Document text
Page 1 of 264
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948928
Page 2 of 264
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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/19/2020
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948929
Page 3 of 264
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Demography
1.Subject ID [11951131]
2.Birth Date: UNK/UNK/1953
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948930
Page 4 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948931
Page 5 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948932
Page 6 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/19/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948933
Page 7 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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: Apr/1/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[pollinosis]
Start Date: Oct/1/1999
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Psoriasis vulgaris]
Start Date: Oct/1/1999
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[diabetes mellitus type 2]
Start Date: Oct/24/2019
Ongoing: YES
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948934
Page 8 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[scoliosis]
Start Date: Aug/30/2018
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[retropatellar arthrosis]
Start Date: Dec/11/2017
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[reflux esophagitis]
Start Date: Oct/12/2015
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Postmenopausal]
Start Date: UNK/UNK/2005
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[umbilical hernia]
Start Date: Apr/30/2020
Ongoing: NO
End Date:
May/11/2020
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948935
Page 9 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948936
Page 10 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Oct/19/2020
2.Weight: [88.4]
3.Unit: kg
4.Height: [159.0]
5.Unit: cm
6.Body Mass Index: [35.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948937
Page 11 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948938
Page 12 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/19/2020
2.Randomization Number: [270712]
3.Randomization Group: [ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948939
Page 13 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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/19/2020
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 [BNMDPS]
5.bSample ID [BNMDPT]
5.cSample ID [BN868V]
5.dSample ID [BN868W]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948940
Page 14 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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/19/2020
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 [BN8693]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948941
Page 15 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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/19/2020 13:26
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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948942
Page 16 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948943
Page 17 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948944
Page 18 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948945
Page 19 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948946
Page 20 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948947
Page 21 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948948
Page 22 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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 [BN86GS]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948949
Page 23 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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 11:43
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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948950
Page 24 of 264
***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: 11951131 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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948951
Page 25 of 264
***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: 11951131 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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948952
Page 26 of 264
***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: 11951131 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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948953
Page 27 of 264
***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: 11951131 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 [BN8KLY]
5.bSample ID [BN8KLZ]
5.cSample ID [BNLWPP]
5.dSample ID [BNLWPR]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948954
Page 28 of 264
***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: 11951131 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:
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948955
Page 29 of 264
***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: 11951131 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: [ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948956
Page 30 of 264
***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: 11951131 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 [ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948957
Page 31 of 264
***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: 11951131 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 [ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948958
Page 32 of 264
***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: 11951131 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?
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948959
Page 33 of 264
***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: 11951131 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:
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948960
Page 34 of 264
***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: 11951131 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:
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948961
Page 35 of 264
***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: 11951131 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 [ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948962
Page 36 of 264
***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: 11951131 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:
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948963
Page 37 of 264
***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: 11951131 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 [ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948964
Page 38 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# CategoryAE Ident
ifierAdverse Eve
ntStart DateIs the Adverse Event Stil
l OngoingForm Instanc
e
1. DELETED ADVERSE E
VENT 1 umbilical her
nia Dec/2/2020 UNK
:UNK NO
End Date Time:
Dec/4/2020 UNK:UN
K
Repeating
Pages
2. ADVERSE E
VENT 2 umbilical her
nia Nov/24/2020 UN
K:UNK NO
End Date Time:
Dec/3/2020 UNK:UN
K
Repeating
Pages
3. ADVERSE E
VENT 3 Pain injectio
n side Jan/26/2021 14:3
0 NO
End Date Time:
Jan/27/2021 15:00
Repeating
Pages
4. ADVERSE E
VENT 4 Headache Jan/26/2021 18:0
0 NO
End Date Time:
Jan/28/2021 12:00
Repeating
Pages
5. ADVERSE E
VENT 5 Chills Feb/16/2021 22:0
0 NO
End Date Time:
Feb/17/2021 17:00
Repeating
Pages
6. ADVERSE E
VENT 6 Headache Feb/17/2021 08:0
0 NO
End Date Time:
Feb/17/2021 18:00
Repeating
Pages
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948965
Page 39 of 264
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[umbilical hernia ]
4.Start Date Time: Dec/2/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/4/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948966
Page 40 of 264
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[umbilical hernia recurrence ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020483017 ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948967
Page 41 of 264
***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: 11951131 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)[umbilical hernia]
4.Start Date Time: Nov/24/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/3/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948968
Page 42 of 264
***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: 11951131 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?: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[2020483017]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948969
Page 43 of 264
***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: 11951131 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)[Pain injection side]
4.Start Date Time: Jan/26/2021 14:30
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/27/2021 15:00
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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948970
Page 44 of 264
***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: 11951131 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[ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948971
Page 45 of 264
