Document text
Page 1 of 203
***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: 10461009 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
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910588
Page 2 of 203
***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: 10461009 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/13/2020
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910589
Page 3 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10461009]
2.Birth Date: /1952
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0910590
Page 4 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/13/2020
2.Erroneous Visit
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910591
Page 5 of 203
***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: 10461009 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
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910592
Page 6 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/13/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910593
Page 7 of 203
***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: 10461009 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:[Double Hernia Repair]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Kidney Stone Removal]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Corneal Transplant]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910594
Page 8 of 203
***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: 10461009 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:[Stomach Aneurysm]
Start Date: UNK/UNK/1991
Ongoing: NO
End Date:
UNK/UNK/1991
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Juvenile Petite Mal Seizures]
Start Date: UNK/UNK/1961
Ongoing: NO
End Date:
UNK/UNK/1961
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GERD]
Start Date: Jan/1/2020
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroidism]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910595
Page 9 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BPH]
Start Date: UNK/UNK/2018
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy to Sulfa]
Start Date: UNK/UNK/1960
Ongoing: YES
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910596
Page 10 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/13/2020
2.Weight: [194.0]
3.Unit: LB
4.Height: [72.0]
5.Unit: in
6.Body Mass Index: [26.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910597
Page 11 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/13/2020
2.Randomization Number: [228005]
3.Randomization Group: [ ]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910598
Page 12 of 203
***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: 10461009 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/13/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLXFGY]
5.bSample ID [BLXFGZ]
5.cSample ID [BLXFH0]
5.dSample ID [BPJ270]
5.eSample ID [BPJ271]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910599
Page 13 of 203
***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: 10461009 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/13/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLXFGX]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910600
Page 14 of 203
***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: 10461009 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/13/2020 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
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910601
Page 15 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS
SUBJECT
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910602
Page 16 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910603
Page 17 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910604
Page 18 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was
completed?NO
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910605
Page 19 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was
completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was
completed?NO
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910606
Page 20 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: FOREHEAD
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910607
Page 21 of 203
***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: 10461009 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/1/2020
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 [BPTM21]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910608
Page 22 of 203
***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: 10461009 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/1/2020 09:58
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
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910609
Page 23 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910610
Page 24 of 203
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910611
Page 25 of 203
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was
completed?NO
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910612
Page 26 of 203
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was
completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was
completed?NO
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910613
Page 27 of 203
***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: 10461009 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:
Oct/1/2020
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 [BPW2L7]
5.bSample ID [BPW2L8]
5.cSample ID [BPW2L9]
5.dSample ID [BNTPKP]
5.eSample ID [BNTPKR]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910614
Page 28 of 203
***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: 10461009 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:
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910615
Page 29 of 203
***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: 10461009 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: [ ]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910616
Page 30 of 203
***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: 10461009 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 [ ]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910617
Page 31 of 203
***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: 10461009 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 [ ]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910618
Page 32 of 203
***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: 10461009 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?
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910619
Page 33 of 203
***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: 10461009 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:
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910620
Page 34 of 203
***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: 10461009 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:
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910621
Page 35 of 203
***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: 10461009 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 [ ]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910622
Page 36 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910623
Page 37 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910624
Page 38 of 203
***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: 10461009 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/1/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910625
Page 39 of 203
***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: 10461009 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: [ ]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910626
Page 40 of 203
***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: 10461009 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:
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910627
Page 41 of 203
***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: 10461009 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 [ ]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910628
Page 42 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identi
fierAdverse E
ventStart DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Hiatal Her
nia Dec/13/2020
08:00 NO
End Date Time:
Dec/18/2020 10:00
Repeating
Pages
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910629
Page 43 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 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)[Hiatal Hernia]
4.Start Date Time: Dec/13/2020 08:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/18/2020 10:00
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910630
Page 44 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[2021072376]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910631
Page 45 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryMedication
ErrorStart D
ateIs the medication error S
till OngoingStudy Medication Err
ors ActionForm Instanc
e
1. Repeating
Pages
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910632
Page 46 of 203
***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: 10461009 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[ ]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910633
Page 47 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910634
Page 48 of 203
***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: 10461009 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: //
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910635
Page 49 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. Repeating
Pages
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910636
Page 50 of 203
***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: 10461009 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?
