CRFs for site 1055

Document text

Page 1 of 249
***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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS ST A
GE 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 COHORTS090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000342
Page 2 of 249
***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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent W
as: OBTAINED
Date Written Consent Obtained
Aug/7/2020090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000343
Page 3 of 249
***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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1. Subject ID [10551006]
2.Birth Date: /1955
3.
Sex: FEMALE
4. Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5. Race: (Check X all that apply): WHITE
6. Racial Designation:090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
(b) (6)
FDA-CBER-2021-5683-0000344
Page 4 of 249
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of V
isit Aug/7/2020
2. Erroneous Visit090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000345
Page 5 of 249
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of ExclusionCriterion MetNot Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000346
Page 6 of 249
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/7/2020
2.
Phase of Disposition: SCREENING
3. Status: COMPLETED
4. Specify Status: [ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000347
Page 7 of 249
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/DrugAllergies:[Keratoconus, bilateral eyes]
Start Date: UNK/UNK/1969
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[Seasonal allergies]
Start Date: UNK/UNK/1958
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[Benign Pulmonary Granulomas]
Start Date: UNK/UNK/2009
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[Osteoarthritis, bilateral thumbs]
Start Date: UNK/UNK/2002
Ongoing: YES090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000348
Page 8 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/DrugAllergies:[Hyperlipidemia]
Start Date: Sep/UNK/2018
Ongoing: YES
1.f
Line/MH Number: [6]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[Intermittent urinary tract infections
]
Start Date: UNK/UNK/1973
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/DrugAllergies:[Rosacea]
Start Date: UNK/UNK/2010
Ongoing: YES
1.hLine/MH Number: [8]Disease/Syndrome/Surgery
/Non-Drug Allergies/DrugAllergies:[GERD]
Start Date: Sep/UNK/1993
Ongoing: YES
1.iLine/MH Number: [9]Disease/Syndrome/Surgery
/Non-Drug Allergies/DrugAllergies:[Lactose intolerance]
Start Date: UNK/UNK/1993
Ongoing: YES090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000349
Page 9 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/DrugAllergies:[Hypothyroid]
Start Date: Sep/UNK/1988
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[Post-menopausal]
Start Date: Dec/UNK/2010
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery/Non-Drug Allergies/DrugAllergies:[Sulfite allergy]
Start Date: UNK/UNK/1999
Ongoing: YES090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000350
Page 10 of 249
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/7/2020
2.
Weight: [61.0]
3. Unit: kg
4. Height: [158.0]
5. Unit: cm
6. Body Mass Index: [24.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: FOREHEAD090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000351
Page 11 of 249
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.
Lab Sub-Panel:
3. Collection Date: Not Applicable
//Comments
4. Laboratory Name and Address
(Derived)[ ]
5.Specimen T
ype:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000352
Page 12 of 249
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/7/2020
2.
Randomization Number: [223587]
3. Randomization Group: [ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000353
Page 13 of 249
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.
Sample Type SERUM
3. Sample Collected? YES
Date of Collection:
Aug/7/2020
4. If no sample was collected or
sample was not collected accordingto protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP6S51]
5.bSample ID [BP6S52]
5.cSample ID [BP6S53]
5.dSample ID [BPFTRZ]
5.eSample ID [BPFTS0]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000354
Page 14 of 249
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.
Sample Type NASAL_SWAB
3. Sample Collected? YES
Date of Collection:
Aug/7/2020
4. If no sample was collected or
sample was not collected accordingto protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP6S4Z]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000355
Page 15 of 249
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: V ACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.W
as there a temporary delay of
vaccination?NO
2. Treatment Name [BLINDED THERAPY]
3. Formulation: INJECTION
4. Dose Date Time: Aug/7/2020 10:31
5. Anatomical Location: DELTOID MUSCLE
6. Body Side: LEFT
7. Route: INTRAMUSCULAR
8. Actual Dose: [ ]
9. Unit:
10. Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERV A TION PERIOD
11. Was the subject observed for at
least the protocol specified
observation period afterinvestigational productadministration?YES090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000356
Page 16 of 249
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIAR
Y COLLECTED FOR THIS SUBJECT090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000357
Page 17 of 249
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of V
isit Aug/26/2020
2. Erroneous Visit090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000358
Page 18 of 249
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.W
ere medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptomspresent on the last day theSubject Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptomspresent on the last day theSubject Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptomspresent on the last day theSubject Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptomspresent on the last day theSubject Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptomspresent on the last day theSubject Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptomspresent on the last day theSubject Diary was completed?NO090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000359
Page 19 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day theSubject Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptomspresent on the last day theSubject Diary was completed?NO
3. Injection Site Location: DELTOID MUSCLE
4. Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day theSubject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day theSubject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day theSubject Diary was completed?NO090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000360
Page 20 of 249
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
Vital Signs Details
2.aRecord Identifier: 1
T
emperature: [36.2]
Unit: C
Temperature Location: FOREHEAD090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000361
Page 21 of 249
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2. Lab Sub-Panel: Not Applicable Comments
3. Collection Date: Not Applicable
//Comments
4. Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5. Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable[ ] Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000362
Page 22 of 249
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.
Sample Type NASAL_SWAB
3. Sample Collected? YES
Date of Collection:
Aug/26/2020
4. If no sample was collected or
sample was not collected accordingto protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP6RXN]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000363
Page 23 of 249
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.W
as there a temporary delay of
vaccination?NO
2. Treatment Name [BLINDED THERAPY]
3. Formulation: INJECTION
4. Dose Date Time: Aug/26/2020 10:08
5. Anatomical Location: DELTOID MUSCLE
6. Body Side: LEFT
7. Route: INTRAMUSCULAR
8. Actual Dose: [ ]
9. Unit:
10. Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERV A TION PERIOD
11. Was the subject observed for at
least the protocol specified
observation period afterinvestigational productadministration?YES090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000364
Page 24 of 249
***Confidential*** 
Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of V
isit Sep/24/2020
2. Erroneous Visit090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000365
Page 25 of 249
***Confidential*** 
Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: V ACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.W
ere medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptomspresent on the last day theSubject Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptomspresent on the last day theSubject Diary was completed?YES
Ongoing?NO
Stop Date:Sep/6/2020
2.cSymptom: HEADACHE
Were fever or systemic symptomspresent on the last day theSubject Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptomspresent on the last day theSubject Diary was completed?YES
Ongoing?NO
Stop Date:Sep/6/2020
2.eSymptom: VOMITING
Were fever or systemic symptomspresent on the last day theSubject Diary was completed?NO090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000366
Page 26 of 249
***Confidential***Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: V ACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day theSubject Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptomspresent on the last day theSubject Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptomspresent on the last day theSubject Diary was completed?NO
3. Injection Site Location: DELTOID MUSCLE
4. Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day theSubject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day theSubject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day theSubject Diary was completed?NO090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000367
Page 27 of 249
***Confidential*** 
Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.
Sample Type SERUM
3. Sample Collected? YES
Date of Collection:
Sep/24/2020
4. If no sample was collected or
sample was not collected accordingto protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPV09L]
5.bSample ID [BPV09M]
5.cSample ID [BPFTKC]
5.dSample ID [BPFTKD]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000368
Page 28 of 249
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1. Date of Visit //
2. Erroneous Visit
COVID-19 Illness Visit
3. COVID-19 Illness Visit:090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000369
Page 29 of 249
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Signs and Symptoms
1. Date of Assessment: //
2. Date of First Symptom Started: //3. Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000370
Page 30 of 249
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1. Data Origin
2. Sample Type3. Sample Collected?4. If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000371
Page 31 of 249
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1. Data Origin
2. Sample Type3. Sample Collected?4. If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000372
Page 32 of 249
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
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?090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000373
Page 33 of 249
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1. Category of Clinical Event:
2. Was a diagnosis obtained for
Potential COVID-19 Illness?
3. Toxicity Grade:090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000374
Page 34 of 249
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_CONV A - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONV ALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1. Date of Visit //
2. Erroneous Visit
COVID-19 Illness Visit
3. COVID-19 Illness Visit:090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000375
Page 35 of 249
***Confidential*** 
Header Text: c4591001
Visit: POT_COVID_CONV A - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1. Data Origin
2. Sample Type3. Sample Collected?4. If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000376
Page 36 of 249
***Confidential*** 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000377
Page 37 of 249
***Confidential*** 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1. Assessments090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000378
Page 38 of 249
***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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death:Sep/24/2020
2.