***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: 11951131 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)[Headache]
4.Start Date Time: Jan/26/2021 18:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/28/2021 12:00
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
11.Was a Concomitant Medication
given?YES Comments
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948972
Page 46 of 264
***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: 11951131 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[ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948973
Page 47 of 264
***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: 11951131 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)[Chills]
4.Start Date Time: Feb/16/2021 22:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/17/2021 17:00
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
11.Was a Concomitant Medication
given?NO
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948974
Page 48 of 264
***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: 11951131 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[ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948975
Page 49 of 264
***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: 11951131 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: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Headache]
4.Start Date Time: Feb/17/2021 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/17/2021 18:00
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
11.Was a Concomitant Medication
given?YES
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948976
Page 50 of 264
***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: 11951131 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[ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948977
Page 51 of 264
***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: 11951131 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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948978
Page 52 of 264
***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: 11951131 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[ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948979
Page 53 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948980
Page 54 of 264
***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: 11951131 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: //
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948981
Page 55 of 264
***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: 11951131 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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948982
Page 56 of 264
***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: 11951131 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?
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948983
Page 57 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948984
Page 58 of 264
***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: 11951131 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?
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948985
Page 59 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948986
Page 60 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948987
Page 61 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948988
Page 62 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Unplanned Assessments
1.Assessments
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948989
Page 63 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948990
Page 64 of 264
***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: 11951131 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:
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948991
Page 65 of 264
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948992
Page 66 of 264
***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: 11951131 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?
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948993
Page 67 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948994
Page 68 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948995
Page 69 of 264
***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: 11951131 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: [ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948996
Page 70 of 264
***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: 11951131 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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948997
Page 71 of 264
***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: 11951131 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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948998
Page 72 of 264
***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: 11951131 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: [ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0948999
Page 73 of 264
***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: 11951131 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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949000
Page 74 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949001
Page 75 of 264
***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: 11951131 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: [ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949002
Page 76 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/26/2021
2.Erroneous Visit
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949003
Page 77 of 264
***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: 11951131 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/26/2021
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949004
Page 78 of 264
***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: 11951131 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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949005
Page 79 of 264
***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: 11951131 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/26/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949006
Page 80 of 264
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949007
Page 81 of 264
***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: 11951131 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/26/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8KYD]
5.bSample ID [BN8KYF]
5.cSample ID [BNLW8H]
5.dSample ID [BNLW8J]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949008
Page 82 of 264
***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: 11951131 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/26/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8KY2]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949009
Page 83 of 264
***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: 11951131 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/26/2021 10:18
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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949010
Page 84 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/16/2021
2.Erroneous Visit
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949011
Page 85 of 264
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949012
Page 86 of 264
***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: 11951131 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/16/2021
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 [BN8L3T]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949013
Page 87 of 264
***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: 11951131 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/16/2021 09:56
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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949014
Page 88 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949015
Page 89 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949016
Page 90 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949017
Page 91 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949018
Page 92 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949019
Page 93 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949020
Page 94 of 264
***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: 11951131 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: [ ]
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949021
Page 95 of 264
***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: 11951131 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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949022
Page 96 of 264
***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: 11951131 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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949023
Page 97 of 264
***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: 11951131 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 Feb-22-2021 21:35:53 (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.
