125742 S1 M5 CRF c4591001 1270 12701069

Document text

Page 1 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839522
Page 2 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/4/2020
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839523
Page 3 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12701069]
2.Birth Date: /1989
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): AMERICAN INDIAN OR ALASKA NATIVE
6.Racial Designation:
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839524
Page 4 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839525
Page 5 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839526
Page 6 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839527
Page 7 of 157
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Genital Herpes Simplex]
Start Date: Jul/30/2020
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cyclothymic Disorder]
Start Date: Apr/17/2020
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Acne Vulgaris]
Start Date: Aug/16/2019
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anal Skin Tag]
Start Date: Aug/21/2018
Ongoing: YES
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839528
Page 8 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Intermittent Asthma]
Start Date: Mar/23/2017
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic Rhinitis]
Start Date: Mar/23/2017
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Intermittent Sinus Headache]
Start Date: Oct/25/2019
Ongoing: YES
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839529
Page 9 of 157
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
2.Weight: [107.7]
3.Unit: kg
4.Height: [170.2]
5.Unit: cm
6.Body Mass Index: [37.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839530
Page 10 of 157
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/4/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839531
Page 11 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/4/2020
2.Randomization Number: [82068]
3.Randomization Group: [ ]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839532
Page 12 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
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 [BP1FD2]
5.bSample ID [BP1FD3]
5.cSample ID [BP1FD4]
5.dSample ID [BPJ34N]
5.eSample ID [BPJ34P]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839533
Page 13 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
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 [BP1DWZ]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839534
Page 14 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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/4/2020 11:52
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
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839535
Page 15 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839536
Page 16 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839537
Page 17 of 157
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/30/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839538
Page 18 of 157
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/30/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839539
Page 19 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/30/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1F1M]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839540
Page 20 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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/30/2020 15:56
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
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839541
Page 21 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/28/2020
2.Erroneous Visit
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839542
Page 22 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/28/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRFF2W]
5.bSample ID [BPJ2S0]
5.cSample ID [BPJ2SF]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839543
Page 23 of 157
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839544
Page 24 of 157
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839545
Page 25 of 157
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839546
Page 26 of 157
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839547
Page 27 of 157
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839548
Page 28 of 157
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839549
Page 29 of 157
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839550
Page 30 of 157
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839551
Page 31 of 157
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839552
Page 32 of 157
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839553
Page 33 of 157
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839554
Page 34 of 157
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839555
Page 35 of 157
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839556
Page 36 of 157
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839557
Page 37 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839558
Page 38 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839559
Page 39 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/28/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839560
Page 40 of 157
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death :Jan/13/2021
2.Phase of Disposition: FOLLOW-UP
3.Status: PROTOCOL DEVIATION
4.Specify Status: [RECEIVED COVID 19 VACCINE OUTSIDE OF STUDY - PFIZER
BIONTECH COVID-19 VACCINE 31DEC2020]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839561
Page 41 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839562
Page 42 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839563
Page 43 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  APPENDICITIS  Sep/20/2020
21:00 NO
End Date Time:
Sep/22/2020 10:19
 Repeating
Pages
 2.ADVERSE E
VENT 2  Elevated Cholesterol  Oct/8/2020 1
8:41 YES  Repeating
Pages
 3.ADVERSE E
VENT 3  Elevated Low-Density
Lipoprotein Oct/8/2020 1
8:41 YES  Repeating
Pages
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839564
Page 44 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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)[APPENDICITIS]
4.Start Date Time: Sep/20/2020 21:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/22/2020 10:19
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?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
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
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839565
