125742 S1 M5 CRF c4591001 1117 11171146

Document text

Page 1 of 236
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796288
Page 2 of 236
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/22/2020
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796289
Page 3 of 236
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11171146]
2.Birth Date: 1949
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796290
Page 4 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit Comments
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796291
Page 5 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796292
Page 6 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/22/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: Not Applicable
[ ]Comments
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796293
Page 7 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYSTERECTOMY, TOTAL]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[UTERINE FIBROIDS]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/2014
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MENOPAUSE]
Start Date: UNK/UNK/2000
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ALLERGY, PENCILLIN]
Start Date: UNK/UNK/1959
Ongoing: YES
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796294
Page 8 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SLEEP APNEA]
Start Date: Sep/UNK/2018
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTENSION]
Start Date: Jun/UNK/2018
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OSTEOPOROSIS]
Start Date: UNK/UNK/2012
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BONE SPUR, SHOULDER, RIGHT]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796295
Page 9 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BONE SPUR REMOVAL, SHOULDER, RIGHT]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[IRREGULAR HEART BEAT]
Start Date: UNK/UNK/2018
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HEARING IMPAIRMENT, BILATERAL]
Start Date: UNK/UNK/2012
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[VISION IMPAIRMENT, BILATERAL]
Start Date: UNK/UNK/1990
Ongoing: YES
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796296
Page 10 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[PEPTIC ULCERS]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2017
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[NEUROPATHY, LOWER EXTREMITY, BILATERAL]
Start Date: UNK/UNK/2015
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OSTEOARTHRITIS, HIP, BILATERAL]
Start Date: UNK/UNK/2015
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OSTEOARTHRITIS, THUMB, BILATERAL]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796297
Page 11 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CELLULITIS, ANKLE, RIGHT]
Start Date: Jan/31/2019
Ongoing: NO
End Date:
Feb/9/2019
1.rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ALLERGY, SEASONAL]
Start Date: UNK/UNK/1965
Ongoing: YES
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ALCOHOL USE, 7 DRINKS/WEEK]
Start Date: UNK/UNK/1968
Ongoing: YES
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OSTEOARTHRITIS, KNEE, BILATERAL]
Start Date: UNK/UNK/2017
Ongoing: YES
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GASTROESOPHAGEAL REFLUX DISEASE]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796298
Page 12 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.vLine/MH Number: [22]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[VERTIGO]
Start Date: UNK/UNK/2015
Ongoing: YES
1.wLine/MH Number: [23]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DEEP VEIN THROMBOSIS, LOWER EXTREMITY, BILATERAL]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
1.xLine/MH Number: [24]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ULCERS, GASTRIC]
Start Date: UNK/UNK/2015
Ongoing: YES
1.yLine/MH Number: [25]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[KIDNEY STONE]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2019
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796299
Page 13 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.zLine/MH Number: [26]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MUSCLE SPASM]
Start Date: UNK/UNK/2010
Ongoing: YES
1.aaLine/MH Number: [27]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERCHOLESTEROLEMIA]
Start Date: UNK/UNK/2015
Ongoing: YES
1.abLine/MH Number: [28]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[VITAMIN D DEFICIENCY]
Start Date: UNK/UNK/2017
Ongoing: YES
1.acLine/MH Number: [29]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[PULMONARY ARTERIAL HYPERTENSION]
Start Date: Jan/22/2018
Ongoing: YES
1.adLine/MH Number: [30]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[AORTIC ANEURYSM]
Start Date: Jan/22/2018
Ongoing: YES
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796300
Page 14 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.aeLine/MH Number: [31]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[VENTRICULAR ENLARGEMENT, RIGHT]
Start Date: Jan/22/2010
Ongoing: YES
1.afLine/MH Number: [32]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ATHEROSCLEROTIC DISEASE]
Start Date: Jan/22/2018
Ongoing: YES
1.agLine/MH Number: [33]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CATARACTS, BILATERAL]
Start Date: Jun/UNK/2020
Ongoing: YES
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796301
Page 15 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796302
Page 16 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
2.Weight: [166.8]
3.Unit: LB
4.Height: [62.4]
5.Unit: in
6.Body Mass Index: [30.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [96.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796303
Page 17 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/22/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796304
Page 18 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/22/2020
2.Randomization Number: [263521]
3.Randomization Group: [ ]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796305
Page 19 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM8YNL]
5.bSample ID [BM8YNK]
5.cSample ID [BM8YNJ]
5.dSample ID [BPRV5C]
5.eSample ID [BPRV5D]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796306
Page 20 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM8YMW]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796307
Page 21 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/22/2020 15:57
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796308
Page 22 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796309
Page 23 of 236
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796310
Page 24 of 236
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Oct/12/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796311
Page 25 of 236
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/12/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796312
Page 26 of 236
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/12/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJ8FV]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796313
Page 27 of 236
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/12/2020 14:13
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796314
Page 28 of 236
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/12/2020
2.Erroneous Visit
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796315
Page 29 of 236
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/12/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRSRX2]
5.bSample ID [BRSRX3]
5.cSample ID [BM8YTW]
5.dSample ID [BM8YTX]
5.eSample ID [BM8YTY]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796316
Page 30 of 236
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796317
Page 31 of 236
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796318
Page 32 of 236
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796319
Page 33 of 236
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796320
Page 34 of 236
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796321
Page 35 of 236
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796322
Page 36 of 236
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796323
Page 37 of 236
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796324
Page 38 of 236
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796325
Page 39 of 236
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796326
Page 40 of 236
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796327
Page 41 of 236
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Unplanned Assessments
1.Assessments
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796328
Page 42 of 236
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1. ADVERS
E EVENT 1  PULMONARY EMBOLI  Jan/21/2021
UNK:UNK NO
End Date Time:
Jan/23/2021 UN
K:UNK
 Repeating
Pages
 2. DELETED ADVERS
E EVENT 2  WORSENING AORTIC ANEU
RYSM Jan/21/2021
UNK:UNK YES  Repeating
Pages
 3. ADVERS
E EVENT 3  DEEP VEIN THROMBOSIS, L
OWER EXTREMITY, RIGHT Jan/21/2021
UNK:UNK NO
End Date Time:
Jan/23/2021 UN
K:UNK
 Repeating
Pages
 4. ADVERS
E EVENT 4  HIATAL HERNIA  Jan/21/2021
UNK:UNK YES  Repeating
Pages
 5. ADVERS
E EVENT 5  CATARACTS, WORSENING
CONDITION Feb/3/2021
UNK:UNK YES  Repeating
Pages
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796329
Page 43 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[PULMONARY EMBOLI]
4.Start Date Time: Jan/21/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/23/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796330
