125742 S1 M5 CRF c4591001 1082 10821094

Document text

Page 1 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957205
Page 2 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/11/2020
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957206
Page 3 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Demography
1.Subject ID [10821094]
2.Birth Date: /1961
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:
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957207
Page 4 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/11/2020
2.Erroneous Visit
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957208
Page 5 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957209
Page 6 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/11/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957210
Page 7 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergy to amitriptyline]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cataracts, bilateral]
Start Date: UNK/UNK/2019
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[COPD]
Start Date: UNK/UNK/2015
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[appendicitis]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957211
Page 8 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[appendectomy]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[arthritis]
Start Date: UNK/UNK/2000
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left ankle fracture]
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/1988
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[idiopathic peripheral neuropathy]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957212
Page 9 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[arthritis, bilateral knee]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2015
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left knee replacement]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[right knee replacement]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left ankle open reduction internal fixation]
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/1988
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957213
Page 10 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Aug/11/2020
2.Weight: [120.0]
3.Unit: kg
4.Height: [181.5]
5.Unit: cm
6.Body Mass Index: [36.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957214
Page 11 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/11/2020
2.Randomization Number: [225813]
3.Randomization Group: [ ]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957215
Page 12 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/11/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3NR9]
5.bSample ID [BP3NRB]
5.cSample ID [BP3NRC]
5.dSample ID [BPLDJ6]
5.eSample ID [BPLDJ7]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957216
Page 13 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/11/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3NR8]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957217
Page 14 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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/11/2020 14:51
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957218
Page 15 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957219
Page 16 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957220
Page 17 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
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
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957221
Page 18 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
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
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957222
Page 19 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957223
Page 20 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [BPY6MC]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957224
Page 21 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 13:35
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957225
Page 22 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957226
Page 23 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
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
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957227
Page 24 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
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
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957228
Page 25 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/30/2020
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 [BPY6WY]
5.bSample ID [BPLDXP]
5.cSample ID [BPLDXR]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957229
Page 26 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957230
Page 27 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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: [ ]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957231
Page 28 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957232
Page 29 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957233
Page 30 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957234
Page 31 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957235
Page 32 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957236
Page 33 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957237
Page 34 of 183
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957238
Page 35 of 183
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Unplanned Assessments
1.Assessments
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957239
Page 36 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Sep/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957240
Page 37 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957241
Page 38 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957242
Page 39 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957243
Page 40 of 183
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  New onset type 2 di
abetes Nov/5/2020 UNK:
UNK YES  Repeating
Pages
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957244
Page 41 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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)[New onset type 2 diabetes]
4.Start Date Time: Nov/5/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957245
Page 42 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[etiology unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020445272]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957246
Page 43 of 183
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957247
Page 44 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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[ ]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957248
Page 45 of 183
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957249
Page 46 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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: //
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957250
Page 47 of 183
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957251
Page 48 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957252
Page 49 of 183
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957253
Page 50 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957254
Page 51 of 183
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957255
Page 52 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957256
Page 53 of 183
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957257
Page 54 of 183
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957258
Page 55 of 183
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957259
Page 56 of 183
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957260
Page 57 of 183
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957261
Page 58 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957262
Page 59 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957263
Page 60 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957264
Page 61 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/12/2021
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957265
Page 62 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957266
Page 63 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/12/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957267
Page 64 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/12/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY7BB]
5.bSample ID [BNTL0F]
5.cSample ID [BNTL0G]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957268
Page 65 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/12/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY7B9]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957269
Page 66 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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/12/2021 12:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957270
Page 67 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/12/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957271
Page 68 of 183
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957272
Page 69 of 183
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957273
Page 70 of 183
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957274
Page 71 of 183
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/2/2021
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 [BRDWKL]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957275
Page 72 of 183
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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/2/2021 12:43
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957276
Page 73 of 183
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957277
Page 74 of 183
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/2/2021
3.Comments: [ ]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957278
Page 75 of 183
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957279
Page 76 of 183
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957280
Page 77 of 183
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957281
Page 78 of 183
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957282
Page 79 of 183
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Mar/2/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957283
Page 80 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/30/2020
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957284
Page 81 of 183
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957285
Page 82 of 183
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
William Smith  Approved Mar-08-2021 12:49:53 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamSmith, 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.
