Document text
Page 1 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3
option is equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938317
Page 2 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/5/2020
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938318
Page 3 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Demography
1.Subject ID [11351033]
2.Birth Date: /1953
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:
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938319
Page 4 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/5/2020
2.Erroneous Visit
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938320
Page 5 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Inclusion Criteria Not Met
1.aDescription of Inclusion Criterion
Not MetComments
1.bDescription of Inclusion Criterion
Not MetComments
1.cDescription of Inclusion Criterion
Not MetComments
1.dDescription of Inclusion Criterion
Not MetComments
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938321
Page 6 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/5/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938322
Page 7 of 193
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[nearsighted]
Start Date: UNK/UNK/1966
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cataracts]
Start Date: UNK/UNK/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hearing loss]
Start Date: UNK/UNK/2010
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[deviated nasal septum]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938323
Page 8 of 193
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Rt foot bone spur]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: Jan/UNK/2020
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gallbladder stones]
Start Date: UNK/UNK/1991
Ongoing: NO
End Date:
UNK/UNK/1991
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[anxiety]
Start Date: UNK/UNK/1991
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[depression]
Start Date: UNK/UNK/1998
Ongoing: YES
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938324
Page 9 of 193
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cholecystectomy]
Start Date: UNK/UNK/1991
Ongoing: NO
End Date:
UNK/UNK/1991
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[septoplasty]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[bone spur surgery]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938325
Page 10 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/5/2020
2.Weight: [101.9]
3.Unit: kg
4.Height: [178.0]
5.Unit: cm
6.Body Mass Index: [32.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938326
Page 11 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/5/2020
2.Randomization Number: [223068]
3.Randomization Group: [ ]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938327
Page 12 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/5/2020
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 [BM87XN]
5.bSample ID [BM87XP]
5.cSample ID [BM87XR]
5.dSample ID [BLCWG0]
5.eSample ID [BLCWG1]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938328
Page 13 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/5/2020
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 [BM87XD]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938329
Page 14 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/5/2020 13:31
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938330
Page 15 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938331
Page 16 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938332
Page 17 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938333
Page 18 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938334
Page 19 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938335
Page 20 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BKWFK9]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938336
Page 21 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/27/2020 11:32
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938337
Page 22 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/24/2020
2.Erroneous Visit
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938338
Page 23 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938339
Page 24 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938340
Page 25 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/24/2020
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 [BLGCRS]
5.bSample ID [BLGCRP]
5.cSample ID [BP9TT9]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938341
Page 26 of 193
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938342
Page 27 of 193
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: [ ]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938343
Page 28 of 193
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938344
Page 29 of 193
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938345
Page 30 of 193
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938346
Page 31 of 193
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938347
Page 32 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938348
Page 33 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938349
Page 34 of 193
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938350
Page 35 of 193
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Unplanned Assessments
1.Assessments
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938351
Page 36 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/24/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938352
Page 37 of 193
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Jan/29/2021
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938353
Page 38 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938354
Page 39 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938355
Page 40 of 193
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 numbness on the back of t
he head Sep/4/2020 UNK:
UNK NO
End Date Time:
Sep/4/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 Suicide Jan/29/2021 00:00
NO
End Date Time:
Jan/29/2021 00:00
Repeating
Pages
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938356
Page 41 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[numbness on the back of the head]
4.Start Date Time: Sep/4/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/4/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
[muscle strain]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938357
Page 42 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
12.Was a Non-Drug Treatment given? NO
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[ ]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938358
Page 43 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Suicide]
4.Start Date Time: Jan/29/2021 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/29/2021 00:00
6.Toxicity Grade: 4
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?
YES
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
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:
[unknown]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938359
Page 44 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[2021168370]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938360
Page 45 of 193
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938361
Page 46 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938362
Page 47 of 193
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938363
Page 48 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938364
Page 49 of 193
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938365
Page 50 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938366
Page 51 of 193
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938367
Page 52 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938368
Page 53 of 193
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938369
Page 54 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938370
Page 55 of 193
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938371
Page 56 of 193
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938372
Page 57 of 193
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938373
Page 58 of 193
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938374
Page 59 of 193
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938375
Page 60 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938376
Page 61 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938377
Page 62 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/22/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938378
Page 63 of 193
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938379
Page 64 of 193
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Jan/29/2021
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938380
Page 65 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938381
Page 66 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/25/2021
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938382
Page 67 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938383
Page 68 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Jan/25/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938384
Page 69 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/25/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRCDD6]
5.bSample ID [BSGB9R]
5.cSample ID [BSGB9V]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938385
Page 70 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/25/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9MB5]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938386
Page 71 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/25/2021 10:26
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938387
Page 72 of 193
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938388
Page 73 of 193
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938389
Page 74 of 193
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938390
Page 75 of 193
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938391
Page 76 of 193
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938392
Page 77 of 193
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938393
Page 78 of 193
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938394
Page 79 of 193
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938395
Page 80 of 193
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938396
Page 81 of 193
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Jan/29/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938397
Page 82 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Jan/29/2021
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938398
Page 83 of 193
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938399
Page 84 of 193
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938400
Page 85 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormAug-17-2020 10:10:36 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0938401
Page 86 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1.aAug-06-2020 08:26:43 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938402
Page 87 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1.bAug-06-2020 08:26:57 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938403
Page 88 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1.cAug-06-2020 08:27:09 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938404
Page 89 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1.dAug-06-2020 08:27:19 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938405
Page 90 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormJan-26-2021 12:43:05 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938406
Page 91 of 193
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Feb-26-2021 11:40:05 (UTC-08:00) Pacific Time
(US & Canada)Subject passed away before visit 102 was
conducted.
