125742 S1 M5 CRF c4591001 1082 10821076

Document text

Page 1 of 194
***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: 10821076 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
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956805
Page 2 of 194
***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: 10821076 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/7/2020
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956806
Page 3 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Demography
1.Subject ID [10821076]
2.Birth Date: /1963
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:
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956807
Page 4 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/7/2020
2.Erroneous Visit
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956808
Page 5 of 194
***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: 10821076 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
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956809
Page 6 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/7/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956810
Page 7 of 194
***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: 10821076 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:[hyperopia]
Start Date: UNK/UNK/2005
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[presbyopia]
Start Date: UNK/UNK/2005
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[diabetes mellitus type II]
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/2009
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956811
Page 8 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[gastric bypass surgery]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[benign prostate hyperplasia]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[prostatic surgery]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956812
Page 9 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[spinal fusion]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956813
Page 10 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Aug/7/2020
2.Weight: [87.3]
3.Unit: kg
4.Height: [174.5]
5.Unit: cm
6.Body Mass Index: [28.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956814
Page 11 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/7/2020
2.Randomization Number: [224060]
3.Randomization Group: [ ]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956815
Page 12 of 194
***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: 10821076 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/7/2020
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 [BP3NMX]
5.bSample ID [BP3NMY]
5.cSample ID [BP3NMZ]
5.dSample ID [BPLDH0]
5.eSample ID [BPLDH1]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956816
Page 13 of 194
***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: 10821076 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/7/2020
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 [BP3NMW]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956817
Page 14 of 194
***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: 10821076 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/7/2020 12:28
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956818
Page 15 of 194
***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: 10821076 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
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956819
Page 16 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956820
Page 17 of 194
***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: 10821076 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?YES
Ongoing?
NO
Stop Date:
Aug/14/2020
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956821
Page 18 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?YES
Ongoing?
NO
Stop Date:
Aug/14/2020
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?YES
Ongoing?
NO
Stop Date:
Aug/14/2020
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956822
Page 19 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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: RIGHT
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
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956823
Page 20 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956824
Page 21 of 194
***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: 10821076 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/28/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3P0V]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956825
Page 22 of 194
***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: 10821076 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/28/2020 11:08
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956826
Page 23 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956827
Page 24 of 194
***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: 10821076 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
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956828
Page 25 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
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
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956829
Page 26 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956830
Page 27 of 194
***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: 10821076 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:
Oct/2/2020
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 [BPLDY7]
5.bSample ID [BPLDY8]
5.cSample ID [BPY6X7]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956831
Page 28 of 194
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: 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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/4/2021
2.Erroneous Visit
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956832
Page 29 of 194
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
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: 10821076 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:
Mar/4/2021
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 [BRDWP3]
5.bSample ID [BS3G5K]
5.cSample ID [BS3G5L]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956833
Page 30 of 194
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956834
Page 31 of 194
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 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 [ ]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956835
Page 32 of 194
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956836
Page 33 of 194
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 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 [ ]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956837
Page 34 of 194
***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: 10821076 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:
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956838
Page 35 of 194
***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: 10821076 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: [ ]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956839
Page 36 of 194
***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: 10821076 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 [ ]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956840
Page 37 of 194
***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: 10821076 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 [ ]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956841
Page 38 of 194
***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: 10821076 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?
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956842
Page 39 of 194
***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: 10821076 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:
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956843
Page 40 of 194
***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: 10821076 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:
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956844
Page 41 of 194
***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: 10821076 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 [ ]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956845
Page 42 of 194
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956846
Page 43 of 194
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Unplanned Assessments
1.Assessments
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956847
Page 44 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956848
Page 45 of 194
***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: 10821076 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: [ ]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956849
Page 46 of 194
***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: 10821076 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:
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956850
Page 47 of 194
***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: 10821076 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 [ ]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956851
Page 48 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#CategoryAE Iden
tifierAdverse
EventStart DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  cholelithi
asis Aug/13/2020 U
NK:UNK NO
End Date Time:
Aug/15/2020 UNK:
UNK
 Repeating
Pages
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956852
Page 49 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10821076 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)[cholelithiasis]
4.Start Date Time: Aug/13/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Aug/15/2020 UNK:UNK
6.Toxicity Grade: 3
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956853
Page 50 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
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:
[concurrent illness]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956854
Page 51 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020317805]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956855
Page 52 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956856
Page 53 of 194
***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: 10821076 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[ ]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956857
Page 54 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956858
Page 55 of 194
***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: 10821076 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: //
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956859
Page 56 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956860
Page 57 of 194
***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: 10821076 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?
