Subject Number
Item
Subject Number
integer
Protocol Number
Item
Protocol Number
integer
Date of Birth
Item
Date of Birth
date
Item
Vaccine - possible cause of swelling reaction
text
Code List
Vaccine - possible cause of swelling reaction
CL Item
Plain PRP Vaccine (1)
CL Item
DTPw-HBV Kft Vaccine (2)
Date of physical examination
Item
Date of physical examination
date
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
Date when the swelling was first considered to be a large swelling reaction
Item
Date when the swelling was first considered to be a large swelling reaction
date
If occurring within 24 hrs after vaccination, please specify how long after vaccination
Item
If occurring within 24 hrs after vaccination, please specify how long after vaccination
integer
Size of swelling
Item
Size of swelling
integer
Item
Type of swelling
text
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 (at the site of maximum swelling)
Item
Circumference of swollen limb (at the site of maximum swelling)
integer
Circumference of the opposite limb (at the same level)
Item
Circumference of the opposite limb (at the same level)
integer
Temperature
Item
Temperature
integer
CL Item
Tympanic oral (3)
CL Item
Tympanic rectal (4)
Redness
Item
Redness
boolean
Redness - largest diameter
Item
Redness - largest diameter
integer
Induration
Item
Induration
boolean
Induration - largest diameter
Item
Induration - largest diameter
integer
CL Item
Minor reaction to touch (1)
CL Item
Cries/protest on touch (2)
CL Item
Cries when limb is moved/spontaneously painful (3)
Functional impairment
Item
Functional impairment
boolean
Item
Functional impairment intensity
text
Code List
Functional impairment intensity
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)
Please give a clinical description of the observed large swelling reaction.
Item
Please give a clinical description of the observed large swelling reaction.
text
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
Item
Outcome of the large swelling reaction
text
Code List
Outcome of the large swelling 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 "clinical case description") (4)
Follow-up information
Item
Follow-up information
text
Is there an alternative explanation for the swelling?
Item
Is there an alternative explanation for the swelling?
boolean
If Yes, please specify below
Item
If Yes, please specify below
text
