Document text
Page 1 of 473
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042528
Page 2 of 473
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/12/2020
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042529
Page 3 of 473
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10031186]
2.Birth Date: /1987
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (6)
FDA-CBER-2021-5683-0042530
Page 4 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/12/2020
2.Erroneous Visit
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042531
Page 5 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042532
Page 6 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/12/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042533
Page 7 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[narcolepsy]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[hypothyroid]
Start Date: UNK/UNK/2009
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[obesity]
Start Date: UNK/UNK/2020
Ongoing: YES
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042534
Page 8 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/12/2020
2.Weight: [315.0]
3.Unit: LB
4.Height: [72.0]
5.Unit: in
6.Body Mass Index: [42.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042535
Page 9 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/12/2020
2.Randomization Number: [47001]
3.Randomization Group: [ ]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042536
Page 10 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/12/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP579G]
5.bSample ID [BP579H]
5.cSample ID [BP579J]
5.dSample ID [BKDZ3X]
5.eSample ID [BKDZ3Y]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042537
Page 11 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/12/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP57B6]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042538
Page 12 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/12/2020 10:03
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042539
Page 13 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042540
Page 14 of 473
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/3/2020
2.Erroneous Visit
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042541
Page 15 of 473
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042542
Page 16 of 473
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042543
Page 17 of 473
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042544
Page 18 of 473
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Sep/3/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042545
Page 19 of 473
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/3/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP57LR]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042546
Page 20 of 473
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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/3/2020 09:47
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042547
Page 21 of 473
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042548
Page 22 of 473
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042549
Page 23 of 473
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042550
Page 24 of 473
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042551
Page 25 of 473
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/7/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[low draw]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYL9N]
5.bSample ID [BNWKJW]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042552
Page 26 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/14/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042553
Page 27 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/14/2020
2.Date of First Symptom
Started:Dec/12/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/24/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
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? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042554
Page 28 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
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.Symptoms - Other Text: [ ]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042555
Page 29 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descr
iptionDevice TypeForm Insta
nce
1.Dec/14/
2020 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTI
C TEST Repeating
Pages
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042556
Page 30 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/14/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection
Location:NASOPHARYNX
4.Assay Code and
Description:SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ROCHE MOLECULAR SYSTEMS COBAS SARS-COV-2
7.Test Result: POSITIVE
8.Comments/Findings
/Details:[ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042557
Page 31 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Dec/14/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV29503]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042558
Page 32 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[subject completed self-swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042559
Page 33 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042560
Page 34 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042561
Page 35 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Treatment I
dentifierCon Non-Drug Treatme
nts Pre-specifiedTreatme
ntTreatme
ntStart Dat
eForm Instan
ce
1.Not Applicab
le Not Applicable Not Appli
cable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042562
Page 36 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment
Identifier?Not Applicable
[ ]Comments
2.Concomitant Non-drug
Treatment Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042563
Page 37 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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?YES
Respiratory Illness Diagnosis:
[COVID-19]
Date of Diagnosis:
Dec/14/2020
3.Toxicity Grade: 3
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042564
Page 38 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
1.Not Applicable Not Applicable Not Applicable
Not Applic
able Repeating
Pages
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042565
Page 39 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical
Event:Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042566
Page 40 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category f
or Lab Tes
tVendor
NameCollecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
1.Not Applic
able Not Ap
plicable
Not App
licable Not Ap
plicable
Sponsor-Def
ined Identifi
erTest:Result:
Not Applica
ble Not Ap
plicable
Not Ap
plicable
Not Applica
ble Not Ap
plicable
Not Ap
plicable
Not Applica
ble Not Ap
plicable
Not Ap
plicable
Not Applica
ble Not Ap
plicable
Not Ap
plicable
Not Applica
ble Not Ap
plicable
Not Ap
plicable
Not Applica
ble Not Ap
plicable
Not Ap
plicable
Not Applica
ble Not Ap
plicable
Not Ap
plicable
Repeating
Pages
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042567
Page 41 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and
AddressNot 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
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042568
Page 42 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
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
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042569
Page 43 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042570
Page 44 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042571
Page 45 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042572
Page 46 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042573
Page 47 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042574
Page 48 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category
for Lab T
estVendor Na
me (DERIV
ED)Collect
ion Dat
e:Speci
men T
ypeLab ResultForm Insta
nce
1.Not Appli
cable Not Applica
ble Not Ap
plicable
Not Ap
plicabl
e Sponsor-De
fined Identi
fierTest:Result
:
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e Repeating
Pages
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042575
Page 49 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category
for Lab T
estVendor Na
me (DERIV
ED)Collect
ion Dat
e:Speci
men T
ypeLab ResultForm Insta
nce
Sponsor-De
fined Identi
fierTest:Result
:
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042576
Page 50 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and
AddressNot 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
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042577
Page 51 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042578
Page 52 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042579
Page 53 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042580
Page 54 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042581
Page 55 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042582
Page 56 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042583
Page 57 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042584
Page 58 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042585
Page 59 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042586
FDA-CBER-2021-5683-0042587
Page 61 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in
beats/minute:Not Applicable
[ ]Comments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042588
FDA-CBER-2021-5683-0042589
