125742 S1 M5 CRF c4591001 1129 11291260

Document text

Page 1 of 208
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 version06 OCT 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803680
Page 2 of 208
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Nov/20/2020
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803681
Page 3 of 208
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Demography
1.Subject ID [11291260]
2.Birth Date: /2003
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803682
Page 4 of 208
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/20/2020
2.Erroneous Visit
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803683
Page 5 of 208
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803684
Page 6 of 208
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathNov/20/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803685
Page 7 of 208
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[penicillin allergy]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[peanuts allergy]
Start Date: UNK/UNK/2004
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[tree nuts allergy]
Start Date: UNK/UNK/2004
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[legumes allergy]
Start Date: UNK/UNK/2004
Ongoing: YES
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803686
Page 8 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[chickpeas allergy]
Start Date: UNK/UNK/2004
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[flaxseed allergy]
Start Date: UNK/UNK/2004
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[pollen allergy]
Start Date: UNK/UNK/2007
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[seasonal allergies oak]
Start Date: UNK/UNK/2004
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[right hand neuropathy]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803687
Page 9 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[asthma]
Start Date: UNK/UNK/2003
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[eczema]
Start Date: UNK/UNK/2003
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[bronchoscopy]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803688
Page 10 of 208
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803689
Page 11 of 208
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Nov/20/2020
2.Weight: [130.8]
3.Unit: LB
4.Height: [64.5]
5.Unit: in
6.Body Mass Index: [22.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [96.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803690
Page 12 of 208
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/20/2020
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:
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803691
Page 13 of 208
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition
1.Randomization Date : Nov/20/2020
2.Randomization Number: [116482]
3.Randomization Group: [ ]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803692
Page 14 of 208
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/20/2020
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 [BMPP2F]
5.bSample ID [BMPP2G]
5.cSample ID [BR6XYM]
5.dSample ID [BR6XYN]
5.eSample ID [BR6XYP]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803693
Page 15 of 208
***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, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/20/2020
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 [BR6XTD]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803694
Page 16 of 208
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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: Nov/20/2020 17:04
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803695
Page 17 of 208
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803696
Page 18 of 208
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803697
Page 19 of 208
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803698
Page 20 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
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
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803699
Page 21 of 208
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Dec/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803700
Page 22 of 208
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Dec/15/2020
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:
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803701
Page 23 of 208
***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, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/15/2020
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 [BN69BS]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803702
Page 24 of 208
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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: Dec/15/2020 15:16
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803703
Page 25 of 208
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803704
Page 26 of 208
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803705
Page 27 of 208
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
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
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803706
Page 28 of 208
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/12/2021
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 [BRL3NV]
5.bSample ID [BRL3NW]
5.cSample ID [BRL3NX]
5.dSample ID [BS970T]
5.eSample ID [BS970V]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803707
Page 29 of 208
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803708
Page 30 of 208
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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: [ ]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803709
Page 31 of 208
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803710
Page 32 of 208
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803711
Page 33 of 208
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803712
Page 34 of 208
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803713
Page 35 of 208
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803714
Page 36 of 208
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803715
Page 37 of 208
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803716
Page 38 of 208
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803717
Page 39 of 208
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
# CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
 1. ADVERSE E
VENT 1  Anaphylactoid R
eaction Jan/27/2021
10:30 NO
End Date Time:
Jan/27/2021 11:24
 Repeating
Pages
 2. DELETED ADVERSE E
VENT 2  shortness of brea
th Jan/27/2021
11:00 NO
End Date Time:
Jan/27/2021 11:24
 Repeating
Pages
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803718
Page 40 of 208
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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)[Anaphylactoid Reaction]
4.Start Date Time: Jan/27/2021 10:30
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/27/2021 11:24
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803719
Page 41 of 208
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021082081]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803720
Page 42 of 208
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[shortness of breath ]
4.Start Date Time: Jan/27/2021 11:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/27/2021 11:24
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803721
Page 43 of 208
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021082081 ]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803722
Page 44 of 208
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803723
Page 45 of 208
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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[ ]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803724
Page 46 of 208
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803725
Page 47 of 208
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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: //
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803726
Page 48 of 208
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803727
Page 49 of 208
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803728
Page 50 of 208