Page 45 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[UNKNOWN]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?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[2020369295]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839566
Page 46 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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)[Elevated Cholesterol]
4.Start Date Time: Oct/8/2020 18:41
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).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
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839567
Page 47 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839568
Page 48 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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)[Elevated Low-Density Lipoprotein]
4.Start Date Time: Oct/8/2020 18:41
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).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
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839569
Page 49 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839570
Page 50 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839571
Page 51 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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[ ]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839572
Page 52 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of MedicationStart
DateForm Instan
ce
 1.1  VACCINATI
ONS NO  Flulaval Quadrivalent 2020-2
021 PF (Influenza Vaccine) Oct/28/
2020 Repeating
Pages
 2.2  VACCINATI
ONS NO  Pfizer Biontech Covid 19 mR
NA Vaccine Dec/31
/2020 Repeating
Pages
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839573
Page 53 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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).[Flulaval Quadrivalent 2020-2021 PF (Influenza Vaccine)]
5.Date: Oct/28/2020
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839574
Page 54 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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).[Pfizer Biontech Covid 19 mRNA Vaccine]
5.Date: Dec/31/2020
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839575
Page 55 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839576
Page 56 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839577
Page 57 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839578
Page 58 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839579
Page 59 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839580
Page 60 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839581
Page 61 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839582
Page 62 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839583
Page 63 of 157
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839584
Page 64 of 157
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839585
Page 65 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839586
Page 66 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839587
Page 67 of 157
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839588
Page 68 of 157
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839589
Page 69 of 157
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839590
Page 70 of 157
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839591
Page 71 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839592
Page 72 of 157
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is NOT willing to return for Vaccination 3 OR otherwise not
eligible
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839593
Page 73 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/13/2021
2.Primary Reason for Unblinding: OTHER
If other, specify:
[Due to use of non-study Covid 19 Vaccine]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839594
Page 74 of 157
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839595
Page 75 of 157
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839596
Page 76 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Jan/13/2021
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839597
Page 77 of 157
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839598
Page 78 of 157
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Nicola Klein  Approved Mar-09-2021 15:49:39 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NicolaKlein, 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.
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839599
Page 79 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-04-2020 13:26:04 (UTC-08:00) Pacific
Time (US & Canada)Charlie Chao N/A
Not Applicable
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839600
Page 80 of 157
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Nicola Klein  Approved Mar-09-2021 15:49:39 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NicolaKlein, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-29-2021 08:57:52 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Nicola Klein  Approved Jan-22-2021 13:14:09 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NicolaKlein, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-14-2021 15:46:43 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839601
Page 81 of 157
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Affidavit:
N/A
Nicola Klein  Approved Nov-02-2020 15:24:23 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NicolaKlein, 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.
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839602
Page 82 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-04-2020 13:25:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-04-2020 13:25:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
STAGE 3 COHORTSInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839603
Page 83 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-04-2020 13:25:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
OBTAINED
Date Written Consent Obtaine
d
Sep/4/2020Initial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839604
Page 84 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-28-2020
02:21:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed event recorded in AE CRF
Sep-25-2020
08:40:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered DONE
Sep-25-2020
04:08:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Open
edSAE RECON 1: The event
was reported to Pfizer
Safety however, the AE
form is blank and no record
of APPENDICITIS event.
Please confirm and update
AE CRF for the missing
event.
Sep-24-2020
17:38:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Please clarify query - data
is already entered
Sep-24-2020
02:30:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020369295
APPENDICITIS(onset
date:20Sep2020)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.