Page 63 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042590
Page 64 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating
Pages
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042591
Page 65 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Applicable
[ ]Comments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042592
Page 66 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nStart D
ateForm Instan
ce
1.Not Applicabl
e Not Applicab
le Not Applicable Not Applic
able Not App
licable Repeating
Pages
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042593
Page 67 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042594
Page 68 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
1.Not Applicable Not Applicable Not Applicabl
e Not Applicable Repeating
Pages
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042595
Page 69 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042596
Page 70 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/15/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042597
Page 71 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/15/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/15/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYLJV]
5.bSample ID [BNWKVG]
5.cSample ID [BNWKVH]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042598
Page 72 of 473
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042599
Page 73 of 473
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Unplanned Assessments
1.Assessments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042600
Page 74 of 473
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/7/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042601
Page 75 of 473
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042602
Page 76 of 473
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042603
Page 77 of 473
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042604
Page 78 of 473
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Ev
ent Still OngoingForm Instan
ce
1.ADVERS
E EVENT 1 Exposure During p
artner Pregnancy Sep/17/2020
UNK:UNK YES Repeating
Pages
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042605
Page 79 of 473
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Exposure During partner Pregnancy]
4.Start Date Time: Sep/17/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: Not Applicable Comments
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042606
Page 80 of 473
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is
due to:
OTHER
If Other, specify:
[Partner became Pregnant]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042607
Page 81 of 473
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:UNKNOWN
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042608
Page 82 of 473
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042609
Page 83 of 473
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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[ ]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042610
Page 84 of 473
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042611
Page 85 of 473
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042612
Page 86 of 473
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042613
Page 87 of 473
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042614
Page 88 of 473
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042615
Page 89 of 473
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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?
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042616
FDA-CBER-2021-5683-0042617
Page 91 of 473
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042618
Page 92 of 473
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042619
Page 93 of 473
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042620
Page 94 of 473
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042621
Page 95 of 473
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042622
Page 96 of 473
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042623
Page 97 of 473
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/8/2021
2.Erroneous Visit
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042624
Page 98 of 473
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042625
Page 99 of 473
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/8/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042626
Page 100 of 473
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042627
Page 101 of 473
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042628
Page 102 of 473
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042629
Page 103 of 473
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/19/2021
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042630
Page 104 of 473
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042631
Page 105 of 473
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/19/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042632
Page 106 of 473
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/19/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYLK2]
5.bSample ID [BNWKVR]
5.cSample ID [BNWKVS]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042633
Page 107 of 473
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/19/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYLJZ]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042634
Page 108 of 473
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/19/2021 10:38
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042635
Page 109 of 473
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042636
Page 110 of 473
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/9/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYLMR]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042637
Page 111 of 473
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/9/2021 09:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042638
Page 112 of 473
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042639
Page 113 of 473
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/11/2021
3.Comments: [ ]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042640
Page 114 of 473
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042641
Page 115 of 473
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042642
Page 116 of 473
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042643
Page 117 of 473
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042644
Page 118 of 473
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Mar/11/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042645
Page 119 of 473
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/7/2020
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042646
Page 120 of 473
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042647
Page 121 of 473
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042648
Page 122 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormAug-13-2020 09:39:39 (UTC-05:00)
Eastern Time (US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042649
Page 123 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormJan-15-2021 09:43:05 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042650
Page 124 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Jan-15-2021 09:43:05 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042651
Page 125 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Jan-15-2021 09:43:05 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042652
Page 126 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Jan-15-2021 09:43:05 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042653
Page 127 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Jan-15-2021 09:43:05 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042654
Page 128 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5Jan-15-2021 09:43:05 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042655
Page 129 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6Jan-15-2021 09:43:05 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042656
Page 130 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormJan-15-2021 09:43:22 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042657
Page 131 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Jan-15-2021 09:43:22 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042658
Page 132 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Jan-15-2021 09:43:22 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042659
Page 133 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Jan-15-2021 09:43:22 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042660
Page 134 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Jan-15-2021 09:43:22 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042661
Page 135 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042662
Page 136 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Jan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042663
Page 137 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Jan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042664
Page 138 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Jan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042665
Page 139 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Jan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042666
Page 140 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.aJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042667
