125742 S1 M5 CRF c4591001 1265 12651101

Document text

Page 1 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838316
Page 2 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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/11/2020
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838317
Page 3 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12651101]
2.Birth Date: /1973
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838318
Page 4 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/11/2020
2.Erroneous Visit
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838319
Page 5 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838320
Page 6 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/11/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838321
Page 7 of 331
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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:[Syncope and collapse]
Start Date: Oct/7/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sinus tachycardia]
Start Date: Jun/5/2007
Ongoing: NO
End Date:
UNK/UNK/2007
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Single seizure, unspecified type]
Start Date: Jun/5/2007
Ongoing: NO
End Date:
Jun/5/2007
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Major depressive disorder, recurrent episode]
Start Date: Jan/25/2007
Ongoing: YES
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838322
Page 8 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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:[Irritable bowel syndrome]
Start Date: Jun/17/2004
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastroesophageal reflux disease]
Start Date: Apr/10/2006
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Generalized anxiety disorder]
Start Date: Feb/28/2008
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Overactive bladder]
Start Date: Aug/6/2010
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fibromyalgia]
Start Date: Nov/2/2007
Ongoing: YES
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838323
Page 9 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fatty liver]
Start Date: Oct/18/2006
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetes mellitus, type 2]
Start Date: May/26/2011
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bipolar 1 disorder, mixed, moderate]
Start Date: Jan/26/2010
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic abdominal pain]
Start Date: Aug/17/2006
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic kidney disease, stage 2]
Start Date: Feb/11/2014
Ongoing: YES
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838324
Page 10 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Dyslipidemia]
Start Date: Jun/27/2013
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastroparesis]
Start Date: Dec/31/2014
Ongoing: YES
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Peripheral neuropathy]
Start Date: May/3/2013
Ongoing: YES
1.rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: Jan/19/2017
Ongoing: YES
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: Aug/16/2016
Ongoing: YES
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838325
Page 11 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Benign fasciculation cramp syndrome]
Start Date: Aug/30/2013
Ongoing: YES
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic pancreatitis]
Start Date: Jan/19/2017
Ongoing: YES
1.vLine/MH Number: [22]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Obesity]
Start Date: Apr/13/2011
Ongoing: YES
1.wLine/MH Number: [23]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right blepharospasm]
Start Date: Oct/9/2014
Ongoing: YES
1 xLine/MH Number: [24]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Colonoscopy with biopsy]
Start Date: Nov/15/2010
Ongoing: NO
End Date:
Nov/15/2010
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838326
Page 12 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.yLine/MH Number: [25]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Colonoscopy with biopsy]
Start Date: Jul/8/2014
Ongoing: NO
End Date:
Jul/8/2014
1.zLine/MH Number: [26]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fallopian tube ligation]
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1998
1.aaLine/MH Number: [27]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Laparoscopic hysterectomy]
Start Date: Dec/12/2013
Ongoing: NO
End Date:
Dec/12/2013
1.abLine/MH Number: [28]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Laparascopic lysis of intra-abdominal adhesion]
Start Date: May/15/2015
Ongoing: NO
End Date:
May/15/2015
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838327
Page 13 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.acLine/MH Number: [29]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Laparascopic salpingectomy (bilateral)]
Start Date: Dec/12/2013
Ongoing: NO
End Date:
Dec/12/2013
1.adLine/MH Number: [30]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diagnostic laparoscopy]
Start Date: May/15/2015
Ongoing: NO
End Date:
May/15/2015
1.aeLine/MH Number: [31]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Drug allergy - Nexium [Esomeprazole Magnesium]]
Start Date: Jan/17/2008
Ongoing: YES
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838328
Page 14 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/11/2020
2.Weight: [81.0]
3.Unit: kg
4.Height: [149.9]
5.Unit: cm
6.Body Mass Index: [36.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838329
Page 15 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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/11/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838330
Page 16 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/11/2020
2.Randomization Number: [88271]
3.Randomization Group: [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838331
Page 17 of 331
***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, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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/11/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP956J]
5.bSample ID [BP956K]
5.cSample ID [BP956L]
5.dSample ID [BMNCC1]
5.eSample ID [BMNCC2]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838332
Page 18 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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/11/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP950Y]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838333
Page 19 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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/11/2020 12:02
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838334
Page 20 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838335
Page 21 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838336
Page 22 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838337
Page 23 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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:
Not Done: NOT DONE
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838338
Page 24 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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 [BPY4BL]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838339
Page 25 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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 11:53
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838340
Page 26 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838341
Page 27 of 331
***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, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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:
Nov/11/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Date of Visit differs from Date of Collection because the participant was a No Show
for their lab appointment scheduled for 11/06/20. The lab appointment was rescheduled
to and completed on 11/11/20.]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9YZ2]
5.bSample ID [BMNN2F]
5.cSample ID [BMNN2G]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838342
Page 28 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/2/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838343
Page 29 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/2/2020
2.Date of First Symptom Started: Oct/27/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/6/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838344
Page 30 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Co
llectionSpecimen Typ
eSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
 1.Nov/2/2020
 SWABBED M
ATERIAL NASOPHARYNX  SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838345
Page 31 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/2/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [CLIA certified laboratory]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838346
Page 32 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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_SELF
3.Sample Collected? YES
Date of Collection:
Nov/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 [CV01558]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838347
Page 33 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Telephone visit was conducted; subject did not come on site for nasal swab.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838348
Page 34 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838349
Page 35 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838350
Page 36 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838351
Page 37 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838352
Page 38 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838353
