and SmPC report about the harms outcomes that matter?

The Package inserts provide warnings and precautions that report those serious side effects that might occur, and the recipient of the vaccine should be made aware of them.  

The European regulators consider myocarditis and pericarditis “very rare” (< 1/10 000), whereas the FDA report the chance is “very low”. The FDA considers serious, low-frequency adv…