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910637
Page 51 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryTreatment Ident
ifierCon Non-Drug Treatments Pre-
specifiedTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910638
Page 52 of 203
***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: 10461009 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?
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910639
Page 53 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910640
Page 54 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910641
Page 55 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910642
Page 56 of 203
***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: 10461009 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:
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910643
Page 57 of 203
***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: 10461009 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?
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910644
Page 58 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910645
Page 59 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910646
Page 60 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910647
Page 61 of 203
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 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 per local/national recommendations and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910648
Page 62 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/19/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910649
Page 63 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910650
Page 64 of 203
***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: 10461009 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: [ ]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910651
Page 65 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910652
Page 66 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/25/2021
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910653
Page 67 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 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
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910654
Page 68 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/25/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910655
Page 69 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 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:
Jan/25/2021
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 [BLXFDF]
5.bSample ID [BLXFDG]
5.cSample ID [BLXFDH]
5.dSample ID [BS7KNV]
5.eSample ID [BS7KNW]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910656
Page 70 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 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:
Jan/25/2021
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 [BLXFDN]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910657
Page 71 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/25/2021 13:45
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910658
Page 72 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910659
Page 73 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 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:
Feb/17/2021
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 [BJS6T8]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910660
Page 74 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/17/2021 14:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910661
Page 75 of 203
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910662
Page 76 of 203
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910663
Page 77 of 203
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910664
Page 78 of 203
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910665
Page 79 of 203
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910666
Page 80 of 203
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910667
Page 81 of 203
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT
- UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910668
Page 82 of 203
***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: 10461009 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/1/2020
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910669
Page 83 of 203
***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: 10461009 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
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910670
Page 84 of 203
***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: 10461009 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-11-2021 12:34:56 (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.
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910671
Page 85 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-13-2020 17:51:29 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0910672
Page 86 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-25-2021 19:55:17 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0910673
Page 87 of 203
***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: 10461009 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-11-2021 12:34:56 (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 Jan-25-2021 19:39:18 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Ernest
Hendrix Approved Oct-08-2020 13:40:28 (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.
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0910674
Page 88 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
N/A Oct-01-2020 12:48:12 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Ernest
Hendrix Approved Sep-15-2020 13:42:20 (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.
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0910675
Page 89 of 203
***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: 10461009 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-13-2020
17:50:55
(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-13-2020
17:50:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910676
Page 90 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-13-2020
17:51:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent O
btained
Aug/13/2020Initial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910677
Page 91 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-13-2020
17:50:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10461009Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-13-2020
17:50:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1952Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-13-2020
17:58:56
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
MALETranscription
Error
Aug-13-2020
17:51:12
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910678
Page 92 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-13-2020
17:51:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LAT
INO(A) OR OF SPANIS
H ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-13-2020
17:51:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910679
Page 93 of 203
***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: 10461009 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-13-2020
17:51:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/13/2020Initial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910680
Page 94 of 203
***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: 10461009 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-13-2020
17:51:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-13-2020
17:51:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-13-2020
17:51:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910681
Page 95 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-13-2020
17:53:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Double Hern
ia Repair
Start Date: UNK/UNK/2
011
Ongoing: NO
End Date:
UNK/UN
K/2011Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-13-2020
17:53:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020
17:53:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Double Hernia RepairInitial Entry
1.a Start Date:
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910682
Page 96 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-13-2020
17:53:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-13-2020
17:53:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2011Initial Entry
1.b
Date Location User Value Reason
Aug-13-2020
17:53:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Kidney Stone
Removal
Start Date: UNK/UNK/2
018
Ongoing: NO
End Date:
UNK/UN
K/2018Initial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910683
Page 97 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Aug-13-2020
17:53:48
(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-13-2020
