Document text
Page 1 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792076
Page 2 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/12/2020
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792077
Page 3 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11141006]
2.Birth Date: /1947
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:
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792078
Page 4 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/12/2020
2.Erroneous Visit
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792079
Page 5 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792080
Page 6 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/12/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792081
Page 7 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic to Phenergren]
Start Date: Aug/1/2005
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: Apr/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cataract Oculus Sinister]
Start Date: Jan/UNK/2020
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Subcutaneous Cyst Oculus Dexter]
Start Date: Aug/UNK/2019
Ongoing: NO
End Date:
Aug/12/2020
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792082
Page 8 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Eye periorbital ecchymosis]
Start Date: Aug/12/2020
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: Aug/1/2005
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hyperlipidemia]
Start Date: Aug/1/2005
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Coronary Artery Disease]
Start Date: Aug/UNK/2005
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Acute Myocardial Infarction]
Start Date: Aug/1/2005
Ongoing: NO
End Date:
Aug/1/2005
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792083
Page 9 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Benign prostatic hyperplasia]
Start Date: Jan/UNK/2014
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bursitis Right Shoulder]
Start Date: Jun/1/2018
Ongoing: NO
End Date:
Jun/UNK/2019
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis Generalized]
Start Date: Jan/UNK/1967
Ongoing: YES
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Total knee replacement, left]
Start Date: Jan/UNK/2020
Ongoing: NO
End Date:
Jan/UNK/2020
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792084
Page 10 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cyst removal of Subcutaneous cyst, right eye]
Start Date: Aug/12/2020
Ongoing: NO
End Date:
Aug/12/2020
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Angina Recurrent]
Start Date: UNK/UNK/2005
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Ejection Fraction Less then 30% Abnormal]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Automatic Implantable Cardioverter Defibrillators Implant]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792085
Page 11 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Aug/12/2020
2.Weight: [87.5]
3.Unit: kg
4.Height: [177.0]
5.Unit: cm
6.Body Mass Index: [27.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792086
Page 12 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/12/2020
2.Randomization Number: [226610]
3.Randomization Group: [ ]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792087
Page 13 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/12/2020
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 [BPR75H]
5.bSample ID [BPR75G]
5.cSample ID [BP5FFK]
5.dSample ID [BP5FFL]
5.eSample ID [BP5FFM]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792088
Page 14 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/12/2020
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 [BP5FF7]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792089
Page 15 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/12/2020 19:26
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
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792090
Page 16 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792091
Page 17 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792092
Page 18 of 199
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day
the Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792093
Page 19 of 199
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792094
Page 20 of 199
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792095
Page 21 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5FYC]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792096
Page 22 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/1/2020 11:28
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
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792097
Page 23 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792098
Page 24 of 199
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day
the Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792099
Page 25 of 199
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792100
Page 26 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/6/2020
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 [BP5G3K]
5.bSample ID [BPR7G8]
5.cSample ID [BPR7G9]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792101
Page 27 of 199
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792102
Page 28 of 199
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPVPV3]
5.bSample ID [BPR733]
5.cSample ID [BPR734]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792103
Page 29 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792104
Page 30 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792105
Page 31 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792106
Page 32 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792107
Page 33 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792108
Page 34 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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: [ ]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792109
Page 35 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792110
Page 36 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792111
Page 37 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792112
Page 38 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792113
Page 39 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792114
Page 40 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792115
Page 41 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792116
Page 42 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Unplanned Assessments
1.Assessments
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792117
Page 43 of 199
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/6/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792118
Page 44 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792119
Page 45 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792120
Page 46 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792121
Page 47 of 199
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Ventricular Tachyca
rdia Dec/11/2020 UN
K:UNK NO
End Date Time:
Dec/15/2020 UNK:UN
K
Repeating
Pages
2.ADVERSE E
VENT 2 Hypokalemia Dec/12/2020 UN
K:UNK NO
End Date Time:
Dec/20/2020 UNK:UN
K
Repeating
Pages
3.ADVERSE E
VENT 3 pulmonary embolis
m Jan/7/2021 UNK:
UNK NO
End Date Time:
Jan/10/2021 UNK:UN
K
Repeating
Pages
4.ADVERSE E
VENT 4 Blood coagulation
disorder Jan/7/2021 UNK:
UNK YES Repeating
Pages
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792122
Page 48 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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)[Ventricular Tachycardia]
4.Start Date Time: Dec/11/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/15/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
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
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792123
Page 49 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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:
[Related to his coronary artery disease, has defibrillation.]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020501074]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792124
Page 50 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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)[Hypokalemia]
4.Start Date Time: Dec/12/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/20/2020 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:
[Metabolic]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792125
Page 51 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792126
Page 52 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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)[pulmonary embolism]
4.Start Date Time: Jan/7/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/10/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[blood coagulation disorder]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792127
Page 53 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792128
Page 54 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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)[Blood coagulation disorder] Comments
4.Start Date Time: Jan/7/2021 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:
[BLOOD COUGULATION DISORDER]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792129
Page 55 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?: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[ ]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792130
Page 56 of 199
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792131
Page 57 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[ ]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792132
Page 58 of 199
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792133
Page 59 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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: //
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792134
Page 60 of 199
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792135
Page 61 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792136
Page 62 of 199
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792137
Page 63 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792138
Page 64 of 199
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792139
Page 65 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792140
Page 66 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792141
Page 67 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792142
Page 68 of 199
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792143
Page 69 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792144
Page 70 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792145
Page 71 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792146
Page 72 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792147
Page 73 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792148
Page 74 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792149
Page 75 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792150
Page 76 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792151
Page 77 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/26/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792152
Page 78 of 199
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792153
Page 79 of 199
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792154
Page 80 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/6/2020
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792155
Page 81 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792156
Page 82 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792157
Page 83 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-12-2020 18:55:02 (UTC-06:00) Central
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0792158
Page 84 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Feb-01-2021 09:32:20 (UTC-06:00) Central
Time (US & Canada)Correct as entered, no further information
provided. This is as per query.
