Document text
Page 1 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS ST
AGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3
option is equivalent to PHASE 2/3.
1. Select appropriate response -
Protocol version24 JUL 2020
2. Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006266
Page 2 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Informed Consent
1.
Consent Was: OBTAINED
Date Written Consent Obtained
Sep/10/2020090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006267
Page 3 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Demography
1.
Subject ID [10811194]
2. Birth Date: /1968
3. Sex: FEMALE
4. Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5. Race: (Check X all that apply): WHITE
6. Racial Designation:090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
(b) (6)
FDA-CBER-2021-5683-0006268
Page 4 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.
Date of Visit Sep/10/2020
2. Erroneous Visit090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006269
Page 5 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Done
Exclusion Criteria Met
2.Description of Exclusion CriterionMetNot Done090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006270
Page 6 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Screening
1.
Date of Completion/Discontinuation
/DeathSep/10/2020
2. Phase of Disposition: SCREENING
3. Status: COMPLETED
4. Specify Status: [ ]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006271
Page 7 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number:
[1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic obstructive pulmonary disease]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]Disease/Syndrome/Surgery
/Non-Drug Allergies/DrugAllergies:[Hypertension]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroidism]
Start Date: UNK/UNK/1995
Ongoing: YES
1.dLine/MH Number: [4]Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis of the knees]
Start Date: UNK/UNK/2018
Ongoing: YES
1.eLine/MH Number: [5]Disease/Syndrome/Surgery
/Non-Drug Allergies/DrugAllergies:[Attention deficit disorder]
Start Date: UNK/UNK/2017
Ongoing: YES090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006272
Page 8 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/DrugAllergies:[Postmenopausal]
Start Date: UNK/UNK/2018
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[Allergy to oral NSAIDs]
Start Date: UNK/UNK/2007
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[Allergy to Sulfa drugs]
Start Date: UNK/UNK/2002
Ongoing: YES090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006273
Page 9 of 355
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.
Date: Sep/10/2020
2. Weight: [210.8]
3. Unit: LB
4. Height: [66.0]
5. Unit: in
6. Body Mass Index: [34.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.1]
Unit: F
Temperature Location: ORAL CA VITY090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006274
Page 10 of 355
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Lab Urinalysis
1.
Lab Panel: URINALYSIS
2. Lab Sub-Panel: PREGNANCY
3. Collection Date: Sep/10/2020
4. Laboratory Name and Address
(Derived)[STUDY SITE]
5. Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006275
Page 11 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition
1.
Randomization Date : Sep/10/2020
2. Randomization Number: [86545]
3. Randomization Group: [ ]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006276
Page 12 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.
Data Origin SITE
2. Sample Type SERUM
3. Sample Collected? YES
Date of Collection:
Sep/10/2020
4. If no sample was collected or sample
was not collected according toprotocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1HP2]
5.bSample ID [BP1HP3]
5.cSample ID [BP1HP4]
5.dSample ID [BRTXMH]
5.eSample ID [BRTXMJ]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006277
Page 13 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.
Data Origin SITE
2. Sample Type NASAL_SWAB
3. Sample Collected? YES
Date of Collection:
Sep/10/2020
4. If no sample was collected or sample
was not collected according toprotocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP97R3]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006278
Page 14 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination
1.
Was there a temporary delay of
vaccination?NO
2. Treatment Name [BLINDED THERAPY]
3. Formulation: INJECTION
4. Dose Date Time: Sep/10/2020 12:44
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 after investigational productadministration?YES090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006279
Page 15 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Reactogenicity Diary
1.
Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006280
Page 16 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.
Date of Visit Sep/29/2020
2. Erroneous Visit090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006281
Page 17 of 355
***Confidential***
Header Text: c4591001
Visit: V2_V AX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.
Date: Sep/29/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CA VITY090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006282
Page 18 of 355
***Confidential***
Header Text: c4591001
Visit: V2_V AX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Lab Urinalysis
1.
Lab Panel: URINALYSIS
2. Lab Sub-Panel: PREGNANCY
3. Collection Date: Sep/29/2020
4. Laboratory Name and Address
(Derived)[STUDY SITE]
5. Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006283
Page 19 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.
Data Origin SITE
2. Sample Type NASAL_SWAB
3. Sample Collected? YES
Date of Collection:
Sep/29/2020
4. If no sample was collected or sample
was not collected according toprotocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP97WB]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006284
Page 20 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
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/29/2020 13:39
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 after investigational productadministration?YES090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006285
Page 21 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.
Date of Visit Oct/27/2020
2. Erroneous Visit090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006286
Page 22 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.
Data Origin SITE
2. Sample Type SERUM
3. Sample Collected? YES
Date of Collection:
Oct/27/2020
4. If no sample was collected or sample
was not collected according toprotocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS64MF]
5.bSample ID [BS64MG]
5.cSample ID [BRDCPV]
5.dSample ID [BRDCPW]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006287
Page 23 of 355
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006288
Page 24 of 355
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Electronic Sample Tracking
1. Data Origin
2. Sample Type
3. Sample Collected?
4. If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006289
Page 25 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006290
Page 26 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Electronic Sample Tracking
1. Data Origin
2. Sample Type
3. Sample Collected?
4. If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006291
Page 27 of 355
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006292
Page 28 of 355
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Electronic Sample Tracking
1. Data Origin
2. Sample Type
3. Sample Collected?
4. If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006293
Page 29 of 355
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.
