Document text
Page 1 of 190
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948738
Page 2 of 190
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/17/2020
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948739
Page 3 of 190
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Demography
1.Subject ID [11951059]
2.Birth Date: UNK/UNK/1953
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948740
Page 4 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/17/2020
2.Erroneous Visit
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948741
Page 5 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948742
Page 6 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/17/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948743
Page 7 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: Sep/7/2011
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Carpal Tunnel Syndrome]
Start Date: May/25/2009
Ongoing: YES
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948744
Page 8 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948745
Page 9 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Oct/17/2020
2.Weight: [95.4]
3.Unit: kg
4.Height: [171.0]
5.Unit: cm
6.Body Mass Index: [32.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948746
Page 10 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/17/2020
2.Randomization Number: [270204]
3.Randomization Group: [ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948747
Page 11 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/17/2020
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 [BNMDJH]
5.bSample ID [BNMDJJ]
5.cSample ID [BN8X0B]
5.dSample ID [BN8X0T]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948748
Page 12 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/17/2020
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 [BN8WZP]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948749
Page 13 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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/17/2020 10:29
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
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948750
Page 14 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948751
Page 15 of 190
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/7/2020
2.Erroneous Visit
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948752
Page 16 of 190
***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, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948753
Page 17 of 190
***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, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948754
Page 18 of 190
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Nov/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948755
Page 19 of 190
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/7/2020
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 [BN86GN]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948756
Page 20 of 190
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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: Nov/7/2020 10:54
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
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948757
Page 21 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/5/2020
2.Erroneous Visit
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948758
Page 22 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948759
Page 23 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948760
Page 24 of 190
***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, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/5/2020
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 [BN8KLB]
5.bSample ID [BN8KLC]
5.cSample ID [BNLWP3]
5.dSample ID [BNLWP4]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948761
Page 25 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948762
Page 26 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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: [ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948763
Page 27 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948764
Page 28 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948765
Page 29 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948766
Page 30 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948767
Page 31 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948768
Page 32 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948769
Page 33 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948770
Page 34 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948771
Page 35 of 190
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EV
ENT 1 Chills Jan/28/2021 20:00 NO
End Date Time:
Jan/29/2021 06:00
Repeating
Pages
2.ADVERSE EV
ENT 2 Myalgia Jan/28/2021 20:00 NO
End Date Time:
Jan/29/2021 06:00
Repeating
Pages
3.ADVERSE EV
ENT 3 muscle pain Feb/18/2021 16:30 NO
End Date Time:
Feb/19/2021 13:00
Repeating
Pages
4.ADVERSE EV
ENT 4 Chills Feb/18/2021 16:30 NO
End Date Time:
Feb/19/2021 13:00
Repeating
Pages
5.ADVERSE EV
ENT 5 absolute arrhyth
mia Feb/25/2021 UNK:
UNK YES Repeating
Pages
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948772
Page 36 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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)[Chills]
4.Start Date Time: Jan/28/2021 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/29/2021 06:00
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948773
Page 37 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948774
Page 38 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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)[Myalgia]
4.Start Date Time: Jan/28/2021 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/29/2021 06:00
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948775
Page 39 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948776
Page 40 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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)[muscle pain]
4.Start Date Time: Feb/18/2021 16:30
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/19/2021 13:00
6.Toxicity Grade: 2
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948777
Page 41 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948778
Page 42 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Chills]
4.Start Date Time: Feb/18/2021 16:30
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/19/2021 13:00
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948779
Page 43 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948780
Page 44 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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)[absolute arrhythmia]
4.Start Date Time: Feb/25/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
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
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948781
Page 45 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
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[ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948782
Page 46 of 190
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948783
Page 47 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948784
Page 48 of 190
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948785
Page 49 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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: //
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948786
Page 50 of 190
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948787
Page 51 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948788
Page 52 of 190
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948789
Page 53 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948790
Page 54 of 190
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948791
Page 55 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948792
Page 56 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948793
Page 57 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Unplanned Assessments
1.Assessments
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948794
Page 58 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948795
Page 59 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948796
Page 60 of 190
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948797
Page 61 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948798
Page 62 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948799
Page 63 of 190
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Dec/5/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948800
Page 64 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948801
Page 65 of 190
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948802
Page 66 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948803
Page 67 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/25/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948804
Page 68 of 190
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948805
Page 69 of 190
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948806
Page 70 of 190
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948807
Page 71 of 190
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/28/2021
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948808
Page 72 of 190
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948809
Page 73 of 190
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/28/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948810
Page 74 of 190
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/28/2021
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 [BN8KZK]
5.bSample ID [BN8KZL]
5.cSample ID [BNLW9C]
5.dSample ID [BNLW9D]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948811
Page 75 of 190
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/28/2021
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 [BN8KZJ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948812
Page 76 of 190
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/28/2021 09:31
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948813
Page 77 of 190
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948814
Page 78 of 190
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/18/2021
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 [BN8L54]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948815
Page 79 of 190
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/18/2021 09:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948816
Page 80 of 190
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948817
Page 81 of 190
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948818
Page 82 of 190
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948819
Page 83 of 190
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948820
Page 84 of 190
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948821
Page 85 of 190
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948822
Page 86 of 190
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948823
Page 87 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/5/2020
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948824
Page 88 of 190
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948825
Page 89 of 190
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Axel Schaefer Approved Mar-11-2021 14:27:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AxelSchaefer, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948826
Page 90 of 190
***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, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-17-2020 11:30:40 (UTC+01:00) Sarajevo,
Skopje, Warsaw, Zagrebn.a.