Page 44 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[CURRENT DVT, PRIOR HX OF DVT]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021064848]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796331
Page 45 of 236
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[WORSENING AORTIC ANEURYSM ]
4.Start Date Time: Jan/21/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[PREEXISTING CONDITION ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796332
Page 46 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796333
Page 47 of 236
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[DEEP VEIN THROMBOSIS, LOWER EXTREMITY, RIGHT]
4.Start Date Time: Jan/21/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/23/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796334
Page 48 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[PRIOR HISTORY OF DVT]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021064848]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796335
Page 49 of 236
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[HIATAL HERNIA]
4.Start Date Time: Jan/21/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[ETIOLOGY UNKNOWN]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796336
Page 50 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796337
Page 51 of 236
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[CATARACTS, WORSENING CONDITION]
4.Start Date Time: Feb/3/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[PRE EXISTING CONDITON]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796338
Page 52 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796339
Page 53 of 236
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796340
Page 54 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error
associated with any adverse events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796341
Page 55 of 236
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796342
Page 56 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796343
Page 57 of 236
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796344
Page 58 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796345
Page 59 of 236
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796346
Page 60 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796347
Page 61 of 236
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796348
Page 62 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796349
Page 63 of 236
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Nov/12/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796350
Page 64 of 236
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796351
Page 65 of 236
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796352
Page 66 of 236
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796353
Page 67 of 236
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796354
Page 68 of 236
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796355
Page 69 of 236
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796356
Page 70 of 236
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796357
Page 71 of 236
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796358
Page 72 of 236
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796359
Page 73 of 236
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/19/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796360
Page 74 of 236
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796361
Page 75 of 236
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796362
Page 76 of 236
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796363
Page 77 of 236
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/19/2021
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796364
Page 78 of 236
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796365
Page 79 of 236
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death :Jan/19/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796366
Page 80 of 236
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/19/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796367
Page 81 of 236
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/19/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRSRHZ]
5.bSample ID [BRSRJ0]
5.cSample ID [BR6RNS]
5.dSample ID [BR6RNT]
5.eSample ID [BR6RNV]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796368
Page 82 of 236
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/19/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP58ZY]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796369
Page 83 of 236
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/19/2021 14:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796370
Page 84 of 236
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796371
Page 85 of 236
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/9/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796372
Page 86 of 236
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/9/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR6RV6]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796373
Page 87 of 236
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/9/2021 14:45
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796374
Page 88 of 236
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796375
Page 89 of 236
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796376
Page 90 of 236
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796377
Page 91 of 236
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796378
Page 92 of 236
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796379
Page 93 of 236
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796380
Page 94 of 236
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796381
Page 95 of 236
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/12/2020
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796382
Page 96 of 236
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796383
Page 97 of 236
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-10-2021 11:09:37 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796384
Page 98 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Oct-06-2020 16:29:22 (UTC-06:00) Central Time
(US & Canada)
2Sep-28-2020 14:05:08 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0796385
Page 99 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormSep-28-2020 14:05:39 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0796386
Page 100 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Sep-28-2020 14:06:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0796387
Page 101 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Oct-06-2020 16:29:41 (UTC-06:00) Central Time
(US & Canada)
4Sep-29-2020 16:52:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0796388
Page 102 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Oct-06-2020 16:29:55 (UTC-06:00) Central Time
(US & Canada)
4Sep-29-2020 16:49:57 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0796389
Page 103 of 236
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormJan-22-2021 21:19:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0796390
Page 104 of 236
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-10-2021 11:09:37 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-25-2020 20:35:21 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-16-2020 16:28:25 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-12-2020 18:20:03 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796391
Page 105 of 236
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Larkin
Wadsworth Approved Nov-12-2020 10:39:13 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LarkinWadsworth, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0796392
Page 106 of 236
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-28-2020 14:04:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-28-2020 14:04:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796393
Page 107 of 236
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-28-2020 14:04:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/22/2020Initial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796394
Page 108 of 236
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-28-2020 14:03:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11171146Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-28-2020 14:03:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1949Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-28-2020 14:04:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-28-2020 14:04:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-28-2020 14:04:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796395
Page 109 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-01-2020 06:49:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-30-2020 15:02:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Sep-29-2020 11:57:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly review
and complete
‘Immunogenicity,
Nasal Swab forms' at
this visit. Thank you
Sep-28-2020 14:05:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Oct-07-2020 07:09:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query.
Oct-06-2020 16:29:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Oct-06-2020 16:29:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Oct-06-2020 00:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM1: Data is not
updated as per
query. As this visit
was performed on
22Sep2020, kindly
consider to remove
item level comment
'Not Applicable' at
'Erroneous visit'
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796396
Page 110 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
field on this page.
