Vaccine Administration
Vaccine
Only one box must be ticked by vaccine
text
if Replacement vial, record number
integer
If Wrong vial number, please record the correct one
integer
Side/ Site/ Route
Administration according to Protocol
Has the study vaccine been administered according to protocol?
boolean
If No, please tick all items that apply: Side
integer
Site
text
Route
text
Comment
text
Vaccine 2
Only one box must be ticked by vaccine 2
text
if Replacement vial, record number
integer
If Wrong vial number, please record the correct one
integer
Side/ Site/ Route
Administration according to Protocol
Has the study vaccine been administered according to protocol?
boolean
If No, please tick all items that apply: Side
integer
Site
text
Route
text
Comment
text
Non administration
Please tick the ONE most appropriate category for non-administration
text
If SAE, record the event number
integer
If Non-SAE, record the event number
integer
e.g., consent withdrawal, protocol violation, etc
text
Please tick who took the decision
text
Immediate Post-Vaccination Observation
If any adverse events occurred during the immediate post-vaccination time (30 min), fill in the SAE or Non-SAE form.
text
Any other vaccines administered must be recorded in the Concomitant Vaccination form
text