Sep-04-2020
13:24:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12701069Item copied from previous
form
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (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-2021-5683-0839605
Page 85 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2. Birth Date:
Date Location User Value Reason
Sep-04-2020 13:24:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1989Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-04-2020 13:25:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-04-2020 13:25:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-04-2020 13:25:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
AMERICAN INDIAN OR AL
ASKA NATIVEInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839606
Page 86 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-04-2020 13:25:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Sep/4/2020Initial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839607
Page 87 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-04-2020 13:26:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Sep/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-04-2020 13:26:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-04-2020 13:26:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
COMPLETEDInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839608
Page 88 of 157
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Sep-04-2020 13:26:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Genital Herpes
Simplex
Start Date: Jul/30/2020
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-04-2020 13:26:53
(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
Sep-04-2020 13:26:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Genital Herpes SimplexInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-04-2020 13:26:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Jul/30/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-04-2020 13:26:53
(UTC-08:00) PacificACV0PFEINFP6000  Charlie
ChaoData Entry:
YESInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839609
Page 89 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada)
1.b
Date Location User Value Reason
Sep-04-2020 13:27:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Cyclothymic
Disorder
Start Date: Apr/17/2020
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-04-2020 13:27:20
(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
Sep-04-2020 13:27:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Cyclothymic DisorderInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-04-2020 13:27:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Apr/17/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-04-2020 13:27:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
YESInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839610
Page 90 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.c
Date Location User Value Reason
Sep-04-2020 13:27:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Acne Vulg
aris
Start Date: Aug/16/20
19
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Sep-04-2020 13:27:47
(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
Sep-04-2020 13:27:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Acne VulgarisInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-04-2020 13:27:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Aug/16/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-04-2020 13:27:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
YESInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839611
Page 91 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.d
Date Location User Value Reason
Sep-04-2020 13:28:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:Anal Skin
Tag
Start Date: Aug/21/20
18
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Sep-04-2020 13:28:13
(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
Sep-04-2020 13:28:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Anal Skin TagInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-04-2020 13:28:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Aug/21/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-04-2020 13:28:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
YESInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839612
Page 92 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.e
Date Location User Value Reason
Sep-04-2020 13:28:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:Intermittent A
sthma
Start Date: Mar/23/2017
Ongoing: YESInitial Entry
1.e Line/MH Number:
Date Location User Value Reason
Sep-04-2020 13:28:37
(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
Sep-04-2020 13:28:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Intermittent AsthmaInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-04-2020 13:28:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Mar/23/2017Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-04-2020 13:28:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
YESInitial Entry
1.f
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839613
Page 93 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-04-2020 13:29:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6
Medical History
Term:Allergic Rhi
nitis
Start Date: Mar/23/201
7
Ongoing: YESInitial Entry
1.f Line/MH Number:
Date Location User Value Reason
Sep-04-2020 13:29:02
(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
Sep-04-2020 13:29:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Allergic RhinitisInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-04-2020 13:29:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Mar/23/2017Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-04-2020 13:29:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
YESInitial Entry
1.g
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839614
Page 94 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-11-2020 11:48:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:7
Medical Hist
ory Term:Intermittent Si
nus Headache
Start Date: Oct/25/2019
Ongoing: YESNew Information
Sep-04-2020 13:29:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:7
Medical History
Term:Sinus Head
ache
Start Date: Oct/25/201
9
Ongoing: YESInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839615
Page 95 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.g Line/MH Number:
Date Location User Value Reason
Sep-04-2020 13:29:26
(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
Sep-11-2020 11:48:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Intermittent Sinus HeadacheNew Information
Sep-04-2020 13:29:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Sinus HeadacheInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-04-2020 13:29:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Oct/25/2019Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-14-2020 11:09:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-11-2020 11:49:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered NO headache at
time of enrollment,
inclusion criteria
#3 met
Sep-08-2020 14:38:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Please confirm if
Sinus Headache
was Ongoing at
Screening, and
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839616
Page 96 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
ensure Inclusion
Criteria #3 was
met.