Date of Visit Oct/12/2020
2. Erroneous Visit
COVID-19 Illness Visit
3. COVID-19 Illness Visit: COVID_A090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006294
Page 30 of 355
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/12/2020
2.
Date of First Symptom Started: Oct/9/2020
3. Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Fatigue]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006295
Page 31 of 355
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Locat
ionAssay Code and Descript
ionDevice Typ
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating
Pages090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006296
Page 32 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
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
[ ]Comments090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006297
Page 33 of 355
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.
Data Origin SITE
2. Sample Type NASAL_SWAB_SELF
3. Sample Collected? YES
Date of Collection:
Oct/12/2020
4. If no sample was collected or sample
was not collected according toprotocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV34836]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006298
Page 34 of 355
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.
Data Origin SITE Comments
2. Sample Type NASAL_SWAB Comments
3. Sample Collected? NO Comments
4. If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Self Swab collected] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID
[ ]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006299
Page 35 of 355
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
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 Visits or Contacts: NO
1.cPhysician or HealthcareProfessional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
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-19 illness?NO090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006300
Page 36 of 355
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
#Treatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicabl
e Not Applicabl
e Not Applicable Repeating
Pages090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006301
Page 37 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.
What is the treatment Identifier? Not Applicable
[ ]Comments
2. Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3. Treatment: Not Applicable Comments
4. Treatment: Not Applicable
[ ]Comments
5. Start Date: Not Applicable
//Comments
6. Ongoing? Not Applicable Comments090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006302
Page 38 of 355
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Illness Details
1.
Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2. Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3. Toxicity Grade: 2090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006303
Page 39 of 355
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
# Category of Clinical Event: Subcategory of Clinical Event Diagno sis Obtained Toxicity Grade Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006304
Page 40 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.
Category of Clinical Event: Not Applicable Comments
2. Subcategory of Clinical Event: Not Applicable Comments
3. Was a diagnosis obtained? Not Applicable Comments
4. Toxicity Grade: Not Applicable Comments090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006305
Page 41 of 355
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
#Category for L
ab TestVendor Na
meCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Applic
able Not Applica
ble Not Applicable Sponsor-Defined I
dentifierTest: Result:
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applicable
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applicable Repeating
Pages090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006306
Page 42 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.
Lab Panel: Not Applicable Comments
2. Laboratory Name and Address Not Applicable
[ ]Comments
3. Collection Date: Not Applicable
//Comments
4. Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID:
Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result:
Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]UnitComments090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006307
Page 43 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result:
Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]High
[ ]
UnitComments
5.cSponsor ID:Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result:
Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low[ ]
High
[ ]UnitComments090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006308
Page 44 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result:
Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]High
[ ]
UnitComments
5.eSponsor ID:Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result:
Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low[ ]
High
[ ]UnitComments090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006309
Page 45 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not ApplicableLow
[ ]High[ ]UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not ApplicableLow
[ ]High[ ]UnitComments090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006310
Page 46 of 355
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable
Not Applicable Not Applic
able Not Applicable Sponsor-Defined
IdentifierTest: Result:
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Applicable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Applicable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Applicable Repeating
Pages090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006311
Page 47 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.
Lab Panel: Not Applicable Comments
2. Laboratory Name and Address Not Applicable
[ ]Comments
3. Collection Date: Not Applicable
//Comments
4. Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID:
Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result:
Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]UnitComments090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006312
Page 48 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result:
Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]High
[ ]
UnitComments
5.cSponsor ID:Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result:
Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low[ ]
High
[ ]UnitComments090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006313
Page 49 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result:
Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]High
[ ]
UnitComments
5.eSponsor ID:Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result:
Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low[ ]
High
[ ]UnitComments090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006314
Page 50 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not ApplicableLow
[ ]High[ ]UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not ApplicableLow
[ ]High[ ]UnitComments090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006315
Page 51 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result:
Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]High
[ ]
UnitComments
5.iSponsor ID:Not Applicable
[ ]Comments
Test: Basophils_PX610
Result:
Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low[ ]
High
[ ]UnitComments090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006316
Page 52 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result:
Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]High
[ ]
UnitComments090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006317
Page 53 of 355
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
# Date: Vital Signs Details Form Instance
1. Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable Not Applicable Not Applicable Repeating Pages090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006318
Page 54 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.
Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier:
Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006319
Page 55 of 355
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
# Date: Vital Signs Details Form Instance
1. Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006320
Page 56 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.
Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier:
Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006321
Page 57 of 355
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
# Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Not Applicable Not Applicable Not Applicable Repeating Pages090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006322
Page 58 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.
Date Time of Assessment: Not Applicable
//Comments
2. Arterial Blood Gases PaO2 (mmHg): Not Applicable
[ ]Comments
3. FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006323
Page 59 of 355
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applic
able Repeating
Pages090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006324
Page 60 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.
What is the medication identifier? Not Applicable
[ ]Comments
2. Category: Not Applicable Comments
3. Concomitant Medications
Pre-specified:Not Applicable Comments
4. Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade orproprietary name. Include clarifyinginformation in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ] Comments
5. Start Date: Not Applicable
//Comments
6. Ongoing? Not Applicable Comments090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006325
Page 61 of 355
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
# Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006326
Page 62 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.
Date of Assessment: Not Applicable
//Comments
2. Location of Assessment: Not Applicable Comments
3. Type of Imaging Exam: Not Applicable Comments
4. Assessment: Not Applicable Comments090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006327
Page 63 of 355
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONV A - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONV ALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1. Date of Visit //
2. Erroneous Visit
COVID-19 Illness Visit
3. COVID-19 Illness Visit:090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006328
Page 64 of 355
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONV A - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Electronic Sample Tracking
1. Data Origin
2. Sample Type
3. Sample Collected?4. If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006329
Page 65 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006330
Page 66 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Unplanned Assessments
1. Assessments090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006331
Page 67 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Treatment
1.
