Item
Serious Adverse Event (SAE)
text
C3897642 (UMLS CUI [1])
Code List
Serious Adverse Event (SAE)
CL Item
Initial report (Initial report )
CL Item
Additional info (Additional info)
CL Item
Additional info (Additional info)
CL Item
Additional info (Additional info)
Serious Adverse Event, Diagnosis
Item
Diagnosis (or signs and symptoms if not known)
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Serious Adverse Event, Start Date, Start Time
Item
Date and time started
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Intensity (maximum)
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Intensity (maximum)
Serious Adverse Event, Relationship, Vaccines
Item
In your opinion, did the vaccine possibly contribute to the SAE?
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
CL Item
Recovered with sequelae (2)
Item
Action taken with respect to Study Vaccine
text
C2826626 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Code List
Action taken with respect to Study Vaccine
CL Item
Vaccination course stopped (3)
CL Item
Vaccination course postponed (2)
Item
Events after further vaccination
text
C1519255 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0441471 (UMLS CUI [1,4])
Code List
Events after further vaccination
CL Item
Event reappeared (1)
CL Item
Event did not reappear (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item
Specify criteria for considering this as a Serious Adverse Event
text
C1519255 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Code List
Specify criteria for considering this as a Serious Adverse Event
CL Item
Results in death (Autopsy?) (1)
CL Item
Life threatening (2)
CL Item
Results in persistent or significant disability/ incapacity (3)
CL Item
Requires in-patient hospitalization (Admission/Discharge Date) (4)
CL Item
Prolongation of existing hospitalization (Discharge date) (5)
CL Item
Congenital anomaly / birth defect in the offspring of a study subject (6)
CL Item
"Medically important" event (7)
Item
Other events (not SAE) to be reported in the same way
text
C0441471 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Code List
Other events (not SAE) to be reported in the same way
Item
Other possible contributors
text
C1519255 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Code List
Other possible contributors
CL Item
Medical history (record in section 15) (1)
CL Item
Other medication (record in section 14) (2)
CL Item
Protocol required procedure (3)
CL Item
Other procedure (4)
CL Item
Lack of efficacy (5)
CL Item
Erroneous administration (6)
CL Item
Other, specify (7)
Serious Adverse Event, Withdraw
Item
Was subject withdrawn due to this specific SAE?
boolean
C1519255 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Vaccines, Experimental
Item
Vaccine (specify mixed or separate)
text
C0042210 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Vaccines, Dose, Number
Item
Dose No
integer
C0042210 (UMLS CUI [1,1])
C1115464 (UMLS CUI [1,2])
Vaccines, Lot Number
Item
Lot No
integer
C0042210 (UMLS CUI [1,1])
C1115660 (UMLS CUI [1,2])
Vaccines, Drug Administration Routes, Anatomical Site
Item
Route / Site
text
C0042210 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
Vaccines, Date in time
Item
Date
date
C0042210 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Agent
Item
Drug / Vaccine
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Agent, Medication dose
Item
Dosage
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Frequencies
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Item
Route
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Start Date
Item
Start date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, End Date
Item
End date
date
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Disease
Item
Condition
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Serious Adverse Event, Disease, Present
Item
Still present?
boolean
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
Serious Adverse Event, Pharmaceutical Preparations
Item
Drug
text
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Serious Adverse Event, Pharmaceutical Preparations, Dosage
Item
Dosage
text
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Serious Adverse Event, Pharmaceutical Preparations, Frequencies
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Serious Adverse Event, Pharmaceutical Preparations, Drug Administration Routes
Item
Route
text
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Serious Adverse Event, Pharmaceutical Preparations, Start Date
Item
Start date
date
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Pharmaceutical Preparations, End Date
Item
End date
date
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Operative Surgical Procedure
Item
Surgical treatment for this SAE
text
C1519255 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Serious Adverse Event, Description
Item
Description
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Investigator Signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Please PRINT Name
text
C2826892 (UMLS CUI [1])
Serious Adverse Event, Comment
Item
Comments
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Investigator Signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Please PRINT Name
text
C2826892 (UMLS CUI [1])