125742 S1 M5 CRF c4591001 1131 11311094

Document text

Page 1 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934691
Page 2 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/27/2020
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934692
Page 3 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Demography
1.Subject ID [11311094]
2.Birth Date: /1971
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:
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934693
Page 4 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934694
Page 5 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934695
Page 6 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934696
Page 7 of 222
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Myopia]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[contact lens wearer]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hyperlipidemia]
Start Date: UNK/UNK/2014
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[inguinal hernia]
Start Date: UNK/UNK/1981
Ongoing: NO
End Date:
UNK/UNK/1981
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934697
Page 8 of 222
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[erectile dysfunction]
Start Date: Aug/UNK/2019
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[anxiety]
Start Date: Jan/UNK/2010
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[inguinal hernia surgical repair]
Start Date: UNK/UNK/1981
Ongoing: NO
End Date:
UNK/UNK/1981
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934698
Page 9 of 222
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
2.Weight: [95.9]
3.Unit: kg
4.Height: [177.1]
5.Unit: cm
6.Body Mass Index: [30.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934699
Page 10 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/27/2020
2.Randomization Number: [70504]
3.Randomization Group: [ ]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934700
Page 11 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
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 [BN6DP1]
5.bSample ID [BN6DP2]
5.cSample ID [BN6DP3]
5.dSample ID [BL9VXP]
5.eSample ID [BL9VXR]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934701
Page 12 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
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 [BN6DWT]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934702
Page 13 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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/27/2020 16:20
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
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934703
Page 14 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934704
Page 15 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934705
Page 16 of 222
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934706
Page 17 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/16/2020
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 [BN6F25]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934707
Page 18 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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/16/2020 16:47
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
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934708
Page 19 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934709
Page 20 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP99WK]
5.bSample ID [BL9VNF]
5.cSample ID [BL9VNG]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934710
Page 21 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/29/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934711
Page 22 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/29/2020
2.Date of First Symptom Started: Nov/27/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/30/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4 hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934712
Page 23 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [joint pain]
5.bSymptoms - Other Text: [nasal congestion]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934713
Page 24 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934714
Page 25 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934715
Page 26 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Nov/29/2020
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 [CV16296]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934716
Page 27 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[home nasal swab collected.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934717
Page 28 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934718
Page 29 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Treatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934719
Page 30 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934720
Page 31 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934721
Page 32 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934722
Page 33 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934723
Page 34 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934724
Page 35 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934725
Page 36 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category for L
ab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934726
Page 37 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934727
Page 38 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934728
Page 39 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934729
Page 40 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934730
Page 41 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934731
Page 42 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934732
Page 43 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934733
Page 44 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934734
Page 45 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934735
Page 46 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934736
Page 47 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934737
Page 48 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/28/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/28/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934738
Page 49 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/28/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/28/2020
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 [BR0F5B]
5.bSample ID [BS7XN3]
5.cSample ID [BS7XN4]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934739
Page 50 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934740
Page 51 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Unplanned Assessments
1.Assessments
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934741
Page 52 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/15/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934742
Page 53 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934743
Page 54 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934744
Page 55 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934745
Page 56 of 222
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1. ADVERSE
EVENT 1  Suicidal Attempt  Mar/3/2021 U
NK:UNK NO
End Date Time:
Mar/5/2021 UNK:
UNK
 Repeating
Pages
 2. ADVERSE
EVENT 2  Major Depressive Disor
der, single episode Mar/3/2021 U
NK:UNK YES  Repeating
Pages
 3. ADVERSE
EVENT 3  Increased Anxiety  Mar/2/2021 U
NK:UNK YES  Repeating
Pages
 4. DELETED ADVERSE
EVENT 4  carbon monoxide poiso
ning Mar/3/2021 U
NK:UNK NO
End Date Time:
Mar/5/2021 UNK:
UNK
 Repeating
Pages
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934746
Page 57 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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)[Suicidal Attempt]
4.Start Date Time: Mar/3/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/5/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934747
Page 58 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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:
[Worsening anxiety and depression due to pandemic]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021247383]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934748
Page 59 of 222
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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)[Major Depressive Disorder, single episode]
