125742 S1 M5 CRF c4591001 1046 10461118

Document text

Page 1 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910942
Page 2 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/27/2020
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910943
Page 3 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10461118]
2.Birth Date: /1996
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0910944
Page 4 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910945
Page 5 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910946
Page 6 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910947
Page 7 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Pancreatitis]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Tonsillitis]
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2001
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Obsessive Compulsive Disorder]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910948
Page 8 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hair Loss]
Start Date: UNK/UNK/2017
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Tonsillectomy]
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2001
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Cholecystectomy]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910949
Page 9 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Inflamed Gallbladder]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910950
Page 10 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
2.Weight: [307.0]
3.Unit: LB
4.Height: [61.0]
5.Unit: in
6.Body Mass Index: [58.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: FOREHEAD
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910951
Page 11 of 153
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/27/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910952
Page 12 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/27/2020
2.Randomization Number: [70566]
3.Randomization Group: [ ]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910953
Page 13 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
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 [BP19NY]
5.bSample ID [BP19NZ]
5.cSample ID [BP19P0]
5.dSample ID [BPJ26B]
5.eSample ID [BPJ26C]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910954
Page 14 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
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 [BP19NX]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910955
Page 15 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/27/2020 13:30
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
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910956
Page 16 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910957
Page 17 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/18/2020
2.Erroneous Visit
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910958
Page 18 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/18/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: FOREHEAD
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910959
Page 19 of 153
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/18/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910960
Page 20 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/18/2020
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 [BPW2D0]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910961
Page 21 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/18/2020 12:20
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
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910962
Page 22 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910963
Page 23 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[Due to multiple attempts, it was unsuccessful.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910964
Page 24 of 153
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/12/2021
2.Erroneous Visit
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910965
Page 25 of 153
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/12/2021
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 [BJLXF6]
5.bSample ID [BNTPJY]
5.cSample ID [BNTPJZ]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910966
Page 26 of 153
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910967
Page 27 of 153
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910968
Page 28 of 153
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910969
Page 29 of 153
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910970
Page 30 of 153
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910971
Page 31 of 153
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910972
Page 32 of 153
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910973
Page 33 of 153
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910974
Page 34 of 153
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910975
Page 35 of 153
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910976
Page 36 of 153
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910977
Page 37 of 153
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910978
Page 38 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910979
Page 39 of 153
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910980
Page 40 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/16/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910981
Page 41 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910982
Page 42 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910983
Page 43 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910984
Page 44 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Ide
ntifierAdverse Ev
entStart DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Pregnancy
Exposure Jan/UNK/2021
UNK:UNK YES  Repeating
Pages
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910985
Page 45 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[Pregnancy Exposure]
4.Start Date Time: Jan/UNK/2021 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 2
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910986
Page 46 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910987
Page 47 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910988
Page 48 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910989
Page 49 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910990
Page 50 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910991
Page 51 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: //
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910992
Page 52 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910993
Page 53 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910994
Page 54 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910995
Page 55 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910996
Page 56 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910997
Page 57 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910998
Page 58 of 153
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910999
Page 59 of 153
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911000
Page 60 of 153
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911001
Page 61 of 153
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911002
Page 62 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911003
Page 63 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911004
Page 64 of 153
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911005
Page 65 of 153
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911006
Page 66 of 153
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911007
Page 67 of 153
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911008
Page 68 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911009
Page 69 of 153
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911010
Page 70 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/4/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911011
Page 71 of 153
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911012
Page 72 of 153
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911013
Page 73 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/16/2020
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911014
Page 74 of 153
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911015
Page 75 of 153
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Ernest
Hendrix Approved Mar-12-2021 17:17:00 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ErnestHendrix, 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.
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911016
Page 76 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-27-2020 18:58:46 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911017
Page 77 of 153
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Ernest
Hendrix Approved Mar-12-2021 17:17:00 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ErnestHendrix, 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 Mar-12-2021 16:47:09 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Ernest
Hendrix Approved Mar-11-2021 14:42:29 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0911018
Page 78 of 153
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, ErnestHendrix, 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 Feb-12-2021 18:22:33 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Ernest
Hendrix Approved Oct-22-2020 14:50:58 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ErnestHendrix, 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.
