Document text
Page 1 of 249
***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: 11351143 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
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938510
Page 2 of 249
***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: 11351143 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/17/2020
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938511
Page 3 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Demography
1.Subject ID [11351143]
2.Birth Date: /1956
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:
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938512
Page 4 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/17/2020
2.Erroneous Visit
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938513
Page 5 of 249
***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: 11351143 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
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938514
Page 6 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/17/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938515
Page 7 of 249
***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: 11351143 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:[reading glasses]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[overweight]
Start Date: UNK/UNK/2000
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left shoulder injury]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hyperlipidemia]
Start Date: Feb/UNK/2020
Ongoing: YES
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938516
Page 8 of 249
***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: 11351143 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:[left shoulder replacement]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[narcolepsy]
Start Date: UNK/UNK/2000
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[pre-diabetic]
Start Date: UNK/UNK/2013
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[low testosterone]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938517
Page 9 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[keloid scar (left knee)]
Start Date: UNK/UNK/1966
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[erectile dysfunction]
Start Date: UNK/UNK/2010
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[pulmonary nodule]
Start Date: Apr/UNK/2020
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: UNK/UNK/2015
Ongoing: YES
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[circadian rhythm sleep disorder]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938518
Page 10 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[depression]
Start Date: UNK/UNK/1995
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[sleep apnea]
Start Date: UNK/UNK/2018
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cataplexy]
Start Date: UNK/UNK/2000
Ongoing: YES
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[inguinal hernia]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938519
Page 11 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[obese]
Start Date: UNK/UNK/2000
Ongoing: YES
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[inguinal hernia repair]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938520
Page 12 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/17/2020
2.Weight: [83.3]
3.Unit: kg
4.Height: [167.0]
5.Unit: cm
6.Body Mass Index: [29.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938521
Page 13 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/17/2020
2.Randomization Number: [230960]
3.Randomization Group: [ ]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938522
Page 14 of 249
***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: 11351143 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/17/2020
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 [BM87MC]
5.bSample ID [BM87MD]
5.cSample ID [BM87MF]
5.dSample ID [BLCWNR]
5.eSample ID [BLCWNS]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938523
Page 15 of 249
***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: 11351143 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/17/2020
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 [BM87M9]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938524
Page 16 of 249
***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: 11351143 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/17/2020 14:57
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
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938525
Page 17 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938526
Page 18 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938527
Page 19 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938528
Page 20 of 249
***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: 11351143 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:
Sep/9/2020
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 [BP9TG9]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938529
Page 21 of 249
***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: 11351143 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: Sep/9/2020 13:19
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
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938530
Page 22 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938531
Page 23 of 249
***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: 11351143 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:
Oct/7/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP93R5]
5.bSample ID [BLGD03]
5.cSample ID [BLGD08]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938532
Page 24 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938533
Page 25 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/12/2020
2.Date of First Symptom Started: Oct/10/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/18/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? YES
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938534
Page 26 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938535
Page 27 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of Collec
tionSpecimen T
ypeSpecimen Collection Lo
cationAssay Code and Descr
iptionDevice Ty
peForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938536
Page 28 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938537
Page 29 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 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_SELF
3.Sample Collected? YES
Date of Collection:
Oct/12/2020
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 [CV04139]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938538
Page 30 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: 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: 11351143 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? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[subject submitted self swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938539
Page 31 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938540
Page 32 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938541
Page 33 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Treatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntTreatme
ntStart Dat
eForm Instance
1. Repeating
Pages
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938542
Page 34 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938543
Page 35 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938544
Page 36 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
1. Repeating Pages
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938545
Page 37 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938546
Page 38 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category for La
b TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938547
Page 39 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938548
Page 40 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938549
Page 41 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938550
Page 42 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938551
Page 43 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938552
Page 44 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938553
Page 45 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938554
Page 46 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxygen
)Form Instance
1. Repeating Pages
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938555
Page 47 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938556
Page 48 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938557
Page 49 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 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.Start Date: //
6.Ongoing?