Phase of Disposition: V ACCINATION
3. Status: COMPLETED
4. Specify Status: [ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000379
Page 39 of 249
***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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1. Date of
Completion/Discontinuation/Death
://
2. Phase of Disposition:
3. Status:4. Specify Status: [ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000380
Page 40 of 249
***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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1. Date of Visit //
2. Erroneous Visit
COVID-19 Repeat Swab
3. COVID-19 Repeat Swab:090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000381
Page 41 of 249
***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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1. Data Origin
2. Sample Type3. Sample Collected?4. If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000382
Page 42 of 249
***Confidential*** 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
# CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
 1.ADVERSE EV
ENT 1 Urinary Tract Infe
ction Sep/1/2020 22:01 NO
End Date Time:
Sep/6/2020 08:00
 Repeating
Pages
 2.ADVERSE EVENT 2 Injection site pain 
 Dec/22/2020 09
:02 NO
End Date Time:
Dec/24/2020 08:00
 Repeating
Pages
 3.ADVERSE EVENT 3 injection site pain 
 Jan/11/2021 14:
00 NO
End Date Time:
Jan/12/2021 18:00
 Repeating
Pages
 4.ADVERSE EVENT 4 chills Jan/11/2021 19:
00 NO
End Date Time:
Jan/11/2021 20:00
 Repeating
Pages
 5.ADVERSE EVENT 5 fatigue Jan/12/2021 12:00 NO
End Date Time:
Jan/12/2021 15:00
 Repeating
Pages
 6.ADVERSE EVENT 6 lymph node swelling Jan/12/2021 12:00 NO
End Date Time:
Jan/12/2021 15:00
 Repeating
Pages090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000383
Page 43 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
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)[Urinary Tract Infection]
4. Start Date Time: Sep/1/2020 22:01
5. Is the adverse event still ongoing? NO
End Date Time:Sep/6/2020 08:00
6. Toxicity Grade: 1
7. Is the adverse event serious?
If Yes, NOTIFY PFIZERIMMEDIATELY .
Fatal; Life-threatening; Inpatient
hospitalization or prolongation ofexisting hospitalization; Persistentor significant disability/incapacity;Congenital anomaly/birth defect;Important medical event (i.e. mayjeopardize subject and may requiremedical/surgical intervention toprevent above outcomes).NO
8. Is this adverse event the result of a
study Medication Error?If Yes, record the type ofmedication error on the MedicationError 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:[Bacterial Infection]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000384
Page 44 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
10. Latest Action Taken with Study
Treatment:NOT APPLICABLE
11. Was a Concomitant Medication
given?YES
12. Was a Non-Drug Treatment given? NO
13. What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14. Did the adverse event cause the
subject to be discontinued from the
study?NO
15. Serious Adverse Event Number:
For Pfizer Use Only[ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000385
Page 45 of 249
***Confidential*** 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.
AE ID: [2]
3. Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Injection site pain]
4. Start Date Time: Dec/22/2020 09:02
5. Is the adverse event still ongoing? NO
End Date Time:Dec/24/2020 08:00
6. Toxicity Grade: 2
7. Is the adverse event serious?
If Yes, NOTIFY PFIZERIMMEDIATELY .
Fatal; Life-threatening; Inpatient
hospitalization or prolongation ofexisting hospitalization; Persistentor significant disability/incapacity;Congenital anomaly/birth defect;Important medical event (i.e. mayjeopardize subject and may requiremedical/surgical intervention toprevent above outcomes).NO
8. Is this adverse event the result of a
study Medication Error?If Yes, record the type ofmedication error on the MedicationError Log.NO
9. Is this event related to study
treatment:RELATED
10. Latest Action Taken with Study
Treatment:NOT APPLICABLE090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000386
Page 46 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
11. Was a Concomitant Medication
given?YES
12. Was a Non-Drug Treatment given? NO
13. What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14. Did the adverse event cause the
subject to be discontinued from the
study?NO
15. Serious Adverse Event Number:
For Pfizer Use Only[ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000387
Page 47 of 249
***Confidential*** 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.
AE ID: [3]
3. Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[injection site pain]
4. Start Date Time: Jan/11/2021 14:00
5. Is the adverse event still ongoing? NO
End Date Time:Jan/12/2021 18:00
6. Toxicity Grade: 1
7. Is the adverse event serious?
If Yes, NOTIFY PFIZERIMMEDIATELY .
Fatal; Life-threatening; Inpatient
hospitalization or prolongation ofexisting hospitalization; Persistentor significant disability/incapacity;Congenital anomaly/birth defect;Important medical event (i.e. mayjeopardize subject and may requiremedical/surgical intervention toprevent above outcomes).NO
8. Is this adverse event the result of a
study Medication Error?If Yes, record the type ofmedication error on the MedicationError Log.NO
9. Is this event related to study
treatment:RELATED
10. Latest Action Taken with Study
Treatment:NOT APPLICABLE090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000388
Page 48 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
11. Was a Concomitant Medication
given?YES
12. Was a Non-Drug Treatment given? NO
13. What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14. Did the adverse event cause the
subject to be discontinued from the
study?NO
15. Serious Adverse Event Number:
For Pfizer Use Only[ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000389
Page 49 of 249
***Confidential*** 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.
AE ID: [4]
3. Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[chills]
4. Start Date Time: Jan/11/2021 19:00
5. Is the adverse event still ongoing? NO
End Date Time:Jan/11/2021 20:00
6. Toxicity Grade: 1
7. Is the adverse event serious?
If Yes, NOTIFY PFIZERIMMEDIATELY .
Fatal; Life-threatening; Inpatient
hospitalization or prolongation ofexisting hospitalization; Persistentor significant disability/incapacity;Congenital anomaly/birth defect;Important medical event (i.e. mayjeopardize subject and may requiremedical/surgical intervention toprevent above outcomes).NO
8. Is this adverse event the result of a
study Medication Error?If Yes, record the type ofmedication error on the MedicationError Log.NO
9. Is this event related to study
treatment:RELATED
10. Latest Action Taken with Study
Treatment:NOT APPLICABLE090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000390
Page 50 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
11. Was a Concomitant Medication
given?NO
12. Was a Non-Drug Treatment given? NO
13. What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14. Did the adverse event cause the
subject to be discontinued from the
study?NO
15. Serious Adverse Event Number:
For Pfizer Use Only[ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000391
Page 51 of 249
***Confidential*** 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.
AE ID: [5]
3. Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[fatigue]
4. Start Date Time: Jan/12/2021 12:00
5. Is the adverse event still ongoing? NO
End Date Time:Jan/12/2021 15:00
6. Toxicity Grade: 1
7. Is the adverse event serious?
If Yes, NOTIFY PFIZERIMMEDIATELY .
Fatal; Life-threatening; Inpatient
hospitalization or prolongation ofexisting hospitalization; Persistentor significant disability/incapacity;Congenital anomaly/birth defect;Important medical event (i.e. mayjeopardize subject and may requiremedical/surgical intervention toprevent above outcomes).NO
8. Is this adverse event the result of a
study Medication Error?If Yes, record the type ofmedication error on the MedicationError Log.NO
9. Is this event related to study
treatment:RELATED
10. Latest Action Taken with Study
Treatment:NOT APPLICABLE090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000392
Page 52 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
11. Was a Concomitant Medication
given?NO
12. Was a Non-Drug Treatment given? NO
13. What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14. Did the adverse event cause the
subject to be discontinued from the
study?NO
15. Serious Adverse Event Number:
For Pfizer Use Only[ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000393
Page 53 of 249
***Confidential*** 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.
AE ID: [6]
3. Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[lymph node swelling]
4. Start Date Time: Jan/12/2021 12:00
5. Is the adverse event still ongoing? NO
End Date Time:Jan/12/2021 15:00
6. Toxicity Grade: 1
7. Is the adverse event serious?
If Yes, NOTIFY PFIZERIMMEDIATELY .
Fatal; Life-threatening; Inpatient
hospitalization or prolongation ofexisting hospitalization; Persistentor significant disability/incapacity;Congenital anomaly/birth defect;Important medical event (i.e. mayjeopardize subject and may requiremedical/surgical intervention toprevent above outcomes).NO
8. Is this adverse event the result of a
study Medication Error?If Yes, record the type ofmedication error on the MedicationError Log.NO
9. Is this event related to study
treatment:RELATED
10. Latest Action Taken with Study
Treatment:NOT APPLICABLE090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000394
Page 54 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
11. Was a Concomitant Medication
given?NO
12. Was a Non-Drug Treatment given? NO
13. What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14. Did the adverse event cause the
subject to be discontinued from the
study?NO
15. Serious Adverse Event Number:
For Pfizer Use Only[ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000395
Page 55 of 249
***Confidential*** 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.     
Repeating
Pages090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000396
Page 56 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
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 adverseevents?
10. Serious Adverse Event Number:
For Pfizer Use Only[ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000397
Page 57 of 249
***Confidential*** 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
V ACCINATIONS
Form Version: 22-Apr-2020 21:03Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart Da
teForm Instanc
e
 1.1 V ACCINATIONS NO Influenza Vacci
ne Sep/20/2
020 Repeating
Pages090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000398
Page 58 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
V ACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier?
[1]
2. Category: V ACCINATIONS
3. Concomitant Medications
Pre-specified:NO
4. Medication:
Provide the complete generic drug
name (including salt form, whereapplicable). Where generic name isunknown, enter the full trade orproprietary name. Includeclarifying information in theMedication text (e.g., Ingredient(s),route, use, formulation).[Influenza Vaccine]
5. Date: Sep/20/2020090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000399
Page 59 of 249
***Confidential*** 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.     
Repeating
Pages090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000400
Page 60 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier?
