125742 S1 M5 CRF c4591001 1047 10471114

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 16 Plus Documents

185

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Page 1 of 185
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911673
Page 2 of 185
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/2/2020
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911674
Page 3 of 185
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10471114]
2.Birth Date: /1944
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0911675
Page 4 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911676
Page 5 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911677
Page 6 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/2/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911678
Page 7 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left Eye Vision Loss]
Start Date: Apr/UNK/2020
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bilateral broken Knees]
Start Date: UNK/UNK/1953
Ongoing: NO
End Date:
UNK/UNK/1953
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2000
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[High Cholestrol]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911679
Page 8 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Congestive Heart Failure]
Start Date: UNK/UNK/2000
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Joint Pain]
Start Date: UNK/UNK/2000
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/2000
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tinnitis]
Start Date: UNK/UNK/2000
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroidism]
Start Date: UNK/UNK/1999
Ongoing: YES
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911680
Page 9 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastroesophageal Reflux Disease]
Start Date: UNK/UNK/2000
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Angioplasty]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bilateral Hip Replacement]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911681
Page 10 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
2.Weight: [220.0]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [32.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911682
Page 11 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/2/2020
2.Randomization Number: [250505]
3.Randomization Group: [ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911683
Page 12 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
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 [BN5Y2J]
5.bSample ID [BN5Y2K]
5.cSample ID [BN5Y2L]
5.dSample ID [BLB6MV]
5.eSample ID [BLB6MW]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911684
Page 13 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
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 [BN5Y5N]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911685
Page 14 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/2/2020 15:25
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
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911686
Page 15 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911687
Page 16 of 185
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911688
Page 17 of 185
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911689
Page 18 of 185
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
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 [BM953D]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911690
Page 19 of 185
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/23/2020 14:40
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
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911691
Page 20 of 185
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911692
Page 21 of 185
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911693
Page 22 of 185
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911694
Page 23 of 185
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911695
Page 24 of 185
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911696
Page 25 of 185
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911697
Page 26 of 185
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911698
Page 27 of 185
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911699
Page 28 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911700
Page 29 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: [ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911701
Page 30 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911702
Page 31 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911703
Page 32 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911704
Page 33 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911705
Page 34 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911706
Page 35 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911707
Page 36 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911708
Page 37 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911709
Page 38 of 185
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Oct/22/2020 Comments
2.Phase of Disposition: VACCINATION Comments
3.Status: ADVERSE EVENT Comments
4.Specify Status: [ ] Comments
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911710
Page 39 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911711
Page 40 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911712
Page 41 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911713
Page 42 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  vomiting  Sep/24/2020 19:
00 NO
End Date Time:
Sep/24/2020 23:00
 Repeating
Pages
 2.ADVERSE E
VENT 2  diarrhea  Sep/24/2020 19:
00 NO
End Date Time:
Sep/24/2020 23:00
 Repeating
Pages
 3.ADVERSE E
VENT 3  nausea  Sep/24/2020 19:
00 NO
End Date Time:
Sep/24/2020 23:00
 Repeating
Pages
 4.ADVERSE E
VENT 4  multi focal Cerebral Vascul
ar Accidents Oct/18/2020 UN
K:UNK YES  Repeating
Pages
 5.ADVERSE E
VENT 5  Cervical spine fracture  Oct/18/2020 UN
K:UNK YES  Repeating
Pages
 6.ADVERSE E
VENT 6  Dysphagia  Oct/28/2020 UN
K:UNK YES  Repeating
Pages
 7.ADVERSE E
VENT 7  Accidental Fall  Oct/18/2020 UN
K:UNK NO
End Date Time:
Oct/18/2020 UNK:UN
K
 Repeating
Pages
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911714
Page 43 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[vomiting]
4.Start Date Time: Sep/24/2020 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/24/2020 23:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911715
Page 44 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911716
Page 45 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[diarrhea]
4.Start Date Time: Sep/24/2020 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/24/2020 23:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911717
Page 46 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911718
Page 47 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[nausea]
4.Start Date Time: Sep/24/2020 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/24/2020 23:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911719
Page 48 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911720
Page 49 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[multi focal Cerebral Vascular Accidents]
4.Start Date Time: Oct/18/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911721
Page 50 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[medical history of hypertension and congestive heart failure]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020429739]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911722
Page 51 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Cervical spine fracture]
4.Start Date Time: Oct/18/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[accidental fall]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911723
Page 52 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911724
Page 53 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Dysphagia]
4.Start Date Time: Oct/28/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[stroke]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911725