Not Done
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938407
Page 92 of 193
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Jan-26-2021 12:42:34 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Peter Winkle Approved Jan-25-2021 08:53:39 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PeterWinkle, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-22-2021 16:10:13 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Peter Winkle Approved Jan-21-2021 13:36:46 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PeterWinkle, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-24-2020 14:59:52 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938408
Page 93 of 193
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Affidavit:
N/A
Peter Winkle Approved Oct-21-2020 16:22:48 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PeterWinkle, 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-19-2020 09:28:43 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Peter Winkle Approved Oct-13-2020 16:06:37 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PeterWinkle, 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-13-2020 10:11:40 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Peter Winkle Approved Oct-12-2020 08:16:24 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938409
Page 94 of 193
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Affidavit:
By my dated signature below, I, PeterWinkle, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Sep-24-2020 13:45:34 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Peter Winkle Approved Sep-14-2020 12:03:33 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PeterWinkle, 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.
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938410
Page 95 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-06-2020 08:17:05
(UTC-08:00) Pacific 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-06-2020 08:17:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938411
Page 96 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-06-2020 08:17:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/5/2020Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938412
Page 97 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-06-2020 08:16:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11351033Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-06-2020 08:16:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1953Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-06-2020 08:17:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-06-2020 08:17:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-06-2020 08:17:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938413
Page 98 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-06-2020 08:17:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/5/2020Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938414
Page 99 of 193
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.a
Date Location User Value Reason
Aug-06-2020 08:27:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Criterion Description:Transcription Error
Aug-06-2020 08:26:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Criterion Descriptio
n:Not Applicabl
eInitial Entry
Aug-06-2020 08:25:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Criterion Description:Transcription Error
Aug-06-2020 08:24:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Crit
erio
n De
scrip
tion:Male or female participants be
tween the ages of 18 and 55 ye
ars, inclusive, 65 and 85 years,
inclusive, or 18 and 85 years, i
nclusive, at randomization (de
pendent upon study phase)Transcription Error
(DELETED)
Aug-06-2020 08:18:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Crit
erio
n De
scrip
tion:Male or female participants be
tween the ages of 18 and 55 ye
ars, inclusive, 65 and 85 years,
inclusive, or 18 and 85 years, i
nclusive, at randomization (de
pendent upon study phase)Initial Entry
1.a Description of Inclusion Criterion Not Met
Date Location User Value Reason
Aug-18-2020 22:00:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Per site confirmation
Aug-18-2020 09:03:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Form level comment
was added
17/AUG/2020
@10:10:36
(UTC-08:00), under
"reason for
incomplete".
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938415
Page 100 of 193
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-18-2020 03:54:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM query: The form
level comment is still
not present. Kindly
update using comment
bubble on top right
corner of the form.
Thank you.
Aug-17-2020 10:11:36
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Form comment "Not
Applicable" was
added.
Aug-17-2020 06:09:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened As per Protocol
amendment 5
(24Jul2020). INC EXC
form is not applicable.
Please add Form level
comment “Not
Applicable” if
Inclusion/Exclusion
was added in error, or
confirm.