Page 39 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838354
Page 40 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
 1.       Sponsor-Defined Ident
ifierTest
:Resul
t:Repeating
Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838355
Page 41 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838356
Page 42 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for La
b TestVendor Name (DER
IVED)Collection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838357
Page 43 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838358
Page 44 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838359
Page 45 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838360
Page 46 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838361
Page 47 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838362
Page 48 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838363
Page 49 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838364
Page 50 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838365
Page 51 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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.Start Date: //
6.Ongoing?
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838366
Page 52 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838367
Page 53 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/02/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838368
Page 54 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/11/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838369
Page 55 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/11/2020
2.Date of First Symptom Started: Dec/10/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/10/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Chest pain]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838370
Page 56 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.bSymptoms - Other Text: [Dizzyness]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838371
Page 57 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Collectio
nSpecimen Typ
eSpecimen Collection Locati
onAssay Code and Descripti
onDevice Typ
eForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838372
Page 58 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838373
Page 59 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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_SELF
3.Sample Collected? YES
Date of Collection:
Dec/17/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RR08237]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838374
Page 60 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Subject will collect nasal self-swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838375
Page 61 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?NO
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838376
Page 62 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838377
Page 63 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838378
Page 64 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838379
Page 65 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838380
Page 66 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838381
Page 67 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
 1.       Sponsor-Defined Ident
ifierTest
:Resul
t:Repeating
Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838382
Page 68 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838383
Page 69 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for La
b TestVendor Name (DER
IVED)Collection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838384
Page 70 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838385
Page 71 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838386
Page 72 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838387
Page 73 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838388
Page 74 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838389
Page 75 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838390
Page 76 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838391
Page 77 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838392
Page 78 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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.Start Date: //
6.Ongoing?
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838393
Page 79 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838394
Page 80 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838395
Page 81 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/30/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/30/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838396
Page 82 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/30/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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:
Nov/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 [BR9Z0M]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838397
Page 83 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled Visit
on Jan/08/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/8/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838398
Page 84 of 331
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled Visit
on Jan/08/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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:
Jan/8/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS68N1]
5.bSample ID [BS68N2]
5.cSample ID [BR9Z04]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838399
Page 85 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838400
Page 86 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838401
Page 87 of 331
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/6/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838402
Page 88 of 331
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838403
Page 89 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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:
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838404
Page 90 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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 [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838405
Page 91 of 331
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
 1.ADVERSE EV
ENT 1  Hypoglycemia  Sep/12/2020 UNK:
UNK NO
End Date Time:
Sep/13/2020 UNK:UNK
 Repeating
Pages
 2.ADVERSE EV
ENT 2  Confusion/altered mental
status Sep/28/2020 UNK:
UNK NO
End Date Time:
Sep/29/2020 UNK:UNK
 Repeating
Pages
 3.ADVERSE EV
ENT 3  Abdominal pain  Sep/25/2020 UNK:
UNK NO
End Date Time:
Oct/8/2020 UNK:UNK
 Repeating
Pages
 4.ADVERSE EV
ENT 4  Allergic reaction  Oct/30/2020 UNK:
UNK NO
End Date Time:
Nov/1/2020 UNK:UNK
 Repeating
Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838406
Page 92 of 331
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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)[Hypoglycemia]
4.Start Date Time: Sep/12/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/13/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
CONCOMITANT DRUG TREATMENT
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838407
Page 93 of 331
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020380079]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838408
Page 94 of 331
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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)[Confusion/altered mental status]
4.Start Date Time: Sep/28/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/29/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
CONCOMITANT DRUG TREATMENT
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838409
Page 95 of 331
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838410
Page 96 of 331
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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)[Abdominal pain]
4.Start Date Time: Sep/25/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/8/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Suspected irritable bowel syndrome]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838411
Page 97 of 331
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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[ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838412
Page 98 of 331
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Allergic reaction]
4.Start Date Time: Oct/30/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/1/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[None]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838413
Page 99 of 331
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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[ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838414
Page 100 of 331
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
 1.          Repeating
Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838415
Page 101 of 331
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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[ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838416
Page 102 of 331
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart Dat
eForm Instanc
e
 1.1  VACCINATIONS  NO  Flulaval Quadriv
alent Oct/22/20
20 Repeating
Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838417
Page 103 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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]
5.Date: Oct/22/2020
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838418
Page 104 of 331
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838419
Page 105 of 331
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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?
