Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item
Cohort
integer
C0599755 (UMLS CUI [1])
CL Item
HIV-neg. exposed (2)
CL Item
HIV-neg. unexposed, 3+1 schedule (3)
CL Item
HIV-neg. unexposed, 3+0 schedule (4)
CL Item
HIV-neg. unexposed, 2+1 schedule (5)
Item
Visit Type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
CL Item
Interim Analysis at/after Visit 6 (1)
CL Item
End of Study Analysis at/after Visit 10 (2)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Date of physical examination
Item
Date of physical examination
date
C0031809 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Examination performed by study member during large swelling reaction period
Item
Was the examination performed by a member of study personnel during the large swelling reaction period
boolean
C0031809 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0443286 (UMLS CUI [1,5])
C1948053 (UMLS CUI [1,6])
Date when swelling first considered a large swelling
Item
Date when the swelling was first considered to be a large swelling reaction
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,4])
C1698059 (UMLS CUI [1,5])
C0549177 (UMLS CUI [1,6])
Time after vaccination
Item
If occurring within 24 hours after vaccination, please specify how long after vaccination
integer
C2745955 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
Size of swelling
Item
Size of swelling
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Item
Type of swelling
integer
C0038999 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
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)
Circumference of swollen limb
Item
Circumference of swollen limb
integer
C0424682 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
Circumference of the opposite limb
Item
Circumference of the opposite limb
integer
C0424682 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C1521805 (UMLS CUI [1,3])
Associated signs: Temperature measurement
Item
Associated signs: Temperature measurement
float
C0886414 (UMLS CUI [1])
Item
Route of temperature measurement
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Code List
Route of temperature measurement
Associated signs: Redness
Item
Associated signs: Redness
boolean
C0037088 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Size of Redness
Item
Size of Redness
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Associated signs: Induration
Item
Associated signs: Induration
boolean
C0037088 (UMLS CUI [1,1])
C0332534 (UMLS CUI [1,2])
Size of induration
Item
Size of induration
integer
C0332534 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Associated signs: Pain
Item
Associated signs: Pain
boolean
C0037088 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Item
Intensity of pain at administration site
integer
C0521491 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Intensity of pain at administration site
CL Item
Grade 1: Minor reaction to touch (1)
CL Item
Grade 2: Cries / protests on touch (2)
CL Item
Grade 3: Cries when limb is moved /spontaneously painful (3)
Associated signs: functional impairment
Item
Associated signs: functional impairment
boolean
C0037088 (UMLS CUI [1,1])
C4062321 (UMLS CUI [1,2])
Item
Intensity of functional impairment
integer
C4062321 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
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)
Case description
Item
Case description
text
C0678257 (UMLS CUI [1,1])
C0868928 (UMLS CUI [1,2])
Last date when the swelling was still considered to be a large swelling reaction
Item
Last date when the swelling was still considered to be a large swelling reaction:
date
C0038999 (UMLS CUI [1,1])
C1698059 (UMLS CUI [1,2])
C0549177 (UMLS CUI [1,3])
C1698059 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
If swelling lasting for less than 24 hours, please specify duration
Item
If swelling lasting for less than 24 hours, please specify duration (hours)
integer
C0038999 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item
Outcome of the large swellling reaction
integer
C0085565 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
Code List
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 "Case Description" section) (4)
Is there an alternative explanation for the swelling (e.g.: allergy, infection, trauma, underlying conditions)
Item
Is there an alternative explanation for the swelling? (e.g.: allergy, infection, trauma, underlying conditions)
boolean
C0038999 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0681841 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
C3714660 (UMLS CUI [4])
C0009488 (UMLS CUI [5])
Specify alternative explanation for the swelling
Item
Specify alternative explanation for the swelling.
text
C0038999 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0681841 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])