Not Applicable
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948827
Page 91 of 190
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormJan-28-2021 13:42:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948828
Page 92 of 190
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Axel Schaefer Approved Mar-11-2021 14:27:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AxelSchaefer, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-11-2021 12:25:03 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer Approved Feb-22-2021 21:30:42 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AxelSchaefer, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-18-2021 08:50:51 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948829
Page 93 of 190
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Axel Schaefer Approved Jan-31-2021 20:12:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AxelSchaefer, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-29-2021 10:12:59 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer Approved Jan-28-2021 18:41:49 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AxelSchaefer, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-28-2021 13:41:25 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer Approved Jan-25-2021 20:58:32 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948830
Page 94 of 190
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Affidavit:
By my dated signature below, I, AxelSchaefer, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-25-2021 16:54:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer Approved Dec-05-2020 12:21:49 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AxelSchaefer, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-05-2020 09:44:21 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer Approved Nov-08-2020 15:20:04 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0948831
Page 95 of 190
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Affidavit:
By my dated signature below, I, AxelSchaefer, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-07-2020 13:54:40 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer Approved Nov-03-2020 20:04:09 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AxelSchaefer, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0948832
Page 96 of 190
***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, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-17-2020 11:18:51
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-17-2020 11:18:51
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948833
Page 97 of 190
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-17-2020 11:18:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Oct/17/2020Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948834
Page 98 of 190
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-17-2020 11:19:51
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
11951059Transcription Error
Oct-17-2020 11:18:43
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11951060Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-17-2020 11:17:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
UNK/UNK/1953Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-17-2020 11:19:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-17-2020 11:19:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO
(A) OR OF SPANISH ORIGI
NInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-17-2020 11:19:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948835
Page 99 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-17-2020 11:30:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/17/2020Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948836
Page 100 of 190
***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, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-17-2020 11:30:24
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-17-2020 11:30:24
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-17-2020 11:30:24
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948837
Page 101 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.a
Date Location User Value Reason
Oct-17-2020 12:55:50
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Hypertensi
on
Start Date: Sep/7/2011
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-17-2020 12:55:50
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-17-2020 12:55:50
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-17-2020 12:55:50
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sep/7/2011Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-17-2020 12:55:50
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948838
Page 102 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Oct-17-2020 12:56:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Carpal Tunnel S
yndrome
Start Date: May/25/2009
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Oct-17-2020 12:56:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-17-2020 12:56:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Carpal Tunnel SyndromeInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-17-2020 12:56:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
May/25/2009Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-17-2020 12:56:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948839
Page 103 of 190
***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, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-17-2020 12:54:29
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
The subject is NOT known to
be HIV POSITIVEInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948840
Page 104 of 190
***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, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Oct-17-2020 12:56:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/17/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-17-2020 12:56:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
95.4Initial Entry
3. Unit:
Date Location User Value Reason
Oct-17-2020 12:56:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-17-2020 12:56:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
171.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-17-2020 12:56:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-17-2020 12:56:38
(UTC+01:00) Sarajevo,ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
32.6Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948841
Page 105 of 190
***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, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Skopje, Warsaw, Zagreb
7.a
Date Location User Value Reason
Oct-17-2020 12:56:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 36.5
Temperature Un
it:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-17-2020 12:56:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-17-2020 12:56:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-17-2020 12:56:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-17-2020 12:56:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948842
Page 106 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-17-2020 13:00:10
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/17/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-17-2020 13:00:10
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
270204Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948843
Page 107 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-17-2020 13:00:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-17-2020 13:00:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-17-2020 14:40:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-17-2020 13:00:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-17-2020 13:00:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/17/2020Initial Entry
5.a
Date Location User Value Reason
Oct-17-2020 14:40:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BNMDJHInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948844
Page 108 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User Value Reason
Oct-17-2020 14:40:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BNMDJHInitial Entry
5.b
Date Location User Value Reason
Oct-17-2020 14:41:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BNMDJJInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-17-2020 14:41:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BNMDJJInitial Entry
5.c
Date Location User Value Reason
Oct-17-2020 14:41:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BN8X0BInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-17-2020 14:41:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN8X0BInitial Entry
5.d
Date Location User Value Reason
Oct-17-2020 14:41:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BN8X0TInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948845
Page 109 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.d Sample ID
Date Location User Value Reason
Oct-17-2020 14:41:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN8X0TInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948846
Page 110 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-17-2020 13:00:23
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-17-2020 13:00:23
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-17-2020 14:41:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-17-2020 13:00:23
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-17-2020 13:00:23
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/17/2020Initial Entry
5.a
Date Location User Value Reason
Oct-17-2020 14:41:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BN8WZPInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948847
Page 111 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User Value Reason
Oct-17-2020 14:41:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN8WZPInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948848
Page 112 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-17-2020 13:55:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-17-2020 13:55:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-17-2020 13:55:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-17-2020 13:55:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/17/2020 10:29Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-17-2020 13:55:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-17-2020 13:55:41
(UTC+01:00) Sarajevo,ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0948849
Page 113 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Skopje, Warsaw, Zagreb
7. Route:
Date Location User Value Reason
Oct-17-2020 13:55:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-17-2020 13:55:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-17-2020 13:55:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948850
Page 114 of 190
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-17-2020 13:55:48
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E
-DIARY COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948851
Page 115 of 190
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-07-2020 13:54:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Nov/7/2020Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948852
Page 116 of 190
***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, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: FE
V
ER
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 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
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948853
Page 117 of 190
***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, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.b Symptom:
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 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
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948854
Page 118 of 190
***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, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.c Symptom:
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 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
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:N
OInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948855
Page 119 of 190
***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, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.d Symptom:
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 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
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948856
Page 120 of 190
***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, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.e Symptom:
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 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
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948857
Page 121 of 190
***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, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.f Symptom:
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 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
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAIN
Were fever or syst
emic symptoms p
resent on the last
day the Subject D
iary was complete
d?:NOInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948858
Page 122 of 190
***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, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.g Symptom:
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUS
CLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syst
emic symptoms pr
esent on the last d
ay the Subject Dia
ry was completed?
:NOInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948859
Page 123 of 190
***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, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.h Symptom:
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOIN
T PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Injection Site Reaction
::RE
DN
ES
SInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948860
Page 124 of 190
***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, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:NO
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 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
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Injection Site Reactio
n::SW
ELL
ING
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948861
Page 125 of 190
***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, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 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
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Injection Site React
ion::PAIN
AT INJ
ECTIO
N SIT
E
Were injection site
reactions present o
n the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948862
Page 126 of 190
***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, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 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
Nov-07-2020 13:54:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948863
Page 127 of 190
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Nov-07-2020 13:55:10
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Nov/7/2020Initial Entry
2.a
Date Location User Value Reason
Nov-07-2020 13:55:10
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Record Identifi
er::1
Temperature: 36.9
Temperature U
nit:C
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-07-2020 13:55:10
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-07-2020 13:55:10
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948864
Page 128 of 190
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Nov-07-2020 13:55:10
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-07-2020 13:55:10
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948865
Page 129 of 190
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-07-2020 13:55:21
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-07-2020 13:55:21
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-07-2020 14:46:00
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-07-2020 13:55:21
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-07-2020 13:55:21
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/7/2020Initial Entry
5.a
Date Location User Value Reason
Nov-07-2020 14:46:00
(UTC+01:00) Sarajevo,ACV0PFEINFP6000 Data Entry:
Sample ID: BN86GNInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948866
Page 130 of 190
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Skopje, Warsaw, Zagreb
5.a Sample ID
Date Location User Value Reason
Nov-07-2020 14:46:00
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN86GNInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948867
Page 131 of 190
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-07-2020 13:55:36
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-07-2020 13:55:36
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-07-2020 13:55:36
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-07-2020 13:55:36
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Nov/7/2020 10:54Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-07-2020 13:55:36
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948868
Page 132 of 190
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Nov-07-2020 13:55:36
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-07-2020 13:55:36
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-07-2020 13:55:36
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-07-2020 13:55:36
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948869
Page 133 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-05-2020 09:44:21
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Dec/5/2020Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948870
Page 134 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 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
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948871
Page 135 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
GU
E
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:NO
2.b Symptom:
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 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
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948872
Page 136 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.c Symptom:
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 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-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:N
OInitial Entry
2.d Symptom:
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 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-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948873
Page 137 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 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-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948874
Page 138 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.f Symptom:
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 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
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WORS
ENED M
USCLE
PAIN
Were fever or syst
emic symptoms pr
esent on the last d
ay the Subject Dia
ry was completed?
:NOInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948875
Page 139 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.g Symptom:
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUS
CLE 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-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syste
mic symptoms pre
sent on the last day
the Subject Diary
was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOIN
T PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948876
Page 140 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
3. Injection Site Location:
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Injection Site Reaction:
:RE
DN
ES
S
Were injection site reac
tions present on the last
day the Subject Diary
was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 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-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948877
Page 141 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Injection Site Reaction
::SW
ELL
ING
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 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-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Injection Site Reacti
on::PAIN
AT INJ
ECTIO
N SIT
E
Were injection site r
eactions present on t
he last day the Subj
ect Diary was compl
eted?:NOInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948878
Page 142 of 190
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.c Injection Site Reaction:
Date Location User Value Reason
Dec-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 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-05-2020 09:44:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948879
Page 143 of 190
***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, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-05-2020 09:45:12
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-05-2020 09:45:12
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-05-2020 10:52:15
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-05-2020 09:45:12
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-05-2020 09:45:12
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/5/2020Initial Entry
5.a
Date Location User Value Reason
Dec-05-2020 10:52:15
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BN8KLBInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948880
Page 144 of 190
***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, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User Value Reason
Dec-05-2020 10:52:15
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN8KLBInitial Entry
5.b
Date Location User Value Reason
Dec-05-2020 10:52:49
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BN8KLCInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-05-2020 10:52:49
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN8KLCInitial Entry
5.c
Date Location User Value Reason
Dec-05-2020 10:54:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BNLWP3Initial Entry
5.c Sample ID
Date Location User Value Reason
Dec-05-2020 10:54:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BNLWP3Initial Entry
5.d
Date Location User Value Reason
Dec-05-2020 10:54:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BNLWP4Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948881
Page 145 of 190
***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, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.d Sample ID
Date Location User Value Reason
Dec-05-2020 10:54:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BNLWP4Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0948882
Page 146 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Jan-29-2021 10:12:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Form Created
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948883
Page 147 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Jan-29-2021 10:14:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Form Created
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948884
