Non-serious adverse Event
Item
Has any non-serious adverse event occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
boolean
C1518404 (UMLS CUI [1])
AE No.
Item
AE No.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Description
Item
Description
text
C0678257 (UMLS CUI [1])
Item
Administration Site
text
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Code List
Administration Site
CL Item
Administration Site (L)
CL Item
Non-administration Site (G)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
NSAE Started Immediately
Item
during immediate postvaccination period (30 minutes)
boolean
C0574845 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C0205253 (UMLS CUI [1,3])
End date
Item
Date Stopped
date
C0806020 (UMLS CUI [1])
Item
Maximum Intensity
text
C1710066 (UMLS CUI [1])
Code List
Maximum Intensity
CL Item
Mild (1)
C2945599 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (2)
C0205081 (UMLS CUI-1)
(Comment:en)
CL Item
Severe (3)
C0205082 (UMLS CUI-1)
(Comment:en)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Outcome
integer
C1705586 (UMLS CUI [1])
CL Item
Recovered/Resolved (1)
C1709863 (UMLS CUI-1)
(Comment:en)
CL Item
Recovering/Resolving (2)
C1709864 (UMLS CUI-1)
(Comment:en)
CL Item
Not recovered/Not resolved (3)
C1709277 (UMLS CUI-1)
(Comment:en)
CL Item
Recovered/Resolved with sequelae (4)
C1709862 (UMLS CUI-1)
(Comment:en)
Comment
Item
For GSK
text
C0947611 (UMLS CUI [1])