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803729
Page 51 of 208
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803730
Page 52 of 208
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803731
Page 53 of 208
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803732
Page 54 of 208
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803733
Page 55 of 208
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Unplanned Assessments
1.Assessments
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803734
Page 56 of 208
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803735
Page 57 of 208
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803736
Page 58 of 208
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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:
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803737
Page 59 of 208
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803738
Page 60 of 208
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803739
Page 61 of 208
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803740
Page 62 of 208
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Jan/12/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803741
Page 63 of 208
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803742
Page 64 of 208
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803743
Page 65 of 208
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803744
Page 66 of 208
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/20/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803745
Page 67 of 208
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803746
Page 68 of 208
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803747
Page 69 of 208
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803748
Page 70 of 208
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/25/2021
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803749
Page 71 of 208
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803750
Page 72 of 208
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/25/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803751
Page 73 of 208
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/25/2021
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:
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803752
Page 74 of 208
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/25/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS9737]
5.bSample ID [BS973N]
5.cSample ID [BRMX28]
5.dSample ID [BRMX27]
5.eSample ID [BRMX1F]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803753
Page 75 of 208
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/25/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMX0F]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803754
Page 76 of 208
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/25/2021 16:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803755
Page 77 of 208
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803756
Page 78 of 208
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803757
Page 79 of 208
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/17/2021
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 [BTZPLG]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803758
Page 80 of 208
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Incomplete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?YES
Date of First Delay:
Feb/17/2021
Reason(s) for Temporary Delay of Vaccination
FEVER OR ACUTE ILLNESS
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?
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803759
Page 81 of 208
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803760
Page 82 of 208
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803761
Page 83 of 208
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803762
Page 84 of 208
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803763
Page 85 of 208
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803764
Page 86 of 208
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803765
Page 87 of 208
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Jan/27/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803766
Page 88 of 208
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Answered Queries, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Jan/12/2021
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803767
Page 89 of 208
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803768
Page 90 of 208
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803769
Page 91 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormNov-23-2020 11:49:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0803770
Page 92 of 208
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormJan-26-2021 16:20:41 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803771
Page 93 of 208
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormMar-12-2021 11:51:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0803772
Page 94 of 208
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
1Mar-12-2021 11:51:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0803773
Page 95 of 208
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
2Mar-12-2021 11:51:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0803774
Page 96 of 208
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
3Mar-12-2021 11:51:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0803775
Page 97 of 208
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
4Mar-12-2021 11:51:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0803776
Page 98 of 208
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
5Mar-12-2021 11:51:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0803777
Page 99 of 208
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
6.aMar-12-2021 11:51:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0803778
Page 100 of 208
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
6.aMar-12-2021 11:51:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0803779
Page 101 of 208
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
6.aMar-12-2021 11:51:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0803780
Page 102 of 208
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803781
Page 103 of 208
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Nov-21-2020 16:08:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Alex Hill Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Nov-21-2020 16:08:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Alex Hill Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0803782
Page 104 of 208
***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, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Consent Was:
Date Location User Value Reason
Nov-21-2020 16:08:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Alex Hill Data Entry:
OBTAINED
Date Written Consent Obtained
Nov/20/2020Initial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0803783
Page 105 of 208
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Subject ID
Date Location User Value Reason
Nov-21-2020 16:07:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11291260Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Nov-21-2020 16:07:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/2003Enrollment Entry
3. Sex:
Date Location User Value Reason
Nov-21-2020 16:09:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Alex Hill Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Nov-21-2020 16:09:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Alex Hill Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Nov-21-2020 16:09:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Alex Hill Data Entry:
WHITEInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0803784
Page 106 of 208
***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, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-21-2020 16:09:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Alex Hill Data Entry:
Nov/20/2020Initial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0803785
Page 107 of 208
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Nov-23-2020 11:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-23-2020 11:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Nov-23-2020 11:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803786