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957286
Page 83 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormAug-12-2020 10:59:26 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957287
Page 84 of 183
***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, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormJan-13-2021 14:23:55 (UTC-05:00) Eastern
Time (US & Canada)Not applicable
Not Applicable
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957288
Page 85 of 183
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
William Smith  Approved Mar-08-2021 12:49:53 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamSmith, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-05-2021 14:47:06 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William Smith  Approved Feb-13-2021 14:48:51 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamSmith, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-10-2021 14:00:10 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957289
Page 86 of 183
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
William Smith  Approved Jan-20-2021 11:25:56 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamSmith, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-19-2020 16:26:01 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William Smith  Approved Nov-12-2020 14:36:30 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamSmith, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-10-2020 13:22:54 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William Smith  Approved Oct-06-2020 16:53:49 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957290
Page 87 of 183
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Affidavit:
By my dated signature below, I, WilliamSmith, 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 Sep-30-2020 11:40:41 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William Smith  Approved Sep-11-2020 14:17:00 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamSmith, 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 Aug-20-2020 11:46:38 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William Smith  Approved Aug-14-2020 19:56:25 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957291
Page 88 of 183
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Affidavit:
By my dated signature below, I, WilliamSmith, 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.
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957292
Page 89 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-11-2020 16:42:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-11-2020 16:42:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957293
Page 90 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-11-2020 16:42:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/11/2020Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957294
Page 91 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-11-2020 16:42:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10821094Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-11-2020 16:42:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1961Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-11-2020 16:42:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-11-2020 16:42:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-11-2020 16:42:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957295
Page 92 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-12-2020 10:59:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957296
Page 93 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-12-2020 10:59:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-12-2020 10:59:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-12-2020 10:59:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957297
Page 94 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.a
Date Location User Value Reason
Aug-12-2020 11:07:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical Histor
y Term:allergy to amitri
ptyline
Start Date: UNK/UNK/200
5
Ongoing: NO
End Date:
UNK/UNK/2
005Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-12-2020 11:07:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 11:07:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
allergy to amitriptylineInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-12-2020 11:07:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957298
Page 95 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-12-2020 11:07:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.b
Date Location User Value Reason
Aug-12-2020 15:14:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numbe
r:2
Medical History
Term:cataracts, bila
teral
Start Date: UNK/UNK/2
019
Ongoing: YESTranscription Error
Aug-12-2020 11:09:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:cataracts
Start Date: UNK/UNK/2
019
Ongoing: YESInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957299
Page 96 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.b Line/MH Number:
Date Location User Value Reason
Aug-12-2020 11:09:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 15:14:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cataracts, bilateralTranscription Error
Aug-12-2020 11:09:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cataractsInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-12-2020 11:09:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-12-2020 11:09:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-12-2020 11:10:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:COPD
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957300
Page 97 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.c Line/MH Number:
Date Location User Value Reason
Aug-12-2020 11:10:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 11:10:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COPDInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-12-2020 11:10:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-12-2020 11:10:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-12-2020 11:10:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:appendicitis
Start Date: UNK/UNK/201
6Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957301
Page 98 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Ongoing: NO
End Date:
UNK/UNK/
2016
1.d Line/MH Number:
Date Location User Value Reason
Aug-12-2020 11:10:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 11:10:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
appendicitisInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-12-2020 11:10:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-12-2020 11:10:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2016Initial Entry
1.e
Date Location User Value Reason
Aug-12-2020 11:10:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957302
Page 99 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Medical History
Term:appendectomy
Start Date: UNK/UNK/201
6
Ongoing: NO
End Date:
UNK/UNK/
2016
1.e Line/MH Number:
Date Location User Value Reason
Aug-12-2020 11:10:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 11:10:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
appendectomyInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-12-2020 11:10:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-12-2020 11:10:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2016Initial Entry
1.f
Date Location User Value Reason
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957303
Page 100 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-12-2020 11:11:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:arthritis
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
1.f Line/MH Number:
Date Location User Value Reason
Aug-12-2020 11:11:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 11:11:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
arthritisInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-12-2020 11:11:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-12-2020 11:11:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-12-2020 15:16:01
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
Line/MH Numb 7Transcription Error
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0957304
