125742 S1 M5 CRF c4591001 1131 11311140

Document text

Page 1 of 193
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935741
Page 2 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/4/2020
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935742
Page 3 of 193
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Demography
1.Subject ID [11311140]
2.Birth Date: /1943
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935743
Page 4 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935744
Page 5 of 193
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935745
Page 6 of 193
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935746
Page 7 of 193
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[eye glass wearer]
Start Date: UNK/UNK/1949
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[laser vision correction surgery]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[cataracts, bilaterally]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2018
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935747
Page 8 of 193
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[cataract surgery, bilaterally]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[hole in right ear drum]
Start Date: Aug/18/2020
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[aortic valve defect]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
Jun/UNK/2020
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935748
Page 9 of 193
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[double cardiac bypass surgery]
Start Date: Jun/1/2020
Ongoing: NO
End Date:
Jun/1/2020
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[high blood pressure]
Start Date: UNK/UNK/2010
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[elevated LDL cholesterol]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935749
Page 10 of 193
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.jLine/MH Number: [10]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[coronary artery disease]
Start Date: Jun/UNK/2020
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[prostate tumors, malignant]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
Apr/UNK/2016
1.lLine/MH Number: [12] Comments
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[recurrent lower back pain from injury] Comments
Start Date: Aug/6/2020 Comments
Ongoing: YES Comments
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935750
Page 11 of 193
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.mLine/MH Number: [13]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[wet age-related macular degeneration]
Start Date: UNK/UNK/2007
Ongoing: YES
1.nLine/MH Number: [14]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[interstitial cystitis]
Start Date: UNK/UNK/2010
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[tonsillectomy and adenoidectomy]
Start Date: UNK/UNK/1949
Ongoing: NO
End Date:
UNK/UNK/1949
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935751
Page 12 of 193
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.pLine/MH Number: [16]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[left knee meniscus surgical repair]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
1.qLine/MH Number: [17]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[aortic valve replacement]
Start Date: Jun/UNK/2020
Ongoing: NO
End Date:
Jun/UNK/2020
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935752
Page 13 of 193
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
2.Weight: [96.4]
3.Unit: kg
4.Height: [189.1]
5.Unit: cm
6.Body Mass Index: [27.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935753
Page 14 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/4/2020
2.Randomization Number: [252073]
3.Randomization Group: [ ]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935754
Page 15 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
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 [BN6DS0]
5.bSample ID [BL9VZZ]
5.cSample ID [BL9W00]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935755
Page 16 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
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 [BN6DYC]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935756
Page 17 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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/4/2020 10:28
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935757
Page 18 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935758
Page 19 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/24/2020
2.Erroneous Visit
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935759
Page 20 of 193
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935760
Page 21 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/24/2020
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 [BN6F3R]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935761
Page 22 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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/24/2020 09:43
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935762
Page 23 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935763
Page 24 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/22/2020
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 [BP99XF]
5.bSample ID [BS7X6X]
5.cSample ID [BS7X6Y]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935764
Page 25 of 193
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935765
Page 26 of 193
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935766
Page 27 of 193
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935767
Page 28 of 193
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935768
Page 29 of 193
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935769
Page 30 of 193
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935770
Page 31 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935771
Page 32 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: [ ]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935772
Page 33 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935773
Page 34 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935774
Page 35 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935775
Page 36 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935776
Page 37 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935777
Page 38 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935778
Page 39 of 193
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935779
Page 40 of 193
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Unplanned Assessments
1.Assessments
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935780
Page 41 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/22/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935781
Page 42 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935782
Page 43 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935783
Page 44 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935784
Page 45 of 193
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#CategoryAE Ide
ntifierAdverse Ev
entStart DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  muscle pain  Sep/24/2020 2
2:00 NO
End Date Time:
Sep/28/2020 UNK
:UNK
 Repeating
Pages
 2.ADVERSE
EVENT 2  headache  Sep/24/2020 2
2:00 NO
End Date Time:
Sep/28/2020 UNK
:UNK
 Repeating
Pages
 3.ADVERSE
EVENT 3  generalized j
oint pain Sep/25/2020
UNK:UNK NO
End Date Time:
Oct/28/2020 UNK:
UNK
 Repeating
Pages
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935785
Page 46 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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)[muscle pain]
4.Start Date Time: Sep/24/2020 22:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/28/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935786
Page 47 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935787
Page 48 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935788
Page 49 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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)[headache]
4.Start Date Time: Sep/24/2020 22:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/28/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935789