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0792159
Page 85 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 Mar-11-2021 15:56:33 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard Glover Approved Mar-02-2021 09:39:43 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardGlover, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-28-2021 14:42:52 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard Glover Approved Jan-25-2021 11:00:54 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792160
Page 86 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Affidavit:
By my dated signature below, I, RichardGlover, 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 Dec-18-2020 11:25:55 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard Glover Approved Oct-13-2020 09:34:39 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardGlover, 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 Oct-06-2020 14:06:56 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard Glover Approved Sep-16-2020 16:39:46 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (6)
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0792161
Page 87 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Affidavit:
By my dated signature below, I, RichardGlover, 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.
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792162
Page 88 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-12-2020 18:53:31
(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
Aug-12-2020 18:53:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792163
Page 89 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-12-2020 18:53:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/12/2020Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792164
Page 90 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-12-2020 18:52:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11141006Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-12-2020 18:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1947Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-12-2020 18:53:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-12-2020 18:53:56
(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
Aug-12-2020 18:53:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792165
Page 91 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-12-2020 18:54:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792166
Page 92 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-12-2020 18:55:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-12-2020 18:55:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-12-2020 18:55:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792167
Page 93 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.a
Date Location User Value Reason
Aug-13-2020 08:40:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:Allergic to Ph
energren
Start Date: Aug/1/2005
Ongoing: YESTranscription Error
Aug-13-2020 08:40:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:1
Medical Histo
ry Term:Allergic to P
energren
Start Date: Aug/1/2005
Ongoing: YESTranscription Error
Aug-12-2020 19:03:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Penergren-Exc
essive Energy
Start Date: Aug/1/2005
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-12-2020 19:03:17
(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
Oct-13-2020 ACV0PFEINFP6000 Query 2: Data updated on
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0792168
Page 94 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
03:22:06
(UTC-06:00)
Central Time
(US & Canada)Deleted MH form.
Oct-08-2020
07:11:52
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: C
andidateDM: CRA request
to update MH.
Please do not raise
query to site.
Candidate query
may be closed
once MH updated
and any added
terms which may
be entered have
coded.
Aug-13-2020
09:57:24
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: C
losedDiscrepancy has
been closed.
Aug-13-2020
08:40:51
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entr
y:
Allergic to
Phenergre
nTranscription
Error
Aug-13-2020
08:40:08
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
AnsweredTranscription
Error
Aug-13-2020
08:40:08
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entr
y:
Allergic to
PenergrenTranscription
Error
Aug-13-2020
07:51:53
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1:
OpenedClarify
PENERGREN-
EXCESSIVE
ENERGY as
follows...The term
is unclear. Are you
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0792169
Page 95 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
reporting
PHENERGAN-
EXCESSIVE
ENERGY? If so,
update the
verbatim term as
such and clarify
further. Are you
reporting
SEDATIVE
THERAPY?
PSYCHIATRIC
DISORDER
PROPHYLAXIS?
PARADOXICAL
DRUG
REACTION? If
so, update the
verbatim term as
such. Otherwise
clarify and edit the
term. Thank you.
