Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1])
Code List
Vaccine Administration
CL Item
Engerix-B Vaccine (1)
CL Item
Replacement vial (comment) (2)
CL Item
Wrong vial number (comment) (3)
CL Item
Not administered (comment) (4)
Item
Side/ Site Route
integer
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
Code List
Side/ Site Route
CL Item
Upper left Anterolateral thigh I.M. (1)
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item
If study vaccine has not been administered according to the Protocol, please check all items that apply
integer
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Code List
If study vaccine has not been administered according to the Protocol, please check all items that apply
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item
Has the subject experienced any of the following local (at administration site) signs/symptoms during the solicited period?
text
C0037088 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,4])
Code List
Has the subject experienced any of the following local (at administration site) signs/symptoms during the solicited period?
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1])
Redness size Day 0
Item
Redness size Day 0
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 1
Item
Redness size Day 1
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 2
Item
Redness size Day 2
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size Day 3
Item
Redness size Day 3
integer
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness Ongoing after Day 3?
Item
Redness Ongoing after Day 3?
boolean
C0332575 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Redness is ongoing, record date of last Day of Symptoms
Item
If Redness is ongoing, record date of last Day of Symptoms
date
C0332575 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1])
Swelling Size Day 0
Item
Swelling Size Day 0
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 1
Item
Swelling Size Day 1
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 2
Item
Swelling Size Day 2
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size Day 3
Item
Swelling Size Day 3
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Ongoing after Day 3?
Item
Swelling Ongoing after Day 3? +
boolean
C0038999 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Swelling is ongoing, record date of last Day of Symptoms
Item
If Swelling is ongoing, record date of last Day of Symptoms
date
C0038999 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1])
Item
Pain intensity Day 0
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 0
Item
Pain intensity Day 1
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 1
Item
Pain intensity Day 2
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 2
Item
Pain intensity Day 3
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity Day 3
Pain Ongoing after Day 3?
Item
Pain Ongoing after Day 3?
boolean
C0030193 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Pain is ongoing, record date of last Day of Symptoms
Item
If Pain is ongoing, record date of last Day of Symptoms
date
C0030193 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Item
Has the subject experienced any of the following general solicited signs/symptoms during the solicited period?
text
C0037088 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Code List
Has the subject experienced any of the following general solicited signs/symptoms during the solicited period?
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Item
Temperature Route
integer
C0005903 (UMLS CUI [1,1])
C0449687 (UMLS CUI [1,2])
Code List
Temperature Route
CL Item
Tympanic oral (3)
CL Item
Tympanic rectal (4)
Temperature Day 0
Item
Temperature Day 0
float
C0005903 (UMLS CUI [1])
Item
Temperature not taken Day 0
integer
C0437722 (UMLS CUI [1])
Code List
Temperature not taken Day 0
Temperature Day 1
Item
Temperature Day 1
float
C0005903 (UMLS CUI [1])
Item
Temperature not taken Day 1
integer
C0437722 (UMLS CUI [1])
Code List
Temperature not taken Day 1
Temperature Day 2
Item
Temperature Day 2
float
C0005903 (UMLS CUI [1])
Item
Temperature not taken Day 2
integer
C0437722 (UMLS CUI [1])
Code List
Temperature not taken Day 2
Temperature Day 3
Item
Temperature Day 3
float
C0005903 (UMLS CUI [1])
Item
Temperature not taken Day 3
integer
C0437722 (UMLS CUI [1])
Code List
Temperature not taken Day 3
Fever ongoing after Day 3?
Item
Fever ongoing after Day 3?
boolean
C0015967 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Fever is ongoing, record date of last Day of Symptoms
Item
If Fever is ongoing, record date of last Day of Symptoms
date
C0015967 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Fever - Causality?
Item
Fever - Causality?
boolean
C0015967 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Irritability/ Fussiness
Item
Irritability/ Fussiness
boolean
C0022107 (UMLS CUI [1])
Item
Irritability/ Fussiness intensity Day 0
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Irritability/ Fussiness intensity Day 0
Item
Irritability/ Fussiness intensity Day 1
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Irritability/ Fussiness intensity Day 1
Item
Irritability/ Fussiness intensity Day 2
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Irritability/ Fussiness intensity Day 2
Item
Irritability/ Fussiness intensity Day 3
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Irritability/ Fussiness intensity Day 3
Irritability/ Fussiness ongoing after Day 3?
Item
Irritability/ Fussiness ongoing after Day 3?
boolean
C0022107 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Irritability/ Fussiness is ongoing, record date of last Day of Symptoms
Item
If Irritability/ Fussiness is ongoing, record date of last Day of Symptoms
date
C0022107 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Irritability/ Fussiness - Causality?
Item
Irritability/ Fussiness - Causality?
boolean
C0022107 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Drowsiness
Item
Drowsiness
boolean
C0013144 (UMLS CUI [1])
Item
Drowsiness intensity Day 0
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Drowsiness intensity Day 0
Item
Drowsiness intensity Day 1
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Drowsiness intensity Day 1
Item
Drowsiness intensity Day 2
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Drowsiness intensity Day 2
Item
Drowsiness intensity Day 3
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Drowsiness intensity Day 3
Drowsiness ongoing after Day 3?
Item
Drowsiness ongoing after Day 3?
boolean
C0013144 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Drowsiness is ongoing, record date of last Day of Symptoms
Item
If Drowsiness is ongoing, record date of last Day of Symptoms
date
C0013144 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Drowsiness - Causality?
Item
Drowsiness - Causality?
boolean
C0013144 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Loss of appetite
Item
Loss of appetite
boolean
C1971624 (UMLS CUI [1])
Item
Loss of appetite intensity Day 0
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Loss of appetite intensity Day 0
Item
Loss of appetite intensity Day 1
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Loss of appetite intensity Day 1
Item
Loss of appetite intensity Day 2
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Loss of appetite intensity Day 2
Item
Loss of appetite intensity Day 3
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Loss of appetite intensity Day 3
Loss of appetite ongoing after Day 3?
Item
Loss of appetite ongoing after Day 3?
boolean
C1971624 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
If Loss of appetite is ongoing, record date of last Day of Symptoms
Item
If Loss of appetite is ongoing, record date of last Day of Symptoms
date
C1971624 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Loss of appetite - Causality?
Item
Loss of appetite - Causality?
boolean
C1971624 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])