4.Start Date Time: Mar/3/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
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(b) (4)
FDA-CBER-2021-5683-0934749
Page 60 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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:
[Situational stress due to pandemic]
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?: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[2021247375]
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(b) (4)
FDA-CBER-2021-5683-0934750
Page 61 of 222
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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)[Increased Anxiety]
4.Start Date Time: Mar/2/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934751
Page 62 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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:
[Stress related to pandemic]
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?: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[2021247366]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934752
Page 63 of 222
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[carbon monoxide poisoning ]
4.Start Date Time: Mar/3/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/5/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934753
Page 64 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[worsening anxiety and depression due to the pandemic ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021247383 ]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934754
Page 65 of 222
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934755
Page 66 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934756
Page 67 of 222
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934757
Page 68 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: //
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934758
Page 69 of 222
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934759
Page 70 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934760
Page 71 of 222
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934761
Page 72 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934762
Page 73 of 222
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934763
Page 74 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934764
Page 75 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934765
Page 76 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934766
Page 77 of 222
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934767
Page 78 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934768
Page 79 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934769
Page 80 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/3/2021
2.Erroneous Visit
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934770
Page 81 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934771
Page 82 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/3/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934772
Page 83 of 222
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934773
Page 84 of 222
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934774
Page 85 of 222
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934775
Page 86 of 222
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/10/2021
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934776
Page 87 of 222
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934777
Page 88 of 222
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Feb/10/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934778
Page 89 of 222
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/10/2021
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 [BKM7HZ]
5.bSample ID [BS2DPB]
5.cSample ID [BS2DPC]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934779
Page 90 of 222
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/10/2021
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 [BR0G97]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934780
Page 91 of 222
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/10/2021 09:19
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934781
Page 92 of 222
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934782
Page 93 of 222
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/8/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRR8WG]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934783
Page 94 of 222
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/8/2021 14:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934784
Page 95 of 222
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934785
Page 96 of 222
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934786
Page 97 of 222
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934787
Page 98 of 222
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934788
Page 99 of 222
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934789
Page 100 of 222
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934790
Page 101 of 222
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934791
Page 102 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/15/2020
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934792
Page 103 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934793
Page 104 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934794
Page 105 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormAug-27-2020 17:57:03 (UTC-05:00) Eastern
Time (US & Canada)no inclusion or exclusion criteria met
Not Applicable
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0934795
Page 106 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormNov-30-2020 09:44:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0934796
Page 107 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Nov-30-2020 09:44:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0934797
Page 108 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Nov-30-2020 09:44:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0934798
Page 109 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Nov-30-2020 09:44:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0934799
Page 110 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Nov-30-2020 09:44:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0934800
Page 111 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Nov-30-2020 09:44:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0934801
Page 112 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6Nov-30-2020 09:44:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0934802
Page 113 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
7Nov-30-2020 09:44:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0934803
Page 114 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
8Nov-30-2020 09:44:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0934804
Page 115 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
9Nov-30-2020 09:44:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0934805
Page 116 of 222
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormFeb-10-2021 13:35:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0934806
Page 117 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-04-2021 08:57:44 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Randall Approved Jan-22-2021 12:30:56 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamRandall, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-30-2020 09:42:39 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Randall Approved Oct-29-2020 06:40:42 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamRandall, 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.
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934807
Page 118 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
 N/A Oct-26-2020 07:51:33 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Randall Approved Oct-22-2020 17:51:37 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamRandall, 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-22-2020 08:52:47 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Randall Approved Oct-20-2020 16:22:23 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamRandall, 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.
