Document text
Page 1 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021216
Page 2 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/18/2020
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021217
Page 3 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Demography
1.Subject ID [10851129]
2.Birth Date: /1985
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (6)
FDA-CBER-2021-5683-0021218
Page 4 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/18/2020
2.Erroneous Visit
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021219
Page 5 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021220
Page 6 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021221
Page 7 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021222
Page 8 of 358
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Aug/18/2020
2.Weight: [155.3]
3.Unit: LB
4.Height: [70.1]
5.Unit: in
6.Body Mass Index: [22.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021223
Page 9 of 358
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/18/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021224
Page 10 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/18/2020
2.Randomization Number: [55274]
3.Randomization Group: [ ]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021225
Page 11 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/18/2020
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 [BMD7NT]
5.bSample ID [BMD7NV]
5.cSample ID [BMD7NW]
5.dSample ID [BLD1ZM]
5.eSample ID [BLD1ZN]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021226
Page 12 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/18/2020
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 [BMD7NS]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021227
Page 13 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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/18/2020 17:19
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
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021228
Page 14 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021229
Page 15 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021230
Page 16 of 358
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021231
Page 17 of 358
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/10/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021232
Page 18 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/10/2020
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 [BP5BN4]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021233
Page 19 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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/10/2020 17:06
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
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021234
Page 20 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/8/2020
2.Erroneous Visit
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021235
Page 21 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/8/2020
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 [BP9NGH]
5.bSample ID [BNVTGZ]
5.cSample ID [BNVTH0]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021236
Page 22 of 358
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021237
Page 23 of 358
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021238
Page 24 of 358
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021239
Page 25 of 358
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021240
Page 26 of 358
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021241
Page 27 of 358
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021242
Page 28 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021243
Page 29 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/13/2021
2.Date of First Symptom Started: Jan/12/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/13/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
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? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021244
Page 30 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
5.Symptoms - Other Text: [ ]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021245
Page 31 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loca
tionAssay Code and Descrip
tionDevice Type Form Instance
1.Not Applicable Not Applicabl
e Not Applicable Not Applicable Not Applicab
le Repeating
Pages
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021246
Page 32 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021247
Page 33 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Jan/13/2021
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 [RW90153]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021248
Page 34 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 swab performed]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021249
Page 35 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021250
Page 36 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Treatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicabl
e Not Applicabl
e Not Applicab
le Repeating
Pages
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021251
Page 37 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021252
Page 38 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021253
Page 39 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021254
Page 40 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021255
Page 41 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Category for L
ab TestVendor Na
meCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Applic
able Not Applica
ble Not Applic
able Sponsor-Defined I
dentifierTest: Result:
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able Repeating
Pages
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021256
Page 42 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021257
Page 43 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021258
Page 44 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021259
Page 45 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021260
Page 46 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable
Not Applicable Not Applic
able Not Appli
cable Sponsor-Defined
IdentifierTest: Result:
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021261
Page 47 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021262
Page 48 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021263
Page 49 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021264
Page 50 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021265
Page 51 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021266
Page 52 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021267
Page 53 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021268
Page 54 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021269
Page 55 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021270
Page 56 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021271
Page 57 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021272
Page 58 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021273
Page 59 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applic
able Repeating
Pages
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021274
Page 60 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021275
Page 61 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021276
Page 62 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021277
Page 63 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/10/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021278
Page 64 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/10/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [BR6WC9]
5.bSample ID [BLD2C7]
5.cSample ID [BLD2C8]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021279
Page 65 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021280
Page 66 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Unplanned Assessments
1.Assessments
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021281
Page 67 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/8/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021282
Page 68 of 358
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Feb/24/2021
2.Phase of Disposition: FOLLOW-UP
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021283
Page 69 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021284
Page 70 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021285
Page 71 of 358
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instance
1.ADVERSE EV
ENT 1 Exposure During Preg
nancy Dec/23/2020 UNK:
UNK YES Repeating
Pages
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021286
Page 72 of 358
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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)[Exposure During Pregnancy]
4.Start Date Time: Dec/23/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: Not Applicable Comments
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021287
Page 73 of 358
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021288
Page 74 of 358
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#CategoryMedication E
rrorStart DateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1.Not Applica
ble Not Applicable
Not Applica
ble Not Applicable Not Applicable Repeating
Pages
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021289
Page 75 of 358
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Medication Error
1.Category: Not Applicable Comments
2.Medication Error (Type of
Medication Error):Not Applicable
[ ]Comments
3.Start Date: Not Applicable
//Comments
4.Is the medication error still ongoing? Not Applicable Comments
5.Latest Action Taken with Study
Treatment:Not Applicable Comments
