Pre- existing conditions or signs and/ or symptoms present in the subject
Item
Are you aware of any pre- existing conditions or signs and/ or symptoms present in the subject prior to the start of the study?
boolean
C0521987 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0037088 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C2347804 (UMLS CUI [2,4])
Date of vaccination
Item
Date of vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Pre- Vaccination temperature
Item
Pre- Vaccination temperature
float
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Vaccine administration
text
C2368628 (UMLS CUI [1])
Code List
Vaccine administration
CL Item
DTPw- HBV/Hib Vaccine (S)
CL Item
DTPw- HBV/Hib Vaccine (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (N)
Item
Why not administered?
text
C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Why not administered?
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Non- serious adverse event (complete the Non- serious Adverse Event section) (AEX)
CL Item
Other, please specify (e.g.: consent withdrawal, protocol violation,...) (OTH)
Replacement vial
Item
Replacement vial
text
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
Wrong vial number
Item
Wrong vial number
text
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
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, check all that apply.
text
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Code List
If study vaccine has not been administered according to the Protocol, check all that apply.
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
If other reason for vaccine not administered, please specify.
Item
If other reason for vaccine not administered, please specify.
text
C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
If vaccine not administered, please tick who took the decision
text
C2368628 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Code List
If vaccine not administered, please tick who took the decision
CL Item
Parents/ Guardians (P)
Item
Has the subject experienced any of the following signs/ symptoms at the administration site during the solicited period?
text
C0037088 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
Code List
Has the subject experienced any of the following signs/ symptoms at the administration site 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)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1])
Size of redness Day 0
Item
If redness, enter size at Day 0
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Size of redness Day 1
Item
If redness, enter size at Day 1
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Size of redness Day 2
Item
If redness, enter size at Day 2
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Size of redness Day 3
Item
If redness, enter size at Day 3
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Redness ongoing after day 3?
Item
Redness ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of redness
Item
Date of last day of redness
date
C0332575 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Redness - medically attended visit?
Item
Redness - medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
Item
Redness - specify medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Code List
Redness - specify medically attended visit
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1])
Size of swelling Day 0
Item
If swelling, enter size at Day 0
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Size of swelling Day 1
Item
If swelling, enter size at Day 1
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Size of swelling Day 2
Item
If swelling, enter size at Day 2
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Size of swelling Day 3
Item
If swelling, enter size at Day 3
integer
C0456389 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Swelling ongoing after day 3?
Item
Swelling ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of swelling
Item
Date of last day of swelling
date
C0038999 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Swelling - medically attended visit?
Item
Swelling - medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
Item
Swelling - specify medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Code List
Swelling - specify medically attended visit
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1])
Item
If pain, enter Intensity at Day 0
integer
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Code List
If pain, enter Intensity at Day 0
Item
If pain, enter Intensity at Day 1
integer
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Code List
If pain, enter Intensity at Day 1
Item
If pain, enter Intensity at Day 2
integer
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Code List
If pain, enter Intensity at Day 2
Item
If pain, enter Intensity at Day 3
integer
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Code List
If pain, enter Intensity at Day 3
Pain ongoing after day 3?
Item
Pain ongoing after day 3?
boolean
C0030193 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of pain
Item
Date of last day of pain
date
C0030193 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Pain - medically attended visit?
Item
Pain - medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
Item
Pain - specify medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Code List
Pain - specify medically attended visit
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C0037088 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
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)
Item
General Symptoms
text
C0159028 (UMLS CUI [1])
Code List
General Symptoms
CL Item
Irritability/ Fussiness (IR)
CL Item
Loss of appetite (LO)
Fever - Body temperature Day 0
Item
Fever - Body temperature Day 0
float
C0039476 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Fever - Body temperature Day 0 not taken
integer
C0437722 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Code List
Fever - Body temperature Day 0 not taken
Fever - Body temperature Day 1
Item
Fever - Body temperature Day 1
float
C0039476 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Fever - Body temperature Day 1 not taken
integer
C0437722 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Code List
Fever - Body temperature Day 1 not taken
Fever - Body temperature Day 2
Item
Fever - Body temperature Day 2
float
C0039476 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Fever - Body temperature Day 2 not taken
integer
C0437722 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Code List
Fever - Body temperature Day 2 not taken
Fever - Body temperature Day 3
Item
Fever - Body temperature Day 3
float
C0039476 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Fever - Body temperature Day 3 not taken
integer
C0437722 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Code List
Fever - Body temperature Day 3 not taken
Is fever ongoing after day 3?