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934808
Page 119 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-27-2020 17:56:23
(UTC-05:00) Eastern
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-27-2020 17:56:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934809
Page 120 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-27-2020 17:56:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/27/2020Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934810
Page 121 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-27-2020 17:56:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11311094Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-27-2020 17:56:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1971Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-27-2020 17:56:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-27-2020 17:56:39
(UTC-05:00) Eastern
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-27-2020 17:56:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934811
Page 122 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-27-2020 17:56:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934812
Page 123 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-27-2020 17:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-27-2020 17:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-27-2020 17:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934813
Page 124 of 222
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.a
Date Location User Value Reason
Aug-28-2020 08:57:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Myopia
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-28-2020 08:57:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 08:57:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MyopiaInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-28-2020 08:57:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-28-2020 08:57:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934814
Page 125 of 222
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.b
Date Location User Value Reason
Aug-28-2020 08:59:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:contact lens w
earer
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-28-2020 08:59:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 08:59:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
contact lens wearerInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-28-2020 08:59:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-28-2020 08:59:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934815
Page 126 of 222
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Aug-28-2020 09:00:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:hyperlipidem
ia
Start Date: UNK/UNK/2
014
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Aug-28-2020 09:00:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 09:00:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
hyperlipidemiaInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-28-2020 09:00:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-28-2020 09:00:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934816
Page 127 of 222
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-28-2020 09:01:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4
Medical History
Term:inguinal hernia
Start Date: UNK/UNK/19
81
Ongoing: NO
End Date:
UNK/UNK/
1981Initial Entry
1.d Line/MH Number:
Date Location User Value Reason
Aug-28-2020 09:01:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 09:01:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inguinal herniaInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-28-2020 09:01:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1981Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-28-2020 09:01:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1981Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934817
Page 128 of 222
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.e
Date Location User Value Reason
Aug-28-2020 09:02:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:erectile dysfun
ction
Start Date: Aug/UNK/201
9
Ongoing: YESInitial Entry
1.e Line/MH Number:
Date Location User Value Reason
Aug-28-2020 09:02:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 09:02:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
erectile dysfunctionInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-28-2020 09:02:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/UNK/2019Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-28-2020 09:02:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934818
Page 129 of 222
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Aug-28-2020 09:02:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Te
rm:anxiety
Start Date: Jan/UNK/20
10
Ongoing: YESInitial Entry
1.f Line/MH Number:
Date Location User Value Reason
Aug-28-2020 09:02:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 09:02:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
anxietyInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-28-2020 09:02:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2010Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-28-2020 09:02:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934819
Page 130 of 222
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-28-2020 09:03:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7
Medical Hist
ory Term:inguinal hernia sur
gical repair
Start Date: UNK/UNK/1981
Ongoing: NO
End Date:
UNK/UNK/19
81Initial Entry
1.g Line/MH Number:
Date Location User Value Reason
Aug-28-2020 09:03:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 09:03:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inguinal hernia surgical repairInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-28-2020 09:03:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1981Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-28-2020 09:03:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1981Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934820
Page 131 of 222
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020 09:04:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-28-2020 09:04:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
95.9Initial Entry
3. Unit:
Date Location User Value Reason
Aug-28-2020 09:04:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-28-2020 09:04:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
177.1Initial Entry
5. Unit:
Date Location User Value Reason
Aug-28-2020 09:04:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-28-2020 09:04:36 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (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-2021-5683-0934821
Page 132 of 222
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) 30.6
7.a
Date Location User Value Reason
Aug-28-2020 09:04:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 36.9
Temperature Uni
t:C
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-28-2020 09:04:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-28-2020 09:04:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-28-2020 09:04:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-28-2020 09:04:36
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (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-2021-5683-0934822
Page 133 of 222
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada)
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0934823
Page 134 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-28-2020 09:04:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-28-2020 09:04:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
70504Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934824
Page 135 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 17:58:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 17:58:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 17:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-27-2020 17:58:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-27-2020 17:58:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020 17:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN6DP1Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934825
Page 136 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 17:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN6DP1Initial Entry
5.b
Date Location User Value Reason
Aug-27-2020 17:58:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN6DP2Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-27-2020 17:58:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN6DP2Initial Entry
5.c
Date Location User Value Reason
Aug-27-2020 17:58:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN6DP3Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-27-2020 17:58:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN6DP3Initial Entry
5.d
Date Location User Value Reason