Sep-04-2020 13:29:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie Chao Data Entry:
YESInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839617
Page 97 of 157
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020 13:30:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Sep/4/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-04-2020 13:30:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
107.7Initial Entry
3. Unit:
Date Location User Value Reason
Sep-04-2020 13:30:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-04-2020 13:30:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
170.2Initial Entry
5. Unit:
Date Location User Value Reason
Sep-04-2020 13:30:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839618
Page 98 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-04-2020 13:30:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
37.2Initial Entry
7.a
Date Location User Value Reason
Sep-04-2020 13:30:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Record Identifier
::1
Temperature: 98.6
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-04-2020 13:30:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-04-2020 13:30:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
98.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-04-2020 13:30:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839619
Page 99 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-04-2020 13:30:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
ORAL CAVITYInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839620
Page 100 of 157
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-04-2020 13:30:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-04-2020 13:30:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-04-2020 13:30:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Sep/4/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-04-2020 13:30:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-04-2020 13:30:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839621
Page 101 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-04-2020 13:30:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-04-2020 13:30:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-04-2020 13:30:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Sep-04-2020 13:30:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
NEGATIVEInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839622
Page 102 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-04-2020 13:30:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Sep/4/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-04-2020 13:30:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
82068Initial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839623
Page 103 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020 13:30:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020 13:30:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020 13:31:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-04-2020 13:30:58
(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-04-2020 13:30:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839624
Page 104 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-04-2020 13:31:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Sample ID: BP1FD2Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-04-2020 13:31:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
BP1FD2Initial Entry
5.b
Date Location User Value Reason
Sep-04-2020 13:31:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Sample ID: BP1FD3Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-04-2020 13:31:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
BP1FD3Initial Entry
5.c
Date Location User Value Reason
Sep-04-2020 13:31:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Sample ID: BP1FD4Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-04-2020 13:31:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
BP1FD4Initial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839625
Page 105 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.d
Date Location User Value Reason
Sep-04-2020 13:31:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Sample ID: BPJ34NInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-04-2020 13:31:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
BPJ34NInitial Entry
5.e
Date Location User Value Reason
Sep-04-2020 13:31:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Sample ID: BPJ34PInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-04-2020 13:31:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
BPJ34PInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839626
Page 106 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020 13:31:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020 13:31:58
(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-04-2020 13:32:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-04-2020 13:31:58
(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-04-2020 13:31:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839627
Page 107 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-04-2020 13:32:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Sample ID: BP1DWZInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-04-2020 13:32:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
BP1DWZInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839628
Page 108 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-04-2020 13:32:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020 13:32:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020 13:32:25
(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-04-2020 13:32:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Sep/4/2020 11:52Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020 13:32:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839629
Page 109 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-04-2020 13:32:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-04-2020 13:32:25
(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-04-2020 13:32:25
(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-04-2020 13:32:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
YESInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839630
Page 110 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-04-2020 13:32:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839631
Page 111 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-07-2020 04:12:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed As per site
confirmation -
updated PD
tracker
Oct-06-2020 11:31:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Subject V2 is out
of window due to
having surgery and
being hospitalized.
Subject was
recovering from
her surgery during
the V2 window
Oct-06-2020 04:41:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened PDQ: DOV at this
visit is out of
window (3 day)
from DOV
(04/Sep/2020) at
V1D1VX1L.
Please either
update DOV or
confirm whether
visit is out of
window due to
temporary delay of
vaccination/ else
provide details as
appropriate.
Sep-30-2020 17:12:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
Sep-30-2020 02:27:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-29-2020 10:42:16 ACV0PFEINFP6000  Query 1: Answered V2 has not taken
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839632
Page 112 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00) Pacific
Time (US & Canada)place
Sep-29-2020 07:48:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly
review and
complete ‘Date of
Visit, Nasal Swab,
Pregnancy Test,
Vaccination, Vital
Signs' forms at this
visit. Thank you.
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0839633
Page 113 of 157
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Sep-30-2020 17:13:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
2.a
Date Location User Value Reason
Sep-30-2020 17:13:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 97.4
Temperature U
nit:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-30-2020 17:13:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-30-2020 17:13:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-30-2020 17:13:19 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839634
Page 114 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00) Pacific
Time (US & Canada)F
2.a Temperature Location:
Date Location User Value Reason
Sep-30-2020 17:13:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839635
Page 115 of 157