Item
Is fever ongoing after day 3?
boolean
C0015967 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of fever.
Item
Date of last day of fever.
date
C0015967 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Fever - Causality?
Item
Fever - Causality?
boolean
C0015967 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Fever - medically attended visit?
Item
Fever - medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
Item
Fever - specify medically attended visit.
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Code List
Fever - specify medically attended visit.
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Item
Irritability/ Fussiness - Intensity Day 0
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Code List
Irritability/ Fussiness - Intensity Day 0
Item
Irritability/ Fussiness - Intensity Day 1
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Code List
Irritability/ Fussiness - Intensity Day 1
Item
Irritability/ Fussiness - Intensity Day 2
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Code List
Irritability/ Fussiness - Intensity Day 2
Item
Irritability/ Fussiness - Intensity Day 3
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Code List
Irritability/ Fussiness - Intensity Day 3
Is irritability/ fussiness ongoing after day 3?
Item
Is irritability/ fussiness ongoing after day 3?
boolean
C0022107 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of irritability/ fussiness.
Item
Date of last day of irritability/ fussiness.
date
C0022107 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Irritability/ Fussiness- Causality?
Item
Irritability/ Fussiness- Causality?
boolean
C0022107 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Irritability/ Fussiness- medically attended visit?
Item
Irritability/Fussiness - medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,3])
Item
Irritability/ Fussiness- specify medically attended visit.
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Code List
Irritability/ Fussiness- specify medically attended visit.
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Item
Drowsiness - Intensity Day 0
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Code List
Drowsiness - Intensity Day 0
Item
Drowsiness - Intensity Day 1
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Code List
Drowsiness - Intensity Day 1
Item
Drowsiness - Intensity Day 2
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Code List
Drowsiness - Intensity Day 2
Item
Drowsiness - Intensity Day 3
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Code List
Drowsiness - Intensity Day 3
Is drowsiness ongoing after day 3?
Item
Is drowsiness ongoing after day 3?
boolean
C0013144 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of drowsiness.
Item
Date of last day of drowsiness.
date
C0013144 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Drowsiness - Causality?
Item
Drowsiness - Causality?
boolean
C0013144 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Drowsiness - medically attended visit?
Item
Drowsiness - medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
Item
Drowsiness - specify medically attended visit.
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Code List
Drowsiness - specify medically attended visit.
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Item
Loss of appetite - Intensity Day 0
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])
C0011008 (UMLS CUI [1,3])
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])
C0011008 (UMLS CUI [1,3])
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])
C0011008 (UMLS CUI [1,3])
Code List
Loss of appetite - Intensity Day 3
Is loss of appetite ongoing after day 3?
Item
Is loss of appetite ongoing after day 3?
boolean
C1971624 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
If loss of appetite is ongoing after day 3, record date of last day of symptoms.
Item
Date of last day of loss of appetite.
date
C1971624 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Loss of appetite - Causality?
Item
Loss of appetite - Causality?
boolean
C1971624 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Loss of appetite - medically attended visit?
Item
Loss of appetite - medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])
Item
Loss of appetite - specify medically attended visit.
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Code List
Loss of appetite - specify medically attended visit.
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
In case of intensity 3: Was the crying continuous
Item
In case of intensity 3: Was the crying continuous (i.e. episodic, not interrupted within the time period of 3 hours by e.g. naps)?
boolean
C0518690 (UMLS CUI [1])
C2721683 (UMLS CUI [2])
In case of intensity 3: was the crying unaltered >=3 hours?
Item
In case of intensity 3: was the crying unaltered >=3 hours?
boolean
C0518690 (UMLS CUI [1,1])
C0438697 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])