Page 148 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Feb-22-2021 09:43:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Form Created
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948885
Page 149 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Feb-22-2021 09:44:24
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Form Created
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948886
Page 150 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Mar-11-2021 12:25:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Form Created
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948887
Page 151 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Jan-29-2021 10:12:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-29-2021 10:12:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-02-2021 19:07:31
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-01-2021 19:22:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Query 1: Answered I confirm
Feb-01-2021 17:31:49
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Query 1: Opened please confirm that
chills were a side
effect and that no
COVID Illness was
suspected
Jan-29-2021 10:12:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
ChillsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-29-2021 10:12:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Jan/28/2021 20:00Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (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-2021-5683-0948888
Page 152 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-29-2021 10:12:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/29/2021 06:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-29-2021 10:12:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-29-2021 10:12:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-29-2021 10:12:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-29-2021 10:12:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (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-2021-5683-0948889
Page 153 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-29-2021 10:12:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-29-2021 10:13:27
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-29-2021 10:12:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-29-2021 10:12:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-29-2021 10:12:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (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-2021-5683-0948890
Page 154 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Jan-29-2021 10:14:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-29-2021 10:14:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-29-2021 10:14:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
MyalgiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-29-2021 10:14:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Jan/28/2021 20:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-29-2021 10:14:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/29/2021 06:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948891
Page 155 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Jan-29-2021 10:14:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-29-2021 10:14:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-29-2021 10:14:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-29-2021 10:14:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-29-2021 10:14:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-29-2021 10:14:01 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0948892
Page 156 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNO
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-29-2021 10:14:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-29-2021 10:14:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-29-2021 10:14:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948893
Page 157 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Feb-22-2021 09:43:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-22-2021 09:43:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-22-2021 09:43:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
muscle painInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-22-2021 09:43:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Feb/18/2021 16:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-22-2021 09:43:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/19/2021 13:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948894
Page 158 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Feb-22-2021 09:43:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-22-2021 09:43:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-22-2021 09:43:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-22-2021 09:43:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-22-2021 09:43:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-22-2021 09:43:14 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0948895
Page 159 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebYES
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-22-2021 09:43:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-22-2021 09:43:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-22-2021 09:43:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948896
Page 160 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Feb-22-2021 09:44:24
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-22-2021 09:44:24
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-22-2021 09:44:24
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
ChillsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-22-2021 09:44:24
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Feb/18/2021 16:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-22-2021 09:44:24
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/19/2021 13:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948897
Page 161 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Feb-22-2021 09:44:24
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-22-2021 09:44:24
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-22-2021 09:44:24
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-22-2021 09:44:24
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-22-2021 09:44:24
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-22-2021 13:33:30 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0948898
Page 162 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebYES
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-22-2021 09:44:24
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-22-2021 09:44:24
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-22-2021 09:44:24
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948899
Page 163 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Mar-11-2021 12:25:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-11-2021 12:25:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-11-2021 12:25:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
absolute arrhythmiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-11-2021 12:25:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Feb/25/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 12:25:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-11-2021 12:25:03 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0948900
Page 164 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, Zagreb2
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-11-2021 12:25:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE absolute
arrhythmia:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Mar-11-2021 12:25:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabil
ity/incapacity?
NO
Is this serious event life threateInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948901
Page 165 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
ning?
NO
Other medically important seri
ous event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-11-2021 12:25:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-11-2021 12:25:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-11-2021 12:25:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-11-2021 12:25:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948902
Page 166 of 190
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-11-2021 12:25:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-11-2021 12:25:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-11-2021 12:25:03
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948903
Page 167 of 190
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-05-2020 10:26:12
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Dec/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-05-2020 10:26:12
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-05-2020 10:26:12
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948904
Page 168 of 190
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-25-2021 16:55:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948905
Page 169 of 190
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-29-2021 16:57:21
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible per other protocol all
owance(s) and confirmed to
have received only placebo a
t Vaccination 1/2Transcription Error
Jan-25-2021 16:56:46
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible per local/national rec
ommendations and confirme
d to have received only place
bo at Vaccination 1/2Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0948906
Page 170 of 190
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-25-2021 16:54:43