Page 54 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911726
Page 55 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Accidental Fall]
4.Start Date Time: Oct/18/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/18/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[accident]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911727
Page 56 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911728
Page 57 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911729
Page 58 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911730
Page 59 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911731
Page 60 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: //
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911732
Page 61 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911733
Page 62 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911734
Page 63 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911735
Page 64 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911736
Page 65 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911737
Page 66 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911738
Page 67 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911739
Page 68 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911740
Page 69 of 185
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911741
Page 70 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911742
Page 71 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911743
Page 72 of 185
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911744
Page 73 of 185
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911745
Page 74 of 185
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911746
Page 75 of 185
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911747
Page 76 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911748
Page 77 of 185
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911749
Page 78 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/13/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911750
Page 79 of 185
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911751
Page 80 of 185
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911752
Page 81 of 185
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Oct/22/2020
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911753
Page 82 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911754
Page 83 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911755
Page 84 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-02-2020 15:37:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911756
Page 85 of 185
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-06-2020 10:37:38 (UTC-06:00) Central
Time (US & Canada)Subject is currently in the hospital
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911757
Page 86 of 185
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-06-2020 10:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911758
Page 87 of 185
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-10-2020 08:41:16 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911759
Page 88 of 185
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-10-2020 08:41:16 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911760
Page 89 of 185
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-10-2020 08:41:16 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911761
Page 90 of 185
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-10-2020 08:41:16 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911762
Page 91 of 185
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-10-2020 08:41:16 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4Nov-06-2020 10:39:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911763
Page 92 of 185
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - Comments
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormMar-10-2021 08:13:34 (UTC-06:00) Central
Time (US & Canada)
FormMar-04-2021 08:31:55 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911764
Page 93 of 185
***Confidential***
Header Text: c4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Mar-10-2021 08:13:34 (UTC-06:00) Central
Time (US & Canada)
1Mar-04-2021 08:31:55 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911765
Page 94 of 185
***Confidential***
Header Text: c4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Mar-10-2021 08:13:34 (UTC-06:00) Central
Time (US & Canada)
2Mar-04-2021 08:31:55 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911766
Page 95 of 185
***Confidential***
Header Text: c4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Mar-10-2021 08:13:34 (UTC-06:00) Central
Time (US & Canada)
3Mar-04-2021 08:31:55 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911767
Page 96 of 185
***Confidential***
Header Text: c4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Mar-10-2021 08:13:34 (UTC-06:00) Central
Time (US & Canada)
4Mar-04-2021 08:31:55 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911768
Page 97 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-22-2021 13:09:05 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-21-2021 09:49:20 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-30-2020 10:50:19 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-15-2020 13:06:47 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0911769
Page 98 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
 N/A Nov-13-2020 16:02:13 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-12-2020 20:31:17 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0911770
Page 99 of 185
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-02-2020 15:36:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-02-2020 15:36:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911771
Page 100 of 185
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-02-2020 15:36:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/2/2020Initial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911772
Page 101 of 185
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-02-2020 15:36:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10471114Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-02-2020 15:36:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1944Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-02-2020 15:37:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-02-2020 15:37:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-02-2020 15:37:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(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-2021-5683-0911773
Page 102 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-02-2020 15:37:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911774
Page 103 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-02-2020 15:37:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-02-2020 15:37:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-02-2020 15:37:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911775
Page 104 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Sep-03-2020 08:46:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Left Eye Vision
Loss
Start Date: Apr/UNK/2020
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-03-2020 08:46:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 08:46:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Left Eye Vision LossInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-03-2020 08:46:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Apr/UNK/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-03-2020 08:46:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911776
Page 105 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-03-2020 08:47:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:Bilateral broken
Knees
Start Date: UNK/UNK/1953
Ongoing: NO
End Date:
UNK/UNK/1