Oct-04-2020 19:37:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Oct-01-2020 06:49:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: As this visit
was performed on
22Sep2020, kindly
consider to remove
item level comment
'Not Applicable'
added at 'Erroneous
visit' field.
Sep-28-2020 14:05:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0796397
Page 111 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-28-2020 14:06:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-28-2020 14:06:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-28-2020 14:06:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
4. Specify Status:
Date Location User Value Reason
Sep-28-2020 14:06:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796398
Page 112 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.a
Date Location User Value Reason
Sep-28-2020 14:06:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:HYSTERECTOM
Y, TOTAL
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/201
4Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-28-2020 14:06:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 14:06:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HYSTERECTOMY, TOTALInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-28-2020 14:06:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-28-2020 14:06:57 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0796399
Page 113 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00) Central
Time (US & Canada)NO
End Date:
UNK/UNK/2014
1.b
Date Location User Value Reason
Sep-28-2020 14:07:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:UTERINE FIBR
OIDS
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/2
014Initial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796400
Page 114 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.b Line/MH Number:
Date Location User Value Reason
Sep-28-2020 14:07:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 14:07:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UTERINE FIBROIDSInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-28-2020 14:07:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-28-2020 14:07:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2014Initial Entry
1.c
Date Location User Value Reason
Sep-28-2020 14:07:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History T
erm:MENOPAUS
E
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796401
Page 115 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.c Line/MH Number:
Date Location User Value Reason
Sep-28-2020 14:07:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 14:07:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MENOPAUSEInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-28-2020 14:07:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-28-2020 14:07:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-28-2020 14:08:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4
Medical Histor
y Term:ALLERGY, PEN
CILLIN
Start Date: UNK/UNK/1959
Ongoing: YESInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796402
Page 116 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.d Line/MH Number:
Date Location User Value Reason
Sep-28-2020 14:08:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 14:08:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ALLERGY, PENCILLINInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-28-2020 14:08:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1959Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-28-2020 14:08:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-28-2020 14:08:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Te
rm:SLEEP APN
EA
Start Date: Sep/UNK/20
18
Ongoing: YESInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796403
Page 117 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.e Line/MH Number:
Date Location User Value Reason
Sep-28-2020 14:08:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 14:08:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SLEEP APNEAInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-28-2020 14:08:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/UNK/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-28-2020 14:08:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-28-2020 14:09:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:HYPERTENS
ION
Start Date: Jun/UNK/201
8
Ongoing: YESInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796404
Page 118 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.f Line/MH Number:
Date Location User Value Reason
Sep-28-2020 14:09:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 14:09:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HYPERTENSIONInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-28-2020 14:09:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/UNK/2018Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-28-2020 14:09:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-28-2020 14:09:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:OSTEOPORO
SIS
Start Date: UNK/UNK/20
12
Ongoing: YESInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796405
Page 119 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.g Line/MH Number:
Date Location User Value Reason
Sep-28-2020 14:09:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 14:09:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OSTEOPOROSISInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-28-2020 14:09:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-28-2020 14:09:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Sep-28-2020 14:10:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:8
Medical His
tory Term:BONE SPUR, SHO
ULDER, RIGHT
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016Initial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796406
Page 120 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.h Line/MH Number:
Date Location User Value Reason
Sep-28-2020 14:10:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 14:10:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BONE SPUR, SHOULDER, RIG
HTInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-28-2020 14:10:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-28-2020 14:10:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2016Initial Entry
1.i
Date Location User Value Reason
Sep-28-2020 14:10:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:9
Medical H
istory Ter
m:BONE SPUR REMOV
AL, SHOULDER, RIG
HT
Start Date
:UNK/UNK/2016Initial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796407
Page 121 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Ongoing: NO
End Date:
UNK/UNK/2016
1.i Line/MH Number:
Date Location User Value Reason
Sep-28-2020 14:10:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 14:10:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BONE SPUR REMOVAL, SHOU
LDER, RIGHTInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-28-2020 14:10:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-28-2020 14:10:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2016Initial Entry
1.j
Date Location User Value Reason
Sep-28-2020 14:11:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:10
Medical Histo
ry Term:IRREGULAR HE
ART BEATInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796408
Page 122 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Start Date: UNK/UNK/2018
Ongoing: YES
1.j Line/MH Number:
Date Location User Value Reason
Sep-28-2020 14:11:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 14:11:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
IRREGULAR HEART BEATInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-28-2020 14:11:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-28-2020 14:11:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796409
Page 123 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.k
Date Location User Value Reason
Sep-28-2020 14:12:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:11
Medical His
tory Term:HEARING IMPAIR
MENT, BILATERA
L
Start Date: UNK/UNK/2012
Ongoing: YESInitial Entry
1.k Line/MH Number:
Date Location User Value Reason
Sep-28-2020 14:12:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 14:12:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HEARING IMPAIRMENT, BILA
TERALInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-28-2020 14:12:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-28-2020 14:12:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.l
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796410
