125742 S1 M5 CRF c4591001 1131 11311100

Document text

Page 1 of 412
***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: 11311100 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
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935329
Page 2 of 412
***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: 11311100 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
Aug/28/2020
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935330
Page 3 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Demography
1.Subject ID [11311100]
2.Birth Date: /1955
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:
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935331
Page 4 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935332
Page 5 of 412
***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: 11311100 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
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935333
Page 6 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935334
Page 7 of 412
***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: 11311100 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:[myopia]
Start Date: UNK/UNK/1965
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[eye glass wearer]
Start Date: UNK/UNK/1965
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[allergic rhinitis, seasonal]
Start Date: UNK/UNK/1990
Ongoing: YES
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935335
Page 8 of 412
***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: 11311100 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:[sleep apnea]
Start Date: UNK/UNK/2015
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[C-PAP wearer]
Start Date: UNK/UNK/2015
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[triple by-pass heart surgery]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935336
Page 9 of 412
***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: 11311100 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:[chest pain]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[evidence of past cardiac infarction]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
1.iLine/MH Number: [9]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[high blood pressure]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935337
Page 10 of 412
***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: 11311100 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:[hyperlipidemia]
Start Date: UNK/UNK/2005
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[right bundle branch block]
Start Date: UNK/UNK/2003
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[1st degree atrioventricular block]
Start Date: UNK/UNK/2003
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[gallstones]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935338
Page 11 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.nLine/MH Number: [14]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[inguinal hernia]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.oLine/MH Number: [15]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[inguinal hernia surgical repair]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.pLine/MH Number: [16]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[kidney stones]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935339
Page 12 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.qLine/MH Number: [17]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[chronic kidney disease, stage 2]
Start Date: UNK/UNK/2013
Ongoing: YES
1.rLine/MH Number: [18]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[diabetic neuropathy in both feet]
Start Date: UNK/UNK/2010
Ongoing: YES
1.sLine/MH Number: [19]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[polycythemia]
Start Date: UNK/UNK/2015
Ongoing: YES
1.tLine/MH Number: [20]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[hypothyroidism]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935340
Page 13 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.uLine/MH Number: [21]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[type II diabetes, with no history of ketoacidosis]
Start Date: UNK/UNK/1995
Ongoing: YES
1.vLine/MH Number: [22]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[osteoarthritis in lumbar spine]
Start Date: UNK/UNK/2000
Ongoing: YES
1.wLine/MH Number: [23]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[osteoarthritis in neck]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935341
Page 14 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.xLine/MH Number: [24]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[recurrent back pain]
Start Date: UNK/UNK/1980
Ongoing: NO
End Date:
UNK/UNK/2013
1.yLine/MH Number: [25]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[recurrent neck pain]
Start Date: UNK/UNK/2018
Ongoing: YES
1.zLine/MH Number: [26]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[motor vehicle accident]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935342
Page 15 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.aaLine/MH Number: [27]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[L4-L5-S1 spinal fusion surgery]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1.abLine/MH Number: [28]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[appendectomy]
Start Date: UNK/UNK/1965
Ongoing: NO
End Date:
UNK/UNK/1965
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935343
Page 16 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
2.Weight: [111.0]
3.Unit: kg
4.Height: [186.0]
5.Unit: cm
6.Body Mass Index: [32.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935344
Page 17 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/28/2020
2.Randomization Number: [242851]
3.Randomization Group: [ ]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935345
Page 18 of 412
***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: 11311100 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:
Aug/28/2020Comments
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 [BN6DPB]
5.bSample ID [BN6DPC]
5.cSample ID [BN6DPD]
5.dSample ID [BL9VXX]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935346
Page 19 of 412
***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: 11311100 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:
Aug/28/2020
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 [BN6DWX]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935347
Page 20 of 412
***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: 11311100 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: Aug/28/2020 11:28
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
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935348
Page 21 of 412
***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: 11311100 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
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935349
Page 22 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935350
Page 23 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935351
Page 24 of 412
***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: 11311100 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/16/2020
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 [BN6F26]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935352
Page 25 of 412
***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: 11311100 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/16/2020 16:56
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
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935353
Page 26 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
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(b) (4)
FDA-CBER-2021-5683-0935354
Page 27 of 412
***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: 11311100 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/14/2020
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 [BP99W6]
5.bSample ID [BL9VMP]
5.cSample ID [BL9VMR]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935355
Page 28 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/13/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935356
Page 29 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/13/2020
2.Date of First Symptom
Started:Nov/12/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/30/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935357
Page 30 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Nasal Congestion]
5.bSymptoms - Other Text: [Elevated blood sugar to 250]
5.cSymptoms - Other Text: [upper left chest pain]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935358
Page 31 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descr
iptionDevice TypeForm Insta
nce
 1.Nov/14/
2020 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTI
C TEST Repeating
Pages
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935359
Page 32 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/14/2020 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection
Location:NASOPHARYNX Comments
4.Assay Code and
Description:SEVERE ACUTE RESP SYNDROME
CORONAVIRUS 2Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: POSITIVE Comments
8.Comments/Findings
/Details:[ ] Comments
9.Trade Name Other, Specify: [NALT unknown] Comments
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935360
Page 33 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 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_SELF
3.Sample Collected? YES
Date of Collection:
Nov/13/2020
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 [CV03501]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935361
Page 34 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 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? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[home nasal swab was delivered]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935362
Page 35 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935363
Page 36 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
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?YES
Has the subject been in intensive care due to potential
COVID-19 illness?
