125742 S1 M5 CRF c4591001 1109 11091204

Document text

Page 1 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976941
Page 2 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/11/2020
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976942
Page 3 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Demography
1.Subject ID [11091204]
2.Birth Date: /1992
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0976943
Page 4 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/11/2020
2.Erroneous Visit
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976944
Page 5 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976945
Page 6 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/11/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976946
Page 7 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[RECONSTRUCTIVE RIGHT EAR SURGERY]
Start Date: Jan/1/2013
Ongoing: NO
End Date:
Jan/1/2013
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[BILATERAL LASIK SURGERY]
Start Date: Jan/1/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[SEASONAL ALLERGIES]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976947
Page 8 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Aug/11/2020
2.Weight: [200.0]
3.Unit: LB
4.Height: [72.0]
5.Unit: in
6.Body Mass Index: [27.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976948
Page 9 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/11/2020
2.Randomization Number: [46006]
3.Randomization Group: [ ]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976949
Page 10 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/11/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPXZKW]
5.bSample ID [BPXZKX]
5.cSample ID [BPXZKY]
5.dSample ID [BHJH7T]
5.eSample ID [BHJH7V]
5.fSample ID [BHJH7W]
5.gSample ID [BHJH7X]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976950
Page 11 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/11/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPXZKZ]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976951
Page 12 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/11/2020 13:15
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976952
Page 13 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976953
Page 14 of 224
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976954
Page 15 of 224
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976955
Page 16 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976956
Page 17 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976957
Page 18 of 224
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976958
Page 19 of 224
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPXSLZ]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976959
Page 20 of 224
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/4/2020 14:18
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976960
Page 21 of 224
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976961
Page 22 of 224
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976962
Page 23 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976963
Page 24 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976964
Page 25 of 224
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/30/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BMNG7M]
5.bSample ID [BMNG7N]
5.cSample ID [BPXTL4]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976965
Page 26 of 224
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976966
Page 27 of 224
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/26/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRF6GR]
5.bSample ID [BS9XDR]
5.cSample ID [BS9XDS]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976967
Page 28 of 224
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976968
Page 29 of 224
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976969
Page 30 of 224
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976970
Page 31 of 224
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976971
Page 32 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976972
Page 33 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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: [ ]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976973
Page 34 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976974
Page 35 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976975
Page 36 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976976
Page 37 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976977
Page 38 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976978
Page 39 of 224
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976979
Page 40 of 224
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Aug/13/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/13/2020
2.Erroneous Visit
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976980
Page 41 of 224
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Aug/13/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976981
Page 42 of 224
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Aug/13/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/13/2020
Contact Outcome:
VISIT NOT ARRANGED, REACTION NO LONGER
PRESENT
3.Comments: [Subject is to contact site if anything new occurs.]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976982
Page 43 of 224
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled
Visit on Aug/18/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/18/2020
2.Erroneous Visit
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976983
Page 44 of 224
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled
Visit on Aug/18/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976984
Page 45 of 224
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled
Visit on Aug/18/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/18/2020
Contact Outcome:
VISIT NOT ARRANGED, REACTION NO LONGER
PRESENT
3.Comments: [All symptoms are resolved as of 14/AUG/2020.]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976985
Page 46 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Sep/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976986
Page 47 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976987
Page 48 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976988
Page 49 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976989
Page 50 of 224
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Categor
yAE Id
entifie
rAdverse Ev
entStart DateIs the Adverse E
vent Still Ongoin
gForm Insta
nce
 1. ADVER
SE EVE
NT 1 ACUTE AP
PENDICITI
S Aug/17/20
20 UNK:U
NK NO
End Date Time:
Sep/2/2020 U
NK:UNK
 Repeating
Pages
 2. ADVER
SE EVE
NT 2 Peritoneal
Abscess Aug/17/20
20 UNK:U
NK NO
End Date Time:
Sep/2/2020 U
NK:UNK
 Repeating
Pages
 3. DELETED ADVER
SE EVE
NT 3 PERITONE
AL ABSCE
SS Sep/2/2020
UNK:UNK
 NO  Repeating
Pages
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976990
Page 51 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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)[ACUTE APPENDICITIS]