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838420
Page 106 of 331
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838421
Page 107 of 331
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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?
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838422
Page 108 of 331
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838423
Page 109 of 331
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838424
Page 110 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838425
Page 111 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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:
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838426
Page 112 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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:
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838427
Page 113 of 331
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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?
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838428
Page 114 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838429
Page 115 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838430
Page 116 of 331
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838431
Page 117 of 331
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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 willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838432
Page 118 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/27/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838433
Page 119 of 331
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838434
Page 120 of 331
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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: [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838435
Page 121 of 331
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/16/2021
2.Erroneous Visit
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838436
Page 122 of 331
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/16/2021
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838437
Page 123 of 331
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838438
Page 124 of 331
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Feb/16/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838439
Page 125 of 331
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838440
Page 126 of 331
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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:
Feb/16/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9Z3B]
5.bSample ID [BS68TK]
5.cSample ID [BS68TL]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838441
Page 127 of 331
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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:
Feb/16/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9YT4]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838442
Page 128 of 331
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/16/2021 09:17
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838443
Page 129 of 331
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838444
Page 130 of 331
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838445
Page 131 of 331
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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:
Mar/8/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9Z6T]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838446
Page 132 of 331
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/8/2021 09:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838447
Page 133 of 331
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838448
Page 134 of 331
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838449
Page 135 of 331
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838450
Page 136 of 331
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838451
Page 137 of 331
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838452
Page 138 of 331
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838453
Page 139 of 331
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838454
Page 140 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/6/2020
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838455
Page 141 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838456
Page 142 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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
William Towner  Approved Mar-09-2021 20:07:57 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamTowner, 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.
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838457
Page 143 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-11-2020 14:25:35 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0838458
Page 144 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-11-2020 12:53:53 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838459
Page 145 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-11-2020 12:53:53 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838460
Page 146 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-11-2020 12:53:53 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838461
Page 147 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-11-2020 12:53:53 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838462
Page 148 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-11-2020 12:53:53 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838463
Page 149 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Dec-11-2020 12:53:53 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838464
Page 150 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Dec-11-2020 12:53:53 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838465
Page 151 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Dec-11-2020 12:53:53 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838466
Page 152 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Dec-11-2020 12:53:53 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838467
Page 153 of 331
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Dec-11-2020 12:53:53 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838468
Page 154 of 331
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-16-2021 11:25:14 (UTC-08:00) Pacific Time
(US & Canada)Jasmine Lopez Not Applicable
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838469
Page 155 of 331
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Feb-16-2021 11:26:52 (UTC-08:00) Pacific Time
(US & Canada)Jasmine Lopez Patient is not a female of childbearing potential.
Not Done
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838470
Page 156 of 331
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormMar-08-2021 15:15:37 (UTC-08:00) Pacific Time
(US & Canada)Patient is not a female of childbearing potential.
Not Done
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0838471
Page 157 of 331
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Mar-08-2021 15:15:37 (UTC-08:00) Pacific Time
(US & Canada)Patient is not a female of childbearing potential.
Not Done
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0838472
Page 158 of 331
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Mar-08-2021 15:15:37 (UTC-08:00) Pacific Time
(US & Canada)Patient is not a female of childbearing potential.
Not Done
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0838473
Page 159 of 331
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Mar-08-2021 15:15:37 (UTC-08:00) Pacific Time
(US & Canada)Patient is not a female of childbearing potential.
Not Done
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0838474
Page 160 of 331
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Mar-08-2021 15:15:37 (UTC-08:00) Pacific Time
(US & Canada)Patient is not a female of childbearing potential.