Date of Completion/Discontinuation
/Death :Oct/27/2020
2. Phase of Disposition: V ACCINATION
3. Status: COMPLETED
4. Specify Status: [ ]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006332
Page 68 of 355
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Follow-Up
1.
Date of Completion/Discontinuation
/Death :Nov/4/2020
2. Phase of Disposition: FOLLOW-UP
3. Status: DEATH
4. Specify Status: [ ]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006333
Page 69 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1. Date of Visit //
2. Erroneous Visit
COVID-19 Repeat Swab
3. COVID-19 Repeat Swab:090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006334
Page 70 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Electronic Sample Tracking
1. Data Origin
2. Sample Type
3. Sample Collected?4. If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006335
Page 71 of 355
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
# CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
1.ADVERSE EVE
NT 1 Myocardial Infarct
ion Nov/4/2020 UNK:UNK NO
End Date Time:
Nov/4/2020 UNK:UNK
Repeating
Pages090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006336
Page 72 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.
Category: ADVERSE EVENT
2. AE ID: [1]
3. Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Myocardial Infarction]
4. Start Date Time: Nov/4/2020 UNK:UNK
5. Is the adverse event still ongoing? NO
End Date Time:
Nov/4/2020 UNK:UNK
6. Toxicity Grade: 4
7. Is the adverse event serious?
If Yes, NOTIFY PFIZERIMMEDIATELY .
Fatal; Life-threatening; Inpatient
hospitalization or prolongation ofexisting hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;Important medical event (i.e. mayjeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?NO
Did this serious event result in death?
YES
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?
YES
Other medically important serious event
NO
8. Is this adverse event the result of a
study Medication Error?If Yes, record the type of medication
error on the Medication Error Log.NO
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:[Hypertensive cardiovascular disease]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006337
Page 73 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
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?:FATAL
14. Did the adverse event cause the
subject to be discontinued from the
study?YES
15. Serious Adverse Event Number: For
Pfizer Use Only[2020447660]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006338
Page 74 of 355
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006339
Page 75 of 355
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Medication Error
1.
Category:
2. Medication Error (Type of
Medication Error):[ ]
3. Start Date: //
4. Is the medication error still ongoing?5. Latest Action Taken with Study
Treatment:
6. Was a Concomitant Medication
given?
7. Was a Non-Drug Treatment given?8. Did the Medication Error cause the
subject to be discontinued from the
study?
9. Was this medication error associated
with any adverse events?
10. Serious Adverse Event Number: For
Pfizer Use Only[ ]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006340
Page 76 of 355
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
V ACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006341
Page 77 of 355
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
V ACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Concomitant Medications
1.
What is the medication identifier? [ ]
2. Category:
3. Concomitant Medications
Pre-specified:
4. Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade orproprietary name. Include clarifyinginformation in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5. Date: //090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006342
Page 78 of 355
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006343
Page 79 of 355
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
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 name is
unknown, enter the full trade or
proprietary name. Include clarifyinginformation in the Medication text(e.g., Ingredient(s), route, use,
formulation).[ ]
5. Dose: [ ]
6. Dose Unit:
7. Dose Frequency:
8. Route:
9. Start Date: //
10. Ongoing?090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006344
Page 80 of 355
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
# Category Treatment Identifier Con Non-Drug Treatments Pre-specif ied Treatment Start Date Form Instance
1. Repeating Pages090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006345
Page 81 of 355
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
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?090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006346
Page 82 of 355
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006347
Page 83 of 355
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Transfusion Type:
2.
Date of Transfusion: //090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006348
Page 84 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006349
Page 85 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Vital Signs
1. Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:Temperature Location:090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006350
Page 86 of 355
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Lab Urinalysis
1. Lab Panel:
2. Lab Sub-Panel:
3. Collection Date: //
4. Laboratory Name and Address
(Derived)[ ]
5. Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:Not Done:090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006351
Page 87 of 355
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: V ACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Vaccination
1. Was there a temporary delay of
vaccination?
2. Treatment Name [ ]
3. Formulation:
4. Dose Date Time: //
5. Anatomical Location:6. Body Side:
7. Route:
8. Actual Dose: [ ]
9. Unit:
10. Timeframe Subject Was Observed
11. Was the subject observed for at least
the protocol specified observation
period after investigational productadministration?090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006352
Page 88 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1. Contact Type:
2. Was contact made?
3. Comments: [ ]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006353
Page 89 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1. Contact Type:
2. Was contact made?
3. Comments: [ ]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006354
Page 90 of 355
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006355
Page 91 of 355
***Confidential***
Header Text: c4591001
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Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Informed Consent - Asymptomatic Surveillance
1. Consent Was:090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006356
Page 92 of 355
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Electronic Sample Tracking
1. Data Origin
2. Sample Type
3. Sample Collected?
4. If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006357
Page 93 of 355
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Electronic Sample Tracking
1. Data Origin
2. Sample Type
3. Sample Collected?
4. If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006358
Page 94 of 355
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006359
Page 95 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Further Vaccination Confirmation
1. Select appropriate response - Is
participant willing to return for
Vaccination 3?090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006360
Page 96 of 355
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Treatment Unblinded
1. Date Treatment Unblinded : //
2. Primary Reason for Unblinding:090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006361
Page 97 of 355
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Withdrawal Of Consent
1. Withdrawal of Consent Date : //090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006362
Page 98 of 355
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Death Details
1.