Aug-12-2020
19:03:17
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entr
y:
Penergren-
Excessive
EnergyInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-12-2020 19:03:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/1/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-12-2020 19:03:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792170
Page 96 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Aug-12-2020 19:04:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Seasonal Alle
rgies
Start Date: Apr/UNK/20
10
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-12-2020 19:04:12
(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
Aug-12-2020 19:04:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Seasonal AllergiesInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-12-2020 19:04:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/UNK/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-12-2020 19:04:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792171
Page 97 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-13-2020 08:44:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:3
Medical Histo
ry Term:Cataract Oculu
s Sinister
Start Date: Jan/UNK/2020
Ongoing: YESTranscription Error
Aug-12-2020 19:05:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:Cataract O
S
Start Date: Jan/UNK/2
020
Ongoing: YESInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792172
Page 98 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.c Line/MH Number:
Date Location User Value Reason
Aug-12-2020 19:05:13
(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
Aug-13-2020 08:44:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Cataract Oculus SinisterTranscription Error
Aug-12-2020 19:05:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Cataract OSInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-12-2020 19:05:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2020Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-12-2020 19:05:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-13-2020 08:43:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:4
Medical Hi
story Term:Subcutaneous Cys
t Oculus Dexter
Start Date: Aug/UNK/2019Transcription Error
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792173
Page 99 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Ongoing: NO
End Date:
Aug/12/2020
Aug-12-2020 19:14:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:4
Medical Histo
ry Term:Subcutaneous
Cyst OD
Start Date: Aug/UNK/201
9
Ongoing: NO
End Date:
Aug/12/202
0Transcription Error
Aug-12-2020 19:13:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:4
Medical Histo
ry Term:Subcutaneous
Cyst OD
Start Date: Aug/12/2020
Ongoing: NO
End Date:
Aug/12/202
0Transcription Error
Aug-12-2020 19:07:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4
Medical Histor
y Term:Subcutaneous
Cyst OD
Start Date: Aug/12/2020
Ongoing: YESInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792174
Page 100 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.d Line/MH Number:
Date Location User Value Reason
Aug-12-2020 19:07:00
(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
Aug-13-2020
09:57:37
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1:
ClosedDiscrepancy has
been closed.
Aug-13-2020
08:43:06
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
AnsweredTranscription Error
Aug-13-2020
08:43:06
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
Subcutan
eous Cyst
Oculus D
exterTranscription Error
Aug-13-2020
05:43:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1:
OpenedClarify
SUBCUTANEOUS
CYST OD as
follows...Please
expand
abbreviation OD
and update the
verbatim term.
Thank you.
Aug-12-2020
19:07:00
(UTC-06:00)
Central TimeACV0PFEINFP6000 Data Ent
ry:
Subcutan
eous CystInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0792175
Page 101 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(US &
Canada)OD
1.d Start Date:
Date Location User Value Reason
Aug-12-2020 19:14:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/UNK/2019Transcription Error
Aug-12-2020 19:07:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-12-2020 19:13:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Aug/12/2020Transcription Error
Aug-12-2020 19:07:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-12-2020 19:12:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5
Medical Hist
ory Term:Right Eye periorbi
tal ecchymosis
Start Date: Aug/12/2020
Ongoing: YESInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792176
Page 102 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.e Line/MH Number:
Date Location User Value Reason
Aug-12-2020 19:12:21
(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
Aug-12-2020 19:12:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Right Eye periorbital ecchymosi
sInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-18-2020 00:23:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Per site
confirmation
Aug-14-2020 08:30:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Confirming,
subject visited eye
doctor on the day
of, but prior to,
screening visit, for
removal of
subcutaneous cyst.
Subject does meet
Inclusion Criteria
#3 per Investigator.
Aug-14-2020 03:14:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM Query: Thank
you for your
response. Please
confirm if Medical
History occurred
prior to vaccination
even on same day
(date 12/Aug
/2020). Please
review and update
as appropriate.
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0792177
Page 103 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-12-2020 19:30:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Aug-12-2020 19:26:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is after
or equal to the first
vaccination date
12/Aug/2020.
Please review and
update as
appropriate.
