Report of physical examination
Date of physical examination
date
Was the examination performed by a member of study personnel during the large swelling reaction period:
boolean
If hospitalization is required, please also complete a Serious Adverse Event (SAE) Form and contact GlaxoSmithKline Biologicals within 24 hours after becoming aware of the SAE.
date
Hours after Event
text
Size of swelling
text
Please specify in section 7
integer
Circumference of affected site
text
Circumference of the opposite site
text
Please record the temperature. If temperature has been taken more than once a day please report the highest value. Please check a Yes/No box for each symptom occurring during the extensive swelling period. If other symptoms are associated lnduration with the large swelling reaction please specify under section
text
Route
text
If yes, please specify diameter below.
boolean
Redness Diameter
float
If yes, plase specify diameter below.
boolean
Largest Diameter of Induration
text
Pain
boolean
Intensity of pain at injection site grade 1: Minor reaction to touch grade 2: Cries/protests on touch grade 3: Cries when limb is moved/spontaneously painful
integer
Functional impairment
partialDatetime
Intensity of functional impairment: Grade 1: Easily tolerated, causing minimal discomfort and not interfering with everyday activities Grade 2: Sufficiently discomforting to interfere with normal everyday activities Grade 3: Prevents normal everyday activities
integer
Clinical case descri tion and outcome of the adverse event
Please give a clinical description of the observed large swelling reaction, including a description of the joint involved and specific associated symptoms. Please mention also eventual diagnostic(s) procedures and thera eutic interventions.
text
Last date when the swelling was still considered to be large swellin reaction:
date
If lasting for less than 24 hours, please specify duration (hours)
time
If Not recovered / not resolved, please provide further follow-up data If Recovered with sequelae / resolved with sequelae, please specify under section 7
integer
(e.g.: allergy, infection, trauma, under/ in conditions) if yes, please specify below
boolean
Alternative Explanation: Specification
text