Date of Collection / Notification of
Death:Nov/11/2020
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [Myocardial Infarction]090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006363
Page 99 of 355
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Subject Status
1.
Subject Status DISCONTINUED
2. Subject Status Date Nov/4/2020090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006364
Page 100 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Casebook Signature Form
1.
Casebook Signature Click Here to Enable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006365
Page 101 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
James Fry Approved Jan-23-2021 12:19:24 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JamesFry, verify that all case report form pages accurately display the results of theexaminations, 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 electron ic
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.090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006366
Page 102 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
Form
Sep-10-2020 12:57:11 (UTC-05:00) Eastern Time
(US & Canada)Tawnyn Ebner
(pfe.tebner)All inclusions and exclusions met
Not Done090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006367
Page 103 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
Form
Oct-13-2020 11:38:02 (UTC-05:00) Eastern Time
(US & Canada)Lora Morris
(pfe.lmorris)Not Done
Form Oct-12-2020 12:59:26 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006368
Page 104 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
1
Oct-13-2020 11:38:02 (UTC-05:00) Eastern Time
(US & Canada)Lora Morris(pfe.lmorris)Not Done
1 Oct-12-2020 12:59:26 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006369
Page 105 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
2
Oct-13-2020 11:38:02 (UTC-05:00) Eastern Time
(US & Canada)Lora Morris(pfe.lmorris)Not Done
2 Oct-12-2020 12:59:26 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006370
Page 106 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
3
Oct-13-2020 11:38:02 (UTC-05:00) Eastern Time
(US & Canada)Lora Morris(pfe.lmorris)Not Done
3 Oct-12-2020 12:59:26 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006371
Page 107 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
4
Oct-13-2020 11:38:02 (UTC-05:00) Eastern Time
(US & Canada)Lora Morris(pfe.lmorris)Not Done
4 Oct-12-2020 12:59:26 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006372
Page 108 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5
Oct-13-2020 11:38:02 (UTC-05:00) Eastern Time
(US & Canada)Lora Morris(pfe.lmorris)Not Done
5 Oct-12-2020 12:59:26 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006373
Page 109 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
6
Oct-13-2020 11:38:02 (UTC-05:00) Eastern Time
(US & Canada)Lora Morris(pfe.lmorris)Not Done
6 Oct-12-2020 12:59:26 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006374
Page 110 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
7
Oct-13-2020 11:38:02 (UTC-05:00) Eastern Time
(US & Canada)Lora Morris(pfe.lmorris)Not Done
7 Oct-12-2020 12:59:26 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006375
Page 111 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
8
Oct-13-2020 11:38:02 (UTC-05:00) Eastern Time
(US & Canada)Lora Morris(pfe.lmorris)Not Done
8 Oct-12-2020 12:59:26 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006376
Page 112 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
9
Oct-13-2020 11:38:02 (UTC-05:00) Eastern Time
(US & Canada)Lora Morris(pfe.lmorris)Not Done
9 Oct-12-2020 12:59:26 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006377
Page 113 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
Form
Nov-07-2020 19:26:57 (UTC-05:00) Eastern Time
(US & Canada)Lora Morris
(pfe.lmorris)Telehealth Visit
Form Oct-15-2020 13:09:30 (UTC-05:00) Eastern Time
(US & Canada)Lora Morris(pfe.lmorris)Telehealth Visit
Not Done090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006378
Page 114 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
1
Nov-07-2020 19:26:57 (UTC-05:00) Eastern Time
(US & Canada)Lora Morris(pfe.lmorris)Telehealth Visit
1 Oct-15-2020 13:09:30 (UTC-05:00) Eastern Time
(US & Canada)Lora Morris(pfe.lmorris)Telehealth Visit
Not Done090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006379
Page 115 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
2
Nov-07-2020 19:26:57 (UTC-05:00) Eastern Time
(US & Canada)Lora Morris(pfe.lmorris)Telehealth Visit
2 Oct-15-2020 13:09:30 (UTC-05:00) Eastern Time
(US & Canada)Lora Morris(pfe.lmorris)Telehealth Visit
Not Done090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006380
Page 116 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
3
Nov-07-2020 19:26:57 (UTC-05:00) Eastern Time
(US & Canada)Lora Morris(pfe.lmorris)Telehealth Visit
3 Oct-15-2020 13:09:30 (UTC-05:00) Eastern Time
(US & Canada)Lora Morris(pfe.lmorris)Telehealth Visit
Not Done090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006381
Page 117 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
4
Nov-07-2020 19:26:57 (UTC-05:00) Eastern Time
(US & Canada)Lora Morris(pfe.lmorris)Telehealth Visit
4 Oct-15-2020 13:09:30 (UTC-05:00) Eastern Time
(US & Canada)Lora Morris(pfe.lmorris)Telehealth Visit
Not Done090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006382
Page 118 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
Form
Oct-12-2020 13:00:23 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006383
Page 119 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
1
Oct-12-2020 13:00:23 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006384
Page 120 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
2
Oct-12-2020 13:00:23 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006385
Page 121 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
3
Oct-12-2020 13:00:23 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006386
Page 122 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
4
Oct-12-2020 13:00:23 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006387
Page 123 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5
Oct-12-2020 13:00:23 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006388
Page 124 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
6
Oct-12-2020 13:00:23 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006389
Page 125 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
Form
Oct-12-2020 13:01:10 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006390
Page 126 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
1
Oct-12-2020 13:01:10 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006391
Page 127 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
2
Oct-12-2020 13:01:10 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006392
Page 128 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
3
Oct-12-2020 13:01:10 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006393
Page 129 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
4
Oct-12-2020 13:01:10 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006394
Page 130 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
Form
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006395
Page 131 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
1
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006396
Page 132 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
2
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006397
Page 133 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
3
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006398
Page 134 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
4
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006399
Page 135 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.a
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006400
Page 136 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.a
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006401
Page 137 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.a
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006402
Page 138 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.a
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006403
Page 139 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.b
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006404
Page 140 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.b
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006405
Page 141 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.b
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006406
Page 142 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.b
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006407
Page 143 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.c
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006408
Page 144 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.c
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006409
Page 145 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.c
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006410
Page 146 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.c
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006411
Page 147 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.d
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006412
Page 148 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.d
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006413
Page 149 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.d
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006414
Page 150 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.d
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006415
Page 151 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.e
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006416
Page 152 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.e
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006417
Page 153 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.e
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006418
Page 154 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.e
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006419
Page 155 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.f
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006420
Page 156 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.f
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006421
Page 157 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.f
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006422
Page 158 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.f
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006423
Page 159 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.g
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006424
Page 160 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.g