[ ]
2. Category:
3. Concomitant Medications
Pre-specified:
4. Medication:
Provide the complete generic drug
name (including salt form, whereapplicable). Where generic name isunknown, enter the full trade orproprietary name. Includeclarifying information in theMedication text (e.g., Ingredient(s),route, use, formulation).[ ]
5. Dose: [ ]
6. Dose Unit:
7. Dose Frequency:8. Route:9. Start Date: //
10. Ongoing?090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000401
Page 61 of 249
***Confidential*** 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.     
Repeating Pages090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000402
Page 62 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
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?090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000403
Page 63 of 249
***Confidential*** 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.   
Repeating Pages090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000404
Page 64 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Transfusion Type:
2.Date of Transfusion: //090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000405
Page 65 of 249
***Confidential*** 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000406
Page 66 of 249
***Confidential*** 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1. Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:Temperature Location:090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000407
Page 67 of 249
***Confidential*** 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Lab Urinalysis
1. Lab Panel:
2. Lab Sub-Panel:3. Collection Date: //
4. Laboratory Name and Address
(Derived)[ ]
5. Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:Not Done:090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000408
Page 68 of 249
***Confidential*** 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: V ACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Vaccination
1. Was there a temporary delay of
vaccination?
2. Treatment Name [ ]
3. Formulation:
4. Dose Date Time: //
5. Anatomical Location:6. Body Side:7. Route:8. Actual Dose: [ ]
9. Unit:
10. Timeframe Subject Was Observed
11. Was the subject observed for at
least the protocol specified
observation period afterinvestigational productadministration?090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000409
Page 69 of 249
***Confidential*** 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1. Contact Type:
2. Was contact made?3. Comments: [ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000410
Page 70 of 249
***Confidential*** 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1. Contact Type:
2. Was contact made?3. Comments: [ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000411
Page 71 of 249
***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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of V
isit Dec/16/2020
2. Erroneous Visit090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000412
Page 72 of 249
***Confidential*** 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER V ACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return forV
accination 3?Participant is willing to return for Vaccination 3
Participant is:eligible per local/national recommendations and confirmed to have receivedonly placebo at Vaccination 1/2090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000413
Page 73 of 249
***Confidential*** 
Header Text: c4591001
Visit: V101_V AX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of V
isit Dec/22/2020
2. Erroneous Visit090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000414
Page 74 of 249
***Confidential*** 
Header Text: c4591001
Visit: V101_V AX3 Form: INFORMED CONSENT - FURTHER V ACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent W
as: OBTAINED
Date Written Consent Obtained
Dec/22/2020090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000415
Page 75 of 249
***Confidential*** 
Header Text: c4591001
Visit: V101_V AX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
V ACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of ExclusionCriterion MetNot Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000416
Page 76 of 249
***Confidential*** 
Header Text: c4591001
Visit: V101_V AX3 Form: DISPOSITION - SCREENING FOR FURTHER V ACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death:Dec/22/2020
2.
Phase of Disposition: REPEAT SCREENING 1
3. Status: COMPLETED
4. Specify Status: [ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000417
Page 77 of 249
***Confidential*** 
Header Text: c4591001
Visit: V101_V AX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2. Lab Sub-Panel: Not Applicable Comments
3. Collection Date: Not Applicable
//Comments
4. Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5. Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable[ ] Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000418
Page 78 of 249
***Confidential*** 
Header Text: c4591001
Visit: V101_V AX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.
Sample Type SERUM
3. Sample Collected? YES
Date of Collection:
Dec/22/2020
4. If no sample was collected or
sample was not collected accordingto protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR2PLR]
5.bSample ID [BS3B2Z]
5.cSample ID [BS3B30]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000419
Page 79 of 249
***Confidential*** 
Header Text: c4591001
Visit: V101_V AX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.
Sample Type NASAL_SWAB
3. Sample Collected? YES
Date of Collection:
Dec/22/2020
4. If no sample was collected or
sample was not collected accordingto protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR2PLN]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000420
Page 80 of 249
***Confidential*** 
Header Text: c4591001
Visit: V101_V AX3 Form: V ACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.W
as there a temporary delay of
vaccination?NO
2. Treatment Name [BNT162b2]
3. Formulation: INJECTION
4. Dose Date Time: Dec/22/2020 09:02
5. Anatomical Location: DELTOID MUSCLE
6. Body Side: LEFT
7. Route: INTRAMUSCULAR
8. Actual Dose: [30.0]
9. Unit: ug
10. Timeframe Subject Was Observed 30 MINUTES
11. Was the subject observed for at
least the protocol specified
observation period afterinvestigational productadministration?YES090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000421
Page 81 of 249
***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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded :
Dec/17/2020
2. Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITION AL V ACCINATION090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000422
Page 82 of 249
***Confidential*** 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1. Withdrawal of Consent Date : //090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000423
Page 83 of 249
***Confidential*** 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1. Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000424
Page 84 of 249
***Confidential*** 
Header Text: c4591001
Visit: V102_V AX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of V
isit Jan/11/2021
2. Erroneous Visit090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000425
Page 85 of 249
***Confidential*** 
Header Text: c4591001
Visit: V102_V AX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2. Lab Sub-Panel: Not Applicable Comments
3. Collection Date: Not Applicable
//Comments
4. Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5. Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable[ ] Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000426
Page 86 of 249
***Confidential*** 
Header Text: c4591001
Visit: V102_V AX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.
Sample Type NASAL_SWAB
3. Sample Collected? YES
Date of Collection:
Jan/11/2021
4. If no sample was collected or
sample was not collected accordingto protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR2PNW]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000427
Page 87 of 249
***Confidential*** 
Header Text: c4591001
Visit: V102_V AX4 Form: V ACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.W
as there a temporary delay of
vaccination?NO
2. Treatment Name [BNT162b2]
3. Formulation: INJECTION
4. Dose Date Time: Jan/11/2021 09:00
5. Anatomical Location: DELTOID MUSCLE
6. Body Side: LEFT
7. Route: INTRAMUSCULAR
8. Actual Dose: [30.0]
9. Unit: ug
10. Timeframe Subject Was Observed 30 MINUTES
11. Was the subject observed for at
least the protocol specified
observation period afterinvestigational productadministration?YES090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000428
Page 88 of 249
***Confidential*** 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of V
isit Feb/12/2021
2. Erroneous Visit090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000429
Page 89 of 249
***Confidential*** 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Contact Outcome
1.Contact T
ype: TELEPHONE VISIT
2. Was contact made? YES
Date of Contact:
Feb/12/2021
3. Comments: [ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000430
Page 90 of 249
***Confidential*** 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000431
Page 91 of 249
***Confidential*** 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1. Contact Type:
2. Was contact made?3. Comments: [ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000432
Page 92 of 249
***Confidential*** 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000433
Page 93 of 249
***Confidential*** 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1. Contact Type:
2. Was contact made?3. Comments: [ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000434
Page 94 of 249
***Confidential*** 
Header Text: c4591001
Visit: FURTHER_V ACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death:Feb/12/2021
2.