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938558
Page 50 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938559
Page 51 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938560
Page 52 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/11/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938561
Page 53 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/11/2020Form: 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: 11351143 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:
Nov/11/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRFZGG]
5.bSample ID [BSJV55]
5.cSample ID [BSJV54]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938562
Page 54 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938563
Page 55 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Unplanned Assessments
1.Assessments
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938564
Page 56 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/7/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938565
Page 57 of 249
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938566
Page 58 of 249
***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: 11351143 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:
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938567
Page 59 of 249
***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: 11351143 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 [ ]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938568
Page 60 of 249
***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: 11351143 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 acute cholecysti
tis Oct/14/2020 UNK
:UNK NO
End Date Time:
Oct/17/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 urinary tract inf
ection Oct/15/2020 UNK
:UNK NO
End Date Time:
Oct/17/2020 UNK:UNK
Repeating
Pages
3.ADVERSE EV
ENT 3 myocardial infar
ction Nov/18/2020 UN
K:UNK NO
End Date Time:
Nov/20/2020 UNK:UN
K
Repeating
Pages
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938569
Page 61 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 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)[acute cholecystitis]
4.Start Date Time: Oct/14/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/17/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
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
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938570
Page 62 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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:
[gallstones]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020411501]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938571
Page 63 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 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)[urinary tract infection]
4.Start Date Time: Oct/15/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/17/2020 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
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938572
Page 64 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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:
[bacterial infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?: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[ ]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938573
Page 65 of 249
***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: 11351143 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: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[myocardial infarction]
4.Start Date Time: Nov/18/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/20/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938574
Page 66 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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:
[hypertension and hyperlipidemia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020465939]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938575
Page 67 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
1. Repeating
Pages
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938576
Page 68 of 249
***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: 11351143 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[ ]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938577
Page 69 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart Da
teForm Instanc
e
1.1 VACCINATION
S NO fluzone quadri
valent Oct/10/2
020 Repeating
Pages
2.2 VACCINATION
S NO shingrix Nov/6/2
020 Repeating
Pages
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938578
Page 70 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[fluzone quadrivalent]
5.Date: Oct/10/2020
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938579
Page 71 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [2]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[shingrix]
5.Date: Nov/6/2020
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938580
Page 72 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938581
Page 73 of 249
***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: 11351143 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?
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938582
Page 74 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
1. Repeating
Pages
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938583
Page 75 of 249
***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: 11351143 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?
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938584
Page 76 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938585
Page 77 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938586
Page 78 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938587
Page 79 of 249
***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: 11351143 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:
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938588
Page 80 of 249
***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: 11351143 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?
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938589
Page 81 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938590
Page 82 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938591
Page 83 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938592
Page 84 of 249
***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: 11351143 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
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938593
Page 85 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/8/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938594
Page 86 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938595
Page 87 of 249
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938596
Page 88 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938597
Page 89 of 249
***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: 11351143 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
Feb/9/2021
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938598
Page 90 of 249
***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: 11351143 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
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938599
Page 91 of 249
***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: 11351143 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 :Feb/9/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938600
Page 92 of 249
***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: 11351143 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:
Feb/9/2021
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 [BR9MK1]
5.bSample ID [BSG9V0]
5.cSample ID [BSG9V1]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938601
Page 93 of 249
***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: 11351143 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:
Feb/9/2021
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 [BR9MK6]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938602
Page 94 of 249
***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: 11351143 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: Feb/9/2021 10:15
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
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938603
Page 95 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/1/2021
2.Erroneous Visit
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938604
Page 96 of 249
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 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:
Mar/1/2021
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 [BRGVM5]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938605
Page 97 of 249
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 11351143 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: Mar/1/2021 11:26
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
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938606
Page 98 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938607
Page 99 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938608
Page 100 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938609
Page 101 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938610
Page 102 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938611
Page 103 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938612
Page 104 of 249
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938613
Page 105 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/7/2020
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938614
Page 106 of 249
***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: 11351143 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
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938615
Page 107 of 249
***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: 11351143 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
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938616
Page 108 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormAug-18-2020 09:38:32 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0938617
Page 109 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormOct-13-2020 10:50:27 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0938618
Page 110 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Oct-13-2020 10:50:27 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0938619
Page 111 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Oct-13-2020 10:50:27 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0938620
Page 112 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Oct-13-2020 10:50:27 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0938621
Page 113 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Oct-13-2020 10:50:27 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0938622
Page 114 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Oct-13-2020 10:50:27 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0938623
Page 115 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6Oct-13-2020 10:50:27 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0938624
Page 116 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
7Oct-13-2020 10:50:27 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0938625
Page 117 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
8Oct-13-2020 10:50:27 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0938626
Page 118 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
9Oct-13-2020 10:50:27 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0938627
Page 119 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormFeb-10-2021 15:40:44 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0938628
Page 120 of 249
***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: 11351143 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 Feb-08-2021 12:10:51 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Peter Winkle Approved Jan-25-2021 08:33:43 (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 14:56:05 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Peter Winkle Approved Nov-12-2020 10:17:55 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938629
Page 121 of 249
***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: 11351143 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 Nov-11-2020 12:11:04 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-10-2020 14:22:35 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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-05-2020 20:10:06 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Peter Winkle Approved Oct-29-2020 11:51:18 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938630
Page 122 of 249
***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: 11351143 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 Oct-27-2020 16:03:50 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Peter Winkle Approved Oct-26-2020 14:55:51 (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-24-2020 06:56:25 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Peter Winkle Approved Oct-23-2020 15:08:14 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938631
Page 123 of 249
***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: 11351143 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 Oct-23-2020 08:48:57 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Peter Winkle Approved Oct-16-2020 07:20:28 (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.