Page 108 of 208
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.a
Date Location User Value Reason
Nov-23-2020 11:51:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:penicillin alle
rgy
Start Date: UNK/UNK/2
010
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Nov-23-2020 11:51:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-23-2020 11:51:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
penicillin allergyInitial Entry
1.a Start Date:
Date Location User Value Reason
Nov-23-2020 11:51:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Nov-23-2020 11:51:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803787
Page 109 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.b
Date Location User Value Reason
Nov-23-2020 11:52:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:peanuts allerg
y
Start Date: UNK/UNK/2
004
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Nov-23-2020 11:52:32
(UTC-05:00) Eastern
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
Nov-23-2020 11:52:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
peanuts allergyInitial Entry
1.b Start Date:
Date Location User Value Reason
Nov-23-2020 11:52:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2004Initial Entry
1.b Ongoing:
Date Location User Value Reason
Nov-23-2020 11:52:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803788
Page 110 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Nov-23-2020 11:53:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:tree nuts aller
gy
Start Date: UNK/UNK/2
004
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Nov-23-2020 11:53:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-23-2020 11:53:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
tree nuts allergyInitial Entry
1.c Start Date:
Date Location User Value Reason
Nov-23-2020 11:53:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2004Initial Entry
1.c Ongoing:
Date Location User Value Reason
Nov-23-2020 11:53:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803789
Page 111 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Nov-23-2020 11:53:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:legumes aller
gy
Start Date: UNK/UNK/2
004
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Nov-23-2020 11:53:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-23-2020 11:53:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
legumes allergyInitial Entry
1.d Start Date:
Date Location User Value Reason
Nov-23-2020 11:53:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2004Initial Entry
1.d Ongoing:
Date Location User Value Reason
Nov-23-2020 11:53:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Nov-23-2020 11:54:01
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number 5Initial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803790
Page 112 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada) :
Medical History T
erm:chickpeas alle
rgy
Start Date: UNK/UNK/2
004
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Nov-23-2020 11:54:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-23-2020 11:54:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
chickpeas allergyInitial Entry
1.e Start Date:
Date Location User Value Reason
Nov-23-2020 11:54:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2004Initial Entry
1.e Ongoing:
Date Location User Value Reason
Nov-23-2020 11:54:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Nov-23-2020 11:54:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:6Initial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803791
Page 113 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical History T
erm:flaxseed aller
gy
Start Date: UNK/UNK/2
004
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Nov-23-2020 11:54:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-23-2020 11:54:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
flaxseed allergyInitial Entry
1.f Start Date:
Date Location User Value Reason
Nov-23-2020 11:54:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2004Initial Entry
1.f Ongoing:
Date Location User Value Reason
Nov-23-2020 11:54:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Nov-23-2020 11:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:pollen allergyInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803792
Page 114 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Start Date: UNK/UNK/2
007
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Nov-23-2020 11:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-23-2020 11:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
pollen allergyInitial Entry
1.g Start Date:
Date Location User Value Reason
Nov-23-2020 11:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
1.g Ongoing:
Date Location User Value Reason
Nov-23-2020 11:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Nov-23-2020 11:56:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:8
Medical History
Term:seasonal allergi
es oak
Start Date: UNK/UNK/200
4Initial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803793
Page 115 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoing: YES
1.h Line/MH Number:
Date Location User Value Reason
Nov-23-2020 11:56:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-23-2020 11:56:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
seasonal allergies oakInitial Entry
1.h Start Date:
Date Location User Value Reason
Nov-23-2020 11:56:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2004Initial Entry
1.h Ongoing:
Date Location User Value Reason
Nov-23-2020 11:56:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Nov-23-2020 11:57:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:9
Medical History
Term:right hand neur
opathy
Start Date: UNK/UNK/201
8
Ongoing: YESInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803794
Page 116 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.i Line/MH Number:
Date Location User Value Reason
Nov-23-2020 11:57:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-23-2020 11:57:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
right hand neuropathyInitial Entry
1.i Start Date:
Date Location User Value Reason
Nov-23-2020 11:57:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.i Ongoing:
Date Location User Value Reason
Nov-23-2020 11:57:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Nov-23-2020 11:57:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:10
Medical History T
erm:asthma
Start Date: UNK/UNK/2
003
Ongoing: YESInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803795
Page 117 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.j Line/MH Number:
Date Location User Value Reason
Nov-23-2020 11:57:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-23-2020 11:57:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
asthmaInitial Entry
1.j Start Date:
Date Location User Value Reason
Nov-23-2020 11:57:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2003Initial Entry
1.j Ongoing:
Date Location User Value Reason
Nov-23-2020 11:57:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803796
Page 118 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.k
Date Location User Value Reason
Nov-23-2020 12:04:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:11
Medical History T
erm:eczema
Start Date: UNK/UNK/2
003
Ongoing: YESInitial Entry
1.k Line/MH Number:
Date Location User Value Reason
Nov-23-2020 12:04:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-23-2020 12:04:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
eczemaInitial Entry
1.k Start Date:
Date Location User Value Reason
Nov-23-2020 12:04:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2003Initial Entry
1.k Ongoing:
Date Location User Value Reason
Nov-23-2020 12:04:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803797
Page 119 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.l
Date Location User Value Reason
Nov-23-2020 12:07:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:12
Medical History
Term:bronchoscopy
Start Date: UNK/UNK/20
16
Ongoing: NO
End Date:
UNK/UNK/
2016Initial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0803798
Page 120 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.l Line/MH Number:
Date Location User Value Reason