Aug-12-2020 19:12:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-12-2020 19:12:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792178
Page 104 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.f
Date Location User Value Reason
Aug-12-2020 19:13:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Te
rm:Hypertensi
on
Start Date: Aug/1/200
5
Ongoing: YESInitial Entry
1.f Line/MH Number:
Date Location User Value Reason
Aug-12-2020 19:13:11
(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
Aug-12-2020 19:13:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-12-2020 19:13:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/1/2005Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-12-2020 19:13:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792179
Page 105 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.g
Date Location User Value Reason
Aug-12-2020 19:15:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:Hyperlipide
mia
Start Date: Aug/1/2005
Ongoing: YESInitial Entry
1.g Line/MH Number:
Date Location User Value Reason
Aug-12-2020 19:15:13
(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
Aug-12-2020 19:15:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HyperlipidemiaInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-12-2020 19:15:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/1/2005Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-12-2020 19:15:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792180
Page 106 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Aug-12-2020 19:16:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:8
Medical Histor
y Term:Coronary Arter
y Disease
Start Date: Aug/UNK/2005
Ongoing: YESInitial Entry
1.h Line/MH Number:
Date Location User Value Reason
Aug-12-2020 19:16:04
(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
Aug-12-2020 19:16:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Coronary Artery DiseaseInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-12-2020 19:16:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/UNK/2005Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-12-2020 19:16:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792181
Page 107 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-12-2020 19:17:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:9
Medical Hist
ory Term:Acute Myocardia
l Infarction
Start Date: Aug/1/2005
Ongoing: NO
End Date:
Aug/1/2005Initial Entry
1.i Line/MH Number:
Date Location User Value Reason
Aug-12-2020 19:17:25
(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
Aug-12-2020 19:17:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Acute Myocardial InfarctionInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-12-2020 19:17:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/1/2005Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-12-2020 19:17:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Aug/1/2005Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792182
Page 108 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.j
Date Location User Value Reason
Aug-12-2020 19:18:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:10
Medical Histo
ry Term:Benign prostatic
hyperplasia
Start Date: Jan/UNK/2014
Ongoing: YESInitial Entry
1.j Line/MH Number:
Date Location User Value Reason
Aug-12-2020 19:18:39
(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
Aug-12-2020 19:18:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Benign prostatic hyperplasiaInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-12-2020 19:18:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2014Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-12-2020 19:18:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.k
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792183
Page 109 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Aug-12-2020 19:21:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:11
Medical Histo
ry Term:Bursitis Right
Shoulder
Start Date: Jun/1/2018
Ongoing: NO
End Date:
Jun/UNK/2
019New Information
Aug-12-2020 19:20:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:11
Medical Histor
y Term:Bursitis
Start Date: Jun/1/2018
Ongoing: NO
End Date:
Jun/UNK/
2019Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792184
Page 110 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.k Line/MH Number:
Date Location User Value Reason
Aug-12-2020 19:20:07
(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
Aug-12-2020 19:21:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Bursitis Right ShoulderNew Information
Aug-12-2020 19:20:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BursitisInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-12-2020 19:20:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/1/2018Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-12-2020 19:20:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jun/UNK/2019Initial Entry
1.l
Date Location User Value Reason
Aug-12-2020 19:20:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:12Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792185
Page 111 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Medical Histo
ry Term:Osteoarthritis G
eneralized
Start Date: Jan/UNK/1967
Ongoing: YES
1.l Line/MH Number:
Date Location User Value Reason
Aug-12-2020 19:20:55
(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
Aug-12-2020 19:20:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Osteoarthritis GeneralizedInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-12-2020 19:20:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/1967Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-12-2020 19:20:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Aug-13-2020 09:47:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:13Apologies for the
'extra' information
added in error.
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792186
Page 112 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Medical His
tory Term:Total knee repla
cement, left
Start Date: Jan/UNK/2020
Ongoing: NO
End Date:
Jan/UNK/20
20
Aug-13-2020 08:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/M
H Num
ber:13
Medical
History
Term:Total knee replacem
ent-Left Osteoarthri
tis Generalized
Start Da
te:Jan/UNK/2020
Ongoin
g:NO
End Date:
Jan/UNK/2020Transcription Error
Aug-12-2020 19:23:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:13
Medical
History
Term:Total knee replace
ment-Left Osteoart
hritis Generalized
Start Da
te:Jan/UNK/2020
Ongoing
:NOInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792187
Page 113 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.m Line/MH Number:
Date Location User Value Reason
Aug-12-2020 19:23:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Aug-13-2020
11:03:30
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy has been
closed.
Aug-13-2020
09:47:01
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dApologies for the 'extra'
information added in
error.
Aug-13-2020
09:47:01
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Total
knee r
eplace
ment,
leftApologies for the 'extra'
information added in
error.
Aug-13-2020
08:48:42
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedMultiple concepts in the
term TOTAL KNEE
REPLACEMENT-LEFT
OSTEOARTHRITIS
GENERALIZED. Split
the term into TOTAL
KNEE
REPLACEMENT and
LEFT KNEE
OSTEOARTHRITIS
GENERALIZED and
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0792188
Page 114 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
submit separately.
Thank you.
Aug-12-2020
19:23:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Total
knee r
eplace
ment-
Left
Osteo
arthrit
is Gen
eraliz
edInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-12-2020 19:23:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2020Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-13-2020 08:26:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jan/UNK/2020Transcription Error
Aug-12-2020 19:23:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.n
Date Location User Value Reason
Aug-14-2020 08:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:14Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0792189
Page 115 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Medical H
istory Ter
m:Cyst removal of Sub
cutaneous cyst, right
eye
Start Date
:Aug/12/2020
Ongoing: NO
End Date:
Aug/12/2020
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792190
Page 116 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.n Line/MH Number:
Date Location User Value Reason
Aug-14-2020 08:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 08:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Cyst removal of Subcutaneous
cyst, right eyeInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-17-2020 11:32:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-17-2020 11:08:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered I did confirm in
my previous
response that this
procedure was
prior to the
screening visit. I
am not sure how
much clearer I can
state it. Subject
had procedure
done on the same
day as, but prior to
the screening visit.
