Local Symptoms - Redness (at injection site)
Day
integer
please measure the greatest diameter
integer
Ongoing after Day 3?
boolean
If Yes, record date of last day of symptoms
date
Medical attended visit?
boolean
Local Symptoms - Swelling (at injection site)
Day
integer
please measure the greatest diameter
integer
Ongoing after Day 3?
boolean
If Yes, record date of last day of symptoms
date
Medical attended visit?
boolean
Local Symptoms - Pain (at injection site)
Day
integer
Intensity
integer
Ongoing after day 3?
boolean
If Yes, record date of last day of symptoms
date
Medically attended visit?
boolean
Other Local Symptoms
please specify side(s) and site(s)
text
Intensity
text
Start date
date
End date
date
Ongoing?
boolean
Medically attended visit?
boolean
MEDICATION
Trade/Generic name
text
Reason
text
Total Daily Dose
text
Start date
date
End date
date
Ongoing
boolean
GENERAL SYMPTOMS
Temperature
Tick Yes from following limits Axillary, Oral > 37.5 °C Rectal > 38 °C
boolean
t°
float
Route
text
Ongoing after day 6?
boolean
Date of last day of symptoms
date
Causality?
boolean
Medically attended visit
boolean
Type of Medical involvement
boolean
Fatigue
Fatigue
boolean
Day
integer
fatigue intensity
text
Ongoing after day 6?
boolean
Date of last day of symptoms
date
Causality?
boolean
Medically attended visit
boolean
Type of Medical Attention
text
Headache
Headache
boolean
Day
text
Intensity
text
Ongoing after day 6?
boolean
Date of last day of symptoms
date
Causality?
boolean
Medically attended visit
boolean
Type of Medical Attention
text
Gastrointestinal symptoms
Gastrointestinal symptoms
boolean
Day
integer
Intensity
text
Ongoing after day 6?
boolean
Date of last day of symptoms
date
Causality?
boolean
Medically attended visit
boolean
Type of Medical Attention
text
Malaise
Malaise
boolean
Day
text
Intensity
text
Ongoing after day 6?
boolean
Date of last day of symptoms
date
Medically attended visit
boolean
Type of Medical Attention
text
Myalgia
Myalgia
boolean
Day
text
intensity
text
Ongoing after day 6?
boolean
Date of last day of symptoms
date
Causality
boolean
Medically attended visit
boolean
Type of Medical Attention
text
Other Symptoms
Description
text
Mild (an adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities); Moderate (An adverse event which is sufficiently discomforting to interfere with normal everyday activities); Severe (An adverse event which prevents normal, everyday activities: e.g attendance at school/kindergarten/a day-care centre and would cause parents/guardians to seek medical advice)
text
Start Date
date
End Date
date
Ongoing?
boolean
Medically attended visit?
boolean
Medication
Trade Name/Generic Name
text
Reason
text
Total Daily Dose?
text
Start Date
date
End Date
date
Ongoing?
boolean