Nov-23-2020 12:07:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-23-2020 12:07:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
bronchoscopyInitial Entry
1.l Start Date:
Date Location User Value Reason
Nov-23-2020 12:07:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.l Ongoing:
Date Location User Value Reason
Nov-23-2020 12:07:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2016Initial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803799
Page 121 of 208
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Nov-23-2020 12:08:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803800
Page 122 of 208
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date:
Date Location User Value Reason
Nov-23-2020 12:10:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/20/2020Initial Entry
2. Weight:
Date Location User Value Reason
Nov-23-2020 12:10:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
130.8Initial Entry
3. Unit:
Date Location User Value Reason
Nov-23-2020 12:10:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Nov-23-2020 12:10:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
64.5Initial Entry
5. Unit:
Date Location User Value Reason
Nov-23-2020 12:10:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Nov-23-2020 12:10:20
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
22.1Initial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803801
Page 123 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada)
7.a
Date Location User Value Reason
Nov-23-2020 12:10:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 96.5
Temperature Unit
:F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Nov-23-2020 12:10:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Dec-02-2020 23:35:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-02-2020 10:36:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered NCS per
investigator
Nov-23-2020 12:10:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature 96.5 F
is outside of
Normal Range 97 -
99.5 F.
Nov-23-2020 12:10:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
96.5Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0803802
Page 124 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Nov-23-2020 12:10:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Nov-23-2020 12:10:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803803
Page 125 of 208
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-23-2020 12:10:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-23-2020 12:10:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-23-2020 12:10:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/20/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-23-2020 12:10:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-23-2020 12:10:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803804
Page 126 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Nov-23-2020 12:10:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Nov-23-2020 12:10:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-23-2020 12:10:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-23-2020 12:10:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803805
Page 127 of 208
***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, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Randomization Date :
Date Location User Value Reason
Nov-23-2020 12:36:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/20/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Nov-23-2020 12:36:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
116482Initial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803806
Page 128 of 208
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-23-2020 16:45:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-23-2020 16:45:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-23-2020 16:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-23-2020 16:45:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-23-2020 16:45:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/20/2020Initial Entry
5.a
Date Location User Value Reason
Nov-23-2020 16:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMPP2FInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803807
Page 129 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a Sample ID
Date Location User Value Reason
Nov-23-2020 16:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BMPP2FInitial Entry
5.b
Date Location User Value Reason
Nov-23-2020 16:48:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMPP2GInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-23-2020 16:48:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BMPP2GInitial Entry
5.c
Date Location User Value Reason
Nov-23-2020 16:49:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR6XYMInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-23-2020 16:49:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR6XYMInitial Entry
5.d
Date Location User Value Reason
Nov-23-2020 16:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR6XYNInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803808
Page 130 of 208
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.d Sample ID
Date Location User Value Reason
Nov-23-2020 16:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR6XYNInitial Entry
5.e
Date Location User Value Reason
Nov-23-2020 16:49:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR6XYPInitial Entry
5.e Sample ID
Date Location User Value Reason
Nov-23-2020 16:49:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR6XYPInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803809
Page 131 of 208
***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, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-23-2020 16:20:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-23-2020 16:20:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-23-2020 16:20:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-23-2020 16:20:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-23-2020 16:20:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/20/2020Initial Entry
5.a
Date Location User Value Reason
Nov-23-2020 16:20:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR6XTDInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803810
Page 132 of 208
***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, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a Sample ID
Date Location User Value Reason
Nov-23-2020 16:20:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR6XTDInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803811
Page 133 of 208
***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, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-23-2020 12:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-23-2020 12:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-23-2020 12:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-23-2020 12:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/20/2020 17:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-23-2020 12:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-23-2020 12:38:17
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803812
Page 134 of 208
***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, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada)
7. Route:
Date Location User Value Reason
Nov-23-2020 12:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-23-2020 12:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-23-2020 12:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803813
Page 135 of 208
***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, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Nov-23-2020 12:40:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803814
Page 136 of 208
***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, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User ValueReason
Dec-21-2020
04:35:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Clo
sedClosed per SITE
response, added to
PD tracker for
Clinical Review
Dec-18-2020
14:31:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: An
swere
dOriginal value is
correct
Dec-18-2020
02:25:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
2: Op
enedPDQ: Date of visit at
V2_VAX2_L is out
of window for 2
days from
V1_DAY1_VAX1_L
Dose Date. Please
verify and update.