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938632
Page 124 of 249
***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: 11351143 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-18-2020 09:37:13
(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-18-2020 09:37:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938633
Page 125 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-18-2020 09:37:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/17/2020Initial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938634
Page 126 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-18-2020 09:37:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11351143Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-18-2020 09:37:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1956Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-18-2020 09:37:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-18-2020 09:37:50
(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-18-2020 09:37:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938635
Page 127 of 249
***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: 11351143 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-18-2020 09:38:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938636
Page 128 of 249
***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: 11351143 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-18-2020 09:39:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-18-2020 09:39:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-18-2020 09:39:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938637
Page 129 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.a
Date Location User Value Reason
Aug-18-2020 09:39:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:reading glass
es
Start Date: UNK/UNK/
2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-18-2020 09:39:46
(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
Nov-06-2020 01:44:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Deleted Query is invalid
or does not apply
Nov-04-2020 20:53:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Candidate DM: Do not issue
query. Site
request to update
form. Delete
query after
updates are made.
Aug-18-2020 09:39:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
reading glassesInitial Entry
1.a Start Date:
090177e196ae3d58\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-2021-5683-0938638
Page 130 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Aug-18-2020 09:39:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-18-2020 09:39:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Dec-03-2020 10:45:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numb
er:2
Medical History
Term:overweight
Start Date: UNK/UNK/
2000
Ongoing: YESChanged
Information
Dec-03-2020 10:45:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numb
er:2
Medical History
Term:overweight
Start Date: UNK/UNK/
2019
Ongoing: YESChanged
Information
Aug-18-2020 09:40:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:overweight/
obese
Start Date: UNK/UNK/
2019Initial Entry
090177e196ae3d58\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-2021-5683-0938639
Page 131 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Aug-18-2020 09:40:42
(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
Dec-03-2020 10:45:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
overweightChanged
Information
Aug-18-2020 09:40:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
overweight/obeseInitial Entry
1.b Start Date:
Date Location User Value Reason
Dec-03-2020 10:45:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Changed
Information
Aug-18-2020 09:40:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-18-2020 09:40:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
090177e196ae3d58\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-2021-5683-0938640
Page 132 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-18-2020 09:41:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:left shoulder i
njury
Start Date: UNK/UNK/20
11
Ongoing: NO
End Date:
UNK/UNK
/2011Initial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938641
Page 133 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.c Line/MH Number:
Date Location User Value Reason
Aug-18-2020 09:41:45
(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-18-2020 09:41:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
left shoulder injuryInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-18-2020 09:41:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-18-2020 09:41:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2011Initial Entry
1.d
Date Location User Value Reason
Aug-18-2020 09:42:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:hyperlipide
mia
Start Date: Feb/UNK/2
020Initial Entry
090177e196ae3d58\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-2021-5683-0938642
Page 134 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Aug-18-2020 09:42:34
(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-18-2020 09:42:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hyperlipidemiaInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-18-2020 09:42:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/UNK/2020Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-18-2020 09:42:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-18-2020 09:43:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5
Medical Histo
ry Term:left shoulder rep
lacement
Start Date: UNK/UNK/201
1Initial Entry
090177e196ae3d58\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-2021-5683-0938643
Page 135 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Ongoing: NO
End Date:
UNK/UNK/2
011
1.e Line/MH Number:
Date Location User Value Reason
Aug-18-2020 09:43:15
(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-18-2020 09:43:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
left shoulder replacementInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-18-2020 09:43:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-18-2020 09:43:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2011Initial Entry
1.f
Date Location User Value Reason
Nov-06-2020 09:45:03 ACV0PFEINFP6000 Data Entry: per query request,
090177e196ae3d58\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-2021-5683-0938644
Page 136 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-08:00) Pacific
Time (US & Canada)Line/MH Numb
er:6
Medical History
Term:narcolepsy
Start Date: UNK/UNK/
2000
Ongoing: YESterm was updated
Nov-05-2020 20:10:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:narcolepsy wit
h cataplexy
Start Date: UNK/UNK/20
00
Ongoing: YESInitial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0938645
Page 137 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.f Line/MH Number:
Date Location User Value Reason
Nov-05-2020 20:10:06
(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
Nov-06-2020
12:50:23
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1:
ClosedDiscrepancy has
been closed.
Nov-06-2020
09:45:03
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
Answeredper query
request, term
was updated
Nov-06-2020
09:45:03
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data Entr
y:
narcolepsyper query
request, term
was updated
Nov-06-2020
04:08:10
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1:
OpenedMultiple
concepts in the
term
NARCOLEPSY
WITH
CATAPLEXY.
Split the term
into
NARCOLEPSY
and separately
CATAPLEXY.
Submit each
term as a
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0938646
Page 138 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
separate record.
Thank you.
