Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
Yes (please complete the form below) (4)
If Yes, record t°
Item
If Yes, record t°
float
Ongoing after days 7?
Item
Ongoing after days 7?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit
Item
Medically attended visit
boolean
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Irritability/Fussiness
Item
Irritability/Fussiness
boolean
Item
If Yes, record intensity
text
Code List
If Yes, record intensity
Ongoing after days 7?
Item
Ongoing after days 7?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit
Item
Medically attended visit
boolean
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Drowsiness
Item
Drowsiness
boolean
Item
If Yes, record intensity
text
Code List
If Yes, record intensity
Ongoing after days 7?
Item
Ongoing after days 7?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit
Item
Medically attended visit
boolean
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Loss of Appetite
Item
Loss of Appetite
boolean
Item
If Yes, record intensity
text
Code List
If Yes, record intensity
Ongoing after days 7?
Item
Ongoing after days 7?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit
Item
Medically attended visit
boolean
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Vomiting
Item
Vomiting
boolean
Item
If Yes, record number
integer
Code List
If Yes, record number
Ongoing after days 7?
Item
Ongoing after days 7?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Item
Medically attended visit
text
Code List
Medically attended visit
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Diarrhea
Item
Diarrhea
boolean
If Yes, record number of looser than normal stools
Item
If Yes, record number of looser than normal stools
integer
Ongoing after days 7?
Item
Ongoing after days 7?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Item
Medically attended visit
text
Code List
Medically attended visit
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Was the crying continuous (i.r. not episodec, not interrupted within the time period of 3 hours by e.g. naps)?
Item
Was the crying continuous (i.r. not episodec, not interrupted within the time period of 3 hours by e.g. naps)?
boolean
Was the crying unaltered >=3 hours?
Item
Was the crying unaltered >=3 hours?
boolean