Phase of Disposition: OPEN LABEL TREATMENT
3. Status: COMPLETED
4. Specify Status: [ ]090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000435
Page 95 of 249
***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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW
-UP
2. Subject Status Date Sep/24/2020090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000436
Page 96 of 249
***Confidential*** 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000437
Page 97 of 249
***Confidential*** 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Helen Stacey Approved Mar-01-2021 16:27:45 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HelenStacey, verify that all case report form pages accurately display the results of theexaminations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electron ic
signature is to be the legally binding equivalent of my handwritten signature.To this I do attest by supplying my user name and password and clicking the button marked Submit below.090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000438
Page 98 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
Form Aug-07-2020 12:25:25 (UTC-08:00) Pacific
Time (US & Canada)Julie Glazier(pfe.jglazier)Not applicable
Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000439
Page 99 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
3 Aug-07-2020 12:29:37 (UTC-08:00) Pacific
Time (US & Canada)Julie Glazier(pfe.jglazier)Not applicable
Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000440
Page 100 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
Form Aug-26-2020 11:42:40 (UTC-08:00) Pacific
Time (US & Canada)Megan Pastores
(pfe.mpastores)Not Applicable
Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000441
Page 101 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
1 Aug-26-2020 11:42:40 (UTC-08:00) Pacific
Time (US & Canada)Megan Pastores
(pfempastores)Not Applicable
Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000442
Page 102 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
2 Aug-26-2020 11:42:40 (UTC-08:00) Pacific
Time (US & Canada)Megan Pastores
(pfempastores)Not Applicable
Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000443
Page 103 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
3 Aug-26-2020 11:42:40 (UTC-08:00) Pacific
Time (US & Canada)Megan Pastores
(pfempastores)Not Applicable
Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000444
Page 104 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
4 Aug-26-2020 11:42:40 (UTC-08:00) Pacific
Time (US & Canada)Megan Pastores
(pfempastores)Not Applicable
Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000445
Page 105 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
5 Aug-26-2020 11:42:40 (UTC-08:00) Pacific
Time (US & Canada)Megan Pastores
(pfempastores)Not Applicable
Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000446
Page 106 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
6.a Aug-26-2020 11:42:40 (UTC-08:00) Pacific
Time (US & Canada)Megan Pastores
(pfempastores)Not Applicable
Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000447
Page 107 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
6.a Aug-26-2020 11:42:40 (UTC-08:00) Pacific
Time (US & Canada)Megan Pastores
(pfempastores)Not Applicable
Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000448
Page 108 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
6.a Aug-26-2020 11:42:40 (UTC-08:00) Pacific
Time (US & Canada)Megan Pastores
(pfempastores)Not Applicable
Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000449
Page 109 of 249
***Confidential***Header Text: c4591001
Visit: V101_V AX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
V ACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
Form Dec-22-2020 10:08:53 (UTC-08:00) Pacific
Time (US & Canada)Elle Billman(pfe.ebillman)Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000450
Page 110 of 249
***Confidential***Header Text: c4591001
Visit: V101_V AX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
Form Dec-22-2020 10:10:24 (UTC-08:00) Pacific
Time (US & Canada)Elle Billman(pfe.ebillman)Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000451
Page 111 of 249
***Confidential***Header Text: c4591001
Visit: V101_V AX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
1 Dec-22-2020 10:10:24 (UTC-08:00) Pacific
Time (US & Canada)Elle Billman(pfe.ebillman)Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000452
Page 112 of 249
***Confidential***Header Text: c4591001
Visit: V101_V AX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
2 Dec-22-2020 10:10:24 (UTC-08:00) Pacific
Time (US & Canada)Elle Billman(pfe.ebillman)Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000453
Page 113 of 249
***Confidential***Header Text: c4591001
Visit: V101_V AX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
3 Dec-22-2020 10:10:24 (UTC-08:00) Pacific
Time (US & Canada)Elle Billman(pfe.ebillman)Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000454
Page 114 of 249
***Confidential***Header Text: c4591001
Visit: V101_V AX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
4 Dec-22-2020 10:10:24 (UTC-08:00) Pacific
Time (US & Canada)Elle Billman(pfe.ebillman)Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000455
Page 115 of 249
***Confidential***Header Text: c4591001
Visit: V101_V AX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
5 Dec-22-2020 10:10:24 (UTC-08:00) Pacific
Time (US & Canada)Elle Billman(pfe.ebillman)Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000456
Page 116 of 249
***Confidential***Header Text: c4591001
Visit: V101_V AX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
6.a Dec-22-2020 10:10:24 (UTC-08:00) Pacific
Time (US & Canada)Elle Billman(pfe.ebillman)Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000457
Page 117 of 249
***Confidential***Header Text: c4591001
Visit: V101_V AX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
6.a Dec-22-2020 10:10:24 (UTC-08:00) Pacific
Time (US & Canada)Elle Billman(pfe.ebillman)Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000458
Page 118 of 249
***Confidential***Header Text: c4591001
Visit: V101_V AX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
6.a Dec-22-2020 10:10:24 (UTC-08:00) Pacific
Time (US & Canada)Elle Billman(pfe.ebillman)Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000459
Page 119 of 249
***Confidential***Header Text: c4591001
Visit: V102_V AX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
Form Jan-11-2021 10:00:10 (UTC-08:00) Pacific
Time (US & Canada)Elle Billman
(pfe.ebillman)Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000460
Page 120 of 249
***Confidential***Header Text: c4591001
Visit: V102_V AX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
1 J
an-11-2021 10:00:10 (UTC-08:00) Pacific Time
(US & Canada)Elle Billman
(pfe.ebillman)Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000461
Page 121 of 249
***Confidential***Header Text: c4591001
Visit: V102_V AX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
2 J
an-11-2021 10:00:10 (UTC-08:00) Pacific Time
(US & Canada)Elle Billman
(pfe.ebillman)Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000462
Page 122 of 249
***Confidential***Header Text: c4591001
Visit: V102_V AX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
3 J
an-11-2021 10:00:10 (UTC-08:00) Pacific Time
(US & Canada)Elle Billman
(pfe.ebillman)Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000463
Page 123 of 249
***Confidential***Header Text: c4591001
Visit: V102_V AX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
4 J
an-11-2021 10:00:10 (UTC-08:00) Pacific Time
(US & Canada)Elle Billman
(pfe.ebillman)Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000464
Page 124 of 249
***Confidential***Header Text: c4591001
Visit: V102_V AX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
5 J
an-11-2021 10:00:10 (UTC-08:00) Pacific Time
(US & Canada)Elle Billman
(pfe.ebillman)Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000465
Page 125 of 249
***Confidential***Header Text: c4591001
Visit: V102_V AX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
6.a Jan-11-2021 10:00:10 (UTC-08:00) Pacific Time
(US & Canada)Elle Billman
(pfe.ebillman)Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000466
Page 126 of 249
***Confidential***Header Text: c4591001
Visit: V102_V AX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
6.a Jan-11-2021 10:00:10 (UTC-08:00) Pacific Time
(US & Canada)Elle Billman
(pfe.ebillman)Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000467
Page 127 of 249
***Confidential***Header Text: c4591001
Visit: V102_V AX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Item Date User Comment
6.a Jan-11-2021 10:00:10 (UTC-08:00) Pacific Time
(US & Canada)Elle Billman
(pfe.ebillman)Not Applicable090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000468
Page 128 of 249
***Confidential***Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Helen Stacey Approved Mar-01-2021 16:27:45 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HelenStacey, verify that all case report form pages accurately display the results of theexaminations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electron ic
signature is to be the legally binding equivalent of my handwritten signature.To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Megan Pastores N/A Mar-01-2021 15:21:53 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signaturesinvalidated
Affidavit:N/A
Helen Stacey Approved Feb-17-2021 07:51:38 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:By my dated signature below, I, HelenStacey, verify that all case report form pages accurately display the results of theexaminations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electron ic
signature is to be the legally binding equivalent of my handwritten signature.To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Julie Glazier N/A Feb-16-2021 16:44:04 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signaturesinvalidated
Affidavit:N/A090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000469
Page 129 of 249
***Confidential***Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Helen Stacey Approved Feb-12-2021 15:40:02 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HelenStacey, verify that all case report form pages accurately display the results of theexaminations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electron ic
signature is to be the legally binding equivalent of my handwritten signature.To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Elle Billman N/A Feb-12-2021 10:55:39 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signaturesinvalidated
Affidavit:N/A
Helen Stacey Approved Jan-20-2021 16:25:48 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:By my dated signature below, I, HelenStacey, verify that all case report form pages accurately display the results of theexaminations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electron ic
signature is to be the legally binding equivalent of my handwritten signature.To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Elle Billman N/A Dec-18-2020 15:14:48 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signaturesinvalidated
Affidavit:N/A
Helen Stacey Approved Nov-02-2020 13:17:04 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000470
Page 130 of 249
***Confidential***Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, HelenStacey, verify that all case report form pages accurately display the results of theexaminations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electron ic
signature is to be the legally binding equivalent of my handwritten signature.To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Julie Glazier N/A Nov-02-2020 11:49:05 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signaturesinvalidated
Affidavit:N/A
Helen Stacey Approved Oct-12-2020 08:40:16 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:By my dated signature below, I, HelenStacey, verify that all case report form pages accurately display the results of theexaminations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electron ic
signature is to be the legally binding equivalent of my handwritten signature.To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Megan Pastores N/A Sep-24-2020 10:16:54 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signaturesinvalidated
Affidavit:N/A
Helen Stacey Approved Sep-10-2020 09:53:32 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000471
Page 131 of 249
***Confidential***Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, HelenStacey, verify that all case report form pages accurately display the results of theexaminations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electron ic
signature is to be the legally binding equivalent of my handwritten signature.To this I do attest by supplying my user name and password and clicking the button marked Submit below.090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000472
Page 132 of 249
***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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User
Value Reason
Aug-07-2020 12:24:18
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User
Value Reason
Aug-07-2020 12:24:18
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:STAGE 3 COHORTSInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000473
Page 133 of 249
***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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User
Value Reason
