CRFs for site 1096

Document text

Page 1 of 492
***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: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and ST AGE 2 from thi
s 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 COHORTS090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007339
Page 2 of 492
***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: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Informed Consent
1. Consent Was: OBT AINED
Date Written Consent Obtained
Aug/13/2020090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007340
Page 3 of 492
***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: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Demography
1. Subject ID [10961017]
2. Birth Date: /1956
3. Sex: MALE
4.Ethnicity: NOT HISP
ANIC OR LATINO(A) OR OF SPANISH ORIGIN
5. Race: (Check X all that apply): WHITE
6. Racial Designation:090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
(b) (6)
FDA-CBER-2021-5683-0007341
Page 4 of 492
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1. Date of Visit Aug/13/2020
2.Erroneous V
isit090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007342
Page 5 of 492
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of ExclusionCriterion MetNot Applicable090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007343
Page 6 of 492
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Screening
1. Date of
Completion/Discontinuation/DeathAug/13/2020
2. Phase of Disposition: SCREENING
3.Status: COMPLETED
4.
Specify Status: [ ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007344
Page 7 of 492
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/DrugAllergies:[sulfa allergy]
Start Date: UNK/UNK/1960
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[hyperlipidemia]
Start Date: UNK/UNK/2008
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[seasonal allegies]
Start Date: UNK/UNK/1975
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[appendectomy]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:UNK/UNK/2003090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007345
Page 8 of 492
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/DrugAllergies:[appendicitis]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:UNK/UNK/2003
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[Gastrointestinal perforation]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:UNK/UNK/2003
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[SURGERY FOR SMALL VESSEL]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:UNK/UNK/2003
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[hernia]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:UNK/UNK/2009090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007346
Page 9 of 492
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/DrugAllergies:[hernia repair surgery]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:UNK/UNK/2009
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[right foot morton's]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:UNK/UNK/2012
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[torn meniscus in right knee]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:UNK/UNK/2015
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[Right Knee surgery]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:UNK/UNK/2015090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007347
Page 10 of 492
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/DrugAllergies:[right tivia tear]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:UNK/UNK/2009
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[vasectomy]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:UNK/UNK/1990090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007348
Page 11 of 492
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1. Date: Aug/13/2020
2. W eight: [233.4]
3.
Unit: LB
4. Height: [76.5]
5. Unit: in
6. Body Mass Index: [28.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.0]
Unit: F
Temperature Location: ORAL CA VITY090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007349
Page 12 of 492
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition
1. Randomization Date : Aug/13/2020
2. Randomization Number: [228445]
3.
Randomization Group: [ ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007350
Page 13 of 492
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1. Data Origin SITE
2. Sample T ype SERUM
3.
Sample Collected? YES
Date of Collection:
Aug/13/2020
4. If no sample was collected or
sample was not collectedaccording to protocol, pleaseprovide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5DS6]
5.bSample ID [BP5DS7]
5.cSample ID [BP5DS8]
5.dSample ID [BPRHW6]
5.eSample ID [BPRHW7]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007351
Page 14 of 492
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1. Data Origin SITE
2. Sample T ype NASAL_SW
AB
3. Sample Collected? YES
Date of Collection:
Aug/13/2020
4. If no sample was collected or
sample was not collectedaccording to protocol, pleaseprovide reason:[ ]
Aliquot
Please enter barcode for each aliquot.5.aSample ID [BP5DRJ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007352
Page 15 of 492
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: V ACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
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/13/2020 17:57
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 OBSERV A TION PERIOD
11. Was the subject observed for at
least the protocol specified
observation period afterinvestigational productadministration?YES090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007353
Page 16 of 492
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Reactogenicity Diary
1. Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007354
Page 17 of 492
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1. Date of Visit Sep/1/2020
2.Erroneous V
isit090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007355
Page 18 of 492
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1. Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
We
re fever or systemic
symptoms present on the last daythe Subject Diary wascompleted?NO
2.bSymptom: FATIGUE
Were fever or systemicsymptoms present on the last daythe Subject Diary wascompleted?NO
2.cSymptom: HEADACHE
Were fever or systemicsymptoms present on the last daythe Subject Diary wascompleted?NO
2.dSymptom: CHILLS
Were fever or systemicsymptoms present on the last daythe Subject Diary wascompleted?NO
2.eSymptom: VOMITING
Were fever or systemicsymptoms present on the last daythe Subject Diary wascompleted?NO090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007356
Page 19 of 492
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last daythe Subject Diary wascompleted?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemicsymptoms present on the last daythe Subject Diary wascompleted?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemicsymptoms present on the last daythe Subject Diary wascompleted?NO
3. Injection Site Location: DELTOID MUSCLE
4. Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day theSubject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day theSubject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day theSubject Diary was completed?NO090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007357
Page 20 of 492
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1. Date: Sep/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location:
ORAL CA VITY090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007358
Page 21 of 492
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1. Data Origin SITE
2. Sample T ype NASAL_SW
AB
3. Sample Collected? YES
Date of Collection:
Sep/1/2020
4. If no sample was collected or
sample was not collectedaccording to protocol, pleaseprovide reason:[ ]
Aliquot
Please enter barcode for each aliquot.5.aSample ID [BP96DD]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007359
Page 22 of 492
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination
1. Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.
Formulation: INJECTION
4. Dose Date Time: Sep/1/2020 10:28
5. Anatomical Location: DELTOID MUSCLE
6. Body Side: LEFT
7. Route: INTRAMUSCULAR
8. Actual Dose: [ ]
9. Unit:
10. Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERV A TION PERIOD
11. Was the subject observed for at
least the protocol specified
observation period afterinvestigational productadministration?YES090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007360
Page 23 of 492
***Confidential*** 
Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1. Date of Visit Sep/29/2020
2.Erroneous V
isit090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007361
Page 24 of 492
***Confidential*** 
Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: V ACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1. Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
We
re fever or systemic
symptoms present on the last daythe Subject Diary wascompleted?NO
2.bSymptom: FATIGUE
Were fever or systemicsymptoms present on the last daythe Subject Diary wascompleted?NO
2.cSymptom: HEADACHE
Were fever or systemicsymptoms present on the last daythe Subject Diary wascompleted?NO
2.dSymptom: CHILLS
Were fever or systemicsymptoms present on the last daythe Subject Diary wascompleted?NO
2.eSymptom: VOMITING
Were fever or systemicsymptoms present on the last daythe Subject Diary wascompleted?NO090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007362
Page 25 of 492
***Confidential***Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: V ACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last daythe Subject Diary wascompleted?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemicsymptoms present on the last daythe Subject Diary wascompleted?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemicsymptoms present on the last daythe Subject Diary wascompleted?NO
3. Injection Site Location: DELTOID MUSCLE
4. Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day theSubject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day theSubject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day theSubject Diary was completed?NO090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007363
Page 26 of 492
***Confidential*** 
Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1. Data Origin SITE
2. Sample T ype SERUM
3.