Else, confirm in
query response
appropriately.
Dec-17-2020
23:26:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies
query
Dec-17-2020
12:56:19
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dChanged data per
query
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0803815
Page 137 of 208
***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, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Dec-17-2020
07:20:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Op
enedDM: Kindly review
and complete ‘Nasal
Swab, Vaccination
form' at this visit.
Thank you.
Dec-16-2020
13:20:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Dec/1
5/202
0Initial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0803816
Page 138 of 208
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
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
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803817
Page 139 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
GU
E
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NO
2.b Symptom:
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
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
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803818
Page 140 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.c Symptom:
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
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
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
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
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803819
Page 141 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
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
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803820
Page 142 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.f Symptom:
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
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
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms prese
nt on the last day the
Subject Diary was c
ompleted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803821
Page 143 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.h
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803822
Page 144 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803823
Page 145 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.b Injection Site Reaction:
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
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
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-16-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803824
Page 146 of 208
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date:
Date Location User Value Reason
Dec-16-2020 13:21:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/15/2020Initial Entry
2.a
Date Location User Value Reason
Dec-16-2020 13:21:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 97.5
Temperature Unit
:F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Dec-16-2020 13:21:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Dec-16-2020 13:21:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Dec-16-2020 13:21:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803825
Page 147 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.a Temperature Location:
Date Location User Value Reason
Dec-16-2020 13:21:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803826
Page 148 of 208
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-16-2020 13:22:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Dec-16-2020 13:22:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-16-2020 13:22:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/15/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Dec-16-2020 13:22:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Dec-16-2020 13:22:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803827
Page 149 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Dec-16-2020 13:22:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Dec-16-2020 13:22:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Dec-16-2020 13:22:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Dec-16-2020 13:22:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803828
Page 150 of 208
***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, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-17-2020 12:55:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-17-2020 12:55:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-17-2020 12:56:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-17-2020 12:55:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-17-2020 12:55:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/15/2020Initial Entry
5.a
Date Location User Value Reason
Dec-17-2020 12:56:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN69BSInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803829
Page 151 of 208
***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, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a Sample ID
Date Location User Value Reason
Dec-17-2020 12:56:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN69BSInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803830
Page 152 of 208
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-17-2020 12:17:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-17-2020 12:17:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Dec-17-2020 12:17:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-17-2020 12:17:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/15/2020 15:16Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-17-2020 12:17:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-17-2020 12:17:50
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803831
Page 153 of 208
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada)
7. Route:
Date Location User Value Reason
Dec-17-2020 12:17:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-17-2020 12:17:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Dec-17-2020 12:17:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803832
Page 154 of 208
***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, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-18-2021 02:13:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-15-2021 13:24:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Jan-15-2021 03:40:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Jan-13-2021 11:31:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Changed data per
query
Jan-13-2021 05:35:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened DM: If V3 is
completed kindly,
consider updating
EOT visit or else
clarify. Thank you.
Jan-13-2021 05:35:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly
consider to update
missing SAMP
TRK form or else
clarify. Thank you.