Nov-05-2020
20:10:06
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data Entr
y:
narcolepsy
with catap
lexyInitial Entry
1.f Start Date:
Date Location User Value Reason
Nov-05-2020 20:10:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.f Ongoing:
Date Location User Value Reason
Nov-05-2020 20:10:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Nov-05-2020 20:11:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7
Medical History
Term:pre-diabetic
Start Date: UNK/UNK/
2013
Ongoing: YESInitial Entry
090177e196ae3d58\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-2021-5683-0938647
Page 139 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.g Line/MH Number:
Date Location User Value Reason
Nov-05-2020 20:11:02
(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
Nov-05-2020 20:11:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
pre-diabeticInitial Entry
1.g Start Date:
Date Location User Value Reason
Nov-05-2020 20:11:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2013Initial Entry
1.g Ongoing:
Date Location User Value Reason
Nov-05-2020 20:11:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Nov-05-2020 20:11:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:8
Medical History
Term:low testoster
one
Start Date: UNK/UNK/
2010
Ongoing: YESInitial Entry
090177e196ae3d58\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-2021-5683-0938648
Page 140 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.h Line/MH Number:
Date Location User Value Reason
Nov-05-2020 20:11:30
(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
Nov-05-2020 20:11:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
low testosteroneInitial Entry
1.h Start Date:
Date Location User Value Reason
Nov-05-2020 20:11:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938649
Page 141 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.h Ongoing:
Date Location User Value Reason
Nov-05-2020 20:11:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Nov-05-2020 20:12:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:9
Medical Histor
y Term:keloid scar (le
ft knee)
Start Date: UNK/UNK/19
66
Ongoing: YESInitial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938650
Page 142 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.i Line/MH Number:
Date Location User Value Reason
Nov-05-2020 20:12:46
(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
Nov-05-2020 20:12:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
keloid scar (left knee)Initial Entry
1.i Start Date:
Date Location User Value Reason
Nov-05-2020 20:12:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1966Initial Entry
1.i Ongoing:
Date Location User Value Reason
Nov-05-2020 20:12:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Nov-05-2020 20:13:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:10
Medical History
Term:erectile dysfu
nction
Start Date: UNK/UNK/2
010
Ongoing: YESInitial Entry
090177e196ae3d58\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-2021-5683-0938651
Page 143 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.j Line/MH Number:
Date Location User Value Reason
Nov-05-2020 20:13:24
(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
Nov-05-2020 20:13:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
erectile dysfunctionInitial Entry
1.j Start Date:
Date Location User Value Reason
Nov-05-2020 20:13:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.j Ongoing:
Date Location User Value Reason
Nov-05-2020 20:13:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Nov-05-2020 20:14:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:11
Medical History
Term:pulmonary n
odule
Start Date: Apr/UNK/20
20
Ongoing: YESInitial Entry
090177e196ae3d58\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-2021-5683-0938652
Page 144 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.k Line/MH Number:
Date Location User Value Reason
Nov-05-2020 20:14:00
(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
Nov-10-2020 20:02:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 1: Closed Response satisfies
query
Nov-09-2020 20:22:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered clarification to be
updated
Nov-08-2020 16:06:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 1: Opened GPDClin: Please
clarify if more
definitive
diagnosis has been
made, at least
please indicate it is
benign or
malignant.
Nov-05-2020 20:14:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
pulmonary noduleInitial Entry
1.k Start Date:
Date Location User Value Reason
Nov-05-2020 20:14:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/UNK/2020Initial Entry
1.k Ongoing:
Date Location User Value Reason
Nov-05-2020 20:14:00 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d58\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)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0938653
Page 145 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-08:00) Pacific
Time (US & Canada)YES
1.l
Date Location User Value Reason
Nov-05-2020 20:14:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:12
Medical History
Term:hypertension
Start Date: UNK/UNK/
2015
Ongoing: YESInitial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0938654
Page 146 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.l Line/MH Number:
Date Location User Value Reason
Nov-05-2020 20:14:45
(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
Nov-05-2020 20:14:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hypertensionInitial Entry
1.l Start Date:
Date Location User Value Reason
Nov-05-2020 20:14:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.l Ongoing:
Date Location User Value Reason
Nov-05-2020 20:14:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Nov-11-2020 12:11:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:13
Medical His
tory Term:circadian rhyth
m sleep disorder
Start Date: UNK/UNK/201
8
Ongoing: YESChanged
Information
090177e196ae3d58\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-2021-5683-0938655
Page 147 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Nov-05-2020 20:15:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:13
Medical History
Term:sleep disord
er
Start Date: UNK/UNK/
2018
Ongoing: YESInitial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938656
Page 148 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.m Line/MH Number:
Date Location User Value Reason
Nov-05-2020 20:15:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-11-2020 12:21:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 1: Closed Response satisfies
query
Nov-11-2020 12:11:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Nov-11-2020 12:11:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
circadian rhythm sleep disorde
rChanged
Information
Nov-10-2020 20:05:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 1: Reissued:Opened GPDClin: As
informed by CRA,
the sleep disorder
is "circadian
rhythm sleep
disorder, delayed
sleep phase type
and shift work
type'. If this is the
case, please
modify the term to
circadian rhythm
sleep disorder.