Page 124 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Sep-28-2020 14:13:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:12
Medical His
tory Term:VISION IMPAIRM
ENT, BILATERAL
Start Date: UNK/UNK/1990
Ongoing: YESInitial Entry
1.l Line/MH Number:
Date Location User Value Reason
Sep-28-2020 14:13:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 14:13:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VISION IMPAIRMENT, BILATE
RALInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-28-2020 14:13:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-28-2020 14:13:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Sep-28-2020 14:13:49
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796411
Page 125 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada) Line/MH Numbe
r:13
Medical History
Term:PEPTIC ULCE
RS
Start Date: UNK/UNK/201
5
Ongoing: NO
End Date:
UNK/UNK/
2017
1.m Line/MH Number:
Date Location User Value Reason
Sep-28-2020 14:13:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 14:13:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PEPTIC ULCERSInitial Entry
1.m Start Date:
Date Location User Value Reason
Sep-28-2020 14:13:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-28-2020 14:13:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.n
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796412
Page 126 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Sep-28-2020 14:14:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:14
Medical
History T
erm:NEUROPATHY, LOW
ER EXTREMITY, BIL
ATERAL
Start Date
:UNK/UNK/2015
Ongoing: YESInitial Entry
1.n Line/MH Number:
Date Location User Value Reason
Sep-28-2020 14:14:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 14:14:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEUROPATHY, LOWER EXTR
EMITY, BILATERALInitial Entry
1.n Start Date:
Date Location User Value Reason
Sep-28-2020 14:14:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-28-2020 14:14:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796413
Page 127 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-28-2020 14:15:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:15
Medical His
tory Term:OSTEOARTHRITIS
, HIP, BILATERAL
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
1.o Line/MH Number:
Date Location User Value Reason
Sep-28-2020 14:15:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 14:15:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OSTEOARTHRITIS, HIP, BILAT
ERALInitial Entry
1.o Start Date:
Date Location User Value Reason
Sep-28-2020 14:15:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.o Ongoing:
Date Location User Value Reason
Sep-28-2020 14:15:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.p
Date Location User Value Reason
Sep-28-2020 14:15:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:16Initial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796414
Page 128 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Medical Hi
story Term
:OSTEOARTHRITIS,
THUMB, BILATER
AL
Start Date: UNK/UNK/2015
Ongoing: YES
1.p Line/MH Number:
Date Location User Value Reason
Sep-28-2020 14:15:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 14:15:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OSTEOARTHRITIS, THUMB, B
ILATERALInitial Entry
1.p Start Date:
Date Location User Value Reason
Sep-28-2020 14:15:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.p Ongoing:
Date Location User Value Reason
Sep-28-2020 14:15:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.q
Date Location User Value Reason
Sep-28-2020 14:16:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:17
Medical Hist
ory Term:CELLULITIS, AN
KLE, RIGHTInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796415
Page 129 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Start Date: Jan/31/2019
Ongoing: NO
End Date:
Feb/9/2019
1.q Line/MH Number:
Date Location User Value Reason
Sep-28-2020 14:16:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 14:16:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CELLULITIS, ANKLE, RIGHTInitial Entry
1.q Start Date:
Date Location User Value Reason
Sep-28-2020 14:16:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/31/2019Initial Entry
1.q Ongoing:
Date Location User Value Reason
Sep-28-2020 14:16:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Feb/9/2019Initial Entry
1.r
Date Location User Value Reason
Sep-28-2020 14:16:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:18Initial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796416
Page 130 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Medical Histor
y Term:ALLERGY, SEA
SONAL
Start Date: UNK/UNK/1965
Ongoing: YES
1.r Line/MH Number:
Date Location User Value Reason
Sep-28-2020 14:16:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 14:16:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ALLERGY, SEASONALInitial Entry
1.r Start Date:
Date Location User Value Reason
Sep-28-2020 14:16:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1965Initial Entry
1.r Ongoing:
Date Location User Value Reason
Sep-28-2020 14:16:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.s
Date Location User Value Reason
Sep-28-2020 14:17:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:19
Medical Hist
ory Term:ALCOHOL USE, 7
DRINKS/WEEK
Start Date: UNK/UNK/1968Initial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796417
Page 131 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Ongoing: YES
1.s Line/MH Number:
Date Location User Value Reason
Sep-28-2020 14:17:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 14:17:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ALCOHOL USE, 7 DRINKS/WE
EKInitial Entry
1.s Start Date:
Date Location User Value Reason
Sep-28-2020 14:17:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1968Initial Entry
1.s Ongoing:
Date Location User Value Reason
Sep-28-2020 14:17:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.t
Date Location User Value Reason
Nov-25-2020 20:35:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:20
Medical Hi
story Term:OSTEOARTHRITIS,
KNEE, BILATERAL
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796418
Page 132 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.t Line/MH Number:
Date Location User Value Reason
Nov-25-2020 20:35:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
20Initial Entry
1.t Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-25-2020 20:35:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OSTEOARTHRITIS, KNEE, BIL
ATERALInitial Entry
1.t Start Date:
Date Location User Value Reason
Nov-25-2020 20:35:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.t Ongoing:
Date Location User Value Reason
Nov-25-2020 20:35:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796419
Page 133 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.u
Date Location User Value Reason
Nov-25-2020 20:35:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:21
Medical Hi
story Term
:GASTROESOPHAG
EAL REFLUX DISE
ASE
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
1.u Line/MH Number:
Date Location User Value Reason
Nov-25-2020 20:35:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21Initial Entry
1.u Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-25-2020 20:35:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
GASTROESOPHAGEAL REFL
UX DISEASEInitial Entry
1.u Start Date:
Date Location User Value Reason
Nov-25-2020 20:35:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.u Ongoing:
Date Location User Value Reason
Nov-25-2020 20:35:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.v
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796420
Page 134 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Nov-25-2020 20:36:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:22
Medical History T
erm:VERTIGO
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
1.v Line/MH Number:
Date Location User Value Reason
Nov-25-2020 20:36:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
22Initial Entry
1.v Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-25-2020 20:36:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VERTIGOInitial Entry
1.v Start Date:
Date Location User Value Reason
Nov-25-2020 20:36:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.v Ongoing:
Date Location User Value Reason
Nov-25-2020 20:36:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.w
Date Location User Value Reason
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796421
Page 135 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Mar-02-2021 10:11:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/M