953Initial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-03-2020 08:47:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 08:47:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Bilateral broken KneesInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-03-2020 08:47:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1953Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-03-2020 08:47:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1953Initial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911777
Page 106 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c
Date Location User Value Reason
Sep-03-2020 08:49:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History T
erm:Hypertension
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Sep-03-2020 08:49:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 08:49:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-03-2020 08:49:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-03-2020 08:49:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911778
Page 107 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-03-2020 08:49:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History T
erm:High Cholestr
ol
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Sep-03-2020 08:49:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 08:49:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
High CholestrolInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-03-2020 08:49:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-03-2020 08:49:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-03-2020 08:50:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5Initial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911779
Page 108 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical Histor
y Term:Congestive Heart
Failure
Start Date: UNK/UNK/2000
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Sep-03-2020 08:50:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 08:50:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Congestive Heart FailureInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-03-2020 08:50:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-03-2020 08:50:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-03-2020 08:51:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History T
erm:Joint Pain
Start Date: UNK/UNK/2
000Initial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911780
Page 109 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Sep-03-2020 08:51:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 08:51:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Joint PainInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-03-2020 08:51:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-03-2020 08:51:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-03-2020 08:52:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:Seasonal Aller
gies
Start Date: UNK/UNK/20
00
Ongoing: YESInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911781
Page 110 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Sep-03-2020 08:52:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 08:52:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Seasonal AllergiesInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-03-2020 08:52:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-03-2020 08:52:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Sep-03-2020 08:52:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History T
erm:Tinnitis
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911782
Page 111 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Sep-03-2020 08:52:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 08:52:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TinnitisInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-03-2020 08:52:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-03-2020 08:52:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Sep-03-2020 08:53:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History T
erm:Hypothyroidi
sm
Start Date: UNK/UNK/1
999
Ongoing: YESInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911783
Page 112 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.i Line/MH Number:
Date Location User Value Reason
Sep-03-2020 08:53:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 08:53:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypothyroidismInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-03-2020 08:53:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1999Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-03-2020 08:53:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Sep-03-2020 08:53:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:10
Medical Histo
ry Term:Gastroesophageal
Reflux Disease
Start Date: UNK/UNK/2000
Ongoing: YESInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911784
Page 113 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.j Line/MH Number:
Date Location User Value Reason
Sep-03-2020 08:53:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 08:53:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Gastroesophageal Reflux DiseaseInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-03-2020 08:53:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-03-2020 08:53:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911785
Page 114 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.k
Date Location User Value Reason
Sep-03-2020 08:54:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:11
Medical History
Term:Angioplasty
Start Date: UNK/UNK/200
0
Ongoing: NO
End Date:
UNK/UNK/
2000Initial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911786
Page 115 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.k Line/MH Number:
Date Location User Value Reason
Sep-03-2020 08:54:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 08:54:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
AngioplastyInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-03-2020 08:54:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-03-2020 08:54:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2000Initial Entry
1.l
Date Location User Value Reason
Sep-03-2020 08:55:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:12
Medical Histor
y Term:Bilateral Hip Repl
acement
Start Date: UNK/UNK/1990Initial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911787
Page 116 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
UNK/UNK/19
90
1.l Line/MH Number:
Date Location User Value Reason
Sep-03-2020 08:55:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 08:55:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Bilateral Hip ReplacementInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-03-2020 08:55:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-03-2020 08:55:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1990Initial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911788
Page 117 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-03-2020 08:45:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-03-2020 08:45:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
220.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-03-2020 08:45:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-03-2020 08:45:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
69.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-03-2020 08:45:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-03-2020 08:45:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
32.5Initial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911789
Page 118 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a
Date Location User Value Reason
Sep-03-2020 08:45:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.1
Temperature Unit: F
Temperature Locati
on::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-03-2020 08:45:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-03-2020 08:45:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.1Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-03-2020 08:45:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-03-2020 08:45:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911790