Nov-09-2020 20:17:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered clarification to be
updated
Nov-08-2020 16:09:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 1: Opened GPDClin: If the
sleep disorder is
the sleep apnea
also listed in MHx,
090177e196ae3d58\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)
FDA-CBER-2021-5683-0938657
Page 149 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
please remove it. If
not, please be more
specific of the
sleep disorder.
Nov-05-2020 20:15:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
sleep disorderInitial Entry
1.m Start Date:
Date Location User Value Reason
Nov-05-2020 20:15:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.m Ongoing:
Date Location User Value Reason
Nov-05-2020 20:15:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Nov-05-2020 20:15:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:14
Medical History
Term:depression
Start Date: UNK/UNK/
1995
Ongoing: YESInitial Entry
090177e196ae3d58\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-2021-5683-0938658
Page 150 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.n Line/MH Number:
Date Location User Value Reason
Nov-05-2020 20:15:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-05-2020 20:15:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
depressionInitial Entry
1.n Start Date:
Date Location User Value Reason
Nov-05-2020 20:15:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.n Ongoing:
Date Location User Value Reason
Nov-05-2020 20:15:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Nov-05-2020 20:15:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:15
Medical History
Term:sleep apnea
Start Date: UNK/UNK/
2018
Ongoing: YESInitial Entry
090177e196ae3d58\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-2021-5683-0938659
Page 151 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.o Line/MH Number:
Date Location User Value Reason
Nov-05-2020 20:15:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-05-2020 20:15:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
sleep apneaInitial Entry
1.o Start Date:
Date Location User Value Reason
Nov-05-2020 20:15:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.o Ongoing:
Date Location User Value Reason
Nov-05-2020 20:15:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.p
Date Location User Value Reason
Nov-06-2020 09:45:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:16
Medical History
Term:cataplexy
Start Date: UNK/UNK/
2000
Ongoing: YESInitial Entry
090177e196ae3d58\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-2021-5683-0938660
Page 152 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.p Line/MH Number:
Date Location User Value Reason
Nov-06-2020 09:45:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-06-2020 09:45:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cataplexyInitial Entry
1.p Start Date:
Date Location User Value Reason
Nov-06-2020 09:45:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938661
Page 153 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.p Ongoing:
Date Location User Value Reason
Nov-06-2020 09:45:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.q
Date Location User Value Reason
Dec-03-2020 10:44:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:17
Medical Histor
y Term:inguinal hernia
Start Date: UNK/UNK/20
00
Ongoing: NO
End Date:
UNK/UNK
/2000Initial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938662
Page 154 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.q Line/MH Number:
Date Location User Value Reason
Dec-03-2020 10:44:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-03-2020 10:44:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inguinal herniaInitial Entry
1.q Start Date:
Date Location User Value Reason
Dec-03-2020 10:44:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.q Ongoing:
Date Location User Value Reason
Dec-03-2020 10:44:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2000Initial Entry
1.r
Date Location User Value Reason
Dec-03-2020 10:45:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:18
Medical History
Term:obese
Start Date: UNK/UNK/
2000Initial Entry
090177e196ae3d58\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-2021-5683-0938663
Page 155 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Ongoing: YES
1.r Line/MH Number:
Date Location User Value Reason
Dec-03-2020 10:45:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-03-2020 10:45:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
obeseInitial Entry
1.r Start Date:
Date Location User Value Reason
Dec-03-2020 10:45:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.r Ongoing:
Date Location User Value Reason
Dec-03-2020 10:45:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.s
Date Location User Value Reason
Dec-03-2020 10:50:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:19
Medical Histor
y Term:inguinal hernia
repair
Start Date: UNK/UNK/20
00Initial Entry
090177e196ae3d58\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-2021-5683-0938664
Page 156 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Ongoing: NO
End Date:
UNK/UNK/
2000
1.s Line/MH Number:
Date Location User Value Reason
Dec-03-2020 10:50:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-03-2020 10:50:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inguinal hernia repairInitial Entry
1.s Start Date:
Date Location User Value Reason
Dec-03-2020 10:50:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.s Ongoing:
Date Location User Value Reason
Dec-03-2020 10:50:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2000Initial Entry
090177e196ae3d58\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-2021-5683-0938665
Page 157 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-18-2020 09:43:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-18-2020 09:43:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
83.3Initial Entry
3. Unit:
Date Location User Value Reason
Aug-18-2020 09:43:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-18-2020 09:43:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
167.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-18-2020 09:43:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3d58\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-2021-5683-0938666
Page 158 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-28-2020 08:42:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Luke
CunliffeQuery 1: Closed Response satisfies
query.
Oct-27-2020 17:14:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered data is correct per
subject source
Oct-27-2020 02:28:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: There
is an inconsistency
between the
Medical History
and the BMI value
at Visit 1, the
Medical Hx has an
entry of Obesity
that is Ongoing,
however the BMI
value is less than
30, Please clarity
the entry of
Obesity and update
CRF entry.