Aug-06-2020 08:27:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Aug-06-2020 08:26:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Aug-06-2020 08:25:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Itemset row was
undeleted in order to
clear CRF
Aug-06-2020 08:25:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Aug-06-2020 08:24:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Male or female participants betwee
n the ages of 18 and 55 years, inclu
sive, 65 and 85 years, inclusive, or
18 and 85 years, inclusive, at rand
omization (dependent upon study p
hase)Transcription Error
(DELETED)
Aug-06-2020 08:18:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Male or female participants betwee
n the ages of 18 and 55 years, inclu
sive, 65 and 85 years, inclusive, or
18 and 85 years, inclusive, at randInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938416
Page 101 of 193
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
omization (dependent upon study p
hase)
1.b
Date Location User Value Reason
Aug-06-2020 08:27:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Criterion Description:Transcription Error
Aug-06-2020 08:26:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Criterion Descriptio
n:Not Applicabl
eInitial Entry
Aug-06-2020 08:25:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Criterion Description:Transcription Error
Aug-06-2020 08:18:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Crite
rion
Desc
ripti
on:Participants who are willing a
nd able to comply with all sch
eduled visits, vaccination plan
, laboratory tests, lifestyle con
siderations, and other study pr
oceduresInitial Entry
1.b Description of Inclusion Criterion Not Met
Date Location User Value Reason
Aug-06-2020 08:27:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Aug-06-2020 08:26:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Aug-06-2020 08:25:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Aug-06-2020 08:18:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participants who are willing and able
to comply with all scheduled visits, v
accination plan, laboratory tests, lifes
tyle considerations, and other study p
roceduresInitial Entry
1.c
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938417
Page 102 of 193
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Aug-06-2020 08:27:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Criterion Description:Transcription Error
Aug-06-2020 08:27:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Criterion Descriptio
n:Not Applicabl
eInitial Entry
Aug-06-2020 08:25:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Criterion Description:Transcription Error
Aug-06-2020 08:18:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Crit
erio
n De
scrip
tion:Healthy participants who are d
etermined by medical history,
physical examination (if requi
red), and clinical judgment of
the investigator to be eligible f
or inclusion in the studyInitial Entry
1.c Description of Inclusion Criterion Not Met
Date Location User Value Reason
Aug-06-2020 08:27:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Aug-06-2020 08:27:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Aug-06-2020 08:25:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Aug-06-2020 08:18:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Healthy participants who are determi
ned by medical history, physical exa
mination (if required), and clinical ju
dgment of the investigator to be eligi
ble for inclusion in the studyInitial Entry
1.d
Date Location User Value Reason
Aug-06-2020 08:27:47
(UTC-08:00) Pacific TimeACV0PFEINFP6000 Data Entry:
Criterion Description:Transcription Error
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938418
Page 103 of 193
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
Aug-06-2020 08:27:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Criterion Descriptio
n:Not Applicabl
eInitial Entry
Aug-06-2020 08:25:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Criterion Description:Transcription Error
Aug-06-2020 08:19:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Crite
rion
Desc
ripti
on:Capable of giving personal si
gned informed consent, which
includes compliance with the
requirements and restrictions l
isted in the ICD and in this pr
otocolInitial Entry
1.d Description of Inclusion Criterion Not Met
Date Location User Value Reason
Aug-06-2020 08:27:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Aug-06-2020 08:27:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Aug-06-2020 08:25:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Aug-06-2020 08:19:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Capable of giving personal signed inf
ormed consent, which includes compl
iance with the requirements and restri
ctions listed in the ICD and in this pr
otocolInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0938419
Page 104 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-06-2020 08:25:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-06-2020 08:25:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-06-2020 08:25:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938420
Page 105 of 193
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.a
Date Location User Value Reason
Aug-06-2020 08:29:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:nearsighted
Start Date: UNK/UNK/19
66
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-06-2020 08:29:58
(UTC-08:00) Pacific 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-06-2020 08:29:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
nearsightedInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-06-2020 08:29:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1966Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-06-2020 08:29:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938421
Page 106 of 193
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-06-2020 08:31:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Ter
m:cataracts
Start Date: UNK/UNK/20
17
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-06-2020 08:31:13
(UTC-08:00) Pacific 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-06-2020 08:31:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cataractsInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-06-2020 08:31:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-06-2020 08:31:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-06-2020 08:31:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:hearing loss
Start Date: UNK/UNK/20
10Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938422
Page 107 of 193
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Aug-06-2020 08:31:43
(UTC-08:00) Pacific 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-06-2020 08:31:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
hearing lossInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-06-2020 08:31:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-06-2020 08:31:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-06-2020 08:32:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:deviated nasal se
ptum
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/20
17Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938423
Page 108 of 193
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.d Line/MH Number:
Date Location User Value Reason
Aug-06-2020 08:32:39
(UTC-08:00) Pacific 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-06-2020 08:32:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
deviated nasal septumInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-06-2020 08:32:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-06-2020 08:32:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.e
Date Location User Value Reason
Aug-06-2020 08:33:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:Rt foot bone spu
r
Start Date: UNK/UNK/201
7
Ongoing: NO
End Date:
UNK/UNK/2
017Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938424
Page 109 of 193
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.e Line/MH Number:
Date Location User Value Reason
Aug-06-2020 08:33:41
(UTC-08:00) Pacific 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-06-2020 08:33:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Rt foot bone spurInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-06-2020 08:33:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-06-2020 08:33:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.f
Date Location User Value Reason
Nov-24-2020 14:59:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number: 6
Medical History Ter
m:hypertension
Start Date: Jan/UNK/20
20
Ongoing: YESChanged Information
Aug-06-2020 08:34:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Te
rm:hypertensionInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938425
Page 110 of 193
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Start Date: UNK/UNK/20
20
Ongoing: YES
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938426
Page 111 of 193
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.f Line/MH Number:
Date Location User Value Reason
Aug-06-2020 08:34:19
(UTC-08:00) Pacific 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-06-2020 08:34:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
hypertensionInitial Entry
1.f Start Date:
Date Location User Value Reason
Nov-24-2020 14:59:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2020Changed Information
Aug-12-2020 17:50:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Aug-11-2020 08:56:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered The particular month
that this condition
started is not on
subject's record BUT
the patient has had it
for a while, so it
definitely began a
while before the
vaccination.
