The US Food and Drug Administration MedWatch System Is Activated When

The U.S. Food and Drug Administration MedWatch system is activated when:

A) There is an adverse event to a vaccine
B) A patient has a severe reaction that is noted in the "Severe Reaction" section on the medication label
C) A lactating woman takes a medication that is potentially toxic to the breastfeeding infant
D) An adverse event or serious problem that is not already identified on the label occurs