Page 119 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-02-2020 15:38:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-02-2020 15:38:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
250505Initial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911791
Page 120 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020 15:42:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020 15:42:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020 15:42:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-02-2020 15:42:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-02-2020 15:42:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-02-2020 15:42:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN5Y2JInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911792
Page 121 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Sep-02-2020 15:42:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN5Y2JInitial Entry
5.b
Date Location User Value Reason
Sep-02-2020 15:42:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN5Y2KInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-02-2020 15:42:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN5Y2KInitial Entry
5.c
Date Location User Value Reason
Sep-02-2020 15:42:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN5Y2LInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-02-2020 15:42:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN5Y2LInitial Entry
5.d
Date Location User Value Reason
Sep-02-2020 15:43:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLB6MVInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (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-2021-5683-0911793
Page 122 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Sep-02-2020 15:43:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLB6MVInitial Entry
5.e
Date Location User Value Reason
Sep-02-2020 15:43:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLB6MWInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-02-2020 15:43:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLB6MWInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911794
Page 123 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020 15:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020 15:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020 15:43:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-02-2020 15:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-02-2020 15:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-02-2020 15:43:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN5Y5NInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911795
Page 124 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Sep-02-2020 15:43:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN5Y5NInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911796
Page 125 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-02-2020 15:38:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-02-2020 15:38:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-02-2020 15:38:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-02-2020 15:38:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020 15:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-02-2020 15:38:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-02-2020 15:38:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911797
Page 126 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7. Route:
Date Location User Value Reason
Sep-02-2020 15:38:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-02-2020 15:38:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-02-2020 15:38:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911798
Page 127 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-02-2020 15:38:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911799
Page 128 of 185
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-17-2020 03:47:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-16-2020 08:53:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered This was a vaccine
reaction that took
place the night of
his vaccine. it has
been listed as an ae
Oct-16-2020 05:49:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Illness eDiary: As
per Illness ediary
records, subject
reported "Yes" for
the question "Have
you experienced
any of the
following?” for the
COVID-19
symptoms or
diagnosis on
30SEP2020. But
there is no COVID
Illness visit reported
in the database.
Sep-23-2020 14:36:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911800
Page 129 of 185
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-24-2020 08:27:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
2.a
Date Location User Value Reason
Sep-24-2020 08:27:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.5
Temperature Unit: F
Temperature Locati
on::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-24-2020 08:27:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-24-2020 08:27:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-24-2020 08:27:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911801
Page 130 of 185
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-24-2020 08:27:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911802
Page 131 of 185
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020 14:36:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020 14:36:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-23-2020 14:36:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-23-2020 14:36:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-23-2020 14:36:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-23-2020 14:36:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM953DInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911803
Page 132 of 185
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Sep-23-2020 14:36:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM953DInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911804
Page 133 of 185
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-24-2020 08:27:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-24-2020 08:27:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-24-2020 08:27:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-24-2020 08:27:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020 14:40Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-24-2020 08:27:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-24-2020 08:27:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911805
Page 134 of 185
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7. Route:
Date Location User Value Reason
Sep-24-2020 08:27:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-24-2020 08:27:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-24-2020 08:27:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911806
Page 135 of 185
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-06-2020 10:38:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0911807
Page 136 of 185
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-10-2020 08:41:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-10-2020 08:41:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-11-2020 02:50:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-10-2020 14:50:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject had an SAE
and was not able to
come for visit at
this time.
Nov-10-2020 11:56:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: Please provide
in your response
why Visit 3 is
marked Not
Applicable. Thank
you.
Nov-10-2020 08:43:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered not applicable
marked
Nov-10-2020 08:41:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911808
Page 137 of 185
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-09-2020 22:28:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly
consider to update
this form if require
else mark as Not
applicable by
selecting form level
comment. Thank
you.