17:53:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Kidney Stone RemovalInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-13-2020
17:53:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-13-2020
17:53:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.c
Date Location User Value Reason
090177e196ae402f\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-2021-5683-0910684
Page 98 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-13-2020
17:54:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:Corneal Tra
nsplant
Start Date: UNK/UNK/
2018
Ongoing: NO
End Date:
UNK/UN
K/2018Initial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910685
Page 99 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Aug-13-2020
17:54:28
(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-13-2020
17:54:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Corneal TransplantInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-13-2020
17:54:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-13-2020
17:54:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.d
Date Location User Value Reason
090177e196ae402f\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-2021-5683-0910686
Page 100 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-13-2020
17:55:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Hist
ory Term:Stomach An
eurysm
Start Date: UNK/UNK/
1991
Ongoing: NO
End Date:
UNK/UN
K/1991Initial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910687
Page 101 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Aug-13-2020
17:55:25
(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-13-2020
17:55:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Stomach AneurysmInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-13-2020
17:55:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1991Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-13-2020
17:55:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1991Initial Entry
1.e
Date Location User Value Reason
090177e196ae402f\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-2021-5683-0910688
Page 102 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-13-2020
17:56:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical Hi
story Term
:Juvenile Petite
Mal Seizures
Start Date: UNK/UNK/19
61
Ongoing: NO
End Date:
UNK/UNK
/1961Initial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910689
Page 103 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Aug-13-2020
17:56:00
(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-13-2020
17:56:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Juvenile Petite Mal Seizur
esInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-13-2020
17:56:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1961Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-13-2020
17:56:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1961Initial Entry
1.f
Date Location User Value Reason
090177e196ae402f\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-2021-5683-0910690
Page 104 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-13-2020
18:14:06
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:GERD
Start Date: Jan/1/2
020
Ongoing: YESTranscription
Error
Aug-13-2020
17:56:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:GERD
Start Date: UNK/UN
K/2020
Ongoing: YESInitial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910691
Page 105 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Aug-13-2020
17:56:35
(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
Aug-13-2020
17:56:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
GERDInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-13-2020
18:14:06
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-13-2020
18:14:06
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2020Transcription
Error
Aug-13-2020
17:59:48
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is
after or equal to
the first
vaccination date
13/Aug/2020.
Please review
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910692
Page 106 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
and update as
appropriate.
Aug-13-2020
17:56:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2020Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-13-2020
17:56:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-13-2020
17:56:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7
Medical Histo
ry Term:Hypothyro
idism
Start Date: UNK/UN
K/2010
Ongoing: YESInitial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910693
Page 107 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Aug-13-2020
17:56:59
(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
Aug-13-2020
17:56:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HypothyroidismInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-13-2020
17:56:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-13-2020
17:56:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
090177e196ae402f\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-2021-5683-0910694
Page 108 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-13-2020
17:57:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Histo
ry Term:BPH
Start Date: UNK/UN
K/2018
Ongoing: YESInitial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910695
Page 109 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Aug-13-2020
17:57:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020
17:57:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPHInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-13-2020
17:57:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-13-2020
17:57:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
090177e196ae402f\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-2021-5683-0910696
Page 110 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-13-2020
17:57:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:9
Medical Histo
ry Term:Allergy to
Sulfa
Start Date: UNK/UN
K/1960
Ongoing: YESInitial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910697
Page 111 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.i Line/MH Number:
Date Location User Value Reason
Aug-13-2020
17:57:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020
17:57:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Allergy to SulfaInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-13-2020
17:57:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1960Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-13-2020
17:57:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae402f\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-2021-5683-0910698
Page 112 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-13-2020
17:58:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/13/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-13-2020
17:58:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
194.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-13-2020
17:58:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-13-2020
17:58:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
72.0Initial Entry
5. Unit:
090177e196ae402f\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-2021-5683-0910699
Page 113 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-13-2020
17:58:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-13-2020
17:58:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
26.3Initial Entry
7.a
Date Location User Value Reason
Aug-13-2020
17:58:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identif
ier::1
Temperature: 97.4
Temperature
Unit:F
Temperature L
ocation::FOREH
EADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-13-2020
17:58:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
090177e196ae402f\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-2021-5683-0910700
Page 114 of 203
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-13-2020
17:58:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.4Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-13-2020
17:58:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-13-2020
17:58:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae402f\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-2021-5683-0910701
Page 115 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-13-2020
17:59:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/13/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-13-2020
17:59:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
228005Initial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910702
Page 116 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-13-2020
17:59:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020
17:59:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-13-2020
19:09:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-13-2020
17:59:22
(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.