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0911019
Page 79 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-27-2020
14:41:25
(UTC-06:00)
Central 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-27-2020
14:41:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911020
Page 80 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-27-2020
14:41:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/27/2020Initial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911021
Page 81 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-27-2020
14:41:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10461118Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-27-2020
14:41:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1996Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-27-2020
14:41:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911022
Page 82 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-27-2020
14:41:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-27-2020
14:41:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911023
Page 83 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-27-2020
14:42:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911024
Page 84 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-27-2020
14:42:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-27-2020
14:42:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-27-2020
14:42:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911025
Page 85 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-27-2020
14:42:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:Pancreatiti
s
Start Date
:UNK/UN
K/2019
Ongoing: NO
End Date
:
UNK/U
NK/201
9Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-27-2020
14:42:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911026
Page 86 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-27-2020
14:42:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
PancreatitisInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-27-2020
14:42:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-27-2020
14:42:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.b
Date Location User Value Reason
Aug-27-2020
14:43:42
(UTC-06:00)
Central Time (USACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2Initial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911027
Page 87 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada) Medical H
istory Ter
m:Tonsillitis
Start Date
:UNK/UN
K/2001
Ongoing: NO
End Date
:
UNK/U
NK/200
1
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911028
Page 88 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Aug-27-2020
14:43:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020
14:43:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
TonsillitisInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-27-2020
14:43:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2001Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-27-2020
14:43:42ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911029
Page 89 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
UNK/UNK/2001
1.c
Date Location User Value Reason
Aug-27-2020
14:44:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical
History
Term:Obsessive
Compulsive
Disorder
Start Da
te:UNK/UNK/
2015
Ongoing
:YESInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911030
Page 90 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Aug-27-2020
14:44:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020
14:44:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Obsessive Compulsi
ve DisorderInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-27-2020
14:44:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-27-2020
14:44:20ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911031
Page 91 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.d
Date Location User Value Reason
Aug-27-2020
14:44:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical His
tory Term:Hair Los
s
Start Date: UNK/U
NK/201
7
Ongoing: YESInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911032
Page 92 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Aug-27-2020
14:44:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020
14:44:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Hair LossInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-27-2020
14:44:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-27-2020
14:44:44ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911033
Page 93 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.e
Date Location User Value Reason
Aug-27-2020
14:45:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical H
istory Ter
m:Tonsillecto
my
Start Date
:UNK/UN
K/2001
Ongoing: NO
End Date
:
UNK/U
NK/200
1Initial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911034
Page 94 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Aug-27-2020
14:45:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020
14:45:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
TonsillectomyInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-27-2020
14:45:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2001Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-27-2020
14:45:21ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911035
Page 95 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
UNK/UNK/2001
1.f
Date Location User Value Reason
Aug-27-2020
14:46:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:6
Medical H
istory Ter
m:Cholecyste
ctomy
Start Date
:UNK/UN
K/2019
Ongoing: NO
End Date
:
UNK/U
NK/201
9Initial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911036
Page 96 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Aug-27-2020
14:46:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
17:20:57
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Sep-01-2020
07:42:27
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answer
edChanged data per
query
Sep-01-2020
00:57:14
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery:
Cholecystectomy
please also record
the
condition/disease
that led to the
surgery/procedure
being required.
Please review and
update.
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911037
Page 97 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-30-2020
21:45:34
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Candid
ateClinQuery:
Cholecystectomy
please also record
the
condition/disease
that led to the
surgery/procedure
being required.
Please review and
update.
Aug-27-2020
14:46:03
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CholecystectomyInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-27-2020
14:46:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-27-2020
14:46:03
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911038
Page 98 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada) UNK/UNK/2019
1.g
Date Location User Value Reason
Sep-01-2020
07:42:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical H
istory Ter
m:Inflamed G
allbladder
Start Date
:UNK/UN
K/2019
Ongoing: NO
End Date
:
UNK/U
NK/201
9Initial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911039
Page 99 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Sep-01-2020
07:42:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020
07:42:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Inflamed GallbladderInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-01-2020
07:42:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-01-2020
07:42:18ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911040
Page 100 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
UNK/UNK/2019
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911041
Page 101 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-27-2020
14:47:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-31-2020
01:52:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Aug-28-2020
10:52:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered NCS
Aug-28-2020
01:20:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Reissued:
OpenedDM 1: Please
confirm
Weight "307"
recorded is
clinically
significant or
not.