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Nov-10-2020 08:41:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Nov-06-2020 10:39:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0911809
Page 138 of 185
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-10-2021 12:35:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 3: Closed Response satisfies query
Mar-10-2021 08:16:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Closed Close Auto Query
Mar-10-2021 08:16:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020Transcription Error
Mar-10-2021 08:15:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Opened Response to "Date of
Completion/Discontinuation
/Death" 22/Oct/2021 is a
future date relative to when
it was entered on 10/Mar
/2021. Please correct.
Mar-10-2021 08:15:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Initial Entry
Mar-10-2021 08:15:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2021Initial Entry
Mar-10-2021 08:13:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Mar-10-2021 03:17:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 3: Reissued:Opened CLINQUERY: Thanks,
since v3 was not performed
due to the adverse event,
please update EOT status as
selection ADVERSE
EVENT dated when V3
missed. That then reports
end of Rx phase but subject
still reported as on study
Mar-09-2021 08:14:16
(UTC-06:00) CentralACV0PFEINFP6000  Query 3: Answered Subject had a stroke and is
still recovering. did not do
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911810
Page 139 of 185
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) visit 3 for this but I am still
following for the study.
Mar-09-2021 07:18:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 3: Opened CLINQUERY: V3 has not
been reported yet timepoint
has passed - please clarify
reason for lack of V3 to
determine date/status for
end of first treatment phase
(vax1/vax2/V3)
Mar-04-2021 22:47:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies query
Mar-04-2021 08:32:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Changed data per query
Mar-04-2021 08:31:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Mar-04-2021 03:29:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened DM: Kindly consider to
update this form if require
else mark as Not applicable
by selecting form level
comment. Thank you.
Mar-04-2021 03:29:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Mar-03-2021 10:45:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered subject is still enrolled in
study.
Mar-03-2021 03:37:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM Requery 1: As per
response, please confirm
whether subject continues
in the study after recovering
SAE. If no, please update
FUP form since Visit3 is
not done. Else, please
clarify. Thank you.
Mar-02-2021 09:23:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered subject is still recovering
from SAE.
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0911811
Page 140 of 185
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-23-2021 21:18:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Erica Weaver Query 1: Opened DM: DOV for V3 is marked
as NOT DONE. If this is
correct, please indicate the
date and reason why the
participant did not complete
the treatment period as
defined in CCG (Vax 1 -
Visit 3). Also if no longer in
study please complete FUP
form.
2. Phase of Disposition:
Date Location User Value Reason
Mar-10-2021 08:15:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
Mar-10-2021 08:13:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Mar-04-2021 08:31:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Status:
Date Location User Value Reason
Mar-12-2021
22:00:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
2: Clos
edAuto closed by
Validation Check:
VC_DS001_25
Mar-12-2021
13:22:02
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Katherine Puig Query
2: Reis
sued:O
penedDM: 'Action Taken
with Study
Treatment' was
correct to be reported
as NOT
APPLICABLE since
both vaccinations
were administered.
Can this please be
reverted and we will
then close the query
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0911812
Page 141 of 185
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(I am very sorry
about this). Thank
you.
Mar-12-2021
09:01:33
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Ans
weredupdated per query
Mar-11-2021
22:32:15
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Reis
sued:O
penedIf Status is
ADVERSE EVENT
on EOT, Response to
"' Action Taken with
Study Treatment'
should be DRUG
WITHDRAWN on
AE page. However,
there is no Adverse
Event with ' Action
Taken with Study
Treatment' reported
as DRUG
WITHDRAWN.
Please review and
update
Mar-11-2021
07:50:35
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Ans
weredI completed this as
per query instructed.
The subject had
finished vaccinations
ans the drug was not
withdrawn
Mar-10-2021
17:28:52
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
2: Ope
nedDMW7665966;Status
is reported as
Adverse Event, but
there is no Adverse
Event with 'Latest
Action Taken with
Study Treatment'
reported as DRUG
WITHDRAWN.
Please review and
update as appropriate.
Mar-10-2021 ACV0PFEINFP6000  auto query Query Close Auto Query
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911813
Page 142 of 185
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
08:16:34
(UTC-06:00)
Central Time
(US &
Canada)(autoquery) 1: Clos
ed
Mar-10-2021
08:15:46
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Ope
nedResponse to "Status"
is ADVERSE
EVENT but "Specify
Status" is Provided.