Aug-17-2020 01:03:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM Query: Thank
you for your
response. Please
confirm if Medical
History occurred
prior to
vaccination even
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0792191
Page 117 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
on same day (date
12/Aug/2020).
Please review and
update as
appropriate.
Aug-14-2020 08:32:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Correct as entered.
Procedure was
prior to screening
visit.
Aug-14-2020 08:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is after
or equal to the first
vaccination date
12/Aug/2020.
Please review and
update as
appropriate.
Aug-14-2020 08:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-14-2020 08:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Aug/12/2020Initial Entry
1.o
Date Location User Value Reason
Oct-08-2020 09:44:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:15
Medical History
Term:Angina Recu
rrent
Start Date: UNK/UNK/2
005
Ongoing: YESInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792192
Page 118 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.o Line/MH Number:
Date Location User Value Reason
Oct-08-2020 09:44:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-08-2020 09:44:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Angina RecurrentInitial Entry
1.o Start Date:
Date Location User Value Reason
Oct-08-2020 09:44:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.o Ongoing:
Date Location User Value Reason
Oct-08-2020 09:44:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.p
Date Location User Value Reason
Mar-12-2021 15:22:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:16
Medical
History T
erm:Ejection Fraction L
ess then 30% Abnor
mal
Start Date
:UNK/UNK/2011Changed
Information
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792193
Page 119 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Ongoing: NO
End Date:
UNK/UNK/201
1
Mar-11-2021 15:56:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:16
Medical His
tory Term:Ejection Fraction
Less then 30%
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/20
11Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792194
Page 120 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.p Line/MH Number:
Date Location User Value Reason
Mar-11-2021 15:56:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-12-2021
17:56:57
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1:
ClosedDiscrepancy has
been closed.
Mar-12-2021
15:22:47
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
Answere
dChanged
Information
Mar-12-2021
15:22:47
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data En
try:
Ejection
Fraction
Less then
30% Abn
ormalChanged
Information
Mar-12-2021
01:59:13
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1:
OpenedClarify EJECTION
FRACTION LESS
THEN 30% as
follows...The term
appears incomplete.
Are you reporting
EJECTION
FRACTION LESS
THAN
30%-DECREASED?
EJECTION
FRACTION LESS
THAN
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0792195
Page 121 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
30%-ABNORMAL?
If so, update the
verbatim term as
such. Otherwise
please clarify and
edit the term. Thank
you.
Mar-11-2021
15:56:33
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data En
try:
Ejection
Fraction
Less then
30%Initial Entry
1.p Start Date:
Date Location User Value Reason
Mar-11-2021 15:56:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.p Ongoing:
Date Location User Value Reason
Mar-11-2021 15:56:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2011Initial Entry
1.q
Date Location User Value Reason
Mar-12-2021 15:18:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/M
H Numb
er:17
Medical
History
Term:Automatic Implantabl
e Cardioverter Defibr
illators Implant
Start Da
te:UNK/UNK/2011Changed
Information
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792196
Page 122 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Ongoing
:NO
End Date:
UNK/UNK/2011
Mar-11-2021 15:58:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/
MH N
umber
:17
Medic
al Hist
ory Te
rm:Automatic Implantable
Cardioverter Defibrillat
ors Implant- ejection fr
action Less then 30%
Start
Date:UNK/UNK/2011
Ongoi
ng:NO
End Date:
UNK/UNK/2011Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0792197
Page 123 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.q Line/MH Number:
Date Location User Value Reason
Mar-11-2021 15:58:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-13-2021
02:28:29
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 2:
OpenedClarify
AUTOMATIC
IMPLANTABLE
CARDIOVERTER
DEFIBRILLATORS
IMPLANT as
follows...Device
only reported. Are
you reporting
AUTOMATIC
IMPLANTABLE
CARDIOVERTER
DEFIBRILLATORS
IMPLANT
INSERTION?
REMOVAL? USER?
MALFUNCTION?
Other? If so, update
the verbatim term as
such. Otherwise
clarify and update
the term as
appropriate. Thank
you.
Mar-12-2021
17:57:31
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1:
ClosedDiscrepancy has
been closed.