NO
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935364
Page 37 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Hospitalization Catego
ryHospitalization
TermAdmission
DateOngoing Form Instance
 1.HOSPITALIZATION ST
ATUS HOSPITAL   Nov/21/2020
 NO
Discharge D
ate:
Nov/24/20
20
 Repeating
Pages
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935365
Page 38 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Nov/21/2020
4.Ongoing? NO
Discharge Date:
Nov/24/2020
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935366
Page 39 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Treatmen
t Identifie
rCon Non-Drug Tr
eatments Pre-spec
ifiedTreatment TreatmentStart
DateForm Insta
nce
 1.1  YES  HIGH FLOW O
XYGEN THER
APY HIGH FLOW O
XYGEN THER
APY Nov/2
1/202
0 Repeating
Pages
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935367
Page 40 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Not Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment
Identifier?[1]
2.Concomitant Non-drug
Treatment Pre-specified:YES
3.Treatment: HIGH FLOW OXYGEN THERAPY
4.Treatment: [HIGH FLOW OXYGEN THERAPY]
5.Start Date: Nov/21/2020
6.Ongoing? NO
End Date:
Nov/30/2020
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935368
Page 41 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?YES
Respiratory Illness Diagnosis:
[Covid-19]
Date of Diagnosis:
Nov/16/2020
3.Toxicity Grade: 3
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935369
Page 42 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935370
Page 43 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical
Event:Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935371
Page 44 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category
for Lab
TestVendor NameColle
ction
Date:Speci
men
TypeLab ResultForm Insta
nce
 1.CLINIC
AL CHE
MISTRY Springfield region
al medical center,
100 medical cente
r Nov/2
3/202
0 BLO
OD Sponsor-
Defined I
dentifierTest:Re
sul
t:
329  C Reactive
Protein_PX
329 [ ] 
30  Alanine A
minotransfe
rase_PX30 28 
28  Aspartate A
minotransfe
rase_PX28 35 
35  Alkaline Ph
osphatase_
PX35 44 
21  Bilirubin_P
X21 0.4
 
47  Blood Urea
Nitrogen_P
X47 53 
48  Creatinine_
PX48 0.9
 Repeating
Pages
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935372
Page 45 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and
Address[Springfield regional medical center,100 medical center]
3.Collection Date: Nov/23/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
mg/dL
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935373
Page 46 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [28]
Not Done:
LNMT Low
[10]
High
[40]
Unit
U/L
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [35]
Not Done:
LNMT Low
[15]
High
[37]
Unit
U/L
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935374
Page 47 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [44]
Not Done:
LNMT Low
[40]
High
[128]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.4]
Not Done:
LNMT Low
[0.0]
High
[1.0]
Unit
mg/dL
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935375
Page 48 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [53]
Not Done:
LNMT Low
[6]
High
[23]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.9]
Not Done:
LNMT Low
[0.9]
High
[1.3]
Unit
mg/dL
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935376
Page 49 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category
for Lab T
estVendor Name
(DERIVED)Collect
ion Da
te:Speci
men T
ypeLab ResultForm Insta
nce
 1.HEMATO
LOGY Springfield reg
ional medical
center Nov/23
/2020 BLOO
D Sponsor-D
efined Ide
ntifierTest:Res
ult:
1  Hemoglo
bin_PX1 10 
2  Hematoc
rit_PX2 29.
0 
3  Erythroc
ytes_PX3
 3.1
9 
5  Platelets_
PX5 266
 
7  Leukocyt
es_PX7 6.6 
608  Neutroph
ils_PX60
8 [ ] 
609  Eosinoph
ils_PX60
9 [ ] 
612  Monocyt
es_PX61
2 8.0 
610  Basophil
s_PX610 [ ] Repeating
Pages
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935377
Page 50 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category
for Lab T
estVendor Name
(DERIVED)Collect
ion Da
te:Speci
men T
ypeLab ResultForm Insta
nce
Sponsor-D
efined Ide
ntifierTest:Res
ult:
611  Lymphoc
ytes_PX6
11 23.