Aug-11-2020 07:10:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened Start date of ongoing
med hx entry
(hypertension) is
UNK/UNK/2020.
Please revise partial
date to include month
Aug-09-2020 22:49:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Per site confirmation
Aug-07-2020 08:18:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered medical history
occurred prior to
vaccination date
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938427
Page 112 of 193
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-07-2020 04:08:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM Review: Thank
you for your
response. Please
confirm if Medical
History occurred
prior to vaccination
even on same day
(date 05/Aug/2020).
Please review and
update as appropriate.
Aug-06-2020 10:57:30
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Aug-06-2020 08:42:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is after or
equal to the first
vaccination date
05/Aug/2020. Please
review and update as
appropriate.
Aug-06-2020 08:34:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2020Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-06-2020 08:34:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-06-2020 08:35:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:gallbladder stone
s
Start Date: UNK/UNK/199
1
Ongoing: NO
End Date:
UNK/UNK/1
991Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938428
Page 113 of 193
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.g Line/MH Number:
Date Location User Value Reason
Aug-06-2020 08:35:15
(UTC-08:00) Pacific 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-06-2020 08:35:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
gallbladder stonesInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-06-2020 08:35:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1991Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-06-2020 08:35:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1991Initial Entry
1.h
Date Location User Value Reason
Aug-06-2020 08:37:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Ter
m:anxiety
Start Date: UNK/UNK/19
91
Ongoing: YESInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938429
Page 114 of 193
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.h Line/MH Number:
Date Location User Value Reason
Aug-06-2020 08:37:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-06-2020 08:37:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
anxietyInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-06-2020 08:37:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1991Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-06-2020 08:37:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938430
Page 115 of 193
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.i
Date Location User Value Reason
Aug-06-2020 08:37:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Te
rm:depression
Start Date: UNK/UNK/19
98
Ongoing: YESInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938431
Page 116 of 193
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.i Line/MH Number:
Date Location User Value Reason
Aug-06-2020 08:37:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-04-2021 05:20:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response satisfies
query
Feb-26-2021 11:41:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Data is not in subject
record
Feb-24-2021 05:59:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Medical Monitor_ Pls
advise if the subject
had additional history
of suicidal attempts
or recent
hospitalization due to
depression. Thanks.