6.Was a Concomitant Medication
given?Not Applicable Comments
7.Was a Non-Drug Treatment given? Not Applicable Comments
8.Did the Medication Error cause the
subject to be discontinued from the
study?Not Applicable Comments
9.Was this medication error associated
with any adverse events?Not Applicable Comments
10.Serious Adverse Event Number: For
Pfizer Use OnlyNot Applicable
[ ]Comments
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021290
Page 76 of 358
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021291
Page 77 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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: //
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021292
Page 78 of 358
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021293
Page 79 of 358
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021294
Page 80 of 358
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021295
Page 81 of 358
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021296
Page 82 of 358
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021297
Page 83 of 358
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021298
Page 84 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021299
Page 85 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021300
Page 86 of 358
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021301
Page 87 of 358
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021302
Page 88 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021303
Page 89 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021304
Page 90 of 358
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021305
Page 91 of 358
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021306
Page 92 of 358
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021307
Page 93 of 358
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021308
Page 94 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/16/2021
2.Erroneous Visit
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021309
Page 95 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021310
Page 96 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/16/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021311
Page 97 of 358
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Queries, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021312
Page 98 of 358
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021313
Page 99 of 358
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021314
Page 100 of 358
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021315
Page 101 of 358
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not Met
Exclusion Criteria Met
2.Description of Exclusion Criterion
Met
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021316
Page 102 of 358
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021317
Page 103 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Feb/24/2021
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021318
Page 104 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021319
Page 105 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021320
Page 106 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormAug-19-2020 09:52:14 (UTC-06:00) Central Time
(US & Canada)Angi Cox
(pfe.acox1)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021321
Page 107 of 358
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormAug-19-2020 09:55:47 (UTC-06:00) Central Time
(US & Canada)Angi Cox
(pfe.acox1)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021322
Page 108 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormJan-13-2021 15:38:09 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021323
Page 109 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Jan-13-2021 15:38:09 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021324
Page 110 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Jan-13-2021 15:38:09 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021325
Page 111 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Jan-13-2021 15:38:09 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021326
Page 112 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Jan-13-2021 15:38:09 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021327
Page 113 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5Jan-13-2021 15:38:09 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021328
Page 114 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Jan-13-2021 15:38:09 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021329
Page 115 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
7Jan-13-2021 15:38:09 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021330
Page 116 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
8Jan-13-2021 15:38:09 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021331
Page 117 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
9Jan-13-2021 15:38:09 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021332
Page 118 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormJan-13-2021 15:40:28 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021333
Page 119 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Jan-13-2021 15:40:28 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021334
Page 120 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Jan-13-2021 15:40:28 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021335
Page 121 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Jan-13-2021 15:40:28 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021336
Page 122 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Jan-13-2021 15:40:28 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021337
Page 123 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5Jan-13-2021 15:40:28 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021338
Page 124 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Jan-13-2021 15:40:28 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021339
Page 125 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormJan-13-2021 15:41:00 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021340
Page 126 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Jan-13-2021 15:41:00 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021341
Page 127 of 358
***Confidential***
Header Text: c4591001
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Subject No: 10851129 Subject Initials: ---
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2Jan-13-2021 15:41:00 (UTC-06:00) Central Time
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
3Jan-13-2021 15:41:00 (UTC-06:00) Central Time
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090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
4Jan-13-2021 15:41:00 (UTC-06:00) Central Time
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
FormJan-13-2021 15:41:20 (UTC-06:00) Central Time
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
1Jan-13-2021 15:41:20 (UTC-06:00) Central Time
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Jan-13-2021 15:41:20 (UTC-06:00) Central Time
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Jan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
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090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021348
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Jan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021349
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
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090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021350
Page 136 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
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090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021351
Page 137 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
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090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021352
Page 138 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
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090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021353
Page 139 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
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090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021354
Page 140 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
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090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021355
Page 141 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021356
Page 142 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021357
Page 143 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021358
Page 144 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021359
Page 145 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021360
Page 146 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021361
Page 147 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021362
Page 148 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021363
Page 149 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021364
Page 150 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021365
Page 151 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021366
Page 152 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021367
Page 153 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021368
Page 154 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021369
Page 155 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.fJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021370
Page 156 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.fJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021371