Jan-12-2021 15:06:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/12/2021Initial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803833
Page 155 of 208
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
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
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803834
Page 156 of 208
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
GU
E
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NO
2.b Symptom:
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
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
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803835
Page 157 of 208
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.c Symptom:
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
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
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
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
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803836
Page 158 of 208
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
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
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803837
Page 159 of 208
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.f Symptom:
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
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
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms prese
nt on the last day the
Subject Diary was c
ompleted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803838
Page 160 of 208
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.h
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803839
Page 161 of 208
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803840
Page 162 of 208
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.b Injection Site Reaction:
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
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
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-12-2021 15:07:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803841
Page 163 of 208
***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, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-15-2021 13:23:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-15-2021 13:23:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-15-2021 13:23:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-15-2021 13:23:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-15-2021 13:23:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/12/2021Initial Entry
5.a
Date Location User Value Reason
Jan-15-2021 13:23:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRL3NVInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803842
Page 164 of 208
***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, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a Sample ID
Date Location User Value Reason
Jan-15-2021 13:23:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRL3NVInitial Entry
5.b
Date Location User Value Reason
Jan-15-2021 13:23:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRL3NWInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-15-2021 13:23:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRL3NWInitial Entry
5.c
Date Location User Value Reason
Jan-15-2021 13:24:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRL3NXInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-15-2021 13:24:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRL3NXInitial Entry
5.d
Date Location User Value Reason
Jan-15-2021 13:24:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS970TInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803843
Page 165 of 208
***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, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.d Sample ID
Date Location User Value Reason
Jan-15-2021 13:24:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS970TInitial Entry
5.e
Date Location User Value Reason
Jan-15-2021 13:24:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS970VInitial Entry
5.e Sample ID
Date Location User Value Reason
Jan-15-2021 13:24:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS970VInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803844
Page 166 of 208
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Date Location User Value Reason
Jan-28-2021 10:43:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803845
Page 167 of 208
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Mar-12-2021 13:02:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Alex Hill Form Deleted Changed
Information
Jan-28-2021 10:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0803846
Page 168 of 208
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Category:
Date Location User Value Reason
Jan-28-2021 10:43:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-28-2021 10:43:48
(UTC-05:00) Eastern
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-12-2021 12:59:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Alex Hill Data Entry:
Anaphylactoid ReactionChanged
Information
Feb-01-2021 10:22:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response satisfies
query
Jan-28-2021 13:53:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered No, subject reported
hives and then SOB
for this event. No
other symptoms
reported.
Jan-28-2021 12:58:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened CLINICAL_ Pls
advice if the subject
presented any other
symptoms prior this
the event. Thanks.
Jan-28-2021 10:43:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
hives left armInitial Entry
4. Start Date Time:
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0803847
Page 169 of 208
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Jan-28-2021 10:43:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/27/2021 10:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-12-2021 13:00:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Alex Hill Data Entry:
NO
End Date Time:
Jan/27/2021 11:24Changed
Information
Jan-28-2021 10:43:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/27/2021 11:04Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-12-2021 15:34:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Katherine
LiauQuery 2: Reissued:Candidate Please unlock form
Mar-11-2021 16:34:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Alex Hill Query 2: Answered Please unlock form
Mar-09-2021 10:29:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened CLINQUERY:
Hives on arm is
usually not a life
threatening AE,
please clarify why
hives on arm is
considered life
threatening.
Feb-04-2021 20:22:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-03-2021 12:50:55
(UTC-05:00) EasternACV0PFEINFP6000  Query 1: Answered SAE updated
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0803848
Page 170 of 208
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada)
Feb-01-2021 19:50:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Hives:
As per protocol
section 10.3.3 Grade
4 toxicity grading =
Life Threatening”
which meets
seriousness criteria.
If the toxicity grade
is correct, please
immediately submit
a SAE form to
safety and update
seriousness
Jan-28-2021 10:43:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-12-2021 15:56:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Katherine
LiauQuery 2: Reissued:Candidate pls unfreeze form
Mar-11-2021 16:34:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Alex Hill Query 2: Answered Please unlock form
Mar-09-2021 13:56:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Katherine
LiauQuery 2: Opened GPD: Please
confirm if hives is
considered life
threatening; else,
update response
accordingly.
Jan-29-2021 13:12:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0803849
Page 171 of 208
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Jan-28-2021 10:43:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE hives left
arm: Response to
"Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Jan-28-2021 10:43:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in
death?
NO
Did this serious event require or
prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabilit
y/incapacity?
NO
Is this serious event life threate
ning?
YES
Other medically important serio
us event
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803850
Page 172 of 208
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Feb-04-2021 23:10:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-04-2021 10:12:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Item 10 now
complete in both
AE log and SAE
followup faxed
Feb-04-2021 06:18:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Please update Item
10 as response is
still missing
Feb-03-2021 12:48:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Feb-01-2021 03:49:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: Please
complete item #10.
Thank you.