Aug-07-2020 12:24:27
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:OBTAINED
Date Written Consent Obtained
Aug/7/2020Initial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000474
Page 134 of 249
***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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User V
alue Reason
Aug-07-2020 12:24:09
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:10551006Item copied fromprevious form
2. Birth Date:
Date Location User V
alue Reason
Aug-07-2020 12:24:07
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
/1955Enrollment Entry
3. Sex:
Date Location User V
alue Reason
Aug-07-2020 12:24:55
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:FEMALEInitial Entry
4. Ethnicity:
Date Location User V
alue Reason
Aug-07-2020 12:24:55
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User V
alue Reason
Aug-07-2020 12:24:55
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:WHITEInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
(b) (6)
FDA-CBER-2021-5683-0000475
Page 135 of 249
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User
Value Reason
Aug-07-2020 12:25:09
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:Aug/7/2020Initial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000476
Page 136 of 249
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User
Value Reason
Aug-07-2020 12:25:53
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:Aug/7/2020Initial Entry
2. Phase of Disposition:
Date Location User
Value Reason
Aug-07-2020 12:25:53
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:SCREENINGInitial Entry
3. Status:
Date Location User
Value Reason
Aug-07-2020 12:25:53
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:COMPLETEDInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000477
Page 137 of 249
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User
Value Reason
Aug-07-2020 12:45:01
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Line/MH Number:1
Medical History Term:Keratoconus, bilateral eyes
Start Date: UNK/UNK/1969
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User
Value Reason
Aug-07-2020 12:45:01
(UTC-08:00) PacificTime (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-07-2020 12:45:01
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:Keratoconus, bilateral eyesInitial Entry
1.a Start Date:
Date Location User
Value Reason
Aug-07-2020 12:45:01
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:UNK/UNK/1969Initial Entry
1.a Ongoing:
Date Location User
Value Reason
Aug-07-2020 12:45:01
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:YESInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000478
Page 138 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
1.b
Date Location User Value Reason
Aug-07-2020 12:45:21
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Line/MH Number:2
Medical History Term:Seasonal allergies
Start Date: UNK/UNK/1958
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User
Value Reason
Aug-07-2020 12:45:21
(UTC-08:00) PacificTime (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-07-2020 12:45:21
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:Seasonal allergiesInitial Entry
1.b Start Date:
Date Location User
Value Reason
Aug-07-2020 12:45:21
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:UNK/UNK/1958Initial Entry
1.b Ongoing:
Date Location User
Value Reason
Aug-07-2020 12:45:21
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:YESInitial Entry
1.c090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000479
Page 139 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-07-2020 12:46:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Line/MH Number:3
Medical History Term:Benign PulmonaryGranulomas
Start Date: UNK/UNK/2009
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date
Location User Value Reason
Aug-07-2020 12:46:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User
Value Reason
Aug-07-2020 12:46:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:Benign Pulmonary GranulomasInitial Entry
1.c Start Date:
Date Location User
Value Reason
Aug-07-2020 12:46:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:UNK/UNK/2009Initial Entry
1.c Ongoing:
Date Location User
Value Reason
Aug-07-2020 12:46:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:YESInitial Entry
1.d
Date Location User
Value Reason
Aug-07-2020 12:46:29 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000480
Page 140 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
(UTC-08:00) Pacific
Time (US & Canada)(autocalc) Line/MH Number:4
Medical History Term:Osteoarthritis, bilateral thumbs
Start Date: UNK/UNK/2002
Ongoing: YES
1.d Line/MH Number:
Date Location User Value ReasonAug-07-2020 12:46:29
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)
Data Entry:4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User
Value Reason
Aug-07-2020 12:46:29
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:Osteoarthritis, bilateral thumbsInitial Entry
1.d Start Date:
Date Location User
Value Reason
Aug-07-2020 12:46:29
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:UNK/UNK/2002Initial Entry
1.d Ongoing:
Date Location User
Value Reason
Aug-07-2020 12:46:29
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:YESInitial Entry
1.e
Date Location User
Value Reason
Aug-07-2020 12:46:51
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Line/MH Number: 5
Medical History T e
rm:HyperlipidemiaInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000481
Page 141 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Start Date: Sep/UNK/20
18
Ongoing: YES
1.e Line/MH Number:
Date Location User Value ReasonAug-07-2020 12:46:51
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)
Data Entry:5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User
Value Reason
Aug-07-2020 12:46:51
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:HyperlipidemiaInitial Entry
1.e Start Date:
Date Location User
Value Reason
Aug-07-2020 12:46:51
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:Sep/UNK/2018Initial Entry
1.e Ongoing:
Date Location User
Value Reason
Aug-07-2020 12:46:51
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:YESInitial Entry
1.f
Date Location User
Value Reason
Nov-02-2020 11:49:05
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:
Line/MH Number:6
Medical History Term:Intermittent urinar
y tract infections
Start Date: UNK/UNK/1973
Ongoing: YESChangedInformation(DELETED)090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000482
Page 142 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Aug-07-2020 12:47:34
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:
Line/MH Number:6
Medical History T erm:Intermittent urinary tract infections
Start Date: UNK/UNK/1973
Ongoing: YESChangedInformation
Aug-07-2020 12:47:20(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
auto calc
(autocalc)Data Entry:
Line/MH Number:6
Medical History T erm:Occasional urinary tract infections
Start Date: UNK/UNK/1973
Ongoing: YESInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000483
Page 143 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Nov-02-2020 11:49:05
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:6 ChangedInformation(DELETED)
Aug-07-2020 12:47:20(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)
Data Entry:6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User
Value Reason
Nov-02-2020 11:49:05
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:Intermittent urinary tract infectio
nsChangedInformation(DELETED)
Aug-13-2020 22:37:48(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Katherine
Liau(pfe.liaukf)Query 1: Closed Response satisfies
query
Aug-13-2020 11:50:00(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier)Query 1: Answered Original value is
correct
Aug-12-2020 06:56:07(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Hayley
Wyper(pfe.wyperh)Query 1: Opened GPD Clin: Per IC3
and Criteria forTemporary Delay ofEnrolment (Protocol5.5), please confirmstability ofsymptoms within 6weeks of enrolmentand no acute eventwithin 48h beforestudy interventionadministration
Aug-07-2020 12:47:34(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier)
Data Entry:Intermittent urinary tract infectionsChangedInformation
Aug-07-2020 12:47:20(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier)
Data Entry:Occasional urinary tract infectionsInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000484
Page 144 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
1.f Start Date:
Date Location User Value Reason
Nov-02-2020 11:49:05
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:UNK/UNK/1973 ChangedInformation(DELETED)
Aug-07-2020 12:47:20(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier)
Data Entry:UNK/UNK/1973Initial Entry
1.f Ongoing:
Date Location User
Value Reason
Nov-02-2020 11:49:05
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:YES ChangedInformation(DELETED)
Aug-07-2020 12:47:20(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier)
Data Entry:YESInitial Entry
1.g
Date Location User
Value Reason
Aug-07-2020 12:47:50
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Line/MH Number:7
Medical History Term:Rosacea
Start Date: UNK/UNK/2010
Ongoing: YESInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000485
Page 145 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Aug-07-2020 12:47:50
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User
Value Reason
Aug-07-2020 12:47:50
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:RosaceaInitial Entry
1.g Start Date:
Date Location User
Value Reason
Aug-07-2020 12:47:50
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:UNK/UNK/2010Initial Entry
1.g Ongoing:
Date Location User
Value Reason
Aug-07-2020 12:47:50
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:YESInitial Entry
1.h
Date Location User
Value Reason
Aug-07-2020 12:48:29
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Line/MH Number: 8
Medical History T e
rm:GERD
Start Date: Sep/UNK/1993
Ongoing: YESInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000486
Page 146 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Aug-07-2020 12:48:29
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User
Value Reason
Aug-07-2020 12:48:29
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:GERDInitial Entry
1.h Start Date:
Date Location User
Value Reason
Aug-07-2020 12:48:29
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:Sep/UNK/1993Initial Entry
1.h Ongoing:
Date Location User
Value Reason
Aug-07-2020 12:48:29
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:YESInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000487
Page 147 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.i
Date Location User
Value Reason
Aug-07-2020 12:48:48
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Line/MH Number:9
Medical HistoryTerm:Lactose intolerance
Start Date: UNK/UNK/1993
Ongoing: YESInitial Entry
1.i Line/MH Number:
Date Location User
Value Reason
Aug-07-2020 12:48:48
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User
Value Reason
Aug-07-2020 12:48:48
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:Lactose intoleranceInitial Entry
1.i Start Date:
Date Location User
Value Reason
Aug-07-2020 12:48:48
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:UNK/UNK/1993Initial Entry
1.i Ongoing:
Date Location User
Value Reason
Aug-07-2020 12:48:48
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:YESInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000488
Page 148 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
1.j
Date Location User Value Reason
Aug-07-2020 12:49:06
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Line/MH Number: 10
Medical History T e
rm:Hypothyroid
Start Date: Sep/UNK/1988
Ongoing: YESInitial Entry
1.j Line/MH Number:
Date Location User
Value Reason
Aug-07-2020 12:49:06
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User
Value Reason
Aug-07-2020 12:49:06
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:HypothyroidInitial Entry
1.j Start Date:
Date Location User
Value Reason
Aug-07-2020 12:49:06
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:Sep/UNK/1988Initial Entry
1.j Ongoing:
Date Location User
Value Reason
Aug-07-2020 12:49:06
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:YESInitial Entry
1.k
Date Location User
Value Reason090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000489
Page 149 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Aug-07-2020 12:49:28
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Line/MH Number:11
Medical History Term:Post-menopausal
Start Date: Dec/UNK/2010
Ongoing: YESInitial Entry
1.k Line/MH Number:
Date Location User
Value Reason
Aug-07-2020 12:49:28
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User
Value Reason
Aug-07-2020 12:49:28
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:Post-menopausalInitial Entry
1.k Start Date:
Date Location User
Value Reason
Aug-07-2020 12:49:28
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:Dec/UNK/2010Initial Entry
1.k Ongoing:
Date Location User
Value Reason
Aug-07-2020 12:49:28
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:YESInitial Entry
1.l
Date Location User
Value Reason
Aug-07-2020 12:49:51
(UTC-08:00) PacificACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000490
Page 150 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) Line/MH Number
:12
Medical History Term:Sulfite allergy
Start Date: UNK/UNK/1999