Page 101 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada) er:
Medical History
Term:left ankle fract
ure
Start Date: UNK/UNK/19
88
Ongoing: NO
End Date:
UNK/UNK/
1988
Aug-12-2020 11:13:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:7
Medical History
Term:ankle fracture
Start Date: UNK/UNK/19
88
Ongoing: NO
End Date:
UNK/UNK/
1988Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0957305
Page 102 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.g Line/MH Number:
Date Location User Value Reason
Aug-12-2020 11:13:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 15:16:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
left ankle fractureTranscription Error
Aug-12-2020 11:13:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ankle fractureInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-12-2020 11:13:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1988Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-12-2020 11:13:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1988Initial Entry
1.h
Date Location User Value Reason
Aug-25-2020 08:08:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:8
Medical Hist
ory Term:idiopathic periphe
ral neuropathy
Start Date: UNK/UNK/2000Transcription Error
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957306
Page 103 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Ongoing: YES
Aug-12-2020 11:13:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:8
Medical History
Term:peripheral neur
opathy
Start Date: UNK/UNK/20
00
Ongoing: YESInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957307
Page 104 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.h Line/MH Number:
Date Location User Value Reason
Aug-12-2020 11:13:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 20:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-25-2020 08:08:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Aug-25-2020 08:08:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
idiopathic peripheral neuropathyTranscription Error
Aug-24-2020 05:08:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery:
peripheral
neuropathy: Please
add the underlying
cause (e.g. diabetes,
hypertension etc.) to
the reported term; if
no underlying cause
has been identified
please add
"idiopathic".
Aug-23-2020 18:58:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Candidate ClinQuery:
peripheral
neuropathy: Please
add the underlying
cause (e.g. diabetes,
hypertension etc.) to
the reported term; if
no underlying cause
has been identified
please add
"idiopathic".
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957308
Page 105 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-12-2020 11:13:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
peripheral neuropathyInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-12-2020 11:13:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-12-2020 11:13:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957309
Page 106 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.i
Date Location User Value Reason
Aug-13-2020 08:51:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Num
ber:9
Medical Histor
y Term:arthritis, bilater
al knee
Start Date: UNK/UNK/200
0
Ongoing: NO
End Date:
UNK/UNK/
2015Transcription Error
Aug-12-2020 15:16:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:9
Medical History
Term:arthritis, bilater
al knee
Start Date: UNK/UNK/20
00
Ongoing: YESInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957310
Page 107 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.i Line/MH Number:
Date Location User Value Reason
Aug-12-2020 15:16:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 15:16:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
arthritis, bilateral kneeInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-12-2020 15:16:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-13-2020 08:51:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2015Transcription Error
Aug-12-2020 15:16:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Aug-12-2020 15:17:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:10
Medical History
Term:left knee replac
ementInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957311
Page 108 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Start Date: UNK/UNK/201
3
Ongoing: NO
End Date:
UNK/UNK/
2013
1.j Line/MH Number:
Date Location User Value Reason
Aug-12-2020 15:17:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 15:17:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
left knee replacementInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-12-2020 15:17:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-12-2020 15:17:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
1.k
Date Location User Value Reason
Aug-12-2020 15:17:23 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957312
Page 109 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Line/MH Num
ber:11
Medical Histor
y Term:right knee replac
ement
Start Date: UNK/UNK/201
5
Ongoing: NO
End Date:
UNK/UNK/2
015
1.k Line/MH Number:
Date Location User Value Reason
Aug-12-2020 15:17:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 15:17:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
right knee replacementInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-12-2020 15:17:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-12-2020 15:17:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957313
Page 110 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.l
Date Location User Value Reason
Aug-12-2020 15:18:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:12
Medical Hi
story Term
:left ankle open reduc
tion internal fixation
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/1988Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957314
Page 111 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.l Line/MH Number:
Date Location User Value Reason
Aug-12-2020 15:18:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 15:18:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
left ankle open reduction internal f
ixationInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-12-2020 15:18:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1988Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-12-2020 15:18:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1988Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957315
Page 112 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date:
Date Location User Value Reason
Aug-12-2020 11:01:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-12-2020 11:01:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
120.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-12-2020 11:01:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-12-2020 11:01:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
181.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-12-2020 11:01:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-12-2020 11:01:40
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
36.4Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957316
Page 113 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada)
7.a
Date Location User Value Reason
Aug-12-2020 11:01:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.3
Temperature Unit: C
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-12-2020 11:01:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-12-2020 11:01:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
36.3Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-12-2020 11:01:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-12-2020 11:01:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957317
Page 114 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-12-2020 10:59:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-12-2020 10:59:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
225813Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957318
Page 115 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-12-2020 11:18:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-12-2020 11:18:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-12-2020 11:18:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-12-2020 11:18:43
(UTC-05:00) Eastern
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.
