125742 S1 M5 CRF c4591001 1120 11201350

Document text

Page 1 of 247
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 version06 OCT 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799447
Page 2 of 247
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/20/2020
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799448
Page 3 of 247
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Demography
1.Subject ID [11201350]
2.Birth Date: /1953
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799449
Page 4 of 247
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799450
Page 5 of 247
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799451
Page 6 of 247
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/20/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799452
Page 7 of 247
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: UNK/UNK/1992
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[congestive heart failure]
Start Date: UNK/UNK/1992
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[generalized body pain]
Start Date: UNK/UNK/2010
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[insomnia]
Start Date: UNK/UNK/1994
Ongoing: YES
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799453
Page 8 of 247
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[low testosterone]
Start Date: UNK/UNK/2010
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[quadruple bypass surgery]
Start Date: Dec/UNK/1992
Ongoing: NO
End Date:
Dec/UNK/1992
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[heart attack]
Start Date: UNK/UNK/1992
Ongoing: NO
End Date:
UNK/UNK/1992
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[pacemaker difibulator implant]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799454
Page 9 of 247
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[chronic neck pain]
Start Date: UNK/UNK/2009
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[chronic back pain]
Start Date: UNK/UNK/2007
Ongoing: YES
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799455
Page 10 of 247
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799456
Page 11 of 247
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Oct/20/2020
2.Weight: [95.1]
3.Unit: kg
4.Height: [175.0]
5.Unit: cm
6.Body Mass Index: [31.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799457
Page 12 of 247
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/20/2020
2.Randomization Number: [271448]
3.Randomization Group: [ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799458
Page 13 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
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 [BMN85J]
5.bSample ID [BMN85K]
5.cSample ID [BP8WH2]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799459
Page 14 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
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 [BP8WH0]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799460
Page 15 of 247
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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: Oct/20/2020 16:20
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799461
Page 16 of 247
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799462
Page 17 of 247
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799463
Page 18 of 247
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?YES
Ongoing?
NO
Stop Date:
Oct/24/2020
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
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
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799464
Page 19 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?YES
Ongoing?
NO
Stop Date:
Oct/24/2020
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
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
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799465
Page 20 of 247
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Jan/20/2021
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799466
Page 21 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/20/2021
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 [BHVSNC]
5.bSample ID [ ]
5.cSample ID [ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799467
Page 22 of 247
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?YES
Date of First Delay:
Dec/10/2020
Reason(s) for Temporary Delay of Vaccination
FEVER OR ACUTE ILLNESS
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Jan/20/2021 14:51 Comments
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT Comments
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES Comments
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799468
Page 23 of 247
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799469
Page 24 of 247
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
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?Not Done Comments
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799470
Page 25 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
3.Injection Site Location: Not Done Comments
4.Injection Site Body Side: Not Done Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?Not Done Comments
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?Not Done Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?Not Done Comments
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799471
Page 26 of 247
***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, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type SERUM Comments
3.Sample Collected? YES
Date of Collection:
Feb/24/2021Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BHVTCV]
5.bSample ID [BJ3D1N]
5.cSample ID [BJ3D1P]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799472
Page 27 of 247
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799473
Page 28 of 247
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799474
Page 29 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799475
Page 30 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799476
Page 31 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799477
Page 32 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799478
Page 33 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799479
Page 34 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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: [ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799480
Page 35 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799481
Page 36 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799482
Page 37 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799483
Page 38 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799484
Page 39 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799485
Page 40 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799486
Page 41 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799487
Page 42 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799488
Page 43 of 247
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
 1. ADVERSE
EVENT 1  WOUND PUMP DRAINA
GE Dec/7/2020 U
NK:UNK YES  Repeating
Pages
 2. ADVERSE
EVENT 2  PACE MAKER BATTER
Y CHARGE Nov/17/2020
UNK:UNK NO
End Date Time:
Nov/17/2020 UN
K:UNK
 Repeating
Pages
 3. ADVERSE
EVENT 3  HEMATOMA  Nov/23/2020
UNK:UNK NO
End Date Time:
Nov/23/2020 UN
K:UNK
 Repeating
Pages
 4. DELETED ADVERSE
EVENT 4  SUTURE SITE INFECTI
ON Dec/3/2020 U
NK:UNK YES  Repeating
Pages
 5. ADVERSE
EVENT 5  Postoperative wound infec
tion to left upper chest Nov/23/2020
UNK:UNK YES  Repeating
Pages
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799489
Page 44 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[WOUND PUMP DRAINAGE]
4.Start Date Time: Dec/7/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[UNKNOWN]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799490
Page 45 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799491
Page 46 of 247
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[PACE MAKER BATTERY CHARGE]
4.Start Date Time: Nov/17/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/17/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[HISTORY PACE MAKER]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799492
Page 47 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799493
Page 48 of 247
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[HEMATOMA]
4.Start Date Time: Nov/23/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/23/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[UNKNOWN]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799494
Page 49 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799495
Page 50 of 247
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[SUTURE SITE INFECTION ]
4.Start Date Time: Dec/3/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[UNKNOWN ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799496
