Has any vaccine other than Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?the study vaccine(s) been administered one starting 30 days prior to the vaccine dose and ending one month after the vaccine dose?
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
boolean
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Trade Name/ (Generic) Name
Item
Trade Name/ (Generic) Name
text
C2360065 (UMLS CUI [1,1])
C0592502 (UMLS CUI [1,2])
Item
Administration Route
text
C0013153 (UMLS CUI [1])
Code List
Administration Route
CL Item
Intramuscular (IM)
CL Item
Intraarticular (IR)
CL Item
Subcutaneous (SC)
Administration Date
Item
Administration Date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Have any medications/treatments been administered during study period?
Item
Have any medications/treatments been administered during study period?
boolean
C0013227 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
Trade/ Generic Name
Item
Trade/ Generic Name
text
C2360065 (UMLS CUI [1])
Item
Medical Indication
integer
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Code List
Medical Indication
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
Administration Route
Item
Administration Route
text
C0013153 (UMLS CUI [1])
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication End Date
Item
Medication End Date
date
C2826744 (UMLS CUI [1])
Item
Tick box if continuing at end of study
integer
C1553904 (UMLS CUI [1,1])
C2983670 (UMLS CUI [1,2])
Code List
Tick box if continuing at end of study
CL Item
Continuing at end of study (1)
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
boolean
C1518404 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
AE No
Item
AE No
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-Serious Adverse Event Description
Item
Non-Serious Adverse Event Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event location
text
C1518404 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Code List
Non-Serious Adverse Event location
CL Item
Administration site (L)
CL Item
Non-administration site (G)
Item
If Administation sites, specify vaccine
integer
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Code List
If Administation sites, specify vaccine
CL Item
Twinrix Adult (720/20) vaccine (1)
CL Item
Engerix (20 µg) vaccine (2)
CL Item
Havrix (720 EL.U) vaccine (3)
Date Non-Serious Adverse Event Started
Item
Date Non-Serious Adverse Event Started
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Start Date during immediate post-vaccination period (30 minutes)
integer
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0205253 (UMLS CUI [1,5])
Code List
Non-Serious Adverse Event Start Date during immediate post-vaccination period (30 minutes)
CL Item
Start Date during immediate post-vaccination period (30 minutes) (1)
Date Non-Serious Adverse Event Stopped
Item
Date Non-Serious Adverse Event Stopped
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Intensity
integer
C1518404 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Code List
Non-Serious Adverse Event Intensity
Relationship to investigational products:
Item
Relationship to investigational products:
boolean
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item
Non-Serious Adverse Event Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Code List
Non-Serious Adverse Event Outcome
CL Item
Recovered/ Resolved (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ not resolved (3)
CL Item
Recovered with sequelae/ Resolved with sequelae (4)