Aug-06-2020 08:37:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
depressionInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-06-2020 08:37:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1998Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-06-2020 08:37:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938432
Page 117 of 193
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-06-2020 08:38:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:10
Medical History T
erm:cholecystectomy
Start Date: UNK/UNK/199
1
Ongoing: NO
End Date:
UNK/UNK/1
991Initial Entry
1.j Line/MH Number:
Date Location User Value Reason
Aug-06-2020 08:38:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-06-2020 08:38:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cholecystectomyInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-06-2020 08:38:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1991Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-06-2020 08:38:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1991Initial Entry
1.k
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938433
Page 118 of 193
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Aug-06-2020 08:39:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:11
Medical History T
erm:septoplasty
Start Date: UNK/UNK/201
7
Ongoing: NO
End Date:
UNK/UNK/2
017Initial Entry
1.k Line/MH Number:
Date Location User Value Reason
Aug-06-2020 08:39:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-06-2020 08:39:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
septoplastyInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-06-2020 08:39:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-06-2020 08:39:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938434
Page 119 of 193
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.l
Date Location User Value Reason
Aug-06-2020 08:40:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:12
Medical History T
erm:bone spur surger
y
Start Date: UNK/UNK/201
7
Ongoing: NO
End Date:
UNK/UNK/2
017Initial Entry
1.l Line/MH Number:
Date Location User Value Reason
Aug-06-2020 08:40:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-06-2020 08:40:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
bone spur surgeryInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-06-2020 08:40:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-06-2020 08:40:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938435
Page 120 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-06-2020 08:40:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/5/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-06-2020 08:40:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
101.9Initial Entry
3. Unit:
Date Location User Value Reason
Aug-06-2020 08:40:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-06-2020 08:40:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
178.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-06-2020 08:40:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-06-2020 08:40:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
32.2Initial Entry
7.a
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938436
Page 121 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Aug-06-2020 08:40:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.9
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-06-2020 08:40:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-06-2020 08:40:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-06-2020 08:40:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-06-2020 08:40:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938437
Page 122 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-06-2020 08:42:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/5/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-06-2020 08:42:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
223068Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938438
Page 123 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-06-2020 08:42:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-06-2020 08:42:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-06-2020 12:54:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-06-2020 08:42:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-06-2020 08:42:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/5/2020Initial Entry
5.a
Date Location User Value Reason
Aug-06-2020 12:54:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM87XNInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938439
Page 124 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-06-2020 12:54:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BM87XNInitial Entry
5.b
Date Location User Value Reason
Aug-06-2020 12:54:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM87XPInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-06-2020 12:54:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BM87XPInitial Entry
5.c
Date Location User Value Reason
Aug-06-2020 12:54:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM87XRInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-06-2020 12:54:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BM87XRInitial Entry
5.d
Date Location User Value Reason
Aug-06-2020 12:55:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLCWG0Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938440
Page 125 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.d Sample ID
Date Location User Value Reason
Aug-06-2020 12:55:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLCWG0Initial Entry
5.e
Date Location User Value Reason
Aug-06-2020 12:55:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLCWG1Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-06-2020 12:55:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLCWG1Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938441
Page 126 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-06-2020 08:42:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-06-2020 08:42:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-06-2020 12:56:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-06-2020 08:42:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-06-2020 08:42:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/5/2020Initial Entry
5.a
Date Location User Value Reason
Aug-06-2020 12:56:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM87XDInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938442
Page 127 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-06-2020 12:56:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BM87XDInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938443
Page 128 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-06-2020 08:42:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-06-2020 08:42:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-06-2020 08:42:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-06-2020 08:42:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/5/2020 13:31Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-06-2020 08:42:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-06-2020 08:42:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938444
Page 129 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Aug-06-2020 08:42:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-06-2020 08:42:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-06-2020 08:42:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938445
Page 130 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-06-2020 08:43:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DIAR
Y COLLECTED FOR THIS SUBJEC
TInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938446
Page 131 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-27-2020 12:29:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938447
Page 132 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific 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-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FAT
IG
UEInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938448
Page 133 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NO
2.b Symptom:
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific 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-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific 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-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938449
Page 134 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.d
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific 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-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938450
Page 135 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.e Symptom:
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific 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-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific 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-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-27-2020 12:30:27 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0938451
Page 136 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-08:00) Pacific Time
(US & Canada)Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NO
2.g Symptom:
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE P
AINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0938452
Page 137 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.h Symptom:
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT PAI
NInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions
present on the last day the Su
bject Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific TimeACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0938453
Page 138 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactions
present on the last day the S
ubject Diary was completed
?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific 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-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: PAIN A
T INJEC
TION SI
TEInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0938454
Page 139 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-27-2020 12:30:27
(UTC-08:00) Pacific 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-27-2020 12:30:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938455
Page 140 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-27-2020 12:30:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2.a