Page 51 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
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?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799497
Page 52 of 247
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Postoperative wound infection to left upper chest]
4.Start Date Time: Nov/23/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
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
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799498
Page 53 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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:
[Pacemaker replacement]
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?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020492747]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799499
Page 54 of 247
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799500
Page 55 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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[ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799501
Page 56 of 247
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799502
Page 57 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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: //
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799503
Page 58 of 247
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799504
Page 59 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799505
Page 60 of 247
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799506
Page 61 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799507
Page 62 of 247
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799508
Page 63 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799509
Page 64 of 247
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/02/2021Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799510
Page 65 of 247
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/02/2021Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799511
Page 66 of 247
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/02/2021Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/2/2021
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799512
Page 67 of 247
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799513
Page 68 of 247
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799514
Page 69 of 247
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799515
Page 70 of 247
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799516
Page 71 of 247
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799517
Page 72 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799518
Page 73 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799519
Page 74 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799520
Page 75 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799521
Page 76 of 247
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Feb/24/2021 Comments
2.Phase of Disposition: VACCINATION Comments
3.Status: COMPLETED Comments
4.Specify Status: [ ] Comments
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799522
Page 77 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799523
Page 78 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799524
Page 79 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799525
Page 80 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/12/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799526
Page 81 of 247
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Done
//Comments
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799527
Page 82 of 247
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Done
//Comments
Cause of Death
2.Cause of Death Status: Not Done
Cause of Death: Not Done
[ ]
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799528
Page 83 of 247
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Feb/24/2021
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799529
Page 84 of 247
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Casebook Signature Form
1.Casebook Signature
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799530
Page 85 of 247
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799531
Page 86 of 247
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormOct-21-2020 08:12:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799532
Page 87 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Jan-22-2021 09:07:14 (UTC-05:00) Eastern
Time (US & Canada)
4Jan-11-2021 15:45:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799533
Page 88 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
6Mar-04-2021 09:07:25 (UTC-05:00) Eastern
Time (US & Canada)
6Jan-11-2021 15:45:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799534
Page 89 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
11Mar-04-2021 09:07:07 (UTC-05:00) Eastern
Time (US & Canada)
11Jan-11-2021 15:45:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799535
Page 90 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormJan-11-2021 15:49:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799536
Page 91 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Jan-11-2021 15:49:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799537
Page 92 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.aJan-11-2021 15:49:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799538
Page 93 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.bJan-11-2021 15:49:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799539
Page 94 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.cJan-11-2021 15:49:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799540
Page 95 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.dJan-11-2021 15:49:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799541
Page 96 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.eJan-11-2021 15:49:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799542
Page 97 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2 fJan-11-2021 15:49:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799543
Page 98 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.gJan-11-2021 15:49:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799544
Page 99 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2 hJan-11-2021 15:49:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799545
Page 100 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Jan-11-2021 15:49:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799546
Page 101 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Jan-11-2021 15:49:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799547
Page 102 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aJan-11-2021 15:49:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799548
Page 103 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bJan-11-2021 15:49:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799549
Page 104 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cJan-11-2021 15:49:31 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799550
Page 105 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormMar-11-2021 14:42:18 (UTC-05:00) Eastern
Time (US & Canada)
FormJan-11-2021 15:49:46 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799551
Page 106 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Mar-11-2021 14:42:18 (UTC-05:00) Eastern
Time (US & Canada)
1Jan-11-2021 15:49:46 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799552
Page 107 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Mar-11-2021 14:42:18 (UTC-05:00) Eastern
Time (US & Canada)
2Jan-11-2021 15:49:46 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799553
Page 108 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Mar-11-2021 14:42:18 (UTC-05:00) Eastern
Time (US & Canada)
3Jan-11-2021 15:49:46 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799554
Page 109 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Mar-11-2021 14:42:18 (UTC-05:00) Eastern
Time (US & Canada)
4Jan-11-2021 15:49:46 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799555
Page 110 of 247
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormMar-12-2021 09:01:07 (UTC-05:00) Eastern
Time (US & Canada)
FormJan-27-2021 09:15:36 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799556
Page 111 of 247
***Confidential***
Header Text: c4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Mar-12-2021 09:01:07 (UTC-05:00) Eastern
Time (US & Canada)
1Jan-27-2021 09:15:36 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799557
Page 112 of 247
***Confidential***
Header Text: c4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Mar-12-2021 09:01:07 (UTC-05:00) Eastern