Sample Collected? YES
Date of Collection:
Sep/29/2020
4. If no sample was collected or
sample was not collectedaccording to protocol, pleaseprovide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNZNH2]
5.bSample ID [BNVTLX]
5.cSample ID [BNVTLY]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007364
Page 27 of 492
***Confidential*** 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1. Date of Visit Feb/23/2021
2.Erroneous V
isit090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007365
Page 28 of 492
***Confidential*** 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1. Data Origin SITE
2. Sample T ype SERUM
3.
Sample Collected? YES
Date of Collection:
Feb/23/2021
4. If no sample was collected or
sample was not collectedaccording to protocol, pleaseprovide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNZNMH]
5.bSample ID [BSH4KG]
5.cSample ID [BSH4KH]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007366
Page 29 of 492
***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: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007367
Page 30 of 492
***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: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Electronic Sample Tracking
1. Data Origin
2. Sample Type3. Sample Collected?4. If no sample was collected or
sample was not collected
according to protocol, pleaseprovide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007368
Page 31 of 492
***Confidential*** 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1. Date of Visit Feb/23/2021
2.Erroneous V
isit ERRONEOUS VISIT090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007369
Page 32 of 492
***Confidential*** 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1. Data Origin Not Applicable Comments
2. Sample Type Not Applicable Comments
3. Sample Collected? Not Applicable Comments
4. If no sample was collected or
sample was not collected
according to protocol, pleaseprovide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ]
5.bSample ID [ ]
5.cSample ID [ ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007370
Page 33 of 492
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1. Date of Visit Oct/29/2020
2.Erroneous V
isit
COVID-19 Illness Visit
3. COVID-19 Illness Visit: COVID_A090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007371
Page 34 of 492
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Signs and Symptoms
1. Date of Assessment: Oct/29/2020
2. Date of First Symptom Started: Oct/20/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/31/2020
Symptoms
4.aSymptoms: FEVER
W
as symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? NO090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007372
Page 35 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [nasal congestion]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007373
Page 36 of 492
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
#Date of Collect
ionSpecimen T
ypeSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
 1.Not Done Not Done Not Done Not Done Not Done 
Repeating
Pages090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007374
Page 37 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1. Actual Date of Collection: Not Done
//Comments
2. Specimen Type: Not Done Comments
3. Specimen Collection Location: Not Done Comments
4. Assay Code and Description: Not Done Comments
5. Device Type: Not Done Comments
6. Trade Name: Not Done Comments
7. Test Result: Not Done Comments
8. Comments/Findings/Details: Not Done
[ ]Comments
9. Trade Name Other, Specify: Not Done
[ ]Comments090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007375
Page 38 of 492
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1. Data Origin SITE
2. Sample T ype NASAL_SW
AB_SELF
3. Sample Collected? YES
Date of Collection:
Oct/29/2020
4. If no sample was collected or
sample was not collectedaccording to protocol, pleaseprovide reason:[ ]
Aliquot
Please enter barcode for each aliquot.5.aSample ID [CV11242]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007376
Page 39 of 492
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1. Data Origin SITE
2. Sample T ype NASAL_SW
AB
3. Sample Collected? NO
4. If no sample was collected or
sample was not collected
according to protocol, pleaseprovide reason:[home swab was collected]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007377
Page 40 of 492
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of V isits or Contacts: NO
1.bPhysician or HealthcareProfessional:EMERGENCY ROOM
Occurrence of V isits or Contacts:
NO
1.cPhysician or HealthcareProfessional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:[1]
1.dPhysician or HealthcareProfessional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or HealthcareProfessional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or HealthcareProfessional: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-19illness?NO090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007378
Page 41 of 492
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
#Treatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.Not Done Not Done Not Done Not Done Not Done
 Repeating Pages090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007379
Page 42 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1. What is the treatment Identifier? Not Done
[ ]Comments
2. Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3. Treatment: Not Done Comments
4. Treatment: Not Done
[ ]Comments
5. Start Date: Not Done
//Comments
6. Ongoing? Not Done Comments090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007380
Page 43 of 492
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Illness Details
1. Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.W
as a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[upper respiratory tract infection]
Date of Diagnosis:
Oct/22/2020
3. Toxicity Grade: 1090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007381
Page 44 of 492
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Done Not Done Not Done Not Done 
Repeating Pages090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007382
Page 45 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1. Category of Clinical Event: Not Done Comments
2. Subcategory of Clinical Event: Not Done Comments
3. Was a diagnosis obtained? Not Done Comments
4. Toxicity Grade: Not Done Comments090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007383
Page 46 of 492
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done Not Done Not Done Not Done Sponsor-Defined I
dentifierTest: Result:
Not Done Not Do
ne Not Do
ne 
Not Done Not Do
ne Not Done 
Not Done Not Do
ne Not Done 
Not Done Not Do
ne Not Done 
Not Done Not Do
ne Not Done 
Not Done Not Do
ne Not Done 
Not Done Not Do
ne Not Done Repeating
Pages090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007384
Page 47 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1. Lab Panel: Not Done Comments
2. Laboratory Name and Address Not Done
[ ]Comments
3. Collection Date: Not Done
//Comments
4. Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not DoneLow
[ ]High[ ]UnitComments090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007385
Page 48 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not DoneLow
[ ]High[ ]UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not DoneLow
[ ]High[ ]UnitComments090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007386
Page 49 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not DoneLow
[ ]High[ ]UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not DoneLow
[ ]High[ ]UnitComments090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007387
Page 50 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not DoneLow
[ ]High[ ]UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not DoneLow
[ ]High[ ]UnitComments090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007388
Page 51 of 492
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.Not Done Not Done Not Done Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done Not D