Page 50 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935790
Page 51 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935791
Page 52 of 193
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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)[generalized joint pain]
4.Start Date Time: Sep/25/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/28/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935792
Page 53 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935793
Page 54 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935794
Page 55 of 193
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935795
Page 56 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935796
Page 57 of 193
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935797
Page 58 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: //
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935798
Page 59 of 193
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935799
Page 60 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935800
Page 61 of 193
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935801
Page 62 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935802
Page 63 of 193
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935803
Page 64 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935804
Page 65 of 193
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935805
Page 66 of 193
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935806
Page 67 of 193
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935807
Page 68 of 193
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935808
Page 69 of 193
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935809
Page 70 of 193
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935810
Page 71 of 193
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935811
Page 72 of 193
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935812
Page 73 of 193
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935813
Page 74 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/4/2021
2.Erroneous Visit
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935814
Page 75 of 193
***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, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935815
Page 76 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/4/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935816
Page 77 of 193
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935817
Page 78 of 193
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935818
Page 79 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/22/2020
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935819
Page 80 of 193
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935820
Page 81 of 193
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935821
Page 82 of 193
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormSep-04-2020 14:40:06 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935822
Page 83 of 193
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1.lSep-04-2020 14:49:02 (UTC-05:00)
Eastern Time (US & Canada)etiology of back pain, moving house
furniture
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935823
Page 84 of 193
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1.lSep-04-2020 14:49:02 (UTC-05:00)
Eastern Time (US & Canada)etiology of back pain, moving house
furniture
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935824
Page 85 of 193
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1.lSep-04-2020 14:49:02 (UTC-05:00)
Eastern Time (US & Canada)etiology of back pain, moving house
furniture
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935825
Page 86 of 193
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1.lSep-04-2020 14:49:02 (UTC-05:00)
Eastern Time (US & Canada)etiology of back pain, moving house
furniture
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935826
Page 87 of 193
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Jan-28-2021 17:03:43 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Randall Approved Jan-22-2021 12:42:57 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamRandall, 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 Jan-18-2021 10:24:10 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935827
Page 88 of 193
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Affidavit:
N/A
William
Randall Approved Nov-16-2020 15:40:58 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamRandall, 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-16-2020 08:44:28 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Randall Approved Nov-13-2020 12:59:13 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935828
Page 89 of 193
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Affidavit:
By my dated signature below, I, WilliamRandall, 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 11:19:21 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Randall Approved Oct-29-2020 08:36:36 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamRandall, 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.
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935829
Page 90 of 193
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-04-2020
14:38:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-04-2020
14:38:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935830
Page 91 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-04-2020
14:39:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Sep/4/2020Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935831
Page 92 of 193
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-04-2020
14:38:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11311140Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-04-2020
14:38:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1943Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-04-2020
14:39:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935832
Page 93 of 193
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-04-2020
14:39:41
(UTC-05:00)
Eastern 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-04-2020
14:39:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935833
Page 94 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-04-2020
14:39:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935834
Page 95 of 193
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-04-2020
14:40:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-04-2020
14:40:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-04-2020
14:40:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935835
Page 96 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.a
Date Location User Value Reason
Sep-04-2020
14:40:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:eye glass
wearer
Start Date: UNK/U
NK/194
9
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-04-2020
14:40:52
(UTC-05:00)
Eastern 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-04-2020
14:40:52
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
eye glass wearerInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935836
Page 97 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
& Canada)
1.a Start Date:
Date Location User Value Reason
Sep-04-2020
14:40:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1949Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-04-2020
14:40:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-04-2020
14:41:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/
MH N
umber
:2
Medic
al Hist
ory Te
rm:laser visio
n correctio
n surgeryTranscription
Error
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935837
Page 98 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Start
Date:UNK/UN
K/2005
Ongoi
ng:NO
End Date
:
UNK/U
NK/20
05
Sep-04-2020
14:41:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:2
Medical
History
Term:laser visi
on correc
tin
Start D
ate:UNK/UN
K/2005
Ongoin
g:NO
End Da
te:
UNK/
UNK/
2005Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935838
Page 99 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.b Line/MH Number:
Date Location User Value Reason
Sep-04-2020
14:41:17
(UTC-05:00)