Time (US & Canada)
2Jan-27-2021 09:15:36 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799558
Page 113 of 247
***Confidential***
Header Text: c4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Mar-12-2021 09:01:07 (UTC-05:00) Eastern
Time (US & Canada)
3Jan-27-2021 09:15:36 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799559
Page 114 of 247
***Confidential***
Header Text: c4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Mar-12-2021 09:01:07 (UTC-05:00) Eastern
Time (US & Canada)
4Jan-27-2021 09:15:36 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799560
Page 115 of 247
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormFeb-26-2021 11:36:46 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799561
Page 116 of 247
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Feb-26-2021 11:36:46 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799562
Page 117 of 247
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormFeb-26-2021 11:36:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799563
Page 118 of 247
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Feb-26-2021 11:36:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799564
Page 119 of 247
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799565
Page 120 of 247
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-21-2020 08:10:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-21-2020 08:10:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799566
Page 121 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-21-2020 08:11:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/20/2020Initial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799567
Page 122 of 247
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-21-2020 08:10:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11201350Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-21-2020 08:10:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1953Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-21-2020 08:11:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-21-2020 08:11:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR O
F SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-21-2020 08:11:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799568
Page 123 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-21-2020 08:12:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799569
Page 124 of 247
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-21-2020 08:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-21-2020 08:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-21-2020 08:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799570
Page 125 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.a
Date Location User Value Reason
Oct-21-2020 08:14:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:hypertension
Start Date: UNK/UNK/1
992
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-21-2020 08:14:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-17-2020 10:09:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response satisfies query
Dec-17-2020 10:01:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered UPDATED
Dec-16-2020 10:42:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Clinical_
AER#2020492747_Suture
site infection (Pace maker
removal_was reported as
serious in Safety database
but not recorded on AE
log of CRF. Please
confirm and update CRF.
Thank you.
Oct-21-2020 08:14:32
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
hypertensionInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0799571
Page 126 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
1.a Start Date:
Date Location User Value Reason
Oct-21-2020 08:14:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1992Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-21-2020 08:14:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-21-2020 08:14:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:congestive heart
failure
Start Date: UNK/UNK/199
2
Ongoing: YESInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799572
Page 127 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.b Line/MH Number:
Date Location User Value Reason
Oct-21-2020 08:14:53
(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
Oct-21-2020 08:14:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
congestive heart failureInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-21-2020 08:14:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1992Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-21-2020 08:14:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-21-2020 08:15:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:generalized bod
y pain
Start Date: UNK/UNK/201
0
Ongoing: YESInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799573
Page 128 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.c Line/MH Number:
Date Location User Value Reason
Oct-21-2020 08:15:23
(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
Oct-21-2020 08:15:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
generalized body painInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-21-2020 08:15:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-21-2020 08:15:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-21-2020 08:15:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:insomnia
Start Date: UNK/UNK/1
994
Ongoing: YESInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799574
Page 129 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.d Line/MH Number:
Date Location User Value Reason
Oct-21-2020 08:15:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 08:15:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
insomniaInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-21-2020 08:15:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1994Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-21-2020 08:15:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Oct-21-2020 08:16:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:low testostero
ne
Start Date: UNK/UNK/2
010
Ongoing: YESInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799575
Page 130 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.e Line/MH Number:
Date Location User Value Reason
Oct-21-2020 08:16:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 08:16:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
low testosteroneInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-21-2020 08:16:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-21-2020 08:16:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-21-2020 08:27:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:quadruple bypass
surgery
Start Date: Dec/UNK/1992
Ongoing: NO
End Date:
Dec/UNK/199
2Initial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799576
Page 131 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.f Line/MH Number:
Date Location User Value Reason
Oct-21-2020 08:27:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 08:27:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
quadruple bypass surgeryInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-21-2020 08:27:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/UNK/1992Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-21-2020 08:27:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Dec/UNK/1992Initial Entry
1.g
Date Location User Value Reason
Oct-21-2020 08:27:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7
Medical History
Term:heart attack
Start Date: UNK/UNK/199
2Initial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799577
Page 132 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Ongoing: NO
End Date:
UNK/UNK/
1992
1.g Line/MH Number:
Date Location User Value Reason
Oct-21-2020 08:27:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 08:27:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
heart attackInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-21-2020 08:27:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1992Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-21-2020 08:27:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1992Initial Entry
1.h
Date Location User Value Reason
Oct-21-2020 08:28:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8Initial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799578
Page 133 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Medical Histo
ry Term:pacemaker difibula
tor implant
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/201
0
1.h Line/MH Number:
Date Location User Value Reason
Oct-21-2020 08:28:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 08:28:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