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006425
Page 161 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.g
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006426
Page 162 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.g
Oct-12-2020 13:01:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006427
Page 163 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
Form
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006428
Page 164 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
1
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006429
Page 165 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
2
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006430
Page 166 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
3
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006431
Page 167 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
4
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006432
Page 168 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.a
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006433
Page 169 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.a
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006434
Page 170 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.a
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006435
Page 171 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.a
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006436
Page 172 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.b
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006437
Page 173 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.b
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006438
Page 174 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.b
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006439
Page 175 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.b
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006440
Page 176 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.c
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006441
Page 177 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.c
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006442
Page 178 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.c
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006443
Page 179 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.c
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006444
Page 180 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.d
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006445
Page 181 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.d
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006446
Page 182 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.d
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006447
Page 183 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.d
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006448
Page 184 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.e
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006449
Page 185 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.e
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006450
Page 186 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.e
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006451
Page 187 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.e
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006452
Page 188 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.f
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006453
Page 189 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.f
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006454
Page 190 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.f
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006455
Page 191 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.f
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006456
Page 192 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.g
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006457
Page 193 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.g
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006458
Page 194 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.g
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006459
Page 195 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.g
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006460
Page 196 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.h
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006461
Page 197 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.h
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006462
Page 198 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.h
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006463
Page 199 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.h
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006464
Page 200 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.i
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006465
Page 201 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.i
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006466
Page 202 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.i
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006467
Page 203 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.i
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006468
Page 204 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.j
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006469
Page 205 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.j
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006470
Page 206 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.j
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006471
Page 207 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5.j
Oct-12-2020 13:02:08 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006472
Page 208 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
Form
Oct-12-2020 13:02:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006473
Page 209 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
1
Oct-12-2020 13:02:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006474
Page 210 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
2.a
Oct-12-2020 13:02:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006475
Page 211 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
2.a
Oct-12-2020 13:02:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006476
Page 212 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
2.a
Oct-12-2020 13:02:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006477
Page 213 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
2.a
Oct-12-2020 13:02:38 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006478
Page 214 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
Form
Oct-12-2020 13:03:00 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006479
Page 215 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
1
Oct-12-2020 13:03:00 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006480
Page 216 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
2.a
Oct-12-2020 13:03:00 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006481
Page 217 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
Form
Oct-12-2020 13:03:21 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006482
Page 218 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
1
Oct-12-2020 13:03:21 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006483
Page 219 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
2
Oct-12-2020 13:03:21 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006484
Page 220 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
3
Oct-12-2020 13:03:21 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006485
Page 221 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
Form
Oct-12-2020 13:03:41 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006486
Page 222 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
1
Oct-12-2020 13:03:41 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006487
Page 223 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
2
Oct-12-2020 13:03:41 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006488
Page 224 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
3
Oct-12-2020 13:03:41 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006489
Page 225 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
4
Oct-12-2020 13:03:41 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006490
Page 226 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
5
Oct-12-2020 13:03:41 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006491
Page 227 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
6
Oct-12-2020 13:03:41 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006492
Page 228 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
Form
Oct-12-2020 13:04:10 (UTC-05:00) Eastern Time
(US & Canada)James Fry
(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006493
Page 229 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
1
Oct-12-2020 13:04:10 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006494
Page 230 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
2
Oct-12-2020 13:04:10 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006495
Page 231 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
3
Oct-12-2020 13:04:10 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006496
Page 232 of 355
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Item Date User Comment
4
Oct-12-2020 13:04:10 (UTC-05:00) Eastern Time
(US & Canada)James Fry(pfe.jfry)Not Applicable090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006497
Page 233 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
James Fry Approved Jan-23-2021 12:19:24 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JamesFry, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electron ic
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.
Lora Morris N/A Nov-24-2020 08:25:32 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signaturesinvalidated
Affidavit:N/A
Michael Butcher Approved Nov-17-2020 14:15:02 (UTC-05:00) Easter n
Time (US & Canada)BOOK Signed
Affidavit:By my dated signature below, I, MichaelButcher, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electron ic
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.
Lora Morris N/A Nov-11-2020 15:19:14 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Butcher Approved Nov-10-2020 13:00:20 (UTC-05:00) Easter n
Time (US & Canada)BOOK Signed090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006498
Page 234 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Affidavit:
By my dated signature below, I, MichaelButcher, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electron ic
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.