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0949024
Page 98 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-19-2020 13:31:10 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949025
Page 99 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-07-2020 14:38:52 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949026
Page 100 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-07-2020 14:38:52 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949027
Page 101 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-07-2020 14:38:52 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949028
Page 102 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-07-2020 14:38:52 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949029
Page 103 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Nov-07-2020 14:38:52 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949030
Page 104 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Nov-07-2020 14:38:52 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949031
Page 105 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aNov-07-2020 14:38:52 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949032
Page 106 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aNov-07-2020 14:38:52 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949033
Page 107 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aNov-07-2020 14:38:52 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949034
Page 108 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-07-2020 14:16:56 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949035
Page 109 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-07-2020 14:16:56 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949036
Page 110 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-07-2020 14:16:56 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949037
Page 111 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-07-2020 14:16:56 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949038
Page 112 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Nov-07-2020 14:16:56 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949039
Page 113 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Nov-07-2020 14:16:56 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949040
Page 114 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aNov-07-2020 14:16:56 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949041
Page 115 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aNov-07-2020 14:16:56 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949042
Page 116 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aNov-07-2020 14:16:56 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949043
Page 117 of 264
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
11Jan-28-2021 19:58:27 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebPatient took 1 paracetamol 500mg on 27 Jan
2021
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949044
Page 118 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormJan-26-2021 18:01:16 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949045
Page 119 of 264
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormJan-26-2021 18:01:50 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949046
Page 120 of 264
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Jan-26-2021 18:01:50 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949047
Page 121 of 264
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Jan-26-2021 18:01:50 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949048
Page 122 of 264
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Jan-26-2021 18:01:50 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949049
Page 123 of 264
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Jan-26-2021 18:01:50 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949050
Page 124 of 264
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Jan-26-2021 18:01:50 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949051
Page 125 of 264
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aJan-26-2021 18:01:50 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949052
Page 126 of 264
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aJan-26-2021 18:01:50 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949053
Page 127 of 264
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aJan-26-2021 18:01:50 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949054
Page 128 of 264
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-16-2021 11:27:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949055
Page 129 of 264
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-16-2021 11:27:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949056
Page 130 of 264
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-16-2021 11:27:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949057
Page 131 of 264
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-16-2021 11:27:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949058
Page 132 of 264
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-16-2021 11:27:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949059
Page 133 of 264
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Feb-16-2021 11:27:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949060
Page 134 of 264
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aFeb-16-2021 11:27:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949061
Page 135 of 264
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aFeb-16-2021 11:27:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949062
Page 136 of 264
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aFeb-16-2021 11:27:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949063
Page 137 of 264
***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: 11951131 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 Feb-22-2021 21:35:53 (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 14:08:45 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer Approved Feb-16-2021 14:47:26 (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-16-2021 11:25:07 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949064
Page 138 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Axel Schaefer Approved Jan-31-2021 20:24:23 (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 19:56:34 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer Approved Jan-27-2021 08:23:16 (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-26-2021 18:00:59 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer Approved Jan-25-2021 21:06:28 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949065
Page 139 of 264
***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: 11951131 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 13:47:08 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer Approved Jan-21-2021 14:02:27 (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-21-2021 10:44:02 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit
N/A
Axel Schaefer Approved Jan-19-2021 16:44:32 (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.
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949066
Page 140 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
N/A Jan-19-2021 15:34:43 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer Approved Dec-23-2020 21:02:56 (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-22-2020 12:54:53 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer Approved Dec-09-2020 19:41:49 (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 Dec-07-2020 16:30:49 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949067
Page 141 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Axel Schaefer Approved Dec-06-2020 13:10:25 (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 12:46:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer Approved Dec-05-2020 12:33:48 (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 12:31:17 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer Approved Nov-10-2020 09:18:20 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949068
Page 142 of 264
***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: 11951131 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 14:16:02 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer Approved Nov-04-2020 17:50:58 (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.
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949069
Page 143 of 264
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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-19-2020 13:30:47
(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-19-2020 13:30:47
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949070
Page 144 of 264
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-19-2020 13:30:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/19/2020Initial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949071
Page 145 of 264
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-19-2020 13:29:07
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11951131Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-19-2020 13:30:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
UNK/UNK/1953Transcription Error
Oct-19-2020 13:29:04
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
UNK/UNK/1968Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-19-2020 13:30:37
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-19-2020 13:30:37
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-19-2020 13:30:37
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949072
Page 146 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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-19-2020 13:31:04
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949073
Page 147 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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-19-2020 13:31:21
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020 13:31:21
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020 13:31:21
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949074
Page 148 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.a
Date Location User Value Reason
Jan-21-2021 10:44:02
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Line/MH Number: 1
Medical History Te
rm:hypertensi
on
Start Date: Apr/1/200
0
Ongoing: YESTranscription Error
Oct-19-2020 18:50:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:hypertensi
on
Start Date: Oct/1/200
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-19-2020 18:50:38
(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-19-2020 18:50:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
hypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Jan-21-2021 10:44:02
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Apr/1/2000Transcription Error
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949075
Page 149 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Oct-19-2020 18:50:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/1/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-19-2020 18:50:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-19-2020 18:52:06
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Term
:pollinosis
Start Date: Oct/1/199
9
Ongoing: YESInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949076
Page 150 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.b Line/MH Number:
Date Location User Value Reason
Oct-19-2020 18:52:06
(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-19-2020 18:52:06
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
pollinosisInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-19-2020 18:52:06
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/1/1999Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-19-2020 18:52:06
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-19-2020 18:53:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Psoriasis vulg
aris
Start Date: Oct/1/1999
Ongoing: YESInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949077
Page 151 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.c Line/MH Number:
Date Location User Value Reason
Oct-19-2020 18:53:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 15:36:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-20-2020 19:30:23
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Query 1: Answered no systemic treatment
with steroids or
immunosuppressive
drugs for the ongoing
psoriasis
Oct-20-2020 18:26:10
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Query 1: Opened is the patient under
systemic treatment
with steroids or
immunosuppressive
drugs for the ongoing
psoriasis?