pacemaker difibulator implantInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-21-2020 08:28:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-21-2020 08:28:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2010Initial Entry
1.i
Date Location User Value Reason
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799579
Page 134 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-21-2020 08:28:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:9
Medical History T
erm:chronic neck
pain
Start Date: UNK/UNK/2
009
Ongoing: YESInitial Entry
1.i Line/MH Number:
Date Location User Value Reason
Oct-21-2020 08:28:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 08:28:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
chronic neck painInitial Entry
1.i Start Date:
Date Location User Value Reason
Oct-21-2020 08:28:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2009Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-21-2020 08:28:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Oct-21-2020 08:28:49
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number 10Initial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799580
Page 135 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada) :
Medical History T
erm:chronic back
pain
Start Date: UNK/UNK/2
007
Ongoing: YES
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799581
Page 136 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.j Line/MH Number:
Date Location User Value Reason
Oct-21-2020 08:28:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 08:28:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
chronic back painInitial Entry
1.j Start Date:
Date Location User Value Reason
Oct-21-2020 08:28:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
1.j Ongoing:
Date Location User Value Reason
Oct-21-2020 08:28:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799582
Page 137 of 247
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-21-2020 08:29:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known to be H
IV POSITIVEInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799583
Page 138 of 247
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Oct-21-2020 08:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-21-2020 08:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
95.1Initial Entry
3. Unit:
Date Location User Value Reason
Oct-21-2020 08:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-21-2020 08:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
175.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-21-2020 08:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-21-2020 08:31:13
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
31.1Initial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799584
Page 139 of 247
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
7.a
Date Location User Value Reason
Oct-21-2020 08:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.8
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-21-2020 08:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-21-2020 08:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
36.8Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-21-2020 08:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-21-2020 08:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799585
Page 140 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-21-2020 08:33:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-21-2020 08:33:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
271448Initial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799586
Page 141 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020 08:33:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020 08:33:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 15:11:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-21-2020 08:33:39
(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.
Oct-21-2020 08:33:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020 15:11:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMN85JInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799587
Page 142 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.a Sample ID
Date Location User Value Reason
Oct-21-2020 15:11:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BMN85JInitial Entry
5.b
Date Location User Value Reason
Oct-21-2020 15:11:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMN85KInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-21-2020 15:11:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BMN85KInitial Entry
5.c
Date Location User Value Reason
Oct-21-2020 15:12:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8WH2Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-21-2020 15:12:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8WH2Initial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799588
Page 143 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020 08:33:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020 08:33:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 15:11:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-21-2020 08:33:56
(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.
Oct-21-2020 08:33:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020 15:11:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8WH0Initial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799589
Page 144 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.a Sample ID
Date Location User Value Reason
Oct-21-2020 15:11:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8WH0Initial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799590
Page 145 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-21-2020 08:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-21-2020 08:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-21-2020 08:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-21-2020 08:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020 16:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-21-2020 08:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-21-2020 08:34:26
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799591
Page 146 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
7. Route:
Date Location User Value Reason
Oct-21-2020 08:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-21-2020 08:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-21-2020 08:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799592
Page 147 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-21-2020 08:34:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799593
Page 148 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User ValueReason
Mar-08-2021
08:17:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Del
etedChanged
Information
Mar-08-2021
08:17:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Jan/20
/2021Changed
Information
Mar-04-2021
17:27:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Ca
ndidat
eDM: Do not issue
query; do not freeze
forms. Per query
response on Nasal
Swab, site needs to
update all visit
forms. Query can be
closed after updates
are made.
Dec-31-2020
03:34:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Clo
sedResponse satisfies
query
Dec-30-2020
10:20:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Nov/9
/2020New Information
Dec-30-2020
10:20:36
(UTC-05:00)ACV0PFEINFP6000  Query
2: An
swereSUBJECT CAME
IN FOR VAX2
VACCINATION
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799594
Page 149 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time
(US &
Canada)dUPDATED
Dec-30-2020
07:13:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Rei
ssued:
Opene
dDM 2: Thanks for
the response,
however the SWAB
PFE, VACIN TRT
forms are yet to be
updated, kindly
review and update,
else clarify.
Dec-22-2020
01:33:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Rei
ssued:
Candi
dateDM: Please review
VACIN TRT form
once entered.
Thanks.
Dec-21-2020
09:22:29
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: An
swere
dSubject has not
came in for vax
Dec-21-2020
04:10:34
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedClosed per SITE
response, added to
PD tracker for
Clinical Review
Dec-21-2020
01:46:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Rei
ssued:
Opene
dDM1: Please
complete VACIN
TRT form.
Dec-18-2020
09:16:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: An
swere
dupdated
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799595
Page 150 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Dec-18-2020
08:56:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dTHIS IS CORRECT
Dec-18-2020
05:09:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Op
enedDM: Kindly
consider to update
missing SWAB PFE,
VACIN TRT forms
or else clarify.
