Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C0037088 (UMLS CUI [1])
C1515974 (UMLS CUI [2,1])
C2368628 (UMLS CUI [2,2])
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
Item
Local Symptoms
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Item
Redness, Swelling, Ecchymosis - Day
integer
C0332575 (UMLS CUI [1])
C0038999 (UMLS CUI [2])
C0013491 (UMLS CUI [3])
Code List
Redness, Swelling, Ecchymosis - Day
Redness Size
Item
Redness Size
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling Size
Item
Swelling Size
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Ecchymosis Size
Item
Ecchymosis Size
integer
C0013491 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Item
Pain Intensity
integer
C1320357 (UMLS CUI [1])
CL Item
Painful on touch (1)
CL Item
Painful when limb is moved (2)
CL Item
Spontaneously painful / prevents normal activity (3)
Symptom Ongoing after Day 6?
Item
Symptom Ongoing after Day 6?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
If Symptom is Ongoing after Day 6, enter Date of last Day of Symptoms
Item
If Symptom is Ongoing after Day 6, enter Date of last Day of Symptoms
date
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Item
Medically attended visit type
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Code List
Medically attended visit type
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C0037088 (UMLS CUI [1])
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
Item
General Symptoms
text
C0159028 (UMLS CUI [1])
Code List
General Symptoms
Item
Temperature Measurement Site
text
C0489453 (UMLS CUI [1])
Code List
Temperature Measurement Site
CL Item
Rectal (not recommended) (R)
Item
Fever, Fatigue, Headache, Muscle Ache, Shivering, Arthralgia - Day
integer
C0015967 (UMLS CUI [1])
C0015672 (UMLS CUI [2])
C0018681 (UMLS CUI [3])
C0231528 (UMLS CUI [4])
C0036973 (UMLS CUI [5])
C0003862 (UMLS CUI [6])
Code List
Fever, Fatigue, Headache, Muscle Ache, Shivering, Arthralgia - Day
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Temperature - Not Done
integer
C0886414 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Code List
Temperature - Not Done
Item
Fatigue Intensity
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Fatigue Intensity
CL Item
Easily tolerated (1)
CL Item
Interferes with normal activity (2)
CL Item
That prevents normal activity (3)
Item
Headache Intensity
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Headache Intensity
CL Item
Easily tolerated (1)
CL Item
Interferes with normal activity (2)
CL Item
That prevents normal activity (3)
Item
Muscle Ache Intensity
integer
C0231528 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Muscle Ache Intensity
CL Item
Easily tolerated (1)
CL Item
Interferes with normal activity (2)
CL Item
That prevents normal activity (3)
Item
Shivering Intensity
integer
C0036973 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Shivering Intensity
CL Item
Easily tolerated (1)
CL Item
Interferes with normal activity (2)
CL Item
That prevents normal activity (3)
Item
Arthralgia intensity
integer
C0003862 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Arthralgia intensity
CL Item
Easily tolerated (1)
CL Item
Interferes with normal activity (2)
CL Item
That prevents normal activity (3)
Symptom Ongoing after Day 6?
Item
Symptom Ongoing after Day 6?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
If Symptom is Ongoing after Day 6, enter Date of last Day of Symptoms
Item
If Symptom is Ongoing after Day 6, enter Date of last Day of Symptoms
date
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Causality?
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Item
Medically attended visit type
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Code List
Medically attended visit type
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events between Visit 1 and Visit 2?
text
C1519255 (UMLS CUI [1])
C1518404 (UMLS CUI [2])
C0545082 (UMLS CUI [3])
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events between Visit 1 and Visit 2?
CL Item
Information not available (U)
CL Item
No vaccine administered (NA)
CL Item
Yes (Fill in the Non-Serious Adverse Event section or Serious Adverse Event report, as appropriate) (Y)