one Not D
one 
Not Done Not D
one Not Done 
Not Done Not D
one Not Done 
Not Done Not D
one Not Done 
Not Done Not D
one Not Done 
Not Done Not D
one Not Done 
Not Done Not D
one Not Done 
Not Done Not D
one Not Done 
Not Done Not D
one Not Done 
Not Done Not D
one Not Done Repeating
Pages090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007389
Page 52 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1. Lab Panel: Not Done Comments
2. Laboratory Name and Address Not Done
[ ]Comments
3. Collection Date: Not Done
//Comments
4. Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not DoneLow
[ ]High[ ]UnitComments090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007390
Page 53 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not DoneLow
[ ]High[ ]UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not DoneLow
[ ]High[ ]UnitComments090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007391
Page 54 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not DoneLow
[ ]High[ ]UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not DoneLow
[ ]High[ ]UnitComments090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007392
Page 55 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not DoneLow
[ ]High[ ]UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not DoneLow
[ ]High[ ]UnitComments090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007393
Page 56 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
5 hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not DoneLow
[ ]High[ ]UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not DoneLow
[ ]High[ ]UnitComments090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007394
Page 57 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not DoneLow
[ ]High[ ]UnitComments090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007395
Page 58 of 492
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
# Date: Vital Signs Details Form Instance
 1. Not Done Record Identifier: Systolic: Diastolic:
Not Done Not Done Not Done Repeating Pages090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007396
Page 59 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1. Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done[ ] Comments
Diastolic: Not Done[ ] Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007397
Page 60 of 492
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
# Date: Vital Signs Details Form Instance
 1. Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007398
Page 61 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1. Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007399
Page 62 of 492
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
# Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction  of Inhaled Oxygen) Form Instance
 1.Not Done Not Done Not Done 
Repeating Pages090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007400
Page 63 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1. Date Time of Assessment: Not Done
//Comments
2. Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3. FiO2 (Fraction of Inhaled
Oxygen):Not Done[ ] Comments090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007401
Page 64 of 492
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS
Form Version: 06-Jul-2020 21:55Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007402
Page 65 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1. What is the medication identifier? Not Done
[ ]Comments
2. Category: Not Done Comments
3. Concomitant Medications
Pre-specified:Not Done Comments
4. Medication:
Provide the complete generic drug
name (including salt form, whereapplicable). Where generic nameis unknown, enter the full trade orproprietary name. Includeclarifying information in theMedication text (e.g.,Ingredient(s), route, use,formulation).Not Done
[ ]
Comments
5. Start Date: Not Done// Comments
6. Ongoing? Not Done Comments090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007403
Page 66 of 492
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
# Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1. Not Done Not Done Not Done Not Done 
Repeating Pages090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007404
Page 67 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1. Date of Assessment: Not Done
//Comments
2. Location of Assessment: Not Done Comments
3. Type of Imaging Exam: Not Done Comments
4. Assessment: Not Done Comments090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007405
Page 68 of 492
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_CONV A 1 - Unscheduled
Visit on Dec/07/2020Form: DATE OF VISIT - ILLNESS CONV ALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1. Date of Visit Dec/7/2020
2.Erroneous V
isit
COVID-19 Illness Visit
3. COVID-19 Illness Visit: COVID_A1090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007406
Page 69 of 492
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_CONV A 1 - Unscheduled
Visit on Dec/07/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1. Data Origin SITE
2. Sample T ype SERUM
3.
Sample Collected? YES
Date of Collection:
Dec/7/2020
4. If no sample was collected or
sample was not collectedaccording to protocol, pleaseprovide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BSJ600]
5.bSample ID [BSJ601]
5.cSample ID [BR856J]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007407
Page 70 of 492
***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: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007408
Page 71 of 492
***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: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Unplanned Assessments
1. Assessments090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007409
Page 72 of 492
***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: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Treatment
1. Date of
Completion/Discontinuation/Death
:Sep/29/2020
2. Phase of Disposition: VACCINA
TION
3. Status: COMPLETED
4. Specify Status: [ ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007410
Page 73 of 492
***Confidential*** 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Disposition - Follow-Up
1. Date of
Completion/Discontinuation/Death
://
2. Phase of Disposition:
3. Status:4. Specify Status: [ ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007411
Page 74 of 492
***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: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1. Date of Visit //
2. Erroneous Visit
COVID-19 Repeat Swab
3. COVID-19 Repeat Swab:090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007412
Page 75 of 492
***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: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Electronic Sample Tracking
1. Data Origin
2. Sample Type3. Sample Collected?4. If no sample was collected or
sample was not collected
according to protocol, pleaseprovide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007413
Page 76 of 492
***Confidential*** 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
# CategoryAE Iden
tifierAdverse Even
tStart DateIs the Adverse Event St
ill OngoingForm Instanc
e
 1. ADVERSE E
VENT 1 Head Injury Nov/29/2020 U
NK:UNK NO
End Date Time:
Dec/17/2020 UNK:UNK
 Repeating
Pages
 2. ADVERSE EVENT 2 BROKEN SA
CRUM Nov/29/2020 UNK:UNK YES 
Repeating
Pages
 3. ADVERSE EVENT 3 Fall Nov/29/2020 U
NK:UNK NO
End Date Time:
Nov/29/2020 UNK:UNK
 Repeating
Pages
 4. DELETED ADVERSE EVENT 4 Fall Related I
njuries Nov/29/2020 UNK:UNK YES 
Repeating
Pages
 5. DELETED ADVERSE EVENT 5 Head Injury Nov/29/2020 U
NK:UNK YES 
Repeating
Pages
 6. DELETED ADVERSE EVENT 6 Broken Sacru
m Nov/29/2020 UNK:UNK YES 
Repeating
Pages
 7. ADVERSE EVENT 7 Neck Pain Nov/30/2020 U
NK:UNK YES 
Repeating
Pages
 8. ADVERSE EVENT 8 Right Shoulde
r Pain Nov/30/2020 UNK:UNK YES 
Repeating
Pages090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007414
Page 77 of 492
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
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, notindividual symptoms)[Head Injury]
4.