Not Done
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0838475
Page 161 of 331
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Mar-08-2021 15:15:37 (UTC-08:00) Pacific Time
(US & Canada)Patient is not a female of childbearing potential.
Not Done
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0838476
Page 162 of 331
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aMar-08-2021 15:15:37 (UTC-08:00) Pacific Time
(US & Canada)Patient is not a female of childbearing potential.
Not Done
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0838477
Page 163 of 331
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aMar-08-2021 15:15:37 (UTC-08:00) Pacific Time
(US & Canada)Patient is not a female of childbearing potential.
Not Done
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0838478
Page 164 of 331
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aMar-08-2021 15:15:37 (UTC-08:00) Pacific Time
(US & Canada)Patient is not a female of childbearing potential.
Not Done
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0838479
Page 165 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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
William Towner  Approved Mar-09-2021 20:07:57 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamTowner, 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-27-2021 14:45:54 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William Towner  Approved Jan-22-2021 12:26:40 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamTowner, 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-21-2021 09:53:55 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William Towner  Approved Jan-20-2021 18:03:08 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838480
Page 166 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Affidavit:
By my dated signature below, I, WilliamTowner, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-24-2020 09:40:08 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William Towner  Approved Nov-16-2020 08:23:29 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamTowner, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-13-2020 15:09:00 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William Towner  Approved Nov-11-2020 14:26:52 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamTowner, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-11-2020 14:23:24 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838481
Page 167 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Affidavit:
N/A
William Towner  Approved Nov-11-2020 12:33:32 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamTowner, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-10-2020 17:17:22 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William Towner  Approved Nov-10-2020 10:47:43 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamTowner, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-02-2020 14:38:48 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William Towner  Approved Nov-02-2020 11:39:02 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838482
Page 168 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Affidavit:
By my dated signature below, I, WilliamTowner, 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.
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838483
Page 169 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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-11-2020 14:24:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-11-2020 14:24:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838484
Page 170 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-11-2020 14:24:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/11/2020Initial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838485
Page 171 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-11-2020 14:24:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12651101Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-11-2020 14:24:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1973Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-11-2020 14:25:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-11-2020 14:25:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-11-2020 14:25:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838486
Page 172 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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-11-2020 14:25:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020Initial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838487
Page 173 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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-11-2020 14:25:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-11-2020 14:25:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-11-2020 14:25:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838488
Page 174 of 331
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Sep-11-2020 14:26:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:Syncope and colla
pse
Start Date: Oct/7/2005
Ongoing: NO
End Date:
UNK/UNK/20
05Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:26:41
(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-11-2020 14:26:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Syncope and collapseInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-11-2020 14:26:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-11-2020 14:26:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838489
Page 175 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b
Date Location User Value Reason
Sep-11-2020 14:27:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:Sinus tachycardia
Start Date: Jun/5/2007
Ongoing: NO
End Date:
UNK/UNK/2
007Initial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:27:15
(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-11-2020 14:27:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sinus tachycardiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-11-2020 14:27:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/5/2007Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-11-2020 14:27:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2007Initial Entry
1.c
Date Location User Value Reason
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838490
Page 176 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-11-2020 14:27:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:Single seizure, unspe
cified type
Start Date: Jun/5/2007
Ongoing: NO
End Date:
Jun/5/2007Initial Entry
1.c Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:27:38
(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-11-2020 14:27:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Single seizure, unspecified typeInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-11-2020 14:27:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/5/2007Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-11-2020 14:27:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jun/5/2007Initial Entry
1.d
Date Location User Value Reason
Sep-11-2020 14:28:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4Initial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838491
Page 177 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Medical Hist
ory Term:Major depressive disord
er, recurrent episode
Start Date: Jan/25/2007
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:28:12
(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-11-2020 14:28:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Major depressive disorder, recurrent ep
isodeInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-11-2020 14:28:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/25/2007Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-11-2020 14:28:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-11-2020 14:28:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:Irritable bowel syn
drome
Start Date: Jun/17/2004
Ongoing: YESInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838492
Page 178 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.e Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:28:33
(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-11-2020 14:28:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Irritable bowel syndromeInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-11-2020 14:28:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/17/2004Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-11-2020 14:28:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-11-2020 14:28:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:Gastroesophageal ref