Aug-27-2020 17:58:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BL9VXPInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (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-2021-5683-0934826
Page 137 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.d Sample ID
Date Location User Value Reason
Aug-27-2020 17:58:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BL9VXPInitial Entry
5.e
Date Location User Value Reason
Aug-27-2020 17:58:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BL9VXRInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-27-2020 17:58:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BL9VXRInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934827
Page 138 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 17:57:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 17:57:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 17:57:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-27-2020 17:57:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-27-2020 17:57:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020 17:57:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN6DWTInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934828
Page 139 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 17:57:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN6DWTInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934829
Page 140 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-28-2020 09:06:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020 09:06:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020 09:06:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-28-2020 09:06:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/27/2020 16:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020 09:06:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-28-2020 09:06:18 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0934830
Page 141 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00) Eastern
Time (US & Canada)LEFT
7. Route:
Date Location User Value Reason
Aug-28-2020 09:06:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-28-2020 09:06:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-28-2020 09:06:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0934831
Page 142 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-28-2020 09:06:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934832
Page 143 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-17-2020 09:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934833
Page 144 of 222
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-17-2020 09:47:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
2.a
Date Location User Value Reason
Sep-17-2020 09:47:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 36.7
Temperature Uni
t:C
Temperature Loc
ation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-17-2020 09:47:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-17-2020 09:47:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-17-2020 09:47:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (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-2021-5683-0934834
Page 145 of 222
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.a Temperature Location:
Date Location User Value Reason
Sep-17-2020 09:47:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934835
Page 146 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 19:03:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 19:03:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-16-2020 19:03:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-16-2020 19:03:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-16-2020 19:03:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-16-2020 19:03:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN6F25Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934836
Page 147 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Sep-16-2020 19:03:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN6F25Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934837
Page 148 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-17-2020 09:48:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-17-2020 09:48:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-17-2020 09:48:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-17-2020 09:48:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020 16:47Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-17-2020 09:48:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-17-2020 09:48:13 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0934838
Page 149 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00) Eastern
Time (US & Canada)LEFT
7. Route:
Date Location User Value Reason
Sep-17-2020 09:48:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-17-2020 09:48:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-17-2020 09:48:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0934839
Page 150 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-22-2020 08:52:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020Transcription Error
Oct-16-2020 09:06:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934840
Page 151 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 17:13:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 17:13:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User ValueReason
Oct-22-2020
15:06:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Clo
sedResponse satisfies
query
Oct-22-2020
08:53:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: An
swere
dChanged data per
query
Oct-22-2020
07:34:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Rei
ssued:
Opene
dDM: Thank you for
confirmation. DOV
form is not frozen.
SAMP TRK form is
unfrozen as well if
any updates to be
made. Please
consider to update
as appropriate.
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0934841
Page 152 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-21-2020
08:52:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: An
swere
dDate of visit is an
error- it should be
15OCT2020;
however, DOV is
frozen. If unfrozen,
will update EDC.
Thank you for your
help.
Oct-21-2020
02:34:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
2: Op
enedDMW5086945;Date
of Collection is not
equal to Date of
Visit. Please clarify
or correct.
Oct-15-2020
17:13:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Del
etedClose Auto Query
Oct-15-2020
17:13:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Ca
ndidat
e'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-15-2020
17:13:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
YES
Date
of C
ollec
tion:
Oc
t/1
5/2
02
0Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934842
Page 153 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a
Date Location User Value Reason
Oct-15-2020 17:13:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP99WKInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-15-2020 17:13:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP99WKInitial Entry
5.b
Date Location User Value Reason
Oct-15-2020 17:13:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BL9VNFInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-15-2020 17:13:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BL9VNFInitial Entry
5.c
Date Location User Value Reason
Oct-15-2020 17:13:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BL9VNGInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-15-2020 17:13:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BL9VNGInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (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-2021-5683-0934843
Page 154 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-30-2020 09:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Nov-30-2020 09:42:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in
the Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Nov-30-2020 09:42:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Nov-30-2020 09:42:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/29/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-30-2020 09:42:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934844
Page 155 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/29/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/27/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-18-2021 15:13:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-18-2021 10:38:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Feb-18-2021 10:38:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resol
ved:
Nov/30/2020New Information
Feb-12-2021 05:47:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 60 days have
passed since the
Date of First
Symptom Started
and Ongoing is
YES. Please
confirm if
symptoms are truly
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (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-2021-5683-0934845
Page 156 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
ongoing. Else,
please enter Date
of Last Symptom
Resolved.