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956861
Page 58 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956862
Page 59 of 194
***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: 10821076 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?
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956863
Page 60 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956864
Page 61 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956865
Page 62 of 194
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956866
Page 63 of 194
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10821076 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:
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956867
Page 64 of 194
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10821076 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?
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956868
Page 65 of 194
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956869
Page 66 of 194
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956870
Page 67 of 194
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956871
Page 68 of 194
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956872
Page 69 of 194
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 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 [ ]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956873
Page 70 of 194
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 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 [ ]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956874
Page 71 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956875
Page 72 of 194
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 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 and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956876
Page 73 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/14/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956877
Page 74 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956878
Page 75 of 194
***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: 10821076 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: [ ]
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956879
Page 76 of 194
***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: 10821076 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 Oct/2/2020
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956880
Page 77 of 194
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 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
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956881
Page 78 of 194
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 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-09-2021 08:50:53 (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.
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956882
Page 79 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormAug-07-2020 15:03:46 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956883
Page 80 of 194
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 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-09-2021 08:50:53 (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-08-2021 11:08:29 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Smith Approved Feb-15-2021 10:50:48 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956884
Page 81 of 194
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 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 Feb-12-2021 11:38:39 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Smith Approved Oct-12-2020 09:13:25 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956885
Page 82 of 194
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 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 Oct-02-2020 12:12:55 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Smith Approved Sep-11-2020 14:13:28 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956886
Page 83 of 194
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 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.
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956887
Page 84 of 194
***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: 10821076 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-07-2020
15:02:52
(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-07-2020
15:02:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956888
Page 85 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-07-2020
15:03:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent
Obtained
Aug/7/2020Initial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956889
Page 86 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-07-2020
15:02:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10821076Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-07-2020
15:02:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1963Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-07-2020
15:03:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956890
Page 87 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-07-2020
15:03:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR L
ATINO(A) OR OF SP
ANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-07-2020
15:03:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956891
Page 88 of 194
***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: 10821076 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-07-2020
15:03:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/7/2020Initial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956892
Page 89 of 194
***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: 10821076 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-07-2020
15:04:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-07-2020
15:04:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-07-2020
15:04:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956893
Page 90 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.a
Date Location User Value Reason
Aug-07-2020
15:06:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:hyperopi
a
Start Date: UNK/U
NK/200
5
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-07-2020
15:06:01
(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-07-2020
15:06:01
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
hyperopiaInitial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956894
Page 91 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Eastern Time (US
& Canada)
1.a Start Date:
Date Location User Value Reason
Aug-07-2020
15:06:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-07-2020
15:06:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-07-2020
15:06:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:presbyop
iaInitial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956895
Page 92 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Start Date: UNK/U
NK/200
5
Ongoing: YES
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956896
Page 93 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.b Line/MH Number:
Date Location User Value Reason
Aug-07-2020
15:06:13
(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-07-2020
15:06:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
presbyopiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-07-2020
15:06:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.b Ongoing:
Date Location User Value Reason
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956897
Page 94 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-07-2020
15:06:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-07-2020
15:07:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical
History T
erm:diabetes me
llitus type I
I
Start Dat
e:UNK/UNK
/2004
Ongoing: NO
End Date:
UNK/U
NK/200
9Initial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956898
Page 95 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.c Line/MH Number:
Date Location User Value Reason
Aug-07-2020
15:07:00
(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-07-2020
15:07:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
diabetes mellitus type I
IInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-07-2020
15:07:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2004Initial Entry
1.c Ongoing:
Date Location User Value Reason
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956899
Page 96 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-07-2020
15:07:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2009Initial Entry
1.d
Date Location User Value Reason
Aug-07-2020
15:07:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical
History T
erm:gastric byp
ass surgery
Start Dat
e:UNK/UNK
/2009
Ongoing: NO
End Date:
UNK/U
NK/200
9Initial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956900
Page 97 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.d Line/MH Number:
Date Location User Value Reason
Aug-07-2020
15:07:23
(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-07-2020
15:07:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
gastric bypass surgeryInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-07-2020
15:07:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2009Initial Entry
1.d Ongoing:
Date Location User Value Reason
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956901
Page 98 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-07-2020
15:07:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2009Initial Entry
1.e
Date Location User Value Reason
Aug-07-2020
15:11:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical
History
Term:benign prost
ate hyperpla
sia
Start Dat
e:UNK/UNK/
2012
Ongoing
:NO