Ongoing: YES
1.l Line/MH Number:
Date Location User Value ReasonAug-07-2020 12:49:51
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)
Data Entry:12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User
Value Reason
Aug-07-2020 12:49:51
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:Sulfite allergyInitial Entry
1.l Start Date:
Date Location User
Value Reason
Aug-07-2020 12:49:51
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:UNK/UNK/1999Initial Entry
1.l Ongoing:
Date Location User
Value Reason
Aug-07-2020 12:49:51
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:YESInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000491
Page 151 of 249
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User
Value Reason
Aug-07-2020 12:26:22
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:Aug/7/2020Initial Entry
2. Weight:
Date Location User
Value Reason
Aug-07-2020 12:26:22
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:61.0Initial Entry
3. Unit:
Date Location User
Value Reason
Aug-07-2020 12:26:22
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:kgInitial Entry
4. Height:
Date Location User
Value Reason
Aug-07-2020 12:26:22
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:158.0Initial Entry
5. Unit:
Date Location User
Value Reason
Aug-07-2020 12:26:22
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:cmInitial Entry
6. Body Mass Index:
Date Location User
Value Reason
Aug-07-2020 12:26:22
(UTC-08:00) PacificACV0PFEINFP6000 auto calc
(autocalc)Data Entry:24.4Initial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000492
Page 152 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7.a
Date Location User Value Reason
Aug-07-2020 12:26:22
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:
Record Identifier:: 1
Temperature: 36.7
T
emperature Unit: C
Temperature Location::FOREHEADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-07-2020 12:26:22
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier)
Data Entry:1Initial Entry
7.a Temperature:
Date Location User
Value Reason
Aug-07-2020 12:26:22(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier)
Data Entry:36.7Initial Entry
7.a Unit:
Date Location User
Value Reason
Aug-07-2020 12:26:22
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:CInitial Entry
7.a Temperature Location:
Date Location User
Value Reason
Aug-07-2020 12:26:22
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:FOREHEADInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000493
Page 153 of 249
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
3. Collection Date:
Date Location User
Value Reason
Aug-07-2020 12:29:37
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:Not ApplicableInitial Entry
6.a
Date Location User
Value Reason
Aug-07-2020 12:28:23
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:
Sponsor-Defined Identifier:113
Tes
t:: Choriogonadotropin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-07-2020 12:28:23
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)
Data Entry:113Initial Entry
6.a Test:
Date Location User
Value Reason
Aug-07-2020 12:28:23
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User
Value Reason
Aug-07-2020 12:28:23
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:NOT DONEInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000494
Page 154 of 249
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User
Value Reason
Aug-07-2020 12:30:53
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:Aug/7/2020Initial Entry
2. Randomization Number:
Date Location User
Value Reason
Aug-07-2020 12:30:53
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:223587Initial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000495
Page 155 of 249
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User
Value Reason
Aug-07-2020 12:36:28
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:SITEInitial Entry
2. Sample Type
Date Location User
Value Reason
Aug-07-2020 12:36:28
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:SERUMInitial Entry
3. Sample Collected?
Date Location User
Value Reason
Aug-07-2020 12:36:37
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-07-2020 12:36:28(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however nobarcodes areentered. Pleasereview and correctas appropriate.
Aug-07-2020 12:36:28(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier)
Data Entry:YES
Date of Collection:
Aug/7/2020Initial Entry
5.a
Date Location User
Value Reason
Aug-07-2020 12:36:37
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:
Sample ID: BP6S51Initial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000496
Page 156 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Aug-07-2020 12:36:37
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:BP6S51Initial Entry
5.b
Date Location User
Value Reason
Aug-07-2020 12:36:51
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:
Sample ID: BP6S52Initial Entry
5.b Sample ID
Date Location User
Value Reason
Aug-07-2020 12:36:51
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:BP6S52Initial Entry
5.c
Date Location User
Value Reason
Aug-07-2020 12:37:03
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:
Sample ID: BP6S53Initial Entry
5.c Sample ID
Date Location User
Value Reason
Aug-07-2020 12:37:03
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:BP6S53Initial Entry
5.d
Date Location User
Value Reason
Aug-07-2020 12:37:28
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:
Sample ID: BPFTRZInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000497
Page 157 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Aug-07-2020 12:37:28
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:BPFTRZInitial Entry
5.e
Date Location User
Value Reason
Aug-07-2020 12:37:40
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:
Sample ID: BPFTS0Initial Entry
5.e Sample ID
Date Location User
Value Reason
Aug-07-2020 12:37:40
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:BPFTS0Initial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000498
Page 158 of 249
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User
Value Reason
Aug-07-2020 12:38:00
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:SITEInitial Entry
2. Sample Type
Date Location User
Value Reason
Aug-07-2020 12:38:00
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User
Value Reason
Aug-07-2020 12:38:10
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-07-2020 12:38:00(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however nobarcodes areentered. Pleasereview and correctas appropriate.
Aug-07-2020 12:38:00(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier)
Data Entry:YES
Date of Collection:
Aug/7/2020Initial Entry
5.a
Date Location User
Value Reason
Aug-07-2020 12:38:10
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:
Sample ID: BP6S4ZInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000499
Page 159 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Aug-07-2020 12:38:10
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:BP6S4ZInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000500
Page 160 of 249
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: V ACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User
Value Reason
Aug-07-2020 12:32:45
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:NOInitial Entry
2. Treatment Name
Date Location User
Value Reason
Aug-07-2020 12:32:45
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User
Value Reason
Aug-07-2020 12:32:45
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:INJECTIONInitial Entry
4. Dose Date Time:
Date Location User
Value Reason
Aug-07-2020 12:32:45
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:Aug/7/2020 10:31Initial Entry
5. Anatomical Location:
Date Location User
Value Reason
Aug-07-2020 12:32:45
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User
Value Reason
Aug-07-2020 12:32:45
(UTC-08:00) PacificACV0PFEINFP6000 Julie Glazier
(pfe.jglazier)Data Entry:LEFTInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000501
Page 161 of 249
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: V ACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Aug-07-2020 12:32:45
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:INTRAMUSCULARInitial Entry
10. Timeframe Subject Wa
s Observed
Date Location User Value Reason
Aug-07-2020 12:32:45(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)
Data Entry:THE PROTOCOL SPECIFIED OBSERV
ATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational productadministration?
Date Location User Value Reason
Aug-07-2020 12:32:45
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier)
Data Entry:YESInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000502
Page 162 of 249
***Confidential*** 
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User
Value Reason
Aug-07-2020 12:33:52
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:YES - REACTOGENICITY E-DIARY COLLECTED FOR THIS
SUBJECTInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000503
Page 163 of 249
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User V
alue Reason
Aug-26-2020 11:11:01
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:Aug/26/2020Initial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000504
Page 164 of 249
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION 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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
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
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe.mpastores)Data Entry:NOInitial Entry
2.a
Date Location User Value Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe.mpastores)Data Entry:
Symptom:: FEVER
Were fever or systemic symptoms present on the last day the Subject Diarywas completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe.mpastores)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
Aug-26-2020 11:40:02(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe.mpastores)Data Entry:NOInitial Entry
2.b
Date Location User Value Reason
Aug-27-2020 09:24:34
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:
Symptom:: FATITranscription Error090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000505
Page 165 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION 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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
GU
E
Were fever or systemic symptoms present on the last day the Subject Diarywas completed?:NO
Aug-26-2020 11:40:02(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores)
Data Entry:
Symptom:: FATIGUE
W
ere fever or syste
mic symptoms present on the last daythe Subject Diarywas completed?:YES
Ongoing?
NO
StopDate:
Aug/11/2020Initial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000506
Page 166 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION 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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
2.b Symptom:
Date Location User Value Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 14:07:45(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Erik Sundgaard
(pfe.sundgaardea)Query 1: Closed Response satisfies
query
Aug-27-2020 09:24:34(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Aug-27-2020 09:24:34(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan Pastores
(pfe mpastores)
Data Entry:NOTranscription Error
Aug-27-2020 08:04:42(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Isaac Arasavalli
(pfe.arasai)Query 1: Opened eDiary: Per eDiary
records, FA
TIGUE
is not reported onLast day (Day 7)however the lastday in inform isentered as 'Yes' forthe same. Pleaseverify and update.Else, clarify.Thanks.
Aug-26-2020 11:40:02(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan Pastores
(pfe mpastores)
Data Entry:YES
Ongoing?
NO
Stop Date:
Aug/11/2020Initial Entry
2.c090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000507
Page 167 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION 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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-27-2020 09:24:54
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores) Data Entry:
Symptom:: HEADACHE
Were fever or systemic symptoms present on thelast day the Subject Diary was completed?:NOTranscription Error
Aug-26-2020 11:40:02(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe
mpastores)Data Entry:
Symptom:: HEADACHE
Were fever or systemic symptoms present on the last daythe Subject Diarywas completed?:YES
Ongoing?
NO
StopDate:
Aug/12/2020Initial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000508
Page 168 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION 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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
2.c Symptom:
Date Location User Value Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 14:07:17(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Erik Sundgaard
(pfe.sundgaardea)Query 1: Closed Response satisfies
query
Aug-27-2020 09:24:54(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Aug-27-2020 09:24:54(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan Pastores
(pfe mpastores)
Data Entry:NOTranscription Error
Aug-27-2020 08:05:02(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Isaac Arasavalli
(pfe.arasai)Query 1: Opened eDiary: Per eDiary
records,HEADACHE is notreported on Lastday (Day 7)however the lastday in inform isentered as 'Yes' for
the same. Please
verify and update.Else, clarify
.
