Diary Cards for Dose 2 (Primary)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Item
Dose Number
text
Dose Number
Code List
Dose Number
CL Item
Dose 1 (1)
CL Item
Dose 2 (2)
CL Item
Dose 3 (3)
Subject Number
Item
Subject Number
integer
Item Group
Dose 2 - Local Symptoms - Vaccine 1
signs or symptoms at injection site
Item
Please fill in the section below and assess the occurrence of any signs or symptoms at injection site
text
Item
Side of injection
text
Injection side
Code List
Side of injection
CL Item
Left (1)
CL Item
Right (2)
Item
Site of injection
text
Injection site
Code List
Site of injection
CL Item
Arm (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item Group
Redness (Local Symptoms)
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Size
Item
Size
float
Ongoing after day 3?
Item
Is the symptom ongoing after day 3?
boolean
last day of symptoms
Item
If Yes, please record the last day of symptoms
date
medically attended visit
Item
Was the visit medically attended?
boolean
Item Group
Swelling (Local Symptoms)
Item
Day
text
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Size
Item
Size
float
Ongoing after day 3?
Item
Is the symptom ongoing after day 3?
boolean
last day of symptoms
Item
If Yes, please record the last day of symptoms
date
medically attended visit?
Item
Was the visit medically attended?
boolean
Item Group
Pain (Local Symptoms)
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Intensity
integer
Intensity
Code List
Intensity
CL Item
absent (1)
CL Item
minor reaction to touch (2)
CL Item
cries /protests on touch (3)
CL Item
cries when limb is moved / spontaneously painful (4)
Ongoing after day 3?
Item
Is the symptom ongoing after day 3?
boolean
last day of symptom
Item
If Yes, please record the last day of symptom
date
medically attended visit?
Item
Was the visit medically attended?
boolean
Item Group
Dose 2 - Local Symptoms - Vaccine 2
signs or symptoms at injection site
Item
Please fill in the section below and assess the occurrence of any signs or symptoms at injection site
text
Item
Injection Side
text
Injection Side
Code List
Injection Side
CL Item
Left (1)
CL Item
Right (2)
Item
Injection Site
text
Injection Site
Code List
Injection Site
CL Item
Arm (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item Group
Redness (Local Symptoms)
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Size
Item
Size
float
Ongoing after day 3?
Item
Is the symptom ongoing after day 3?
boolean
the last day of symptom
Item
If Yes, please record the last day of symptom
date
medically attended visit
Item
Was the visit medically attended?
boolean
Item Group
Swelling (Local Symptoms)
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Size
Item
Size
float
Ongoing after day 3?
Item
Is the symptom ongoing after day 3?
boolean
last day of symptom
Item
If Yes, please record the last day of symptom
date
medically attended visit?
Item
Was the visit medically attended?
boolean
Item Group
Pain (Local Symptoms)
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Intensity
integer
Intensity
Code List
Intensity
CL Item
absent (1)
CL Item
minor reaction to touch (2)
CL Item
cries /protests on touch (3)
CL Item
cries when limb is moved / spontaneously painful (4)
Ongoing after day 3?
Item
Is the symptom ongoing after day 3?
boolean
last day of symptom
Item
If Yes, please record the last day of symptom
date
medically attended visit
Item
Was the visit medically attended?
boolean
Item Group
Dose 2 - Other Local Symptoms
Description
Item
Describe the side(s), site(s), and other details
text
Item
Please record the intensity of a symptom
integer
Intensity
Code List
Please record the intensity of a symptom
CL Item
mild  (1)
CL Item
moderate  (2)
CL Item
severe (3)
Start date
Item
Start date
date
End date
Item
End date
date
Ongoing?
Item
Is the symptom/event ongoing after day 3?
boolean
Medically attended visit?
Item
Was the visit medically attended?
boolean
Item Group
Dose 2 - General Symptoms
signs or symptoms at injection site
Item
Please fill in the section below and assess the occurrence of any signs or symptoms at injection site
text
Item Group
Temperature (General Symptoms)
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Body Temperature
Item
Please record temperature
float
Item
Type of temperature taking
text
Type of temperature taking
Code List
Type of temperature taking
CL Item
Axillary (1)
CL Item
Rectal (2)
Ongoing after day 3?
Item
Is the symptom ongoing after day 3?
boolean
last day of symptoms
Item
If Yes, please record the last day of symptoms
date
Medically attended visit?
Item
Was the visit medically attended?
boolean
Item Group
Irritability / Fussiness (General Symptoms)
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Intensity
integer
Intensity
Code List
Intensity
CL Item
Behavior as usual (1)
CL Item
Crying more than usual / no effect on normal activity (2)
CL Item
Crying more than usual / interferes with normal activity (3)
CL Item
Crying that cannot be comforted / prevents normal activity (4)
Ongoing after day 3?
Item
Is the symptom ongoing after day 3?
boolean
last day of symptoms
Item
If Yes, please record the last day of symptoms
date
medically attended visit?
Item
Was the visit medically attended?
boolean
Item Group
Drowsiness (General Symptoms)
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Intensity
integer
Intensity
Code List
Intensity
CL Item
Behavior as usual (1)
CL Item
Drowsiness easily tolerated (2)
CL Item
Drowsiness that interferes with normal activity (3)
CL Item
Drowsiness that prevents normal activity (4)
Ongoing after day 3?
Item
Is the symptom ongoing after day 3?
boolean
last day of symptoms
Item
If Yes, please record the last day of symptoms
date
medically attended visit?
Item
Was the visit medically attended?
boolean
Item Group
Loss of Appetite (General Symptoms)
Item
Day
text
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Intensity
integer
Intensity
Code List
Intensity
CL Item
Appetite as usual (1)
CL Item
Eating less than usual / no effect on normal activity (2)
CL Item
Eating less than usual / interferes with normal activity (3)
CL Item
Not eating at all (4)
ongoing after day 3?
Item
Is the symptom ongoing after day 3?
boolean
last day of symptoms
Item
If Yes, please record the last day of symptoms
date
Medically attended visit?
Item
Was the visit medically attended?
boolean
Item Group
Dose 2 - Other General Symptoms
Symptom description
Item
Describe the side(s), site(s), and other details below
text
Item
Intensity
text
Intensity
Code List
Intensity
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
Start date
Item
Start date
date
End date
Item
End date
boolean
ongoing
Item
Is the symptom / event ongoing?
boolean
medically attended visit
Item
Was the visit medically attended?
boolean
Item Group
Dose 2 - Medication
Trade / Generic Name
Item
Trade / Generic Name
text
Reason
Item
Reason
text
Total Daily Dose
Item
Total Daily Dose
text
Start Date
Item
Start Date
date
End Date
Item
End Date
date
Ongoing?
Item
Is the medication treatment ongoing?
boolean
Item Group
Reminder
diary card date reminder
Item
Please do not forget to bring back the diary card on
date
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