Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item
Workbook number
integer
C2986015 (UMLS CUI [1])
Code List
Workbook number
Item
Visit type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
CL Item
Screening (all WB's) (1)
CL Item
Visit Month 6 (WB1+3) (2)
CL Item
Visit Month 12 (WB2+4) (3)
CL Item
Visit Day 21(WB3+4) (4)
Date of vaccine administration
Item
Date of vaccine administration
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Item
Route of temperature measurement
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Code List
Route of temperature measurement
CL Item
Axillary (preferable) (A)
Item
Vaccine administration
text
C2368628 (UMLS CUI [1])
Code List
Vaccine administration
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (N)
Replacement vial number
Item
If replacement vial, note the number
text
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Wrong vial number
Item
If wrong vial, note number
text
C0184301 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item
Has the study vaccine been administered according to the Protocol?
text
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Code List
Has the study vaccine been administered according to the Protocol?
Item
Side of vaccination
integer
C0042196 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Code List
Side of vaccination
Item
Site of vaccination
integer
C1515974 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Code List
Site of vaccination
Item
Route of vaccination
integer
C0013153 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Code List
Route of vaccination
Item
Reason for non administration
text
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Reason for non administration
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
SAE Number
Item
SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number
Item
AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Solicited AE Number
Item
Solicited AE Number
text
C1517001 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Other reason for non administration
Item
If there is an other reason for non administration, please specify
text
C3840932 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Item
Please tick who made the decision
text
C0679006 (UMLS CUI [1])
Code List
Please tick who made the decision