4.Start Date Time: Aug/17/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/2/2020 UNK:UNK
6.Toxicity Grade: 4
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976991
Page 52 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[ACUTE APPENDICITIS WITH PERITONEAL
ABSCESS]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976992
Page 53 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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[2020326724]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976993
Page 54 of 224
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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)[Peritoneal Abscess]
4.Start Date Time: Aug/17/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/2/2020 UNK:UNK
6.Toxicity Grade: 4
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976994
Page 55 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Acute appendicitis with peritoneal abscess]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976995
Page 56 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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[2020326724]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976996
Page 57 of 224
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted,
Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[PERITONEAL ABSCESS ]
4.Start Date Time: Sep/2/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
//
6.Toxicity Grade: 4
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0976997
Page 58 of 224
***Confidential***
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[ACUTE APPENDICITIS ]
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
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
FDA-CBER-2021-5683-0976998
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***Confidential***
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
FDA-CBER-2021-5683-0976999
Page 60 of 224
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977000
Page 61 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977001
Page 62 of 224
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977002
Page 63 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977003
Page 64 of 224
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977004
Page 65 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977005
Page 66 of 224
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977006
Page 67 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977007
Page 68 of 224
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977008
Page 69 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977009
Page 70 of 224
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977010
Page 71 of 224
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977011
Page 72 of 224
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977012
Page 73 of 224
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977013
Page 74 of 224
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977014
Page 75 of 224
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977015
Page 76 of 224
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977016
Page 77 of 224
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977017
Page 78 of 224
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977018
Page 79 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977019
Page 80 of 224
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977020
Page 81 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/17/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977021
Page 82 of 224
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977022
Page 83 of 224
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977023
Page 84 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/30/2020
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977024
Page 85 of 224
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977025
Page 86 of 224
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Bruce
Rankin Approved Mar-10-2021 13:02:24 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977026
Page 87 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormAug-11-2020 14:41:51 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977027
Page 88 of 224
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Bruce
Rankin Approved Mar-10-2021 13:02:24 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Feb-18-2021 20:41:30 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Bruce
Rankin Approved Oct-12-2020 09:20:11 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977028
Page 89 of 224
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Affidavit:
By my dated signature below, I, BruceRankin, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Sep-30-2020 11:35:37 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Bruce
Rankin Approved Sep-14-2020 17:01:59 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977029
Page 90 of 224
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Affidavit:
By my dated signature below, I, BruceRankin, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977030
Page 91 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-11-2020
14:40:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-11-2020
14:40:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977031
Page 92 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-11-2020
14:41:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/11/2020Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977032
Page 93 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-01-2020
06:04:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2: C
losedrecorded in CRF
Aug-26-2020
09:20:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2: A
nsweredChanged data per query
Aug-26-2020
05:36:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2: O
penedSAE
RECON:AER#2020326724
APPENDICITIS(onset
date:17Aug2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Aug-19-2020
01:31:22
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Query 1: C
losedResponse satisfies query
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977033
Page 94 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US &
Canada)
Aug-18-2020
11:44:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1: A
nsweredChanged data per query
Aug-17-2020
07:21:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1: R
eissued:Op
enedPDQ: Requery: Thank you
for confirming subject was
contacted. As per section
8.43 of CRF Completion
Requirements, please
consider updating
UNPLANNED VISIT form
and select the appropriate
Contact Outcome option
present on UNPLANNED
VISIT (UNPL) form.
Aug-14-2020
16:15:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1: A
nsweredThe subject was contacted
and the PI was informed.
Per PI the subject was
instructed to monitor, use
appropriate medication to
control pain and to contact
the site if the pain
continued to get worse. Per
the subject the pain is no
longer severe.