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910703
Page 117 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-13-2020
17:59:22
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/13/2020Initial Entry
5.a
Date Location User Value Reason
Aug-13-2020
19:09:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLXFGYInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-13-2020
19:09:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLXFGYInitial Entry
5.b
Date Location User Value Reason
Aug-13-2020
19:09:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLXFGZInitial Entry
090177e196ae402f\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-2021-5683-0910704
Page 118 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b Sample ID
Date Location User Value Reason
Aug-13-2020
19:09:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLXFGZInitial Entry
5.c
Date Location User Value Reason
Aug-13-2020
19:09:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLXFH0Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-13-2020
19:09:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLXFH0Initial Entry
5.d
Date Location User Value Reason
Aug-13-2020
19:10:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPJ270Initial Entry
090177e196ae402f\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-2021-5683-0910705
Page 119 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Aug-13-2020
19:10:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPJ270Initial Entry
5.e
Date Location User Value Reason
Aug-13-2020
19:10:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPJ271Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-13-2020
19:10:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPJ271Initial Entry
090177e196ae402f\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-2021-5683-0910706
Page 120 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-13-2020
17:59:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020
17:59:28
(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-13-2020
19:10:26
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-13-2020
17:59:28
(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.
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910707
Page 121 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-13-2020
17:59:28
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/13/2020Initial Entry
5.a
Date Location User Value Reason
Aug-13-2020
19:10:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLXFGXInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-13-2020
19:10:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLXFGXInitial Entry
090177e196ae402f\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-2021-5683-0910708
Page 122 of 203
***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: 10461009 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-13-2020
17:59:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-13-2020
17:59:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-13-2020
17:59:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-13-2020
17:59:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/13/2020 12:20Initial Entry
5. Anatomical Location:
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910709
Page 123 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-13-2020
17:59:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-13-2020
17:59:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-13-2020
17:59:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-13-2020
17:59:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERI
ODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Aug-13-2020
17:59:48ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910710
Page 124 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0910711
Page 125 of 203
***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: 10461009 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-13-2020
17:59:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICI
TY E-DIARY COLLECT
ED FOR THIS SUBJECTInitial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910712
Page 126 of 203
***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: 10461009 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-01-2020
11:51:43
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0910713
Page 127 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
V
E
R
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
090177e196ae402f\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-2021-5683-0910714
Page 128 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
UE
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:N
OInitial Entry
090177e196ae402f\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-2021-5683-0910715
Page 129 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.b Symptom:
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or syste
mic symptoms pre
sent on the last day
the Subject Diary
was completed?:NOInitial Entry
090177e196ae402f\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-2021-5683-0910716
Page 130 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.c Symptom:
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: C
HI
LL
S
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:N
OInitial Entry
090177e196ae402f\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-2021-5683-0910717
Page 131 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.d Symptom:
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TIN
G
Were fever or syst
emic symptoms pr
esent on the last da
y the Subject Diar
y was completed?:NOInitial Entry
090177e196ae402f\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-2021-5683-0910718
Page 132 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.e Symptom:
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or syste
mic symptoms pres
ent on the last day
the Subject Diary
was completed?:NOInitial Entry
090177e196ae402f\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-2021-5683-0910719
Page 133 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.f Symptom:
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED M
USCLE
PAIN
Were fever or s
ystemic sympt
oms present on
the last day the
Subject Diary
was completed
?:NOInitial Entry
090177e196ae402f\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-2021-5683-0910720
Page 134 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.g Symptom:
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED
MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAIN
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:NOInitial Entry
090177e196ae402f\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-2021-5683-0910721
Page 135 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.h Symptom:
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED J
OINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
090177e196ae402f\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-2021-5683-0910722
Page 136 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reac
tion::RE
DN
ES
S
Were injection site
reactions present o
n the last day the S
ubject Diary was c
ompleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-01-2020
11:53:04ACV0PFEINFP6000 Data Entry:
Injection Site Rea SWInitial Entry
090177e196ae402f\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) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0910723
Page 137 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US &
Canada)ction:: EL
LIN
G
Were injection site
reactions present o
n the last day the
Subject Diary was
completed?:NO
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Re
action::PAIN
AT IN
JECT
ION S
ITEInitial Entry
090177e196ae402f\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-2021-5683-0910724
Page 138 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were injection si
te reactions pres
ent on the last d
ay the Subject D
iary was comple
ted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SI
TEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
11:53:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae402f\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-2021-5683-0910725
Page 139 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020
11:53:19
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
2.a
Date Location User Value Reason
Sep-01-2020
11:53:19
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Record Identif
ier::1
Temperature: 97.6
Temperature
Unit:F
Temperature
Location::FOREH
EADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-01-2020
11:53:19
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
090177e196ae402f\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-2021-5683-0910726
Page 140 of 203
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-01-2020
11:53:19
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
97.6Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-01-2020
11:53:19
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-01-2020
11:53:19
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae402f\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-2021-5683-0910727
Page 141 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020
11:53:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020
11:53:28
(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-01-2020
14:19:56
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-01-2020
11:53:28
(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.
