Non-Serious Adverse Events
If yes, fill in the next itemgroup once per NSAE.
boolean
Non-Serious Adverse Events Details
AE No
integer
Non-Serious Adverse Event Description
text
if at administration site, fill in next item
text
Non-Serious Adverse Event vaccine administration site
text
(for GSK)
text
Date Non-Serious Adverse Event Started
date
Non-Serious Adverse Event Start Date immediately post vaccination
boolean
Date Non-Serious Adverse Event Stopped
date
1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice).
integer
Is there a reasonable possibility that the AE may have been caused by the investigational product? NO: The adverse event is not causally related to administration of the study vaccine(s). There are other, more likely causes and administration of the study vaccine(s) is not suspected to have contributed to the adverse event. YES: There is a reasonable possibility that the vaccine contributed to the adverse event.
boolean
Not recovered / Not resolved: AE is ongoing at the time the subject completes the study or becomes lost to follow-up
integer