Page 157 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.fJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021372
Page 158 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.fJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021373
Page 159 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.gJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021374
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Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021375
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021376
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gJan-13-2021 15:41:20 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021377
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021378
Page 164 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Jan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021379
Page 165 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Jan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021380
Page 166 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Jan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021381
Page 167 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Jan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021382
Page 168 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021383
Page 169 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021384
Page 170 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021385
Page 171 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
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090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021386
Page 172 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
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090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021387
Page 173 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
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090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021388
Page 174 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021389
Page 175 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021390
Page 176 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021391
Page 177 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021392
Page 178 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021393
Page 179 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021394
Page 180 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021395
Page 181 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021396
Page 182 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021397
Page 183 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021398
Page 184 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021399
Page 185 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021400
Page 186 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021401
Page 187 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021402
Page 188 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.fJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021403
Page 189 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.fJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021404
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.fJan-13-2021 15:41:48 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021405
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
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5.fJan-13-2021 15:41:48 (UTC-06:00) Central Time
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090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
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Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
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5.gJan-13-2021 15:41:48 (UTC-06:00) Central Time
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5.gJan-13-2021 15:41:48 (UTC-06:00) Central Time
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5.hJan-13-2021 15:41:48 (UTC-06:00) Central Time
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Site No: 1085 Site Name: (1085) Ventavia Research Group
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5.hJan-13-2021 15:41:48 (UTC-06:00) Central Time
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5.iJan-13-2021 15:41:48 (UTC-06:00) Central Time
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Subject No: 10851129 Subject Initials: ---
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5.iJan-13-2021 15:41:48 (UTC-06:00) Central Time
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Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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5.iJan-13-2021 15:41:48 (UTC-06:00) Central Time
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Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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5.iJan-13-2021 15:41:48 (UTC-06:00) Central Time
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Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
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Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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5.jJan-13-2021 15:41:48 (UTC-06:00) Central Time
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
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Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
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5.jJan-13-2021 15:41:48 (UTC-06:00) Central Time
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Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.jJan-13-2021 15:41:48 (UTC-06:00) Central Time
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.jJan-13-2021 15:41:48 (UTC-06:00) Central Time
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Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
FormJan-13-2021 15:42:09 (UTC-06:00) Central Time
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Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Jan-13-2021 15:42:09 (UTC-06:00) Central Time
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Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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2.aJan-13-2021 15:42:09 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
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Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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2.aJan-13-2021 15:42:09 (UTC-06:00) Central Time
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Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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2.aJan-13-2021 15:42:09 (UTC-06:00) Central Time
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Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.aJan-13-2021 15:42:09 (UTC-06:00) Central Time
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Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
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***Confidential***
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Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Jan-13-2021 15:42:25 (UTC-06:00) Central Time
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FDA-CBER-2021-5683-0021430
Page 216 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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2.aJan-13-2021 15:42:25 (UTC-06:00) Central Time
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Page 217 of 358
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Jan/13/2021Form: OXYGENATION PARAMETERS - Comments
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Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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Page 218 of 358
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: OXYGENATION PARAMETERS - Comments
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Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Jan-13-2021 15:42:40 (UTC-06:00) Central Time
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Page 219 of 358
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: OXYGENATION PARAMETERS - Comments
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Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Jan-13-2021 15:42:40 (UTC-06:00) Central Time
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Page 220 of 358
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: OXYGENATION PARAMETERS - Comments
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Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Jan-13-2021 15:42:40 (UTC-06:00) Central Time
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FDA-CBER-2021-5683-0021435
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***Confidential***
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Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
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Jan/13/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
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Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Jan-13-2021 15:42:57 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
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FDA-CBER-2021-5683-0021437
Page 223 of 358
***Confidential***
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Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
2Jan-13-2021 15:42:57 (UTC-06:00) Central Time
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090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021438
Page 224 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Jan-13-2021 15:42:57 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021439