Aug-12-2020 11:18:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/11/2020Initial Entry
5.a
Date Location User Value Reason
Aug-12-2020 11:18:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3NR9Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957319
Page 116 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a Sample ID
Date Location User Value Reason
Aug-12-2020 11:18:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP3NR9Initial Entry
5.b
Date Location User Value Reason
Aug-12-2020 11:18:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3NRBInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-12-2020 11:18:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP3NRBInitial Entry
5.c
Date Location User Value Reason
Aug-12-2020 11:19:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3NRCInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-12-2020 11:19:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP3NRCInitial Entry
5.d
Date Location User Value Reason
Aug-12-2020 11:19:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLDJ6Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (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-2021-5683-0957320
Page 117 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.d Sample ID
Date Location User Value Reason
Aug-12-2020 11:19:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPLDJ6Initial Entry
5.e
Date Location User Value Reason
Aug-20-2020 11:46:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLDJ7Transcription Error
Aug-12-2020 11:19:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLDJ9Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957321
Page 118 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.e Sample ID
Date Location User ValueReason
Aug-20-2020
13:49:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Aug-20-2020
11:46:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dTranscription Error
Aug-20-2020
11:46:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BPLD
J7Transcription Error
Aug-20-2020
11:20:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM 1: The form is
unfreeze, please
update the correct
barcode.
Aug-20-2020
07:15:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dplease unfreeze the
data point for
correction. incorrect
barcode scanned.
Aug-20-2020
05:48:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW4238418;The
barcode BPLDJ9 is
recorded for two
subjects 10821094
and 10821096, Please
review and update as
appropriate.
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0957322
Page 119 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-12-2020
11:19:34
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BPLD
J9Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957323
Page 120 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-12-2020 11:18:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-12-2020 11:18:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-12-2020 11:18:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-12-2020 11:18:24
(UTC-05:00) Eastern
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.
Aug-12-2020 11:18:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/11/2020Initial Entry
5.a
Date Location User Value Reason
Aug-12-2020 11:18:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3NR8Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0957324
Page 121 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a Sample ID
Date Location User Value Reason
Aug-12-2020 11:18:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP3NR8Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0957325
Page 122 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-12-2020 11:00:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-12-2020 11:00:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-12-2020 11:00:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-12-2020 11:00:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020 14:51Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-12-2020 11:00:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-12-2020 11:00:29
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0957326
Page 123 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada)
7. Route:
Date Location User Value Reason
Aug-12-2020 11:00:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-12-2020 11:00:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-12-2020 11:00:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0957327
Page 124 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-11-2020 03:44:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Query closed per site
response.
Sep-10-2020 08:02:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered E-Diary did not
activate
Sep-10-2020 06:05:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened eDiary RQ1: Thank
you for response.
Please review the
VAX2 ediary records
for the subject are not
available. Kindly
verify and confirm in
the query response.
Sep-10-2020 06:02:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Per site confirmation
Sep-09-2020 10:02:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Transcription Error
Sep-09-2020 10:02:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Sep-09-2020 10:02:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY
E-DIARY COLLECTED FO
R THIS SUBJECTTranscription Error
Sep-09-2020 02:06:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened eDiary: eDiary
records are available
for Vax 1. However,
eDiary records for
Vax 2 is not available.