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910728
Page 142 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-01-2020
11:53:28
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020
14:19:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPTM21Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020
14:19:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPTM21Initial Entry
090177e196ae402f\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-2021-5683-0910729
Page 143 of 203
***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: 10461009 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-01-2020
11:55:19
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User ValueReason
Sep-02-2020
02:19:37
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy
has been
closed.
Sep-01-2020
19:14:24
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedNull Term:
Verbatim
term must
not be
null/blank.
Sep-01-2020
18:58:26
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data
Entry
:
BLIN
DED
THE
RAP
YInitial Entry
Sep-01-2020 ACV0PFEINFP6000 auto calc DataTranscription
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0910730
Page 144 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
14:20:23
(UTC-06:00)
Central Time
(US &
Canada)(autocalc) Entry
:Error
Sep-01-2020
11:55:19
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data
Entry
:
BLIN
DED
THE
RAP
YInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020
18:58:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
Sep-01-2020
14:20:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription
Error
Sep-01-2020
11:55:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-01-2020
18:58:26
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
Sep/1/2020 09:58Initial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0910731
Page 145 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US &
Canada)
Sep-01-2020
14:20:23
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry: Transcription
Error
Sep-01-2020
11:55:19
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020 09:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020
18:58:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
Sep-01-2020
14:20:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription
Error
Sep-01-2020
11:55:19
(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-01-2020
11:55:19
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae402f\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-2021-5683-0910732
Page 146 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US &
Canada)
7. Route:
Date Location User Value Reason
Sep-01-2020
18:58:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
Sep-01-2020
14:20:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription
Error
Sep-01-2020
11:55:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-01-2020
18:58:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIF
IED OBSERVATION PER
IODInitial Entry
Sep-01-2020
14:20:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription
Error
Sep-01-2020
11:55:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIF
IED OBSERVATION PER
IODInitial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910733
Page 147 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Sep-01-2020
11:55:19
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0910734
Page 148 of 203
***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: 10461009 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-01-2020
12:48:12
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2020Initial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0910735
Page 149 of 203
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
V
E
R
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
090177e196ae402f\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-2021-5683-0910736
Page 150 of 203
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
UE
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:N
OInitial Entry
090177e196ae402f\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-2021-5683-0910737
Page 151 of 203
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.b Symptom:
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or syste
mic symptoms pre
sent on the last day
the Subject Diary
was completed?:NOInitial Entry
090177e196ae402f\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-2021-5683-0910738
Page 152 of 203
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.c Symptom:
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: C
HI
LL
S
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:N
OInitial Entry
090177e196ae402f\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-2021-5683-0910739
Page 153 of 203
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.d Symptom:
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TIN
G
Were fever or syst
emic symptoms pr
esent on the last da
y the Subject Diar
y was completed?:NOInitial Entry
090177e196ae402f\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-2021-5683-0910740
Page 154 of 203
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.e Symptom:
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or syste
mic symptoms pres
ent on the last day
the Subject Diary
was completed?:NOInitial Entry
090177e196ae402f\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-2021-5683-0910741
Page 155 of 203
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.f Symptom:
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED M
USCLE
PAIN
Were fever or s
ystemic sympt
oms present on
the last day the
Subject Diary
was completed
?:NOInitial Entry
090177e196ae402f\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-2021-5683-0910742
Page 156 of 203
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.g Symptom:
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED
MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAIN
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:NOInitial Entry
090177e196ae402f\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-2021-5683-0910743
Page 157 of 203
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.h Symptom:
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED J
OINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
090177e196ae402f\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-2021-5683-0910744
Page 158 of 203
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reac
tion::RE
DN
ES
S
Were injection site
reactions present o
n the last day the S
ubject Diary was c
ompleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-01-2020
12:49:15ACV0PFEINFP6000 Data Entry:
Injection Site Rea SWInitial Entry
090177e196ae402f\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) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0910745
Page 159 of 203
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US &
Canada)ction:: EL
LIN
G
Were injection site
reactions present o
n the last day the
Subject Diary was
completed?:NO
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Re
action::PAIN
AT IN
JECT
ION S
ITEInitial Entry
090177e196ae402f\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-2021-5683-0910746
Page 160 of 203
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were injection si
te reactions pres
ent on the last d
ay the Subject D
iary was comple
ted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SI
TEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
12:49:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae402f\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-2021-5683-0910747
Page 161 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020
12:49:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020
12:49:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020
15:45:18
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-01-2020
12:49:26
(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.