Page 225 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Jan-13-2021 15:42:57 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021440
Page 226 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5Jan-13-2021 15:42:57 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021441
Page 227 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Jan-13-2021 15:42:57 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021442
Page 228 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormJan-13-2021 15:43:14 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021443
Page 229 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Jan-13-2021 15:43:14 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021444
Page 230 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Jan-13-2021 15:43:14 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021445
Page 231 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Jan-13-2021 15:43:14 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021446
Page 232 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Jan-13-2021 15:43:14 (UTC-06:00) Central Time
(US & Canada)Claudia Alonzo
(pfe.calonzo)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021447
Page 233 of 358
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Mar-03-2021 14:27:32 (UTC-06:00) Central Time
(US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021448
Page 234 of 358
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormFeb-24-2021 13:35:18 (UTC-06:00) Central Time
(US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021449
Page 235 of 358
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Feb-24-2021 13:35:18 (UTC-06:00) Central Time
(US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021450
Page 236 of 358
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Feb-24-2021 13:35:18 (UTC-06:00) Central Time
(US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021451
Page 237 of 358
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Feb-24-2021 13:35:18 (UTC-06:00) Central Time
(US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021452
Page 238 of 358
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Feb-24-2021 13:35:18 (UTC-06:00) Central Time
(US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021453
Page 239 of 358
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5Feb-24-2021 13:35:18 (UTC-06:00) Central Time
(US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021454
Page 240 of 358
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Feb-24-2021 13:35:18 (UTC-06:00) Central Time
(US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021455
Page 241 of 358
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
7Feb-24-2021 13:35:18 (UTC-06:00) Central Time
(US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021456
Page 242 of 358
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
8Feb-24-2021 13:35:18 (UTC-06:00) Central Time
(US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021457
Page 243 of 358
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
9Feb-24-2021 13:35:18 (UTC-06:00) Central Time
(US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021458
Page 244 of 358
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
10Feb-24-2021 13:35:18 (UTC-06:00) Central Time
(US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021459
Page 245 of 358
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormMar-03-2021 13:25:16 (UTC-06:00) Central Time
(US & Canada)Chyann Stewart
(pfe.cstewart)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021460
Page 246 of 358
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Mar-03-2021 13:25:16 (UTC-06:00) Central Time
(US & Canada)Chyann Stewart
(pfe.cstewart)Not Applicable
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021461
Page 247 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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
Banika Ervin N/A Feb-10-2021 12:35:20 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Gregory Fuller Approved Jan-21-2021 13:10:08 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GregoryFuller, 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.
Claudia Alonzo N/A Jan-13-2021 15:35:38 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Gregory Fuller Approved Oct-22-2020 13:13:22 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GregoryFuller, 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.
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021462
Page 248 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-19-2020 09:51:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-19-2020 09:51:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021463
Page 249 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-19-2020 09:51:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/18/2020Initial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021464
Page 250 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-19-2020 09:51:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10851129Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-19-2020 09:51:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1985Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-19-2020 09:52:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-19-2020 09:52:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-19-2020 09:52:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
WHITEInitial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
(b) (6)
FDA-CBER-2021-5683-0021465
Page 251 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-19-2020 09:52:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Aug/18/2020Initial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021466
Page 252 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-19-2020 09:52:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Aug/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-19-2020 09:52:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-19-2020 09:52:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021467
Page 253 of 358
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Aug-19-2020 09:56:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Aug/18/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-19-2020 09:56:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
155.3Initial Entry
3. Unit:
Date Location User Value Reason
Aug-19-2020 09:56:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-19-2020 09:56:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
70.1Initial Entry
5. Unit:
Date Location User Value Reason
Aug-19-2020 09:56:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-19-2020 09:56:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22.2Initial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021468
Page 254 of 358
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
7.a
Date Location User Value Reason
Aug-19-2020 09:56:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Record Identifier:: 1
Temperature: 98.5
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-19-2020 09:56:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-19-2020 09:56:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
98.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-19-2020 09:56:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-19-2020 09:56:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021469
Page 255 of 358
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-19-2020 09:56:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-19-2020 09:56:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-19-2020 09:56:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Aug/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-19-2020 09:56:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-19-2020 09:56:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-19-2020 09:56:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021470
Page 256 of 358
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-19-2020 09:56:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-19-2020 09:56:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-19-2020 09:56:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
NEGATIVEInitial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021471
Page 257 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-19-2020 09:56:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Aug/18/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-19-2020 09:56:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
55274Initial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021472
Page 258 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 09:53:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 09:53:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-19-2020 09:53:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-19-2020 09:53:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-19-2020 09:53:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
YES
Date of Collection:
Aug/18/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020 09:53:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Sample ID: BMD7NTInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021473
Page 259 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Aug-19-2020 09:53:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
BMD7NTInitial Entry
5.b
Date Location User Value Reason
Aug-19-2020 09:54:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Sample ID: BMD7NVInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-19-2020 09:54:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
BMD7NVInitial Entry
5.c
Date Location User Value Reason
