125742 S1 M5 CRF c4591001 1152 11521053

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
178
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941230
Page 2 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/13/2020
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941231
Page 3 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Demography
1.Subject ID [11521053]
2.Birth Date: 1990
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941232
Page 4 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/13/2020
2.Erroneous Visit
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941233
Page 5 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941234
Page 6 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/13/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941235
Page 7 of 178
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[appendectomy]
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2001
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[appendicitis]
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2001
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941236
Page 8 of 178
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Aug/13/2020
2.Weight: [216.4]
3.Unit: LB
4.Height: [64.0]
5.Unit: in
6.Body Mass Index: [37.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941237
Page 9 of 178
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/13/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941238
Page 10 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/13/2020
2.Randomization Number: [49402]
3.Randomization Group: [ ]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941239
Page 11 of 178
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/13/2020
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 [BPYK8K]
5.bSample ID [BPYK8L]
5.cSample ID [BPYK8M]
5.dSample ID [BNWK0W]
5.eSample ID [BNWK0X]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941240
Page 12 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/13/2020
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 [BPYKWX]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941241
Page 13 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/13/2020 13:09
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941242
Page 14 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941243
Page 15 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941244
Page 16 of 178
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941245
Page 17 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941246
Page 18 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941247
Page 19 of 178
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941248
Page 20 of 178
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/1/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941249
Page 21 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
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 [BPYL5R]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941250
Page 22 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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/1/2020 12:03
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941251
Page 23 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941252
Page 24 of 178
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941253
Page 25 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941254
Page 26 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941255
Page 27 of 178
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
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 [BP0SR6]
5.bSample ID [BP0SR7]
5.cSample ID [BNT3BY]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941256
Page 28 of 178
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941257
Page 29 of 178
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRLNLN]
5.bSample ID [BRLNLP]
5.cSample ID [BS6KXW]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941258
Page 30 of 178
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941259
Page 31 of 178
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941260
Page 32 of 178
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941261
Page 33 of 178
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941262
Page 34 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941263
Page 35 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941264
Page 36 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941265
Page 37 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941266
Page 38 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941267
Page 39 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941268
Page 40 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941269
Page 41 of 178
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941270
Page 42 of 178
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941271
Page 43 of 178
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Unplanned Assessments
1.Assessments
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941272
Page 44 of 178
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Sep/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941273
Page 45 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941274
Page 46 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941275
Page 47 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941276
Page 48 of 178
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#CategoryAE Iden
tifierAdverse
EventStart DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Nausea  Feb/13/2021 U
NK:UNK YES  Repeating
Pages
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941277
Page 49 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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)[Nausea]
4.Start Date Time: Feb/13/2021 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 2
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941278
Page 50 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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:
[pregnancy]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941279
Page 51 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941280
Page 52 of 178
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941281
Page 53 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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[ ]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941282
Page 54 of 178
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941283
Page 55 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941284
Page 56 of 178
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941285
Page 57 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941286
Page 58 of 178
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941287
Page 59 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941288
Page 60 of 178
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941289
Page 61 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941290
Page 62 of 178
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941291
Page 63 of 178
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941292
Page 64 of 178
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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:
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941293
Page 65 of 178
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941294
Page 66 of 178
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941295
Page 67 of 178
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941296
Page 68 of 178
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941297
Page 69 of 178
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941298
Page 70 of 178
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941299
Page 71 of 178
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941300
Page 72 of 178
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/22/2021
2.Erroneous Visit
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941301
Page 73 of 178
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941302
Page 74 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/22/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941303
Page 75 of 178
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941304
Page 76 of 178
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941305
Page 77 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/30/2020
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941306
Page 78 of 178
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941307
Page 79 of 178
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Donald
Brandon Approved Mar-09-2021 23:09:56 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DonaldBrandon, 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.
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941308
Page 80 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormAug-13-2020 16:57:22 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941309
Page 81 of 178
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Donald
Brandon Approved Mar-09-2021 23:09:56 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DonaldBrandon, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Feb-25-2021 13:48:10 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Donald
Brandon Approved Oct-12-2020 15:36:58 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941310
Page 82 of 178
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Affidavit:
By my dated signature below, I, DonaldBrandon, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Sep-30-2020 18:37:44 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Donald
Brandon Approved Sep-11-2020 14:30:07 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DonaldBrandon, 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.