0 
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935378
Page 51 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and
Address[Springfield regional medical center]
3.Collection Date: Nov/23/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [10]
Not Done:
LNMT Low
[13.5]
High
[18.0]
Unit
g/dL
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935379
Page 52 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [29.0]
Not Done:
LNMT Low
[42]
High
[52]
Unit
%
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [3.19]
Not Done:
LNMT Low
[4.6]
High
[6.2]
Unit
10^6/cu mm
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935380
Page 53 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [266]
Not Done:
LNMT Low
[140]
High
[440]
Unit
10^6/cu mm
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [6.6]
Not Done:
LNMT Low
[4.0]
High
[10.5]
Unit
10^6/cu mm
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935381
Page 54 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935382
Page 55 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [8.0]
Not Done:
LNMT Low
[0]
High
[4]
Unit
%
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935383
Page 56 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [23.0]
Not Done:
LNMT Low
[24]
High
[44]
Unit
%
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935384
Page 57 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Date: Vital Signs Details Form Instance
 1.Nov/24/2020 Record Identifier: Systolic: Diastolic:
1  120  59 Repeating Pages
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935385
Page 58 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [120]
Diastolic: [59]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in
beats/minute:[88]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935386
Page 59 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Date: Vital Signs Details Form Instance
 1.Nov/24/2020 Record Identifier: Oxygen Saturation
1  95.0 Repeating Pages
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935387
Page 60 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/24/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [95.0]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935388
Page 61 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating
Pages
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935389
Page 62 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Applicable
[ ]Comments
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935390
Page 63 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nStart D
ateForm Instan
ce
 1.Not Applicabl
e Not Applicab
le Not Applicable  Not Applic
able Not App
licable Repeating
Pages
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935391
Page 64 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935392
Page 65 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.Nov/20/2020  CHEST  X-RAY  UNKNOWN  Repeating
Pages
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935393
Page 66 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Nov/20/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: UNKNOWN
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935394
Page 67 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/11/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/11/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935395
Page 68 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/11/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 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:
Dec/11/2020
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 [BR0F46]
5.bSample ID [BS7XLG]
5.cSample ID [BS7XLH]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935396
Page 69 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935397
Page 70 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Unplanned Assessments
1.Assessments
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935398
Page 71 of 412
***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: 11311100 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/14/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935399
Page 72 of 412
***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: 11311100 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: [ ]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935400
Page 73 of 412
***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: 11311100 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:
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935401
Page 74 of 412
***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: 11311100 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 [ ]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935402
Page 75 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#CategoryAE Iden
tifierAdverse
EventStart DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  body ach
es Feb/2/2021 U
NK:UNK NO
End Date Time:
Feb/3/2021 UNK:U
NK
 Repeating
Pages
 2.ADVERSE
EVENT 2  chills  Feb/2/2021 U
NK:UNK NO
End Date Time:
Feb/3/2021 UNK:U
NK
 Repeating
Pages
 3.ADVERSE
EVENT 3  fatigue  Feb/2/2021 U
NK:UNK NO
End Date Time:
Feb/4/2021 08:00
 Repeating
Pages
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935403
Page 76 of 412
***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: 11311100 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)[body aches]
4.Start Date Time: Feb/2/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/3/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935404
Page 77 of 412
***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: 11311100 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
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935405
Page 78 of 412
***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: 11311100 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[ ]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935406
Page 79 of 412
***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: 11311100 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)[chills]
4.Start Date Time: Feb/2/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/3/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935407
Page 80 of 412
***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: 11311100 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?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935408
Page 81 of 412
***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: 11311100 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[ ]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935409
Page 82 of 412
***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: 11311100 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)[fatigue]
4.Start Date Time: Feb/2/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/4/2021 08:00
6.Toxicity Grade: 2
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935410
Page 83 of 412
***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: 11311100 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?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935411
Page 84 of 412
***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: 11311100 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[ ]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935412
Page 85 of 412
***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: 11311100 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
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935413
Page 86 of 412
***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: 11311100 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[ ]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935414
Page 87 of 412
***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: 11311100 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
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935415
Page 88 of 412
***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: 11311100 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: //
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935416
Page 89 of 412
***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: 11311100 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
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935417
Page 90 of 412
***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: 11311100 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?
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935418
Page 91 of 412
***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: 11311100 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
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935419
Page 92 of 412
***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: 11311100 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?
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935420
Page 93 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935421
Page 94 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935422
Page 95 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935423
Page 96 of 412
***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: 11311100 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:
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935424
Page 97 of 412
***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: 11311100 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?