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:NEW OR INCRE
ASED COUGH
Symptom
Present:YESInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (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-2021-5683-0934846
Page 157 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.b Symptoms:
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COUG
HInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREAS
ED SHORTNESS OF
BREATH
Sympto
m Prese
nt:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHOR
TNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (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-2021-5683-0934847
Page 158 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREA
SED MUSCLE PAI
N
Symptom
Present:NOInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934848
Page 159 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.e Symptoms:
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUSC
LE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW LOSS OF TA
STE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR SM
ELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (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-2021-5683-0934849
Page 160 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREA
SED SORE THROA
T
Symptom
Present:YESInitial Entry
4.g Symptoms:
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE
THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHE
A
Symptom Presen
t:NOInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934850
Page 161 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.h Symptoms:
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITIN
G
Symptom Present
:NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Nov-30-2020 09:43:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (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-2021-5683-0934851
Page 162 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Nov-30-2020 09:43:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Other: joint painInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Nov-30-2020 09:43:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
joint painInitial Entry
5.b
Date Location User Value Reason
Nov-30-2020 09:44:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Ot
her:nasal congest
ionInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Nov-30-2020 09:44:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
nasal congestionInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934852
Page 163 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Nov-30-2020 09:44:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-30-2020 09:44:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Nov-30-2020 09:44:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Nov-30-2020 09:44:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Device Type:
Date Location User Value Reason
Nov-30-2020 09:44:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6. Trade Name:
Date Location User Value Reason
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (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-2021-5683-0934853
Page 164 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Nov-30-2020 09:44:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
7. Test Result:
Date Location User Value Reason
Nov-30-2020 09:44:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Nov-30-2020 09:44:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Nov-30-2020 09:44:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934854
Page 165 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-30-2020 09:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-30-2020 09:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-30-2020 09:45:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-30-2020 09:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-30-2020 09:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/29/2020Initial Entry
5.a
Date Location User Value Reason
Nov-30-2020 09:45:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: CV16296Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934855
Page 166 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Nov-30-2020 09:45:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CV16296Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934856
Page 167 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-30-2020 09:46:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-30-2020 09:46:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-30-2020 09:46:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Nov-30-2020 09:46:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
home nasal swab collected.Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934857
Page 168 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.a
Date Location User Value Reason
Nov-30-2020 09:46:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner
:SPECIA
LIST
Occurrence of Visits
or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Nov-30-2020 09:46:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-30-2020 09:46:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Nov-30-2020 09:46:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitio
ner:EMERGEN
CY ROOM
Occurrence of Vi
sits or Contacts:NOInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934858
Page 169 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Nov-30-2020 09:46:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-30-2020 09:46:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Nov-30-2020 09:46:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practit
ioner:PRIMARY C
ARE PHYSIC
IAN
Occurrence of
Visits or Conta
cts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Nov-30-2020 09:46:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-30-2020 09:46:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (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-2021-5683-0934859
Page 170 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Nov-30-2020 09:46:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitione
r:URGENT
CARE
Occurrence of Visit
s or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Nov-30-2020 09:46:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-30-2020 09:46:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Nov-30-2020 09:46:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practit
ioner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934860
Page 171 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Nov-30-2020 09:46:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATIO
NInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-30-2020 09:46:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Nov-30-2020 09:46:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits or
Contacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Nov-30-2020 09:46:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-30-2020 09:46:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (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-2021-5683-0934861
Page 172 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Nov-30-2020 09:46:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934862
Page 173 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/29/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Nov-30-2020 09:47:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNES
SInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Nov-30-2020 09:47:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Nov-30-2020 09:47:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934863
Page 174 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/28/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-28-2020 15:55:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/28/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-28-2020 15:55:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934864
Page 175 of 222
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/28/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-28-2020 15:58:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-28-2020 15:58:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-28-2020 16:28:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-28-2020 15:58:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-28-2020 15:58:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/28/2020Initial Entry
5.a
Date Location User Value Reason
Dec-28-2020 16:28:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR0F5BInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0934865
Page 176 of 222
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/28/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Dec-28-2020 16:28:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR0F5BInitial Entry
5.b
Date Location User Value Reason
Dec-28-2020 16:28:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS7XN3Initial Entry
5.b Sample ID
Date Location User Value Reason
Dec-28-2020 16:28:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS7XN3Initial Entry
5.c
Date Location User Value Reason
Dec-28-2020 16:28:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS7XN4Initial Entry
5.c Sample ID
Date Location User Value Reason
Dec-28-2020 16:28:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS7XN4Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (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-2021-5683-0934866
Page 177 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-26-2020 09:07:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-26-2020 07:51:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered "day" part of the
date was entered
one number lower
than actual. Date
now updated
Oct-26-2020 07:51:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020"day" part of the
date was entered
one number lower
than actual. Date
now updated
Oct-26-2020 03:49:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: As per CRF
guidelines, the
treatment period is
defined as 1st
vaccination visit
through the
1-month post
vaccination visit
after the 2nd
vaccination. Please
update date of EOT
to match the date
the Visit 3(1
month) visit was
completed.
