Supplemental Qualifiers for AE

Data Value
unknown etiology but headache is more than 7 days post COVID vaccine
no organic cause; multiple life stressors
Most likely due to anxiety/fear of receiving an injection
Local adenopathy. Do not think related to study agent
bacterial infection secondary to puncture wound
Inadequate Medication treatment for depression
overuse injury from running, patellar tendonitis
Environmental, unknown source, per investigator.
Mild swollen lymph node from probable microbial infection, per investigator. (b)(6)
subject chipped tooth while eating hard candy
ESCHERICHIA COLI INFECTION, SELF LACERATION