Mar-12-2021
15:18:37ACV0PFEINFP6000 auto query
(autoquery)Query 1:
AnswereChanged
Information
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0792198
Page 124 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00)
Central Time
(US &
Canada)d
Mar-12-2021
15:18:37
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data En
try:
Automati
c Implant
able Car
dioverter
Defibrill
ators Imp
lantChanged
Information
Mar-12-2021
01:59:48
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1:
OpenedMultiple actions for
AUTOMATIC
IMPLANTABLE
CARDIOVERTER
DEFIBRILLATORS
IMPLANT-
EJECTION
FRACTION LESS
THEN 30%. Split
the term into
AUTOMATIC
IMPLANTABLE
CARDIOVERTER
DEFIBRILLATORS
IMPLANTATION
and EJECTION
FRACTION LESS
THAN 30% and
submit separately.
Also please clarify
the part EJECTION
FRACTION LESS
THAN 30% further.
Are you reporting
EJECTION
FRACTION LESS
THAN
30%-DECREASED?
EJECTION
FRACTION LESS
THAN
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0792199
Page 125 of 199
***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, Queries, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
30%-ABNORMAL?
If so, update the
verbatim term as
such. Otherwise
please clarify and
edit the term. Thank
you.
Mar-11-2021
15:58:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data En
try:
Automati
c Implant
able Car
dioverter
Defibrill
ators Imp
lant- ejec
tion fract
ion Less
then 30%Initial Entry
1.q Start Date:
Date Location User Value Reason
Mar-11-2021 15:58:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.q Ongoing:
Date Location User Value Reason
Mar-11-2021 15:58:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2011Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792200
Page 126 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Aug-12-2020 19:24:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-12-2020 19:24:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
87.5Initial Entry
3. Unit:
Date Location User Value Reason
Aug-12-2020 19:24:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-12-2020 19:24:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
177.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-12-2020 19:24:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792201
Page 127 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-12-2020 19:24:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27.9Initial Entry
7.a
Date Location User Value Reason
Aug-12-2020 19:24:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 36.9
Temperature Uni
t:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-12-2020 19:24:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-12-2020 19:24:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-12-2020 19:24:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792202
Page 128 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-12-2020 19:24:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792203
Page 129 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-12-2020 19:25:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-12-2020 19:25:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
226610Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792204
Page 130 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-12-2020 19:47:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-12-2020 19:47:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-12-2020 19:49:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-12-2020 19:47:16
(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.
Aug-12-2020 19:47:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/12/2020Initial Entry
5.a
Date Location User Value Reason
Aug-12-2020 19:49:05
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Sample ID: BPR75HInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792205
Page 131 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Aug-12-2020 19:49:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPR75HInitial Entry
5.b
Date Location User Value Reason
Aug-12-2020 19:49:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR75GInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-12-2020 19:49:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPR75GInitial Entry
5.c
Date Location User Value Reason
Aug-12-2020 19:50:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5FFKInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-12-2020 19:50:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5FFKInitial Entry
5.d
Date Location User Value Reason
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (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-2021-5683-0792206
Page 132 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-12-2020 19:50:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5FFLInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-12-2020 19:50:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5FFLInitial Entry
5.e
Date Location User Value Reason
Aug-12-2020 19:51:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5FFMInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-12-2020 19:51:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5FFMInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792207
Page 133 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-12-2020 19:47:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-12-2020 19:47:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-12-2020 19:48:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-12-2020 19:47:44
(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.
Aug-12-2020 19:47:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/12/2020Initial Entry
5.a
Date Location User Value Reason
Aug-12-2020 19:48:17
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Sample ID: BP5FF7Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792208
Page 134 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Aug-12-2020 19:48:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5FF7Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792209
Page 135 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-12-2020 19:26:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-12-2020 19:26:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-12-2020 19:26:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-12-2020 19:26:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020 19:26Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-12-2020 19:26:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792210
Page 136 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-12-2020 19:26:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-12-2020 19:26:42
(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
Aug-12-2020 19:26:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-12-2020 19:26:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792211
Page 137 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-12-2020 19:27:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-
DIARY COLLECTED FOR TH
IS SUBJECTInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792212
Page 138 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-01-2020 13:07:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792213
Page 139 of 199
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 13:12:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792214
Page 140 of 199
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada) Symptom:: FA
TI
GU
E
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NO
2.b Symptom:
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792215
Page 141 of 199
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.c Symptom:
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792216
Page 142 of 199
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.e
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792217
Page 143 of 199
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.f Symptom:
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792218
Page 144 of 199
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.g Symptom:
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSC
LE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WORS
ENED J
OINT PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792219
Page 145 of 199
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.h Symptom:
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT
PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-01-2020 13:12:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-01-2020 13:12:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792220
Page 146 of 199
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site reacti
ons present on the last d
ay the Subject Diary wa
s completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792221
Page 147 of 199
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.c
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 13:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792222
Page 148 of 199
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020 13:11:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
2.a
Date Location User Value Reason
Sep-01-2020 13:14:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 37.1
Temperature Uni
t:C
Temperature Loc
ation::ORAL CA
VITYChanged
Information
Sep-01-2020 13:11:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 37.1
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-01-2020 13:11:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792223
Page 149 of 199
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-01-2020 13:14:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-01-2020 13:11:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Temperature 37.1 F