Date Location User Value Reason
Aug-27-2020 12:30:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.4
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-27-2020 12:30:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-27-2020 12:30:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
36.4Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-27-2020 12:30:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938456
Page 141 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-27-2020 12:30:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938457
Page 142 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 12:30:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 12:30:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 17:19:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-27-2020 12:30:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-27-2020 12:30:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020 17:19:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BKWFK9Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938458
Page 143 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-27-2020 17:19:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BKWFK9Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938459
Page 144 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-27-2020 12:31:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-27-2020 12:31:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-27-2020 12:31:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-27-2020 12:31:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020 11:32Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-27-2020 12:31:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-27-2020 12:31:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938460
Page 145 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Aug-27-2020 12:31:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-27-2020 12:31:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-27-2020 12:31:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938461
Page 146 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-24-2020 13:45:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/24/2020Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938462
Page 147 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FAT
IG
UEInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938463
Page 148 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NO
2.b Symptom:
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938464
Page 149 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.d
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938465
Page 150 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.e Symptom:
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-24-2020 13:45:47 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0938466
Page 151 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-08:00) Pacific Time
(US & Canada)Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NO
2.g Symptom:
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE P
AINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0938467
Page 152 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.h Symptom:
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT PAI
NInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions
present on the last day the Su
bject Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific TimeACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938468
Page 153 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactions
present on the last day the S
ubject Diary was completed
?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: PAIN A
T INJEC
TION SI
TEInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938469
Page 154 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 13:45:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938470
Page 155 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020 13:45:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020 13:45:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020 15:51:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-24-2020 13:45:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-24-2020 13:45:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/24/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020 15:51:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLGCRSInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938471
Page 156 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-24-2020 15:51:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLGCRSInitial Entry
5.b
Date Location User Value Reason
Sep-24-2020 15:51:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLGCRPInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-24-2020 15:51:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLGCRPInitial Entry
5.c
Date Location User Value Reason
Sep-24-2020 15:51:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9TT9Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-24-2020 15:51:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP9TT9Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938472
Page 157 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Sep-24-2020 13:46:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-24-2020 13:46:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-24-2020 13:46:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938473
Page 158 of 193
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-03-2021 05:26:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-02-2021 16:41:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Mar-02-2021 16:41:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/29/2021Initial Entry
Mar-01-2021 20:01:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2020373811, the
date of death was
reported as 29Jan2021
in Safety database but
missing in CRF. Please
confirm correct date of
death. If safety update
is required, please
submit a follow-up
form.
2. Phase of Disposition:
Date Location User Value Reason
Mar-02-2021 16:41:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Mar-03-2021 10:43:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 2: Closed Response satisfies
query
Mar-03-2021 10:11:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered Changed data per
query
Mar-03-2021 10:09:11 ACV0PFEINFP6000 Hayley Query 2: Opened CLINQUERY: Death
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0938474
Page 159 of 193
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-08:00) Pacific Time
(US & Canada)Wyper of subject is reported.
Please also complete
the EOT2 page to
reflect end of
treatment
Mar-02-2021 16:41:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-02-2021 16:41:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Response to 'Status'
is 'Death' on
Disposition- Folow
up, but 'Death' CRF is
not yet initiated.
Please review and
update as appropriate.
Mar-02-2021 16:41:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DEATHInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0938475
Page 160 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Oct-13-2020 10:11:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938476
Page 161 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Feb-26-2021 16:35:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938477
Page 162 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category:
Date Location User Value Reason
Oct-13-2020 10:11:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-13-2020 10:11:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-04-2021 05:02:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response satisfies
query
Feb-26-2021 11:37:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Feb-24-2021 05:56:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Medical Monitor, the
additional SAE of
"Suicide" has been
reported to safety
(AER# 2021168370).
Pls revise AE log and
update accordingly.
Thanks.
Oct-13-2020 10:11:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
numbness on the back of the headInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-13-2020 10:11:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020 UNK:UNKInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0938478
Page 163 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-03-2020 10:56:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/4/2020 UNK:UNKChanged Information
Oct-13-2020 10:11:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/4/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-13-2020 10:11:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-13-2020 10:11:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-13-2020 10:11:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938479
Page 164 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-22-2020
10:31:39
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Clos
edResponse
satisfies query
Oct-20-2020
09:46:15
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Ans
weredreason for AE
was "other -
muscle strain".
Oct-20-2020
05:07:27
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 2: Open
edPlease review
"If not related
to study
treatment other"
field, the
following text
was indicated in
the comment
field [muscle
strain]. Any
symptoms, AEs
or other key
data should be
collected on the
appropriate
page. Please
review and
update as
necessary.
Oct-19-2020
22:16:59
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Clos
edResponse
satisfies query
Oct-19-2020
09:28:43
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Ans
weredNew
Information
Oct-19-2020
09:28:43
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELAT
ED
If Not Relate
d to study treNew
Information
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0938480
Page 165 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
atment(s), thi
s event is du
e to:
OTHER
If Other, s
pecify:
muscle s
train
Oct-17-2020
04:00:32
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reiss
ued:OpenedThank you for
your response.
Please update
'Specify' field,
when data is
available. Keep
this query open
until data is
updated.
Oct-16-2020
18:33:05
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Ans
wered"other" to be
updated
Oct-16-2020
00:20:40
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Open
edDM: The
response for "If
Not Related to
study
treatment(s),
this event is due
to is reported as
"Other",
however
specify is
missing? kindly
review and
update.
