Did the subject return for visit 2?
Item
Did the subject return for visit 2?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
If subject did not return for visit 2, please tick the ONE most appropriate reason and skip the following pages of this visit.
text
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0392360 (UMLS CUI [2])
Code List
If subject did not return for visit 2, please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Non- Serious adverse event (complete the Non- serious Adverse Event form) (AEX)
CL Item
Other, please specify (e.g.: consent withdrawal, Protocol violation,...) (OTH)
Please specify Serious Adverse Event
Item
Please specify Serious Adverse Event
text
C1519255 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Please specify Non- serious adverse event
Item
Please specify Non- serious adverse event
text
C2348235 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Specify other reason for subject didn't return for visit 2
Item
Specify other reason for subject didn't return for visit 2
text
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Please tick who took descision
text
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0679006 (UMLS CUI [1,4])
Code List
Please tick who took descision
CL Item
Parents/ Guardians (P)
1. Date of physical examination
Item
1. Date of physical examination
date
C2826643 (UMLS CUI [1])
Was the examination performed by a member of study personnel during the large swelling reaction period?
Item
Was the examination performed by a member of study personnel during the large swelling reaction period?
boolean
C0035173 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
2. Date when the swelling was first considered to be a large swelling reaction
Item
2. Date when the swelling was first considered to be a large swelling reaction:
date
C0038999 (UMLS CUI [1,1])
C0549177 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
2.1 Specify how long after vaccination swelling occured
Item
2.1 If swelling occuring within 24 hours after vaccination, please specify how long after vaccination:
integer
C0038999 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
3. Size of swelling
Item
3. Size of swelling:
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Item
4. Type of swelling
integer
C0038999 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
4. Type of swelling
CL Item
Local swelling around injection site, not involving adjacent joint (1)
CL Item
Diffuse swelling, not involving adjacent joint (2)
CL Item
Swelling, involving adjacent joint (3)
5a. Circumference of swollen limb (at the site of maximum swelling):
Item
5a. Circumference of swollen limb (at the site of maximum swelling):
integer
C0424682 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
5b. Circumference of the opposite limb (at the same level):
Item
5b. Circumference of the opposite limb (at the same level):
integer
C0424682 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C1521805 (UMLS CUI [1,3])
6a. Associated signs
Item
6a. Associated signs - Temperature
float
C0037088 (UMLS CUI [1])
C0005903 (UMLS CUI [2])
Item
6a. Temperature measurement site
text
C0489453 (UMLS CUI [1])
Code List
6a. Temperature measurement site
CL Item
Tympanic rectal (Y)
6b. Redness
Item
6b. Redness
boolean
C0332575 (UMLS CUI [1])
6b. Largest diameter of Redness
Item
6b. Largest diameter of Redness
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
6c. Induration
Item
6c. Induration
boolean
C0332534 (UMLS CUI [1])
6c. Induration largest diameter
Item
6c. Largest diameter of induration
integer
C0332534 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
6d. Pain at administration site
Item
6d. Pain at administration site
boolean
C0521491 (UMLS CUI [1])
Item
6d. Intensity of pain at administration site
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
Code List
6d. Intensity of pain at administration site
CL Item
Grade 1 (Minor reaction to touch) (1)
CL Item
Cries / protests on touch (2)
CL Item
Cries when limbs is moved / spontaneously painful (3)
6e. Functional impairment
Item
6e. Functional impairment
boolean
C4062321 (UMLS CUI [1])
Item
6e. Intensity of Functional impairment
integer
C4062321 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
6e. Intensity of Functional impairment
CL Item
Grade 1 (Easily tolerated, causing minimal discomfort and not interfering with everyday activities) (1)
CL Item
Grade 2 (Sufficiently discomforting to interfere with normal everyday activities) (2)
CL Item
Grade 3 (Prevents normal everyday activities) (3)
7. Case description
Item
7. Case description
text
C0678257 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0868928 (UMLS CUI [1,3])
8. Last date when the swelling was still considered to be a large swelling reaction
Item
8. Last date when the swelling was still considered to be a large swelling reaction:
date
C0038999 (UMLS CUI [1,1])
C0549177 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
8.1 If swelling lasting for less than 24 hours, please specify duration
Item
8.1 If swelling lasting for less than 24 hours, please specify duration (hours)
integer
C0038999 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item
9. Outcome of the large swellling reaction:
integer
C0085565 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
Code List
9. Outcome of the large swellling reaction:
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered/ not resolved (please provide further follow- up data) (3)
CL Item
Recovered with sequelae / resolved with sequelae (please specify under section 7) (4)
10. Is there an alternative explanation for the swelling
Item
10. Is there an alternative explanation for the swelling? (e.g.: allergy, infection, trauma, underlying conditions)
boolean
C0038999 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
C3714660 (UMLS CUI [4])
C0009488 (UMLS CUI [5])
10.1 Specify alternative explanation for the swelling
Item
10.1 Specify alternative explanation for the swelling.
text
C0038999 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
undefined item
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
boolean
C0304229 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Trade / (Generic) Name
Item
Trade / (Generic) Name
text
C2360065 (UMLS CUI [1])
C0592502 (UMLS CUI [2])
Item
Route
text
C0013153 (UMLS CUI [1])
CL Item
Intramuscular (IM)
CL Item
Subcutaneous (SC)
Administration date
Item
Administration date
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])