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-25-2021 16:54:43
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948907
Page 171 of 190
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-28-2021 13:41:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Jan/28/2021Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948908
Page 172 of 190
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-28-2021 13:41:32
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/28/2021Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948909
Page 173 of 190
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-28-2021 13:42:21
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Jan/28/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-28-2021 13:42:21
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-28-2021 13:42:21
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948910
Page 174 of 190
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-28-2021 13:42:33
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-28-2021 13:42:33
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-28-2021 14:16:23
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-28-2021 13:42:33
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-28-2021 13:42:33
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/28/2021Initial Entry
5.a
Date Location User Value Reason
Jan-29-2021 15:05:49
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BN8KZKTranscription Error
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948911
Page 175 of 190
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Jan-28-2021 14:16:23
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BN8KZLInitial Entry
5.a Sample ID
Date Location User ValueReason
Jan-29-2021
21:18:12
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_01
Jan-29-2021
15:05:49
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription Error
Jan-29-2021
15:05:49
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Data
Entry
:
BN8K
ZKTranscription Error
Jan-28-2021
21:40:36
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7047517;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Jan-28-2021
14:16:23
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Data
Entry
:
BN8K
ZLInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0948912
Page 176 of 190
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.b
Date Location User Value Reason
Jan-28-2021 14:16:31
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BN8KZLInitial Entry
5.b Sample ID
Date Location User ValueReason
Jan-29-2021
21:18:12
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_01
Jan-29-2021
15:06:10
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Query
1: An
swere
dChanged data per
query
Jan-28-2021
21:40:36
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7047518;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Jan-28-2021
14:16:31
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Data
Entry
:
BN8K
ZLInitial Entry
5.c
Date Location User Value Reason
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0948913
Page 177 of 190
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Jan-28-2021 14:16:54
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BNLW9CInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-28-2021 14:16:54
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BNLW9CInitial Entry
5.d
Date Location User Value Reason
Jan-28-2021 14:17:00
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BNLW9DInitial Entry
5.d Sample ID
Date Location User Value Reason
Jan-28-2021 14:17:00
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BNLW9DInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948914
Page 178 of 190
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-28-2021 13:42:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-28-2021 13:42:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-28-2021 14:17:18
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-28-2021 13:42:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-28-2021 13:42:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/28/2021Initial Entry
5.a
Date Location User Value Reason
Jan-28-2021 14:17:18
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BN8KZJInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948915
Page 179 of 190
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User Value Reason
Jan-28-2021 14:17:18
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN8KZJInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948916
Page 180 of 190
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-28-2021 13:42:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-28-2021 13:42:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-28-2021 13:42:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-28-2021 13:42:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Jan/28/2021 09:31Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-28-2021 13:42:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-28-2021 13:42:59
(UTC+01:00) Sarajevo,ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948917
Page 181 of 190
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Skopje, Warsaw, Zagreb
7. Route:
Date Location User Value Reason
Jan-28-2021 13:42:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-28-2021 13:42:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-28-2021 13:42:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-28-2021 13:42:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-28-2021 13:42:59
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948918
Page 182 of 190
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-18-2021 08:50:51
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Feb/18/2021Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948919
Page 183 of 190
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-18-2021 08:51:08
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-18-2021 08:51:08
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-18-2021 08:52:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-18-2021 08:51:08
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-18-2021 08:51:08
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/18/2021Initial Entry
5.a
Date Location User Value Reason
Feb-18-2021 08:52:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BN8L54Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948920
Page 184 of 190
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User Value Reason
Feb-18-2021 08:52:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN8L54Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948921
Page 185 of 190
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-18-2021 10:04:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-18-2021 10:04:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-18-2021 10:04:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-23-2021 18:01:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-22-2021 15:16:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Query 1: Answered patient didnt have a
covid Illness. It was
side effect.
Feb-19-2021 19:01:39
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Query 1: Opened The patient
reported a COVID
illness symptom in
the illness diary on
Feb.19th: is an
unplanned
assessment
indicated?
Feb-18-2021 10:04:55 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948922
Page 186 of 190
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebFeb/18/2021 09:10
5. Anatomical Location:
Date Location User Value Reason
Feb-18-2021 10:04:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-18-2021 10:04:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-18-2021 10:04:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-18-2021 10:04:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-18-2021 10:04:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-18-2021 10:04:55
(UTC+01:00) Sarajevo,ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948923
Page 187 of 190
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Skopje, Warsaw, Zagreb
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-18-2021 10:04:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948924
Page 188 of 190
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-05-2020 10:26:12
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-17-2020 13:00:10
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-17-2020 11:30:24
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-01-2021 17:24:24
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-29-2021 17:31:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Query 1: Answered patient answered
the covid illness
diary with yes
because he had side
effects.
Jan-29-2021 17:23:51
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Query 1: Opened the patient reported
a COVID symptom
in the illness diary
on Jan 29th:is an in
person COVID
illness visit or
telehealth visit
going to be
performed?
Dec-05-2020 10:26:12
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/5/2020Initial Entry
Oct-17-2020 13:00:10
(UTC+01:00) Sarajevo,ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/17/2020Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948925
Page 189 of 190
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Skopje, Warsaw, Zagreb
Oct-17-2020 11:30:24
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/17/2020Initial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948926
Page 190 of 190
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-03-2020 19:18:39
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f9b\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0948927