Oct-27-2020 02:21:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Luke
CunliffeQuery 1: Candidate ClinQuery: There
is an inconsistency
between the
Medical History
and the BMI value
at Visit 1, the
Medical Hx has an
entry of Obesity
that is Ongoing,
however the BMI
value is less than
30, Please clarity
the entry of
Obesity and update
CRF entry.
Aug-18-2020 09:43:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
29.9Initial Entry
7.a
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0938667
Page 159 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Aug-18-2020 09:43:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 36.6
Temperature Uni
t:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-18-2020 09:43:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-18-2020 09:43:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-18-2020 09:43:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-18-2020 09:43:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d58\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-2021-5683-0938668
Page 160 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-18-2020 09:44:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-18-2020 09:44:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
230960Initial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938669
Page 161 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-18-2020 09:44:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-18-2020 09:44:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-18-2020 12:06:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-18-2020 09:44:51
(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-18-2020 09:44:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938670
Page 162 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-18-2020 12:06:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM87MCInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-18-2020 12:06:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM87MCInitial Entry
5.b
Date Location User Value Reason
Aug-18-2020 12:06:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM87MDInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-18-2020 12:06:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM87MDInitial Entry
5.c
Date Location User Value Reason
Aug-18-2020 12:07:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM87MFInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-18-2020 12:07:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM87MFInitial Entry
090177e196ae3d58\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-2021-5683-0938671
Page 163 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.d
Date Location User Value Reason
Aug-18-2020 12:07:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLCWNRInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-18-2020 12:07:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLCWNRInitial Entry
5.e
Date Location User Value Reason
Aug-18-2020 12:07:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLCWNSInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-18-2020 12:07:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLCWNSInitial Entry
090177e196ae3d58\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-2021-5683-0938672
Page 164 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-18-2020 09:45:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-18-2020 09:45:10
(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-18-2020 12:07:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-18-2020 09:45:10
(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-18-2020 09:45:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938673
Page 165 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-18-2020 12:07:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM87M9Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-18-2020 12:07:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM87M9Initial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938674
Page 166 of 249
***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: 11351143 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-18-2020 09:45:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-18-2020 09:45:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-18-2020 09:45:38
(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-18-2020 09:45:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/17/2020 14:57Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-18-2020 09:45:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938675
Page 167 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-18-2020 09:45:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-18-2020 09:45:38
(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-18-2020 09:45:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-18-2020 09:45:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938676
Page 168 of 249
***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: 11351143 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-18-2020 09:45:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938677
Page 169 of 249
***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: 11351143 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-10-2020 08:52:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938678
Page 170 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-10-2020 08:52:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
2.a
Date Location User Value Reason
Sep-10-2020 08:52:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 36.8
Temperature Uni
t:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-10-2020 08:52:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-10-2020 08:52:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-10-2020 08:52:36 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d58\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-2021-5683-0938679
Page 171 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-08:00) Pacific
Time (US & Canada)C
2.a Temperature Location:
Date Location User Value Reason
Sep-10-2020 08:52:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0938680
Page 172 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020 08:52:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020 08:52:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020 16:27:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-10-2020 08:52:45
(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-10-2020 08:52:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938681
Page 173 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-10-2020 16:27:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9TG9Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-10-2020 16:27:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9TG9Initial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938682
Page 174 of 249
***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: 11351143 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
Sep-10-2020 08:53:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-10-2020 08:53:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-10-2020 08:53:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-10-2020 08:53:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020 13:19Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020 08:53:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938683
Page 175 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-10-2020 08:53:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-10-2020 08:53:28
(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
Sep-10-2020 08:53:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-10-2020 08:53:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938684
Page 176 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-24-2020
06:56:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Oct-23-2020
12:52:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered SAE is entered in AE CRF
Oct-23-2020
04:12:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020411501
acute cholecystitis(onset
date:14Oct2020)was
reported as serious in
Safety database but
missing in AE CRF. Please
confirm and update CRF. If
safety update is required,
submit a follow-up SAE
Form.
Oct-07-2020
15:00:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/7/2020Initial Entry
090177e196ae3d58\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-2021-5683-0938685
Page 177 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020 15:00:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020 15:00:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020 16:49:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-07-2020 15:00:46
(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.
Oct-07-2020 15:00:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938686
Page 178 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-07-2020 16:49:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP93R5Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-07-2020 16:49:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP93R5Initial Entry
5.b
Date Location User Value Reason
Oct-07-2020 16:49:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLGD03Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-07-2020 16:49:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLGD03Initial Entry
5.c
Date Location User Value Reason
Oct-07-2020 16:49:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLGD08Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-07-2020 16:49:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLGD08Initial Entry
090177e196ae3d58\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-2021-5683-0938687
Page 179 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-13-2020 10:52:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-13-2020 10:48:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in the
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Oct-13-2020 10:48:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of Collection
in both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Oct-13-2020 10:48:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-13-2020 10:48:08
(UTC-08:00) PacificACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938688
Page 180 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada)
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938689
Page 181 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/10/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-25-2021 07:42:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed data updated
Feb-25-2021 00:40:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Feb-25-2021 00:40:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Reso
lved:
Oct/18/2020Changed
Information
Feb-15-2021 22:51:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: Page
unfreeze kindly
consider updating
data as
appropriate. Thank
you.
