Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
undefined item
Item
If any of these adverse events are serious according to Protocol definition, please report event to GSK monitor by telephone or fax within 24 hours (see Protocol) and complete the Serious Adverse Event form.
text
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C0037088 (UMLS CUI [1])
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (U)
CL Item
No vaccine administered (NA)
CL Item
Yes, please tick No/Yes for each symptom. If yes is ticked, please complete all items. (Y)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Item
Location of fever measurement
text
C0449687 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Code List
Location of fever measurement
Fever
Item
Fever Day 0
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever taken? Day 0
boolean
Fever
Item
Fever taken? Day 1
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 1
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever taken? Day 2
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 2
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever taken? Day 3
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 3
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever taken? Day 4
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 4
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever taken? Day 5
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 5
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever taken? Day 6
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 6
float
C0015967 (UMLS CUI [1])
Fever
Item
Fever taken? Day 7
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever Day 7
float
C0015967 (UMLS CUI [1])
Ongoing symptom
Item
Ongoing after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
Code List
Medically attended visit
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Irritability
Item
Irritability/ Fussiness
boolean
C0022107 (UMLS CUI [1])
Item
Irritability/Fussiness Intensity Day 0
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Code List
Irritability/Fussiness Intensity Day 0
Item
Intensity of Irritability/fussiness Day 1
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Code List
Intensity of Irritability/fussiness Day 1
Item
Intensity of Irritability/fussiness Day 2
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Code List
Intensity of Irritability/fussiness Day 2
Item
Intensity of irritability/fussiness day 3
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Code List
Intensity of irritability/fussiness day 3
Item
Intensity of irritability/fussiness day 4
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Code List
Intensity of irritability/fussiness day 4
Item
Intensity of irritability/fussiness Day 5
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Code List
Intensity of irritability/fussiness Day 5
Item
Intensity of irritability/fussiness Day 6
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Code List
Intensity of irritability/fussiness Day 6
Item
Intensity of irritability/fussiness Day 7
integer
C0518690 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Code List
Intensity of irritability/fussiness Day 7
Ongoing symptom
Item
Ongoing after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,3])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0022107 (UMLS CUI [1,2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0022107 (UMLS CUI [1,4])
Code List
Medically attended visit Type
CL Item
Emergency room (ER)
CL Item
Hospitalization (HO)
CL Item
Medical doctor (MD)
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0022107 (UMLS CUI [1,4])
Drowsiness
Item
Drowsiness
boolean
C0013144 (UMLS CUI [1])
Item
Drowsiness Intensity Day 0
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Drowsiness Intensity Day 0
Item
Intensity of Drowsiness Day 1
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Intensity of Drowsiness Day 1
Item
Intensity of drowsiness Day 2
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Intensity of drowsiness Day 2
Item
Intensity of Drowsiness Day 3
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Intensity of Drowsiness Day 3
Item
Intensity of Drowsiness Day 4
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Intensity of Drowsiness Day 4
Item
Intensity of Drowsiness Day 5
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Intensity of Drowsiness Day 5
Item
Intensity of Drowsiness Day 6
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Intensity of Drowsiness Day 6
Item
Intensity of Drowsiness Day 7
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Intensity of Drowsiness Day 7
Ongoing symptom?
Item
Ongoing after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0013144 (UMLS CUI [1,2])
Causality
Item
Causality
boolean
C0015127 (UMLS CUI [1,1])
C0013144 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0013144 (UMLS CUI [1,4])
Code List
Medically attended visit Type
CL Item
Emergency room (ER)
CL Item
Hospitalization (HO)
CL Item
Medical doctor (MD)
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])
C0522510 (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])
C0522510 (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])
C0522510 (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])
C0522510 (UMLS CUI [1,2])
Code List
Loss of appetite, Intensity Day 3
Item
Loss of appetite, Intensity Day 4
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Loss of appetite, Intensity Day 4
Item
Loss of appetite, Intensity Day 5
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Loss of appetite, Intensity Day 5
Item
Loss of appetite, Intensity Day 6
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Loss of appetite, Intensity Day 6
Item
Loss of appetite, Intensity Day 7
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Loss of appetite, Intensity Day 7
Ongoing symptom
Item
Ongoing after day 7?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C1971624 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C1971624 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1971624 (UMLS CUI [1,4])
Code List
Medically attended visit Type
CL Item
Emergency room (ER)
CL Item
Hospitalization (HO)
CL Item
Medical doctor (MD)