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910748
Page 162 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-01-2020
12:49:26
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/1/2020Initial Entry
5.a
Date Location User Value Reason
Oct-01-2020
15:45:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW2L7Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-01-2020
15:45:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPW2L7Initial Entry
5.b
Date Location User Value Reason
Oct-01-2020
15:45:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW2L8Initial Entry
090177e196ae402f\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-2021-5683-0910749
Page 163 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b Sample ID
Date Location User Value Reason
Oct-01-2020
15:45:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPW2L8Initial Entry
5.c
Date Location User Value Reason
Oct-01-2020
15:45:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW2L9Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-01-2020
15:45:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPW2L9Initial Entry
5.d
Date Location User Value Reason
Oct-01-2020
15:45:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNTPKPInitial Entry
090177e196ae402f\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-2021-5683-0910750
Page 164 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Oct-01-2020
15:45:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNTPKPInitial Entry
5.e
Date Location User Value Reason
Oct-01-2020
15:46:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNTPKRInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-01-2020
15:46:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNTPKRInitial Entry
090177e196ae402f\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-2021-5683-0910751
Page 165 of 203
***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: 10461009 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-01-2020
16:17:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-01-2020
16:17:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-01-2020
16:17:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910752
Page 166 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Jan-25-2021 19:39:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910753
Page 167 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Jan-25-2021 19:39:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-25-2021 19:39:18
(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
Feb-17-2021
00:33:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Feb-01-2021
16:37:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Answered This was faxed.
Feb-01-2021
15:35:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Reissued:Op
enedClinical - Thank
you for clarifying
event term as
Hiatal Hernia;
please submit
symptoms,
090177e196ae402f\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) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910754
Page 168 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
workup and
treatment for HH
as a SAE update
Jan-29-2021
16:06:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Hiatal HerniaTranscription
Error
Jan-28-2021
03:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Jan-27-2021
16:26:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Answered I will get this sent
Jan-27-2021
16:26:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Reissued:Op
enedClinical Thank
you; please submit
a SAE safety
update reporting
the side and
(non-procedural)
event term
Jan-27-2021
16:18:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Transcription
Error
Jan-27-2021
16:18:53
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Data Entry:
Right Inguinal HerniaTranscription
Error
090177e196ae402f\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) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910755
Page 169 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada)
Jan-27-2021
13:51:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Opened Clinical Event
term is Inguinal
Hernia (SIDE is
MISSING);
however, SAE
report has
procedure term
'Hernia Repair'.
Please submit a
SAE safety update
to revise event
term to the clinical
event, with SIDE.
Jan-27-2021
08:18:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription
Error
Jan-27-2021
08:18:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Inguinal HerniaTranscription
Error
Jan-26-2021
14:52:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Reissued:Op
enedGPDCLIN: Please
update the term to
include the
diagnosis/medical
condition that let
to the surgery
rather than the
surgery itself.
please ensure
location of hernia
is specified.
090177e196ae402f\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) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0910756
Page 170 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-26-2021
08:55:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered This is a new
surgery. He had it
previously and had
to have it again.
Jan-26-2021
06:37:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened GPDCLIN: Hernia
repair is listed as a
grade 4 AE while
per medical
history page
subject underwent
bilateral hernia
repair in 2011.
Please specify the
location of current
and former hernia
and record as AE
the reason for
surgery instead of
the surgery.
Jan-26-2021
06:34:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed new query issued
Jan-26-2021
06:31:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN: Hernia
repair is listed as
AE while per
medical history
page subject
underwent
bilateral hernia
repair in 2011.
please clarify the
location of current
and former repair
090177e196ae402f\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) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0910757
Page 171 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
and clarify if
elective surgery or
specify reason for
surgery. Else,
clarify.