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-30-2020 17:13:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-30-2020 17:13:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-30-2020 17:13:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-30-2020 17:13:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-30-2020 17:13:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839636
Page 116 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-30-2020 17:13:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-30-2020 17:13:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-30-2020 17:13:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX
113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-30-2020 17:13:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839637
Page 117 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-30-2020 17:14:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-30-2020 17:14:08
(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-30-2020 17:14:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
Sep-30-2020 17:14:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1F1MInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-30-2020 17:14:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1F1MInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839638
Page 118 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-30-2020 17:14:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-30-2020 17:14:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-30-2020 17:14:24
(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-30-2020 17:14:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020 15:56Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-30-2020 17:14:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839639
Page 119 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-30-2020 17:14:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-30-2020 17:14:24
(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-30-2020 17:14:24
(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-30-2020 17:14:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839640
Page 120 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-28-2020 16:52:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Oct/28/2020Initial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839641
Page 121 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020 16:52:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020 16:52:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020 16:52:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-28-2020 16:52:33
(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-28-2020 16:52:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
YES
Date of Collection:
Oct/28/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839642
Page 122 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-28-2020 16:52:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Sample ID: BRFF2WInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-28-2020 16:52:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
BRFF2WInitial Entry
5.b
Date Location User Value Reason
Oct-28-2020 16:52:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Sample ID: BPJ2S0Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-28-2020 16:52:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
BPJ2S0Initial Entry
5.c
Date Location User Value Reason
Oct-28-2020 16:53:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Sample ID: BPJ2SFInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-28-2020 16:53:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
BPJ2SFInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839643
Page 123 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-28-2020 16:53:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Oct/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-28-2020 16:53:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-28-2020 16:53:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
COMPLETEDInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839644
Page 124 of 157
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-18-2021 14:24:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/13/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-18-2021 14:24:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Jan-18-2021 14:24:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PROTOCOL DEVIATIONInitial Entry
4. Specify Status:
Date Location User ValueReason
Jan-21-2021
08:05:49
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse
satisfies query
Jan-20-2021
15:13:09
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dNew
Information
Jan-20-2021 ACV0PFEINFP6000  DataNew
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839645
Page 125 of 157
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
15:13:09
(UTC-08:00)
Pacific Time
(US &
Canada)Entry
:
RECE
IVED
COVI
D 19
VAC
CINE
OUT
SIDE
OF S
TUD
Y - P
FIZE
R BI
ONT
ECH
COVI
D-19
VAC
CINE
31DE
C202
0Information
Jan-19-2021
02:55:10
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Op
enedPlease review
Specify Status
field, the
following text
was indicated
in the comment
field [covid].
Vaccination
data should be
collected on the
CONMED
VAX page.
Please review
and update as
necessary.
Jan-18-2021
14:24:58ACV0PFEINFP6000  Data
EntryInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839646
Page 126 of 157
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time
(US &
Canada):
RECE
IVED
COVI
D 19
VAC
CINE
OUT
SIDE
OF S
TUD
Y
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839647
Page 127 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Sep-25-2020 08:41:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839648
Page 128 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Oct-29-2020 11:25:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839649
Page 129 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Oct-29-2020 11:27:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839650
Page 130 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Sep-25-2020 08:41:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-25-2020 08:41:29
(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
Oct-23-2020 21:16:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Appreciate the
prompt response.
Thank you.
Oct-22-2020 12:42:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered FOLLOW UP
SAE SENT
Oct-21-2020 08:23:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened COVID testing
has not been
reported in the
SAE submitted to
safety. Please
submit a
follow-up SAE
form to provide
whether COVID
testing was
performed
(yes/no) and if
yes, the results.
Thank you.
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839651
Page 131 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-25-2020 08:41:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
APPENDICITISInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-25-2020 08:41:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/20/2020 21:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-25-2020 08:41:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/22/2020 10:19Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-25-2020 08:41:29
(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
Sep-30-2020 00:42:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Sep-28-2020 10:59:25
(UTC-08:00) PacificACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Answer Auto Query
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (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-2021-5683-0839652
Page 132 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada)
Sep-28-2020 10:59:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associ
ated with congenital anom
aly or birth defect?
NO
Did this serious event resul
t in death?
NO
Did this serious event requ
ire or prolong hospitalizati
on?
NO
Did this serious event resul
t in persistent or significant
disability/incapacity?
NO
Is this serious event life thr
eatening?
NO
Other medically important
serious event
YESNew Information
Sep-28-2020 02:20:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-27-2020 01:38:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened RQ-1: Thanks for
checking OTHER
MEDICALLY
IMPORTANT
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839653
Page 133 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
SERIOUS EVENT
as Yes. Kindly
update other
criteria's with
response either 'Yes'
or 'No'. Thank you
Sep-25-2020 08:42:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered PLEASE CLARIFY
QUERY - OTHER
MEDICALLY
IMPORTANT
SERIOUS EVENT
IS MARKED YES
Sep-25-2020 08:41:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Is this adverse event
serious?' is reported
'Yes', but at least
one seriousness
criteria is missing.
