undefined item
Item
(Please report all serious adverse events only on the Serious Adverse Event (SAE) form).
text
Non-serious adverse event
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])
Adverse event Number
Item
AE No.
text
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Description
Item
Description
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Location of adverse event
text
C0450429 (UMLS CUI [1])
Code List
Location of adverse event
CL Item
Administration site (L)
CL Item
Non-administration site (G)
Investigator Use
Item
For GSK
text
C0008961 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
Start date
Item
Date started
date
C0808070 (UMLS CUI [1])
Date started
Item
Did it start during immediate post-vaccination period (30 minutes)?
boolean
C0808070 (UMLS CUI [1])
End date
Item
Date stopped
date
C0806020 (UMLS CUI [1])
Item
Intensity
integer
C1710066 (UMLS CUI [1])
Relationship to investigational product
Item
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
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)
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,4])
Code List
Medically attended visit Type
CL Item
Emergency room (ER)
CL Item
Hospitalization (HO)
CL Item
Medical doctor (MD)