Aug-14-2020
09:08:48ACV0PFEINFP6000  Query 1: O
penedPDQ: Subject has reported
Severe symptoms/reaction
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977034
Page 95 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00)
Eastern Time
(US &
Canada)in eDiary data on
12Aug2020. Please
confirm if an
UNPLANNED contact was
made and update the data
as appropriate
Aug-11-2020
14:40:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entr
y:
11091204Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-11-2020
14:40:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1992Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-11-2020
14:41:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977035
Page 96 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Aug-11-2020
14:41:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-11-2020
14:41:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977036
Page 97 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-11-2020
14:41:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977037
Page 98 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-11-2020
14:42:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-11-2020
14:42:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-11-2020
14:42:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977038
Page 99 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.a
Date Location User Value Reason
Aug-11-2020
14:48:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/
MH N
umber
:1
Medic
al Hist
ory Te
rm:RECONSTRU
CTIVE RIGH
T EAR SURG
ERY
Start
Date:Jan/1/2013
Ongoi
ng:NO
End Date:
Jan/1/2013Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-11-2020
14:48:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977039
Page 100 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020
14:48:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECONSTRUCTIV
E RIGHT EAR SUR
GERYInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-11-2020
14:48:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/1/2013Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-11-2020
14:48:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/1/2013Initial Entry
1.b
Date Location User Value Reason
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977040
Page 101 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-11-2020
14:49:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:2
Medical
History
Term:BILATERAL
LASIK SUR
GERY
Start D
ate:Jan/1/2015
Ongoin
g:NO
End Date:
UNK/UN
K/2015Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977041
Page 102 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.b Line/MH Number:
Date Location User Value Reason
Aug-11-2020
14:49:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020
14:49:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BILATERAL LASIK
SURGERYInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-11-2020
14:49:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/1/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977042
Page 103 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-11-2020
14:49:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
1.c
Date Location User Value Reason
Aug-11-2020
14:49:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical
History T
erm:SEASON
AL ALLE
RGIES
Start Dat
e:UNK/UN
K/2015
Ongoing: YESInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977043
Page 104 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.c Line/MH Number:
Date Location User Value Reason
Aug-11-2020
14:49:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020
14:49:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
SEASONAL ALLER
GIESInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-11-2020
14:49:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977044
Page 105 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-11-2020
14:49:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977045
Page 106 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Aug-11-2020
14:45:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-11-2020
14:45:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
200.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-11-2020
14:45:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977046
Page 107 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Aug-11-2020
14:45:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
72.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-11-2020
14:45:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-11-2020
14:45:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
27.1Initial Entry
7.a
Date Location User Value Reason
Aug-11-2020
14:45:08
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Record Ide 1Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977047
Page 108 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time (US
& Canada)ntifier::
Temperatu
re:98.7
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-11-2020
14:45:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-11-2020
14:45:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.7Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977048
Page 109 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-11-2020
14:45:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-11-2020
14:45:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977049
Page 110 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-11-2020
14:45:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-11-2020
14:45:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
46006Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977050
Page 111 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-11-2020
14:45:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-11-2020
14:45:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-12-2020
07:08:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-12-2020
06:12:55ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977051
Page 112 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-11-2020
14:45:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-11-2020
14:45:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Aug/11/2020Initial Entry
5.a
Date Location User Value Reason
Aug-12-2020
07:08:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPXZK
WInitial Entry
5.a Sample ID
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977052
Page 113 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Aug-12-2020
07:08:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPXZKWInitial Entry
5.b
Date Location User Value Reason
Aug-12-2020
07:08:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPXZK
XInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-12-2020
07:08:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPXZKXInitial Entry
5.c
Date Location User Value Reason
Aug-12-2020
07:08:42
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Sample I BPXZKInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977053
Page 114 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time (US
& Canada)D: Y
5.c Sample ID
Date Location User Value Reason
Aug-12-2020
07:08:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPXZKYInitial Entry
5.d
Date Location User Value Reason
Aug-12-2020
07:08:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BHJH7
TInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-12-2020
07:08:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BHJH7TInitial Entry
5.e
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977054
Page 115 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Aug-12-2020
07:09:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BHJH7
VInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-12-2020
07:09:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BHJH7VInitial Entry
5.f
Date Location User Value Reason
Aug-12-2020
07:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BHJH7
WInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977055
Page 116 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.f Sample ID
Date Location User Value Reason
Aug-12-2020
07:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BHJH7WInitial Entry
5.g
Date Location User Value Reason
Aug-12-2020
07:09:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BHJH7
XInitial Entry
5.g Sample ID
Date Location User Value Reason
Aug-12-2020
07:09:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BHJH7XInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977056
Page 117 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-11-2020
14:45:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-11-2020
14:45:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-12-2020
07:13:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-12-2020
06:12:55ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977057
Page 118 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-11-2020
14:45:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-11-2020
14:45:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Aug/11/2020Initial Entry
5.a
Date Location User Value Reason
Aug-12-2020
07:13:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPXZK
ZInitial Entry
5.a Sample ID
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977058
Page 119 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Aug-12-2020
07:13:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPXZKZInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977059
Page 120 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-11-2020
14:46:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-11-2020
14:46:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-11-2020
14:46:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977060
Page 121 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-11-2020
14:46:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020 13:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-11-2020
14:46:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-11-2020
14:46:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-11-2020
14:46:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977061
Page 122 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-11-2020
14:46:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-11-2020
14:46:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977062
Page 123 of 224
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-19-2020
19:30:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Aug-18-2020
11:44:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered Changed data
per query
Aug-16-2020
20:19:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened Subject
reported:Pain
at Injection Site
Severity
(Severe) In the
e-diary on 11
Aug, but no
UNPL visit has
occurred.