Thank you.
Dec-18-2020
03:37:31
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Op
enedPDQ: Date of visit at
V2_VAX2_L is out
of window for 28
days from
V1_DAY1_VAX1_L
Dose Date. Please
verify and update.
Else, confirm in
query response
appropriately.
Dec-17-2020
09:58:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Dec/1
0/202
0Initial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0799596
Page 151 of 247
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
Mar-10-2021 19:50:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Deleted Issue resolved
Mar-04-2021 17:28:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Candidate DM: Do not issue
query; do not freeze
forms. Per query
response on Nasal
Swab, site needs to
update all visit
forms. Query can be
closed after updates
are made.
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Dec-17-2020 09:59:12
(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?
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799597
Page 152 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Jan-15-2021 10:52:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FATIGUE
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:YES
Ongoin
g?
NO
Stop
Date:
Oct
/24/
202
0Changed
Information
Dec-18-2020 08:57:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FATI
GUE
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:YES
Ong
oing
?
YE
STranscription Error
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
GU
EInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799598
Page 153 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NO
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799599
Page 154 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.b Symptom:
Date Location User Value Reason
Dec-17-2020 09:59:12
(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
Jan-15-2021 10:52:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Oct/24/2020Changed
Information
Jan-11-2021 08:41:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Per response
Jan-08-2021 10:26:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered yes subject has not
received vax 2
Jan-08-2021 04:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened eDiary: Please
confirm if Fatigue
associated with
Vaccination 1
(20Oct20) is still
ongoing. Else,
Please review and
update stop date as
appropriate. Thanks
Dec-22-2020 07:45:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Data updated by
site.
Dec-18-2020 08:57:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799600
Page 155 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Dec-18-2020 08:57:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
YESTranscription Error
Dec-18-2020 02:02:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened eDiary: Per diary
records, FATIGUE
present on Last day
however inform
entered with 'No'
for the same. Please
verify and update.
If diary entered in
error, please enter
stop date as last
date of diary.
Thanks.
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799601
Page 156 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.c Symptom:
Date Location User Value Reason
Dec-17-2020 09:59:12
(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
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Dec-17-2020 09:59:12
(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
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799602
Page 157 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Dec-17-2020 09:59:12
(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
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Jan-15-2021 10:52:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIARRH
EAChanged
Information
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799603
Page 158 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:YES
Ongoin
g?
NO
Stop
Date:
Oct
/24/
202
0
Dec-18-2020 08:57:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIAR
RHEA
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:YES
Ong
oing
?
YE
STranscription Error
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799604
Page 159 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.f Symptom:
Date Location User Value Reason
Dec-17-2020 09:59:12
(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
Jan-18-2021 02:33:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Data updated by
site.
Jan-15-2021 10:52:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Changed
Information
Jan-15-2021 10:52:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Oct/24/2020Changed
Information
Jan-11-2021 08:40:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened eDiary RQ1:
Thanks for the
detailed response.
Please update stop
date for Diarrhea
once available and
then respond to the
query. Thanks.
Jan-08-2021 14:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered waiting on medical
records to see when
diarrhea stopped
Jan-08-2021 04:20:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened eDiary: Please
confirm if Diarrhea
associated with
Vaccination 1
(20Oct20) is still
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799605
Page 160 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
ongoing. Else,
Please review and
update stop date as
appropriate. Thanks
Dec-22-2020 07:45:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Data updated by
site.
Dec-18-2020 08:57:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Dec-18-2020 08:57:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
YESTranscription Error
Dec-18-2020 02:03:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened eDiary: Per diary
records,
DIARRHEA
present on Last day
however inform
entered with 'No'
for the same. Please
verify and update.
If diary entered in
error, please enter
stop date as last
date of diary.
Thanks.
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
NInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799606
Page 161 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NO
2.g Symptom:
Date Location User Value Reason
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799607
Page 162 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.h Symptom:
Date Location User Value Reason
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PA
INInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Dec-17-2020 09:59:12
(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
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day th
e Subject Diary was comple
ted?:NOInitial Entry
5.a Injection Site Reaction:
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799608
Page 163 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Dec-17-2020 09:59:12
(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
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Dec-17-2020 09:59:12
(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
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799609
Page 164 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:
:PAIN A
T INJE
CTION
SITE
Were injection site reac
tions present on the last
day the Subject Diary
was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-17-2020 09:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799610
Page 165 of 247
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Mar-08-2021 08:18:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Deleted Changed
Information
Mar-08-2021 08:18:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/20/2021Changed
Information
Mar-04-2021 17:28:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Candidate DM: Do not issue
query; do not freeze
forms. Per query
response on Nasal
Swab, site needs to
update all visit
forms. Query can be
closed after updates
are made.