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935425
Page 98 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935426
Page 99 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935427
Page 100 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935428
Page 101 of 412
***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: 11311100 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 per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935429
Page 102 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/28/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935430
Page 103 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935431
Page 104 of 412
***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: 11311100 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: [ ]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935432
Page 105 of 412
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/1/2021
2.Erroneous Visit
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935433
Page 106 of 412
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/1/2021
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935434
Page 107 of 412
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 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
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935435
Page 108 of 412
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/1/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935436
Page 109 of 412
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 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:
Feb/1/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR0FCV]
5.bSample ID [BS2DLH]
5.cSample ID [BS2DLJ]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935437
Page 110 of 412
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 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:
Feb/1/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR0G65]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935438
Page 111 of 412
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/1/2021 13:06
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935439
Page 112 of 412
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/22/2021
2.Erroneous Visit
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935440
Page 113 of 412
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 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:
Feb/22/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR0GD8]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935441
Page 114 of 412
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/22/2021 09:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935442
Page 115 of 412
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935443
Page 116 of 412
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935444
Page 117 of 412
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935445
Page 118 of 412
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935446
Page 119 of 412
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935447
Page 120 of 412
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935448
Page 121 of 412
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935449
Page 122 of 412
***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: 11311100 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/14/2020
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935450
Page 123 of 412
***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: 11311100 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
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935451
Page 124 of 412
***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: 11311100 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
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935452
Page 125 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormAug-28-2020 12:33:12 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935453
Page 126 of 412
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Aug-28-2020 16:38:25 (UTC-05:00)
Eastern Time (US & Canada)only one retain tube yielded
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935454
Page 127 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormNov-16-2020 12:06:26 (UTC-05:00)
Eastern Time (US & Canada)
FormNov-13-2020 10:05:57 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935455
Page 128 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Nov-16-2020 12:06:26 (UTC-05:00)
Eastern Time (US & Canada)
1Nov-13-2020 10:05:57 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935456
Page 129 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Nov-16-2020 12:06:26 (UTC-05:00)
Eastern Time (US & Canada)
2Nov-13-2020 10:05:57 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935457
Page 130 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Nov-16-2020 12:06:26 (UTC-05:00)
Eastern Time (US & Canada)
3Nov-13-2020 10:05:57 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935458
Page 131 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Nov-16-2020 12:06:26 (UTC-05:00)
Eastern Time (US & Canada)
4Nov-13-2020 10:05:57 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935459
Page 132 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Nov-16-2020 12:06:26 (UTC-05:00)
Eastern Time (US & Canada)
5Nov-13-2020 10:05:57 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935460
Page 133 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6Nov-16-2020 12:06:26 (UTC-05:00)
Eastern Time (US & Canada)
6Nov-13-2020 10:05:57 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935461
Page 134 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
7Nov-16-2020 12:06:26 (UTC-05:00)
Eastern Time (US & Canada)
7Nov-13-2020 10:05:57 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935462
Page 135 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
8Nov-16-2020 12:06:26 (UTC-05:00)
Eastern Time (US & Canada)
8Nov-13-2020 10:05:57 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935463
Page 136 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
9Nov-16-2020 12:06:26 (UTC-05:00)
Eastern Time (US & Canada)
9Nov-13-2020 10:05:57 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935464
Page 137 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormJan-22-2021 13:28:32 (UTC-05:00)
Eastern Time (US & Canada)no information on medical report
Not Applicable
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935465
Page 138 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Jan-22-2021 13:28:32 (UTC-05:00)
Eastern Time (US & Canada)no information on medical report
Not Applicable
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935466
Page 139 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Jan-22-2021 13:28:32 (UTC-05:00)
Eastern Time (US & Canada)no information on medical report
Not Applicable
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935467
Page 140 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Jan-22-2021 13:28:32 (UTC-05:00)
Eastern Time (US & Canada)no information on medical report
Not Applicable
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935468
Page 141 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Jan-22-2021 13:28:32 (UTC-05:00)
Eastern Time (US & Canada)no information on medical report
Not Applicable
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935469
Page 142 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormJan-22-2021 13:28:11 (UTC-05:00)
Eastern Time (US & Canada)no information on medical report
Not Applicable
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935470
Page 143 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Jan-22-2021 13:28:11 (UTC-05:00)
Eastern Time (US & Canada)no information on medical report
Not Applicable
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935471
Page 144 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Jan-22-2021 13:28:11 (UTC-05:00)
Eastern Time (US & Canada)no information on medical report
Not Applicable
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935472
Page 145 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Jan-22-2021 13:28:11 (UTC-05:00)
Eastern Time (US & Canada)no information on medical report
Not Applicable
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935473
Page 146 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormDec-23-2020 13:46:33 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935474
Page 147 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Dec-23-2020 13:46:33 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935475
Page 148 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Dec-23-2020 13:46:33 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935476
Page 149 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Dec-23-2020 13:46:33 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935477
Page 150 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Dec-23-2020 13:46:33 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935478
Page 151 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Dec-23-2020 13:46:33 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935479
Page 152 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/13/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6Dec-23-2020 13:46:33 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935480
Page 153 of 412
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormFeb-01-2021 15:42:56 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935481
Page 154 of 412
***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: 11311100 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-22-2021 13:28:11 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Randall Approved Jan-22-2021 12:34:06 (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 Dec-11-2020 10:56:26 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935482
Page 155 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Affidavit:
N/A
William
Randall Approved Dec-03-2020 09:33:50 (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 Dec-02-2020 10:36:13 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Randall Approved Nov-25-2020 05:42:37 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935483
Page 156 of 412
***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: 11311100 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-23-2020 11:16:33 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Randall Approved Nov-16-2020 15:40:15 (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.
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935484
Page 157 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
 N/A Nov-16-2020 12:04:22 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Randall Approved Nov-16-2020 08:43:11 (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-13-2020 10:01:51 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Randall Approved Oct-20-2020 16:23:11 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935485
Page 158 of 412
***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: 11311100 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.
