Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Subject Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item
Has any non-serious adverse events occurred within one month (Day 0 to Day 29) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
text
C1518404 (UMLS CUI [1])
Code List
Has any non-serious adverse events occurred within one month (Day 0 to Day 29) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
CL Item
Yes, please complete the following table. (Yes, please complete the following table.)
adverse event number
Item
AE No.
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
adverse event description
Item
Description
text
C0877248 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
comment
Item
For GSK
text
C0947611 (UMLS CUI [1])
adverse event location
Item
Local (administration site)
boolean
C0877248 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
adverse event location2
Item
Non-administration site
boolean
C0877248 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
adverse event start date
Item
Date started
date
C2697888 (UMLS CUI [1])
immediate post-vaccination reaction
Item
during immediate postvaccination period specified in protocol
boolean
C2697888 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
adverse event end date
Item
Date Stopped
date
C2697886 (UMLS CUI [1])
Item
Intensity
integer
C1710066 (UMLS CUI [1])
causality
Item
Causality In your opinion, did the vaccine possibly contribute to this AE?
boolean
C3641099 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Adverse Event Outcome
text
C1705586 (UMLS CUI [1])
Code List
Adverse Event Outcome
CL Item
Recovered with sequelae (2)
CL Item
Ongoing at subject study conclusion (3)