H Num
ber:23
Medical
History
Term:DEEP VEIN THROM
BOSIS, LOWER EXT
REMITY, BILATERA
L
Start D
ate:UNK/UNK/2019
Ongoin
g:NO
End Date:
UNK/UNK/2019Changed
Information
Feb-19-2021 14:48:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/M
H Numb
er:23
Medical
History
Term:DEEP VEIN THROM
BOSIS, LOWER EXT
REMITY, BILATERA
L
Start Da
te:UNK/UNK/2019
Ongoing
:YESChanged
Information
Nov-25-2020 20:36:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:23
Medical Histo
ry Term:DEEP VEIN TH
ROMBOSIS
Start Date: UNK/UNK/2019
Ongoing: YESInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796422
Page 136 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.w Line/MH Number:
Date Location User Value Reason
Nov-25-2020 20:36:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23Initial Entry
1.w Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-19-2021 14:48:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DEEP VEIN THROMBOSIS, LO
WER EXTREMITY, BILATERA
LChanged
Information
Nov-25-2020 20:36:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DEEP VEIN THROMBOSISInitial Entry
1.w Start Date:
Date Location User Value Reason
Nov-25-2020 20:36:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.w Ongoing:
Date Location User Value Reason
Mar-02-2021 10:11:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2019Changed
Information
Nov-25-2020 20:36:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.x
Date Location User Value Reason
Dec-07-2020 13:00:46
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
Line/MH Numb 24Changed
Information
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796423
Page 137 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada) er:
Medical History
Term:ULCERS, GA
STRIC
Start Date: UNK/UNK/20
15
Ongoing: YES
Nov-25-2020 20:36:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:24
Medical History
Term:ULCERS
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0796424
Page 138 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.x Line/MH Number:
Date Location User Value Reason
Nov-25-2020 20:36:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
24Initial Entry
1.x Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-07-2020 13:40:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Closed closed based on site's
response
Dec-07-2020 13:00:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Dec-07-2020 13:00:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ULCERS, GASTRICChanged Information
Nov-26-2020 15:30:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Opened GPD Clin: Please be
more specific of the
location/organ of the
"ulcers". Also please
confirm if the
"ulcers" are still
present/ongoing.
Thanks
Nov-25-2020 20:36:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ULCERSInitial Entry
1.x Start Date:
Date Location User Value Reason
Nov-25-2020 20:36:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.x Ongoing:
Date Location User Value Reason
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0796425
Page 139 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Nov-25-2020 20:36:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.y
Date Location User Value Reason
Nov-25-2020 20:37:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:25
Medical History
Term:KIDNEY STO
NE
Start Date: UNK/UNK/201
8
Ongoing: NO
End Date:
UNK/UNK/
2019Initial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796426
Page 140 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.y Line/MH Number:
Date Location User Value Reason
Nov-25-2020 20:37:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
25Initial Entry
1.y Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-25-2020 20:37:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
KIDNEY STONEInitial Entry
1.y Start Date:
Date Location User Value Reason
Nov-25-2020 20:37:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.y Ongoing:
Date Location User Value Reason
Nov-25-2020 20:37:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.z
Date Location User Value Reason
Nov-25-2020 20:37:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:26
Medical History T
erm:MUSCLE SP
ASM
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796427
Page 141 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.z Line/MH Number:
Date Location User Value Reason
Nov-25-2020 20:37:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
26Initial Entry
1.z Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-25-2020 20:37:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MUSCLE SPASMInitial Entry
1.z Start Date:
Date Location User Value Reason
Nov-25-2020 20:37:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.z Ongoing:
Date Location User Value Reason
Nov-25-2020 20:37:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.aa
Date Location User Value Reason
Nov-25-2020 20:37:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:27
Medical Histo
ry Term:HYPERCHOLES
TEROLEMIA
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796428
Page 142 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.aa Line/MH Number:
Date Location User Value Reason
Nov-25-2020 20:37:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
27Initial Entry
1.aa Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-25-2020 20:37:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HYPERCHOLESTEROLEMIAInitial Entry
1.aa Start Date:
Date Location User Value Reason
Nov-25-2020 20:37:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.aa Ongoing:
Date Location User Value Reason
Nov-25-2020 20:37:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ab
Date Location User Value Reason
Nov-25-2020 20:38:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:28
Medical Histo
ry Term:VITAMIN D DEF
ICIENCY
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796429
Page 143 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.ab Line/MH Number:
Date Location User Value Reason
Nov-25-2020 20:38:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28Initial Entry
1.ab Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-25-2020 20:38:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VITAMIN D DEFICIENCYInitial Entry
1.ab Start Date:
Date Location User Value Reason
Nov-25-2020 20:38:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.ab Ongoing:
Date Location User Value Reason
Nov-25-2020 20:38:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ac
Date Location User Value Reason
Feb-19-2021 14:49:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:29
Medical Hi
story Term
:PULMONARY ART
ERIAL HYPERTENS
ION
Start Date: Jan/22/2018
Ongoing: YESInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796430
Page 144 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.ac Line/MH Number:
Date Location User Value Reason
Feb-19-2021 14:49:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
29Initial Entry
1.ac Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-19-2021 14:49:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PULMONARY ARTERIAL HYP
ERTENSIONInitial Entry
1.ac Start Date:
Date Location User Value Reason
Feb-19-2021 14:49:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2018Initial Entry
1.ac Ongoing:
Date Location User Value Reason
Feb-19-2021 14:49:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ad
Date Location User Value Reason
Feb-19-2021 14:49:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:30
Medical History
Term:AORTIC ANEU
RYSM
Start Date: Jan/22/2018
Ongoing: YESInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796431
Page 145 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.ad Line/MH Number:
Date Location User Value Reason
Feb-19-2021 14:49:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30Initial Entry
1.ad Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-19-2021 14:49:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
AORTIC ANEURYSMInitial Entry
1.ad Start Date:
Date Location User Value Reason
Feb-19-2021 14:49:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2018Initial Entry
1.ad Ongoing:
Date Location User Value Reason
Feb-19-2021 14:49:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ae
Date Location User Value Reason
Feb-19-2021 14:50:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:31
Medical Hi
story Term
:VENTRICULAR EN
LARGEMENT, RIG
HT
Start Date: Jan/22/2010
Ongoing: YESInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796432
Page 146 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.ae Line/MH Number:
Date Location User Value Reason
Feb-19-2021 14:50:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
