Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Workbook Number
integer
C2986015 (UMLS CUI [1])
Code List
Workbook Number
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
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
Tympanic (oral conversion) (X)
CL Item
Tympanic (rectal conversion) (Y)
Item
Vaccine
integer
C0042210 (UMLS CUI [1])
CL Item
10Pn-PD-DiT or Prevenar Vaccine (1)
CL Item
DTPw-HBV/Hib Vaccine (2)
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 Identifier
Item
If replacement vial, please note the replacement vial Identifier
text
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Wrong vial number
Item
If wrong vial, please note the wrong vial number
integer
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
Item
Side / site route of Vaccination according to the protocol
text
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0013153 (UMLS CUI [2,1])
C0441987 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
Code List
Side / site route of Vaccination according to the protocol
CL Item
Not according to the protocol (NA)
Item
If study vaccine has NOT been administered according to the Protocol, please tick appropriate side.
text
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Code List
If study vaccine has NOT been administered according to the Protocol, please tick appropriate side.
Item
If study vaccine has NOT been administered according to the Protocol, please tick appropriate site.
integer
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Code List
If study vaccine has NOT been administered according to the Protocol, please tick appropriate site.
Item
If study vaccine has NOT been administered according to the Protocol, please tick appropriate route.
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Code List
If study vaccine has NOT been administered according to the Protocol, please tick appropriate route.
Item
Vaccine
integer
C0042210 (UMLS CUI [1])
CL Item
10Pn-PD-DiT or Prevenar Vaccine (1)
CL Item
DTPw-HBV/Hib Vaccine (2)
Item
If vaccine was not administered, please tick the major reason for non administration
text
C2368628 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
If vaccine was not administered, please tick the major reason for non administration
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
SAE Identifier
Item
If you ticked SAE as major reason for non administration, please specify SAE Identifier
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
AE Identifier
Item
If you ticked AE as major reason for non administration, please specify AE Identifier
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Other reason
Item
If you ticked other as major reason for non administration, please specify
text
C3840932 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Item
Please tick who made the decision
text
C0679006 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Please tick who made the decision
CL Item
Parent/Guardians (P)