Start Date Time: Nov/29/2020 UNK:UNK
5. Is the adverse event still ongoing? NO
End Date Time:Dec/17/2020 UNK:UNK
6. Toxicity Grade: 3
7. Is the adverse event serious?
If Yes, NOTIFY PFIZERIMMEDIATELY .
Fatal; Life-threatening; Inpatient
hospitalization or prolongation ofexisting hospitalization; Persistentor significant disability/incapacity;Congenital anomaly/birth defect;Important medical event (i.e. mayjeopardize subject and may requiremedical/surgical intervention toprevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disa bility/incapacity?
NOIs this serious event life threatening?
NO
Other medically important serious event
NO
8. Is this adverse event the result of a
study Medication Error?If Yes, record the type ofmedication error on theMedication Error Log.NO090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007415
Page 78 of 492
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
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:[Fall]
10. Latest Action Taken with Study
Treatment:NOT APPLICABLE
11. Was a Concomitant Medication
given?YES
12. Was a Non-Drug Treatment given? NO
13. What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14. Did the adverse event cause the
subject to be discontinued from the
study?NO
15. Serious Adverse Event Number:
For Pfizer Use Only[2020473499]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007416
Page 79 of 492
***Confidential*** 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1. Category: ADVERSE EVENT
2. AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, notindividual symptoms)[BROKEN SACRUM]
4.
Start Date Time: Nov/29/2020 UNK:UNK
5. Is the adverse event still ongoing? YES
6. Toxicity Grade: 2
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY .
Fatal; Life-threatening; Inpatient
hospitalization or prolongation ofexisting hospitalization; Persistentor significant disability/incapacity;Congenital anomaly/birth defect;Important medical event (i.e. mayjeopardize subject and may requiremedical/surgical intervention toprevent above outcomes).NO
8. Is this adverse event the result of a
study Medication Error?If Yes, record the type ofmedication error on theMedication 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:[Fall]
10. Latest Action Taken with Study
Treatment:NOT APPLICABLE090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007417
Page 80 of 492
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
11. Was a Concomitant Medication
given?NO
12. Was a Non-Drug Treatment given? NO
13. What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14. Did the adverse event cause the
subject to be discontinued from the
study?NO
15. Serious Adverse Event Number:
For Pfizer Use Only[ ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007418
Page 81 of 492
***Confidential*** 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1. Category: ADVERSE EVENT
2. AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, notindividual symptoms)[Fall]
4.
Start Date Time: Nov/29/2020 UNK:UNK
5. Is the adverse event still ongoing? NO
End Date Time:Nov/29/2020 UNK:UNK
6. Toxicity Grade: 2
7. Is the adverse event serious?
If Yes, NOTIFY PFIZERIMMEDIATELY .
Fatal; Life-threatening; Inpatient
hospitalization or prolongation ofexisting hospitalization; Persistentor significant disability/incapacity;Congenital anomaly/birth defect;Important medical event (i.e. mayjeopardize subject and may requiremedical/surgical intervention toprevent above outcomes).NO
8. Is this adverse event the result of a
study Medication Error?If Yes, record the type ofmedication error on theMedication 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:[Fall at home]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007419
Page 82 of 492
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
10. Latest Action Taken with Study
Treatment:NOT APPLICABLE
11. Was a Concomitant Medication
given?NO
12. Was a Non-Drug Treatment given? NO
13. What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14. Did the adverse event cause the
subject to be discontinued from the
study?NO
15. Serious Adverse Event Number:
For Pfizer Use Only[ ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007420
Page 83 of 492
***Confidential*** 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1. Category: ADVERSE EVENT
2. AE ID: [4]
3. Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Fall Related Injuries ]
4. Start Date Time: Nov/29/2020 UNK:UNK
5. Is the adverse event still ongoing? YES
6. Toxicity Grade: 2
7. Is the adverse event serious?
If Yes, NOTIFY PFIZERIMMEDIATELY .
Fatal; Life-threatening; Inpatient
hospitalization or prolongation ofexisting hospitalization; Persistentor significant disability/incapacity;Congenital anomaly/birth defect;Important medical event (i.e. mayjeopardize subject and may requiremedical/surgical intervention toprevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disa bility/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8. Is this adverse event the result of a
study Medication Error?If Yes, record the type ofmedication error on theMedication Error Log.NO090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007421
Page 84 of 492
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
9. Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
CONCOMITANT NON DRUG TREATMENT
10. Latest Action Taken with Study
Treatment:NOT APPLICABLE
11. Was a Concomitant Medication
given?NO
12. Was a Non-Drug Treatment given? NO
13. What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14. Did the adverse event cause the
subject to be discontinued from the
study?NO
15. Serious Adverse Event Number:
For Pfizer Use Only[ ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007422
Page 85 of 492
***Confidential*** 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1. Category: ADVERSE EVENT
2. AE ID: [5]
3. Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Head Injury ]
4. Start Date Time: Nov/29/2020 UNK:UNK
5. Is the adverse event still ongoing? YES
6. Toxicity Grade: 2
7. Is the adverse event serious?
If Yes, NOTIFY PFIZERIMMEDIATELY .
Fatal; Life-threatening; Inpatient
hospitalization or prolongation ofexisting hospitalization; Persistentor significant disability/incapacity;Congenital anomaly/birth defect;Important medical event (i.e. mayjeopardize subject and may requiremedical/surgical intervention toprevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disa bility/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8. Is this adverse event the result of a
study Medication Error?If Yes, record the type ofmedication error on theMedication Error Log.NO090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007423
Page 86 of 492
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
9. Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Fall ]
10. Latest Action Taken with Study
Treatment:NOT APPLICABLE
11. Was a Concomitant Medication
given?NO
12. Was a Non-Drug Treatment given? NO
13. What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14. Did the adverse event cause the
subject to be discontinued from the
study?NO
15. Serious Adverse Event Number:
For Pfizer Use Only[2020473499 ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007424
Page 87 of 492
***Confidential*** 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1. Category: ADVERSE EVENT
2. AE ID: [6]
3. Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Broken Sacrum ]
4. Start Date Time: Nov/29/2020 UNK:UNK
5. Is the adverse event still ongoing? YES
6. Toxicity Grade: 2
7. Is the adverse event serious?
If Yes, NOTIFY PFIZERIMMEDIATELY .