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935486
Page 159 of 412
***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: 11311100 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
Aug-28-2020
12:31:05
(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
Aug-28-2020
12:31:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935487
Page 160 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-28-2020
12:31:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/28/2020Initial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935488
Page 161 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-28-2020
12:30:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11311100Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-28-2020
12:30:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1955Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-28-2020
12:32:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935489
Page 162 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-28-2020
12:32:15
(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
Aug-28-2020
12:32:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935490
Page 163 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-28-2020
12:32:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935491
Page 164 of 412
***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: 11311100 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
Aug-28-2020
12:33:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-28-2020
12:33:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-28-2020
12:33:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935492
Page 165 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.a
Date Location User Value Reason
Aug-28-2020
12:34:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:myopia
Start Date: UNK/U
NK/196
5
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:34:36
(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
Aug-28-2020
12:34:36
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
myopiaInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935493
Page 166 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
& Canada)
1.a Start Date:
Date Location User Value Reason
Aug-28-2020
12:34:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1965Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-28-2020
12:34:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-28-2020
12:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:eye glass
wearer
Start Date: UNK/U
NK/196
5
Ongoing: YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935494
Page 167 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.b Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:34:59
(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
Aug-28-2020
12:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
eye glass wearerInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-28-2020
12:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1965Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-28-2020
12:34:59ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935495
Page 168 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
1.c
Date Location User Value Reason
Aug-28-2020
12:35:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:allergic rhi
nitis, seaso
nal
Start Date
:UNK/UN
K/1990
Ongoing: YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935496
Page 169 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.c Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:35:19
(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
Aug-28-2020
12:35:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
allergic rhinitis, seas
onalInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-28-2020
12:35:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-28-2020
12:35:19ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935497
Page 170 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
1.d
Date Location User Value Reason
Aug-28-2020
12:35:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical His
tory Term:sleep ap
nea
Start Date: UNK/U
NK/201
5
Ongoing: YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935498
Page 171 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.d Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:35:43
(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
Aug-28-2020
12:35:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
sleep apneaInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-28-2020
12:35:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-28-2020
12:35:43ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935499
Page 172 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
1.e
Date Location User Value Reason
Aug-28-2020
12:36:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical His
tory Term:C-PAP
wearer
Start Date: UNK/U
NK/201
5
Ongoing: YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935500
Page 173 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.e Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:36:08
(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
Aug-28-2020
12:36:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
C-PAP wearerInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-28-2020
12:36:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-28-2020
12:36:08ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935501
Page 174 of 412
***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: 11311100 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
Aug-28-2020
12:36:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:6
Medical
History
Term:triple by-pas
s heart surge
ry
Start Dat
e:UNK/UNK/
2003
Ongoing: NO
End Date:
UNK/U
NK/2003Initial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935502
Page 175 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.f Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:36:56
(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
Aug-28-2020
12:36:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
triple by-pass heart s
urgeryInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-28-2020
12:36:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2003Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-28-2020
12:36:56ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935503
Page 176 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/2003
1.g
Date Location User Value Reason
Aug-28-2020
12:38:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical H
istory Ter
m:chest pain
Start Date
:UNK/UN
K/2003
Ongoing: NO
End Date
:
UNK/U
NK/200
3Initial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935504
Page 177 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.g Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:38:20
(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-01-2020
15:19:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Sep-01-2020
08:39:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered Chest pain was
cardiac in
nature per
coordinator.
Aug-31-2020
21:31:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Katherine
PuigQuery 1: Opened GPDCLIN -
Please specify
if CHEST
PAIN is
cardiac or
non-cardiac in
nature and
update as
appropriate.
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0935505
Page 178 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-31-2020
15:57:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Candidate GPDCLIN -
Please specify
if CHEST
PAIN is
cardiac or
non-cardiac in
nature and
update as
appropriate.