Oct-16-2020 09:07:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934867
Page 178 of 222
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-16-2020 09:07:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-16-2020 09:07:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934868
Page 179 of 222
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Mar-05-2021 20:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934869
Page 180 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Mar-05-2021 20:24:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934870
Page 181 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Mar-05-2021 20:26:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934871
Page 182 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Mar-10-2021 15:25:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Deleted New
Information
Mar-10-2021 10:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934872
Page 183 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category:
Date Location User Value Reason
Mar-05-2021 20:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-05-2021 20:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-10-2021 14:05:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed AE of carbon
monoxide poisoning
entered in CRF
Mar-10-2021 10:43:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Mar-10-2021 10:43:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Suicidal AttemptNew Information
Mar-10-2021 04:30:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON:
AER#2021247383,
term was reported as
Suicidal Attempt, by
carbon monoxide
poisoning.Please
consider to split term
and record Carbon
monoxide poisoning
as separate entry.
Mar-05-2021 20:21:54
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
Suicidal Attempt, by carbon mInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0934873
Page 184 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada) onoxide poisoning
4. Start Date Time:
Date Location User Value Reason
Mar-05-2021 20:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/3/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021 20:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Mar/5/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-05-2021 20:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-08-2021 04:17:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-05-2021 20:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Suicidal
Attempt, by carbon
monoxide
poisoning:
Response to "Is the
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934874
Page 185 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Mar-05-2021 20:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabili
ty/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important serio
us event
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-05-2021 20:21:54 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0934875
Page 186 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00) Eastern
Time (US & Canada)NO
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-09-2021 19:09:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-09-2021 15:34:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered per investigator
assessment this
was a single
episode and no
suggestion of the
cause
Mar-09-2021 11:04:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened clinical: Thanks, in
view of response
consider updating
causality
"Worsening anxiety
and depression due
to pandemic" as
there is no
worsening of an
underlying
depression.
Mar-09-2021 11:01:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered No prior
depression and no
prior suicidal
ideation or attempt.
This was just a
single episode
Mar-08-2021 13:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened clinical: pls clarify,
does subject have
history of
depression? This is
not listed in
MedHx CRF. Has
subject had prior
suicidal ideation or
attempts. Thanks
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0934876
Page 187 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Mar-05-2021 20:21:54
(UTC-05:00) Eastern
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:
Worsening anxiety and de
pression due to pandemicInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-05-2021 20:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-05-2021 20:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-05-2021 20:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-05-2021 20:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (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-2021-5683-0934877
Page 188 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Mar-05-2021 20:21:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-08-2021 04:17:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021247383Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934878
Page 189 of 222
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category:
Date Location User Value Reason
Mar-05-2021 20:24:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-05-2021 20:24:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-05-2021 20:24:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Major Depressive Disorder, singl
e episodeInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-05-2021 20:24:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/3/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021 20:24:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934879
Page 190 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Mar-05-2021 20:24:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-08-2021 04:18:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-05-2021 20:24:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Major
Depressive
Disorder, single
episode: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Mar-05-2021 20:24:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
YES
Did this serious event result inInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934880
Page 191 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
persistent or significant disabili
ty/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important seri
ous 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
Mar-05-2021 20:24:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-05-2021 20:24:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
Situational stress due to pa
ndemicInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-05-2021 20:24:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934881
Page 192 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-05-2021 20:24:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-05-2021 20:24:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-05-2021 20:24:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-05-2021 20:24:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-08-2021 04:18:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021247375Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (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-2021-5683-0934882
Page 193 of 222
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category:
Date Location User Value Reason
Mar-05-2021 20:26:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-05-2021 20:26:38
(UTC-05:00) Eastern
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
Mar-05-2021 20:26:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Increased AnxietyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-11-2021 04:44:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidate Pending SDB update
Mar-10-2021 15:24:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered SAE has been
resubmitted
Mar-10-2021 14:08:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened SAE RECON1:
Thanks for
clarifying. Please
confirm submission
of a follow up SAE
form for the onset
date update.