Page 141 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.aJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042668
Page 142 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.aJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042669
Page 143 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.aJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042670
Page 144 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.bJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042671
Page 145 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.bJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042672
Page 146 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.bJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042673
Page 147 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.bJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042674
Page 148 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.cJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042675
Page 149 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.cJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042676
Page 150 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.cJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042677
Page 151 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.cJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042678
Page 152 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.dJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042679
Page 153 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.dJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042680
Page 154 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.dJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042681
Page 155 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.dJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042682
Page 156 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.eJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042683
Page 157 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.eJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042684
Page 158 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.eJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042685
Page 159 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.eJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042686
Page 160 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.fJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042687
Page 161 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.fJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042688
Page 162 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.fJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042689
Page 163 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.fJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042690
Page 164 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.gJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042691
Page 165 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.gJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042692
Page 166 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.gJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042693
Page 167 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.gJan-15-2021 09:43:44 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042694
Page 168 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042695
Page 169 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Jan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042696
Page 170 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Jan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042697
Page 171 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Jan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042698
Page 172 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Jan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042699
Page 173 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.aJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042700
Page 174 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.aJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042701
Page 175 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.aJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042702
Page 176 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.aJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042703
Page 177 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.bJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042704
Page 178 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.bJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042705
Page 179 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.bJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042706
Page 180 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.bJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042707
Page 181 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.cJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042708
Page 182 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.cJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042709
Page 183 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.cJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042710
Page 184 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.cJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042711
Page 185 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.dJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042712
Page 186 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.dJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042713
Page 187 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.dJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042714
Page 188 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.dJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042715
Page 189 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.eJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042716
Page 190 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.eJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042717
Page 191 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.eJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042718
Page 192 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.eJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042719
Page 193 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.fJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042720
Page 194 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.fJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042721
Page 195 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.fJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042722
Page 196 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.fJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042723
Page 197 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.gJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042724
Page 198 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.gJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042725
Page 199 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.gJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042726
Page 200 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.gJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042727
Page 201 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.hJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042728
Page 202 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.hJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042729
Page 203 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.hJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042730
Page 204 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.hJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042731
Page 205 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.iJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042732
Page 206 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.iJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042733
Page 207 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.iJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042734
Page 208 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.iJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042735
Page 209 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.jJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042736
Page 210 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.jJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042737
Page 211 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.jJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042738
Page 212 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5.jJan-15-2021 09:44:02 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042739
Page 213 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormJan-15-2021 09:44:19 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042740
Page 214 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Jan-15-2021 09:44:19 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042741
Page 215 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2.aJan-15-2021 09:44:19 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042742
Page 216 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2.aJan-15-2021 09:44:19 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042743