Fatal; Life-threatening; Inpatient
hospitalization or prolongation ofexisting hospitalization; Persistentor significant disability/incapacity;Congenital anomaly/birth defect;Important medical event (i.e. mayjeopardize subject and may requiremedical/surgical intervention toprevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disa bility/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8. Is this adverse event the result of a
study Medication Error?If Yes, record the type ofmedication error on theMedication Error Log.NO090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007425
Page 88 of 492
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
9. Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[fall]
10. Latest Action Taken with Study
Treatment:NOT APPLICABLE
11. Was a Concomitant Medication
given?NO
12. Was a Non-Drug Treatment given? NO
13. What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14. Did the adverse event cause the
subject to be discontinued from the
study?NO
15. Serious Adverse Event Number:
For Pfizer Use Only[2020473499 ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007426
Page 89 of 492
***Confidential*** 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1. Category: ADVERSE EVENT
2. AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, notindividual symptoms)[Neck Pain]
4.
Start Date Time: Nov/30/2020 UNK:UNK
5. Is the adverse event still ongoing? YES
6. Toxicity Grade: 2
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY .
Fatal; Life-threatening; Inpatient
hospitalization or prolongation ofexisting hospitalization; Persistentor significant disability/incapacity;Congenital anomaly/birth defect;Important medical event (i.e. mayjeopardize subject and may requiremedical/surgical intervention toprevent above outcomes).NO
8. Is this adverse event the result of a
study Medication Error?If Yes, record the type ofmedication error on theMedication 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:[Fall]
10. Latest Action Taken with Study
Treatment:NOT APPLICABLE090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007427
Page 90 of 492
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
11. Was a Concomitant Medication
given?YES
12. Was a Non-Drug Treatment given? NO
13. What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14. Did the adverse event cause the
subject to be discontinued from the
study?NO
15. Serious Adverse Event Number:
For Pfizer Use Only[ ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007428
Page 91 of 492
***Confidential*** 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1. Category: ADVERSE EVENT
2. AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, notindividual symptoms)[Right Shoulder Pain]
4.
Start Date Time: Nov/30/2020 UNK:UNK
5. Is the adverse event still ongoing? YES
6. Toxicity Grade: 2
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY .
Fatal; Life-threatening; Inpatient
hospitalization or prolongation ofexisting hospitalization; Persistentor significant disability/incapacity;Congenital anomaly/birth defect;Important medical event (i.e. mayjeopardize subject and may requiremedical/surgical intervention toprevent above outcomes).NO
8. Is this adverse event the result of a
study Medication Error?If Yes, record the type ofmedication error on theMedication 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:[Fall]
10. Latest Action Taken with Study
Treatment:NOT APPLICABLE090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007429
Page 92 of 492
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
11. Was a Concomitant Medication
given?YES
12. Was a Non-Drug Treatment given? NO
13. What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14. Did the adverse event cause the
subject to be discontinued from the
study?NO
15. Serious Adverse Event Number:
For Pfizer Use Only[ ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007430
Page 93 of 492
***Confidential*** 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
#Catego
ryMedication E
rrorStart Da
teIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
 1.     
Repeating
Pages090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007431
Page 94 of 492
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Medication Error
1. Category:
2. Medication Error (T ype of
Medication Error):[ ]
3.
Start Date: //
4. Is the medication error still
ongoing?
5. Latest Action Taken with Study
Treatment:
6. Was a Concomitant Medication
given?
7. Was a Non-Drug Treatment given?8. Did the Medication Error cause the
subject to be discontinued from the
study?
9. Was this medication error
associated with any adverseevents?
10. Serious Adverse Event Number:
For Pfizer Use Only[ ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007432
Page 95 of 492
***Confidential*** 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
V ACCINATIONS
Form Version: 22-Apr-2020 21:03Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medica
tionStart Da
teForm Instanc
e
 1.1 V ACCINATION
S NO INFLUENZA VACCINE Nov/30/2020 
Repeating
Pages090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007433
Page 96 of 492
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
V ACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1. What is the medication identifier? [1]
2.Category: V
ACCINATIONS
3. Concomitant Medications
Pre-specified:NO
4. Medication:
Provide the complete generic drug
name (including salt form, whereapplicable). Where generic nameis unknown, enter the full trade orproprietary name. Includeclarifying information in theMedication text (e.g.,Ingredient(s), route, use,formulation).[INFLUENZA V ACCINE]
5. Date: Nov/30/2020090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007434
Page 97 of 492
***Confidential*** 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.     
Repeating
Pages090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007435
Page 98 of 492
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
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, whereapplicable). Where generic nameis unknown, enter the full trade orproprietary name. Includeclarifying information in theMedication text (e.g.,Ingredient(s), route, use,formulation).[ ]
5. Dose: [ ]
6. Dose Unit:
7. Dose Frequency:8. Route:9. Start Date: //
10. Ongoing?090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007436
Page 99 of 492
***Confidential*** 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tStart Dat
eForm Instance
 1.     
Repeating Pages090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007437
Page 100 of 492
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
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?090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007438
Page 101 of 492
***Confidential*** 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
# Transfusion Type Date of Transfusion Form Instance
 1.   
Repeating Pages090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007439
Page 102 of 492
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Transfusion Type:
2. Date of Transfusion: //090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007440
Page 103 of 492
***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: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007441
Page 104 of 492
***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: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Vital Signs
1. Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:Temperature Location:090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007442
Page 105 of 492
***Confidential*** 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: V ACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
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 afterinvestigational productadministration?090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007443
Page 106 of 492
***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: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1. Contact Type:
2. Was contact made?3. Comments: [ ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007444
Page 107 of 492
***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: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1. Contact Type:
2. Was contact made?3. Comments: [ ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007445
Page 108 of 492
***Confidential*** 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007446
Page 109 of 492
***Confidential*** 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Informed Consent - Asymptomatic Surveillance
1. Consent Was:090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007447
Page 110 of 492
***Confidential*** 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Electronic Sample Tracking
1. Data Origin
2. Sample Type3. Sample Collected?4. If no sample was collected or
sample was not collected
according to protocol, pleaseprovide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007448
Page 111 of 492
***Confidential*** 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Electronic Sample Tracking
1. Data Origin
2. Sample Type3. Sample Collected?4. If no sample was collected or
sample was not collected
according to protocol, pleaseprovide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007449
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***Confidential*** 
Header Text: c4591001
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UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007450
Page 113 of 492
***Confidential*** 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER V ACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Further Vaccination Confirmation
1. Select appropriate response - Is
participant willing to return for
Vaccination 3?090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007451
Page 114 of 492
***Confidential*** 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Treatment Unblinded
1. Date Treatment Unblinded : J an/16/2021
2.
Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITION AL V ACCINATION090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007452
Page 115 of 492
***Confidential*** 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Withdrawal Of Consent
1. Withdrawal of Consent Date : //090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007453
Page 116 of 492
***Confidential*** 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Death Details
1. Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007454
Page 117 of 492
***Confidential*** 
Header Text: c4591001
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Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Subject Status
1. Subject Status FOLLOW- UP
2.
Subject Status Date Sep/29/2020090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007455
Page 118 of 492
***Confidential*** 
Header Text: c4591001
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Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Casebook Signature Form
1. Casebook Signature Click Here to Enable090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007456
Page 119 of 492
***Confidential*** 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Van Tran Approved Mar-09-2021 1 2:38:34 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, VanTran, verify that all case r eport 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.090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007457
Page 120 of 492
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
Form Aug-13-2020 19:37:20 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Applicable090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007458
Page 121 of 492
***Confidential***Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
Form Mar-01-2021 11:19:19 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Applicable090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007459
Page 122 of 492
***Confidential***Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
1 Mar-01-2021 11:19:19 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Applicable090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007460
Page 123 of 492
***Confidential***Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
2 Mar-01-2021 11:19:19 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Applicable090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007461
Page 124 of 492
***Confidential***Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
3 Mar-01-2021 11:19:19 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Applicable090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007462
Page 125 of 492
***Confidential***Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
4 Mar-01-2021 11:19:19 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Applicable090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007463
Page 126 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
Form Nov-03-2020 10:03:57 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007464
Page 127 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
1 Nov-03-2020 10:03:57 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007465
Page 128 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
2 Nov-03-2020 10:03:57 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007466
Page 129 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
3 Nov-03-2020 10:03:57 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007467
Page 130 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
4 Nov-03-2020 10:03:57 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007468
Page 131 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5 Nov-03-2020 10:03:57 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007469
Page 132 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
6 Nov-03-2020 10:03:57 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007470
Page 133 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
7 Nov-03-2020 10:03:57 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007471
Page 134 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
8 Nov-03-2020 10:03:57 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007472
Page 135 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
9 Nov-03-2020 10:03:57 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007473
Page 136 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
Form Nov-03-2020 10:05:41 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007474
Page 137 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
1 Nov-03-2020 10:05:41 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007475
Page 138 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
2 Nov-03-2020 10:05:41 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007476
Page 139 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
3 Nov-03-2020 10:05:41 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007477
Page 140 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
4 Nov-03-2020 10:05:41 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007478
Page 141 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5 Nov-03-2020 10:05:41 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007479
Page 142 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
6 Nov-03-2020 10:05:41 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007480
Page 143 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
Form Nov-03-2020 10:07:33 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007481
Page 144 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
1 Nov-03-2020 10:07:33 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007482
Page 145 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
2 Nov-03-2020 10:07:33 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007483
Page 146 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
3 Nov-03-2020 10:07:33 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
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Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
4 Nov-03-2020 10:07:33 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007485
Page 148 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
Form Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007486
Page 149 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
1 Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007487
Page 150 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
2 Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007488
Page 151 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
3 Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007489
Page 152 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
4 Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007490
Page 153 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.a Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007491
Page 154 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.a Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007492
Page 155 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.a Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007493
Page 156 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.a Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007494
Page 157 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.b Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007495
Page 158 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.b Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007496
Page 159 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.b Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007497
Page 160 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.b Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007498
Page 161 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.c Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007499
Page 162 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.c Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007500
Page 163 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.c Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007501
Page 164 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.c Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007502
Page 165 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.d Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007503
Page 166 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.d Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007504
Page 167 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.d Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007505
Page 168 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.d Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007506
Page 169 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.e Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007507
Page 170 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.e Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007508
Page 171 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.e Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007509
Page 172 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.e Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007510
Page 173 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5 f Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007511
Page 174 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5 f Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007512
Page 175 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5 f Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007513
Page 176 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5 f Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007514
Page 177 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.g Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007515
Page 178 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.g Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007516
Page 179 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.g Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007517
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***Confidential***Header Text: c4591001
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on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.g Nov-03-2020 10:07:47 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007518
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***Confidential***Header Text: c4591001
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on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
Form Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007519
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***Confidential***Header Text: c4591001
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on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
1 Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007520
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***Confidential***Header Text: c4591001
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on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
2 Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007521
Page 184 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
3 Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007522
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***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
4 Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007523
Page 186 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.a Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007524
Page 187 of 492
***Confidential***Header Text: c4591001
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on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.a Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007525
Page 188 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.a Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007526
Page 189 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.a Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007527
Page 190 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.b Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007528
Page 191 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.b Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007529
Page 192 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.b Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007530
Page 193 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.b Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007531
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***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.c Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007532
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***Confidential***Header Text: c4591001
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on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.c Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007533
Page 196 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.c Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007534
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***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.c Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007535
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***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.d Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007536
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***Confidential***Header Text: c4591001
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on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.d Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007537
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***Confidential***Header Text: c4591001
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on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.d Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007538
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***Confidential***Header Text: c4591001
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on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.d Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007539
Page 202 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.e Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007540
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***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.e Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007541
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***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.e Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007542
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***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.e Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007543
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***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5 f Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007544
Page 207 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5 f Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007545
Page 208 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5 f Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007546
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***Confidential***Header Text: c4591001
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on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5 f Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007547
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***Confidential***Header Text: c4591001
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on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.g Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007548
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on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.g Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007549
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***Confidential***Header Text: c4591001
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on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.g Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007550
Page 213 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.g Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007551
Page 214 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5 h Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007552
Page 215 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5 h Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007553
Page 216 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5 h Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007554
Page 217 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5 h Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007555
Page 218 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.i Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007556
Page 219 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.i Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007557
Page 220 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.i Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007558
Page 221 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.i Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007559
Page 222 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.j Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007560
Page 223 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.j Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007561
Page 224 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.j Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007562
Page 225 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5.j Nov-03-2020 10:08:01 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007563
Page 226 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
Form Nov-03-2020 10:08:16 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007564
Page 227 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
1 Nov-03-2020 10:08:16 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007565
Page 228 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
2.a Nov-03-2020 10:08:16 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007566
Page 229 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
2.a Nov-03-2020 10:08:16 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007567
Page 230 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
2.a Nov-03-2020 10:08:16 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007568
Page 231 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
2.a Nov-03-2020 10:08:16 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007569
Page 232 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
Form Nov-03-2020 10:08:28 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007570
Page 233 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
1 Nov-03-2020 10:08:28 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007571
Page 234 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
2.a Nov-03-2020 10:08:28 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007572
Page 235 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
Form Nov-03-2020 10:08:41 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007573
Page 236 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
1 Nov-03-2020 10:08:41 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007574
Page 237 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
2 Nov-03-2020 10:08:41 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007575
Page 238 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
3 Nov-03-2020 10:08:41 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007576
Page 239 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
Form Nov-03-2020 10:08:53 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007577
Page 240 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
1 Nov-03-2020 10:08:53 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007578
Page 241 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
2 Nov-03-2020 10:08:53 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007579
Page 242 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
3 Nov-03-2020 10:08:53 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007580
Page 243 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
4 Nov-03-2020 10:08:53 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007581
Page 244 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
5 Nov-03-2020 10:08:53 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007582
Page 245 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
6 Nov-03-2020 10:08:53 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007583
Page 246 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
Form Nov-03-2020 10:09:32 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007584
Page 247 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
1 Nov-03-2020 10:09:32 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007585
Page 248 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
2 Nov-03-2020 10:09:32 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007586
Page 249 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
3 Nov-03-2020 10:09:32 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007587
Page 250 of 492
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Item Date User Comment
4 Nov-03-2020 10:09:32 (UTC-06:00) Central
Time (US & Canada)Yvette Davila
(pfe.ydavila)Not Done090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007588
Page 251 of 492
***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, Signed, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Van Tran Approved Mar-09-2021 1 2:38:34 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, VanTran, verify that all case r eport 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.