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911042
Page 102 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-27-2020
18:58:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered Original value
is correct
Aug-27-2020
14:47:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Weight 307 is
outside of
Normal
Range 25 -
136 for kg or
50 - 300 for
lb.
Aug-27-2020
14:47:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
307.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-27-2020
14:47:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-27-2020
14:47:15ACV0PFEINFP6000  Data Entry:
61.0Initial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911043
Page 103 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
5. Unit:
Date Location User Value Reason
Aug-27-2020
14:47:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-27-2020
14:47:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
58.0Initial Entry
7.a
Date Location User Value Reason
Aug-27-2020
14:47:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.1
Temperatu
re Unit:FInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911044
Page 104 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Temperatu
re Location
::FORE
HEAD
7.a Record Identifier:
Date Location User Value Reason
Aug-27-2020
14:47:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-27-2020
14:47:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.1Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-27-2020
14:47:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911045
Page 105 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-27-2020
14:47:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911046
Page 106 of 153
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-27-2020
14:47:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-27-2020
14:47:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-27-2020
14:47:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911047
Page 107 of 153
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-27-2020
14:47:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-27-2020
14:47:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-27-2020
14:47:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911048
Page 108 of 153
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-27-2020
14:47:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-27-2020
14:47:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-27-2020
14:47:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911049
Page 109 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-27-2020
18:59:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-27-2020
18:59:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
70566Initial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911050
Page 110 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020
14:47:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020
14:47:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020
18:59:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-27-2020
14:47:50
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911051
Page 111 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-27-2020
14:47:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020
18:59:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP19N
YInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-27-2020
18:59:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP19NYInitial Entry
5.b
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911052
Page 112 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-27-2020
18:59:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP19N
ZInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-27-2020
18:59:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP19NZInitial Entry
5.c
Date Location User Value Reason
Aug-27-2020
18:59:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP19P0Initial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911053
Page 113 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Aug-27-2020
18:59:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP19P0Initial Entry
5.d
Date Location User Value Reason
Aug-27-2020
19:00:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPJ26BInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-27-2020
19:00:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPJ26BInitial Entry
5.e
Date Location User Value Reason
Aug-27-2020
19:00:10ACV0PFEINFP6000  Data Entry:
Sample ID: BPJ26CInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911054
Page 114 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
5.e Sample ID
Date Location User Value Reason
Aug-27-2020
19:00:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPJ26CInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911055
Page 115 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020
14:47:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020
14:47:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020
19:00:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-27-2020
14:47:59
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911056
Page 116 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-27-2020
14:47:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020
19:00:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP19N
XInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-27-2020
19:00:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP19NXInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911057
Page 117 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-27-2020
14:48:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-27-2020
19:00:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-27-2020
19:00:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911058
Page 118 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-27-2020
19:00:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/27/2020 13:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-27-2020
19:00:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-27-2020
19:00:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-27-2020
19:00:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911059
Page 119 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-27-2020
19:00:52
(UTC-06:00)
Central 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-27-2020
14:48:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911060
Page 120 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-27-2020
14:48:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911061
Page 121 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020
14:32:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911062
Page 122 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020
14:32:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020
14:32:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatur
e:98.0
Temperatur
e Unit:F
Temperatur
e Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020
14:32:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911063
Page 123 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.a Temperature:
Date Location User Value Reason
Sep-18-2020
14:32:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.0Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-18-2020
14:32:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020
14:32:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911064
Page 124 of 153
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-18-2020
14:32:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-18-2020
14:32:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-18-2020
14:32:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911065
Page 125 of 153
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-18-2020
14:32:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-18-2020
14:32:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-18-2020
14:32:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911066
Page 126 of 153
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-18-2020
14:32:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-18-2020
14:32:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-18-2020
14:32:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911067
Page 127 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020
14:33:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020
14:33:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020
14:33:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-18-2020
14:33:06
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911068
Page 128 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-18-2020
14:33:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020
14:33:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPW2D
0Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-18-2020
14:33:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPW2D0Initial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911069
Page 129 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020
14:33:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020
14:33:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020
14:33:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911070
Page 130 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-18-2020
14:33:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020 12:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020
14:33:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-18-2020
14:33:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-18-2020
14:33:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911071
Page 131 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-18-2020
14:33:39
(UTC-06:00)
Central 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-18-2020
14:33:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911072
Page 132 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-16-2020
15:03:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911073
Page 133 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020
15:03:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020
15:03:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020
17:36:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto
Query
Oct-16-2020
17:35:02
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened 'Sample
Collected?' is
marked as No
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911074
Page 134 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)and 'If no
sample was
collected or
sample was not
collected
according to
protocol,
please provide
reason' is
missing. Please
review and
update as
appropriate.
