Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Redness
Item
Redness, size
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size day 0
Item
Redness size day 0
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size day 1
Item
Redness size day 1
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size day 2
Item
Redness size day 2
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness size day 3
Item
Redness size day 3
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size Swelling
Item
Size Swelling
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size Swelling Day 0
Item
Size Swelling Day 0
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size Swelling Day 1
Item
Size Swelling Day 1
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size Swelling Day 2
Item
Size Swelling Day 2
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Size Swelling Day 3
Item
Size Swelling Day 3
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain intensity
Item
Pain intensity
integer
C3840282 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Pain intensity day 0
integer
C3840282 (UMLS CUI [1])
Code List
Pain intensity day 0
Item
Pain intensity day 1
integer
C3840282 (UMLS CUI [1])
Code List
Pain intensity day 1
Item
Pain intensity day 2
integer
C3840282 (UMLS CUI [1])
Code List
Pain intensity day 2
Item
Pain intensity day 3
integer
C3840282 (UMLS CUI [1])
Code List
Pain intensity day 3
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0549178 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Description - please specify side(s) and site(s)
Item
Description - please specify side(s) and site(s)
text
C0441987 (UMLS CUI [1])
C1515974 (UMLS CUI [2])
Item
Intensity
integer
C0522510 (UMLS CUI [1])
CL Item
Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not (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 a young child, such an adverse spontaneously painful event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek. medical advice). (3)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Ongoing
Item
check box if continuing
boolean
C0549178 (UMLS CUI [1])
Trade / Generic Name
Item
Trade / Generic Name
text
C0027365 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medical Indication
Item
Reason
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start date
Item
Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End date
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
pharmacotherapy ongoing
Item
check box if continuing
boolean
C0013216 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C1556354 (UMLS CUI [1])
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not retrievable [U] (2)
CL Item
No vaccine administered [NA] (3)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Item
Fever measurement site
integer
C0489453 (UMLS CUI [1])
Code List
Fever measurement site
CL Item
Oral (recommended) (1)
CL Item
Axillary(recommended) (2)
Fever Day 0
Item
Fever Day 0
float
C0015967 (UMLS CUI [1])
Fever Day 1
Item
Fever Day 1
float
C0015967 (UMLS CUI [1])
Fever Day 2
Item
Fever Day 2
float
C0015967 (UMLS CUI [1])
Fever Day 3
Item
Fever Day 3
float
C0015967 (UMLS CUI [1])
symptom ongoing
Item
Ongoing after day 3?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
date last symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Fatigue
Item
Fatigue
boolean
C0015672 (UMLS CUI [1])
Item
Fatigue Day 0
integer
C0015672 (UMLS CUI [1])
Item
Fatigue Day 1
integer
C0015672 (UMLS CUI [1])
CL Item
Yes, please complete the following table. (2)
Item
Fatigue Day 2
integer
C0015672 (UMLS CUI [1])
CL Item
Yes, please complete the following table. (2)
Item
Fatigue Day 3
integer
C0015672 (UMLS CUI [1])
CL Item
Yes, please complete the following table. (2)
Fatigue ongoing after day 3
Item
Ongoing after day 3?
boolean
C0015672 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Headache
Item
Headache
boolean
C0018681 (UMLS CUI [1])
Item
Headache, Intensity
integer
C0018681 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Headache, Intensity
CL Item
Yes, please complete the following table. (2)
Item
Headache on Day 0
integer
C0018681 (UMLS CUI [1])
Code List
Headache on Day 0
CL Item
Yes, please complete the following table. (2)
Item
Headache on Day 1
integer
C0018681 (UMLS CUI [1])
Code List
Headache on Day 1
CL Item
Yes, please complete the following table. (2)
Item
Headache on Day 2
integer
C0018681 (UMLS CUI [1])
Code List
Headache on Day 2
CL Item
Yes, please complete the following table. (2)
Item
Headache on Day 3
integer
C0018681 (UMLS CUI [1])
Code List
Headache on Day 3
CL Item
Yes, please complete the following table. (2)
Headache ongoing after day 3
Item
Headache ongoing after day 3?
boolean
C0018681 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0018681 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Gastrointestinal symptoms
Item
Gastrointestinal symptoms
boolean
C0426576 (UMLS CUI [1])
Item
Gastrointestinal symptoms, Intensity
integer
C0426576 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Gastrointestinal symptoms, Intensity
CL Item
Yes, please complete the following table. (2)
Item
Gastrointestinal symptoms on Day 0
integer
C0426576 (UMLS CUI [1])
Code List
Gastrointestinal symptoms on Day 0
CL Item
Yes, please complete the following table. (2)
Item
Gastrointestinal symptoms on Day 1
integer
C0426576 (UMLS CUI [1])
Code List
Gastrointestinal symptoms on Day 1
CL Item
Yes, please complete the following table. (2)
Item
Gastrointestinal symptoms on Day 2
integer
C0426576 (UMLS CUI [1])
Code List
Gastrointestinal symptoms on Day 2
CL Item
Yes, please complete the following table. (2)
Item
Gastrointestinal symptoms on Day 3
integer
C0426576 (UMLS CUI [1])
Code List
Gastrointestinal symptoms on Day 3
CL Item
Yes, please complete the following table. (2)
Gastrointestinal symptoms ongoing after day 3
Item
Gastrointestinal symptoms ongoing after day 3?
boolean
C0426576 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0426576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
visit date
Item
PLEASE DO NOT FORGET TO BRING BACK THE DIARY CARD ON
date
C1320303 (UMLS CUI [1])
telephone number
Item
IN CASE OF HOSPITALISATION, PLEASE INFORM
text
C1515258 (UMLS CUI [1])
symptom
Item
Description - please specify side(s) and site(s)
text
C1457887 (UMLS CUI [1])
Intensity
Item
Intensity
integer
C0518690 (UMLS CUI [1])
symptom Start Date
Item
Start date:
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
ongoing
Item
check box if continuing
date
C0549178 (UMLS CUI [1])