Please review and
update as
appropriate.
Sep-25-2020 08:41:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
APPENDICITIS:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Sep-25-2020 08:41:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Other medically important
serious event
YESInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-25-2020 08:41:29 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839654
Page 134 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00) Pacific
Time (US & Canada)NO
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-25-2020 08:41:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
UNKNOWNInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-25-2020 08:41:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-25-2020 08:41:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-25-2020 08:41:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (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-2021-5683-0839655
Page 135 of 157
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-25-2020 08:41:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-25-2020 08:41:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-28-2020 02:20:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020369295Initial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0839656
Page 136 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Oct-29-2020 11:25:31
(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-29-2020 11:25:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-29-2020 11:25:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Elevated CholesterolInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-29-2020 18:32:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/8/2020 18:41Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-21-2021 05:08:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-20-2021 15:14:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered REMAINS
ONOING
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0839657
Page 137 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Jan-18-2021 14:24:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is
still ongoing.
Please review and
update as
appropriate.
Oct-29-2020 11:25:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-29-2020 11:25:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-29-2020 11:25:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-29-2020 12:08:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839658
Page 138 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-29-2020 11:25:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
UnknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-29-2020 11:25:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-29-2020 11:25:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-29-2020 11:25:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-29-2020 11:25:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RE
SOLVEDInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (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-2021-5683-0839659
Page 139 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-29-2020 11:25:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839660
Page 140 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Oct-29-2020 11:27:01
(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-29-2020 11:27:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-29-2020 11:27:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Elevated Low-Density Lipopr
oteinInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-29-2020 18:33:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/8/2020 18:41Transcription Error
Oct-29-2020 11:27:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/8/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-20-2021 21:06:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839661
Page 141 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Jan-20-2021 15:14:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered REMAINS
ONOING
Jan-18-2021 14:24:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up form is
completed and
this Adverse
Event is still
ongoing. Please
review and update
as appropriate.
Oct-29-2020 11:27:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-29-2020 11:27:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-29-2020 11:27:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-29-2020 11:27:01
(UTC-08:00) PacificACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839662
Page 142 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada)
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-29-2020 11:27:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
UnknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-29-2020 11:27:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-29-2020 11:27:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-29-2020 11:27:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839663
Page 143 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-29-2020 11:27:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-29-2020 18:33:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839664
Page 144 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Oct-28-2020 16:53:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Charlie
ChaoForm Created
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839665
Page 145 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Jan-20-2021 15:13:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839666
Page 146 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Oct-28-2020 16:53:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Oct-28-2020 16:53:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Oct-28-2020 16:53:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Oct-28-2020 16:53:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Flulaval Quadrivalent 2020-202
1 PF (Influenza Vaccine)Initial Entry
5. Date:
Date Location User Value Reason
Oct-28-2020 16:53:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Charlie
ChaoData Entry:
Oct/28/2020Initial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839667
Page 147 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Jan-20-2021 15:13:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
2. Category:
Date Location User Value Reason
Jan-20-2021 15:13:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Jan-20-2021 15:13:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Jan-20-2021 15:13:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Pfizer Biontech Covid 19 mRN
A VaccineInitial Entry
5. Date:
Date Location User Value Reason
Jan-20-2021 15:13:52
(UTC-08:00) PacificACV0PFEINFP6000  Data Entry:
Dec/31/2020Initial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839668
Page 148 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada)
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839669
Page 149 of 157
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-14-2021 15:46:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/13/2021Initial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839670
Page 150 of 157
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-14-2021 15:47:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is NOT willing to r
eturn for Vaccination 3 OR oth
erwise not eligibleInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839671
Page 151 of 157
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Mar-02-2021 05:55:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Reminder email is
sent to  To be
marked as
Irreconcilable post
her confirmation.