Jan-25-2021
19:39:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Hernia RepairInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-25-2021
19:39:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/13/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-25-2021
19:39:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/18/2020 10:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-27-2021
16:23:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
090177e196ae402f\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) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910758
Page 172 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-27-2021
16:19:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription
Error
Jan-27-2021
16:19:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
3Transcription
Error
Jan-27-2021
13:50:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Clinical Event
grade is 4;
however, serious
criteria do not
include
life-threatening.
Based on protocol
Sect 10.3.3
Assessment of
Intensity, Grade
4= Life
threatening (Life-
threatening
consequences;
urgent
intervention
indicated). Please
review toxicity
Jan-25-2021
19:39:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
7. Is the adverse event serious?
090177e196ae402f\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) (4),
(b) (6)
FDA-CBER-2021-5683-0910759
Page 173 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent
or significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-23-2021
12:53:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 4: Closed Response
satisfies query
Feb-17-2021
08:01:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 4: Answered The info is not
available
Feb-17-2021
00:40:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 4: Opened Followup for
COVID test
status (yes/no)
during
Hosp/Surgery:
testing (YES/NO
or info not
available) and if
yes, the date and
results.
Feb-17-2021
00:35:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 4: Candidate Clinical -
Followup for
COVID test
status (yes/no)
during
Hosp/Surgery:
testing (YES/NO
or info not
available) and if
090177e196ae402f\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) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910760
Page 174 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
yes, the date and
results.
Feb-01-2021
15:35:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Closed Query closed;
will follow for
requested
COVID test
information.
Jan-27-2021
16:27:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Answered Will Do
Jan-27-2021
16:24:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Opened Clinical COVID
test status
(yes/no) during
Hosp was not
reported in the
SAE. Please
submit a
follow-up SAE
form
[#2021072376] to
document if
COVID testing
was performed
(YES/NO or info
not available) and
if yes, the date
and results.
Jan-27-2021
16:22:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
090177e196ae402f\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) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910761
Page 175 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-27-2021
16:19:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription
Error
Jan-27-2021
16:19:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event a
ssociated with congen
ital anomaly or birth d
efect?
NO
Did this serious event
result in death?
NO
Did this serious event
require or prolong hos
pitalization?
YES
Did this serious event
result in persistent or
significant disability/i
ncapacity?
NO
Is this serious event li
fe threatening?
NO
Other medically impoTranscription
Error
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0910762
Page 176 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
rtant serious event
NO
Jan-27-2021
13:46:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened Clinical Event
serious criteria
are Hosp and
congenital
anomaly/birth
defect; however,
SAE report
serious criterion
is Hosp. Please
review,
harmonize
reporting and
update where
applicable.
Jan-26-2021
08:23:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-25-2021
19:39:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Hernia
Repair: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is
blank.
Jan-25-2021
19:39:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event a
ssociated with congen
ital anomaly or birth d
efect?Initial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910763
Page 177 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
YES
Did this serious event
result in death?
NO
Did this serious event
require or prolong hos
pitalization?
YES
Did this serious event
result in persistent or
significant disability/i
ncapacity?
NO
Is this serious event li
fe threatening?
NO
Other medically impo
rtant serious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-25-2021
19:39:18
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910764
Page 178 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-25-2021
19:39:18
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study tr
eatment(s), this event is
due to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-25-2021
19:39:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-25-2021
19:39:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae402f\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-2021-5683-0910765
Page 179 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-27-2021
16:23:30
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Jan-27-2021
16:19:48
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription
Error
Jan-27-2021
16:19:48
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESTranscription
Error
Jan-27-2021
13:52:53
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened Clinical
Non-drug
treatment is NO;
however, SAE
report states
subject had a
hernia repair
surgery for the
event 'Inguinal
Hernia'. Please
review non-drug
treatment, and
update as
appropriate
Jan-25-2021
19:39:18
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae402f\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)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910766
Page 180 of 203
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-25-2021
19:39:18
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-25-2021
19:39:18
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-26-2021
08:23:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2021072376Initial Entry
090177e196ae402f\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-2021-5683-0910767
Page 181 of 203
***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: 10461009 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-17-2021
08:44:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Jan/19/2021Transcription
Error
Jan-25-2021
19:54:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
090177e196ae402f\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-2021-5683-0910768
Page 182 of 203
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 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
Jan-25-2021
19:54:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to ret
urn for Vaccination 3
Participant is:
eligible per local/natio
nal recommendations a
nd confirmed to have r
eceived only placebo at
Vaccination 1/2Initial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910769
Page 183 of 203
***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: 10461009 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
09:17:50
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Jan/19/2021Transcription
Error
Jan-25-2021
19:54:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-25-2021
19:54:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY F
OR ADDITIONAL VAC
CINATIONInitial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910770
Page 184 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: 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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-25-2021
19:55:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910771
Page 185 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-25-2021
19:55:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent O
btained
Jan/25/2021Initial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910772
Page 186 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 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
Jan-25-2021
19:55:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-25-2021 19:55:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-25-2021
19:55:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae402f\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-2021-5683-0910773
Page 187 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - 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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-25-2021 19:55:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-25-2021 19:55:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-25-2021
19:55:55
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-25-2021
19:55:44
(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.