Mar-10-2021
08:15:46
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:
ADVE
RSE E
VENTInitial Entry
Mar-10-2021
08:13:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:Initial Entry
Mar-04-2021
08:31:55
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:
Not Ap
plicabl
eInitial Entry
4. Specify Status:
Date Location User Value Reason
Mar-10-2021 08:16:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Mar-10-2021 08:15:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
subject continues in study still re
covering from adverse eventInitial Entry
Mar-10-2021 08:13:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911814
Page 143 of 185
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-04-2021 08:31:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0911815
Page 144 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-12-2020 10:45:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0911816
Page 145 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-12-2020 10:46:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0911817
Page 146 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-12-2020 10:46:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0911818
Page 147 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Nov-05-2020 15:12:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0911819
Page 148 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Nov-30-2020 10:50:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0911820
Page 149 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Nov-30-2020 11:00:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0911821
Page 150 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Dec-02-2020 08:16:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0911822
Page 151 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-12-2020 10:45:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-12-2020 10:45:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-12-2020 10:45:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
vomitingInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-12-2020 10:45:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020 19:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-12-2020 10:45:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/24/2020 23:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0911823
Page 152 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-12-2020 10:45:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-12-2020 10:45:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-12-2020 10:45:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-12-2020 10:45:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-12-2020 10:45:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-12-2020 10:45:22
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911824
Page 153 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-12-2020 10:45:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-12-2020 10:45:22
(UTC-06:00) Central
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
Oct-12-2020 10:45:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0911825
Page 154 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-12-2020 10:46:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-12-2020 10:46:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-12-2020 10:46:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
diarrheaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-12-2020 10:46:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020 19:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-12-2020 10:46:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/24/2020 23:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0911826
Page 155 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-12-2020 10:46:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-12-2020 10:46:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-12-2020 10:46:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-12-2020 10:46:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-12-2020 10:46:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-12-2020 10:46:06
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911827
Page 156 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-12-2020 10:46:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-12-2020 10:46:06
(UTC-06:00) Central
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
Oct-12-2020 10:46:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0911828
Page 157 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-12-2020 10:46:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-12-2020 10:46:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-05-2020 21:55:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Nov-05-2020 15:13:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered AE added
Nov-05-2020 05:24:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020429739
approyonset date
(PT:Cerebrovascular
accident) onset date
17Oct2020 was reported as
serious in Safety database
but missing in AE CRF.
Please confirm and update
CRF. If safety update is
required, submit a
follow-up SAE Form.
Oct-12-2020 10:46:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
nauseaInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0911829
Page 158 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4. Start Date Time:
Date Location User Value Reason
Oct-12-2020 10:46:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020 19:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-12-2020 10:46:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/24/2020 23:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-12-2020 10:46:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-12-2020 10:46:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-12-2020 10:46:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0911830
Page 159 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-12-2020 10:46:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-12-2020 10:46:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-12-2020 10:46:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-12-2020 10:46:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-12-2020 10:46:40
(UTC-06:00) Central
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
Oct-12-2020 10:46:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0911831
Page 160 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-05-2020 15:12:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-05-2020 15:12:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-01-2020 16:32:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Dec-01-2020 16:32:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-01-2020 16:30:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Nov-30-2020 12:44:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered update to follow
Nov-30-2020 12:44:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
multi focal Cerebral Vascular Ac
cidentsupdate to follow
Nov-30-2020 11:01:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered added
Nov-30-2020 10:51:27
(UTC-06:00) CentralACV0PFEINFP6000  Query 1: Answered ae added, sorry
thought we had
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911832
Page 161 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) already put it on the
ecrf
Nov-25-2020 12:06:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened Clinical SAE report
states subject
developed a new
swallowing
disorder, treated by
placement of a
gastric feeding tube,
yet it is not on the
AE CRF. Please
review for clinical
significance and
update AE log CRF
as appropriate.