Feb-18-2021 05:31:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidat
ePending guidance
form Team
Feb-16-2021 10:15:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Please clarify
query - this is the
EXACT response
we were given by
Pfizer DM to
answer these
queries, according
to the email
received from DM
"On DM side, we
can document this
as a reconciliation
discrepancy in our
DM Issues Log"
Feb-16-2021 04:52:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened IVRS RQ2: Thank
you for response.
Please confirm date
in Inform when the
subject was
unblinded. If on
09Feb2021, update
Inform
accordingly. Thank
you.
Feb-12-2021 14:12:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Per Pfizer
Direction - The
Unblinding was
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (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)
FDA-CBER-2021-5683-0839672
Page 152 of 157
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
performed using
Form 1 on
13JAN2021 and
Unblinding in
Impala was
performed later on
09FEB2021
Feb-11-2021 22:55:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened IVRS
Reconciliation
RQ1: Thanks for
response. Date
Blind broken
09Feb2021 at
Impala is not
matching with Date
treatment
Unblinded
13Jan2021. Please
review and update
the data with the
help of CRA. Else,
clarify.
Feb-10-2021 09:17:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Please clarify
query = There is no
place in Impala to
document the
unblinding.
Direction from
Pfizer was not
given until
09FEB2021
Feb-09-2021 22:51:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened IVRS
Reconciliation:
Date Blind broken
09Feb2021 at
Impala is not
matching with Date
treatment
Unblinded
13Jan2021. Please
check and update
data as appropriate.
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839673
Page 153 of 157
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Else, clarify. Thank
you.
Jan-14-2021 15:46:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/13/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-10-2021 21:27:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Feb-10-2021 09:12:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Please clarify
query = There is no
place in Impala to
document the
unblinding.
Direction from
Pfizer was not
given until
09FEB2021
Feb-09-2021 23:11:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened IVRS RQ2:
BLIND BROKEN?
Is marked as ‘No’
at IMPALA and
TREATMENT
UNBLINDED
form is completed
in inform. Please
verify and consider
updating consistent
data. Thank you.
Feb-09-2021 16:40:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Treatment
unblinding has
been done in
Impala
Feb-03-2021 01:02:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened DM:Please contact
your CRA to have
instructions on how
to break the blind
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (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-2021-5683-0839674
Page 154 of 157
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
in Impala. This is
required since the
reason for
unblinding is
OTHER. Thank
you.
Feb-02-2021 15:48:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered We need some
specific guidance
for completing the
INFORM screens.
Subject received
Covid vaccine
outside the study
BEFORE being
unblinded. We do
not understand
what is being asked
& cannot move
forward without
some clarification.
Feb-01-2021 01:18:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened IVRS
Reconciliation:
BLIND BROKEN?
Is marked as ‘No’
at IMPALA but
TREATMENT
UNBLINDED
form is completed.
Please confirm if
Blind was broken
at Impala or
outside Impala
with detailed
comment. Thank
you.
Jan-29-2021 10:16:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Jan-29-2021 08:57:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839675
Page 155 of 157
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Jan-29-2021 08:57:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHER
If other, specify:
Due to use of non-study
Covid 19 VaccineNew Information
Jan-28-2021 07:51:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Please clarify
reason for unblind.
If treatment
unblind was
performed due to
use of (or planned
use of) non-study
covid-19 vaccine
(and not for the
purposes of study
revaccination),
please update
status to OTHER
Jan-27-2021 08:22:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Candidate CLINQUERY:
Please clarify
reason for unblind.
If treatment
unblind was
performed due to
use of (or planned
use of) non-study
covid-19 vaccine
(and not for the
purposes of study
revaccination),
please update
status to OTHER
Jan-14-2021 15:46:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FO
R ADDITIONAL VACCIN
ATIONInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839676
Page 156 of 157
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject Status
Date Location User Value Reason
Jan-18-2021 14:24:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-28-2020 16:53:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-04-2020 13:30:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-04-2020 13:26:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jan-18-2021 14:24:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Jan/13/2021Initial Entry
Oct-28-2020 16:53:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/28/2020Initial Entry
Sep-04-2020 13:30:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
Sep-04-2020 13:26:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839677
Page 157 of 157
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701069 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-02-2020 14:34:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ad2feb\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0839678