Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the protocol? [minimum 30 days] after it?
integer
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Code List
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the protocol? [minimum 30 days] after it?
CL Item
Yes, please record concomitant vaccination with trade name and / or generic (2)
CL Item
name, and vaccine administration date. (3)
Trade Name
Item
Trade / (Generic) Name
text
C2360065 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Administration date
Item
Administration date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item
Have any of the above mentioned medications/treatments been administered from 30 days pre-vaccination to 30 days after additional vaccination?
integer
C0013227 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Code List
Have any of the above mentioned medications/treatments been administered from 30 days pre-vaccination to 30 days after additional vaccination?
CL Item
Yes, please complete the following table. (2)
Trade name
Item
Trade / Generic name
text
C2360065 (UMLS CUI [1])
Medical Indication
Item
Medical Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Prophylactic
Item
Prophylactic
boolean
C0199176 (UMLS CUI [1])
Total daily dose
Item
Total daily dose
float
C2348070 (UMLS CUI [1])
Administration Route
Item
Route
text
C0013153 (UMLS CUI [1])
Start date
Item
Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End date
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Continuing Therapy
Item
Continuing at the end of study?
boolean
C1553904 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Subject Number
Item
Subject Number
text
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?
integer
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 (2)
Adverse Event Number
Item
Adverse Event Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Description
Item
Non-serious adverse events: Description
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Non-serious adverse events: Description
integer
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Non-serious adverse events: Description
CL Item
Administration sites (1)
CL Item
Non-administration site (2)
Start Date
Item
Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start
Item
Start: during immediate post-vaccination period (protocol specific: 0 – 30 minutes)
boolean
C0439659 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
End Date
Item
End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Maximum Intensity
Causality
Item
In your opinion, did the vaccine possibly contribute to this AE?
boolean
C0304229 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,4])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
CL Item
Recovered with sequelae (2)
CL Item
Ongoing at subject study conclusion (3)