Please can you
confirm subject
has been
contacted? If
so, report in
UNPL log.
Thanks
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977063
Page 124 of 224
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-11-2020
14:46:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGE
NICITY E-DIARY
COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977064
Page 125 of 224
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-09-2020
05:21:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Sep-09-2020
04:25:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Sep-08-2020
13:00:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Answered OOW PD
NOTED IN
SUBJECT
CHART AND
FILED
Sep-08-2020
13:00:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered OOW PD
NOTED IN
CHART AND
FILED.
Sep-07-2020
20:56:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Opened ClinQuery: Per
protocol, V2
should occur
19-23 days
after V1.
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977065
Page 126 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Please can you
confirm a PD
will be written
for this out of
window visit?
Thanks
Sep-07-2020
03:01:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened PDQ: Date of
visit at this
visit is out of
window (1
day) from Date
of visit
(11/Aug/2020)
at V1D1VX1L
visit. Please
reconcile and
update
accordingly,
else confirm
date is correct
as is.
Sep-04-2020
15:58:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977066
Page 127 of 224
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977067
Page 128 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  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-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:N
OInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977068
Page 129 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.b Symptom:
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  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-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977069
Page 130 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:NO
2.c Symptom:
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  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-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-04-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0977070
Page 131 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)Symptom:: C
HI
L
L
S
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
O
2.d Symptom:
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  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-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977071
Page 132 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.e
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:NOInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977072
Page 133 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.e Symptom:
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  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-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EAInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977073
Page 134 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
O
2.f Symptom:
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  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-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-04-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0977074
Page 135 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AIN
Were fever o
r systemic s
ymptoms pr
esent on the
last day the
Subject Diar
y was compl
eted?:NO
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977075
Page 136 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.g Symptom:
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
JOIN
T PAI
NInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977076
Page 137 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Were fever o
r systemic sy
mptoms pres
ent on the la
st day the Su
bject Diary
was complet
ed?:NO
2.h Symptom:
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977077
Page 138 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::RE
D
NE
SS
Were injection
site reactions pr
esent on the last
day the Subject
Diary was com
pleted?:N
OInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977078
Page 139 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  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-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::SW
EL
LI
NGInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977079
Page 140 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:NO
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  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-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-04-2020
15:58:54ACV0PFEINFP6000  Data Entry:
Injection Site PAIInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0977080
Page 141 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00)
Eastern Time (US
& Canada)Reaction:: N AT
INJE
CTI
ON
SITE
Were injectio
n site reactio
ns present on
the last day t
he Subject Di
ary was comp
leted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020
15:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977081
Page 142 of 224
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020
15:59:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2.a
Date Location User Value Reason
Sep-04-2020
15:59:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:97.8
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-04-2020
15:59:17
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977082
Page 143 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time (US
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-04-2020
15:59:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-04-2020
15:59:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-04-2020
15:59:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977083
Page 144 of 224
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020
14:44:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020
14:44:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020
14:44:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-04-2020
14:44:45ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977084
Page 145 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-04-2020
14:44:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020
14:44:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPXSL
ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-04-2020
14:44:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPXSLZInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977085
Page 146 of 224
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-04-2020
15:59:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020
15:59:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020
15:59:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977086
Page 147 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-04-2020
15:59:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020 14:18Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020
15:59:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-04-2020
15:59:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-04-2020
15:59:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977087
Page 148 of 224
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-04-2020
15:59:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-04-2020
15:59:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977088
Page 149 of 224
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-05-2020
05:42:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed As per site
confirmation -
updated PD
tracker
Oct-03-2020
11:27:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered PD written and
filed.
Oct-01-2020
07:24:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened PDQ: DOV at
this visit is out
of window (-2
day) from
DOV (4/Sep
/2020) at V2.
Please
reconcile and
update
accordingly,
else confirm
date is correct
as is.