Thanks.
Aug-26-2020 11:40:02(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan Pastores
(pfe mpastores)
Data Entry:YES
Ongoing?
NO
Stop Date:
Aug/12/2020Initial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000509
Page 169 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION 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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
2.d
Date Location User Value Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:
Symptom:: CHILLS
Were fever or systemic sy
mptoms present on the last day the Subject Diarywas completed?:NOInitial Entry
2.d Symptom:
Date Location User V
alue Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User V
alue Reason
Aug-26-2020 11:40:02(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores)
Data Entry:NOInitial Entry
2.e
Date Location User V
alue Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:
Symptom:: VOMITING
Were fever or systemic s
ymptoms present on thelast day the Subject Diary was completed?:NOInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000510
Page 170 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION 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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
2.e Symptom:
Date Location User Value Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:VOMITINGInitial Entry
2.e W ere fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User V
alue Reason
Aug-26-2020 11:40:02(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores)
Data Entry:NOInitial Entry
2.f
Date Location User V
alue Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:
Symptom:: DIARRHEA
Were fever or systemic s
ymptoms present on thelast day the Subject Diary was completed?:NOInitial Entry
2.f Symptom:
Date Location User V
alue Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:DIARRHEAInitial Entry
2.f W ere fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User V
alue Reason
Aug-26-2020 11:40:02(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores)
Data Entry:NOInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000511
Page 171 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION 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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
2.g
Date Location User Value Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:
Symptom:: NEW ORWORSENED MUSCLE P A
IN
W
ere fever or syste
mic symptoms present on the last day the Subject Diary was completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores)
Data Entry:NEW OR WORSENED MUSCLE PAINInitial Entry
2.g W
ere fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020 11:40:02(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores)
Data Entry:NOInitial Entry
2.h
Date Location User V
alue Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:
Symptom:: NEW OR WORSENED JOINT PAINInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000512
Page 172 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION 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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Were fever or syste
mic symptoms present on the last day the Subject Diary wascompleted?:NO
2.h Symptom:
Date Location User Value Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores)
Data Entry:NEW OR WORSENED JOINTPAI
NInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:NOInitial Entry
3. Injection Site Location:
Date Location User
Value Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User V
alue Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:LEFTInitial Entry
5.a
Date Location User V
alue Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:
Injection Site Reaction:: REDNESSInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000513
Page 173 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION 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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Were injection site reacti
ons present on the last day the Subject Diary wascompleted?:NO
5.a Injection Site Reaction:
Date Location User Value ReasonAug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores)
Data Entry:REDNESSInitial Entry
5.a W ere injection site reactions present on the last day the Subject Diary was completed?
Date Location User V
alue Reason
Aug-26-2020 11:40:02(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores)
Data Entry:NOInitial Entry
5.b
Date Location User V
alue Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:
Injection Site Reaction:: SWELLING
Were injection site react
ions present on the lastday the Subject Diary was completed?:NOInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000514
Page 174 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION 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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:SWELLINGInitial Entry
5.b W ere injection site reactions present on the last day the Subject Diary was completed?
Date Location User V
alue Reason
Aug-26-2020 11:40:02(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores)
Data Entry:NOInitial Entry
5.c
Date Location User V
alue Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:
Injection Site Reaction::PAIN A
T INJECTIONSITE
W
ere injection site re
actions present on the last day the SubjectDiary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores)
Data Entry:PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User V
alue Reason
Aug-26-2020 11:40:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:NOInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000515
Page 175 of 249
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User V
alue Reason
Aug-26-2020 11:14:12
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:Aug/26/2020Initial Entry
2.a
Date Location User V
alue Reason
Aug-26-2020 11:14:12
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:
Record Identifier:: 1
Temperature: 36.2
T
emperature Unit: C
Temperature Location::FOREHEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-26-2020 11:14:12
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores)
Data Entry:1Initial Entry
2.a Temperature:
Date Location User V
alue Reason
Aug-26-2020 11:14:12
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:36.2Initial Entry
2.a Unit:
Date Location User V
alue Reason
Aug-26-2020 11:14:12
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:CInitial Entry
2.a Temperature Location:090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000516
Page 176 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-26-2020 11:14:12
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:FOREHEADInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000517
Page 177 of 249
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User V
alue Reason
Aug-26-2020 11:42:40
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User V
alue Reason
Aug-26-2020 11:42:40
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:Not ApplicableInitial Entry
3. Collection Date:
Date Location User V
alue Reason
Aug-26-2020 11:42:40
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User V
alue Reason
Aug-26-2020 11:42:40
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:Not ApplicableInitial Entry
5. Specimen Type:
Date Location User V
alue Reason
Aug-26-2020 11:42:40
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:Not ApplicableInitial Entry
6.a
Date Location User V
alue Reason090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000518
Page 178 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Aug-26-2020 11:42:40
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:
Sponsor-Defined Identifier:Not Applicable
Tes
t:: Not Applicable
Result:: Not Applicable
Not Done:: Not ApplicableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-26-2020 11:42:40
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores)
Data Entry:Not ApplicableInitial Entry
6.a Test:
Date Location User V
alue Reason
Aug-26-2020 11:42:40
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:Not ApplicableInitial Entry
6.a Result:
Date Location User V
alue Reason
Aug-26-2020 11:42:40
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:Not ApplicableInitial Entry
6.a Not Done:
Date Location User V
alue Reason
Aug-26-2020 11:42:40
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:Not ApplicableInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000519
Page 179 of 249
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User
Value Reason
Aug-27-2020 09:00:20
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:SITEInitial Entry
2. Sample Type
Date Location User
Value Reason
Aug-27-2020 09:00:20
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User V
alue Reason
Aug-27-2020 09:00:48
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-27-2020 09:00:20(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however nobarcodes areentered. Pleasereview and correctas appropriate.
Aug-27-2020 09:00:20(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores)
Data Entry:YES
Date of Collection:
Aug/26/2020Initial Entry
5.a
Date Location User V
alue Reason
Aug-27-2020 09:00:48
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:
Sample ID: BP6RXNInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000520
Page 180 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 09:00:48
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:BP6RXNInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000521
Page 181 of 249
***Confidential*** 
Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User V
alue Reason
Aug-26-2020 11:42:18
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:NOInitial Entry
2. Treatment Name
Date Location User
Value Reason
Aug-26-2020 11:42:18
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User
Value Reason
Aug-26-2020 11:42:18
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:INJECTIONInitial Entry
4. Dose Date Time:
Date Location User V
alue Reason
Aug-26-2020 11:42:18
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores) Data Entry:Aug/26/2020 10:08Initial Entry
5. Anatomical Location:
Date Location User
Value Reason
Aug-26-2020 11:42:18
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User V
alue Reason
Aug-26-2020 11:42:18
(UTC-08:00) PacificACV0PFEINFP6000 Megan
PastoresData Entry:LEFTInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000522
Page 182 of 249
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) (pfe.mpastores)
7. Route:
Date Location User Value Reason
Aug-26-2020 11:42:18
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:INTRAMUSCULARInitial Entry
10. Timeframe Subject Wa
s Observed
Date Location User Value Reason
Aug-26-2020 11:42:18(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)
Data Entry:THE PROTOCOL SPECIFIED OBSERV
ATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational productadministration?
Date Location User Value Reason
Aug-26-2020 11:42:18
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe.mpastores)
Data Entry:YESInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000523
Page 183 of 249
***Confidential*** 
Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-24-2020 10:16:54
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:Sep/24/2020Initial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000524
Page 184 of 249
***Confidential*** 
Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: V ACCINATION 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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
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-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:NOInitial Entry
2.a
Date Location User Value Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:
Symptom:: FEVER
Were fever or systemic symptoms present on the last day the Subject Diarywas completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)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-24-2020 13:26:14(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:NOInitial Entry
2.b
Date Location User Value Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:
Symptom:: FATI GU
EInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000525
Page 185 of 249
***Confidential***Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: V ACCINATION 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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Were fever or syste
mic symptoms present on the last day the Subject Diary wascompleted?:YES
Ongoing?
NO
StopDate:
Sep/6/2020
2.b Symptom:
Date Location User Value Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores)
Data Entry:FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 13:26:14(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:YES
Ongoing?
NO
Stop Date:
Sep/6/2020Initial Entry
2.c
Date Location User Value Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:
Symptom:: HEADACHEInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000526
Page 186 of 249
***Confidential***Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: V ACCINATION 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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Were fever or systemic s
ymptoms present on thelast day the Subject Diary was completed?:NO
2.c Symptom:
Date Location User Value Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores)
Data Entry:HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 13:26:14(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:NOInitial Entry
2.d
Date Location User Value Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:
Symptom:: CHILLS
Were fever or systemic symptoms present on the last day the Subject Diary wascompleted?:YES
Ongoing?