Please verify and
clarify in query
response. Thank you
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (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-2021-5683-0957328
Page 125 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-09-2020 02:06:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened eDiary: Per Trial Max
Attributes,
Vaccination eDiary is
needed and eDiary
records for Vax 1 is
available. However,
REACTOGENICITY
E-DIARY
COLLECTED FOR
THIS SUBJECT is
‘No’. Please verify
and update or clarify
Sep-09-2020 01:55:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Closed by DM: PM.
Sep-08-2020 08:24:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-08-2020 08:24:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E
-DIARY NOT COLLECTED
FOR THIS SUBJECTTranscription Error
Sep-07-2020 02:40:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM 1: Thanks for
your response.
REACTOGENICITY
E-DIARY
COLLECTED FOR
THIS SUBJECT is
'Yes' however VAX 2
eDiary records are not
available for the
subject. Please verify
and update.
Sep-04-2020 15:30:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY
E-DIARY COLLECTED FO
R THIS SUBJECTTranscription Error
Sep-04-2020 15:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-04-2020 15:25:22 ACV0PFEINFP6000  Data Entry: Transcription Error
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (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-2021-5683-0957329
Page 126 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00) Eastern
Time (US & Canada)NO - REACTOGENICITY E
-DIARY NOT COLLECTED
FOR THIS SUBJECT
Sep-04-2020 08:31:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened eDiary:
REACTOGENICITY
E-DIARY
COLLECTED FOR
THIS SUBJECT is
'Yes' however VAX 2
eDiary records are not
available for the
subject. Please verify
and update. Else,
confirm in query
response
appropriately.
Aug-12-2020 11:00:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY
E-DIARY COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957330
Page 127 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-01-2020 15:46:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957331
Page 128 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
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?
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957332
Page 129 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
GU
E
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NO
2.b Symptom:
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
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-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957333
Page 130 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.c Symptom:
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
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-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
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-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957334
Page 131 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
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-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957335
Page 132 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.f Symptom:
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
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-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSC
LE 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-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957336
Page 133 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.h
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW O
R WORS
ENED J
OINT PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT
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-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957337
Page 134 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
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-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site react
ions present on the last
day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957338
Page 135 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
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-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site re
actions present on the
last day the Subject
Diary was completed
?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020 16:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957339
Page 136 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020 15:47:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
2.a
Date Location User Value Reason
Sep-01-2020 15:47:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 37.1
Temperature Unit: C
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-01-2020 15:47:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-01-2020 15:47:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
37.1Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-01-2020 15:47:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957340
Page 137 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Sep-01-2020 15:47:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957341
Page 138 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020 15:49:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020 15:49:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 15:49:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-01-2020 15:49:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-01-2020 15:49:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020 15:49:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY6MCInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957342
Page 139 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 15:49:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY6MCInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957343
Page 140 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-01-2020 15:48:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-01-2020 15:48:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020 15:48:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-01-2020 15:48:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020 13:35Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020 15:48:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-01-2020 15:48:06
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0957344
Page 141 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-01-2020 15:48:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-01-2020 15:48:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-01-2020 15:48:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0957345
Page 142 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-30-2020 11:40:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957346
Page 143 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
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?
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957347
Page 144 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
GU
E
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NO
2.b Symptom:
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
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-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957348
Page 145 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.c Symptom:
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
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-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
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-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957349
Page 146 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
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-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957350
Page 147 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.f Symptom:
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
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-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSC
LE 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-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957351
Page 148 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.h
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW O
R WORS
ENED J
OINT PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT
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-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957352
Page 149 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
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-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:NOInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957353
Page 150 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
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-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 11:41:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957354
Page 151 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020 13:16:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020 13:16:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020 13:17:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-01-2020 13:16:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-01-2020 13:16:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-01-2020 13:17:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY6WYInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957355
Page 152 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a Sample ID
Date Location User Value Reason
Oct-01-2020 13:17:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY6WYInitial Entry
5.b
Date Location User Value Reason
Nov-19-2020 16:26:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLDXPInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-19-2020 16:26:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPLDXPInitial Entry
5.c
Date Location User Value Reason
Nov-19-2020 16:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLDXRInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-19-2020 16:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPLDXRInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957356
Page 153 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-05-2020 11:37:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Transcription Error
Oct-01-2020 08:28:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-01-2020 08:28:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-01-2020 08:28:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957357
Page 154 of 183
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Date Location User Value Reason
Nov-10-2020 13:22:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957358
Page 155 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-10-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-10-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-02-2020
07:37:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies query
Dec-01-2020
19:22:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Dec-01-2020
14:44:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered follow-up form being
submitted with new term
indicated.