Eastern 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-04-2020
14:41:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
laser vision correcti
on surgeryTranscription
Error
Sep-04-2020
14:41:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
laser vision correcti
nInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-04-2020
14:41:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935839
Page 100 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.b Ongoing:
Date Location User Value Reason
Sep-04-2020
14:41:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.c
Date Location User Value Reason
Sep-04-2020
14:42:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:cataracts, b
ilaterally
Start Date
:UNK/UN
K/2017
Ongoing: NO
End Date
:
UNK/U
NK/201
8Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935840
Page 101 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.c Line/MH Number:
Date Location User Value Reason
Sep-04-2020
14:42:08
(UTC-05:00)
Eastern 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-04-2020
14:42:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
cataracts, bilaterallyInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-04-2020
14:42:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-04-2020
14:42:08ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935841
Page 102 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/2018
1.d
Date Location User Value Reason
Sep-04-2020
14:42:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical
History
Term:cataract sur
gery, bilater
ally
Start Dat
e:UNK/UNK/
2018
Ongoing: NO
End Date:
UNK/U
NK/2018Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935842
Page 103 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.d Line/MH Number:
Date Location User Value Reason
Sep-04-2020
14:42:41
(UTC-05:00)
Eastern 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-04-2020
14:42:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
cataract surgery, bilat
erallyInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-04-2020
14:42:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-04-2020
14:42:41ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935843
Page 104 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/2018
1.e
Date Location User Value Reason
Sep-04-2020
14:43:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical H
istory Ter
m:hole in rig
ht ear dru
m
Start Date
:Aug/18/2
020
Ongoing: YESInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935844
Page 105 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.e Line/MH Number:
Date Location User Value Reason
Sep-04-2020
14:43:13
(UTC-05:00)
Eastern 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-04-2020
14:43:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
hole in right ear dru
mInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-04-2020
14:43:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/18/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-04-2020
14:43:13ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935845
Page 106 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
1.f
Date Location User Value Reason
Sep-04-2020
14:43:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:6
Medical Hi
story Term
:aortic valv
e defect
Start Date: UNK/UN
K/2017
Ongoing: NO
End Dat
e:
Jun/U
NK/20
20Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935846
Page 107 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.f Line/MH Number:
Date Location User Value Reason
Sep-04-2020
14:43:43
(UTC-05:00)
Eastern 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-04-2020
14:43:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
aortic valve defectInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-04-2020
14:43:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-04-2020
14:43:43ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935847
Page 108 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
Jun/UNK/2020
1.g
Date Location User Value Reason
Sep-04-2020
14:44:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:7
Medical
History
Term:double cardi
ac bypass su
rgery
Start Da
te:Jun/1/2020
Ongoing
:NO
End Date:
Jun/1/20
20Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935848
Page 109 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.g Line/MH Number:
Date Location User Value Reason
Sep-04-2020
14:44:36
(UTC-05:00)
Eastern 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-04-2020
14:44:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
double cardiac bypas
s surgeryInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-04-2020
14:44:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jun/1/2020Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-04-2020
14:44:36ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935849
Page 110 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
Jun/1/2020
1.h
Date Location User Value Reason
Sep-04-2020
14:44:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:8
Medical Hi
story Term
:high bloo
d pressur
e
Start Date: UNK/UN
K/2010
Ongoing: YESInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935850
Page 111 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.h Line/MH Number:
Date Location User Value Reason
Sep-04-2020
14:44:58
(UTC-05:00)
Eastern 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-04-2020
14:44:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
high blood pressureInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-04-2020
14:44:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-04-2020
14:44:58ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935851
Page 112 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
1.i
Date Location User Value Reason
Sep-04-2020
14:45:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:9
Medical
History T
erm:elevated L
DL cholest
erol
Start Date
:UNK/UN
K/2018
Ongoing: YESInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935852
Page 113 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.i Line/MH Number:
Date Location User Value Reason
Sep-04-2020
14:45:22
(UTC-05:00)
Eastern 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-04-2020
14:45:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
elevated LDL choles
terolInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-04-2020
14:45:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-04-2020
14:45:22ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935853
Page 114 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
1.j
Date Location User Value Reason
Sep-04-2020
14:45:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:10
Medical H
istory Ter
m:coronary a
rtery disea
se
Start Date
:Jun/UNK/
2020
Ongoing: YESInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935854
Page 115 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.j Line/MH Number:
Date Location User Value Reason
Sep-04-2020
14:45:51
(UTC-05:00)
Eastern 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-04-2020
14:45:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
coronary artery disea
seInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935855
Page 116 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.j Start Date:
Date Location User Value Reason
Sep-04-2020
14:45:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jun/UNK/2020Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-04-2020
14:45:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Sep-04-2020
14:47:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:11
Medical
History T
erm:prostate tum
ors, maligna
nt
Start Dat
e:UNK/UNK/
2016Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935856
Page 117 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Ongoing: NO
End Date:
Apr/UN
K/2016
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935857
Page 118 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.k Line/MH Number:
Date Location User Value Reason
Sep-04-2020
14:47:12
(UTC-05:00)
Eastern 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-10-2020
15:44:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Sep-09-2020
11:34:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answere
dPer coordinator,
subject stated
just receiving
radiation as
treatment for
this condition.