Sep-30-2020
11:35:37
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0977089
Page 150 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time (US
& Canada)
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977090
Page 151 of 224
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977091
Page 152 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  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-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:N
OInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977092
Page 153 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.b Symptom:
Date Location User Value Reason
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  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-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977093
Page 154 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:NO
2.c Symptom:
Date Location User Value Reason
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  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-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-30-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0977094
Page 155 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)Symptom:: C
HI
L
L
S
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
O
2.d Symptom:
Date Location User Value Reason
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  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-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977095
Page 156 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.e
Date Location User Value Reason
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:NOInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977096
Page 157 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.e Symptom:
Date Location User Value Reason
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  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-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EAInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977097
Page 158 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
O
2.f Symptom:
Date Location User Value Reason
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  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-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-30-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0977098
Page 159 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AIN
Were fever o
r systemic s
ymptoms pr
esent on the
last day the
Subject Diar
y was compl
eted?:NO
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977099
Page 160 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.g Symptom:
Date Location User Value Reason
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
JOIN
T PAI
NInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977100
Page 161 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Were fever o
r systemic sy
mptoms pres
ent on the la
st day the Su
bject Diary
was complet
ed?:NO
2.h Symptom:
Date Location User Value Reason
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977101
Page 162 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-30-2020
13:51:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::RE
D
NE
SS
Were injection
site reactions pr
esent on the last
day the Subject
Diary was com
pleted?:N
OInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977102
Page 163 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  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-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::SW
EL
LI
NGInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977103
Page 164 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:NO
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  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-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-30-2020
11:36:07ACV0PFEINFP6000  Data Entry:
Injection Site PAIInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977104
Page 165 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00)
Eastern Time (US
& Canada)Reaction:: N AT
INJE
CTI
ON
SITE
Were injectio
n site reactio
ns present on
the last day t
he Subject Di
ary was comp
leted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020
11:36:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977105
Page 166 of 224
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-30-2020
11:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-30-2020
11:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-30-2020
15:58:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-30-2020
11:36:30ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977106
Page 167 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-30-2020
11:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
Sep-30-2020
15:58:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BMNG7
MInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-30-2020
15:58:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BMNG7MInitial Entry
5.b
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977107
Page 168 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Sep-30-2020
15:58:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BMNG7
NInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-30-2020
15:58:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BMNG7NInitial Entry
5.c
Date Location User Value Reason
Sep-30-2020
16:32:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPXTL
4Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977108
Page 169 of 224
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.c Sample ID
Date Location User Value Reason
Sep-30-2020
16:32:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPXTL4Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977109
Page 170 of 224
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-26-2021
12:51:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/26/2021Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977110
Page 171 of 224
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021
12:51:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-26-2021
12:51:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-01-2021
07:35:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Mar-01-2021
06:10:45ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0977111
Page 172 of 224
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-26-2021
12:51:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-26-2021
12:51:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Feb/26/2021Initial Entry
5.a
Date Location User Value Reason
Mar-01-2021
07:35:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BRF6G
RInitial Entry
5.a Sample ID
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977112
Page 173 of 224
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Mar-01-2021
07:35:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRF6GRInitial Entry
5.b
Date Location User Value Reason
Mar-01-2021
07:36:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BS9XD
RInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-01-2021
07:36:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS9XDRInitial Entry
5.c
Date Location User Value Reason
Mar-01-2021
07:36:21
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Sample I BS9XDInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977113
Page 174 of 224
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time (US
& Canada)D: S
5.c Sample ID
Date Location User Value Reason
Mar-01-2021
07:36:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS9XDSInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977114
Page 175 of 224
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Aug/13/2020Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-18-2020
11:38:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/13/2020Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977115
Page 176 of 224
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Aug/13/2020Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Assessments
Date Location User Value Reason
Aug-18-2020
11:41:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-18-2020
11:38:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Contact
Outcome is
ticked however
'CONTACT
OUTCOME'
form is not
entered. Please
review and
update as
appropriate.
Aug-18-2020
11:38:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CONTACT OUTC
OMEInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977116
Page 177 of 224
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Aug/13/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Contact Type:
Date Location User Value Reason
Aug-18-2020
11:41:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Aug-18-2020
11:41:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Aug/13/2020
Contact Outcome:
VISIT NOT ARR
ANGED, REACT
ION NO LONGE
R PRESENTInitial Entry
3. Comments:
Date Location User Value Reason
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977117
Page 178 of 224
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Aug/13/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-21-2020
05:34:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Aug-20-2020
11:25:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Aug-20-2020
11:25:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Subject is to contact
site if anything new
occurs.Changed
Information
Aug-19-2020
21:46:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery:
Subject contact
outcome states
the reaction is
longer present,
however, the
comments
indicate the
symptom is
ongoing. Please
review and
update as
appropriate.