End Date:
UNK/U
NK/2012Initial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956902
Page 99 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.e Line/MH Number:
Date Location User Value Reason
Aug-07-2020
15:11:10
(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-07-2020
15:11:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
benign prostate hyperp
lasiaInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-07-2020
15:11:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.e Ongoing:
Date Location User Value Reason
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956903
Page 100 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-07-2020
15:11:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2012Initial Entry
1.f
Date Location User Value Reason
Aug-07-2020
15:11:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:6
Medical H
istory Ter
m:prostatic s
urgery
Start Date
:UNK/UN
K/2012
Ongoing: NO
End Date
:
UNK/U
NK/201
2Initial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956904
Page 101 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.f Line/MH Number:
Date Location User Value Reason
Aug-07-2020
15:11:29
(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-07-2020
15:11:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
prostatic surgeryInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-07-2020
15:11:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.f Ongoing:
Date Location User Value Reason
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956905
Page 102 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-07-2020
15:11:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2012Initial Entry
1.g
Date Location User Value Reason
Aug-10-2020
16:12:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical H
istory Ter
m:spinal fusi
on
Start Date
:UNK/UN
K/2015
Ongoing: NO
End Date
:
UNK/U
NK/201
5Initial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956906
Page 103 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.g Line/MH Number:
Date Location User Value Reason
Aug-10-2020
16:12:28
(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-10-2020
16:12:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
spinal fusionInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-10-2020
16:12:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.g Ongoing:
Date Location User Value Reason
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956907
Page 104 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-10-2020
16:12:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956908
Page 105 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date:
Date Location User Value Reason
Aug-07-2020
15:12:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/7/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-07-2020
15:12:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
87.3Initial Entry
3. Unit:
Date Location User Value Reason
Aug-07-2020
15:12:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
090177e196ae3fd9\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-2021-5683-0956909
Page 106 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Aug-07-2020
15:12:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
174.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-07-2020
15:12:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-07-2020
15:12:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.7Initial Entry
7.a
Date Location User Value Reason
Aug-07-2020
15:12:26
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Record Ide 1Initial Entry
090177e196ae3fd9\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-2021-5683-0956910
Page 107 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Eastern Time (US
& Canada)ntifier::
Temperatur
e:36.8
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-07-2020
15:12:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-07-2020
15:12:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
36.8Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956911
Page 108 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-07-2020
15:12:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-07-2020
15:12:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956912
Page 109 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-07-2020
15:04:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/7/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-07-2020
15:04:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
224060Initial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956913
Page 110 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-10-2020
10:24:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-10-2020
10:24:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-10-2020
10:24:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-10-2020
10:24:00ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956914
Page 111 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-10-2020
10:24:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/7/2020Initial Entry
5.a
Date Location User Value Reason
Aug-10-2020
10:24:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP3NM
XInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-10-2020
10:24:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP3NMXInitial Entry
5.b
090177e196ae3fd9\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-2021-5683-0956915
Page 112 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Aug-10-2020
10:24:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP3NM
YInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-10-2020
10:24:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP3NMYInitial Entry
5.c
Date Location User Value Reason
Aug-10-2020
10:24:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP3NM
ZInitial Entry
090177e196ae3fd9\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-2021-5683-0956916
Page 113 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.c Sample ID
Date Location User Value Reason
Aug-10-2020
10:24:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP3NMZInitial Entry
5.d
Date Location User Value Reason
Aug-10-2020
10:24:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLDH0Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-10-2020
10:24:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPLDH0Initial Entry
5.e
Date Location User Value Reason
090177e196ae3fd9\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-2021-5683-0956917
Page 114 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-10-2020
10:24:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLDH1Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-10-2020
10:24:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPLDH1Initial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956918
Page 115 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-10-2020
10:23:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-10-2020
10:23:46
(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-10-2020
10:23:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-10-2020
10:23:46ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956919
Page 116 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-10-2020
10:23:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/7/2020Initial Entry
5.a
Date Location User Value Reason
Aug-10-2020
10:23:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP3NM
WInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-10-2020
10:23:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP3NMWInitial Entry
090177e196ae3fd9\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-2021-5683-0956920
Page 117 of 194
***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: 10821076 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-07-2020
15:05:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-07-2020
15:05:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-07-2020
15:05:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956921
Page 118 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-07-2020
15:05:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/7/2020 12:28Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-07-2020
15:05:20
(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-07-2020
15:05:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-07-2020
15:05:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956922
Page 119 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-07-2020
15:05:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-07-2020
15:05:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956923
Page 120 of 194
***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: 10821076 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
Aug-07-2020
15:04:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENI
CITY E-DIARY COL
LECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956924
Page 121 of 194
***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: 10821076 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-28-2020
13:12:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956925
Page 122 of 194
***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: 10821076 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
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956926
Page 123 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-28-2020
13:16:52
(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
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FATIGU
EInitial Entry
090177e196ae3fd9\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-2021-5683-0956927
Page 124 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was com
pleted?:YES
Ongoin
g?