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941311
Page 83 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-13-2020
16:56:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-13-2020
16:56:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941312
Page 84 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-13-2020
16:56:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/13/2020Initial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941313
Page 85 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-13-2020
16:56:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11521053Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-13-2020
16:55:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1990Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-13-2020
16:57:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941314
Page 86 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-13-2020
16:57:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HISPANIC OR LATI
NO(A) OR OF SPA
NISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-13-2020
16:57:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941315
Page 87 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-13-2020
16:57:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/13/2020Initial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941316
Page 88 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-13-2020
16:57:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-13-2020
16:57:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-13-2020
16:57:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941317
Page 89 of 178
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Aug-13-2020
16:58:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:appendect
omy
Start Date
:UNK/UN
K/2001
Ongoing: NO
End Date
:
UNK/U
NK/200
1Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-13-2020
16:58:09
(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:
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941318
Page 90 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Aug-13-2020
16:58:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
appendectomyInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-13-2020
16:58:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2001Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-13-2020
16:58:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2001Initial Entry
1.b
Date Location User Value Reason
Aug-13-2020
16:58:48
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2Initial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941319
Page 91 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada) Medical H
istory Ter
m:appendiciti
s
Start Date
:UNK/UN
K/2001
Ongoing: NO
End Date
:
UNK/U
NK/200
1
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941320
Page 92 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b Line/MH Number:
Date Location User Value Reason
Aug-13-2020
16:58:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020
16:58:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
appendicitisInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-13-2020
16:58:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2001Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-13-2020
16:58:48ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941321
Page 93 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)End Date:
UNK/UNK/2001
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0941322
Page 94 of 178
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Aug-13-2020
16:59:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/13/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-13-2020
16:59:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
216.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-13-2020
16:59:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941323
Page 95 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-13-2020
16:59:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
64.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-13-2020
16:59:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-13-2020
16:59:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
37.1Initial Entry
7.a
Date Location User Value Reason
Aug-13-2020
16:59:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.8Initial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941324
Page 96 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-13-2020
16:59:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-13-2020
16:59:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-13-2020
16:59:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941325
Page 97 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
7.a Temperature Location:
Date Location User Value Reason
Aug-13-2020
16:59:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941326
Page 98 of 178
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-13-2020
16:59:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-13-2020
16:59:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-13-2020
16:59:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/13/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941327
Page 99 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-13-2020
16:59:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-13-2020
16:59:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-13-2020
16:59:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941328
Page 100 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Aug-13-2020
16:59:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-13-2020
16:59:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-13-2020
16:59:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941329
Page 101 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-13-2020
17:00:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/13/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-13-2020
17:00:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
49402Initial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941330
Page 102 of 178
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-13-2020
17:00:52
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020
17:00:52
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-14-2020
18:08:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-13-2020
17:00:52
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941331
Page 103 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-13-2020
17:00:52
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Aug/13/2020Initial Entry
5.a
Date Location User Value Reason
Aug-14-2020
18:08:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPYK8
KInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-14-2020
18:08:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYK8KInitial Entry
5.b
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941332
Page 104 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Aug-14-2020
18:08:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPYK8
LInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-14-2020
18:08:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYK8LInitial Entry
5.c
Date Location User Value Reason
Aug-14-2020
18:08:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPYK8
MInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941333
Page 105 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.c Sample ID
Date Location User Value Reason
Aug-14-2020
18:08:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYK8MInitial Entry
5.d
Date Location User Value Reason
Aug-14-2020
18:27:39
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BNWK0
WInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-14-2020
18:27:39
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNWK0WInitial Entry
5.e
Date Location User Value Reason
Aug-14-2020
18:27:51ACV0PFEINFP6000  Data Entry:
Sample I BNWK0Initial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941334
Page 106 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)D: X
5.e Sample ID
Date Location User Value Reason
Aug-14-2020
18:27:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNWK0XInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0941335
Page 107 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-13-2020
17:00:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020
17:00:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-14-2020
17:08:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-13-2020
17:00:59
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941336
Page 108 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-13-2020
17:00:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Aug/13/2020Initial Entry
5.a
Date Location User Value Reason
Aug-14-2020
17:08:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPYKW
XInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-14-2020
17:08:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYKWXInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941337
Page 109 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-13-2020
17:01:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-13-2020
17:01:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-13-2020
17:01:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941338
Page 110 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-13-2020
17:01:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/13/2020 13:09Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-13-2020
17:01:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-13-2020
17:01:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-13-2020
17:01:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941339
Page 111 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-13-2020
17:01:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-13-2020
17:01:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941340
Page 112 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-13-2020
17:01:46
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGE
NICITY E-DIARY
COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941341
Page 113 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-01-2020
14:30:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941342
Page 114 of 178
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941343
Page 115 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
OInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941344
Page 116 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.b Symptom:
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
A
D
AC
HEInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941345
Page 117 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Were fever or s
ystemic sympt
oms present on
the last day the