lux disease
Start Date: Apr/10/2006
Ongoing: YESInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838493
Page 179 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.f Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:28:53
(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-11-2020 14:28:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Gastroesophageal reflux diseaseInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-11-2020 14:28:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Apr/10/2006Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-11-2020 14:28:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-11-2020 14:29:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:7
Medical History
Term:Generalized anxiety
disorder
Start Date: Feb/28/2008
Ongoing: YESInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838494
Page 180 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.g Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:29:14
(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 14:29:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Generalized anxiety disorderInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-11-2020 14:29:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/28/2008Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-11-2020 14:29:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Sep-11-2020 14:29:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Ter
m:Overactive blad
der
Start Date: Aug/6/2010
Ongoing: YESInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838495
Page 181 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.h Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:29:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:29:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Overactive bladderInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-11-2020 14:29:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/6/2010Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-11-2020 14:29:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Sep-11-2020 14:30:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Term: Fibromyalgia
Start Date: Nov/2/2007
Ongoing: YESInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838496
Page 182 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.i Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:30:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:30:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FibromyalgiaInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-11-2020 14:30:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/2/2007Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-11-2020 14:30:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Sep-11-2020 14:31:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History Term: Fatty liver
Start Date: Oct/18/2006
Ongoing: YESInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838497
Page 183 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.j Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:31:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:31:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Fatty liverInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-11-2020 14:31:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/18/2006Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-11-2020 14:31:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838498
Page 184 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.k
Date Location User Value Reason
Sep-11-2020 14:32:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:11
Medical History
Term:Diabetes mellitus,
type 2
Start Date: May/26/2011
Ongoing: YESInitial Entry
1.k Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:32:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:32:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Diabetes mellitus, type 2Initial Entry
1.k Start Date:
Date Location User Value Reason
Sep-11-2020 14:32:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
May/26/2011Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-11-2020 14:32:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Sep-11-2020 14:32:29
(UTC-08:00) Pacific TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu 12Initial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838499
Page 185 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(US & Canada) mber:
Medical Histo
ry Term:Bipolar 1 disorder, mi
xed, moderate
Start Date: Jan/26/2010
Ongoing: YES
1.l Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:32:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:32:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Bipolar 1 disorder, mixed, moderateInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-11-2020 14:32:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/26/2010Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-11-2020 14:32:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Sep-11-2020 14:34:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:13
Medical History
Term:Chronic abdomina
l pain
Start Date: Aug/17/2006
Ongoing: YESInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838500
Page 186 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.m Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:34:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:34:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Chronic abdominal painInitial Entry
1.m Start Date:
Date Location User Value Reason
Sep-11-2020 14:34:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2006Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-11-2020 14:34:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Sep-11-2020 14:35:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:14
Medical Histor
y Term:Chronic kidney disea
se, stage 2
Start Date: Feb/11/2014
Ongoing: YESInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838501
Page 187 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.n Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:35:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:35:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Chronic kidney disease, stage 2Initial Entry
1.n Start Date:
Date Location User Value Reason
Sep-11-2020 14:35:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/11/2014Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-11-2020 14:35:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Sep-11-2020 14:36:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 15
Medical History Term: Dyslipidemia
Start Date: Jun/27/2013
Ongoing: YESInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838502
Page 188 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.o Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:36:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:36:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DyslipidemiaInitial Entry
1.o Start Date:
Date Location User Value Reason
Sep-11-2020 14:36:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/27/2013Initial Entry
1.o Ongoing:
Date Location User Value Reason
Sep-11-2020 14:36:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.p
Date Location User Value Reason
Sep-11-2020 14:36:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 16
Medical History Term: Gastroparesis
Start Date: Dec/31/2014
Ongoing: YESInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838503
Page 189 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.p Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:36:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:36:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
GastroparesisInitial Entry
1.p Start Date:
Date Location User Value Reason
Sep-11-2020 14:36:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/31/2014Initial Entry
1.p Ongoing:
Date Location User Value Reason
Sep-11-2020 14:36:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.q
Date Location User Value Reason
Sep-11-2020 14:36:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:17
Medical History T
erm:Peripheral neurop
athy
Start Date: May/3/2013
Ongoing: YESInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838504
Page 190 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.q Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:36:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:36:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Peripheral neuropathyInitial Entry
1.q Start Date:
Date Location User Value Reason
Sep-11-2020 14:36:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