Oct-19-2020 18:53:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Psoriasis vulgarisInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-19-2020 18:53:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/1/1999Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-19-2020 18:53:05
(UTC+01:00) Sarajevo,ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949078
Page 152 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Skopje, Warsaw, Zagreb
1.d
Date Location User Value Reason
Oct-19-2020 18:54:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4
Medical History
Term:diabetes mellitus
type 2
Start Date: Oct/24/2019
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Oct-19-2020 18:54:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 18:54:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
diabetes mellitus type 2Initial Entry
1.d Start Date:
Date Location User Value Reason
Oct-19-2020 18:54:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/24/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-19-2020 18:54:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949079
Page 153 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Oct-19-2020 18:54:46
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Ter
m:scoliosis
Start Date: Aug/30/201
8
Ongoing: YESInitial Entry
1.e Line/MH Number:
Date Location User Value Reason
Oct-19-2020 18:54:46
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 18:54:46
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
scoliosisInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-19-2020 18:54:46
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Aug/30/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-19-2020 18:54:46
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-19-2020 18:55:55
(UTC+01:00) Sarajevo,ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe 6Initial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949080
Page 154 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Skopje, Warsaw, Zagreb r:
Medical History
Term:retropatellar art
hrosis
Start Date: Dec/11/2017
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Oct-19-2020 18:55:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 18:55:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
retropatellar arthrosisInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-19-2020 18:55:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Dec/11/2017Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-19-2020 18:55:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Oct-19-2020 18:57:08
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:reflux esopha
gitisInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949081
Page 155 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Start Date: Oct/12/2015
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Oct-19-2020 18:57:08
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 18:57:08
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
reflux esophagitisInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-19-2020 18:57:08
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/12/2015Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-19-2020 18:57:08
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Oct-28-2020 18:12:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History T
erm:Postmenopau
sal
Start Date: UNK/UNK/2
005
Ongoing: YESInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949082
Page 156 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.h Line/MH Number:
Date Location User Value Reason
Oct-28-2020 18:12:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 18:12:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
PostmenopausalInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-28-2020 18:12:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-28-2020 18:12:14
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Dec-08-2020 15:56:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Te
rm:umbilical her
nia
Start Date: Apr/30/2020
Ongoing: NO
End Date:
May/11/20
20Initial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949083
Page 157 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.i Line/MH Number:
Date Location User Value Reason
Dec-08-2020 15:56:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-08-2020 15:56:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
umbilical herniaInitial Entry
1.i Start Date:
Date Location User Value Reason
Dec-08-2020 15:56:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Apr/30/2020Initial Entry
1.i Ongoing:
Date Location User Value Reason
Dec-08-2020 15:56:01
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NO
End Date:
May/11/2020Initial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949084
Page 158 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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-19-2020 13:33:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949085
Page 159 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Oct-19-2020 13:32:57
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
2. Weight:
Date Location User Value Reason
Jan-21-2021 10:45:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
88.4Transcription Error
Oct-19-2020 13:32:57
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
88.6Initial Entry
3. Unit:
Date Location User Value Reason
Oct-19-2020 13:32:57
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-19-2020 13:32:57
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
159.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-19-2020 13:32:57
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949086
Page 160 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Jan-21-2021 10:45:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
35.0Transcription Error
Oct-19-2020 13:32:57
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
35.0Initial Entry
7.a
Date Location User Value Reason
Oct-19-2020 13:32:57
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 37.2
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-19-2020 13:32:57
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-19-2020 13:32:57
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
37.2Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-19-2020 13:32:57
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949087
Page 161 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Oct-19-2020 13:32:57
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949088
Page 162 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-07-2020 14:38:52
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Nov-07-2020 14:38:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Oct-19-2020 18:49:29
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-07-2020 14:38:52
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Nov-07-2020 14:38:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Oct-19-2020 18:49:29
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-07-2020 14:38:52
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-07-2020 14:38:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-07-2020 14:38:41
(UTC+01:00) Sarajevo,ACV0PFEINFP6000 Data Entry: Transcription Error
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949089
Page 163 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Skopje, Warsaw, Zagreb
Nov-07-2020 14:38:26
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of collection
is reported, but
result is missing.
