date of administration
Item
Date (fill in only if different from visit date)
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature: Axillary
integer
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Vaccine administration (only one box must be ticked by vaccine)
text
C0042210 (UMLS CUI [1])
C3661302 (UMLS CUI [2])
Code List
Vaccine administration (only one box must be ticked by vaccine)
CL Item
InfanrixTMhexa Vaccine ([S])
CL Item
Replacement vial ([R])
CL Item
Wrong vial number |__|__|__|__|__| ([W])
CL Item
Not administered ([N])
vaccine administration according to the Protocol
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1])
Item
side of vaccine administration
text
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Code List
side of vaccine administration
Item
site of vaccine administration
integer
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Code List
site of vaccine administration
Item
route of vaccine administration
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Code List
route of vaccine administration
Item
Why not administered? Please tick the ONE most appropriate category for non administration :
text
C2368628 (UMLS CUI [1,1])
C1548562 (UMLS CUI [1,2])
Code List
Why not administered? Please tick the ONE most appropriate category for non administration :
CL Item
Serious adverse event (complete the Serious Adverse Event form) Please specify SAE N° : |__|__| ([SAE])
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) Please specify unsolicited AE N°: |__|__| or Solicited AE code : |__|__| ([AEX])
CL Item
Other, please specify: (e.g. consent withdrawal, protocol violation...) ([OTH])
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination ?
integer
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination ?
CL Item
Information not available (91)
CL Item
No Vaccine administered (92)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form.unsolicited AE N° (Unsol.): |__|__| or solicited AE code :|__|__| (1)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
integer
C1457887 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
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 (91)
CL Item
No Vaccine administered (92)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (1)
Local symptoms Redness
Item
Redness?
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Ongoing redness
Item
Redness ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Ongoing redness
Item
Date of last day of symptoms of redness:
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit concerning redness
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
Item
Medically attended visit: (see protocol for full definition)
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
Code List
Medically attended visit: (see protocol for full definition)
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical personnel (MD)
Item
Redness day
integer
C0439228 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness size
Item
Size of local redness
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Local symptoms Swelling
Item
Swelling?
boolean
C0038999 (UMLS CUI [1])
Ongoing Swelling
Item
Swelling ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
ongoing swelling
Item
Date of last day of symptoms of swelling:
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit concerning swelling
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
Item
Medically attended visit: (see protocol for full definition)
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
Code List
Medically attended visit: (see protocol for full definition)
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical personnel (MD)
Item
Swelling Day
integer
C0439228 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
Size of swelling
Item
Size of local swelling
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Local symptoms Pain
Item
Pain?
boolean
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Ongoing pain
Item
Pain ongoing after day 3?
boolean
C0030193 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Ongoing pain
Item
Date of last day of symptoms of pain:
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit concerning pain
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
Code List
Medically attended visit
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical personnel (MD)
Item
Pain Day
integer
C0439228 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Item
Pain intensity
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
integer
C0159028 (UMLS CUI [1])
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (91)
CL Item
No vaccine administered (92)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (1)
General Symptoms Fever
Item
Fever?
boolean
C1457887 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0015967 (UMLS CUI [1,4])
Ongoing fever
Item
Fever ongoing after day 3?
boolean
C0015967 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Last date of fever
Item
Date of last day of symptoms of fever
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Fever causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Medically attended visit concerning fever
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)
Fever temperature
Item
Fever temperature axillary
integer
C0039476 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever Day (axillary)
integer
C0015967 (UMLS CUI [1])
Code List
Fever Day (axillary)
General symptoms Irritability / Fussiness
Item
Irritability / Fussiness?
boolean
C0022107 (UMLS CUI [1])
Ongoing Irritability / Fussiness
Item
Irritability / Fussiness ongoing after day 3?
boolean
C0022107 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Irritability / Fussiness
Item
Date of last Irritability / Fussiness
date
C0022107 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality of Irritability / Fussiness
Item
Causality?
boolean
C0022107 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Medically attended visit concerning Irritability / Fussiness
Item
Medically attended visit concerning Irritability / Fussiness
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,3])
Item
Medically attended visit concerning Irritability / Fussiness
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,3])
Code List
Medically attended visit concerning Irritability / Fussiness
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical personnel (MD)
Item
Intensity of Irritability / Fussiness Day
integer
C0022107 (UMLS CUI [1])
Code List
Intensity of Irritability / Fussiness Day
Item
Intensity of Irritability / Fussiness
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Intensity of Irritability / Fussiness
General symptoms Drowsiness
Item
Drowsiness?
boolean
C0013144 (UMLS CUI [1])
Ongoing drowsiness
Item
Drowsiness ongoing after day 3?
boolean
C0013144 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Drowsiness
Item
Date of last Drowsiness
date
C0013144 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality of Drowsiness
Item
Causality?
boolean
C0013144 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Medically attended visit concerning Drowsiness
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
Item
Medically attended visit concerning drowsiness
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
Code List
Medically attended visit concerning drowsiness
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical personnel (MD)
Item
Drowsiness Day
integer
C0013144 (UMLS CUI [1])
Item
Drowsiness intensity
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Drowsiness intensity
General symptoms loss of appetite
Item
Loss of appetite?
boolean
C1971624 (UMLS CUI [1])
Ongoing loss of appetite
Item
Loss of appetite ongoing after day 3?
boolean
C1971624 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last loss of appetite
Item
Date of last loss of appetite
date
C1971624 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality of loss of appetite
Item
Causality?
boolean
C1971624 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Medically attended visit concerning loss of appetite
Item
Medically attended visit concerning loss of appetite
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])
Item
Medically attended visit concerning loss of appetite
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])
Code List
Medically attended visit concerning loss of appetite
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical personnel (MD)
Item
Intensity of loss of appetite day
integer
C1971624 (UMLS CUI [1])
Code List
Intensity of loss of appetite day
Item
Intensity of loss of appetite
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Intensity of loss of appetite