090177e196ae3d58\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-2021-5683-0938690
Page 182 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Feb-15-2021 13:04:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered please unfreeze
form so that data
can be updated.
thank you.
Feb-15-2021 02:53:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Please confirm the
symptoms are still
ongoing for this
COVID Illness. If
all symptoms for
this illness are
resolved; please
update the Last
Symptoms
Resolved Date
else clarify.
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d58\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-2021-5683-0938691
Page 183 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.b
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:NEW OR INCRE
ASED COUGH
Symptom
Present:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COU
GHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREAS
ED SHORTNESS O
F BREATH
Sympto
m Prese
nt:YESInitial Entry
090177e196ae3d58\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-2021-5683-0938692
Page 184 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.c Symptoms:
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHOR
TNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.d
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
090177e196ae3d58\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-2021-5683-0938693
Page 185 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREA
SED MUSCLE PAI
N
Sympto
m Presen
t:YESInitial Entry
4.e Symptoms:
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUS
CLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW LOSS OF T
ASTE OR SMELL
Symptom
Present:NOInitial Entry
090177e196ae3d58\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-2021-5683-0938694
Page 186 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.f Symptoms:
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR S
MELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREA
SED SORE THRO
AT
Sympto
m Presen
t:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE
THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d58\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-2021-5683-0938695
Page 187 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.h
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHE
A
Symptom Presen
t:YESInitial Entry
4.h Symptoms:
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.i
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMITIN
G
Symptom Presen
t:NOInitial Entry
090177e196ae3d58\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-2021-5683-0938696
Page 188 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.i Symptoms:
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-13-2020 10:50:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938697
Page 189 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Oct-13-2020 10:50:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-13-2020 10:50:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Oct-13-2020 10:50:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-13-2020 10:50:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Device Type:
Date Location User Value Reason
Oct-13-2020 10:50:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Trade Name:
090177e196ae3d58\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-2021-5683-0938698
Page 190 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Oct-13-2020 10:50:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
7. Test Result:
Date Location User Value Reason
Oct-13-2020 10:50:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Oct-13-2020 10:50:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Oct-13-2020 10:50:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3d58\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-2021-5683-0938699
Page 191 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - 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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-13-2020 10:52:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020 10:52:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020 17:36:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-13-2020 23:27:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-13-2020 10:52:59
(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.
Oct-13-2020 10:52:59
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0938700
Page 192 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - 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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada) Date of Collection:
Oct/12/2020
5.a
Date Location User Value Reason
Oct-14-2020 17:36:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: CV04139Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-14-2020 17:36:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CV04139Initial Entry
090177e196ae3d58\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-2021-5683-0938701
Page 193 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: 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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-13-2020 10:53:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020 10:53:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020 10:53:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-13-2020 10:53:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
subject submitted self swabInitial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938702
Page 194 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.a
Date Location User Value Reason
Oct-13-2020 10:54:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner
:SPECIA
LIST
Occurrence of Visit
s or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Oct-13-2020 10:54:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-13-2020 10:54:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Oct-13-2020 10:54:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitio
ner:EMERGEN
CY ROOM
Occurrence of V
isits or Contacts
:NOInitial Entry
090177e196ae3d58\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-2021-5683-0938703
Page 195 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Oct-13-2020 10:54:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-13-2020 10:54:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Oct-13-2020 10:54:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practi
tioner:PRIMARY C
ARE PHYSIC
IAN
Occurrence of
Visits or Cont
acts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Oct-13-2020 10:54:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CARE PHYSICIA
NInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-13-2020 10:54:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d58\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-2021-5683-0938704
Page 196 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.d
Date Location User Value Reason
Oct-13-2020 10:54:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practition
er:URGENT
CARE
Occurrence of Visi
ts or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-13-2020 10:54:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-13-2020 10:54:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Oct-13-2020 10:54:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practi
tioner:TELEPHONE
CONSULTAT
ION
Occurrence of
Visits or Cont
acts:NOInitial Entry
090177e196ae3d58\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-2021-5683-0938705
Page 197 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Oct-13-2020 10:54:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
TELEPHONE CONSULTATIO
NInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-13-2020 10:54:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Oct-13-2020 10:54:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits o
r Contacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Oct-13-2020 10:54:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-13-2020 10:54:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
090177e196ae3d58\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-2021-5683-0938706
Page 198 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-13-2020 10:54:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938707
Page 199 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Oct-13-2020 10:54:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLN
ESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Oct-13-2020 10:54:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Oct-13-2020 10:54:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938708
Page 200 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/11/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-11-2020 15:06:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/11/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-11-2020 15:06:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COVID_A1Initial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938709
Page 201 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/11/2020Form: 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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-11-2020 15:06:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-11-2020 15:06:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-12-2020 09:32:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-11-2020 17:24:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-11-2020 15:06:09
(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.