Aug-28-2020
12:38:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
chest painInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-28-2020
12:38:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2003Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-28-2020
12:38:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2003Initial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0935506
Page 179 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.h
Date Location User Value Reason
Aug-28-2020
13:30:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/
MH N
umber
:8
Medic
al Hist
ory Te
rm:evidence of
past cardia
c infarction
Start
Date:UNK/UNK
/2000
Ongoi
ng:NO
End Date:
UNK/U
NK/200
0Changed
Information
Aug-28-2020
12:39:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:8
Medica
l Histor
y Term
:evidence
of past car
diac infarc
tion
Start D
ate:UNK/UN
K/2000Initial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935507
Page 180 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Ongoin
g:YES
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935508
Page 181 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.h Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:39:16
(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
Aug-28-2020
12:39:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
evidence of past card
iac infarctionInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-28-2020
12:39:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-28-2020
13:30:30ACV0PFEINFP6000  Data Entry:
NOChanged
Information
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935509
Page 182 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/200
0
Aug-28-2020
12:39:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-28-2020
12:39:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:9
Medical Hi
story Term
:high bloo
d pressur
e
Start Date: UNK/UN
K/2000
Ongoing: YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935510
Page 183 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.i Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:39:36
(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
Aug-28-2020
12:39:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
high blood pressureInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-28-2020
12:39:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935511
Page 184 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.i Ongoing:
Date Location User Value Reason
Aug-28-2020
12:39:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Aug-28-2020
12:39:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:10
Medical His
tory Term:hyperlipi
demia
Start Date: UNK/U
NK/200
5
Ongoing: YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935512
Page 185 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.j Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:39:57
(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
Aug-28-2020
12:39:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
hyperlipidemiaInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-28-2020
12:39:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-28-2020
12:39:57ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935513
Page 186 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
1.k
Date Location User Value Reason
Aug-28-2020
12:40:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:11
Medical
History T
erm:right bundl
e branch bl
ock
Start Dat
e:UNK/UN
K/2003
Ongoing: YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935514
Page 187 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.k Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:40:29
(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
Aug-28-2020
12:40:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
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blockInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-28-2020
12:40:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2003Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-28-2020
12:40:29ACV0PFEINFP6000  Data Entry:
YESInitial Entry
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(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0935515
Page 188 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
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1.l
Date Location User Value Reason
Aug-28-2020
12:41:32
(UTC-05:00)
Eastern Time (US
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(autocalc)Data Entry:
Line/MH
Number:12
Medical
History
Term:1st degree a
trioventricu
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e:UNK/UNK/
2003
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:YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935516
Page 189 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.l Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:41:32
(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
Aug-28-2020
12:41:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1st degree atrioventri
cular blockInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-28-2020
12:41:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2003Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-28-2020
12:41:32ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935517
Page 190 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
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1.m
Date Location User Value Reason
Aug-28-2020
12:41:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:13
Medical His
tory Term:gallstone
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NK/201
8
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090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935518
Page 191 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.m Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:41:46
(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
Aug-28-2020
12:41:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
gallstonesInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-28-2020
12:41:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-28-2020
12:41:46ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935519
Page 192 of 412
***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: 11311100 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
Aug-28-2020
12:42:08
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Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:14
Medical H
istory Ter
m:inguinal he
rnia
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:UNK/UN
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:
UNK/U
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1Initial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935520
Page 193 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.n Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:42:08
(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
Aug-28-2020
12:42:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inguinal herniaInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-28-2020
12:42:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2011Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-28-2020
12:42:08ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935521
Page 194 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
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UNK/UNK/2011
1.o
Date Location User Value Reason
Aug-28-2020
12:42:30
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Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:15
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History
Term:inguinal her
nia surgical r
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:NO
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UNK/UN
K/2011Initial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935522
Page 195 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.o Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:42:30
(UTC-05:00)
Eastern Time (US
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(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
12:42:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inguinal hernia surgi
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1.o Start Date:
Date Location User Value Reason
Aug-28-2020
12:42:30
(UTC-05:00)
Eastern Time (US
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UNK/UNK/2011Initial Entry
1.o Ongoing:
Date Location User Value Reason
Aug-28-2020
12:42:30ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935523
Page 196 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/2011
1.p
Date Location User Value Reason
Aug-28-2020
12:42:51
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Eastern Time (US
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(autocalc)Data Entry:
Line/MH
Number:16
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istory Ter
m:kidney sto
nes
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:UNK/UN
K/2000
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:
UNK/U
NK/200
0Initial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935524
Page 197 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.p Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:42:51
(UTC-05:00)
Eastern Time (US
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(autocalc)Data Entry:
16Initial Entry
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Aug-28-2020
12:42:51
(UTC-05:00)
Eastern Time (US
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1.p Start Date:
Date Location User Value Reason
Aug-28-2020
12:42:51
(UTC-05:00)
Eastern Time (US
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UNK/UNK/2000Initial Entry
1.p Ongoing:
Date Location User Value Reason
Aug-28-2020
12:42:51ACV0PFEINFP6000  Data Entry:
NOInitial Entry
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(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935525
Page 198 of 412
***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: 11311100 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
Aug-28-2020
12:43:23
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Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:17
Medical
History T
erm:chronic kid
ney disease
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e:UNK/UNK
/2013
Ongoing: YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935526
Page 199 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.q Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:43:23