May/3/2013Initial Entry
1.q Ongoing:
Date Location User Value Reason
Sep-11-2020 14:36:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.r
Date Location User Value Reason
Sep-11-2020 14:37:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 18
Medical History Term: Hypertension
Start Date: Jan/19/2017
Ongoing: YESInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838505
Page 191 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.r Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:37:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:37:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.r Start Date:
Date Location User Value Reason
Sep-11-2020 14:37:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2017Initial Entry
1.r Ongoing:
Date Location User Value Reason
Sep-11-2020 14:37:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.s
Date Location User Value Reason
Sep-11-2020 14:37:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 19
Medical History Term: Asthma
Start Date: Aug/16/2016
Ongoing: YESInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838506
Page 192 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.s Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:37:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:37:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
AsthmaInitial Entry
1.s Start Date:
Date Location User Value Reason
Sep-11-2020 14:37:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/16/2016Initial Entry
1.s Ongoing:
Date Location User Value Reason
Sep-11-2020 14:37:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.t
Date Location User Value Reason
Sep-11-2020 14:38:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:20
Medical Histo
ry Term:Benign fasciculation c
ramp syndrome
Start Date: Aug/30/2013
Ongoing: YESInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838507
Page 193 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.t Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:38:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
20Initial Entry
1.t Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:38:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Benign fasciculation cramp syndromeInitial Entry
1.t Start Date:
Date Location User Value Reason
Sep-11-2020 14:38:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/30/2013Initial Entry
1.t Ongoing:
Date Location User Value Reason
Sep-11-2020 14:38:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838508
Page 194 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.u
Date Location User Value Reason
Sep-11-2020 14:39:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 21
Medical History Te
rm:Chronic pancreat
itis
Start Date: Jan/19/2017
Ongoing: YESInitial Entry
1.u Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:39:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21Initial Entry
1.u Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:39:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Chronic pancreatitisInitial Entry
1.u Start Date:
Date Location User Value Reason
Sep-11-2020 14:39:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2017Initial Entry
1.u Ongoing:
Date Location User Value Reason
Sep-11-2020 14:39:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.v
Date Location User Value Reason
Sep-11-2020 14:41:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 22
Medical History Term: ObesityInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838509
Page 195 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Start Date: Apr/13/2011
Ongoing: YES
1.v Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:41:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
22Initial Entry
1.v Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:41:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ObesityInitial Entry
1.v Start Date:
Date Location User Value Reason
Sep-11-2020 14:41:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Apr/13/2011Initial Entry
1.v Ongoing:
Date Location User Value Reason
Sep-11-2020 14:41:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.w
Date Location User Value Reason
Sep-11-2020 14:41:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 23
Medical History Te
rm:Right blepharosp
asm
Start Date: Oct/9/2014
Ongoing: YESInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838510
Page 196 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.w Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:41:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23Initial Entry
1.w Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:41:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Right blepharospasmInitial Entry
1.w Start Date:
Date Location User Value Reason
Sep-11-2020 14:41:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/9/2014Initial Entry
1.w Ongoing:
Date Location User Value Reason
Sep-11-2020 14:41:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.x
Date Location User Value Reason
Sep-11-2020 14:43:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:24
Medical History
Term:Colonoscopy with
biopsy
Start Date: Nov/15/2010
Ongoing: NO
End Date:
Nov/15/2010Initial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838511
Page 197 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.x Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:43:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
24Initial Entry
1.x Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:43:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Colonoscopy with biopsyInitial Entry
1.x Start Date:
Date Location User Value Reason
Sep-11-2020 14:43:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/15/2010Initial Entry
1.x Ongoing:
Date Location User Value Reason
Sep-11-2020 14:43:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Nov/15/2010Initial Entry
1.y
Date Location User Value Reason
Sep-11-2020 14:43:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:25
Medical History
Term:Colonoscopy with
biopsy
Start Date: Jul/8/2014
Ongoing: NO
End Date:
Jul/8/2014Initial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838512
Page 198 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.y Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:43:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
25Initial Entry
1.y Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:43:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Colonoscopy with biopsyInitial Entry
1.y Start Date:
Date Location User Value Reason
Sep-11-2020 14:43:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/8/2014Initial Entry
1.y Ongoing:
Date Location User Value Reason
Sep-11-2020 14:43:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jul/8/2014Initial Entry
1.z
Date Location User Value Reason
Sep-11-2020 14:46:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:26
Medical History T
erm:Fallopian tube lig
ation
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/19
98Initial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838513
Page 199 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.z Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:46:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
26Initial Entry
1.z Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:46:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Fallopian tube ligationInitial Entry
1.z Start Date:
Date Location User Value Reason
Sep-11-2020 14:46:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1998Initial Entry
1.z Ongoing:
Date Location User Value Reason
Sep-11-2020 14:46:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1998Initial Entry
1.aa
Date Location User Value Reason
Sep-14-2020 09:13:46
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numb
er:27
Medical Histor
y Term:Laparoscopic hyste
rectomy
Start Date: Dec/12/2013
Ongoing: NO
End Date:
Dec/12/2013Transcription Error
Sep-11-2020 14:47:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:27Initial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838514
Page 200 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Medical Histor
y Term:Laparascopic hyster
ectomy
Start Date: Dec/12/2013
Ongoing: NO
End Date:
Dec/12/2013
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838515
Page 201 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.aa Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:47:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
27Initial Entry
1.aa Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-14-2020
10:40:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Closed Discrepancy has been
closed.