Nov-25-2020
06:07:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened SAE
RECON:AER#2020445272,
the term in AE CRF was
updated to 'New onset type
2 diabetes' while retained as
'diabetes' in Safety
Database. Please confirm
correct term. If safety
update is required, please
submit a follow-up form.
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957359
Page 156 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Nov-24-2020
10:45:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Nov-24-2020
10:45:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
New onset type 2 diabetesNew Information
Nov-22-2020
19:50:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Diabetes: Please
update AE term to include
the signs/symptoms that are
observed, or whether this is
a new diagnosis. Also,
please specify the type of
diabetes.
Nov-10-2020
13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
diabetesInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-11-2020 21:59:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-11-2020 12:22:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-11-2020 12:22:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/5/2020 UNK:UNKTranscription Error
Nov-11-2020 11:50:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL - Event
start date is
recorded as
09Nov20; however,
SAE report states
that primary MD
visit and labs (with
glucose 750)
occurred on
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (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-2021-5683-0957360
Page 157 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
05Nov20. If
updated, please
submit a SAE
safety update as
well
Nov-10-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/9/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-10-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-10-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-25-2020 23:12:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Nov-24-2020 10:46:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Medical records still
pending
Nov-23-2020 17:53:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened Clinical COVID test
status during Hosp
was not reported in
the SAE. If med
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (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-2021-5683-0957361
Page 158 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
records obtained,
please submit a
follow-up o
document if COVID
testing was
performed
(YES/NO or info
not available) and if
yes, the date and
results.
Nov-11-2020 22:00:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Query closed; will
follow for SAE
update with the
requested COVID
test info
Nov-11-2020 12:23:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered site awaiting receipt
of medical records
from hospital
Nov-11-2020 11:52:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Clinical COVID test
status (yes/no)
during Hosp was not
reported in the SAE.
Please submit a
follow-up SAE form
[#2020445272] to
document if COVID
testing was
performed
(YES/NO or info
not available) and if
yes, the date and
results.
Nov-11-2020 07:01:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-10-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE diabetes:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957362
Page 159 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Nov-10-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant disa
bility/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important ser
ious event
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-10-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957363
Page 160 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Nov-10-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
etiology unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-12-2020 05:00:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Nov-11-2020 09:27:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered as noted on initial SAE sent
10NOV2020, site is
waiting on medical records
to obtain additional
information
Nov-11-2020 07:04:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020373624
,action taken was reported
as NOT APPLICABLE in
AE CRF while NO DATA
in Safety database. Please
confirm. If safety update is
required, please submit a
follow up form
Nov-10-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-10-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (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-2021-5683-0957364
Page 161 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Nov-10-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-10-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-10-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-11-2020 07:01:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020445272Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957365
Page 162 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-05-2021 11:08:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-02-2021 10:16:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered sources uploaded
Feb-01-2021 15:35:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Upload source for
verification.
