Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
text
C1522541 (UMLS CUI [1])
Item
Visit Number
integer
C0545082 (UMLS CUI [1])
Non-Serious Adverse Events occurred
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
C0877248 (UMLS CUI [1])
AE No.
Item
Number of Adverse Event
boolean
C0877248 (UMLS CUI [1])
Description of Adverse Event
Item
Description of Adverse Event
text
C0877248 (UMLS CUI [1])
Item
Site of Adverse Event
text
C0877248 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Code List
Site of Adverse Event
CL Item
Administration sites: 10Pn-PD-DiT vaccineor Prevenar vaccine (L901)
CL Item
Administration sites: DTPa-HBV-IPV/Hib vaccine (L93)
CL Item
Non-administration site (G)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Start during immediate Post Vaccination Period
Item
Start during immediate Post Vaccination Period
boolean
C0205253 (UMLS CUI [1])
Item
Maximum Intensity:
integer
C0518690 (UMLS CUI [1])
Code List
Maximum Intensity:
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
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)
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])
Item
Medically Attended visit Specification
text
C0018704 (UMLS CUI [1])
Code List
Medically Attended visit Specification
CL Item
Hospitalisation (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)