Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
LOCAL SYMPTOMS (at injection site)
occurrence of local symptoms
Item
Please fill in below and assess the occurrence of any of the following signs or symptoms
text
Item Group
Local Symptoms - Redness
Redness Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
Item Group
Local Symptoms - Swelling
Redness Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
Item Group
Local Symptoms - Induration
Induration Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
Item Group
Local Symptoms - Ecchymosis
Ecchymosis Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
Item Group
Local Symptoms - Pain
CL Item
Painful on touch (2)
CL Item
Painful when limb is moved (3)
CL Item
Pain that prevents normal activity (4)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
Item Group
OTHER LOCAL SYMPTOMS (from Day 0 to Day 20)
Description
Item
Description - please specify side(s) and site(s)
text
CL Item
Mild: An adverse event which is easily tolerated, causing minimal discomfort and not interfering with (1)
CL Item
everyday activities. (everyday activities.)
CL Item
Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. (2)
CL Item
Severe: An adverse event which prevents normal, everyday activities. (In adults/ adolescents, such an adverse would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy). (3)
Start date
Item
Start date
date
End date
Item
End date
date
Ongoing
Item
Ongoing?
boolean
Medically attended Visit?
Item
Medically attended Visit?
boolean
Trade/Generic name
Item
Trade/Generic name
text
Total Daily Dose
Item
Total Daily Dose
text
Start date
Item
Start date
date
End date
Item
End date
date
Ongoing?
Item
Ongoing?
boolean
Item Group
GENERAL SYMPTOMS
Day 0 = date of vaccination
Item
Day 0 = date of vaccination
date
Assessment of signs or symptoms
Item
Please fill in below and assess the occurrence of any of the following signs or symptoms according to the criteria listed hereafter:
text
Item Group
General Symptoms - Temperature
CL Item
Axilliary (preferred) (1)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
Item Group
General Symptoms - Fatigue
CL Item
Easily tolerated (2)
CL Item
Interferes with normal activity (3)
CL Item
That prevents normal activity (4)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
Item Group
General Symptoms - Headache
CL Item
Easily tolerated (2)
CL Item
Interferes with normal activity (3)
CL Item
That prevents normal activity (4)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
Item Group
General Symptoms - Myalgia
CL Item
Easily tolerated (2)
CL Item
Interferes with normal activity (3)
CL Item
That prevents normal activity (4)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
Item Group
General Symptoms - Shivering
CL Item
Easily tolerated (2)
CL Item
Interferes with normal activity (3)
CL Item
That prevents normal activity (4)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
Item Group
General Symptoms - Arthralgia
CL Item
Easily tolerated (2)
CL Item
Interferes with normal activity (3)
CL Item
That prevents normal activity (4)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
Item Group
General Symptoms - Sweating increase
CL Item
Easily tolerated (2)
CL Item
Interferes with normal activity (3)
CL Item
That prevents normal activity (4)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
Item Group
OTHER GENERAL SYMPTOMS
Description
Item
Description - please specify side(s) and site(s)
text
CL Item
Mild: An adverse event which is easily tolerated, causing minimal discomfort and not interfering with everyday activities. (1)
CL Item
Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. (2)
CL Item
Severe: An adverse event which prevents normal, everyday activities. (In adults or adolescents, such an adverse would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy). (3)
Start date
Item
Start date
date
End date
Item
End date
date
Ongoing
Item
Ongoing?
boolean
Medically attended Visit?
Item
Medically attended Visit?
boolean
Diary Card date
Item
PLEASE DO NOT FORGET TO BRING BACK THE DIARY CARD ON
date
contact person
Item
IN CASE OF HOSPITALISATION, PLEASE INFORM
text