Jan-25-2021
19:55:44ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910774
Page 188 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - 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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US &
Canada)Date of Collection:
Jan/25/2021
5.a
Date Location User Value Reason
Jan-25-2021
19:55:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLXFDFInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-25-2021
19:55:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLXFDFInitial Entry
5.b
Date Location User Value Reason
Jan-25-2021
19:56:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLXFDGInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-25-2021
19:56:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLXFDGInitial Entry
090177e196ae402f\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) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910775
Page 189 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - 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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c
Date Location User Value Reason
Jan-25-2021
19:56:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLXFDHInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-25-2021
19:56:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLXFDHInitial Entry
5.d
Date Location User Value Reason
Jan-25-2021
19:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS7KNVInitial Entry
5.d Sample ID
Date Location User Value Reason
Jan-25-2021
19:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS7KNVInitial Entry
5.e
Date Location User Value Reason
090177e196ae402f\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) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910776
Page 190 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - 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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-25-2021
19:56:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS7KNWInitial Entry
5.e Sample ID
Date Location User Value Reason
Jan-25-2021
19:56:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS7KNWInitial Entry
090177e196ae402f\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-2021-5683-0910777
Page 191 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-25-2021 19:56:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-25-2021 19:56:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-25-2021
19:57:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-25-2021
19:56:48
(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.
Jan-25-2021
19:56:48ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910778
Page 192 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US &
Canada)Date of Collection:
Jan/25/2021
5.a
Date Location User Value Reason
Jan-25-2021
19:57:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLXFDNInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-25-2021
19:57:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLXFDNInitial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910779
Page 193 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 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
Jan-25-2021
19:57:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-25-2021 19:57:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-25-2021 19:57:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-25-2021
19:57:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021 13:45Initial Entry
5. Anatomical Location:
Date Location User Value Reason
090177e196ae402f\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-2021-5683-0910780
Page 194 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-25-2021 19:57:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-25-2021
19:57:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-25-2021 19:57:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-25-2021 19:57:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-25-2021 19:57:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910781
Page 195 of 203
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-25-2021 19:57:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Jan-25-2021
19:57:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910782
Page 196 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: 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: 10461009 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-18-2021
12:38:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/17/2021Initial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910783
Page 197 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-18-2021
12:39:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-18-2021
12:39:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-18-2021
12:39:23
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-18-2021
12:39:09
(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.
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910784
Page 198 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-18-2021
12:39:09
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/17/2021Initial Entry
5.a
Date Location User Value Reason
Feb-18-2021
12:39:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BJS6T8Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-18-2021
12:39:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BJS6T8Initial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910785
Page 199 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 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
Feb-18-2021
12:39:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-18-2021
12:39:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-18-2021
12:39:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-18-2021
12:39:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/17/2021 14:05Initial Entry
5. Anatomical Location:
090177e196ae402f\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-2021-5683-0910786
Page 200 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Feb-18-2021
12:39:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-18-2021
12:39:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-18-2021
12:39:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-18-2021
12:39:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-18-2021
12:39:42
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910787
Page 201 of 203
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-18-2021
12:39:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Feb-18-2021
12:39:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910788
Page 202 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-01-2020
16:17:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-13-2020
17:59:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZ
EDInitial Entry
Aug-13-2020
17:51:50
(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-01-2020
16:17:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/1/2020Initial Entry
Aug-13-2020
17:59:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/13/2020Initial Entry
Aug-13-2020
17:51:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/13/2020Initial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910789
Page 203 of 203
***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: 10461009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-15-2020
13:33:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae402f\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0910790