Sep-14-2020
09:13:46
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answer
edTranscription Error
Sep-14-2020
09:13:46
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Laparoscopic hy
sterectomyTranscription Error
Sep-12-2020
11:42:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Opened Clarify
LAPARASCOPIC
HYSTERECTOMY
as follows...Should
the spelling be
LAPAROSCOPIC
HYSTERECTOMY?
If so, edit. Otherwise
clarify. Thank you.
Sep-11-2020
14:47:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Laparascopic hys
terectomyInitial Entry
1.aa Start Date:
Date Location User Value Reason
Sep-11-2020 14:47:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/12/2013Initial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838516
Page 202 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.aa Ongoing:
Date Location User Value Reason
Sep-11-2020 14:47:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Dec/12/2013Initial Entry
1.ab
Date Location User Value Reason
Sep-11-2020 14:47:46
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:28
Medical His
tory Term:Laparascopic lysis of intr
a-abdominal adhesion
Start Date: May/15/2015
Ongoing: NO
End Date:
May/15/2015Initial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838517
Page 203 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.ab Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:47:46
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28Initial Entry
1.ab Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:47:46
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Laparascopic lysis of intra-abdominal
adhesionInitial Entry
1.ab Start Date:
Date Location User Value Reason
Sep-11-2020 14:47:46
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
May/15/2015Initial Entry
1.ab Ongoing:
Date Location User Value Reason
Sep-11-2020 14:47:46
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
May/15/2015Initial Entry
1.ac
Date Location User Value Reason
Sep-11-2020 14:48:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:29
Medical Hist
ory Term:Laparascopic salpingec
tomy (bilateral)
Start Date: Dec/12/2013
Ongoing: NO
End Date:
Dec/12/2013Initial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838518
Page 204 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.ac Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:48:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
29Initial Entry
1.ac Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:48:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Laparascopic salpingectomy (bilateral)Initial Entry
1.ac Start Date:
Date Location User Value Reason
Sep-11-2020 14:48:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/12/2013Initial Entry
1.ac Ongoing:
Date Location User Value Reason
Sep-11-2020 14:48:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Dec/12/2013Initial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838519
Page 205 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.ad
Date Location User Value Reason
Sep-11-2020 14:48:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:30
Medical History
Term:Diagnostic laparos
copy
Start Date: May/15/2015
Ongoing: NO
End Date:
May/15/2015Initial Entry
1.ad Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:48:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30Initial Entry
1.ad Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:48:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Diagnostic laparoscopyInitial Entry
1.ad Start Date:
Date Location User Value Reason
Sep-11-2020 14:48:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
May/15/2015Initial Entry
1.ad Ongoing:
Date Location User Value Reason
Sep-11-2020 14:48:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
May/15/2015Initial Entry
1.ae
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838520
Page 206 of 331
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-11-2020 15:23:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:31
Medical Hi
story Term:Drug allergy - Nexium [
Esomeprazole Magnesiu
m]
Start Date: Jan/17/2008
Ongoing: YESInitial Entry
1.ae Line/MH Number:
Date Location User Value Reason
Sep-11-2020 15:23:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
31Initial Entry
1.ae Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 15:23:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Drug allergy - Nexium [Esomeprazole
Magnesium]Initial Entry
1.ae Start Date:
Date Location User Value Reason
Sep-11-2020 15:23:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/17/2008Initial Entry
1.ae Ongoing:
Date Location User Value Reason
Sep-11-2020 15:23:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838521
Page 207 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Sep-11-2020 14:50:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-11-2020 14:50:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
81.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-11-2020 14:50:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-11-2020 14:50:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
149.9Initial Entry
5. Unit:
Date Location User Value Reason
Sep-11-2020 14:50:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-11-2020 14:50:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
36.0Initial Entry
7.a
Date Location User Value Reason
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (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-2021-5683-0838522
Page 208 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-11-2020 14:50:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 37.0
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-11-2020 14:50:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-11-2020 14:50:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
37.0Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-11-2020 14:50:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-11-2020 14:50:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (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-2021-5683-0838523
Page 209 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-11-2020 14:50:51
(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-11-2020 14:50:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-11-2020 14:50:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-11-2020 14:50:51
(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-11-2020 14:50:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-11-2020 14:50:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::Initial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838524
Page 210 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Sep-11-2020 14:50:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-11-2020 14:50:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-11-2020 14:50:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838525
Page 211 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-11-2020 14:51:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-11-2020 14:51:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
88271Initial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838526
Page 212 of 331
***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, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020 14:51:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020 14:51:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-11-2020 16:56:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-11-2020 14:51:08
(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-11-2020 14:51:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/11/2020Initial Entry
5.a
Date Location User Value Reason
Sep-11-2020 16:56:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP956JInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-11-2020 16:56:16