NO
Stop
Dat
e:
Au
g/
14
/2
02
0
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956928
Page 125 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.b Symptom:
Date Location User Value Reason
Aug-28-2020
13:16:52
(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
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Aug/14/2020Initial Entry
2.c
Date Location User Value Reason
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196ae3fd9\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-2021-5683-0956929
Page 126 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NO
2.c Symptom:
Date Location User Value Reason
Aug-28-2020
13:16:52
(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
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-28-2020
13:16:52ACV0PFEINFP6000  Data Entry:
Symptom:: CHILLSInitial Entry
090177e196ae3fd9\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-2021-5683-0956930
Page 127 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time (US
& Canada)Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was com
pleted?:YES
Ongoin
g?
NO
Stop
Dat
e:
Au
g/
14
/2
02
0
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0956931
Page 128 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.d Symptom:
Date Location User Value Reason
Aug-28-2020
13:16:52
(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
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Aug/14/2020Initial Entry
2.e
Date Location User Value Reason
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VOMITI
NGInitial Entry
090177e196ae3fd9\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-2021-5683-0956932
Page 129 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was com
pleted?:YES
Ongoin
g?
NO
Stop
Dat
e:
Au
g/
14
/2
02
0
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956933
Page 130 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.e Symptom:
Date Location User Value Reason
Aug-28-2020
13:16:52
(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
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Aug/14/2020Initial Entry
2.f
Date Location User Value Reason
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EAInitial Entry
090177e196ae3fd9\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-2021-5683-0956934
Page 131 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NO
2.f Symptom:
Date Location User Value Reason
Aug-28-2020
13:16:52
(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
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-28-2020
13:16:52ACV0PFEINFP6000  Data Entry:
Symptom:: NEWInitial Entry
090177e196ae3fd9\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-2021-5683-0956935
Page 132 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time (US
& Canada)OR W
ORSE
NED
MUSC
LE PA
IN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NO
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0956936
Page 133 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.g Symptom:
Date Location User Value Reason
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAINInitial Entry
090177e196ae3fd9\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-2021-5683-0956937
Page 134 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Were fever or
systemic sym
ptoms presen
t on the last d
ay the Subjec
t Diary was c
ompleted?:NO
2.h Symptom:
Date Location User Value Reason
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D 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
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-28-2020 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956938
Page 135 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)(autocalc) DELTOID MUSCLE
4. Injection Site Body Side:
Date Location User Value Reason
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
5.a
Date Location User Value Reason
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Re
action::RE
D
NE
SS
Were injection si
te reactions pres
ent on the last da
y the Subject Dia
ry was complete
d?:N
OInitial Entry
5.a Injection Site Reaction:
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956939
Page 136 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Aug-28-2020
13:16:52
(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
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:NOInitial Entry
090177e196ae3fd9\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-2021-5683-0956940
Page 137 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-28-2020
13:16:52
(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
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTIO
N SI
TEInitial Entry
090177e196ae3fd9\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-2021-5683-0956941
Page 138 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Were injection
site reactions p
resent on the l
ast day the Su
bject Diary wa
s completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-28-2020
13:16:52
(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
Aug-28-2020
13:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956942
Page 139 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020
13:18:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2.a
Date Location User Value Reason
Aug-28-2020
13:46:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.7
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YTranscription
Error
Aug-28-2020
13:18:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:38.7Initial Entry
090177e196ae3fd9\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-2021-5683-0956943
Page 140 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
Y
2.a Record Identifier:
Date Location User Value Reason
Aug-28-2020
13:18:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-28-2020
13:46:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto
Query
Aug-28-2020
13:46:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-28-2020
13:46:45
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
36.7Transcription
Error
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956944
Page 141 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Eastern Time (US
& Canada)
Aug-28-2020
13:18:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Temperature
38.7 C is outside
of Normal Range
36.1 - 37.5 C.