Aug-19-2020 09:54:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Sample ID: BMD7NWInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-19-2020 09:54:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
BMD7NWInitial Entry
5.d
Date Location User Value Reason
Aug-19-2020 09:54:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Sample ID: BLD1ZMInitial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021474
Page 260 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
5.d Sample ID
Date Location User Value Reason
Aug-19-2020 09:54:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
BLD1ZMInitial Entry
5.e
Date Location User Value Reason
Aug-19-2020 09:55:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Sample ID: BLD1ZNInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-19-2020 09:55:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
BLD1ZNInitial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021475
Page 261 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 09:52:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 09:52:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-19-2020 09:53:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-19-2020 09:52:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-19-2020 09:52:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
YES
Date of Collection:
Aug/18/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020 09:53:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Sample ID: BMD7NSInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021476
Page 262 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Aug-19-2020 09:53:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
BMD7NSInitial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021477
Page 263 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-19-2020 09:57:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-19-2020 09:57:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-19-2020 09:57:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-19-2020 09:57:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Aug/18/2020 17:19Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-19-2020 09:57:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-19-2020 09:57:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
LEFTInitial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021478
Page 264 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
7. Route:
Date Location User Value Reason
Aug-19-2020 09:57:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-19-2020 09:57:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-19-2020 09:57:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
YESInitial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021479
Page 265 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-19-2020 09:57:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021480
Page 266 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-12-2020 10:53:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
Sep/10/2020Initial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021481
Page 267 of 358
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Sep-12-2020 10:54:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
Sep/10/2020Initial Entry
2.a
Date Location User Value Reason
Sep-12-2020 10:54:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
Record Identifier:: 1
Temperature: 97.2
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-12-2020 10:54:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-12-2020 10:54:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
97.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-12-2020 10:54:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021482
Page 268 of 358
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Sep-12-2020 10:54:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021483
Page 269 of 358
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-12-2020 10:54:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-12-2020 10:54:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-12-2020 10:54:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
Sep/10/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-12-2020 10:54:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-12-2020 10:54:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-12-2020 10:54:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021484
Page 270 of 358
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-12-2020 10:54:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-12-2020 10:54:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-12-2020 10:54:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
NEGATIVEInitial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021485
Page 271 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-12-2020 13:51:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-12-2020 13:51:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-12-2020 13:52:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-12-2020 13:51:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-12-2020 13:51:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-12-2020 13:52:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
Sample ID: BP5BN4Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021486
Page 272 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Sep-12-2020 13:52:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
BP5BN4Initial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021487
Page 273 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-12-2020 10:54:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-12-2020 10:54:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-12-2020 10:54:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-12-2020 10:54:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
Sep/10/2020 17:06Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-12-2020 10:54:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-12-2020 10:54:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
LEFTInitial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021488
Page 274 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
7. Route:
Date Location User Value Reason
Sep-12-2020 10:54:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-12-2020 10:54:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-12-2020 10:54:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Katherine
Benitez
(pfe.kbenitez)Data Entry:
YESInitial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021489
Page 275 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-08-2020 14:51:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Oct/8/2020Initial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021490
Page 276 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-08-2020 14:52:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-08-2020 14:52:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-08-2020 14:52:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-08-2020 14:52:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-08-2020 14:52:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
YES
Date of Collection:
Oct/8/2020Initial Entry
5.a
Date Location User Value Reason
Oct-08-2020 14:52:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Sample ID: BP9NGHInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021491
Page 277 of 358
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Oct-08-2020 14:52:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
BP9NGHInitial Entry
5.b
Date Location User Value Reason
Oct-08-2020 14:52:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Sample ID: BNVTGZInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-08-2020 14:52:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
BNVTGZInitial Entry
5.c
Date Location User Value Reason
Oct-08-2020 14:52:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
Sample ID: BNVTH0Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-08-2020 14:52:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Angi Cox
(pfe.acox1)Data Entry:
BNVTH0Initial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021492
Page 278 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-13-2021 15:38:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-13-2021 15:36:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Jan-13-2021 15:35:36
(UTC-06:00) Central 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.
Jan-13-2021 15:35:36
(UTC-06:00) Central 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.
Jan-13-2021 15:35:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Claudia
Alonzo
(pfe.calonzo)Data Entry:
Jan/13/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-13-2021 15:35:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3d90\Final\Final On: 01-Apr-2021 04:38 (GMT)
FDA-CBER-2021-5683-0021493
Page 279 of 358
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/13/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851129 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Jan-13-2021 15:36:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Claudia
Alonzo
(pfe.calonzo)Data Entry:
Jan/13/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jan-13-2021 15:36:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Claudia
Alonzo
(pfe.calonzo)Data Entry:
Jan/12/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Jan-13-2021 15:36:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Claudia
Alonzo
(pfe.calonzo)Data Entry:
NO
Date of Last Symptom Resolved:
Jan/13/2021Initial Entry
4.a
Date Location User Value Reason
Jan-13-2021 15:36:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Claudia
Alonzo
(pfe.calonzo)Data En
…[truncated]