Jan-29-2021 10:09:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Jan-29-2021 10:09:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
Jan-29-2021 03:36:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Please
complete item # 8
and 10. Thank you.
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-28-2021 10:43:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-04-2021
04:51:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies query
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803851
Page 173 of 208
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Feb-19-2021 03:29:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Candid
atepending SDB update
Feb-18-2021 15:18:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered SAE follow up filed
Feb-16-2021 04:01:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened SAE
RECON:AER#2021082081,
action taken was reported as
DRUG WITHDRAWN in
AE CRF while NOT
APPLICABLE in Safety
database.Please confirm
correct action taken. If
safety update is required,
please submit a follow up
form
Feb-15-2021 21:00:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies query
Feb-10-2021 01:02:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Feb-09-2021 15:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered EOT2 disposition-treatment
form status completed
Feb-09-2021 15:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered EOT completed for Vax1
and Vax2. subject qualified
for Vax3, EOT2 completed
specifying status as drug
withdrawn.
Feb-07-2021 19:38:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened ClinQuery: hives left arm:
question 10 states drug was
withdrawn, however, the
EOT page states subject
completed vaccination
period. Please
review/update as
appropriate. Thanks
Feb-05-2021 06:59:19
(UTC-05:00) EasternACV0PFEINFP6000  Query 1: Opened DM: The Latest Action to
Study Treatment is 'DRUG
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0803852
Page 174 of 208
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada) WITHDRAWN', but the
Disposition-Treatment
Form Status is not
completed. Please review
and update as appropriate.
Feb-04-2021 10:10:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-28-2021 10:43:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-28-2021 10:43:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-28-2021 10:43:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-28-2021 10:43:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-29-2021 13:12:31
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
2021082081Initial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803853
Page 175 of 208
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada)
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0803854
Page 176 of 208
***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, Deleted
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Jan-28-2021 10:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-28-2021 10:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-02-2021 18:48:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Feb-01-2021 11:25:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered per Clinical Trial
Manager Lindsay
Kevles, "Per the
safety team, the
symptom
“Shortness of
breath” experienced
by the subject was
due to an allergic
reaction to the
vaccine. This is
specific situation,
we do not expect a
nasal swab to be
collected."
Feb-01-2021 10:14:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response satisfies
query
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0803855
Page 177 of 208
***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, Deleted
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-31-2021 19:22:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened ClinQuery:
shortness of breath:
Per protocol (8.1)
this COVID-19
listed symptom
should trigger a
COVID Visit
irrespective of
perceived etiology
or clinical
significance &
should be captured
on the CRF SOD
form only. NASAL
SWAB needs to be
collected.
Jan-28-2021 13:50:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered no, subject did not
visit ED or
physicians office.
Thanks
Jan-28-2021 13:00:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Medical Monitor_
Pls advice if the
subject needed a
visit to the
Emergency
Department or
Physicians office.
Thanks.
Jan-28-2021 10:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
shortness of breathInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-28-2021 10:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/27/2021 11:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0803856
Page 178 of 208
***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, Deleted
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-28-2021 10:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/27/2021 11:24Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-28-2021 10:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-01-2021 10:32:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-28-2021 10:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE shortness of
breath: Response to
"Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Jan-28-2021 10:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in d
eath?Initial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803857
Page 179 of 208
***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, Deleted
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
NO
Did this serious event require or
prolong hospitalization?
NO
Did this serious event result in p
ersistent or significant disability
/incapacity?
NO
Is this serious event life threaten
ing?
YES
Other medically important serio
us event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-28-2021 10:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-28-2021 10:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803858
Page 180 of 208
***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, Deleted
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
Mar-04-2021
04:51:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Closed SDB updated
Feb-19-2021 03:29:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Reissued:Candid
atepending SDB update
Feb-18-2021 15:19:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered SAE follow up filed
Feb-16-2021 04:01:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Opened SAE
RECON:AER#2021082081,
action taken was reported as
DRUG WITHDRAWN in
AE CRF while NOT
APPLICABLE in Safety
database.Please confirm
correct action taken. If
safety update is required,
please submit a follow up
form
Feb-15-2021 21:00:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies query
Feb-10-2021 01:02:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies query
Feb-09-2021 12:44:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered please see EOT2 form
Feb-09-2021 12:43:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered please see EOT2 form
Feb-07-2021 19:39:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened ClinQuery: shortness of
breath: question 10 states
drug was withdrawn,
however, the EOT page
states subject completed
vaccination period. Please
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0803859
Page 181 of 208
***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, Deleted
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
review/update as
appropriate. Thanks
Feb-05-2021 06:59:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened DM: The Latest Action to
Study Treatment is 'DRUG
WITHDRAWN', but the
Disposition-Treatment
Form Status is not
completed. Please review
and update as appropriate.
