General medical history / physical examination
Date of visit
date
Subject number
integer
pre-existing conditions
text
Cutaneous
text
Cutaneous: diagnosis
text
Eyes
text
Eyes: diagnosis
text
Ears-Nose-Throat
text
Ears-Nose-Throat: diagnosis
text
Cardiovascular
text
Cardiovascular: diagnosis
text
Respiratory
text
Respiratory: diagnosis
text
Gastrointestinal
text
Gastrointestinal: diagnosis
text
Muskuloskeletal
text
Muskuloskeletal: diagnosis
text
Neurological
text
Neurological: diagnosis
text
Genitourinary
text
Genitourinary: diagnosis
text
Haematology
text
Haematology: diagnosis
text
Allergies
text
Allergies: diagnosis
text
Endocrine
text
Endocrine: diagnosis
text
Other (specify)
text
Other
text
Laboratory tests
Blood sample
text
Date of blood sample
date
HCG urine pregnancy test
text
Date of pregnancy test
date
Result from pregnancy test
text
Vaccine administration
Date of vaccine administration
date
Pre-vaccination temperature
float
Route
text
only one box must be ticked by vaccine
text
Twinrix™ Adult (720/20) Vaccine: Has the study vaccine been administered according to the Protocol?
text
Twinrix™ Adult (720/20) Vaccine: specification of not administered according to the protocol
text
Engerix™ (20 μg) Vaccine: specification of not administered according to the protocol
text
Havrix™ (720 EL.U)Vaccine: specification of not administered according to the protocol
text
Please tick the ONE most appropriate category for non administration
text
Specification of reason for non administration
text
IMMEDIATE POST-VACCINATION OBSERVATION If any adverse events occurred during the immediate post-vaccination time (30 minutes) please fill in the Solicited Adverse Events section, the Non-Serious Adverse Event section or a Serious Adverse Event form. If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick prophylactic box. Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section.
text
Unsolicited adverse events
Soliticited adverse events - local symptoms
Soliticited adverse events - local symptoms
text
Local symptoms
text
Local symptoms day 0
float
Local symptoms day 1
float
Local symptoms day 2
float
Local symptoms day 3
float
Ongoing after Day 3
boolean
Date of last day of symptoms (redness)
date
Local symptoms: swelling
text
Local symptoms day 0
float
Local symptoms day 1
float
Local symptoms day 2
float
Local symptoms day 3
float
Ongoing after Day 3
boolean
Date of last day of symptoms (swelling)
date
Local symptoms: pain
text
Intensity of pain day 0
text
Intensity of pain day 1
text
Intensity of pain day 2
text
Intensity of pain day 3
text
Ongoing after Day 3
boolean
Date of last day of symptoms (pain)
date
Solicid adverse events - general symptoms
Soliticed adverse events
text
General symptoms: Fever
boolean
Fever
float
Taking temperature
text
Fever day 0
float
Fever not taken day 0
boolean
Fever day 1
float
Fever not taken day 1
boolean
Fever day 2
float
Fever not taken day 2
boolean
Fever day 3
float
Fever not taken day 3
boolean
Ongoing after Day 3
boolean
Date of last Day of Symptoms
date
Causality
boolean
Fatigue
text
Intensity fatigue day 0
text
Intensity fatigue day 1
text
Intensity fatigue day 2
text
Intensity fatigue day 3
text
Ongoing after Day 3
boolean
Date of last Day of symptoms
date
Causality?
boolean
Headache
text
Intensity headache day 0
text
Intensity headache day 1
text
Intensity headache day 2
text
Intensity headache day 3
text
Ongoing after Day 3
boolean
Date of last Day of Symptoms
date
Causality
boolean
Gastrointestinal symptoms
text
Intensity gastrointestinal symptoms day 0
text
Intensity gastrointestinal symptoms day 1
text
Intensity gastrointestinal symptoms day 2
text
Intensity gastrointestinal symptoms day 3
text
Ongoing after Day 3
boolean
Date of last day of symptoms
date
Causality
boolean