Subject Diary
was completed
?:N
O
2.c Symptom:
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-01-2020
14:31:29ACV0PFEINFP6000  Data Entry:
Symptom:: CInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941346
Page 118 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)HI
L
L
S
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
O
2.d Symptom:
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941347
Page 119 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympt
oms present on
the last day the
Subject Diary
was completed
?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941348
Page 120 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.f
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DI
A
RR
HE
A
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941349
Page 121 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.f Symptom:
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AINInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941350
Page 122 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was co
mpleted?:NO
2.g Symptom:
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-01-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941351
Page 123 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)Symptom:: NEW
OR W
ORSE
NED
JOIN
T PAI
N
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was com
pleted?:NO
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941352
Page 124 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.h Symptom:
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941353
Page 125 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::RE
D
N
ES
S
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941354
Page 126 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::SW
EL
LI
NG
Were injection
site reactions p
resent on the l
ast day the Su
bject Diary wa
s completed?:NOInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941355
Page 127 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAI
N A
T IN
JEC
TIO
N SI
TEInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941356
Page 128 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Were injectio
n site reactio
ns present on
the last day t
he Subject Di
ary was com
pleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:31:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941357
Page 129 of 178
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020
14:31:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
2.a
Date Location User Value Reason
Sep-01-2020
14:31:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.4
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-01-2020
14:31:43
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941358
Page 130 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-01-2020
14:31:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-01-2020
14:31:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-01-2020
14:31:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941359
Page 131 of 178
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-01-2020
14:32:11
(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-01-2020
14:32:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-01-2020
14:32:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941360
Page 132 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-01-2020
14:32:11
(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-01-2020
14:32:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-01-2020
14:32:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941361
Page 133 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Sep-01-2020
14:32:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-01-2020
14:32:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-01-2020
14:32:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941362
Page 134 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020
14:32:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020
14:32:23
(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-01-2020
17:25:39
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-01-2020
14:32:23
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941363
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***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-01-2020
14:32:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020
17:25:39
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPYL5
RInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020
17:25:39
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYL5RInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941364
Page 136 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-01-2020
14:32:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-01-2020
14:32:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020
14:32:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941365
Page 137 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-01-2020
14:32:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020 12:03Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020
14:32:58
(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-01-2020
14:32:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-01-2020
14:32:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941366
Page 138 of 178
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-01-2020
14:32:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-01-2020
14:32:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941367
Page 139 of 178
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-30-2020
18:37:44
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941368
Page 140 of 178
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941369
Page 141 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
OInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941370
Page 142 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.b Symptom:
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
A
D
AC
HEInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941371
Page 143 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Were fever or s
ystemic sympt
oms present on
the last day the
Subject Diary
was completed
?:N
O
2.c Symptom:
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-30-2020
18:38:08ACV0PFEINFP6000  Data Entry:
Symptom:: CInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941372
Page 144 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)HI
L
L
S
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
O
2.d Symptom:
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941373
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***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympt
oms present on
the last day the
Subject Diary
was completed
?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941374
Page 146 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.f
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DI
A
RR
HE
A
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941375
Page 147 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.f Symptom:
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AINInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941376
Page 148 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was co
mpleted?:NO
2.g Symptom:
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-30-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941377
Page 149 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)Symptom:: NEW
OR W
ORSE
NED
JOIN
T PAI
N
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was com
pleted?:NO
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941378
Page 150 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.h Symptom:
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941379
Page 151 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::RE
D
N
ES
S
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941380
Page 152 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::SW
EL
LI
NG
Were injection
site reactions p
resent on the l
ast day the Su
bject Diary wa
s completed?:NOInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941381
Page 153 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAI
N A
T IN
JEC
TIO
N SI
TEInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941382
Page 154 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Were injectio
n site reactio
ns present on
the last day t
he Subject Di
ary was com
pleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
18:38:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941383
Page 155 of 178
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-30-2020
18:38:26
(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
18:38:26
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-30-2020
22:01:26
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-30-2020
18:38:26
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941384
Page 156 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-30-2020
18:38:26
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
Sep-30-2020
22:01:26
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP0SR6Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-30-2020
22:01:26
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP0SR6Initial Entry
5.b
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941385
Page 157 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Sep-30-2020
22:01:34
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP0SR7Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-30-2020
22:01:34
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP0SR7Initial Entry
5.c
Date Location User Value Reason
Sep-30-2020
22:01:41
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BNT3B
YInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941386
Page 158 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.c Sample ID
Date Location User Value Reason
Sep-30-2020
22:01:41
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNT3BYInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941387
Page 159 of 178
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-25-2021
13:50:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/25/2021Initial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941388
Page 160 of 178
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-25-2021
13:51:04
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-25-2021
13:51:04
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021
12:17:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Feb-26-2021
06:11:26
(UTC-08:00)ACV0PFEINFP6000  Query 1: Answere
dI THOUGHT
WE HAD 24
HOURS TO
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941389
Page 161 of 178
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US
& Canada)ENTER
THESE. IS
THAT
INCORRECT?