is outside of
Normal Range 97 -
99.5 F.
Sep-01-2020 13:11:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
37.1Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-01-2020 13:14:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CChanged
Information
Sep-01-2020 13:11:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-01-2020 13:11:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792224
Page 150 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020 08:59:56
(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 08:59:56
(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 09:00:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-02-2020 08:59:56
(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 08:59:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
Sep-02-2020 09:00:04
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Sample ID: BP5FYCInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792225
Page 151 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Sep-02-2020 09:00:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5FYCInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792226
Page 152 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-01-2020 13:12:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-01-2020 13:12:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020 13:12:52
(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-01-2020 13:12:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020 11:28Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020 13:12:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792227
Page 153 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-01-2020 13:12:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-01-2020 13:12:52
(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-01-2020 13:12:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-01-2020 13:12:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792228
Page 154 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-06-2020 14:06:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792229
Page 155 of 199
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792230
Page 156 of 199
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada) Symptom:: FA
TI
GU
E
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NO
2.b Symptom:
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792231
Page 157 of 199
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.c Symptom:
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792232
Page 158 of 199
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.e
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792233
Page 159 of 199
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.f Symptom:
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792234
Page 160 of 199
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.g Symptom:
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSC
LE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WORS
ENED J
OINT PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792235
Page 161 of 199
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.h Symptom:
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT
PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792236
Page 162 of 199
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site reacti
ons present on the last d
ay the Subject Diary wa
s completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792237
Page 163 of 199
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.c
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 14:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792238
Page 164 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020 11:09:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020 11:09:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020 11:10:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-07-2020 11:09:44
(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.
Oct-07-2020 11:09:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/6/2020Initial Entry
5.a
Date Location User Value Reason
Oct-07-2020 11:10:14
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Sample ID: BP5G3KInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792239
Page 165 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Oct-07-2020 11:10:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5G3KInitial Entry
5.b
Date Location User Value Reason
Oct-07-2020 11:41:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR7G8Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-07-2020 11:41:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPR7G8Initial Entry
5.c
Date Location User Value Reason
Oct-07-2020 11:41:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR7G9Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-07-2020 11:41:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPR7G9Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (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-2021-5683-0792240
Page 166 of 199
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-26-2021 10:53:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/25/2021Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792241
Page 167 of 199
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021 10:54:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-26-2021 10:54:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021 10:55:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-26-2021 10:54:55
(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.
Feb-26-2021 10:54:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/25/2021Initial Entry
5.a
Date Location User Value Reason
Feb-26-2021 10:55:10
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Sample ID: BPVPV3Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792242
Page 168 of 199
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Feb-26-2021 10:55:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPVPV3Initial Entry
5.b
Date Location User Value Reason
Feb-26-2021 10:55:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR733Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-26-2021 10:55:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPR733Initial Entry
5.c
Date Location User Value Reason
Feb-26-2021 10:55:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR734Initial Entry
5.c Sample ID
Date Location User Value Reason
Feb-26-2021 10:55:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPR734Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (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-2021-5683-0792243
Page 169 of 199
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-06-2020 14:09:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-06-2020 14:09:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-06-2020 14:09:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792244
Page 170 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Dec-18-2020 11:25:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792245
Page 171 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Jan-11-2021 16:10:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792246
Page 172 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Jan-13-2021 14:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792247
Page 173 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Jan-28-2021 14:42:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792248
Page 174 of 199
***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, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Dec-18-2020 11:25:55
(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-18-2020 11:25:55
(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
Jan-25-2021 16:35:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response satisfies
query
Jan-20-2021 16:29:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered SAE FU Submitted
Jan-06-2021 09:19:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Reissued:Opened Clin: Thanks for
confirming. Please
make every effort
possible to obtain
further information
and respond to the
query once
additional
information is
available.
Dec-28-2020 14:30:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered No further
information,
awaiting Medical
Records.
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0792249
Page 175 of 199
***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, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Dec-23-2020 17:26:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Please submit a FU
form to provide
details regarding
clinical
presentation, other
symptoms of onset
and the workup
including imaging
and covid testing
during hospital
stay. Thank you.
Dec-18-2020 11:25:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Ventricular TachycardiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-18-2020 11:25:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/11/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-18-2020 11:25:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/15/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-18-2020 11:25:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0792250
Page 176 of 199
***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, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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-22-2020 05:21:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-18-2020 11:25:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Ventricular
Tachycardia:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Dec-18-2020 11:25:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant dis
ability/incapacity?