Aug-28-2020
13:18:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature is
greater than or
equal to 38.0 C,
however
'FEVER OR
ACUTE
ILLNESS' is not
ticked for the
reason for
temporary Delay
of vaccination on
VACCINATION
CRF. Please
review and
update as
appropriate.
Aug-28-2020
13:18:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
38.7Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956945
Page 142 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-28-2020
13:18:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Aug-28-2020
13:18:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956946
Page 143 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020
07:41:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020
07:41:37
(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-31-2020
07:41:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-31-2020
07:41:37ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956947
Page 144 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-31-2020
07:41:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020
07:41:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3P0VInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-31-2020
07:41:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP3P0VInitial Entry
090177e196ae3fd9\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-2021-5683-0956948
Page 145 of 194
***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: 10821076 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-28-2020
13:29:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020
13:29:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020
13:29:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956949
Page 146 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-28-2020
13:29:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020 11:08Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020
13:29:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-28-2020
13:29:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-28-2020
13:29:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956950
Page 147 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-28-2020
13:29:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-28-2020
13:29:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956951
Page 148 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-02-2020
12:12:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/2/2020Initial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956952
Page 149 of 194
***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: 10821076 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
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
OInitial Entry
2.a Symptom:
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956953
Page 150 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Oct-02-2020
12:13:31
(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
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
EInitial Entry
090177e196ae3fd9\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-2021-5683-0956954
Page 151 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
O
2.b Symptom:
Date Location User Value Reason
Oct-02-2020
12:13:31
(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
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-02-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3fd9\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-2021-5683-0956955
Page 152 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)Symptom:: HE
A
D
AC
HE
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was complet
ed?:N
O
2.c Symptom:
Date Location User Value Reason
Oct-02-2020
12:13:31
(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
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3fd9\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-2021-5683-0956956
Page 153 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.d
Date Location User Value Reason
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: C
HI
L
L
S
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956957
Page 154 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.d Symptom:
Date Location User Value Reason
Oct-02-2020
12:13:31
(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
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NGInitial Entry
090177e196ae3fd9\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-2021-5683-0956958
Page 155 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:NO
2.e Symptom:
Date Location User Value Reason
Oct-02-2020
12:13:31
(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
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-02-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3fd9\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-2021-5683-0956959
Page 156 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)Symptom:: DI
A
RR
HE
A
Were fever or
systemic sympt
oms present on
the last day the
Subject Diary
was completed
?:N
O
2.f Symptom:
Date Location User Value Reason
Oct-02-2020
12:13:31
(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
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3fd9\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-2021-5683-0956960
Page 157 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.g
Date Location User Value Reason
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AIN
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was co
mpleted?:NOInitial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956961
Page 158 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.g Symptom:
Date Location User Value Reason
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR
WOR
SENE
D JOI
NT P
AINInitial Entry
090177e196ae3fd9\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-2021-5683-0956962
Page 159 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was co
mpleted?:NO
2.h Symptom:
Date Location User Value Reason
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED 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
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956963
Page 160 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Oct-02-2020
12:13:31
(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
Oct-02-2020
12:23:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-02-2020
12:23:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTTranscription
Error
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Injection Site
Body Side
entered on this
page is not
matching with
Body Side
entered on
Vaccination
page of
V2VX2L.
Please review
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956964
Page 161 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
and update as
appropriate.