Please review and
update as
appropriate.
Oct-19-2020 18:49:29
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-07-2020 14:38:52
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Nov-07-2020 14:38:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Oct-19-2020 18:49:29
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-07-2020 14:38:52
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Nov-07-2020 14:38:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Oct-19-2020 18:49:29
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949090
Page 164 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Nov-07-2020 14:38:52
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:Not Applicable
Test:: Choriogonadotro
pin Beta_PX113
Result:: Not Applicable
Not Done:: Not ApplicableInitial Entry
Nov-07-2020 14:38:26
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done::Transcription Error
Oct-19-2020 18:49:29
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Nov-07-2020 14:38:52
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Nov-07-2020 14:38:26
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Oct-19-2020 18:49:29
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-19-2020 18:49:29 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0949091
Page 165 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebChoriogonadotropin Beta_PX1
13
6.a Result:
Date Location User Value Reason
Nov-07-2020 14:38:52
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-07-2020 14:38:26
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry: Transcription Error
Oct-19-2020 18:49:29
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
6.a Not Done:
Date Location User Value Reason
Nov-07-2020 14:38:52
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949092
Page 166 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-19-2020 18:49:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-19-2020 18:49:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
270712Initial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949093
Page 167 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 16:40:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 16:40:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020 16:40:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-19-2020 16:40:09
(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-19-2020 16:40:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020 16:40:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BNMDPSInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949094
Page 168 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User Value Reason
Oct-19-2020 16:40:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BNMDPSInitial Entry
5.b
Date Location User Value Reason
Oct-19-2020 16:40:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BNMDPTInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-19-2020 16:40:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BNMDPTInitial Entry
5.c
Date Location User Value Reason
Oct-19-2020 16:41:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BN868VInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-19-2020 16:41:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN868VInitial Entry
5.d
Date Location User Value Reason
Oct-19-2020 16:41:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BN868WInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (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-2021-5683-0949095
Page 169 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.d Sample ID
Date Location User Value Reason
Oct-19-2020 16:41:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN868WInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949096
Page 170 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 16:41:49
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 16:41:49
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020 16:41:49
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020 16:41:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BN8693Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020 16:41:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN8693Initial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949097
Page 171 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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-19-2020 18:49:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-19-2020 18:49:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-19-2020 18:49:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-19-2020 18:49:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/19/2020 13:26Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-19-2020 18:49:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-19-2020 18:49:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949098
Page 172 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
7. Route:
Date Location User Value Reason
Oct-19-2020 18:49:56
(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-19-2020 18:49:56
(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-19-2020 18:49:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949099
Page 173 of 264
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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-19-2020 13:33:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-D
IARY COLLECTED FOR THIS
SUBJECTInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949100
Page 174 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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 14:16:02
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Nov/7/2020Initial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949101
Page 175 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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 14:16:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-07-2020 14:16:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: FE
V
ER
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
Nov-07-2020 14:16:25
(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 14:16:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Nov-07-2020 14:16:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (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-2021-5683-0949102
Page 176 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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
Nov-07-2020 14:16:25
(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 14:16:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Nov-07-2020 14:16:25
(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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949103
Page 177 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.c Symptom:
Date Location User Value Reason
Nov-07-2020 14:16:25
(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 14:16:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Nov-07-2020 14:16:25
(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
Nov-07-2020 14:16:25
(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 14:16:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (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-2021-5683-0949104
Page 178 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Nov-07-2020 14:16:25
(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
Nov-07-2020 14:16:25
(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 14:16:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Nov-07-2020 14:16:25
(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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949105
Page 179 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.f Symptom:
Date Location User Value Reason
Nov-07-2020 14:16:25
(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 14:16:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Nov-07-2020 14:16:25
(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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949106
Page 180 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.g Symptom:
Date Location User Value Reason
Nov-07-2020 14:16:25
(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 14:16:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Nov-07-2020 14:16:25
(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 da
y the Subject Diar
y was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Nov-07-2020 14:16:25