Lora Morris N/A Nov-07-2020 19:26:57 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Butcher Approved Nov-03-2020 15:14:02 (UTC-05:00) Easter n
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelButcher, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electron ic
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.
Lora Morris N/A Oct-27-2020 12:47:23 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Butcher Approved Oct-16-2020 11:22:44 (UTC-05:00) Easter n Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelButcher, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electron ic
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.090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006499
Page 235 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Select appropriate response - Protocol version
Date
Location User Value Reason
Sep-10-2020 12:56:05
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner) Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date
Location User Value Reason
Sep-10-2020 12:56:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner)Data Entry:
STAGE 3 COHORTSInitial Entry090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006500
Page 236 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Consent Was:
Date
Location User Value Reason
Sep-10-2020 12:56:18
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner) Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/10/2020Initial Entry090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006501
Page 237 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Subject ID
Date Location User
Value Reason
Sep-10-2020 12:55:55
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:10811194Item copied fromprevious form
2. Birth Date:
Date Location User
Value Reason
Sep-10-2020 12:55:52
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
/1968Enrollment Entry
3. Sex:
Date Location User
Value Reason
Sep-10-2020 12:56:34
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner) Data Entry:FEMALEInitial Entry
4. Ethnicity:
Date Location User
Value Reason
Sep-10-2020 12:56:34
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner) Data Entry:NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User
Value Reason
Sep-10-2020 12:56:34
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner) Data Entry:WHITEInitial Entry090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
(b) (6)
FDA-CBER-2021-5683-0006502
Page 238 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date
Location User Value Reason
Sep-10-2020 12:57:00
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner) Data Entry:
Sep/10/2020Initial Entry090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006503
Page 239 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Completion/Discontinuation/Death
Date
Location User Value Reason
Sep-10-2020 12:57:42
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner) Data Entry:
Sep/10/2020Initial Entry
2. Phase of Disposition:
Date
Location User Value Reason
Sep-10-2020 12:57:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date
Location User Value Reason
Sep-10-2020 12:57:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner)Data Entry:
COMPLETEDInitial Entry090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006504
Page 240 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.a
Date
Location User Value Reason
Sep-10-2020 16:41:36
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris) Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory T
erm:Chronic obstructivepulmonary disease
Start Date: UNK/UNK/2015
Ongoing: YESChanged Information
Sep-10-2020 14:58:47(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)
Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory T
erm:Chronic obstructivepulmonary disease
Start Date: Jan/1/2015
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value ReasonSep-10-2020 14:58:47
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)
Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date
Location User Value Reason
Sep-10-2020 14:58:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
Chronic obstructive pulmonary disea
seInitial Entry
1.a Start Date:
Date
Location User Value Reason
Sep-10-2020 16:41:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
UNK/UNK/2015Changed Information
Sep-10-2020 14:58:47
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000
Lora Morris
(pfe.lmorris)Data Entry:
Jan/1/2015Initial Entry090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006505
Page 241 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
1.a Ongoing:
Date Location User Value Reason
Sep-10-2020 14:58:47
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris) Data Entry:
YESInitial Entry
1.b
Date
Location User Value Reason
Sep-10-2020 16:41:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
Line/MH Number: 2
Medical History T
e
rm:Hypertension
Start Date: UNK/UNK/2
015
Ongoing: YESChanged Information
Sep-10-2020 14:59:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History T
er
m:Hypertensio
n
Start Date: Jan/1/2015
Ongoing: YESInitial Entry090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006506
Page 242 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
1.b Line/MH Number:
Date Location User Value Reason
Sep-10-2020 14:59:19
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date
Location User Value Reason
Sep-10-2020 14:59:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
HypertensionInitial Entry
1.b Start Date:
Date
Location User Value Reason
Sep-10-2020 16:41:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
UNK/UNK/2015Changed Information
Sep-10-2020 14:59:19
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000
Lora Morris
(pfe.lmorris)Data Entry:
Jan/1/2015Initial Entry
1.b Ongoing:
Date
Location User Value Reason
Sep-10-2020 14:59:19
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris) Data Entry:
YESInitial Entry
1.c
Date
Location User Value Reason
Sep-10-2020 16:42:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
Line/MH Number: 3
Medical History T
e
rm:Hypothyroidism
Start Date: UNK/UNK/19
95
Ongoing: YESChanged Information
Sep-10-2020 15:00:38
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)
Data Entry:
Line/MH Number: 3Initial Entry090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006507
Page 243 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Medical History Te
rm:Hypothyroidism
Start Date: Jan/1/1995
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Sep-10-2020 15:00:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date
Location User Value Reason
Sep-10-2020 15:00:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
HypothyroidismInitial Entry
1.c Start Date:
Date
Location User Value Reason
Sep-10-2020 16:42:00
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris) Data Entry:
UNK/UNK/1995Changed Information
Sep-10-2020 15:00:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000
Lora Morris
(pfe.lmorris)Data Entry:
Jan/1/1995Initial Entry
1.c Ongoing:
Date
Location User Value Reason
Sep-10-2020 15:00:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
YESInitial Entry
1.d
Date
Location User Value Reason
Sep-10-2020 16:42:14
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris) Data Entry:
Line/MH Numb
er:4
Medical Histor
y T
erm:Osteoarthritis of the kneesChanged Information090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006508
Page 244 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Start Date: UNK/UNK/2018