Feb-04-2021 23:11:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Feb-04-2021 10:12:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Feb-04-2021 10:12:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DRUG WITHDRAWNInitial Entry
Jan-29-2021 03:36:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Please complete this
item. Thank you.
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-28-2021 10:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-28-2021 10:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803860
Page 182 of 208
***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, Deleted
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-28-2021 10:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-28-2021 10:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-01-2021 10:32:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021082081Initial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803861
Page 183 of 208
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-13-2021 11:03:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/12/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-13-2021 11:03:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Jan-13-2021 11:03:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803862
Page 184 of 208
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-22-2021 13:45:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803863
Page 185 of 208
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-22-2021 13:49:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-22-2021 13:47:06
(UTC-05:00) Eastern
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.
Jan-22-2021 13:47:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible per local/national rec
ommendations and confirmed
to have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803864
Page 186 of 208
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-22-2021 13:49:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/20/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-22-2021 13:49:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803865
Page 187 of 208
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-28-2021 10:30:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-27-2021 13:59:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Jan-27-2021 06:54:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly
consider to update
missing SWAB
PFE and SAMP
TRK forms or else
clarify. Thank you.
Jan-26-2021 16:20:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/25/2021Initial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803866
Page 188 of 208
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-26-2021 16:20:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/25/2021Initial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803867
Page 189 of 208
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-26-2021 16:20:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/25/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-26-2021 16:20:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-26-2021 16:20:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803868
Page 190 of 208
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-26-2021 16:21:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-26-2021 16:21:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-26-2021 16:21:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/25/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-26-2021 16:21:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-26-2021 16:21:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803869
Page 191 of 208
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Jan-26-2021 16:21:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-26-2021 16:21:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-26-2021 16:21:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Jan-26-2021 16:21:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803870
Page 192 of 208
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-27-2021 13:57:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-27-2021 13:57:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-27-2021 13:57:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-27-2021 13:57:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-27-2021 13:57:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/25/2021Initial Entry
5.a
Date Location User Value Reason
Jan-27-2021 13:57:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS9737Initial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803871
Page 193 of 208
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a Sample ID
Date Location User Value Reason
Jan-27-2021 13:57:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS9737Initial Entry
5.b
Date Location User Value Reason
Jan-27-2021 13:57:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS973NInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-27-2021 13:57:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS973NInitial Entry
5.c
Date Location User Value Reason
Jan-27-2021 13:58:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRMX28Initial Entry
5.c Sample ID
Date Location User Value Reason
Jan-27-2021 13:58:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRMX28Initial Entry
5.d
Date Location User Value Reason
Jan-27-2021 13:58:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRMX27Initial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803872
Page 194 of 208
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.d Sample ID
Date Location User Value Reason
Jan-27-2021 13:58:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRMX27Initial Entry
5.e
Date Location User Value Reason
Jan-27-2021 13:58:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRMX1FInitial Entry
5.e Sample ID
Date Location User Value Reason
Jan-27-2021 13:58:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRMX1FInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803873
Page 195 of 208
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-27-2021 13:42:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-27-2021 13:42:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-27-2021 13:43:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-27-2021 13:42:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-27-2021 13:42:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/25/2021Initial Entry
5.a
Date Location User Value Reason
Jan-27-2021 13:43:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRMX0FInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803874
Page 196 of 208
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a Sample ID
Date Location User Value Reason
Jan-27-2021 13:43:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRMX0FInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803875
Page 197 of 208
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-26-2021 16:21:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-26-2021 16:21:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-26-2021 16:21:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-26-2021 16:21:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/25/2021 16:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-26-2021 16:21:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-26-2021 16:21:59
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae30b7\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0803876
Page 198 of 208
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291260 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada)
7. Route:
Date Location User Value Reason
Jan-26-2021 16:21:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-26-2021 16:21:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-26-2021 16:21:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Tim
…[truncated]