Sep-08-2020
19:38:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Reissued:
Openedplease leave in
site review until
update made.
thank you
Sep-08-2020
13:49:13
(UTC-05:00)ACV0PFEINFP6000  Query 1: Answere
dPer coordinator,
will confirm
with subject and
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0935858
Page 119 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Eastern Time (US
& Canada)update EDC
appropriately.
Sep-08-2020
13:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY -
Condition
PROSTATE
TUMORS
MALIGNANT
reports an END
date. If a
surgery was
performed,
please add to
MH as a
separate entry.
Sep-04-2020
14:47:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
prostate tumors, m
alignantInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-04-2020
14:47:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.k Ongoing:
Date Location User Value Reason
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0935859
Page 120 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-04-2020
14:47:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Apr/UNK/2016Initial Entry
1.l
Date Location User Value Reason
Sep-04-2020
14:48:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:12
Medical
History
Term:recurrent lo
wer back pai
n from injur
y
Start Da
te:Aug/6/2020
Ongoing
:YESInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935860
Page 121 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.l Line/MH Number:
Date Location User Value Reason
Sep-04-2020
14:48:40
(UTC-05:00)
Eastern 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-04-2020
14:48:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
recurrent lower back
pain from injuryInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-04-2020
14:48:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/6/2020Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-04-2020
14:48:40ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935861
Page 122 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
1.m
Date Location User Value Reason
Sep-04-2020
14:50:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:13
Medical
History
Term:wet age-relat
ed macular d
egeneration
Start Da
te:UNK/UNK/
2007
Ongoing
:YESInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935862
Page 123 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.m Line/MH Number:
Date Location User Value Reason
Sep-04-2020
14:50:07
(UTC-05:00)
Eastern 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-04-2020
14:50:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
wet age-related macu
lar degenerationInitial Entry
1.m Start Date:
Date Location User Value Reason
Sep-04-2020
14:50:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-04-2020
14:50:07ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935863
Page 124 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
1.n
Date Location User Value Reason
Sep-04-2020
14:50:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:14
Medical His
tory Term:interstiti
al cystiti
s
Start Date: UNK/U
NK/2010
Ongoing: YESInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935864
Page 125 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.n Line/MH Number:
Date Location User Value Reason
Sep-04-2020
14:50:24
(UTC-05:00)
Eastern 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-04-2020
14:50:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
interstitial cystitisInitial Entry
1.n Start Date:
Date Location User Value Reason
Sep-04-2020
14:50:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-04-2020
14:50:24ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935865
Page 126 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
1.o
Date Location User Value Reason
Sep-04-2020
14:50:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:15
Medical
History
Term:tonsillectomy
and adenoide
ctomy
Start D
ate:UNK/UNK/1
949
Ongoin
g:NO
End Date:
UNK/UN
K/1949Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935866
Page 127 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.o Line/MH Number:
Date Location User Value Reason
Sep-04-2020
14:50:48
(UTC-05:00)
Eastern 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-04-2020
14:50:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
tonsillectomy and ad
enoidectomyInitial Entry
1.o Start Date:
Date Location User Value Reason
Sep-04-2020
14:50:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1949Initial Entry
1.o Ongoing:
Date Location User Value Reason
Sep-04-2020
14:50:48ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935867
Page 128 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/1949
1.p
Date Location User Value Reason
Sep-04-2020
14:51:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:16
Medical
History
Term:left knee men
iscus surgical
repair
Start D
ate:UNK/UNK/2
000
Ongoin
g:NO
End Date:
UNK/UN
K/2000Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935868
Page 129 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.p Line/MH Number:
Date Location User Value Reason
Sep-04-2020
14:51:22
(UTC-05:00)
Eastern 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-04-2020
14:51:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
left knee meniscus s
urgical repairInitial Entry
1.p Start Date:
Date Location User Value Reason
Sep-04-2020
14:51:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.p Ongoing:
Date Location User Value Reason
Sep-04-2020
14:51:22ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935869
Page 130 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/2000
1.q
Date Location User Value Reason
Sep-04-2020
14:51:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:17
Medical
History T
erm:aortic valve
replacemen
t
Start Dat
e:Jun/UNK/2
020
Ongoing: NO
End Date:
Jun/UN
K/2020Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935870
Page 131 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.q Line/MH Number:
Date Location User Value Reason
Sep-04-2020
14:51:50
(UTC-05:00)
Eastern 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-04-2020
14:51:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
aortic valve replace
mentInitial Entry
1.q Start Date:
Date Location User Value Reason
Sep-04-2020
14:51:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jun/UNK/2020Initial Entry
1.q Ongoing:
Date Location User Value Reason
Sep-04-2020
14:51:50ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935871
Page 132 of 193
***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, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
Jun/UNK/2020
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935872
Page 133 of 193
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020
14:59:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-04-2020
14:59:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
96.4Initial Entry
3. Unit:
Date Location User Value Reason
Sep-04-2020
14:59:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935873
Page 134 of 193
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-04-2020
14:59:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
189.1Initial Entry
5. Unit:
Date Location User Value Reason
Sep-04-2020
14:59:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-04-2020
14:59:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
27.0Initial Entry
7.a
Date Location User Value Reason
Sep-04-2020
14:59:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.5Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935874
Page 135 of 193
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Temperatu
re Unit:C
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-04-2020