Feb-01-2021 00:48:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Jan-29-2021 14:29:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Subject had a delay
of Vax.
Jan-25-2021 02:53:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened DM: Page has been
unfrozen. Please
update.
Jan-22-2021 09:09:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Please unfreeze all
other pages
Jan-22-2021 09:07:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Vital Signs Date is
not same as
Vaccination Date in
the same visit.
Please review and
update as
appropriate or
clarify.
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799611
Page 166 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Dec-30-2020 10:21:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-30-2020 10:21:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/9/2020Transcription Error
Dec-30-2020 10:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Vital Signs Date is
not same as
Vaccination Date in
the same visit.
Please review and
update as
appropriate or
clarify.
Dec-17-2020 09:59:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/10/2020Initial Entry
2.a
Date Location User Value Reason
Mar-08-2021 08:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 98.5
Temperature Uni
t:F
Temperature Loc
ation::ORAL CAV
ITYChanged
Information
Dec-17-2020 09:59:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 98.4
Temperature Uni
t:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799612
Page 167 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Dec-17-2020 09:59:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Mar-08-2021 08:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.5Changed
Information
Dec-17-2020 09:59:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.4Initial Entry
2.a Unit:
Date Location User Value Reason
Dec-17-2020 09:59:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Dec-17-2020 09:59:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799613
Page 168 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-18-2020 09:12:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-18-2020 09:12:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-08-2021 10:01:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rivkah Rosen Query 6: Closed Response satisfies
query
Mar-08-2021 08:17:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 6: Answered Answer Auto Query
Mar-04-2021 17:26:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 6: Reissued:Opened DM: All visit forms
have been unfrozen.
Please update as
needed.
Mar-04-2021 08:59:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 6: Answered Reaching out to
CRA to have
unfrozen.
Mar-01-2021 15:41:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 6: Reissued:Opened DM: Unfrozen.
Please update data
per query response
provided. Thank
you.
Feb-26-2021 15:29:49
(UTC-05:00) EasternACV0PFEINFP6000  Query 6: Answered I NEED THE
WHOLE VISIT
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0799614
Page 169 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada) UNFROZEN
Feb-24-2021 06:42:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 6: Reissued:Opened DM: Please update
data per query
response provided.
Thank you.
Feb-23-2021 16:12:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 6: Answered PLEASE
UNFREEZE DATE
OF VISIT
Feb-23-2021 16:12:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 7: Deleted Close Auto Query
Feb-23-2021 16:11:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 7: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-23-2021 16:11:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 6: Opened Date of Collection
20/Jan/2021 is
greater than Date of
Visit 09/Nov/2020.
Please review and
update as
appropriate, else
clarify.
Feb-23-2021 16:11:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/20/2021New Information
Dec-18-2020 09:15:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Closed Close Auto Query
Dec-18-2020 09:15:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Opened 'Sample Collected?'
is marked as No and
'If no sample was
collected or sample
was not collected
according to
protocol, please
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799615
Page 170 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
provide reason' is
missing. Please
review and update
as appropriate.
Dec-18-2020 09:15:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Deleted Close Auto Query
Dec-18-2020 09:15:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription Error
Dec-18-2020 09:15:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-18-2020 09:15:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
Dec-18-2020 09:14:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened There are more than
1 barcode present
for sample
collection. Please
review and correct
as appropriate.
Dec-18-2020 09:14:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Dec-18-2020 09:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened There are more than
1 barcode present
for sample
collection. Please
review and correct
as appropriate.
Dec-18-2020 09:12:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-18-2020 09:12:10
(UTC-05:00) EasternACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799616
Page 171 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada) barcodes are
entered. Please
review and correct
as appropriate.
Dec-18-2020 09:12:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/10/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Feb-23-2021 16:11:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: New Information
Dec-21-2020 01:51:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Closed as not found
in today's INVALID
CHAR report
Dec-18-2020 09:16:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered updated
Dec-18-2020 09:15:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Entered text has
either a carriage
return (line break)
or extra spaces at
the end of the text
or between words.
Please correct by
removing all data in
the field and
re-enter without
adding extra spaces
or using enter or tab
keys.
