Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Vaccination, Date in time
Item
Day 0 = Date of Vaccination
date
C0042196 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Local Symptoms
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
CL Item
Redness, give size (mm) (1)
CL Item
Swelling, give size (mm) (2)
CL Item
Pain, give intensity (3)
Adverse Event, Symptoms, Local
Item
Day 0
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Item
Day 1
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Item
Day 2
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Item
Day 3
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after Day 3
boolean
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
Adverse Event, Symptoms, Local, End Date
Item
Date of last Day of Symptoms
date
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Adverse Event, Symptoms, Local, Visit/Advice
Item
Medically attended visit
boolean
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
Symptoms, Local, Other
Item
Description - please specify side(s) and site(s)
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Symptoms, Local, Other, Symptom Intensity
Item
Intensity
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,4])
Symptoms, Local, Other, Start Date
Item
Start date
date
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,4])
Symptoms, Local, Other, End Date
Item
End date
date
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Symptoms, Local, Other, Continuous
Item
Check box if continuing
boolean
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
Symptoms, Local, Other, Visit
Item
Medically attended Visit?
boolean
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C020539 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
Pharmaceutical Preparations, Medication name
Item
Trade/Generic name
text
C0013227 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Pharmaceutical Preparations, Indication
Item
Reason
text
C0013227 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Pharmaceutical Preparations, Daily Dose, Total
Item
Total Daily Dose
text
C0013227 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Pharmaceutical Preparations, Start date
Item
Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Pharmaceutical Preparations, End date
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Pharmaceutical Preparations, Continuous
Item
Check box if continuing
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item
General Symptoms
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Code List
General Symptoms
CL Item
Fever, give °C (1)
CL Item
Fever: Oral (Mandatory) (2)
CL Item
Fatigue, give intensity (3)
CL Item
Headache, give intensity (4)
CL Item
Muscle pain, give intensity (5)
CL Item
Chills, give intensity (6)
CL Item
Red eyes, give intensity (7)
CL Item
Joint pain, give intensity (8)
CL Item
Swelling of the face, give intensity (9)
CL Item
Cough, give intensity (10)
CL Item
Chest tightness or difficulty in breathing, give intensity (11)
CL Item
Sore throat or hoarseness or pain on swallowing, give intensity (12)
Adverse Event, General symptom
Item
Day 0
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 1
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 2
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 3
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom, Continuous
Item
Ongoing after Day 3
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Adverse Event, General symptom, End Date
Item
Date of last Day of Symptoms
date
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Adverse Event, General symptom, Visit/Advice
Item
Medically attended visit
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
General symptom, Other
Item
Description - please specify side(s) and site(s)
text
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
General symptom, Other, Symptom Intensity
Item
Intensity
text
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
General symptom, Other, Start date
Item
Start date
date
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
General symptom, Other, End date
Item
End date
date
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
General symptom, Other, Continuous
Item
Check box if continuing
boolean
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
General symptom, Other, Visit
Item
Medically attended Visit?
boolean
C0159028 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])