Aug-18-2020
11:41:21ACV0PFEINFP6000  Data Entry:
Subject is to contactTranscription
Error
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977118
Page 179 of 224
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Aug/13/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00)
Eastern Time (US
& Canada)site if issue does not
resolve.
Aug-18-2020
11:41:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Subject is to contact
site if issue does not
resolveInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977119
Page 180 of 224
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled
Visit on Aug/18/2020Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-18-2020
11:41:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/18/2020Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977120
Page 181 of 224
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled
Visit on Aug/18/2020Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Assessments
Date Location User Value Reason
Aug-18-2020
11:42:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-18-2020
11:42:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Contact
Outcome is
ticked however
'CONTACT
OUTCOME'
form is not
entered. Please
review and
update as
appropriate.
Aug-18-2020
11:42:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CONTACT OUTC
OMEInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977121
Page 182 of 224
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled
Visit on Aug/18/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Contact Type:
Date Location User Value Reason
Aug-18-2020
11:42:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Aug-18-2020
11:42:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Aug/18/2020
Contact Outcome:
VISIT NOT ARR
ANGED, REACT
ION NO LONGE
R PRESENTInitial Entry
3. Comments:
Date Location User Value Reason
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977122
Page 183 of 224
***Confidential***
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled
Visit on Aug/18/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-18-2020
11:43:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
All symptoms are res
olved as of 14/AUG/
2020.Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977123
Page 184 of 224
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Sep-30-2020
11:36:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-30-2020
11:36:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-30-2020
11:36:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977124
Page 185 of 224
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Aug-26-2020
08:47:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977125
Page 186 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Sep-11-2020
12:23:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977126
Page 187 of 224
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Sep-14-2020
13:10:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Deleted Changed
Information
Sep-14-2020
13:09:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977127
Page 188 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Aug-26-2020
08:47:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Aug-26-2020
08:47:10
(UTC-05:00)
Eastern Time (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
Sep-14-2020
06:01:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2: C
losedevent recorded as AE#2
Sep-11-2020 ACV0PFEINFP6000  Query 2: A Changed data per query
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0977128
Page 189 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
12:23:26
(UTC-05:00)
Eastern Time
(US &
Canada)nswered
Sep-10-2020
06:15:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2: O
penedSAE
RECON:AER#2020326724
Peritoneal abscess(onset
date:17Aug2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Sep-09-2020
18:25:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Charu
SabharwalQuery 1: C
losedResponse satisfies query
Sep-09-2020
06:18:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1: A
nsweredThe SAE is NOT ruptured
appendix. Subject was
ONLY treated with
antibiotics. No surgery was
preformed.
Sep-04-2020
17:00:18
(UTC-05:00)ACV0PFEINFP6000  Charu
SabharwalQuery 1: O
penedClinical: SAE (AER
2020326724) course
appears to be consistent w
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977129
Page 190 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time
(US &
Canada)ruptured appendix. If so,
please update event term in
fu SAE term and include
symptoms at presentation,
timing of appendectomy
and abx including
diagnostic imaging.
Aug-28-2020
14:39:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
ACUTE A
PPENDICI
TISChanged Information
Aug-26-2020
08:47:10
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
APPENDI
CITISInitial Entry
4. Start Date Time:
Date Location User Value Reason
Aug-26-2020
08:47:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977130
Page 191 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Sep-04-2020
16:01:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/2/2020 UNK
:UNKChanged
Information
Aug-26-2020
08:47:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Aug-26-2020
08:54:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977131
Page 192 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Oct-29-2020
00:03:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Close
dQuery closed;
will follow for
SAE update with
requested
COVID test info
Oct-28-2020
12:15:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Answ
eredNo SARS-CoV-2
test was done
while in the
hospital. SAE
follow-up was
sent.
Oct-26-2020
22:11:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Reiss
ued:OpenedClinical – Thank
you. If NO
hospital Covid
test was
performed is
known, please
submit this
information on a
follow-up SAE
form, as
pertinent
information for
this trial.
Oct-26-2020
09:11:31
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Answ
eredNo COVID test
was done
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0977132
Page 193 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Oct-25-2020
21:36:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Open
edCOVID testing
has not been
reported in the
SAE submitted
to safety. Please
submit a
follow-up SAE
form
[#2020326724]
to provide
whether COVID
testing was
performed
(yes/no) and if
yes, the results.