Dec-18-2020 09:15:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
No nasal swab collected at this v
isitInitial Entry
5.a
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799617
Page 172 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Feb-23-2021 16:12:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BHVSNCInitial Entry
Dec-18-2020 09:14:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID:Transcription Error
Dec-18-2020 09:12:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMN8HNInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-23-2021 16:12:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BHVSNCInitial Entry
Dec-18-2020 09:14:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-18-2020 09:12:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BMN8HNInitial Entry
5.b
Date Location User Value Reason
Dec-18-2020 09:15:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID:Transcription Error
Dec-18-2020 09:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMN8HPInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799618
Page 173 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.b Sample ID
Date Location User Value Reason
Dec-18-2020 09:15:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-18-2020 09:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BMN8HPInitial Entry
5.c
Date Location User Value Reason
Dec-18-2020 09:15:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID:Transcription Error
Dec-18-2020 09:12:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR5R08Initial Entry
5.c Sample ID
Date Location User Value Reason
Dec-18-2020 09:15:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-18-2020 09:12:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR5R08Initial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799619
Page 174 of 247
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Mar-10-2021 19:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Deleted Issue resolved
Mar-04-2021 17:28:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Candidate DM: Do not issue
query; do not freeze
forms. Per query
response on Nasal
Swab, site needs to
update all visit
forms. Query can be
closed after updates
are made.
Dec-18-2020 09:14:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of First Delay:
Dec/10/2020
Reason(s) for Temporary Delay o
f Vaccination
FEVER OR ACUTE ILLNESSInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-22-2021 09:07:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
Jan-08-2021 10:33:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Dec-30-2020 10:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799620
Page 175 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
3. Formulation:
Date Location User Value Reason
Jan-22-2021 09:07:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
Jan-08-2021 10:33:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Dec-30-2020 10:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-31-2021 23:43:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Jan-29-2021 14:29:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Subject had a delay
of vax.
Jan-25-2021 12:48:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened DM: Please update
data per query
response provided.
Thank you.
Jan-22-2021 09:08:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered all forms are frozen.
Jan-22-2021 09:07:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Dose Date is not
equal to Date of
Visit 09/Nov/2020
of the corresponding
Visit. Please review
and update as
appropriate.
Jan-22-2021 09:07:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Answer Auto Query
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799621
Page 176 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Jan-22-2021 09:07:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/20/2021 14:51Initial Entry
Jan-22-2021 09:07:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Jan-14-2021 23:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidate Please review this
query once data is
entered on
Vaccination CRF.
Jan-13-2021 10:44:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered waiting for CRA to
move forward with
subject
Jan-12-2021 05:16:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Thank you. Please
provide date at
which missing
information will be
available for data
entry.
Jan-11-2021 15:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered UPDATED TO
NOT
APPLICABLE
UNTIL SUBEJCT
GETS VAXED
Jan-11-2021 15:45:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Jan-11-2021 03:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM1: Kindly
review and provide
details on this form
as appropriate to
avoid yellow traffic
light. Else clarify.
Jan-08-2021 10:33:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Answer Auto Query
Jan-08-2021 10:33:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799622
Page 177 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Dec-31-2020 05:38:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: Data is not
updated per query.
Dose Date Time
(9/Nov/2020) is
before Date of First
delay (10/Dec
/2020). Kindly
verify both the dates
and update CRF as
needed. Else clarify
in query response.
Dec-30-2020 10:21:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered TEMP DELAY
UPDATED
Dec-30-2020 10:20:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Dec-30-2020 10:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Dose Date is not
equal to Date of
Visit 10/Dec/2020
of the corresponding
Visit. Please review
and update as
appropriate.
Dec-30-2020 10:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened "Dose Date" is
before "Date of First
delay" 10/Dec/2020.
Please review and
update as
appropriate.
Dec-30-2020 10:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/9/2020 14:14Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-22-2021 09:07:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
Jan-08-2021 10:33:42 ACV0PFEINFP6000  auto calc Data Entry: Transcription Error
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799623
Page 178 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00) Eastern
Time (US & Canada)(autocalc)
Dec-30-2020 10:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Mar-04-2021 09:07:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
Mar-04-2021 09:07:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Jan-11-2021 15:45:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Jan-08-2021 10:34:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-30-2020 10:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-22-2021 09:07:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
Jan-08-2021 10:33:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Dec-30-2020 10:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799624
Page 179 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Jan-22-2021 09:07:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
Jan-08-2021 10:33:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Dec-30-2020 10:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Mar-04-2021 09:07:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
Mar-04-2021 09:07:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Jan-11-2021 15:45:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Jan-08-2021 10:34:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-30-2020 10:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799625
Page 180 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021 10:51:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 4: Closed Response satisfies
query
Mar-12-2021 09:01:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered updated
Mar-12-2021 09:00:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Deleted Close Auto Query
Mar-11-2021 16:09:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 4: Reissued:Opened CLINQUERY: Visit
updated with new
data. Please remove
the 'erroneous' entry
on this page. Please
also update the EOT
page to reflect end
of treatment phase
now that V3 is
complete
Mar-11-2021 14:42:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please either untick
the erroneous visit
button if visit
occurred, or mark
any forms
containing data
within this visit as
Not Done/Not
Applicable at the
form level.