Nov-11-2020 15:06:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938710
Page 202 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/11/2020Form: 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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Nov/11/2020
5.a
Date Location User Value Reason
Nov-12-2020 09:32:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRFZGGInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-12-2020 09:32:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRFZGGInitial Entry
5.b
Date Location User Value Reason
Nov-12-2020 09:32:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSJV55Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-12-2020 09:32:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSJV55Initial Entry
5.c
Date Location User Value Reason
Nov-12-2020 09:33:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSJV54Initial Entry
090177e196ae3d58\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-2021-5683-0938711
Page 203 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/11/2020Form: 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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.c Sample ID
Date Location User Value Reason
Nov-12-2020 09:33:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSJV54Initial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938712
Page 204 of 249
***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: 11351143 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
Oct-07-2020 15:01:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-07-2020 15:01:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-07-2020 15:01:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938713
Page 205 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Oct-23-2020 08:48:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938714
Page 206 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Nov-06-2020 11:51:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938715
Page 207 of 249
***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: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Nov-24-2020 14:56:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938716
Page 208 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category:
Date Location User Value Reason
Oct-23-2020 08:48:57
(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-23-2020 08:48:57
(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
Nov-04-2020 06:05:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response satisfies
query
Nov-03-2020 17:22:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject has a
throat swab that
was Negative on
15OCT2020. This
is in the SAE
follow up report
Nov-01-2020 18:05:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Kindly confirm if
any SARS-CoV-2
(NAAT or other)
tests were
performed on the
SAE submitted to
safety. If test
performed = YES,
please provide FU
report with results.
If test was NOT
done or NOT
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0938717
Page 209 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
available, please
FU as well. Thanks
Oct-23-2020 08:48:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
acute cholecystitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-27-2020 19:48:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-27-2020 16:03:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Start date has been
updated
Oct-27-2020 16:03:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020 UNK:UNKStart date has been
updated
Oct-26-2020 23:19:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened SAE RECON 1:
Please confirm if the
follow up AEM form
was sent to update
the onset date in
Safety database.
Oct-26-2020 11:20:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered subject stomach pain
started on
14OCT2020 and
became severe, so
subject went to
hospital and was
admitted on
15OCT2020.
Oct-25-2020 05:09:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2020411501
acute
cholecystitis>,onset
date was reported as
14Oct2020 in Safety
database however,
090177e196ae3d58\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-2021-5683-0938718
Page 210 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
recorded as
15Oct020 on AE
CRF. Please confirm
correct Onset Date.
If safety update is
required, please
submit a follow-up
SAE form.
Oct-23-2020 08:48:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/15/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-23-2020 08:48:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/17/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-23-2020 08:48:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial 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-24-2020 06:56:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
090177e196ae3d58\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-2021-5683-0938719
Page 211 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-23-2020 08:48:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE acute
cholecystitis:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Oct-23-2020 08:48:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant dis
ability/incapacity?
NO
Is this serious event life threa
tening?
NO
Other medically important se
rious event
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
090177e196ae3d58\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938720
Page 212 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-23-2020 08:48:57
(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
Oct-27-2020
13:18:01
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clos
edResponse
satisfies query
Oct-26-2020
19:32:30
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Ans
weredOriginal value
is correct
Oct-26-2020
15:53:14
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
2: Ope
nedPlease review
"If not related
to study
treatment
other" field,
the following
text was
indicated in
the comment
field
[gallstones].
Any
symptoms,
AEs or other
key data
should be
collected on
the adverse
event page.
090177e196ae3d58\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-2021-5683-0938721
Page 213 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Please review
and update as
necessary.
Oct-26-2020
13:43:18
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Quan Jason Gong Query
1: Clos
edResponse
satisfies query
Oct-26-2020
11:36:44
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredSAE report
mentions
gallbladder
inflammation.
Per PI,
possibly
related to
gallstones.
pending
medical
records.
Oct-26-2020
10:41:26
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Quan Jason Gong Query
1: Ope
nedGPDClin:
Gallstones
were not
mentioned in
the SAE
report or
MHx. Please
clarify if it
was the cause
of the SAE.
Oct-23-2020
08:48:57
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
NOT R
ELATE
D
If Not
Relat
ed to
studyInitial Entry
090177e196ae3d58\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)
FDA-CBER-2021-5683-0938722
Page 214 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
treat
ment(
s), thi
s even
t is du
e to:
OT
HE
R
If
Ot
her
, s
pe
cif
y:
g
a
ll
st
o
n
e
s
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-23-2020 08:48:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0
…[truncated]