Has any non-serious adverse event occurred within one month post-vaccination, excluding those recorded on the Solicited AE forms?
Item
Has any non-serious adverse event occurred within one month post-vaccination, excluding those recorded on the Solicited AE forms?
boolean
If Yes, please complete the section below
Item
If Yes, please complete the section below
text
Description
Item
Description
text
Item
Administration sites
text
Code List
Administration sites
CL Item
DTPw-HBV/Hib Kft vaccine (1)
CL Item
DTPw-HBV Kft vaccine (2)
CL Item
HiberixTM vaccine (3)
CL Item
Non-administration site (4)
Date Started
Item
Date Started
date
Date Stopped
Item
Date Stopped
date
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered with sequelae/resolved with sequelae (4)
Medically attended visit
Item
Medically attended visit
boolean
Item
If Yes, record the type of visit
text
Code List
If Yes, record the type of visit
CL Item
Hospitalisation (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)