Item
Did the subject return for visit 2?
integer
C0008972 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
Code List
Did the subject return for visit 2?
CL Item
Yes, please complete the next pages. (1)
Item
Why didn't the subject return to visit 2?
text
C2348568 (UMLS CUI [1])
Code List
Why didn't the subject return to visit 2?
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
CL Item
Other, please specify (e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...) (OTH)
Number of serious adverse event
Item
SAE No
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
number of unsolicited adverse event
Item
Please specify unsolicited AE No
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
solicited AE code
Item
solicited AE code
text
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
specify other reason
Item
Please specify 'other' most appropriate category for not returning to visit 2.
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Item
Please tick who took the decision
text
C2348568 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Code List
Please tick who took the decision
CL Item
Parents / Guardians (P)
Item
Has a blood sample been taken?
integer
C0005834 (UMLS CUI [1])
Code List
Has a blood sample been taken?
Date blood sample taken
Item
Date blood sample taken
boolean
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Exposure in household to varicella/zoster
Item
Irrespective of whether the subject developed/develops varicella/zoster, was the subject exposed for more than one day to any varicella or zoster case presented by a household member or another person living temporarily within the household between Visit 1 and Visit 2?
boolean
C0008049 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0020052 (UMLS CUI [1,3])
C0740380 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0020052 (UMLS CUI [2,3])
Household Exposure No
Item
Household Exposure No
integer
C0332157 (UMLS CUI [1,1])
C0020052 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Date of onset exposure
Item
Date of onset exposure
date
C0574845 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
Item
Type of exposure
integer
C0332157 (UMLS CUI [1])
Code List
Type of exposure
signs or symptoms of varicella or zoster
Item
Did the subject present any signs of varicella or zoster symptoms between Visit 1 and Visit 2?
boolean
C0037088 (UMLS CUI [1,1])
C0740380 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2,1])
C0008049 (UMLS CUI [2,2])
Number of episodes of varicella/zoster signs and symptoms
Item
How many episodes?
integer
C0037088 (UMLS CUI [1,1])
C0740380 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2,1])
C0008049 (UMLS CUI [2,2])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1])
Item
Route
text
C0005903 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Item
Vaccine administration
text
C2368628 (UMLS CUI [1])
Code List
Vaccine administration
CL Item
Study Vaccine (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (N)
Replacement vial
Item
Replacement vial
text
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Wrong vial number
Item
Wrong vial number
text
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
vaccine administered according to protocol
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Item
Side (vaccine administered)
text
C2368628 (UMLS CUI [1,1])
C0444532 (UMLS CUI [1,2])
C0443246 (UMLS CUI [1,3])
Code List
Side (vaccine administered)
Item
Site (vaccine administered)
text
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Code List
Site (vaccine administered)
CL Item
Upper arm (Deltoid) (10)
Item
Route (vaccine administered)
text
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Code List
Route (vaccine administered)
Comments on vaccine administration
Item
Comments (on vaccine administration)
text
C2368628 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Date of vaccination
Item
Date of vaccination
date
C4301990 (UMLS CUI [1])
Item
Why was the vaccine not administered?
text
C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Why was the vaccine not administered?
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
CL Item
Other, please specify (e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...) (OTH)
Number of serious adverse event
Item
SAE No
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
number of unsolicited adverse event
Item
Please specify unsolicited AE No
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
specify other reason
Item
Please specify 'other' most appropriate category for non administration.
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within 42 days post-vaccination 1?
text
C1519255 (UMLS CUI [1,1])
C0231291 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0231291 (UMLS CUI [2,2])
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within 42 days post-vaccination 1?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
Yes, fill in the Non-Serious Adverse Event (for subset only) pages or Serious Adverse Event form. (Y)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C0851536 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
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)
Administration site erythema
Item
Redness
boolean
C3805283 (UMLS CUI [1])
Size of erythema at administration site Day 0
Item
Size (of redness at administration site) Day 0
integer
C3805283 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of erythema at administration site Day 1
Item
Size (of redness at administration site) Day 1
integer
C3805283 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of erythema at administration site Day 2
Item
Size (of redness at administration site) Day 2
integer
C3805283 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of erythema at administration site Day 3
Item
Size (of redness at administration site) Day 3
integer
C3805283 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Erythema ongoing after day 3
Item
Ongoing after Day 3?
boolean
C3805283 (UMLS CUI [1,1])
C0549178 (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])
Administration site swelling
Item
Swelling
boolean
C3854415 (UMLS CUI [1])
Size of swelling at administration site Day 0
Item
Size (of swelling at administration site) Day 0
integer
C3854415 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of swelling at administration site Day 1
Item
Size (of swelling at administration site) Day 1
integer
C3854415 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of swelling at administration site Day 2
Item
Size (of swelling at administration site) Day 2
integer
C3854415 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of swelling at administration site Day 3
Item
Size (of swelling at administration site) Day 3
integer
C3854415 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling ongoing after day 3
Item
Ongoing after day 3?
boolean
C3854415 (UMLS CUI [1,1])
C0549178 (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])
Administration site pain
Item
Pain
boolean
C0521491 (UMLS CUI [1])
Intensity of pain at administration site Day 0
Item
Intensity (of pain at administration site) Day 0
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
Intensity of pain at administration site Day 1
Item
Intensity (of pain at administration site) Day 1
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
Intensity of pain at administration site Day 2
Item
Intensity (of pain at administration site) Day 2
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
Intensity of pain at administration site Day 3
Item
Intensity (of pain at administration site) Day 3
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
Pain ongoing after day 3
Item
Ongoing after day 3?
boolean
C0521491 (UMLS CUI [1,1])
C0549178 (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])
Item
Has the subject experienced any of the following signs/symptoms during 42 days post-vaccination 2?
text
C0037088 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Code List
Has the subject experienced any of the following signs/symptoms during 42 days post-vaccination 2?
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)
Fever after vaccine administration
Item
Fever
boolean
C0015967 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
General rash / exanthema after vaccine administration
Item
General rash / exanthema
boolean
C0015230 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
salivary gland swelling
Item
Parotid / salivary gland swelling
boolean
C0240925 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Febrile convulsions or suspected signs of meningism after vaccine administration
Item
Febrile convulsions – suspected signs of meningism
boolean
C0009952 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0025287 (UMLS CUI [2,1])
C2368628 (UMLS CUI [2,2])
Varicella or Varicella zoster after vaccine administration
Item
Varicella / zoster
boolean
C0008049 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0740380 (UMLS CUI [2,1])
C2368628 (UMLS CUI [2,2])
Item
Route
text
C0005903 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Episode No
Item
Episode No
integer
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Temperature not taken
Item
Not taken (Temperature)
boolean
C0039476 (UMLS CUI [1])
Causality with vaccination fever
Item
Causality
boolean
C0015967 (UMLS CUI [1,1])
C3641099 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
Medically attended Visit?
Item
Medically attended Visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])