Ongoing: YES
Sep-10-2020 15:01:33
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Line/MH Number:4
Medical History T
erm:Osteoarthritis of the knees
Start Date: Jan/1/2018
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Sep-10-2020 15:01:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date
Location User Value Reason
Sep-10-2020 15:01:33
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris) Data Entry:
Osteoarthritis of the kneesInitial Entry
1.d Start Date:
Date
Location User Value Reason
Sep-10-2020 16:42:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
UNK/UNK/2018Changed Information
Sep-10-2020 15:01:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000
Lora Morris
(pfe.lmorris)Data Entry:
Jan/1/2018Initial Entry
1.d Ongoing:
Date
Location User Value Reason
Sep-10-2020 15:01:33
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris) Data Entry:
YESInitial Entry
1.e
Date
Location User Value Reason090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006509
Page 245 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Sep-10-2020 16:42:27
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris) Data Entry:
Line/MH Number:5
Medical HistoryT
erm:Attention deficitdisorder
Start Date: UNK/UNK/2017
Ongoing: YESChanged Information
Sep-10-2020 15:02:10
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)
Data Entry:
Line/MH Numb
er:5
Medical History
T
erm:Attention deficitdisorder
Start Date: Jan/1/2017
Ongoing: YESInitial Entry090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006510
Page 246 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
1.e Line/MH Number:
Date Location User Value Reason
Sep-10-2020 15:02:10
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date
Location User Value Reason
Sep-10-2020 15:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
Attention deficit disorderInitial Entry
1.e Start Date:
Date
Location User Value Reason
Sep-10-2020 16:42:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
UNK/UNK/2017Changed Information
Sep-10-2020 15:02:10
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000
Lora Morris
(pfe.lmorris)Data Entry:
Jan/1/2017Initial Entry
1.e Ongoing:
Date
Location User Value Reason
Sep-10-2020 15:02:10
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris) Data Entry:
YESInitial Entry
1.f
Date
Location User Value Reason
Sep-10-2020 16:42:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
Line/MH Number: 6
Medical History T
e
rm:Postmenopausal
Start Date: UNK/UNK/20
18
Ongoing: YESChanged Information
Sep-10-2020 15:02:53
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)
Data Entry:
Line/MH Number: 6Initial Entry090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006511
Page 247 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Medical History Te
rm:Postmenopausal
Start Date: Jan/1/2018
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Sep-10-2020 15:02:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date
Location User Value Reason
Sep-10-2020 15:02:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
PostmenopausalInitial Entry
1.f Start Date:
Date
Location User Value Reason
Sep-10-2020 16:42:42
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris) Data Entry:
UNK/UNK/2018Changed Information
Sep-10-2020 15:02:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000
Lora Morris
(pfe.lmorris)Data Entry:
Jan/1/2018Initial Entry
1.f Ongoing:
Date
Location User Value Reason
Sep-10-2020 15:02:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
YESInitial Entry
1.g
Date
Location User Value Reason
Sep-11-2020 10:25:25
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Line/MH Numbe
r:7
Medical History
T
erm:Allergy to oral NSAIDsInitial Entry090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006512
Page 248 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Start Date: UNK/UNK/2007
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Sep-11-2020 10:25:25
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date
Location User Value Reason
Sep-11-2020 10:25:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
Allergy to oral NSAIDsInitial Entry
1.g Start Date:
Date
Location User Value Reason
Sep-11-2020 10:25:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
UNK/UNK/2007Initial Entry
1.g Ongoing:
Date
Location User Value Reason
Sep-11-2020 10:25:25
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris) Data Entry:
YESInitial Entry
1.h
Date
Location User Value Reason
Sep-11-2020 10:26:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:8
Medical History Term:Allergy to Sulfadrugs
Start Date: UNK/UNK/2002
Ongoing: YESInitial Entry090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006513
Page 249 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
1.h Line/MH Number:
Date Location User Value Reason
Sep-11-2020 10:26:04
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date
Location User Value Reason
Sep-11-2020 10:26:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
Allergy to Sulfa drugsInitial Entry090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006514
Page 250 of 355
***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: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.h Start Date:
Date
Location User Value Reason
Sep-11-2020 10:26:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
UNK/UNK/2002Initial Entry
1.h Ongoing:
Date
Location User Value Reason
Sep-11-2020 10:26:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
YESInitial Entry090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006515
Page 251 of 355
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date:
Date
Location User Value Reason
Sep-10-2020 14:47:59
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris) Data Entry:
Sep/10/2020Initial Entry
2. W
eight:
Date Location User Value Reason
Sep-10-2020 14:47:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
210.8Initial Entry
3. Unit:
Date
Location User Value Reason
Sep-10-2020 14:47:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
LBInitial Entry
4. Height:
Date
Location User Value Reason
Sep-10-2020 14:47:59
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris) Data Entry:
66.0Initial Entry
5. Unit:
Date
Location User Value Reason
Sep-10-2020 14:47:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
inInitial Entry
6. Body Mass Index:
Date
Location User Value Reason
Sep-10-2020 14:47:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
34.0Initial Entry
7.a090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006516
Page 252 of 355
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Sep-11-2020 09:28:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
Record Identifier:: 1
T
emperature: 97.1
Temperature Unit: F
Temperature Locati
on::ORAL CA VITYTranscription Error
Sep-10-2020 14:47:59(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)
Data Entry:
Record Identifier:: 1
T
emperature: 97.1
Temperature Unit: F
Temperature Locatio
n::FOREHEADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-10-2020 14:47:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris) Data Entry:
1Initial Entry
7.a T
emperature:
Date Location User Value Reason
Sep-10-2020 14:47:59
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris) Data Entry:
97.1Initial Entry
7.a Unit:
Date
Location User Value Reason
Sep-10-2020 14:47:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
FInitial Entry
7.a T
emperature Location:
Date Location User Value Reason