Nov-25-2020 12:05:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened CLINICAL In SAE,
head MRI report
stated the subject
had multifocal
CVAs. Please
review multiple, not
single, lesion for
clinical significance.
If appropriate,
update AE term and
submit SAE safety
update with
modified term.
Nov-25-2020 11:58:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL On
review of the SAE
report for CVA, an
event of C4 Fracture
has been mentioned,
yet it does not
appear in the CRF.
Please review for
safety and update
AE log CRF
accordingly.
Nov-05-2020 15:12:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
StrokeInitial Entry
4. Start Date Time:
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911833
Page 162 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Nov-14-2020 08:54:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-13-2020 16:02:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-13-2020 16:02:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/18/2020 UNK:UNKTranscription Error
Nov-13-2020 02:53:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON:
AER#2020429739
onset date was
updated to 18Oct2020
in SDB however,
recorded as
17Oct2020 on AE
CRF. Please confirm
correct Onset Date. If
safety update is
required, please
submit a follow-up
SAE form.
Nov-05-2020 15:12:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/17/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-19-2021 03:27:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-18-2021 09:45:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered per last contact with
wife at home but still
recovering
Feb-17-2021 16:21:32
(UTC-06:00) CentralACV0PFEINFP6000  Query 1: Opened CLINQUERY-Please
confirm if "cerebral
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911834
Page 163 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) vascular accident"
remains ongoing
(start date 18 Oct
2020). Else, review
if update can be
applied to end date
and outcome status.
Thank you
Nov-05-2020 15:12:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-05-2020 15:12:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-11-2020 20:56:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Query closed; will
follow for SAE
update with the
requested COVID
test info
Nov-10-2020 14:59:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered subject had a Covid
test that was
negative. update to
foloow.
Nov-10-2020 10:28:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Clinical COVID test
status (yes/no)
during
Hospitalization has
not been reported in
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911835
Page 164 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
the SAE submitted
to safety. Please
submit a follow-up
SAE form
[#2020429739] to
document if COVID
testing was
performed
(YES/NO) and if
yes, the date and
results.
Nov-10-2020 07:23:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed aer entered
Nov-10-2020 07:22:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Answer Auto Query
Nov-09-2020 13:40:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Page is unfrozen
please update For
AE Stroke:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Nov-09-2020 09:32:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered please unfreeze the
page so I can answer
the query
Nov-09-2020 09:20:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened For AE Stroke:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Nov-05-2020 15:12:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Stroke:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0911836
Page 165 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-05-2020 15:12:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabil
ity/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important seri
ous 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
Nov-05-2020 15:12:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0911837
Page 166 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-05-2020 15:12:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
medical history of hypertensi
on and congestive heart failu
reInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-12-2021 09:01:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DRUG WITHDRAWNUpdated per query
request
Nov-05-2020 15:12:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-05-2020 15:12:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-05-2020 15:12:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0911838
Page 167 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-05-2020 15:12:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-05-2020 15:12:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-10-2020 07:22:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020429739Initial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911839
Page 168 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-30-2020 10:50:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-30-2020 10:50:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-30-2020 10:50:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Cervical spine fractureInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-30-2020 10:50:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/18/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-19-2021 03:28:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-18-2021 09:46:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered per last contact with
spouse at home but
still recovering
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911840
Page 169 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-17-2021 16:22:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY-Please
confirm if "cerebral
spine syndrome"
remains ongoing
(start date 18 Oct
2020). Else, review
if update can be
applied to end date
and outcome status.
Thank you
Nov-30-2020 10:50:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-30-2020 10:50:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-30-2020 10:50:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-30-2020 10:50:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911841
Page 170 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-03-2020 19:16:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-02-2020 08:16:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered added
Dec-01-2020 20:20:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: AE of
cervical spine
fracture is
considered related to
'accidental fall'. As
per CRF completion
guidelines please
also record the
accidental fall as a
separate AE entry.