Gabriela
Obeidat N/A Feb-23-2021 16:38:02 (UTC-06:00) Central
Time (US & Canada)Edit - Allsignaturesinvalidated
Affidavit:N/A
Van Tran Approved Feb-22-2021 14:22:24 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:By my dated signature below, I, VanTran, verify that all case r eport 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.
Gabriela
Obeidat N/A Nov-30-2020 15:53:13 (UTC-06:00) Central
Time (US & Canada)Edit - Allsignaturesinvalidated
Affidavit:N/A090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007589
Page 252 of 492
***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, Signed, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Van Tran Approved Nov-04-2020 09:28:37 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, VanTran, verify that all case r eport 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.
Yvette Davila N/A Nov-03-2020 10:01:59 (UTC-06:00) Central
Time (US & Canada)Edit - All
signaturesinvalidated
Affidavit:N/A
Van Tran Approved Oct-13-2020 19:21:06 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:By my dated signature below, I, VanTran, verify that all case r eport 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.
Yvette Davila N/A Sep-29-2020 18:38:37 (UTC-06:00) Central
Time (US & Canada)Edit - All
signaturesinvalidated
Affidavit:N/A
Van Tran Approved Sep-16-2020 14:25:30 (UTC-06:00) Central
Time (US & Canada)BOOK Signed090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007590
Page 253 of 492
***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, Signed, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Affidavit:
By my dated signature below, I, VanTran, verify that all case r eport 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.090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007591
Page 254 of 492
***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: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Select appropriate response - Protocol version
Date Location User V alue Reason
Aug-13-2020 19:35:07
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
Yvette
Davila(pfe.ydavila)Data Entry:24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-13-2020 19:35:07
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
Yvette
Davila(pfe.ydavila)Data Entry:STAGE 3 COHORTSInitial Entry090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007592
Page 255 of 492
***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: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Consent Was:
Date Location User V alue Reason
Aug-13-2020 19:35:17
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
Yvette
Davila(pfe.ydavila)Data Entry:OBTAINED
Date Written Consent Obtained
Aug/13/2020Initial Entry090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007593
Page 256 of 492
***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: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-13-2020 19:35:00
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:10961017Item copied fromprevious form
2. Birth Date:
Date Location User Value Reason
Aug-13-2020 18:39:05
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)
Data Entry:
/1956Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-13-2020 19:35:46
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 Y
vette
Davila(pfe.ydavila)Data Entry:MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-13-2020 19:35:46
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 Y
vette
Davila(pfe.ydavila)Data Entry:NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-13-2020 19:35:46
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 Y
vette
Davila(pfe.ydavila)Data Entry:WHITEInitial Entry090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
(b) (6)
FDA-CBER-2021-5683-0007594
Page 257 of 492
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User V alue Reason
Aug-13-2020 19:36:45
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
Yvette
Davila(pfe.ydavila)Data Entry:Aug/13/2020Initial Entry090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007595
Page 258 of 492
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User V alue Reason
Aug-13-2020 19:37:36
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
Yvette
Davila(pfe.ydavila)Data Entry:Aug/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-13-2020 19:37:36
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
auto calc
(autocalc)Data Entry:SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-13-2020 19:37:36
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
Yvette
Davila(pfe.ydavila)Data Entry:COMPLETEDInitial Entry090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007596
Page 259 of 492
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.a
Date Location User V alue Reason
Aug-13-2020 19:38:33
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
auto calc
(autocalc)Data Entry:
Line/MH Number:1
Medical History Term:sulfa allergy
Start Date: UNK/UNK/1960
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User V alue Reason
Aug-13-2020 19:38:33
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
auto calc
(autocalc)Data Entry:1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 19:38:33
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
Yvette
Davila(pfe.ydavila)Data Entry:sulfa allergyInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-13-2020 19:38:33
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
Yvette
Davila(pfe.ydavila)Data Entry:UNK/UNK/1960Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-13-2020 19:38:33
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
Yvette
Davila(pfe.ydavila)Data Entry:YESInitial Entry090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007597
Page 260 of 492
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
1.b
Date Location User Value Reason
Aug-13-2020 19:38:51
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Line/MH Number:2
Medical History Term:hyperlipidemia
Start Date: UNK/UNK/2008
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User V alue Reason
Aug-13-2020 19:38:51
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
auto calc
(autocalc)Data Entry:2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 19:38:51
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
Yvette
Davila(pfe.ydavila)Data Entry:hyperlipidemiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-13-2020 19:38:51
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
Yvette
Davila(pfe.ydavila)Data Entry:UNK/UNK/2008Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-13-2020 19:38:51
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
Yvette
Davila(pfe.ydavila)Data Entry:YESInitial Entry
1.c090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007598
Page 261 of 492
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Aug-13-2020 19:42:00
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Line/MH Number:3
Medical History Term:seasonal allegies
Start Date: UNK/UNK/1975
Ongoing: YESInitial Entry090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007599
Page 262 of 492
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
1.c Line/MH Number:
Date Location User Value Reason
Aug-13-2020 19:42:00
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value
Reason
Aug-14-2020
07:42:31(UTC-06:00)Central Time(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle(pfe.PFETMS)Query 1: ClosedDiscrepancyhas beenclosed.