Jan-13-2021 14:22:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/12/2021Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957366
Page 163 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-20-2021 07:15:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-14-2021 23:54:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-13-2021 14:23:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-13-2021 14:23:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible per local/national re
commendations and confirm
ed to have received only pla
cebo at Vaccination 1/2Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957367
Page 164 of 183
***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, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-13-2021 14:23:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/12/2021Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957368
Page 165 of 183
***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, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-13-2021 14:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/12/2021Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957369
Page 166 of 183
***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, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-13-2021 14:24:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/12/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-13-2021 14:24:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-13-2021 14:24:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957370
Page 167 of 183
***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, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-13-2021 14:24:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-13-2021 14:24:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-13-2021 14:25:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-13-2021 14:24:46
(UTC-05:00) Eastern
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-13-2021 14:24:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/12/2021Initial Entry
5.a
Date Location User Value Reason
Jan-13-2021 14:25:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY7BBInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957371
Page 168 of 183
***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, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a Sample ID
Date Location User Value Reason
Jan-13-2021 14:25:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY7BBInitial Entry
5.b
Date Location User Value Reason
Jan-13-2021 14:25:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNTL0FInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-13-2021 14:25:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNTL0FInitial Entry
5.c
Date Location User Value Reason
Jan-13-2021 14:25:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNTL0GInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-13-2021 14:25:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNTL0GInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957372
Page 169 of 183
***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, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-13-2021 14:27:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-13-2021 14:27:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-13-2021 14:27:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-13-2021 14:27:40
(UTC-05:00) Eastern
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-13-2021 14:27:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/12/2021Initial Entry
5.a
Date Location User Value Reason
Jan-13-2021 14:27:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY7B9Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957373
Page 170 of 183
***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, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a Sample ID
Date Location User Value Reason
Jan-13-2021 14:27:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY7B9Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957374
Page 171 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-13-2021 14:28:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-13-2021 14:28:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-13-2021 14:28:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-13-2021 14:28:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/12/2021 12:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-13-2021 14:28:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-13-2021 14:28:25
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0957375
Page 172 of 183
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada)
7. Route:
Date Location User Value Reason
Jan-13-2021 14:28:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-13-2021 14:28:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-13-2021 14:28:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-13-2021 14:28:25
(UTC-05:00) Eastern
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-13-2021 14:28:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957376
Page 173 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-20-2021 07:15:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/12/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-20-2021 07:15:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957377
Page 174 of 183
***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, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-10-2021 14:00:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/2/2021Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957378
Page 175 of 183
***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, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-10-2021 14:00:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-10-2021 14:00:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-10-2021 14:00:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-10-2021 14:00:23
(UTC-05:00) Eastern
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.
Feb-10-2021 14:00:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/2/2021Initial Entry
5.a
Date Location User Value Reason
Feb-10-2021 14:00:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRDWKLInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957379
Page 176 of 183
***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, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a Sample ID
Date Location User Value Reason
Feb-10-2021 14:00:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRDWKLInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957380
Page 177 of 183
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-10-2021 14:01:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-10-2021 14:01:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-10-2021 14:01:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-10-2021 14:01:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/2/2021 12:43Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-10-2021 14:01:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-10-2021 14:01:28
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0957381
Page 178 of 183
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada)
7. Route:
Date Location User Value Reason
Feb-10-2021 14:01:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-10-2021 14:01:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-10-2021 14:01:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-10-2021 14:01:28
(UTC-05:00) Eastern
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-10-2021 14:01:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957382
Page 179 of 183
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-08-2021 13:21:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rivkah Rosen Query 1: Closed Response satisfies
query
Mar-08-2021 10:42:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered data updated
Mar-08-2021 05:40:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Patient
completed
Vaccination 3 visit
through the
1-month post
vaccination visit
after the
Vaccination 4.
Please complete
treatment
disposition CRF
and update date of
EOT2 to match date
of visit at visit 103.
Mar-05-2021 14:47:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/2/2021Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0957383
Page 180 of 183
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-05-2021 14:47:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-05-2021 14:47:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Mar/2/2021Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957384
Page 181 of 183
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-08-2021 10:42:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/2/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-08-2021 10:42:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Mar-08-2021 10:42:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957385
Page 182 of 183
***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: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-01-2020 08:28:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-12-2020 10:59:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-12-2020 10:59:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-05-2020 11:37:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/30/2020Transcription Error
Oct-01-2020 08:28:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/1/2020Initial Entry
Aug-12-2020 10:59:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/11/2020Initial Entry
Aug-12-2020 10:59:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/11/2020Initial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957386
Page 183 of 183
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical Research - Knoxville
Subject No: 10821094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Casebook Signature
Date Location User Value Reason
Aug-12-2020 11:19:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3fdb\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957387