31Initial Entry
1.ae Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-19-2021 14:50:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VENTRICULAR ENLARGEME
NT, RIGHTInitial Entry
1.ae Start Date:
Date Location User Value Reason
Feb-19-2021 14:50:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2010Initial Entry
1.ae Ongoing:
Date Location User Value Reason
Feb-19-2021 14:50:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.af
Date Location User Value Reason
Feb-19-2021 14:50:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:32
Medical Hist
ory Term:ATHEROSCLERO
TIC DISEASE
Start Date: Jan/22/2018
Ongoing: YESInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796433
Page 147 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.af Line/MH Number:
Date Location User Value Reason
Feb-19-2021 14:50:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
32Initial Entry
1.af Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-19-2021 14:50:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ATHEROSCLEROTIC DISEASEInitial Entry
1.af Start Date:
Date Location User Value Reason
Feb-19-2021 14:50:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2018Initial Entry
1.af Ongoing:
Date Location User Value Reason
Feb-19-2021 14:50:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ag
Date Location User Value Reason
Feb-19-2021 14:51:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:33
Medical Histo
ry Term:CATARACTS, BI
LATERAL
Start Date: Jun/UNK/2020
Ongoing: YESInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796434
Page 148 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.ag Line/MH Number:
Date Location User Value Reason
Feb-19-2021 14:51:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
33Initial Entry
1.ag Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-19-2021 14:51:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CATARACTS, BILATERALInitial Entry
1.ag Start Date:
Date Location User Value Reason
Feb-19-2021 14:51:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/UNK/2020Initial Entry
1.ag Ongoing:
Date Location User Value Reason
Feb-19-2021 14:51:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796435
Page 149 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-28-2020 14:17:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known to be H
IV POSITIVEInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796436
Page 150 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Sep-28-2020 14:17:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-28-2020 14:17:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
166.8Initial Entry
3. Unit:
Date Location User Value Reason
Sep-28-2020 14:17:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-28-2020 14:17:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
62.4Initial Entry
5. Unit:
Date Location User Value Reason
Sep-28-2020 14:17:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-28-2020 14:17:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.1Initial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796437
Page 151 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7.a
Date Location User Value Reason
Sep-28-2020 14:17:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 96.5
Temperature Unit: F
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-28-2020 14:17:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-01-2020 06:36:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-30-2020 15:03:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered ORIGINAL ENTRY
IS CORRECT PER
INVESTIGATOR,
TEMPERATURE IS
NOT CLINICALLY
SIGNIFICANT
Sep-29-2020 06:02:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: Confirmation on
the out of range value
as clinically
significant or not is
expected. Please
review and confirm.
Thank you.
Sep-28-2020 14:18:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Sep-28-2020 14:17:44
(UTC-06:00) CentralACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature 96.5 F is
outside of Normal
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0796438
Page 152 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada) Range 97 - 99.5 F.
Sep-28-2020 14:17:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
96.5Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-28-2020 14:17:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-28-2020 14:17:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796439
Page 153 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-28-2020 14:17:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-28-2020 14:17:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-28-2020 14:17:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-28-2020 14:17:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-28-2020 14:17:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-28-2020 14:17:57
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796440
Page 154 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Sep-28-2020 14:17:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-28-2020 14:17:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-28-2020 14:17:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796441
Page 155 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-28-2020 14:18:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-28-2020 14:18:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
263521Initial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796442
Page 156 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-29-2020 16:52:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-29-2020 16:52:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-29-2020 16:52:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-29-2020 16:52:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-29-2020 16:52:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-06-2020 16:29:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0796443
Page 157 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-06-2020 01:08:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Not required now
Oct-05-2020 08:55:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: If sample was
collected according
to protocol, please
do not record any
response in this
specified field,
Thank you.
Sep-29-2020 16:52:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.a
Date Location User Value Reason
Sep-29-2020 16:52:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM8YNLInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-29-2020 16:52:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM8YNLInitial Entry
5.b
Date Location User Value Reason
Sep-29-2020 16:53:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM8YNKInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-29-2020 16:53:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM8YNKInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796444
Page 158 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.c
Date Location User Value Reason
Sep-29-2020 16:53:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM8YNJInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-29-2020 16:53:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM8YNJInitial Entry
5.d
Date Location User Value Reason
Sep-29-2020 17:00:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRV5CInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-29-2020 17:00:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPRV5CInitial Entry
5.e
Date Location User Value Reason
Sep-29-2020 17:01:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRV5DInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-29-2020 17:01:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPRV5DInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796445
Page 159 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-29-2020 16:49:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-29-2020 16:49:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-29-2020 16:50:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-29-2020 16:49:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-29-2020 16:49:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-06-2020 16:29:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0796446
Page 160 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-06-2020 01:08:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Not required now
Oct-05-2020 08:55:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: If sample was
collected according
to protocol, please
do not record any
response in this
specified field,
Thank you.