14:59:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-04-2020
14:59:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-04-2020
14:59:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935875
Page 136 of 193
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
7.a Temperature Location:
Date Location User Value Reason
Sep-04-2020
14:59:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935876
Page 137 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-04-2020
14:59:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-04-2020
14:59:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
252073Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935877
Page 138 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020
14:59:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020
14:59:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020
18:29:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-04-2020
14:59:30
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935878
Page 139 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-04-2020
14:59:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020
18:29:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BN6DS
0Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-04-2020
18:29:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN6DS0Initial Entry
5.b
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935879
Page 140 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Sep-04-2020
18:29:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BL9VZ
ZInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-04-2020
18:29:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BL9VZZInitial Entry
5.c
Date Location User Value Reason
Sep-04-2020
18:30:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BL9W0
0Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935880
Page 141 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.c Sample ID
Date Location User Value Reason
Sep-04-2020
18:30:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BL9W00Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935881
Page 142 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020
14:59:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020
14:59:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020
18:30:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-04-2020
14:59:39
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935882
Page 143 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-04-2020
14:59:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020
18:30:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BN6DY
CInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-04-2020
18:30:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN6DYCInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935883
Page 144 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-04-2020
15:00:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020
15:00:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020
15:00:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935884
Page 145 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-04-2020
15:00:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020 10:28Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020
15:00:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-04-2020
15:00:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-04-2020
15:00:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935885
Page 146 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-04-2020
15:00:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-04-2020
15:00:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935886
Page 147 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-04-2020
15:00:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935887
Page 148 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-24-2020
10:48:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935888
Page 149 of 193
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-24-2020
10:48:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
2.a
Date Location User Value Reason
Sep-24-2020
10:48:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.5
Temperatu
re Unit:C
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-24-2020
10:48:59
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935889
Page 150 of 193
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-24-2020
10:48:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
36.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-24-2020
10:48:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-24-2020
10:48:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935890
Page 151 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020
10:49:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020
10:49:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020
18:25:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-24-2020
10:49:07
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935891
Page 152 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-24-2020
10:49:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Sep/24/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020
18:25:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BN6F3
RInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-24-2020
18:25:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN6F3RInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935892
Page 153 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-24-2020
10:49:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-24-2020
10:49:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-24-2020
10:49:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935893
Page 154 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-24-2020
10:49:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020 09:43Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-24-2020
10:49:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-24-2020
10:49:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-24-2020
10:49:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935894
Page 155 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-24-2020
10:49:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-24-2020
10:49:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935895
Page 156 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-22-2020
09:48:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935896
Page 157 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020
09:48:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020
09:48:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020
17:25:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-22-2020
09:48:26
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935897
Page 158 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-22-2020
09:48:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020
17:25:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP99XFInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-22-2020
17:25:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP99XFInitial Entry
5.b
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935898
Page 159 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Oct-22-2020
17:25:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BS7X6
XInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-22-2020
17:25:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS7X6XInitial Entry
5.c
Date Location User Value Reason
Oct-22-2020
17:25:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BS7X6
YInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935899
Page 160 of 193
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.c Sample ID
Date Location User Value Reason
Oct-22-2020
17:25:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS7X6YInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935900
Page 161 of 193
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-22-2020
09:48:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-22-2020
09:48:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-22-2020
09:48:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935901
Page 162 of 193
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Sep-25-2020
17:49:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935902
Page 163 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Sep-25-2020
17:50:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935903
Page 164 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Sep-25-2020
17:52:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935904
Page 165 of 193
***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, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category:
Date Location User Value Reason
Sep-25-2020
17:49:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-25-2020
17:49:44
(UTC-05:00)
Eastern 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
Sep-25-2020
17:49:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
muscle painInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935905
Page 166 of 193
***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, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-25-2020
17:49:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020 22:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-12-2020
14:27:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Nov-12-2020
11:19:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/28/2020
UNK:UNKNew
Information
Nov-12-2020
10:36:18
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answer
edPhysician is
currently
contacting
subject to
update AE
resolution. Will
update EDC
appropriately.
Thank you.
Nov-11-2020
15:12:41
(UTC-05:00)ACV0PFEINFP6000  Query 1: Opened CLINQUERY -
Please verify if
AE is still
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (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-2021-5683-0935906
Page 167 of 193
***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, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Eastern Time
(US & Canada)ongoing, or
update END
DATE and
OUTCOME as
applicable.
Sep-25-2020
17:49:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-25-2020
17:49:44
(UTC-05:00)
Eastern 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
Sep-25-2020
17:49:44ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935907
Page 168 of 193
***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, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
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
Sep-25-2020
17:49:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-25-2020
17:49:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-25-2020
17:49:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935908
Page 169 of 193
***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, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-25-2020
17:49:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-25-2020
17:49:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-12-2020
11:20:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Clos
edClose Auto Query
Nov-12-2020
11:20:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERE
D/RESOLVE
DNew Information
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935909
Page 170 of 193
***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, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Nov-12-2020
11:19:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Ope
nedFor AE muscle pain:
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Sep-25-2020
17:49:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERI
NG/RESOLV
INGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-25-2020
17:49:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935910
Page 171 of 193
***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
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category:
Date Location User Value Reason
Sep-25-2020
17:50:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-25-2020
17:50:41
(UTC-05:00)
Eastern 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
Sep-25-2020
17:50:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
headacheInitial Entry
4. Start Date Time:
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935911
Page 172 of 193
***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
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Sep-25-2020
17:50:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020 22:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-12-2020
14:29:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Nov-12-2020
11:22:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/28/2020
UNK:UNKNew
Information
Nov-12-2020
10:36:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answer
edPhysician is
currently
contacting
subject to
update AE
resolution. Will
update EDC
appropriately.
Thank you.
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935912
Page 173 of 193
***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
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Nov-11-2020
15:12:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY -
Please verify if
AE is still
ongoing, or
update END
DATE and
OUTCOME as
applicable.
Sep-25-2020
17:50:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-25-2020
17:50:41
(UTC-05:00)
Eastern 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
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935913
Page 174 of 193
***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
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-25-2020
17:50:41
(UTC-05:00)
Eastern 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
Sep-25-2020
17:50:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-25-2020
17:50:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-25-2020
17:50:41
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935914
Page 175 of 193
***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
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
& Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-25-2020
17:50:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-25-2020
17:50:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-29-2021
09:53:34
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Clos
edResponse satisfies query
Jan-28-2021
17:03:43
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query
2: Ans
weredTranscription Error
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935915
Page 176 of 193
***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
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Eastern Time
(US &
Canada)
Jan-28-2021
17:03:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry:
RECO
VERE
D/RES
OLVE
DTranscription Error
Jan-28-2021
14:24:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Ope
nedCLINQUERY - Outcome
states
RECOVERING/RESOLVING
yet End Date is reported.
Please confirm and update
Outcome as appropriate.
Nov-12-2020
21:12:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clos
edResponse satisfies query
Nov-12-2020
12:51:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredPhysician will contact subject
to update AE resolution and
update EDC accordingly.