Mar-11-2021 14:42:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Answered New Information
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0799626
Page 181 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Mar-11-2021 14:42:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/24/2021New Information
Mar-09-2021 08:33:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 4: Opened CLINQUERY: Vax
2 was administered
20Jan21. Please
review and confirm
if V3 has been
completed (month
post V2). Page
unfreeze can be
actioned for data
entry, if so.
Jan-12-2021 01:15:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Closed as data
updated.
Jan-11-2021 15:50:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered UPDATED
Jan-11-2021 01:23:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Closing as visit is
marked Erroneous
Jan-11-2021 01:07:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened DM: Erroneous visit
is marked.
However, data is
present on
SYMPRDATE
form. Kindly
consider to erase the
data from
SYMPRDATE form
and add form level
comment by
selecting Not Done
or Not Applicable
option on
SYMPRDATE form
accordingly else,
clarify.
Jan-08-2021 10:35:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered visit entered in error
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0799627
Page 182 of 247
***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, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Jan-08-2021 10:34:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please check
whether other
assessments are
performed at this
visit.
Jan-05-2021 01:39:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Jan-04-2021 08:54:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered UPDATED
Dec-31-2020 04:38:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened DM: If V3 is
performed please
update EOT. Thank
you.
Dec-31-2020 04:36:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly
consider to update
missing SAMP
TRK form or else
clarify. Thank you.
Dec-30-2020 10:22:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/7/2020Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Mar-12-2021 09:00:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Jan-08-2021 10:34:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799628
Page 183 of 247
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Jan-08-2021 10:34:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:Not
Do
neInitial Entry
Jan-11-2021 15:49:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:Transcription Error
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
RInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799629
Page 184 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:N
O
2.a Symptom:
Date Location User Value Reason
Dec-30-2020 10:22:19
(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
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Jan-11-2021 15:49:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TIG
UE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:Not
Do
neInitial Entry
Jan-11-2021 15:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TIG
UETranscription Error
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799630
Page 185 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TIG
UE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
2.b Symptom:
Date Location User Value Reason
Dec-30-2020 10:22:19
(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
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Jan-11-2021 15:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
ACInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799631
Page 186 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
HE
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:Not
Don
e
Jan-11-2021 15:49:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:Transcription Error
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799632
Page 187 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.c Symptom:
Date Location User Value Reason
Dec-30-2020 10:22:19
(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
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Jan-11-2021 15:49:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:Not
Do
neInitial Entry
Jan-11-2021 15:48:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Transcription Error
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799633
Page 188 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Dec-30-2020 10:22:19
(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
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Jan-11-2021 15:48:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:Not
Don
eInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799634
Page 189 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Jan-11-2021 15:48:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:Transcription Error
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Dec-30-2020 10:22:19
(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
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Jan-11-2021 15:48:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799635
Page 190 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:Not
Don
eInitial Entry
Jan-11-2021 15:48:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:Transcription Error
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799636
Page 191 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.f Symptom:
Date Location User Value Reason
Dec-30-2020 10:22:19
(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
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Jan-11-2021 15:48:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:Not DoneInitial Entry
Jan-11-2021 15:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
NTranscription Error
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799637
Page 192 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Jan-11-2021 15:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799638
Page 193 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:Not DoneInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799639
Page 194 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
2.h
Date Location User Value Reason
Jan-11-2021 15:47:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:Transcription Error
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799640
Page 195 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.h Symptom:
Date Location User Value Reason
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Jan-11-2021 15:47:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not DoneInitial Entry
Jan-08-2021 10:34:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Dec-30-2020 10:22:19
(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
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799641
Page 196 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Jan-08-2021 10:34:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:Not
Don
eInitial Entry
Jan-11-2021 15:47:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:Transcription Error
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Dec-30-2020 10:22:19
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799642
Page 197 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Jan-11-2021 15:47:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:Not
Don
eInitial Entry
Jan-11-2021 15:47:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:Transcription Error
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NGInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799643
Page 198 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NO
5.b Injection Site Reaction:
Date Location User Value Reason
Dec-30-2020 10:22:19
(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
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Jan-11-2021 15:47:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:Not Do
neInitial Entry
Jan-11-2021 15:47:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction
::PAIN A
T INJETranscription Error
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799644
Page 199 of 247
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
CTION
SITE
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-11-2021 15:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Jan-11-2021 15:47:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-30-2020 10:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3fff\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799645
Page 200 of 247
***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, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-11-2021 14:42:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
Mar-11-2021 14:42:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Jan-11-2021 15:49:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-11-2021 14:42:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
Mar-11-2021 14:42:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Jan-11-2021 15:49:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-11-2021 14:44:25
(UTC-05:00) Easte
…[truncated]