Oct-16-2020
17:35:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-16-2020
17:35:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription
Error
Oct-16-2020
15:03:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
correct as
appropriate.
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911075
Page 135 of 153
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-16-2020
15:03:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Oct/16/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
Date Location User Value Reason
Oct-16-2020
17:36:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Due to multiple attem
pts, it was unsuccessf
ul.Initial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911076
Page 136 of 153
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021
16:58:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mar/12/2021Initial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911077
Page 137 of 153
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-12-2021
16:59:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-12-2021
16:59:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-12-2021
16:59:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-12-2021
16:59:00
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911078
Page 138 of 153
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-12-2021
16:59:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/12/2021Initial Entry
5.a
Date Location User Value Reason
Mar-12-2021
16:59:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BJLXF
6Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-12-2021
16:59:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BJLXF6Initial Entry
5.b
Date Location User Value Reason
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911079
Page 139 of 153
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-12-2021
16:59:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BNTPJ
YInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-12-2021
16:59:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNTPJYInitial Entry
5.c
Date Location User Value Reason
Mar-12-2021
16:59:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BNTPJ
ZInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-12-2021
16:59:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNTPJZInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911080
Page 140 of 153
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-16-2020
17:36:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-16-2020
17:36:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-16-2020
17:36:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911081
Page 141 of 153
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Mar-12-2021
16:47:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911082
Page 142 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-12-2021
16:47:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-12-2021
16:47:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-12-2021
16:47:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Pregnancy ExposureInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911083
Page 143 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-12-2021
16:47:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2021 UNK:
UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-12-2021
16:47:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-12-2021
16:47:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911084
Page 144 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Mar-12-2021
16:47:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
Pregnancy
Exposure:
Response to
"Is the adverse
event
serious?" is
'Yes' but
"Serious
Adverse
Event
Number" is
blank.
Mar-12-2021
16:47:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious even
t associated with co
ngenital anomaly o
r birth defect?
NO
Did this serious ev
ent result in death?
NO
Did this serious ev
ent require or prolo
ng hospitalization?
NOInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911085
Page 145 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Did this serious ev
ent result in persist
ent or significant di
sability/incapacity?
NO
Is this serious even
t life threatening?
NO
Other medically im
portant serious eve
nt
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-12-2021
16:47:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-12-2021 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911086
Page 146 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
16:47:09
(UTC-06:00)
Central Time (US
& Canada)NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:
unknown
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-12-2021
16:47:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-12-2021
16:47:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911087
Page 147 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-12-2021
16:47:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-12-2021
16:47:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/
NOT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-12-2021
16:47:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911088
Page 148 of 153
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-12-2021
18:22:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/4/2021Initial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911089
Page 149 of 153
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-18-2021
11:50:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willin
g to return for Vacci
nation 3
Participant is:
eligible and NO
T confirmed to h
ave received onl
y placebo at Vac
cination 1/2Transcription
Error
Feb-12-2021
18:22:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is NOT
willing to return for
Vaccination 3 OR ot
herwise not eligibleInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911090
Page 150 of 153
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-17-2021
11:41:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/4/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-17-2021
11:41:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911091
Page 151 of 153
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-16-2020
17:36:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-27-2020
18:59:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-27-2020
14:42:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-16-2020
17:36:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/16/2020Initial Entry
Aug-27-2020
18:59:11ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/27/2020Initial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911092
Page 152 of 153
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
Aug-27-2020
14:42:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/27/2020Initial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911093
Page 153 of 153
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461118 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-09-2020
16:30:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae4032\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911094