Nov-12-2020
11:22:21
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Ope
nedFor AE headache: Response
to "What was the outcome of
this adverse event?" is
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935916
Page 177 of 193
***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
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Eastern Time
(US &
Canada)'Recovering/Resolving' but
AE End Date/Time is present.
Sep-25-2020
17:50:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry:
RECO
VERI
NG/R
ESOL
VINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-28-2020
08:40:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-28-2020
08:40:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription
Error
Sep-26-2020
05:06:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: 'Did the
adverse event
cause the
subject to be
discontinued
from the study?'
is Yes but
neither
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935917
Page 178 of 193
***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
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
DISPOSITION
- TREATMENT
form nor
DISPOSITION
- FOLLOW-UP
has Status as
'ADVERSE
EVENT'. Please
review and
update as
appropriate.
Thank you.
Sep-25-2020
17:50:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Did the adverse
event cause the
subject to be
discontinued
from the study?'
is Yes but
neither
DISPOSITION
- TREATMENT
form nor
DISPOSITION
- FOLLOW-UP
has Status as
''ADVERSE
EVENT''.
Please review
and update as
appropriate.
Sep-25-2020
17:50:41
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935918
Page 179 of 193
***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
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Eastern Time
(US & Canada)
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935919
Page 180 of 193
***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, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category:
Date Location User Value Reason
Sep-25-2020
17:52:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-25-2020
17:52:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-16-2020
09:44:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Nov-16-2020
08:44:28ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0935920
Page 181 of 193
***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, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
Nov-16-2020
08:44:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
generalized joint pa
inChanged
Information
Nov-13-2020
21:33:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened clinical-pls
update CRF to
indicate
specific joints
involved or if
generalized
joint pain.
Thanks
Nov-13-2020
18:08:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Candidate clinical-pls
update CRF to
indicate
specific joints
involved or if
generalized
joint pain.
Thanks
Sep-25-2020
17:52:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
joint painInitial Entry
4. Start Date Time:
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935921
Page 182 of 193
***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, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Sep-25-2020
17:52:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-12-2020
14:29:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Nov-12-2020
11:23:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/28/2020 U
NK:UNKNew
Information
Nov-12-2020
10:36:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answer
edPhysician is
currently
contacting
subject to
update AE
resolution. Will
update EDC
appropriately.
Thank you.
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935922
Page 183 of 193
***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, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Nov-11-2020
15:13:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY -
Please verify if
AE is still
ongoing, or
update END
DATE and
OUTCOME as
applicable.
Sep-25-2020
17:52:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-25-2020
17:52:26
(UTC-05:00)
Eastern 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
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935923
Page 184 of 193
***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, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-25-2020
17:52:26
(UTC-05:00)
Eastern 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
Sep-25-2020
17:52:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-25-2020
17:52:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-25-2020
17:52:26
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935924
Page 185 of 193
***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, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
& Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-25-2020
17:52:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-25-2020
17:52:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-16-2020
08:44:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Clos
edClose Auto Query
Nov-16-2020
08:44:59
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Data Entry:
RECOVERE
D/RESOLVE
DNew Information
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935925
Page 186 of 193
***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, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
Nov-16-2020
08:44:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Ope
nedFor AE generalized
joint pain: Response to
"What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Nov-12-2020
21:12:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Clos
edResponse satisfies
query
Nov-12-2020
12:51:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Ans
weredPhysician will contact
subject to update AE
resolution and update
EDC accordingly.
Nov-12-2020
11:23:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Ope
nedFor AE joint pain:
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Sep-25-2020
17:52:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERI
NG/RESOLV
INGInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935926
Page 187 of 193
***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, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-25-2020
17:52:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935927
Page 188 of 193
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-18-2021
10:24:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/4/2021Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935928
Page 189 of 193
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-18-2021
10:24:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing
to return for Vaccinat
ion 3
Participant is:
eligible and NOT
confirmed to have
received only plac
ebo at Vaccinatio
n 1/2Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935929
Page 190 of 193
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-18-2021
10:24:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/4/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-18-2021
10:24:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935930
Page 191 of 193
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-22-2020
09:48:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-04-2020
14:59:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-04-2020
14:40:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-22-2020
09:48:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/22/2020Initial Entry
Sep-04-2020
14:59:20ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935931
Page 192 of 193
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
Sep-04-2020
14:40:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935932
Page 193 of 193
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-16-2020
10:33:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3ea9\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935933