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
5.a
Date Location User Value Reason
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::RE
D
N
ES
S
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020
12:13:31
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
090177e196ae3fd9\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-2021-5683-0956965
Page 162 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Eastern Time (US
& Canada)
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::SW
EL
LI
NG
Were injection
site reactions
present on the
last day the Su
bject Diary wa
s completed?:NOInitial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956966
Page 163 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020
12:13:31
(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
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAI
N A
T IN
JEC
TIO
N SI
TEInitial Entry
090177e196ae3fd9\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-2021-5683-0956967
Page 164 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Were injectio
n site reactio
ns present on
the last day t
he Subject Di
ary was com
pleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020
12:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956968
Page 165 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-02-2020
12:13:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-02-2020
12:13:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-02-2020
12:14:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-02-2020
12:13:47ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956969
Page 166 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-02-2020
12:13:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Oct/2/2020Initial Entry
5.a
Date Location User Value Reason
Oct-02-2020
12:14:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPLDY
7Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-02-2020
12:14:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPLDY7Initial Entry
090177e196ae3fd9\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-2021-5683-0956970
Page 167 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.b
Date Location User Value Reason
Oct-02-2020
12:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPLDY
8Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-02-2020
12:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPLDY8Initial Entry
5.c
Date Location User Value Reason
Oct-02-2020
12:14:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPY6X
7Initial Entry
090177e196ae3fd9\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-2021-5683-0956971
Page 168 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.c Sample ID
Date Location User Value Reason
Oct-02-2020
12:14:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPY6X7Initial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956972
Page 169 of 194
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 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
11:08:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mar/4/2021Initial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956973
Page 170 of 194
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-08-2021
11:08:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-08-2021
11:08:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-08-2021
11:08:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-08-2021
11:08:42ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956974
Page 171 of 194
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-08-2021
11:08:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/4/2021Initial Entry
5.a
Date Location User Value Reason
Mar-08-2021
11:08:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BRDWP
3Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-08-2021
11:08:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRDWP3Initial Entry
5.b
090177e196ae3fd9\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-2021-5683-0956975
Page 172 of 194
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Mar-08-2021
11:09:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS3G5KInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-08-2021
11:09:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS3G5KInitial Entry
5.c
Date Location User Value Reason
Mar-08-2021
11:09:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS3G5LInitial Entry
090177e196ae3fd9\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-2021-5683-0956976
Page 173 of 194
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.c Sample ID
Date Location User Value Reason
Mar-08-2021
11:09:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS3G5LInitial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956977
Page 174 of 194
***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: 10821076 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
12:07:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/2/2020Transcription
Error
Oct-05-2020
07:27:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-05-2020
07:27:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-05-2020
07:27:07ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd9\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-2021-5683-0956978
Page 175 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956979
Page 176 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Date Location User Value Reason
Aug-14-2020
17:09:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956980
Page 177 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Category:
Date Location User Value Reason
Aug-14-2020
17:09:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Aug-14-2020
17:09:00
(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
Aug-14-2020
17:09:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
cholelithiasisInitial Entry
4. Start Date Time:
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956981
Page 178 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Aug-14-2020
17:09:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/13/2020 UNK:
UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Aug-17-2020
18:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Aug/15/2020 U
NK:UNKNew
Information
Aug-14-2020
17:09:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Aug-14-2020
17:09:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
090177e196ae3fd9\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-2021-5683-0956982
Page 179 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
Oct-29-2020
00:16:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Closed Query closed;
will follow for
SAE update
with the
requested
COVID test
info
Oct-28-2020
08:54:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Answer
edSAE follow up
has been
submitted.
Additional
verbage added
regarding not
receiving
medical records
associated with
SAE.
Oct-27-2020
22:44:25
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Query 3: Opened Clinical – While
awaiting
additional
records (if ever
090177e196ae3fd9\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-2021-5683-0956983
Page 180 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(US & Canada) sent), please
submit Awaiting
Med Records to
Determine if
COVID testing
was Performed
as a SAE safety
followup.
Oct-26-2020
22:41:48
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Oct-26-2020
10:34:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answer
edsite has been
unable to obtain
subject medical
records from
healthcare
facility
Oct-25-2020
21:32:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened COVID testing
has not been
reported in the
SAE submitted
to safety. Please
submit a
follow-up SAE
form
[#2020317805]
to provide
whether
COVID testing
090177e196ae3fd9\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-2021-5683-0956984
Page 181 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
was performed
(yes/no) and if
yes, the results.