Sep-11-2020 09:28:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
ORAL CA VITYTranscription Error
Sep-10-2020 14:47:59
(UTC-05:00) Eastern TimeACV0PFEINFP6000
Lora Morris
(pfe.lmorris)Data Entry:
FOREHEADInitial Entry090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006517
Page 253 of 355
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
(US & Canada)090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006518
Page 254 of 355
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Lab Panel:
Date
Location User Value Reason
Sep-10-2020 14:47:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date
Location User Value Reason
Sep-10-2020 14:47:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date
Location User Value Reason
Sep-10-2020 14:47:00
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris) Data Entry:
Sep/10/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date
Location User Value Reason
Sep-10-2020 14:47:00
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date
Location User Value Reason
Sep-10-2020 14:47:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date
Location User Value Reason
Sep-10-2020 14:14:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006519
Page 255 of 355
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Test:: Choriogonadotropi
n Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Sep-10-2020 14:14:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a T
est:
Date Location User Value Reason
Sep-10-2020 14:14:25
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris) Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date
Location User Value Reason
Sep-10-2020 14:14:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
NOT DONEInitial Entry090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006520
Page 256 of 355
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Randomization Date :
Date
Location User Value Reason
Sep-10-2020 14:14:11
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris) Data Entry:
Sep/10/2020Initial Entry
2. Randomization Number:
Date
Location User Value Reason
Sep-10-2020 14:14:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
86545Initial Entry090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006521
Page 257 of 355
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date
Location User Value Reason
Sep-10-2020 13:00:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date
Location User Value Reason
Sep-10-2020 13:00:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date
Location User Value Reason
Sep-10-2020 13:02:42
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-10-2020 13:00:36(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however nobarcodes are entered.
Please review and
correct asappropriate.
Sep-10-2020 13:00:36(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner)
Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date
Location User Value Reason
Sep-10-2020 13:02:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner)Data Entry:
Sample ID: BP1HP2Initial Entry
5.a Sample ID
Date
Location User Value Reason090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006522
Page 258 of 355
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Sep-10-2020 13:02:42
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner) Data Entry:
BP1HP2Initial Entry
5.b
Date
Location User Value Reason
Sep-10-2020 13:02:52
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner) Data Entry:
Sample ID: BP1HP3Initial Entry
5.b Sample ID
Date
Location User Value Reason
Sep-10-2020 13:02:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner)Data Entry:
BP1HP3Initial Entry
5.c
Date
Location User Value Reason
Sep-10-2020 13:03:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner)Data Entry:
Sample ID: BP1HP4Initial Entry
5.c Sample ID
Date
Location User Value Reason
Sep-10-2020 13:03:01
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner) Data Entry:
BP1HP4Initial Entry
5.d
Date
Location User Value Reason
Sep-10-2020 13:03:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner)Data Entry:
Sample ID: BR TXMHInitial Entry090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006523
Page 259 of 355
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
5.d Sample ID
Date Location User Value Reason
Sep-10-2020 13:03:13
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner) Data Entry:
BRTXMHInitial Entry
5.e
Date
Location User Value Reason
Sep-10-2020 13:03:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner)Data Entry:
Sample ID: BR TXMJInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-10-2020 13:03:20
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner) Data Entry:
BRTXMJInitial Entry090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006524
Page 260 of 355
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date
Location User Value Reason
Sep-10-2020 12:59:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date
Location User Value Reason
Sep-10-2020 12:59:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date
Location User Value Reason
Sep-10-2020 13:00:07
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-10-2020 12:59:08(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however nobarcodes are entered.
Please review and
correct asappropriate.
Sep-10-2020 12:59:08(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner)
Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date
Location User Value Reason
Sep-10-2020 13:00:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner)Data Entry:
Sample ID: BP97R3Initial Entry
5.a Sample ID
Date
Location User Value Reason090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006525
Page 261 of 355
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Sep-10-2020 13:00:07
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Tawnyn
Ebner(pfe.tebner) Data Entry:
BP97R3Initial Entry090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006526
Page 262 of 355
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: V ACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Was there a temporary delay of vaccination?
Date
Location User Value Reason
Sep-10-2020 14:13:48
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris) Data Entry:
NOInitial Entry
2. Treatment Name
Date
Location User Value Reason
Sep-10-2020 14:13:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date
Location User Value Reason
Sep-10-2020 14:13:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date
Location User Value Reason
Sep-10-2020 14:13:48
(UTC-05:00) Eastern Time(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris) Data Entry:
Sep/10/2020 12:44Initial Entry
5. Anatomical Location:
Date
Location User Value Reason
Sep-10-2020 14:13:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date
Location User Value Reason
Sep-10-2020 14:13:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lora Morris
(pfe.lmorris)Data Entry:
LEFTInitial Entry
7. Route:090177e196ae3f03\Final\Final On: 01-A pr-2021 05:06 (GMT )
FDA-CBER-2021-5683-0006527
Page 263 of 355
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: V ACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1081 Site Name: (1081) Sterling Research Group - Mt. Auburn
Subject No: 10811194 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Sep-10-2020 14:13:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject W
as Observed
Date Location User Value Reason
Sep-10-2020 14:13:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto cal
…[truncated]