Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C1457887 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0042196 (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 retrievable (1)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (3)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Redness
Item
Redness, size (mm)
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 0
Item
Redness on Day 0
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 1
Item
Redness on Day 1
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 2
Item
Redness on Day 2
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 3
Item
Redness on Day 3
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness ongoing after day 3
Item
Redness ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medical advice
Item
Medical advice
boolean
C1386497 (UMLS CUI [1])
C0332575 (UMLS CUI [2])
Item
Medical advice Type
text
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [2])
Code List
Medical advice Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Swelling
Item
Swelling, size (mm)
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 0
Item
Swelling on Day 0
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 1
Item
Swelling on Day 1
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 2
Item
Swelling on Day 2
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 3
Item
Swelling on Day 3
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling ongoing after day 3
Item
Swelling ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medical advice
Item
Medical advice
boolean
C1386497 (UMLS CUI [1])
C0038999 (UMLS CUI [2])
Item
Medical advice Type
text
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2])
Code List
Medical advice Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Pain, intensity
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Code List
Pain, intensity
Item
Pain on Day 0
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Pain on Day 1
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Pain on Day 2
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item
Pain on Day 3
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain ongoing after day 3
Item
Pain ongoing after day 3?
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medical advice
Item
Medical advice
boolean
C1386497 (UMLS CUI [1])
C0030193 (UMLS CUI [2])
Item
Medical advice Type
text
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2])
Code List
Medical advice Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever
float
C0015967 (UMLS CUI [1])
Item
Fever, Site of measurement
text
C0449687 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Code List
Fever, Site of measurement
Item
Fever on Day 0
integer
C0015967 (UMLS CUI [1])
Fever on Day 0
Item
Fever on Day 0
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever on Day 1
integer
C0015967 (UMLS CUI [1])
Fever on Day 1
Item
Fever on Day 1
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever on Day 2
integer
C0015967 (UMLS CUI [1])
Fever on Day 2
Item
Fever on Day 2
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever on Day 3
integer
C0015967 (UMLS CUI [1])
Fever on Day 3
Item
Fever on Day 3
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Fever ongoing after day 3
Item
Fever ongoing after day 3?
boolean
C0015967 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
C0015967 (UMLS CUI [2])
Medical advice
Item
Medical advice
boolean
C1386497 (UMLS CUI [1])
C0015967 (UMLS CUI [2])
Item
Medical advice Type
text
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [2])
Code List
Medical advice Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Fatigue
Item
Fatigue
boolean
C0015672 (UMLS CUI [1])
Item
Fatigue, Intensity
integer
C0522510 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
Code List
Fatigue, Intensity
Item
Fatigue on Day 0
integer
C0015672 (UMLS CUI [1])
Code List
Fatigue on Day 0
Item
Fatigue on Day 1
integer
C0015672 (UMLS CUI [1])
Code List
Fatigue on Day 1
Item
Fatigue on Day 2
integer
C0015672 (UMLS CUI [1])
Code List
Fatigue on Day 2
Item
Fatigue on Day 3
integer
C0015672 (UMLS CUI [1])
Code List
Fatigue on Day 3
Fatigue ongoing after day 3
Item
Fatigue ongoing after day 3?
boolean
C0015672 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
C0015672 (UMLS CUI [2])
Medical advice
Item
Medical advice
boolean
C1386497 (UMLS CUI [1])
C0015672 (UMLS CUI [2])
Item
Medical advice Type
text
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015672 (UMLS CUI [2])
Code List
Medical advice Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Headache
Item
Headache
boolean
C0018681 (UMLS CUI [1])
Item
Headache, Intensity
integer
C0522510 (UMLS CUI [1,1])
C0018681 (UMLS CUI [1,2])
Code List
Headache, Intensity
Item
Headache on Day 0
integer
C0018681 (UMLS CUI [1])
Code List
Headache on Day 0
Item
Headache on Day 1
integer
C0018681 (UMLS CUI [1])
Code List
Headache on Day 1
Item
Headache on Day 2
integer
C0018681 (UMLS CUI [1])
Code List
Headache on Day 2
Item
Headache on Day 3
integer
C0018681 (UMLS CUI [1])
Code List
Headache on Day 3
Headache ongoing after day 3
Item
Headache ongoing after day 3?
boolean
C0018681 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0018681 (UMLS CUI [1,2])
Causality
Item
Causality
boolean
C0015127 (UMLS CUI [1])
C0018681 (UMLS CUI [2])
Medical advice
Item
Medical advice
boolean
C1386497 (UMLS CUI [1])
C0018681 (UMLS CUI [2])
Item
Medical advice Type
text
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0018681 (UMLS CUI [2])
Code List
Medical advice Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Nausea
Item
Nausea
boolean
C0027497 (UMLS CUI [1])
Item
Nausea, Intensity
integer
C0522510 (UMLS CUI [1,1])
C0027497 (UMLS CUI [1,2])
Code List
Nausea, Intensity
Item
Nausea on Day 0
integer
C0027497 (UMLS CUI [1])
Code List
Nausea on Day 0
Item
Nausea on Day 1
integer
C0027497 (UMLS CUI [1])
Code List
Nausea on Day 1
Item
Nausea on Day 2
integer
C0027497 (UMLS CUI [1])
Code List
Nausea on Day 2
Item
Nausea on Day 3
integer
C0027497 (UMLS CUI [1])
Code List
Nausea on Day 3
Nausea ongoing after day 3
Item
Nausea ongoing after day 3?
boolean
C0027497 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0027497 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
C0027497 (UMLS CUI [2])
Medical advice
Item
Medical advice
boolean
C1386497 (UMLS CUI [1])
C0027497 (UMLS CUI [2])
Item
Medical advice Type
text
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0027497 (UMLS CUI [2])
Code List
Medical advice Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
General feeling of being ill
Item
General feeling of being ill
boolean
C0231218 (UMLS CUI [1])
Item
General feeling of being ill, Intensity
integer
C0522510 (UMLS CUI [1,1])
C0231218 (UMLS CUI [1,2])
Code List
General feeling of being ill, Intensity
Item
General feeling of being ill on Day 0
integer
C0231218 (UMLS CUI [1])
Code List
General feeling of being ill on Day 0
Item
General feeling of being ill on Day 1
integer
C0231218 (UMLS CUI [1])
Code List
General feeling of being ill on Day 1
Item
General feeling of being ill on Day 2
integer
C0231218 (UMLS CUI [1])
Code List
General feeling of being ill on Day 2
Item
General feeling of being ill on Day 3
integer
C0231218 (UMLS CUI [1])
Code List
General feeling of being ill on Day 3
General feeling of being ill ongoing after day 3
Item
General feeling of being ill ongoing after day 3?
boolean
C0231218 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0231218 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
C0231218 (UMLS CUI [2])
Medical advice
Item
Medical advice
boolean
C1386497 (UMLS CUI [1])
C0231218 (UMLS CUI [2])
Item
Medical advice Type
text
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0231218 (UMLS CUI [2])
Code List
Medical advice Type
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)