Feb-26-2021
03:08:25
(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.
Feb-25-2021
13:51:04
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
correct as
appropriate.
Feb-25-2021
13:51:04
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Feb/25/2021Initial Entry
5.a
Date Location User Value Reason
Feb-26-2021
06:11:44ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941390
Page 162 of 178
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)Sample I
D:BRLNL
N
5.a Sample ID
Date Location User Value Reason
Feb-26-2021
06:11:44
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRLNLNInitial Entry
5.b
Date Location User Value Reason
Feb-26-2021
06:11:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BRLNL
PInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-26-2021
06:11:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRLNLPInitial Entry
5.c
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941391
Page 163 of 178
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Feb-26-2021
06:12:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BS6KX
WInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-26-2021
06:12:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS6KXWInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941392
Page 164 of 178
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-01-2020
10:59:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-01-2020
10:59:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-01-2020
10:59:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941393
Page 165 of 178
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Feb-25-2021
14:18:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941394
Page 166 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Feb-25-2021
14:18:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-25-2021
14:18:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-02-2021
23:05:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Closed Response
satisfies query
Mar-01-2021
14:24:37
(UTC-08:00)ACV0PFEINFP6000  Query 1: Answered The subject has
morning
sickness, not
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0941395
Page 167 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US
& Canada)COVID
Mar-01-2021
06:15:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Opened Clin: Since
NAUSEA is
one of the
CDC-defined
symptoms of
COVID-19,
please consider
whether this
symptom,
could have
been due to
COVID-19 and
should have
triggered a
potential
COVID-19
illness visit
Feb-25-2021
14:18:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NauseaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-25-2021
14:18:10
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000  Data Entry:
Feb/13/2021 UNK:U
NKInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0941396
Page 168 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada)
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-25-2021
14:18:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-25-2021
14:18:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Feb-25-2021
14:18:10ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941397
Page 169 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-25-2021
14:18:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-09-2021
14:56:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: If
Exposure
During
Pregnancy
occurs in a
subject or
subject's
partner, the
investigator
must report
this to Pfizer
Safety on the
Vaccines SAE
report Form
and an EDP
supplemental
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941398
Page 170 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
form. Please
confirm the
SAE & EDP
supplemental
form was
completed
Feb-25-2021
14:18:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to s
tudy treatment(s),
this event is due to
:
OTHER
If Other, specif
y:
pregnancyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-25-2021
14:18:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941399
Page 171 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-25-2021
14:18:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-25-2021
14:18:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-25-2021
14:18:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RES
OLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-25-2021
14:18:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941400
Page 172 of 178
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-25-2021
13:48:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/22/2021Initial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941401
Page 173 of 178
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-25-2021
13:49:34
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-25-2021
13:49:04
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Feb-25-2021
13:49:04
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willin
g to return for Vacc
ination 3
Participant is:
eligible and NO
T confirmed to
have received o
nly placebo at VInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941402
Page 174 of 178
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
accination 1/2
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941403
Page 175 of 178
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-25-2021
13:49:34
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/22/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-25-2021
13:49:34
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941404
Page 176 of 178
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-01-2020
10:59:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-13-2020
17:00:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-13-2020
16:57:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-01-2020
10:59:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/30/2020Initial Entry
Aug-13-2020
17:00:32ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/13/2020Initial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941405
Page 177 of 178
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)
Aug-13-2020
16:57:35
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/13/2020Initial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0941406
Page 178 of 178
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-11-2020
11:26:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2fcc\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0941407
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FDA Knew COVID Vaccine Safety Monitoring System Was ‘Not Sufficient,’ Latest Pfizer Documents Confirm
You must be a CHD Insider to save this article Sign Up Already an Insider? Log in The U.S. Food and Drug Administration this week released its last batch of files related to the licensing of Pfizer’s COVID-19 vaccine for…
FDA Knew COVID Vaccine Safety Monitoring System Was ‘Not Sufficient,’ Latest Pfizer Documents Confirm
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You Are Part of An Experiment in Consent and Choice
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