(UTC-08:00) Pacific TimeACV0PFEINFP6000  Data Entry:
BP956JInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838527
Page 213 of 331
***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, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(US & Canada)
5.b
Date Location User Value Reason
Sep-11-2020 16:56:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP956KInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-11-2020 16:56:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP956KInitial Entry
5.c
Date Location User Value Reason
Sep-11-2020 16:56:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP956LInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-11-2020 16:56:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP956LInitial Entry
5.d
Date Location User Value Reason
Nov-24-2020 09:40:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMNCC1Initial Entry
5.d Sample ID
Date Location User Value Reason
Nov-24-2020 09:40:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BMNCC1Initial Entry
5.e
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838528
Page 214 of 331
***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, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Nov-24-2020 09:40:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMNCC2Initial Entry
5.e Sample ID
Date Location User Value Reason
Nov-24-2020 09:40:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BMNCC2Initial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838529
Page 215 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020 14:51:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020 14:51:14
(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-11-2020 16:57:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-11-2020 14:51:14
(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-11-2020 14:51:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/11/2020Initial Entry
5.a
Date Location User Value Reason
Sep-11-2020 16:57:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP950YInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-11-2020 16:57:22
(UTC-08:00) Pacific TimeACV0PFEINFP6000  Data Entry:
BP950YInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838530
Page 216 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(US & Canada)
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838531
Page 217 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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-11-2020 14:51:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-11-2020 14:51:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-11-2020 14:51:53
(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-11-2020 14:51:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020 12:02Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-11-2020 14:51:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-11-2020 14:51:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838532
Page 218 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-11-2020 14:51:53
(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-11-2020 14:51:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-11-2020 14:51:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838533
Page 219 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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-11-2020 14:52:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838534
Page 220 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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 03:33:42
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Per site confirmation-
entered in error
Oct-06-2020 14:56:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered According to
documentation from
9/18, it appears that
this was done an
accidental entry, as
patient called
regarding having
issues with her
daughter which led to
her daughter taking
her phone and mobile
diary device.
Oct-06-2020 13:00:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened As per Illness ediary
records, subject
reported "Yes" for the
question "Have you
experienced any of the
following?” for the
COVID-19 symptoms
or diagnosis on
18SEP2020. But there
is no COVID Illness
visit reported in the
database. Please
clarify.
Sep-30-2020 13:43:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0838535
Page 221 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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 13:44:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
2.a
Date Location User Value Reason
Sep-30-2020 13:44:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.5
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-30-2020 13:44:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-30-2020 13:44:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
36.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-30-2020 13:44:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-30-2020 13:44:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (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-2021-5683-0838536
Page 222 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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 13:45:02
(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 13:45:02
(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 13:45:02
(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 13:45:02
(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 13:45:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-30-2020 13:45:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::Initial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838537
Page 223 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Sep-30-2020 13:45:02
(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 13:45:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-30-2020 13:45:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838538
Page 224 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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 13:45:09
(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 13:45:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020 09:21:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-01-2020 02:04:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-30-2020 13:45:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-30-2020 13:45:09
(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
Oct-01-2020 09:21:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY4BLInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838539
Page 225 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.a Sample ID
Date Location User Value Reason
Oct-01-2020 09:21:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPY4BLInitial Entry
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838540
Page 226 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 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 13:48:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-30-2020 13:48:26
(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 13:48:26
(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 13:48:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020 11:53Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-30-2020 13:48:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-30-2020 13:48:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3036\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838541
Page 227 of 331
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651101 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-30-2020 13:48:26
(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 13:48:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP
…[truncated]