Page 217 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2.aJan-15-2021 09:44:19 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042744
Page 218 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2.aJan-15-2021 09:44:19 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042745
Page 219 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: VITAL SIGNS - PULSE OX ROOM AIR -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormJan-15-2021 09:44:33 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042746
Page 220 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: VITAL SIGNS - PULSE OX ROOM AIR -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Jan-15-2021 09:44:33 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042747
Page 221 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: VITAL SIGNS - PULSE OX ROOM AIR -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2.aJan-15-2021 09:44:33 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042748
Page 222 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormJan-15-2021 09:44:51 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042749
Page 223 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Jan-15-2021 09:44:51 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042750
Page 224 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Jan-15-2021 09:44:51 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042751
Page 225 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Jan-15-2021 09:44:51 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042752
Page 226 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormJan-15-2021 09:45:06 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042753
Page 227 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Jan-15-2021 09:45:06 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042754
Page 228 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Jan-15-2021 09:45:06 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042755
Page 229 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Jan-15-2021 09:45:06 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042756
Page 230 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Jan-15-2021 09:45:06 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042757
Page 231 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5Jan-15-2021 09:45:06 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042758
Page 232 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6Jan-15-2021 09:45:06 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042759
Page 233 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormJan-15-2021 09:45:20 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042760
Page 234 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Jan-15-2021 09:45:20 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042761
Page 235 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Jan-15-2021 09:45:20 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042762
Page 236 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Jan-15-2021 09:45:20 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042763
Page 237 of 473
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Jan-15-2021 09:45:20 (UTC-05:00)
Eastern Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042764
Page 238 of 473
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6Feb-15-2021 07:11:42 (UTC-05:00)
Eastern Time (US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042765
Page 239 of 473
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormJan-21-2021 11:20:33 (UTC-05:00)
Eastern Time (US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042766
Page 240 of 473
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
Madison
Murphy N/A Feb-09-2021 15:36:16 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward
Walsh Approved Jan-21-2021 21:28:27 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EdwardWalsh, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
Lauren
Mitchell N/A Dec-14-2020 10:58:05 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042767
Page 241 of 473
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Affidavit:
N/A
Edward
Walsh Approved Oct-20-2020 19:50:25 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EdwardWalsh, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
Marie
Francis N/A Oct-07-2020 09:23:51 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward
Walsh Approved Sep-11-2020 14:29:42 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042768
Page 242 of 473
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Affidavit:
By my dated signature below, I, EdwardWalsh, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042769
Page 243 of 473
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-12-2020
10:03:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-12-2020
10:03:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042770
Page 244 of 473
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-12-2020
10:03:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Aug/12/2020Initial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042771
Page 245 of 473
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-12-2020
10:03:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10031186Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-12-2020
10:03:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1987Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-12-2020
10:04:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (6)
FDA-CBER-2021-5683-0042772
Page 246 of 473
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-12-2020
10:04:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-12-2020
10:04:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
WHITEInitial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042773
Page 247 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-12-2020
10:07:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
Aug/12/2020Initial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042774
Page 248 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-12-2020
10:08:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
Aug/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-12-2020
10:08:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-12-2020
10:08:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042775
Page 249 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.a
Date Location User Value Reason
Aug-12-2020
10:09:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:narcolep
sy
Start Date: UNK/U
NK/201
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-12-2020
10:09:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020
10:09:05
(UTC-05:00)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
narcolepsyInitial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042776
Page 250 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Eastern Time (US
& Canada)
1.a Start Date:
Date Location User Value Reason
Aug-12-2020
10:09:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-12-2020
10:09:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-12-2020
10:09:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:hypothyr
oidInitial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042777
Page 251 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Start Date: UNK/U
NK/200
9
Ongoing: YES
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042778
Page 252 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.b Line/MH Number:
Date Location User Value Reason
Aug-12-2020
10:09:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020
10:09:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
hypothyroidInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-12-2020
10:09:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
UNK/UNK/2009Initial Entry
1.b Ongoing:
Date Location User Value Reason
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042779
Page 253 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-12-2020
10:09:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Feb-16-2021
14:01:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:obesity
Start Date: UNK/U
NK/202
0
Ongoing: YESInitial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042780
Page 254 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.c Line/MH Number:
Date Location User Value Reason
Feb-16-2021
14:01:43
(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
Feb-16-2021
14:01:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
obesityInitial Entry
1.c Start Date:
Date Location User Value Reason
Feb-22-2021
15:16:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Gbenga
Akinkunmi
(pfe.akinkg)Query 1: Closed Response
satisfies query
Feb-22-2021
08:28:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Megan Helf
(pfe.ahelf)Query 1: Answered Yes prior to
vaccination
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042781
Page 255 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Feb-16-2021
23:55:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 1: Reissued:
OpenedDM: Please
confirm
historical
condition is
prior to
vaccination or
else clarify.
Thank you.
Feb-16-2021
14:02:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Query 1: Answered Original value
is correct
Feb-16-2021
14:01:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is
after or equal
to the first
vaccination
date 12/Aug
/2020. Please
review and
update as
appropriate.