(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 14:16:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (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-2021-5683-0949107
Page 181 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
3. Injection Site Location:
Date Location User Value Reason
Nov-07-2020 14:16:25
(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 14:16:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Nov-07-2020 14:16:25
(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
Nov-07-2020 14:16:25
(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 14:16:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949108
Page 182 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Nov-07-2020 14:16:25
(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
Nov-07-2020 14:16:25
(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 14:16:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Nov-07-2020 14:16:25
(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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949109
Page 183 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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 14:16:25
(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 14:16:25
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949110
Page 184 of 264
***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, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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 14:16:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Nov/7/2020Initial Entry
2.a
Date Location User Value Reason
Nov-07-2020 14:16:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 36.6
Temperature Un
it:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-07-2020 14:16:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-07-2020 14:16:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-07-2020 14:16:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (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-2021-5683-0949111
Page 185 of 264
***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, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.a Temperature Location:
Date Location User Value Reason
Nov-07-2020 14:16:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949112
Page 186 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-07-2020 14:16:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-07-2020 14:16:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-07-2020 14:16:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-07-2020 14:16:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-07-2020 14:16:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Nov-07-2020 14:16:56
(UTC+01:00) Sarajevo,ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949113
Page 187 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Skopje, Warsaw, Zagreb Sponsor-Defined
Identifier:Not Appli
cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cable
6.a Sponsor ID:
Date Location User Value Reason
Nov-07-2020 14:16:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Nov-07-2020 14:16:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Nov-07-2020 14:16:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Nov-07-2020 14:16:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (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-2021-5683-0949114
Page 188 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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 14:17:10
(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 14:17:10
(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 14:47:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-07-2020 14:17:10
(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 14:17:10
(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 14:47:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BN86GSInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949115
Page 189 of 264
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User Value Reason
Nov-07-2020 14:47:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN86GSInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949116
Page 190 of 264
***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, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 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 14:17:31
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-07-2020 14:17:31
(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 14:17:31
(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 14:17:31
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Nov/7/2020 11:43Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-07-2020 14:17:31
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-07-2020 14:17:31
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949117
Page 191 of 264
***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, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
7. Route:
Date Location User Value Reason
Nov-07-2020 14:17:31
(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 14:17:31
(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 14:17:31
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949118
Page 192 of 264
***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: 11951131 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 12:31:17
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Dec/5/2020Initial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949119
Page 193 of 264
***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: 11951131 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 12:31:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Dec-05-2020 12:31:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: FE
V
ER
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 12:31:42
(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 12:31:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Dec-05-2020 12:31:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (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-2021-5683-0949120
Page 194 of 264
***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: 11951131 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 12:31:42
(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 12:31:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Dec-05-2020 12:31:42
(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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949121
Page 195 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.c Symptom:
Date Location User Value Reason
Dec-05-2020 12:31:42
(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 12:31:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Dec-05-2020 12:31:42
(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 12:31:42
(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 12:31:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (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-2021-5683-0949122
Page 196 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Dec-05-2020 12:31:42
(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 12:31:42
(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 12:31:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Dec-05-2020 12:31:42
(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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949123
Page 197 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.f Symptom:
Date Location User Value Reason
Dec-05-2020 12:31:42
(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 12:31:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Dec-05-2020 12:31:42
(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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949124
Page 198 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.g Symptom:
Date Location User Value Reason
Dec-05-2020 12:31:42
(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 12:31:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Dec-05-2020 12:31:42
(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 da
y the Subject Diar
y was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Dec-05-2020 12:31:42
(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 12:31:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (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-2021-5683-0949125
Page 199 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
3. Injection Site Location:
Date Location User Value Reason
Dec-05-2020 12:31:42
(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 12:31:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Dec-05-2020 12:31:42
(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 12:31:42
(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 12:31:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949126
Page 200 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Dec-05-2020 12:31:42
(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 12:31:42
(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 12:31:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Dec-05-2020 12:31:42
(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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949127
Page 201 of 264
***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: 11951131 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 12:31:42
(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 12:31:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949128
Page 202 of 264
***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: 11951131 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 12:31:53
(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 12:31:53
(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 12:46:33
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-05-2020 12:31:53
(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 12:31:53
(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 12:46:33
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BN8KLYInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949129
Page 203 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User Value Reason
Dec-05-2020 12:46:33
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN8KLYInitial Entry
5.b
Date Location User Value Reason
Dec-05-2020 12:46:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BN8KLZInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-05-2020 12:46:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN8KLZInitial Entry
5.c
Date Location User Value Reason
Dec-05-2020 12:47:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BNLWPPInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-05-2020 12:47:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BNLWPPInitial Entry
5.d
Date Location User Value Reason
Dec-05-2020 12:47:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BNLWPRInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (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-2021-5683-0949130
Page 204 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.d Sample ID
Date Location User Value Reason
Dec-05-2020 12:47:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BNLWPRInitial Entry
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0949131
Page 205 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Jan-19-2021 15:34:43
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Form Deleted Transcription
Error
Dec-05-2020 13:24:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Form Created
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949132
Page 206 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Dec-07-2020 16:30:49
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Form Created
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949133
Page 207 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Jan-28-2021 19:56:34
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Form Created
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949134
Page 208 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Jan-28-2021 19:57:47
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Form Created
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949135
Page 209 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Feb-18-2021 14:08:45
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Form Created
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949136
Page 210 of 264
***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: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Feb-18-2021 14:09:26
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Form Created
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0949137
Page 211 of 264
***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, Deleted, Frozen
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Dec-05-2020 13:24:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-05-2020 13:24:42
(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
Dec-22-2020 15:27:33
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Thank you for your
response. FU has
been noted. Thank
you.
Dec-21-2020 08:02:53
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Query 1: Answered Changed data per
query
Dec-18-2020 19:05:46
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Giselle
CastilloQuery 1: Reissued:Opened Thank you for
confirming, would
you kindly send a
FU report with this
information so this is
added to safety.
Please include
further information
on clinical
presentation if
available. Thank
you.
Dec-14-2020 18:35:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Query 1: Answered yes I confirm
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0949138
Page 212 of 264
***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, Deleted, Frozen
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** THIS REPEATING FORM HAS BEEN DELETED ***
Dec-14-2020 02:48:04
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Giselle
CastilloQuery 1: Reissued:Opened Would you kindly
confirm if the subject
had an elective
surgery for the
umbilical hernia?
Thank you.
Dec-10-2020 18:27:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Query 1: Answered it was only a hernia
no complication
Dec-09-2020 23:38:08
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Per SAE report
AER# 2020483017,
the event required
surgery. Please
clarify the
complication
associated to the
hernia that prompted
intervention (hernia
obstruction/
strangulation...).
Kindly provide
details in a FU
report. Thank you.
Dec-05-2020 13:24:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
umbilical herniaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-31-2020 09:49:31
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-22-2020 15:20:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Dec-22-2020 15:20:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Dec/2/2020 UNK:UNKTranscription Error
Dec-22-2020 12:58:06 ACV0PFEINFP6000 Query 1: Opened SAE RECON:
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0949139
Page 213 of 264
***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, Deleted, Frozen
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** THIS REPEATING FORM HAS BEEN DELETED ***
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebAER#2020483017
,onset date was
recorded as
02Dec2020 in Safety
database however,
recorded as
03Dec2020 on AE
CRF. Please confirm
correct Onset Date. If
safety update is
required, please
submit a follow-up
SAE form.
Dec-05-2020 13:24:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Dec/3/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-05-2020 13:24:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/4/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-05-2020 13:24:42
(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
090177e196ae2f99\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0949140
Page 214 of 264
***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, Deleted, Frozen
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
*** THIS REPEATING FORM HAS BEEN DELETED ***
Dec-22-2020 12:54:53
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Answer Auto
Query
Dec-15-2020 12:32:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Query 1: Reissued:Candidate Wait till SAE# is
entered.
Dec-07-2020 17:26:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Query 1: Answered this number is
coming from
Pfizer.
Dec-07-2020 13:51:48
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Query 1: Opened For AE umbilical
hernia: Response to
"Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Dec-05-2020 13:24:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE umbilical
hernia: Response to
"Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Dec-05-2020 13:24:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
YES
Did this seri
…[truncated]