NO
Is this serious event life threa
tening?Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792251
Page 177 of 199
***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, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
NO
Other medically important se
rious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-18-2020 11:25:55
(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-18-2020 11:25:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
Related to his coronary ar
tery disease, has defibrill
ation.Initial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-18-2020 11:25:55
(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-18-2020 11:25:55 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0792252
Page 178 of 199
***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, Verified
Site No: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00) Central
Time (US & Canada)YES
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-18-2020 11:25:55
(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
Dec-18-2020 11:25:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVED W
ITH SEQUELAEInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-18-2020 11:25:55
(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
Dec-22-2020 05:21:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020501074Initial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792253
Page 179 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Jan-11-2021 16:10:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-11-2021 16:10:25
(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
Jan-11-2021 16:10:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HypokalemiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-11-2021 16:10:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/12/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-11-2021 16:10:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/20/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792254
Page 180 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Jan-11-2021 16:10:25
(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
Jan-11-2021 16:10:25
(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
Jan-11-2021 16:10:25
(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
Jan-15-2021
02:08:57
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
ClosedResponse
satisfies query
Jan-13-2021
14:35:11
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
Answere
dPI specified
AE is due to
Metabolic,
that is what
has been
entered. Not
understanding
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0792255
Page 181 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
what is meant
by "Any
symptoms,
AEs or other
key data
should be
collected on
the
appropriate
page. Please
review and
update as
necessary".
Jan-13-2021
02:47:30
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 1:
OpenedPlease review
"If not related
to study
treatment
other" field,
the following
text was
indicated in
the comment
field
[Metabolic].
Any
symptoms,
AEs or other
key data
should be
collected on
the
appropriate
page. Please
review and
update as
necessary.
Jan-11-2021
16:10:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data En
try:
NOT RE
LATED
If Not
RelatedInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0792256
Page 182 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
to study
treatme
nt(s), th
is event
is due t
o:
OTH
ER
If Ot
her,
spec
ify:
M
eta
bol
ic
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-11-2021 16:10:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-11-2021 16:10:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-11-2021 16:10:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792257
Page 183 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Jan-11-2021 16:10:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVED WI
TH SEQUELAEInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-11-2021 16:10:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792258
Page 184 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Jan-13-2021 14:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-13-2021 14:38:54
(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
Jan-21-2021 12:10:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Closed Response satisfies
query
Jan-20-2021 15:04:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered subject not
hospitalized
Jan-15-2021 14:00:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Opened GPD Clin: AE of
PE listed as non
serious, pls confirm
pt not hospitalized
or seen in ER for
AE, or otherwise
meet criteria for
SAE. If this is SAE
please complete
form and notify
sponsor
immediately. How
was diagnosis
made?
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0792259
Page 185 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Jan-13-2021 14:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
pulmonary embolismInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-13-2021 14:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/7/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-22-2021 13:30:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-22-2021 11:59:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Feb-22-2021 11:59:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/10/2021 UNK:UNKNew Information
Feb-19-2021 09:51:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY -
PULMONARY
EMBOLISM with
Start Date of 07 Jan
21, is still indicated
as ONGOING.
Please review and if
an END date is
known, please
update.
Jan-13-2021 14:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (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-2021-5683-0792260
Page 186 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Jan-13-2021 14:38:54
(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
Jan-13-2021 14:38:54
(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
Jan-13-2021 14:38:54
(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
Jan-29-2021 10:12:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-28-2021 14:43:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Jan-21-2021 09:07:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened clin: requested info
not seen in Argus.
Pls provide start
date of coag
disorder. If prior to
enrollment should
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (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-2021-5683-0792261
Page 187 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
be added to
MedHx CRF, if
after pls report as
separate AE.
Thanks
Jan-20-2021 16:29:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered SAE FU Submitted
Jan-18-2021 08:14:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened clinical: pls advise
if coagulation
disorder refers to a
prior underlying
condition and
update MedHx
CRF as
appropriate. If this
is a new condition,
pls review for
inclusion as
separate AE.
Thanks
Jan-13-2021 14:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
blood coagulation disord
erInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-13-2021 14:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792262
Page 188 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Jan-13-2021 14:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-13-2021 14:38:54
(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
Feb-22-2021 12:00:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-22-2021 12:00:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Feb-22-2021 11:59:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE pulmonary
embolism:
Response to "What
was the outcome of
this adverse event?"
is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Jan-13-2021 14:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-13-2021 14:38:54
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d4f\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0792263
Page 189 of 199
***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: 1114 Site Name: (1114) Alliance for Multispecialty Research Inc
Subject No: 11141006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada)
090177e196ae3d4f\Fina
…[truncated]