Feb-16-2021
14:01:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
UNK/UNK/2020Initial Entry
1.c Ongoing:
Date Location User Value Reason
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042782
Page 256 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Feb-16-2021
14:01:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
YESInitial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042783
Page 257 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Aug-12-2020
10:15:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
Aug/12/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-13-2020
03:28:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Nancy
Vedamuthu
(pfe.vedamn)Query 1: Closed Response
satisfies
query
Aug-12-2020
10:31:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Megan Helf
(pfe.ahelf)Query 1: Answered Original
value is
correct
Aug-12-2020
10:15:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Weight 315 is
outside of
Normal
Range 25 -
136 for kg or
50 - 300 for
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042784
Page 258 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
lb.
Aug-12-2020
10:15:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
315.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-12-2020
10:15:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-12-2020
10:15:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
72.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-12-2020
10:15:20
(UTC-05:00)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
inInitial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042785
Page 259 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Eastern Time (US
& Canada)
6. Body Mass Index:
Date Location User Value Reason
Aug-12-2020
10:15:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
42.7Initial Entry
7.a
Date Location User Value Reason
Aug-12-2020
10:15:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
Record Ide
ntifier::1
Temperatu
re:97.4
Temperatu
re Unit:F
Temperatu
re Location
::FORE
HEADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-12-2020
10:15:20ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
1Initial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042786
Page 260 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00)
Eastern Time (US
& Canada)
7.a Temperature:
Date Location User Value Reason
Aug-12-2020
10:15:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
97.4Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-12-2020
10:15:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-12-2020
10:15:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
FOREHEADInitial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042787
Page 261 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-12-2020
10:14:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
Aug/12/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-12-2020
10:14:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
47001Initial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042788
Page 262 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-12-2020
10:09:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-12-2020
10:09:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-12-2020
15:51:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-12-2020
10:09:54ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042789
Page 263 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-12-2020
10:09:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
YES
Date of Collection
:
Aug/12/2020Initial Entry
5.a
Date Location User Value Reason
Aug-12-2020
15:51:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe.mmurphy)Data Entry:
Sample I
D:BP579
GInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-12-2020
15:51:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe.mmurphy)Data Entry:
BP579GInitial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042790
Page 264 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.b
Date Location User Value Reason
Aug-12-2020
15:51:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe.mmurphy)Data Entry:
Sample I
D:BP579
HInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-12-2020
15:51:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe.mmurphy)Data Entry:
BP579HInitial Entry
5.c
Date Location User Value Reason
Aug-12-2020
15:51:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe.mmurphy)Data Entry:
Sample ID
:BP579
JInitial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042791
Page 265 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.c Sample ID
Date Location User Value Reason
Aug-12-2020
15:51:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe.mmurphy)Data Entry:
BP579JInitial Entry
5.d
Date Location User Value Reason
Aug-12-2020
15:58:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe.mmurphy)Data Entry:
Sample I
D:BKDZ3
XInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-12-2020
15:58:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe.mmurphy)Data Entry:
BKDZ3XInitial Entry
5.e
Date Location User Value Reason
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042792
Page 266 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-12-2020
15:58:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe.mmurphy)Data Entry:
Sample I
D:BKDZ3
YInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-12-2020
15:58:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe.mmurphy)Data Entry:
BKDZ3YInitial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042793
Page 267 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-12-2020
10:10:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-12-2020
10:10:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-12-2020
16:03:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-12-2020
10:10:04ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042794
Page 268 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-12-2020
10:10:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
YES
Date of Collection
:
Aug/12/2020Initial Entry
5.a
Date Location User Value Reason
Aug-12-2020
16:03:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe.mmurphy)Data Entry:
Sample I
D:BP57B
6Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-12-2020
16:03:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe.mmurphy)Data Entry:
BP57B6Initial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042795
Page 269 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-12-2020
10:53:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-12-2020
10:53:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-12-2020
10:53:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042796
Page 270 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-12-2020
10:53:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
Aug/12/2020 10:03Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-12-2020
10:53:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-12-2020
10:53:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-12-2020
10:53:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042797
Page 271 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-12-2020
10:53:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-12-2020
10:53:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
YESInitial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042798
Page 272 of 473
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-12-2020
10:10:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
YES - REACTOGE
NICITY E-DIARY
COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042799
Page 273 of 473
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-03-2020
09:19:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
Sep/3/2020Initial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042800
Page 274 of 473
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
09:20:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-03-2020
09:20:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
Symptom:: F
E
V
E
R
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042801
Page 275 of 473
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-03-2020
09:20:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
09:20:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-03-2020
09:20:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
090177e196ae3d75\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0042802
Page 276 of 473
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester
General Hospital
Subject No: 10031186 Subject Initials: ---
Generated By: pfe
…[truncated]