NO
StopDate:
Sep/6/2020Initial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000527
Page 187 of 249
***Confidential***Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: V ACCINATION 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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
2.d Symptom:
Date Location User Value Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores) Data Entry:CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 13:26:14(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:YES
Ongoing?
NO
Stop Date:
Sep/6/2020Initial Entry
2.e
Date Location User Value Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:
Symptom:: VOMITING
Were fever or systemic symptoms present on thelast day the Subject Diary was completed?:NOInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000528
Page 188 of 249
***Confidential***Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: V ACCINATION 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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
2.e Symptom:
Date Location User Value Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores) Data Entry:VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 13:26:14(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:NOInitial Entry
2.f
Date Location User Value Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:
Symptom:: DIARRHEA
Were fever or systemic symptoms present on thelast day the Subject Diary was completed?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 13:26:14(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:NOInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000529
Page 189 of 249
***Confidential***Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: V ACCINATION 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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
2.g
Date Location User Value Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores) Data Entry:
Symptom:: NEW ORWORSENED MUSCLE PA
IN
Were fever or syste
mic symptoms present on the last day the Subject Diary was completed?:NOInitial Entry
2.g Symptom:
Date Location User V
alue Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores) Data Entry:NEW OR WORSENED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User V
alue Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores) Data Entry:NOInitial Entry
2.h
Date Location User Value Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:
Symptom:: NEW OR WORSENED JOINT PAINInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000530
Page 190 of 249
***Confidential***Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: V ACCINATION 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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Were fever or syste
mic symptoms present on the last day the Subject Diary wascompleted?:NO
2.h Symptom:
Date Location User Value Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores)
Data Entry:NEW OR WORSENED JOINTPAINInitial Entry
2.h W
ere fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 13:26:14(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores)
Data Entry:NOInitial Entry
3. Injection Site Location:
Date Location User V
alue Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:
Injection Site Reaction:: REDNESSInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000531
Page 191 of 249
***Confidential***Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: V ACCINATION 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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Were injection site reacti
ons present on the last day the Subject Diary wascompleted?:NO
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores)
Data Entry:REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 13:26:14(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:NOInitial Entry
5.b
Date Location User Value Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:
Injection Site Reaction:: SWELLING
Were injection site reactions present on the lastday the Subject Diary was completed?:NOInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000532
Page 192 of 249
***Confidential***Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: V ACCINATION 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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores) Data Entry:SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 13:26:14(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:NOInitial Entry
5.c
Date Location User Value Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:
Injection Site Reaction::PAIN A
T INJECTIONSITE
Were injection site re
actions present on the last day the SubjectDiary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User V
alue Reason
Sep-24-2020 13:26:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores) Data Entry:PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 13:26:14(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:NOInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000533
Page 193 of 249
***Confidential*** 
Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User
Value Reason
Sep-24-2020 15:27:49
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:SITEInitial Entry
2. Sample Type
Date Location User
Value Reason
Sep-24-2020 15:27:49
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:SERUMInitial Entry
3. Sample Collected?
Date Location User
Value Reason
Sep-24-2020 15:27:56
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-24-2020 15:27:49(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however nobarcodes areentered. Pleasereview and correctas appropriate.
Sep-24-2020 15:27:49(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier)
Data Entry:YES
Date of Collection:
Sep/24/2020Initial Entry
5.a
Date Location User
Value Reason
Sep-24-2020 15:27:56
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:
Sample ID: BPV09LInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000534
Page 194 of 249
***Confidential***Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Sep-24-2020 15:27:56
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:BPV09LInitial Entry
5.b
Date Location User
Value Reason
Sep-24-2020 15:28:05
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:
Sample ID: BPV09MInitial Entry
5.b Sample ID
Date Location User
Value Reason
Sep-24-2020 15:28:05
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:BPV09MInitial Entry
5.c
Date Location User
Value Reason
Sep-24-2020 15:28:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:
Sample ID: BPFTKCInitial Entry
5.c Sample ID
Date Location User
Value Reason
Sep-24-2020 15:28:14
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:BPFTKCInitial Entry
5.d
Date Location User
Value Reason
Sep-24-2020 15:28:22
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:
Sample ID: BPFTKDInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000535
Page 195 of 249
***Confidential***Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_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: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Sep-24-2020 15:28:22
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier) Data Entry:BPFTKDInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000536
Page 196 of 249
***Confidential*** 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Sep-24-2020 10:55:54
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:Sep/24/2020Initial Entry
2. Phase of Disposition:
Date Location User V
alue Reason
Sep-24-2020 10:55:54
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:V ACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-24-2020 10:55:54
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:COMPLETEDInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000537
Page 197 of 249
***Confidential*** 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Sep-24-2020 13:16:17
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfempastores)Form Created090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000538
Page 198 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Jan-11-2021 10:04:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Elle Billman(pfe.ebillman)Form Created090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000539
Page 199 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Feb-12-2021 10:59:13
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Elle Billman(pfe.ebillman)Form Created090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000540
Page 200 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Feb-12-2021 11:00:29
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Elle Billman(pfe.ebillman)Form Created090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000541
Page 201 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Feb-12-2021 11:01:58
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Elle Billman(pfe.ebillman)Form Created090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000542
Page 202 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Feb-12-2021 11:03:03
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Elle Billman(pfe.ebillman)Form Created090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000543
Page 203 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User V
alue Reason
Sep-24-2020 13:16:17
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User V
alue Reason
Sep-24-2020 13:16:17
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:1Initial Entry
3. Adverse Event:(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-03-2020 04:14:41
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Cavin van
Schalkwyk(pfe.vanscc01)Query 1: Closed MH deleted
Nov-02-2020 11:49:46(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Julie Glazier
(pfe.jglazier)Query 1: Answered AE of UTI is newoccurrence and notpart of baselinemedical history
Nov-01-2020 21:23:25(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Derrick
Newton(pfe newtod07)Query 1: Opened The AE Urinary
Tract Infection wasreported but is alsolisted in MedicalHistory. Pleaseclarify if this is aworsening of thebaseline condition,and if so, pleaseconsider adding"worsening" to theAE term.
Sep-24-2020 13:16:17(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores)
Data Entry:Urinary Tract InfectionInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000544
Page 204 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
4. Start Date Time:
Date Location User Value Reason
Sep-24-2020 13:16:17
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores) Data Entry:Sep/1/2020 22:01Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-24-2020 13:16:17
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:NO
End Date Time:
Sep/6/2020 08:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-24-2020 13:16:17(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIAT
ELY.
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 mayrequire medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-24-2020 13:16:17
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores)
Data Entry:NOInitial Entry
8. Is this adverse event the result of a study Medication Error?If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-24-2020 13:16:17
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:NOInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000545
Page 205 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-24-2020 13:16:17
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores) Data Entry:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
Bacterial InfectionInitial Entry
10. Latest Action Ta
ken with Study Treatment:
Date Location User Value Reason
Sep-24-2020 13:16:17(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores)
Data Entry:NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User V
alue Reason
Sep-24-2020 13:16:17(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores)
Data Entry:YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User V
alue Reason
Sep-24-2020 13:16:17(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores)
Data Entry:NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-24-2020 13:16:17
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 
Megan
Pastores(pfe mpastores)Data Entry:RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000546
Page 206 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-24-2020 13:16:17
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Megan
Pastores(pfe mpastores) Data Entry:NOInitial Entry090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000547
Page 207 of 249
***Confidential*** 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User
Value Reason
Jan-11-2021 10:04:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User
Value Reason
Jan-11-2021 10:04:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc) Data Entry:2Initial Entry
3. Adverse Event:(If possible specify diagnosis, not individual symptoms)
Date Location User
Value Reason
Jan-11-2021 10:04:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Elle Billman
(pfe.ebillman) Data Entry:Injection site painInitial Entry
4. Start Date Time:
Date Location User
Value Reason
Jan-11-2021 10:04:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Elle Billman
(pfe.ebillman) Data Entry:Dec/22/2020 09:02Initial Entry
5. Is the adverse event still ongoing?
Date Location User
Value Reason
Jan-11-2021 10:04:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Elle Billman
(pfe.ebillman) Data Entry:NO
End Date Time:
Dec/24/2020 08:00Initial Entry
6. Toxicity Grade:
Date Location User
Value Reason090177e196ae4079\Final\Final On: 01-A pr-2021 05:41 (GMT )
FDA-CBER-2021-5683-0000548
Page 208 of 249
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1055 Site Name: (1055) Diablo Clinical Research Incorporated
Subject No: 10551006 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:44
Jan-11-2021 10:04:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Elle Billman
(pfe.ebillman) Data Entry:2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIA
TELY.
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 mayrequire medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-11-2021 10:04:02
(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Elle Billman
(pfe.ebillman)
Data Entry:NOInitial Entry
8. Is this adverse event the result of a study Medication Error?If Yes, record the type of medication error on the Medication Error Log.
Date Location User
Value Reason
Jan-11-2021 10:04:02(UTC-08:00) PacificTime (US & Canada)ACV0PFEINFP6000 Elle Billman
(pfe.ebillman)
Data Entry:NOInitial Entry
9. Is this event related to study treatment:
Date Location User
Value Reason
Jan-11-2021 10:04:02
(UTC-08:00) Pacific
…[truncated]