(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
Aug-28-2020
12:43:23
(UTC-05:00)
Eastern Time (US
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chronic kidney disea
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1.q Start Date:
Date Location User Value Reason
Aug-28-2020
12:43:23
(UTC-05:00)
Eastern Time (US
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UNK/UNK/2013Initial Entry
1.q Ongoing:
Date Location User Value Reason
Aug-28-2020
12:43:23ACV0PFEINFP6000  Data Entry:
YESInitial Entry
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(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935527
Page 200 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
1.r
Date Location User Value Reason
Aug-28-2020
12:44:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:18
Medical
History
Term:diabetic neu
ropathy in b
oth feet
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e:UNK/UNK
/2010
Ongoing: YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935528
Page 201 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.r Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:44:01
(UTC-05:00)
Eastern Time (US
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(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
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Aug-28-2020
12:44:01
(UTC-05:00)
Eastern Time (US
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1.r Start Date:
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Aug-28-2020
12:44:01
(UTC-05:00)
Eastern Time (US
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UNK/UNK/2010Initial Entry
1.r Ongoing:
Date Location User Value Reason
Aug-28-2020
12:44:01ACV0PFEINFP6000  Data Entry:
YESInitial Entry
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(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935529
Page 202 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
1.s
Date Location User Value Reason
Aug-28-2020
12:44:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:19
Medical His
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NK/201
5
Ongoing: YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935530
Page 203 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.s Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:44:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
12:44:21
(UTC-05:00)
Eastern Time (US
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polycythemiaInitial Entry
1.s Start Date:
Date Location User Value Reason
Aug-28-2020
12:44:21
(UTC-05:00)
Eastern Time (US
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090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
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(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935531
Page 204 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.s Ongoing:
Date Location User Value Reason
Aug-28-2020
12:44:21
(UTC-05:00)
Eastern Time (US
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YESInitial Entry
1.t
Date Location User Value Reason
Aug-28-2020
12:44:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:20
Medical His
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oidism
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NK/201
5
Ongoing: YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935532
Page 205 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.t Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:44:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
20Initial Entry
1.t Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
12:44:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
hypothyroidismInitial Entry
1.t Start Date:
Date Location User Value Reason
Aug-28-2020
12:44:37
(UTC-05:00)
Eastern Time (US
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UNK/UNK/2015Initial Entry
1.t Ongoing:
Date Location User Value Reason
Aug-28-2020
12:44:37ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935533
Page 206 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
1.u
Date Location User Value Reason
Aug-28-2020
12:45:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:21
Medica
l Histor
y Term
:type II diabet
es, with no hi
story of ketoa
cidosis
Start D
ate:UNK/UNK/1
995
Ongoin
g:YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935534
Page 207 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.u Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:45:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21Initial Entry
1.u Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
12:45:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
type II diabetes, with
no history of ketoaci
dosisInitial Entry
1.u Start Date:
Date Location User Value Reason
Aug-28-2020
12:45:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.u Ongoing:
Date Location User Value Reason
Aug-28-2020
12:45:21ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935535
Page 208 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
1.v
Date Location User Value Reason
Aug-28-2020
12:45:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:22
Medical
History T
erm:osteoarthrit
is in lumba
r spine
Start Dat
e:UNK/UNK
/2000
Ongoing: YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935536
Page 209 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.v Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:45:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
22Initial Entry
1.v Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
12:45:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
osteoarthritis in lum
bar spineInitial Entry
1.v Start Date:
Date Location User Value Reason
Aug-28-2020
12:45:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.v Ongoing:
Date Location User Value Reason
Aug-28-2020
12:45:51ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935537
Page 210 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
1.w
Date Location User Value Reason
Aug-28-2020
12:46:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:23
Medical Hi
story Term
:osteoarthr
itis in nec
k
Start Date: UNK/UN
K/2000
Ongoing: YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935538
Page 211 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.w Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:46:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23Initial Entry
1.w Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
12:46:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
osteoarthritis in neckInitial Entry
1.w Start Date:
Date Location User Value Reason
Aug-28-2020
12:46:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.w Ongoing:
Date Location User Value Reason
Aug-28-2020
12:46:09ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935539
Page 212 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
1.x
Date Location User Value Reason
Aug-28-2020
12:46:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:24
Medical H
istory Ter
m:recurrent b
ack pain
Start Date
:UNK/UN
K/1980
Ongoing: NO
End Date
:
UNK/U
NK/201
3Initial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935540
Page 213 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.x Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:46:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
24Initial Entry
1.x Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
12:46:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
recurrent back painInitial Entry
1.x Start Date:
Date Location User Value Reason
Aug-28-2020
12:46:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.x Ongoing:
Date Location User Value Reason
Aug-28-2020
12:46:39ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935541
Page 214 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/2013
1.y
Date Location User Value Reason
Aug-28-2020
12:47:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:25
Medical Hi
story Term
:recurrent
neck pain
Start Date: UNK/UN
K/2018
Ongoing: YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935542
Page 215 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.y Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:47:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
25Initial Entry
1.y Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
12:47:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
recurrent neck painInitial Entry
1.y Start Date:
Date Location User Value Reason
Aug-28-2020
12:47:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.y Ongoing:
Date Location User Value Reason
Aug-28-2020
12:47:00ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935543
Page 216 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
1.z
Date Location User Value Reason
Aug-28-2020
12:47:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:26
Medical H
istory Ter
m:motor veh
icle accide
nt
Start Date
:UNK/UN
K/2018
Ongoing: YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935544
Page 217 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.z Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:47:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
26Initial Entry
1.z Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
12:47:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
motor vehicle accide
ntInitial Entry
1.z Start Date:
Date Location User Value Reason
Aug-28-2020
12:47:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.z Ongoing:
Date Location User Value Reason
Aug-28-2020
12:47:20ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935545
Page 218 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)
1.aa
Date Location User Value Reason
Aug-28-2020
12:47:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:27
Medical
History
Term:L4-L5-S1 sp
inal fusion s
urgery
Start Da
te:UNK/UNK/
2013
Ongoing
:NO
End Date:
UNK/UN
K/2013Initial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935546
Page 219 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.aa Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:47:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
27Initial Entry
1.aa Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
12:47:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
L4-L5-S1 spinal fusi
on surgeryInitial Entry
1.aa Start Date:
Date Location User Value Reason
Aug-28-2020
12:47:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.aa Ongoing:
Date Location User Value Reason
Aug-28-2020