Sep-29-2020 16:49:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.a
Date Location User Value Reason
Sep-29-2020 16:50:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM8YMWInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-29-2020 16:50:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM8YMWInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796447
Page 161 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-28-2020 14:18:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-28-2020 14:18:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-28-2020 14:18:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-28-2020 14:18:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020 15:57Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-28-2020 14:18:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-28-2020 14:18:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796448
Page 162 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7. Route:
Date Location User Value Reason
Sep-28-2020 14:18:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-28-2020 14:18:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-28-2020 14:18:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796449
Page 163 of 236
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-28-2020 14:18:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796450
Page 164 of 236
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-12-2020 16:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/12/2020Initial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796451
Page 165 of 236
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Oct-12-2020 16:01:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/12/2020Initial Entry
2.a
Date Location User Value Reason
Oct-12-2020 16:01:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.4
Temperature Unit: F
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-12-2020 16:01:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-12-2020 16:01:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.4Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-12-2020 16:01:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796452
Page 166 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Oct-12-2020 16:01:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796453
Page 167 of 236
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-12-2020 16:02:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-12-2020 16:02:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-12-2020 16:02:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/12/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-12-2020 16:02:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-12-2020 16:02:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-12-2020 16:02:27
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796454
Page 168 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Oct-12-2020 16:02:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-12-2020 16:02:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Oct-12-2020 16:02:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796455
Page 169 of 236
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020 14:59:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020 14:59:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020 14:59:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-14-2020 14:59:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-14-2020 14:59:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/12/2020Initial Entry
5.a
Date Location User Value Reason
Oct-14-2020 14:59:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRJ8FVInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796456
Page 170 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Sample ID
Date Location User Value Reason
Oct-14-2020 14:59:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRJ8FVInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796457
Page 171 of 236
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-12-2020 16:02:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-12-2020 16:02:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-12-2020 16:02:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-12-2020 16:02:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/12/2020 14:13Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-12-2020 16:02:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-12-2020 16:02:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796458
Page 172 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7. Route:
Date Location User Value Reason
Oct-12-2020 16:02:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-12-2020 16:02:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-12-2020 16:02:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796459
Page 173 of 236
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-13-2020 15:06:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-13-2020 12:18:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Nov-13-2020 05:11:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The treatment
period is defined as
1st vaccination visit
through the 1-month
post vaccination
visit after the 2nd
vaccination. Please
complete treatment
disposition CRF and
update date of EOT
to match date of
visit at visit 3.
Nov-12-2020 20:11:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/12/2020Initial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0796460
Page 174 of 236
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-12-2020 18:20:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-12-2020 18:20:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-12-2020 18:20:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-12-2020 18:20:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-12-2020 18:20:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/12/2020Initial Entry
5.a
Date Location User Value Reason
Nov-12-2020 18:20:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRSRX2Initial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796461
Page 175 of 236
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Sample ID
Date Location User Value Reason
Nov-12-2020 18:20:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRSRX2Initial Entry
5.b
Date Location User Value Reason
Nov-12-2020 18:20:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRSRX3Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-12-2020 18:20:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRSRX3Initial Entry
5.c
Date Location User Value Reason
Nov-12-2020 18:22:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM8YTWInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-12-2020 18:22:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM8YTWInitial Entry
5.d
Date Location User Value Reason
Nov-12-2020 18:23:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM8YTXInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796462
Page 176 of 236
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.d Sample ID
Date Location User Value Reason
Nov-12-2020 18:23:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM8YTXInitial Entry
5.e
Date Location User Value Reason
Nov-12-2020 18:23:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM8YTYInitial Entry
5.e Sample ID
Date Location User Value Reason
Nov-12-2020 18:23:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM8YTYInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796463
Page 177 of 236
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Jan-22-2021 21:21:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796464
Page 178 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Jan-26-2021 16:55:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Deleted PER MEDICAL
RECORD, PER
INVESTIGATOR
AORTIC
ANEURYSM IS
NOT
WORSENING,
IT IS STABLE.
Jan-22-2021 21:23:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796465
Page 179 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Jan-22-2021 21:24:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796466
Page 180 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Jan-26-2021 16:59:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796467
Page 181 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Feb-11-2021 16:45:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796468
Page 182 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Jan-22-2021 21:21:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-22-2021 21:21:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-22-2021 21:21:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PULMONARY EMBOLIInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-22-2021 21:21:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Jan-22-2021 21:21:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-22-2021 21:21:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/21/2021 UNK:UNKTranscription Error
Jan-22-2021 21:21:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For PULMONARY
EMBOLI: Start date
21/Jan/2020 is before
V1D1VX1L visit
date 22/Sep/2020.
Please review and
update as
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796469
Page 183 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
appropriate.
Jan-22-2021 21:21:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Start date is before
Consent Date 22/Sep
/2020.
Jan-22-2021 21:21:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/21/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-12-2021 10:18:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-11-2021 16:33:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Feb-11-2021 16:33:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/23/2021 UNK:UNKNew Information
Feb-04-2021 13:36:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON: AE
2021064848 has a
cessation date on
23-JAN-2021 in
SDB. Please review
and update
accordingly or
clarify.
Jan-22-2021 21:21:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-19-2021 03:45:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Closed closed based on site's
response
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796470
Page 184 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Feb-18-2021 17:43:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered PER INVESTIGATOR,
CONDITION WOULD
HAVE GONE
UNNOTICED BY
PARTICIPANT,
SUBJECT WAS
ASYMPTOMATIC.
SUBJECT HAD NO
COMPLICATIONS
DURING
ANTICOAGULATION
AND WAS
DISCHARGED W/O
INCIDENT.
CONDITION WAS
INCIDENTAL
FINDING ON
ROUTINE IMAGING
EXAM.