Aug-28-2020
14:41:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious
event associat
ed with cong
enital anomal
y or birth def
ect?
NO
Did this serio
us event resul
t in death?
NO
Did this serioChanged
Information
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0977133
Page 194 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
us event requ
ire or prolong
hospitalizatio
n?
YES
Did this serio
us event resul
t in persistent
or significant
disability/inc
apacity?
NO
Is this serious
event life thre
atening?
NO
Other medica
lly important
serious event
NO
Aug-27-2020
04:34:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Delet
edClose Auto
Query
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977134
Page 195 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-26-2020
15:39:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Close
dAE ID was
entered.
Aug-26-2020
08:57:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answ
eredQuery is
ambiguous
Aug-26-2020
08:47:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Open
edIs this adverse
event serious?' is
reported 'Yes',
but at least one
seriousness
criteria is
missing. Please
review and
update as
appropriate.
Aug-26-2020
08:47:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candi
dateFor AE
APPENDICITIS:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is
blank.
Aug-26-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0977135
Page 196 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
08:47:10
(UTC-05:00)
Eastern Time
(US & Canada)YES
Is this serious
event associat
ed with cong
enital anomal
y or birth def
ect?
NO
Did this serio
us event resul
t in death?
NO
Did this serio
us event requ
ire or prolong
hospitalizatio
n?
YES
Did this serio
us event resul
t in persistent
or significant
disability/inc
apacity?
NO
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0977136
Page 197 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Other medica
lly important
serious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Aug-26-2020
08:47:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-03-2020
07:18:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed SDB causality
was updated to
not related.
issue resolved
Sep-02-2020
13:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered Confirm NOT
RELATED is
correct. An
updated SAE
for to resolve
queries is being
faxes/emailed
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977137
Page 198 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
02/Sep/2020
14:00.
Sep-02-2020
07:27:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Reissued:
OpenedSAE RECON 1:
The causality in
Safety database
was updated to
RELATED,
however, it was
recorded as
NOT
RELATED in
AE CRF. Please
confirm correct
causality.If
safety update is
required, please
submit a
follow-up form.
Aug-31-2020
06:26:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Reissued:
Candidateto check
updated SAE
listing if update
will be reflected
Aug-28-2020
14:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to s
tudy treatment(s),
this event is due t
o:
OTHERChanged
Information
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977138
Page 199 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
If Other, specif
y:
ACUTE APP
ENDICITIS
WITH PERI
TONEAL A
BSCESS
Aug-28-2020
13:51:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered working on
Follow up and
discharge
summary and
will forward
within the next
2 hours.
Aug-27-2020
04:38:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#
2020326724
,Causality for
Blinded
Therapy was
reported as NO
DATA in SAE
form however, it
was recorded as
NOT
RELATED.
Please confirm
correct
outcome.If
safety update is
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977139
Page 200 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
required, please
submit a
follow-up form.
Aug-26-2020
08:47:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to s
tudy treatment(s),
this event is due t
o:
OTHER
If Other, specif
y:
APPENDICI
TISInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Aug-26-2020
08:47:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Aug-26-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0977140
Page 201 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
08:47:10
(UTC-05:00)
Eastern Time (US
& Canada)YES
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Aug-28-2020
13:52:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NONew
Information
Aug-26-2020
08:47:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-07-2020
06:24:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
Closedresolved
Sep-04-2020
16:01:04
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1:
Answere
dChanged Information
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977141
Page 202 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Eastern Time
(US &
Canada)
Sep-04-2020
16:01:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data En
try:
RECOV
ERED/R
ESOLVE
DChanged Information
Sep-03-2020
07:25:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
Reissued
:OpenedSAE RECON 1: The outcome
for was updated to
RECOVERED/RESOLVED
in SDB while it was retained
as
RECOVERING/RESOLVING
in AE CRF.Please confirm
correct outcome. If safety
update is required, please
submit a follow-up form.
Sep-01-2020
06:03:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
Reissued
:Candida
teSAE RECON: To check latest
SAE listing if outcome will
match
Aug-31-2020
11:57:50
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000  Query 1:
Answere
dRECOVERING/RESOLVING
is correct
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977142
Page 203 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Canada)
Aug-31-2020
06:28:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
OpenedSAE
RECON:AER#2020326724
,outcome was updated to NOT
RECOVERED/NOT
RESOLVED in AE CRF
however,reported as
RECOVERING/RESOLVING
on SAE form. Please confirm
correct outcome. If safety
update is required, please
submit a follow-up form.