12:47:55ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935547
Page 220 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/2013
1.ab
Date Location User Value Reason
Aug-28-2020
12:48:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:28
Medical H
istory Ter
m:appendect
omy
Start Date
:UNK/UN
K/1965
Ongoing: NO
End Date
:
UNK/U
NK/196
5Initial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935548
Page 221 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.ab Line/MH Number:
Date Location User Value Reason
Aug-28-2020
12:48:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28Initial Entry
1.ab Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
12:48:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
appendectomyInitial Entry
1.ab Start Date:
Date Location User Value Reason
Aug-28-2020
12:48:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1965Initial Entry
1.ab Ongoing:
Date Location User Value Reason
Aug-28-2020
12:48:21ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935549
Page 222 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/1965
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935550
Page 223 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020
12:49:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-28-2020
12:49:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
111.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-28-2020
12:49:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935551
Page 224 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-28-2020
12:49:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
186.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-28-2020
12:49:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-28-2020
12:49:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
32.1Initial Entry
7.a
Date Location User Value Reason
Aug-28-2020
12:49:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Id
entifier::1
Temperatu
re:36.8Initial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935552
Page 225 of 412
***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: 11311100 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
Aug-28-2020
12:49:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-28-2020
12:49:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
36.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-28-2020
12:49:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935553
Page 226 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
7.a Temperature Location:
Date Location User Value Reason
Aug-28-2020
12:49:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935554
Page 227 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-28-2020
12:49:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-28-2020
12:49:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
242851Initial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935555
Page 228 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020
12:49:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020
12:49:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020
16:37:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-28-2020
12:49:29
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935556
Page 229 of 412
***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: 11311100 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.
Aug-28-2020
12:49:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020
16:37:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BN6DP
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020
16:37:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN6DPBInitial Entry
5.b
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935557
Page 230 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Aug-28-2020
16:37:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BN6DP
CInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-28-2020
16:37:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN6DPCInitial Entry
5.c
Date Location User Value Reason
Aug-28-2020
16:37:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BN6DP
DInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935558
Page 231 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.c Sample ID
Date Location User Value Reason
Aug-28-2020
16:37:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN6DPDInitial Entry
5.d
Date Location User Value Reason
Aug-28-2020
16:38:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BL9VX
XInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-28-2020
16:38:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BL9VXXInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935559
Page 232 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020
12:49:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020
12:49:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020
16:35:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-28-2020
12:49:38
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935560
Page 233 of 412
***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: 11311100 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.
Aug-28-2020
12:49:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020
16:35:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BN6DW
XInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020
16:35:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN6DWXInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935561
Page 234 of 412
***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: 11311100 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
Aug-28-2020
12:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020
12:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020
12:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935562
Page 235 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-28-2020
12:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020 11:28Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020
12:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-28-2020
12:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-28-2020
12:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935563
Page 236 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-28-2020
12:50:28
(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
Aug-28-2020
12:50:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935564
Page 237 of 412
***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: 11311100 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
Aug-28-2020
12:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935565
Page 238 of 412
***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: 11311100 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-17-2020
09:37:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935566
Page 239 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-17-2020
09:38:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
2.a
Date Location User Value Reason
Sep-17-2020
09:38:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.9
Temperatu
re Unit:C
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-17-2020
09:38:02
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935567
Page 240 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-17-2020
09:38:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-17-2020
09:38:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-17-2020
09:38:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935568
Page 241 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020
19:03:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020
19:03:50
(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-16-2020
19:03:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-16-2020
19:03:50
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935569
Page 242 of 412
***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: 11311100 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-16-2020
19:03:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-16-2020
19:03:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN6F26Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-16-2020
19:03:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN6F26Initial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935570
Page 243 of 412
***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: 11311100 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-17-2020
09:38:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-17-2020
09:38:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-17-2020
09:38:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935571
Page 244 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-17-2020
09:38:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020 16:56Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-17-2020
09:38:54
(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-17-2020
09:38:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-17-2020
09:38:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935572
Page 245 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-17-2020
09:38:54
(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-17-2020
09:38:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935573
Page 246 of 412
***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: 11311100 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-14-2020
10:49:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935574
Page 247 of 412
***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: 11311100 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020
10:50:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020
10:50:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020
15:45:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-14-2020
10:50:00
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935575
Page 248 of 412
***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: 11311100 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-14-2020
10:50:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-14-2020
15:45:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP99W
6Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-14-2020
15:45:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP99W6Initial Entry
5.b
090177e196ae3e9e\Final\Final On: 01-Apr-2021 04:56 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935576
Page 249 of 412
***Co
…[truncated]