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0934883
Page 194 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Mar-10-2021 10:57:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered march 2nd is the
correct date safety
data will be updated
to reflect that
Mar-10-2021 06:40:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON:
AER#2021247366
,onset date was
recorded as
03Mar2021 in Safety
database however,
recorded as
02Mar2021 on AE
CRF. Please confirm
correct Onset Date.
If safety update is
required, please
submit a follow-up
SAE form.
Mar-05-2021 20:26:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/2/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021 20:26:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-05-2021 20:26:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (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-2021-5683-0934884
Page 195 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Mar-08-2021 04:18:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-05-2021 20:26:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Increased
Anxiety : Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Mar-05-2021 20:26:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in
death?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabili
ty/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important serio
us eventInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934885
Page 196 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
Mar-05-2021 20:26:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-05-2021 20:26:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
Stress related to pandemicInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-05-2021 20:26:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-05-2021 20:26:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-05-2021 20:26:38 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0934886
Page 197 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00) Eastern
Time (US & Canada)NO
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-05-2021 20:26:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-05-2021 20:26:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-08-2021 04:18:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021247366Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0934887
Page 198 of 222
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Mar-10-2021 10:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-10-2021 10:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-10-2021 10:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
carbon monoxide poisoningInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-10-2021 10:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/3/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-10-2021 10:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Mar/5/2021 UNK:UNKInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934888
Page 199 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
6. Toxicity Grade:
Date Location User Value Reason
Mar-10-2021 10:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-10-2021 14:04:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-10-2021 10:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE carbon
monoxide
poisoning:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Mar-10-2021 10:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
NO
Did this serious event requireInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934889
Page 200 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
or prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabil
ity/incapacity?
NO
Is this serious event life threat
ening?
YES
Other medically important seri
ous 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
Mar-10-2021 10:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-10-2021 10:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
worsening anxiety and dep
ression due to the pandemi
cInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934890
Page 201 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-10-2021 10:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-10-2021 10:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-10-2021 10:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-10-2021 11:00:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-10-2021 11:00:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Mar-10-2021 10:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE carbon
monoxide poisoning:
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Mar-10-2021 10:47:56 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934891
Page 202 of 222
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
(UTC-05:00) Eastern
Time (US & Canada)RECOVERING/RESOLVIN
G
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-10-2021 10:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-10-2021 14:04:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021247383Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934892
Page 203 of 222
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-04-2021 08:58:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/3/2021Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934893
Page 204 of 222
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-04-2021 08:58:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible per local/national rec
ommendations and confirme
d to have received only place
bo at Vaccination 1/2Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934894
Page 205 of 222
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-04-2021 08:57:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/3/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-04-2021 08:57:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934895
Page 206 of 222
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-11-2021 23:27:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-11-2021 15:32:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered data updated
Feb-11-2021 08:11:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly review
and complete
‘Vaccination form'
at this visit. Thank
you.
Feb-10-2021 13:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/10/2021Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0934896
Page 207 of 222
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-10-2021 13:35:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Feb/10/2021Initial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0934897
Page 208 of 222
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-10-2021 13:35:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/10/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-10-2021 13:35:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-10-2021 13:35:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0934898
Page 209 of 222
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-10-2021 13:35:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-10-2021 13:35:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-10-2021 13:35:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-10-2021 13:35:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-10-2021 13:35:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/10/2021Initial Entry
5.a
Date Location User Value Reason
Feb-10-2021 13:35:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BKM7HZInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0934899
Page 210 of 222
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Feb-10-2021 13:35:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BKM7HZInitial Entry
5.b
Date Location User Value Reason
Feb-10-2021 13:36:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS2DPBInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-10-2021 13:36:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS2DPBInitial Entry
5.c
Date Location User Value Reason
Feb-10-2021 13:36:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS2DPCInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-10-2021 13:36:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS2DPCInitial Entry
090177e196ae3eab\Final\Final On: 01-Apr-2021 04:58 (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-2021-5683-0934900
Page 211 of 222
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-10-2021 13:42:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-10-2021 13:42:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-10-2021 13:42:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-10-2021 13:42:05
(UTC-05
…[truncated]