Aug-13-202020:59:51(UTC-06:00)Central Time(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle(pfe.PFETMS)Query 1: OpenedClarifySEASONALALLEGIES asfollows...IfreportingSEASONALALLERGIESedit as such,otherwiseclarify the termfurther. Thankyou.
Aug-13-202019:42:00(UTC-06:00)Central Time(US & Canada)ACV0PFEINFP6000 Yvette Davila
(pfe.ydavila)
Data Entry:seasonal allegiesInitial Entry
1.c Start Date:
Date Location User V alue Reason
Aug-13-2020 19:42:00
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
Yvette
Davila(pfe.ydavila)Data Entry:UNK/UNK/1975Initial Entry
1.c Ongoing:090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007600
Page 263 of 492
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Aug-13-2020 19:42:00
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 Yvette
Davila(pfe.ydavila) Data Entry:YESInitial Entry
1.d
Date Location User Value Reason
Aug-13-2020 19:42:34
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
auto calc
(autocalc)Data Entry:
Line/MH Number:4
Medical HistoryTerm:appendectomy
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003Initial Entry090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007601
Page 264 of 492
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
1.d Line/MH Number:
Date Location User Value Reason
Aug-13-2020 19:42:34
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 19:42:34
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
Yvette
Davila(pfe.ydavila)Data Entry:appendectomyInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-13-2020 19:42:34
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
Yvette
Davila(pfe.ydavila)Data Entry:UNK/UNK/2003Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-13-2020 19:42:34
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
Yvette
Davila(pfe.ydavila)Data Entry:NO
End Date:
UNK/UNK/2003Initial Entry
1.e
Date Location User Value Reason
Aug-13-2020 19:43:08
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
auto calc
(autocalc)Data Entry:
Line/MH Number:5
Medical HistoryTerm:appendicitis
Start Date: UNK/UNK/2003Initial Entry090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007602
Page 265 of 492
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Ongoing: NO
End Date:
UNK/UNK/
2003
1.e Line/MH Number:
Date Location User Value Reason
Aug-13-2020 19:43:08
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 19:43:08
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
Yvette
Davila(pfe.ydavila)Data Entry:appendicitisInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-13-2020 19:43:08
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
Yvette
Davila(pfe.ydavila)Data Entry:UNK/UNK/2003Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-13-2020 19:43:08
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
Yvette
Davila(pfe.ydavila)Data Entry:NO
End Date:
UNK/UNK/2003Initial Entry
1.f
Date Location User Value Reason
Aug-19-2020 08:48:19
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 Gabriela
Obeidat(pfe.gobeidat)
Data Entry:
Line/MH N 6New Information090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007603
Page 266 of 492
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
umber:Medical His
tory Term:Gastrointestinalperforation
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
Aug-18-2020 09:32:08(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 Lizatte
Martinez(pfe.lmartinez1)
Data Entry:
Line/MH Number:6
Medical History Term:blood vessel tear
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003ChangedInformation
Aug-13-2020 19:43:39(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)
Data Entry:
Line/MH Number:6
Medical History Term:vessel torn in small intestine
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003Initial Entry090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007604
Page 267 of 492
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
1.f Line/MH Number:
Date Location User Value Reason
Aug-13-2020 19:43:39
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 17:05:38
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 Samuel Dychter
(pfe.dychts)Query 1: Closed Response satisfies
query
Aug-19-2020 08:48:19(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
auto query
(autoquery)Query 1: Answered New Information
Aug-19-2020 08:48:19(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 Gabriela
Obeidat(pfe.gobeidat)
Data Entry:Gastrointestinal perforationNew Information
Aug-18-2020 11:24:48(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 Samuel Dychter
(pfe.dychts)Query 1: Reissued:Opened GPD MM: The
term was fine astorn vessel in thesmall intestine andshould be returnedas such in medicalhistory. The querywas what was theetiology? W
as it
secondary to theappendicitis? It'sbest to consolidateterms to one majorevent.
Aug-18-2020 09:32:08(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered ChangedInformation
Aug-18-2020 09:32:08(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 Lizatte
Martinez(pfe.lmartinez1)
Data Entry:blood vessel tearChangedInformation090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007605
Page 268 of 492
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Aug-17-2020 16:02:40
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 Samuel Dychter
(pfe.dychts)Query 1: Opened GPD MM: Please
clarify the etiologyof the torn vessel inthe small intestine.
Aug-13-2020 19:43:39(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 Yvette Davila
(pfe.ydavila)
Data Entry:vessel torn in small intestineInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-13-2020 19:43:39
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
Yvette
Davila(pfe.ydavila)Data Entry:UNK/UNK/2003Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-13-2020 19:43:39
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 
Yvette
Davila(pfe.ydavila)Data Entry:NO
End Date:
UNK/UNK/2003Initial Entry
1.g
Date Location User Value Reason
Aug-20-2020 14:17:04
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 Lizatte
Martinez(pfe.lmartinez1)
Data Entry:
Line/MHNumber:7
Medical History Term:SURGERY FORSMALL VESSEL
Start Date:UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003ChangedInformation090177e196ae30a0\Final\Final On: 01-A pr-2021 04:10 (GMT )
FDA-CBER-2021-5683-0007606
Page 269 of 492
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1096 Site Name: (1096) Ventavia Research Group
Subject No: 10961017 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:39
Aug-13-2020 19:44:16
(UTC-06:00) CentralTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Line/MH Number:7
Medical History Term:surgery for small vessel tear
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
…[truncated]