Visit 1 Non-serious adverse events

Non-serious adverse events
Beschrijving

Non-serious adverse events

Alias
UMLS CUI-1
C1518404
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Beschrijving

non-serious adverse events

Datatype

integer

Alias
UMLS CUI [1]
C1518404
Non-serious adverse events
Beschrijving

Non-serious adverse events

Alias
UMLS CUI-1
C1518404
Adverse event
Beschrijving

Adverse event

Datatype

text

Alias
UMLS CUI [1]
C0877248
Description of adverse event
Beschrijving

Description

Datatype

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1518404
Date adverse event started
Beschrijving

Date started or during immediate post-vaccination period (protocol specific: 30 minutes)

Datatype

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0877248
Date adverse event stopped
Beschrijving

Date stopped

Datatype

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0877248
Intensity of adverse event
Beschrijving

Intensity

Datatype

integer

Alias
UMLS CUI [1]
C1710066
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschrijving

Relationship to investigational products

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Outcome of adverse event
Beschrijving

Outcome

Datatype

integer

Alias
UMLS CUI [1]
C1705586
Medically attended visit
Beschrijving

Medically attended visit

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
If yes please specify type:
Beschrijving

Medical attended visit

Datatype

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404

Similar models

Visit 1 Non-serious adverse events

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Non-serious adverse events
C1518404 (UMLS CUI-1)
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?
integer
C1518404 (UMLS CUI [1])
Code List
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
CL Item
No (1)
CL Item
Yes, please complete the following table (2)
Item Group
Non-serious adverse events
C1518404 (UMLS CUI-1)
Item
Adverse event
text
C0877248 (UMLS CUI [1])
Code List
Adverse event
CL Item
Administration site ([L])
CL Item
Non-administration site ([G])
Description
Item
Description of adverse event
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Date started
Item
Date adverse event started
date
C0808070 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Date stopped
Item
Date adverse event stopped
date
C0806020 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Intensity of adverse event
integer
C1710066 (UMLS CUI [1])
Code List
Intensity of adverse event
CL Item
Mild (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Relationship to investigational products
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])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item
Outcome of adverse event
integer
C1705586 (UMLS CUI [1])
Code List
Outcome of adverse event
CL Item
Recovered / Resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / Resolved with sequela (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
If yes please specify type:
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Code List
If yes please specify type:
CL Item
Hospitalisation  (HO)
CL Item
Emergency Room  (ER)
CL Item
MedicalPersonnel (MD)