Aug-28-2020
14:40:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data En
try:
RECOV
ERING/
RESOL
VINGChanged Information
Aug-26-2020
08:47:10
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data En
try:
NOT RE
COVER
ED/NOT
RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Aug-26-2020
08:47:10ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977143
Page 204 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00)
Eastern Time (US
& Canada)
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Aug-27-2020
04:34:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2020326724Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0977144
Page 205 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Sep-11-2020
12:23:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-11-2020
12:23:12
(UTC-05:00)
Eastern Time (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
Sep-11-2020
12:23:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Peritoneal AbscessInitial Entry
4. Start Date Time:
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977145
Page 206 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Sep-11-2020
12:23:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-11-2020
12:23:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/2/2020 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-11-2020
12:23:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977146
Page 207 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Sep-14-2020
13:13:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: C
losedClose Auto Query
Sep-14-2020
13:13:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
YES
Is this ser
ious even
t associat
ed with c
ongenital
anomaly
or birth d
efect?
NO
Did this s
erious ev
ent result
in death?
NOChanged Information
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977147
Page 208 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Did this s
erious ev
ent requir
e or prolo
ng hospit
alization?
YES
Did this s
erious ev
ent result
in persist
ent or sig
nificant d
isability/i
ncapacity
?
NO
Is this ser
ious even
t life thre
atening?
NO
Other me
dically im
portant se
rious eve
nt
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0977148
Page 209 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
NO
Sep-14-2020
06:00:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1: O
penedSAE
RECON:AER#2020326724
Peritoneal abscess(onset
date:17Aug2020)was
reported as serious in
Safety database but repored
as not serious in AE CRF.
If this event is
serious,update to yes.To
downgrade the event in the
Safety Database,please
submit SAE form.
Sep-14-2020
05:57:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: C
andidateFor AE Peritoneal Abscess
: Response to "Is the
adverse event serious?" is
'No' but "Serious Adverse
Event Number" is present.
Sep-11-2020
12:23:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
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
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977149
Page 210 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-11-2020
12:23:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-11-2020
12:23:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:
Acute appendici
tis with peritone
al abscessInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-11-2020
12:23:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977150
Page 211 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-11-2020
12:23:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-11-2020
12:23:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-11-2020
12:23:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977151
Page 212 of 224
***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
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-11-2020
12:23:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-14-2020
05:57:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2020326724Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0977152
Page 213 of 224
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted,
Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Sep-14-2020
13:09:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-14-2020
13:09:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-14-2020
13:09:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
PERITONEAL ABS
CESSInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977153
Page 214 of 224
***Confidential***
4. Start Date Time:
Date Location User Value Reason
Sep-14-2020
13:09:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-14-2020
13:09:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-14-2020
13:09:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Sep-14-2020
13:10:08
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977154
Page 215 of 224
***Confidential***
& Canada)
Sep-14-2020
13:09:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
PERITONEAL
ABSCESS:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Sep-14-2020
13:09:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious eve
nt associated with
congenital anoma
ly or birth defect?
NO
Did this serious e
vent result in deat
h?
NO
Did this serious e
vent require or pr
olong hospitalizat
ion?
YES
Did this serious e
vent result in pers
istent or significa
nt disability/incap
acity?
NOInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977155
Page 216 of 224
***Confidential***
Is this serious eve
nt life threatening
?
NO
Other medically i
mportant serious
event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-14-2020
13:09:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-14-2020
13:09:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:
ACUTE APPE
NDICITISInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977156
Page 217 of 224
***Confidential***
Sep-14-2020
13:09:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-14-2020
13:09:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-14-2020
13:09:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-14-2020
13:10:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: C
losedClose Auto Query
Sep-14-2020
13:09:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: O
penedFor AE PERITONEAL
ABSCESS: Response to
"What was the outcome of
this adverse event?" is
RECOVERED/RESOLVED
but End Date/Time is
missing.
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977157
Page 218 of 224
***Confidential***
Sep-14-2020
13:09:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
RECOVE
RED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-14-2020
13:09:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0977158
Page 219 of 224
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-18-2021
20:41:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/17/2021Initial Entry
090177e196ae3ee1\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0977159
Page 220 of 224
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical
Research Unit
Subject No: 11091204 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-18-2021
20:42:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV
…[truncated]