Oct-13-2020
10:11:40
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELAT
ED
If Not Relate
d to study tre
atment(s), thi
s event is du
e to:Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0938481
Page 166 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
OTHER
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-13-2020 10:11:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-13-2020 10:11:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-13-2020 10:11:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-13-2020 10:11:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-13-2020 10:11:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938482
Page 167 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category:
Date Location User Value Reason
Feb-26-2021 16:35:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-26-2021 16:35:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-26-2021 17:35:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SuicideNew Information
Feb-26-2021 16:35:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Suicidal DeathInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-26-2021 16:35:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/29/2021 00:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-26-2021 17:36:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/29/2021 00:00Changed Information
Feb-26-2021 16:35:04
(UTC-08:00) Pacific TimeACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938483
Page 168 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
6. Toxicity Grade:
Date Location User Value Reason
Feb-26-2021 16:35:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-01-2021 01:23:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-26-2021 17:35:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Suicide :
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Feb-26-2021 16:35:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Suicidal
Death : Response to
"Is the adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Feb-26-2021 16:35:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated wit
h congenital anomaly or birth defe
ct?
NO
Did this serious event result in de
ath?Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0938484
Page 169 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
YES
Did this serious event require or p
rolong hospitalization?
NO
Did this serious event result in per
sistent or significant disability/inc
apacity?
NO
Is this serious event life threatenin
g?
YES
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.
Date Location User Value Reason
Feb-26-2021 16:35:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-03-2021 02:52:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Sonal K Query 1: Closed Response satisfies
query
Mar-02-2021 16:43:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Mar-02-2021 16:43:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHERNew Information
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0938485
Page 170 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
If Other, specify:
unknown
Feb-28-2021 23:53:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The response
for "Is this event
related to study
treatment" Is
reported as 'Not
Related', however
response for, 'Please
indicate what this
event is due to' is
missing. Kindly
review and update.
Feb-26-2021 16:35:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User ValueReason
Mar-03-2021
23:49:40
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Mar-03-2021
10:43:26
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query
3: Clo
sedResponse satisfies query
Mar-03-2021
09:37:42
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
3: Ans
weredChanged Information
Mar-03-2021
09:37:42
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredChanged Information
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0938486
Page 171 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Mar-03-2021
09:37:42
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
NOT
APPL
ICAB
LEChanged Information
Mar-03-2021
06:05:43
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query
3: Op
enedCLINQUERY: Please
update EOT2 page to
match this entry for
treatment discontinuation
due to fatal adverse event
Mar-03-2021
05:32:23
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedsite has updated the output
to fatal
Mar-02-2021
16:45:13
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Ans
weredChanged data per query
Mar-02-2021
00:38:48
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
2: Op
enedThe Adverse Event Action
Taken is DRUG
WITHDRAWN but reason
for treatment
discontinuation is not
reported as ADVERSE
EVENT or DEATH. Please
review and clarify.
Mar-01-2021
20:02:43
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Op
enedSAE
RECON:AER#2021168370
,action taken was reported
as DRUG WITHDRAWN
in AE CRF while NOT
APPLICABLE in Safety
database.Please confirm. If
safety update is required,
please submit a follow up
form
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0938487
Page 172 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Feb-26-2021
16:35:04
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
DRU
G WI
THD
RAW
NInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-26-2021 16:35:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-26-2021 16:35:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-03-2021
05:31:39
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Cl
oseddata updated by
site.
Mar-03-2021
02:32:05
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 4: Cl
osedResponse satisfies
query
Mar-02-2021
16:42:54
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 4: A
nsweredChanged data per
query
Mar-02-2021
16:41:48
(UTC-08:00)
Pacific TimeACV0PFEINFP6000 auto query
(autoquery)Query 2: A
nsweredAnswer Auto Query
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0938488
Page 173 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
Mar-01-2021
08:41:55
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: Re
issued:Open
edDM RQ1: Thanks
for the response
however Date of
Collection /
Notification of
Death on the Death
Details form is not
completed. Please
review and update
as appropriate.
Mar-01-2021
07:27:03
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Cl
osedResponse satisfies
query
Feb-28-2021
20:43:26
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 4: O
penedDMW7483377;The
outcome of this AE
is selected as
FATAL, but there
are no Disposition
eCRFs with a
'Status' of DEATH.
Please review and
update as
appropriate.
Feb-26-2021
17:36:04
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Cl
osedClose Auto Query
Feb-26-2021
17:35:18
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: O
penedFor AE Suicide :
Response to "What
was the outcome of
this adverse event?"
is 'Fatal' but "Is the
adverse event still
ongoing?" is
marked 'Yes'.