Nov-30-2020 10:50:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
accidental fallInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-30-2020 10:50:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0911842
Page 171 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-30-2020 10:50:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-30-2020 10:50:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-30-2020 10:50:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-30-2020 10:50:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0911843
Page 172 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-30-2020 11:00:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-30-2020 11:00:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-30-2020
15:29:15
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Clos
edDiscrepancy has
been closed.
Nov-30-2020
12:45:35
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Ans
weredTranscription
Error
Nov-30-2020
12:45:35
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DysphagiaTranscription
Error
Nov-30-2020
12:30:20
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Open
edClarify
DYPHAGIA as
follows...Should
the spelling be
DYSPHAGIA? If
so, edit.
Otherwise clarify.
Thank you.
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911844
Page 173 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-30-2020
11:00:26
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DyphagiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-30-2020 11:00:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/28/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-19-2021 03:29:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Feb-18-2021 09:47:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered remains ongoing
Feb-17-2021 16:26:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened CLINQUERY-Please
confirm if
"dysphagia" remains
ongoing (start date
28 Oct 2020). Else,
review if update can
be applied to end
date and outcome
status. Thank you
Dec-02-2020 09:48:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Juleen Gayed Query 1: Closed Response satisfies
query
Dec-02-2020 08:06:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered yes
Dec-02-2020 07:55:50
(UTC-06:00) CentralACV0PFEINFP6000  Juleen Gayed Query 1: Opened Clin: Please confirm
if this AE is still
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911845
Page 174 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) ongoing?
Nov-30-2020 11:00:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-30-2020 11:00:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-30-2020 11:00:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-30-2020 11:00:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-30-2020 11:00:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:Initial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0911846
Page 175 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
OTHER
If Other, specify:
stroke
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-30-2020 11:00:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-30-2020 11:00:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-30-2020 11:00:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-30-2020 11:00:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-30-2020 11:00:26
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911847
Page 176 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0911848
Page 177 of 185
***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
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Dec-02-2020 08:16:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-02-2020 08:16:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-02-2020 08:16:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Accidental FallInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-02-2020 08:16:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/18/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-02-2020 08:16:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/18/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0911849
Page 178 of 185
***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
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Dec-02-2020 08:16:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-02-2020 08:16:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-02-2020 08:16:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-02-2020 08:16:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
accidentInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0911850
Page 179 of 185
***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
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Dec-02-2020 08:16:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-02-2020 08:16:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-02-2020 08:16:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-02-2020 08:16:29
(UTC-06:00) Central
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
Dec-02-2020 08:16:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0911851
Page 180 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-08-2021
04:23:35
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query 1
: Close
dResponse satisfies
query
Mar-05-2021
09:42:58
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query 1
: Answ
eredsubject did not
complete V3
therefore EOT is not
complete.
Mar-04-2021
16:57:44
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1
: Opene
dDMW7601748;DOV
is entered for Revax
Contact but
Disposition
Treatment at
END_OF_TRT visit
is null. Please review
and update as
appropriate.
Jan-13-2021
14:33:17
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:
Jan/13/
2021Initial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0911852
Page 181 of 185
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-22-2021 13:09:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2Transcription Error
Jan-13-2021 14:33:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is NOT willing to ret
urn for Vaccination 3 OR otherw
ise not eligibleInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0911853
Page 182 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-13-2021 14:33:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/13/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Feb-22-2021
22:22:01
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_35
Feb-22-2021
13:09:17
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dChanged data per query
Feb-22-2021
03:41:35
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW7348968;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Jan-13-2021
14:33:34
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000  Data
Entry
:
ASSE
SS ELInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0911854
Page 183 of 185
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Canada) IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ON
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911855
Page 184 of 185
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Mar-10-2021 08:15:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Sep-02-2020 15:38:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-02-2020 15:37:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Mar-10-2021 08:16:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/22/2020Transcription Error
Mar-10-2021 08:15:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/22/2021Initial Entry
Sep-02-2020 15:38:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/2/2020Initial Entry
Sep-02-2020 15:37:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/2/2020Initial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911856
Page 185 of 185
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471114 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-12-2020 20:31:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3086\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0911857