Aug-17-2020
16:15:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-14-2020
17:09:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
teFor AE
cholelithiasis:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Aug-14-2020
17:09:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious e
vent associated
with congenital
anomaly or birt
h defect?
NO
Did this serious
event result in d
eath?Initial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956985
Page 182 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
NO
Did this serious
event require or
prolong hospital
ization?
YES
Did this serious
event result in p
ersistent or signi
ficant disability/
incapacity?
NO
Is this serious e
vent life threate
ning?
NO
Other medically
important seriou
s 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.
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956986
Page 183 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Aug-14-2020
17:09:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-16-2020
13:15:48
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Closed Response
satisfies query
Sep-16-2020
09:01:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answere
dcholelithiasis
is confirmed as
the concurrent
illness
Sep-14-2020
09:36:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Reissued:
OpenedMEd Hx has
been unfrozen.
Thanks.
Sep-11-2020
15:27:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answere
dpage remains
frozen.
090177e196ae3fd9\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-2021-5683-0956987
Page 184 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-11-2020
11:52:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Reissued:
OpenedIt has been
unfrozen.
Thank you.
Sep-10-2020
14:58:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answere
dplease
unfreeze page
for data point
update
Sep-10-2020
14:24:43
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Opened Concurrent
illness speaks
in general
terms, subject
has a list of
different
conditions on
Med Hx.
Please revise
and specify
illness related
to event.
Aug-14-2020
17:09:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to
study treatment(s
), this event is du
e to:
OTHERInitial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956988
Page 185 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
If Other, speci
fy:
concurrent il
lness
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Aug-14-2020
17:09:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-11-2020
22:07:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-09-2020
14:25:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answere
dThis is
unknown.
Medical
records have
been requested
several times
but not
received.
090177e196ae3fd9\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-2021-5683-0956989
Page 186 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Oct-09-2020
08:51:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL
Response to
Con Med
Treatment is
NO; please
confirm no
antibiotics
were
administered.
Please review
and update this
field/submit
SAE update
with the new
information if
appropriate.
Aug-14-2020
17:09:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-11-2020
22:09:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-09-2020 ACV0PFEINFP6000  auto query Query 1: Answer Transcription
090177e196ae3fd9\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-2021-5683-0956990
Page 187 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
14:09:06
(UTC-05:00)
Eastern Time
(US & Canada)(autoquery) ed Error
Oct-09-2020
14:09:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESTranscription
Error
Oct-09-2020
08:48:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL
Response to
non-drug
Treatment is
NO; however
SAE report
states
cholecystectomy
was performed
on 14 Aug 20.
Please review
and update if
appropriate.
Aug-14-2020
17:09:00
(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
090177e196ae3fd9\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-2021-5683-0956991
Page 188 of 194
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-17-2020
18:59:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RE
SOLVEDNew
Information
Aug-14-2020
17:09:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERE
D/NOT RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Aug-14-2020
17:09:00
(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
Aug-17-2020
16:15:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2020317805Initial Entry
090177e196ae3fd9\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-2021-5683-0956992
Page 189 of 194
***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: 10821076 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-12-2021
11:38:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956993
Page 190 of 194
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 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
Feb-12-2021
11:39:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing
to return for Vaccina
tion 3
Participant is:
eligible and NOT
confirmed to hav
e received only pl
acebo at Vaccinat
ion 1/2Initial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956994
Page 191 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-12-2021
11:38:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-12-2021
11:38:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956995
Page 192 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-05-2020
07:27:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-07-2020
15:04:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-07-2020
15:04:11
(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
12:07:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/2/2020Transcription
Error
Oct-05-2020 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956996
Page 193 of 194
***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: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
07:27:07
(UTC-05:00)
Eastern Time (US
& Canada)(autocalc) Aug/28/2020
Aug-07-2020
15:04:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/7/2020Initial Entry
Aug-07-2020
15:04:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/7/2020Initial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956997
Page 194 of 194
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1082 Site Name: (1082) New Orleans Center for Clinical
Research - Knoxville
Subject No: 10821076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Casebook Signature
Date Location User Value Reason
Aug-10-2020
09:15:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3fd9\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956998