Feb-12-2021 13:49:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Opened GPD Clin: Can you
please confirm severity
grade of AE
PULMONARY
EMBOLI considering
it is considered serous.
Thanks
Jan-26-2021 16:58:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1PER INVESTIGATOR,
SUBJECT
AYSMPTOMATIC
AND INCIDENTAL
FINDING ON
IMAGING STUDY.
Jan-22-2021 21:21:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0796471
Page 185 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Jan-29-2021 12:05:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Deleted Close Auto Query
Jan-28-2021 08:38:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Jan-26-2021 16:58:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Candidate For AE
PULMONARY
EMBOLI: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Jan-26-2021 16:58:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in d
eath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in p
ersistent or significant disability
/incapacity?
NO
Is this serious event life threaten
ing?
NO
Other medically important serio
us eventChanged Information
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796472
Page 186 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
NO
Jan-26-2021 16:52:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered FAXED ON
22JAN2021,
UPDATE FAXED
26JAN2021
Jan-25-2021 07:21:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened SAE RECON:
PULMONARY
EMBOLI(Onset
date:21Jan2021) is
not reported to Safety
database but marked
serious on AE CRF.
Confirm seriousness
and report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
Jan-25-2021 07:20:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Deleted Query can be
addressed internally
Jan-22-2021 21:21:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
PULMONARY
EMBOLI: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Jan-22-2021 21:21:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in d
eath?
NOInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796473
Page 187 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in p
ersistent or significant disability
/incapacity?
NO
Is this serious event life threaten
ing?
YES
Other medically important serio
us event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-22-2021 21:21:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-27-2021 07:37:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-26-2021 16:53:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Jan-26-2021 16:53:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHERNew Information
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796474
Page 188 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
If Other, specify:
CURRENT DVT, PRIOR
HX OF DVT
Jan-25-2021 08:13:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened clinical: pls advise
as to basis for
assessing AE 1 and
3 as 'related' Did
subject have other
RF for PE/DVT eg
recent prolonged
travel, injury,
surgery? Thanks
Jan-22-2021 21:21:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-22-2021 21:21:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-22-2021 21:21:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-22-2021 21:21:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796475
Page 189 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Feb-12-2021 10:17:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Feb-11-2021 16:34:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Feb-11-2021 16:34:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Feb-11-2021 16:34:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVE
DNew Information
Feb-11-2021 16:33:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For AE PULMONARY
EMBOLI: Response to "What
was the outcome of this
adverse event?" is
'Recovering/Resolving' but
AE End Date/Time is present.
Feb-04-2021 13:37:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON: AE
2021064848 has reported
outcome of
"RECOVERED/RESOLVED"
in SDB. Please review and
update accordingly or clarify.
Jan-22-2021 21:21:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVI
NGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-22-2021 21:21:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-29-2021 12:05:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021064848Initial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796476
Page 190 of 236
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Jan-22-2021 21:23:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-22-2021 21:23:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-22-2021 21:23:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WORSENING AORTIC ANEUR
YSMInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-22-2021 21:23:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/21/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-22-2021 21:23:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796477
Page 191 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-22-2021 21:23:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-22-2021 21:23:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-22-2021 21:23:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-22-2021 21:23:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
PREEXISTING CONDITIO
NInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796478
Page 192 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-22-2021 21:23:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-22-2021 21:23:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-22-2021 21:23:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-26-2021 22:29:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed data deleted.
Jan-26-2021 16:54:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Jan-26-2021 05:18:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Please provide date
which information
will be available for
data entry.
Jan-25-2021 18:15:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered WE HAVE NOT
RECIEVED OR
REVIEWED THE
MEDICAL
RECORDS FROM
THE EVENT NOR
HAVE WE HAD
CONTACT WITH
THE
PARTICIPANT.
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0796479
Page 193 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
OUTCOME IS
UNKNOWN.
Jan-24-2021 22:30:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Response does not
satisfy query. Please
clarify why outcome
is Unknown for AE
wich is still ongoing.
Or correct.
Jan-22-2021 21:28:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Jan-22-2021 21:23:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE
WORSENING
AORTIC
ANEURYSM:
Response to "What
was the outcome of
this adverse event?"
is 'Unknown' but
End Date/Time is
provided or "Is the
adverse event still
ongoing?" is marked
"Yes".
Jan-22-2021 21:23:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNKNOWNInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-22-2021 21:23:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0796480
Page 194 of 236
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Jan-22-2021 21:24:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-22-2021 21:24:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Mar-02-2021
14:56:52
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
4: Clo
sedResponse satisfies
query
Mar-02-2021
10:17:39
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
4: An
swere
dChanged data per
query
Mar-01-2021
11:10:33
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
4: Rei
ssued:
Opene
dCLINQUERY -
Thanks for specifying
Right extremity.
However, as MH
reports DVT in both
legs, please confirm
the RIGHT side was
"Worsening" to
qualify as an AE.
Update term as
applicable.
090177e196ae3da4\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0796481
Page 195 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171146 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Mar-01-2021
09:57:52
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
4: An
swere
dSUBJECT
EXPERIENCED
THROMBOTIC
EVENT IN RIGHT
LEG.
Mar-01-2021
00:43:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
4: Op
enedCLINQUERY - MH
of DVT BILATERAL
Lower Extemities is
ONGOING. Per
guidelines, a MH
condition should not
be reported as an AE
unless it "Worsens".
Please clarify if
worsened on RIGHT
and update as needed.
Feb-26-2021
14:13:49
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
4: Ca
ndidat
eCLINQUERY - MH
of DVT BILATERAL
Lower Extemities is

…[truncated]