Feb-26-2021
16:36:25
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: A
nsweredChanged data per
query
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0938489
Page 174 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Feb-26-2021
16:35:57
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 2: A
nsweredChanged data per
query
Feb-26-2021
16:35:04
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: O
penedResponse to "What
was the outcome of
this adverse event?"
is 'Fatal' but Date of
Collection /
Notification of
Death on the Death
Details form is not
completed. Please
review and update
as appropriate.
Feb-26-2021
16:35:04
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: O
penedFor AE Suicidal
Death : Response to
"What was the
outcome of this
adverse event?" is
'Fatal' but "Is the
adverse event still
ongoing?" is
marked 'Yes'.
Feb-26-2021
16:35:04
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:
FATALInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-03-2021 02:32:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-02-2021 16:42:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Mar-01-2021 03:56:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Did the event
cause the Subject to
be Discontinued from
the Study" on AE
form is YES. Please
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938490
Page 175 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
consider to update
the disposition details
on FUP form. Thank
you.
Feb-26-2021 16:35:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-01-2021 01:23:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2021168370Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938491
Page 176 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-26-2021 12:42:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/22/2021Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938492
Page 177 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-26-2021 12:42:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for Vac
cination 3
Participant is:
eligible per local/national recomm
endations and confirmed to have re
ceived only placebo at Vaccination
1/2Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938493
Page 178 of 193
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Mar-04-2021 05:24:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response satisfies
query
Feb-26-2021 11:34:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered subject got unblinded
on 22JAN2021. Had
received placebo. Got
his first shot on
25JAN2021.
Committed suicide on
29JAN2021. Original
value is correct. It
takes a long time for
the autopsy report to
be released. Will
provide information
then.
Feb-24-2021 06:01:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Medical monitor, the
SAE of "Suicide" has
been reported to
safety (AER#
2021168370). Please
revise this page and
update accordingly.
Additionally, kindly
provide details on the
circumstance of the
event in a FU form.
Thanks
Jan-22-2021 16:10:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/22/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-22-2021 16:10:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR ADDI
TIONAL VACCINATIONInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0938494
Page 179 of 193
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Mar-12-2021 08:56:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: Thank you for
your response.
Please update when
data is available.
Mar-05-2021 09:10:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candidate DM: Thank you for
your response.
Please update when
data is available.
Mar-04-2021 09:59:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered subject committed
suicide. However we
are waiting for the
official death
certificate and
autopsy results.
Based on
experience, it takes
coroner's office a
very long time to
release the
documents. Will
update as soon as
records are obtained.
Thank you!
Mar-03-2021 22:59:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Saumitra Dubey Query 1: Opened P21 Review - Please
update Cause of
Death and rest of the
details on the page.
Mar-02-2021 16:41:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/29/2021Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0938495
Page 180 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-26-2021 12:42:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938496
Page 181 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-26-2021 12:42:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/25/2021Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938497
Page 182 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-26-2021 12:43:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-26-2021 12:43:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-26-2021 12:43:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938498
Page 183 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-26-2021 12:43:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-26-2021 12:43:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-27-2021 10:26:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-26-2021 12:43:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jan-26-2021 12:43:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/25/2021Initial Entry
5.a
Date Location User Value Reason
Jan-27-2021 10:26:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRCDD6Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938499
Page 184 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Jan-27-2021 10:26:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BRCDD6Initial Entry
5.b
Date Location User Value Reason
Jan-27-2021 10:27:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSGB9RInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-27-2021 10:27:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BSGB9RInitial Entry
5.c
Date Location User Value Reason
Jan-27-2021 10:27:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSGB9VInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-27-2021 10:27:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BSGB9VInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938500
Page 185 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-26-2021 12:43:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-26-2021 12:43:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-27-2021 10:27:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-26-2021 12:43:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jan-26-2021 12:43:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/25/2021Initial Entry
5.a
Date Location User Value Reason
Jan-27-2021 10:27:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR9MB5Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938501
Page 186 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Jan-27-2021 10:27:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR9MB5Initial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938502
Page 187 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-26-2021 12:43:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-26-2021 12:43:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-26-2021 12:43:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-26-2021 12:43:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021 10:26Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-26-2021 12:43:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-26-2021 12:43:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938503
Page 188 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Jan-26-2021 12:43:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-26-2021 12:43:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-26-2021 12:43:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-26-2021 12:43:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Jan-26-2021 12:43:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0938504
Page 189 of 193
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-03-2021 10:49:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-26-2021 11:40:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Feb-26-2021 11:40:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-24-2021 12:33:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened It appears the subject
passed away. Please
reconcile with source
and amend if
applicable to note
"Not Done" for Visit
102.
090177e196ae3d5a\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938505
Page 190 of 193
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-03-2021 10:11:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/29/2021Initial Entry
2. Phase of Disposition:
Date Location User Val
…[truncated]