125742 S1 M5 CRF c4591001 1116 11161131

Document text

Page 1 of 184
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol
amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979352
Page 2 of 184
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/4/2020
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979353
Page 3 of 184
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11161131]
2.Birth Date: /1955
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979354
Page 4 of 184
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979355
Page 5 of 184
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979356
Page 6 of 184
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979357
Page 7 of 184
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[High Cholesterol]
Start Date: UNK/UNK/2019
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Heart Palpitations]
Start Date: Sep/4/2018
Ongoing: YES
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979358
Page 8 of 184
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
2.Weight: [135.1]
3.Unit: LB
4.Height: [61.0]
5.Unit: in
6.Body Mass Index: [25.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979359
Page 9 of 184
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/4/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979360
Page 10 of 184
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/4/2020
2.Randomization Number: [253146]
3.Randomization Group: [ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979361
Page 11 of 184
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN65BH]
5.bSample ID [BN65BJ]
5.cSample ID [BLBFG5]
5.dSample ID [BLBFG6]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979362
Page 12 of 184
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN65NT]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979363
Page 13 of 184
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/4/2020 14:40
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979364
Page 14 of 184
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979365
Page 15 of 184
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979366
Page 16 of 184
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979367
Page 17 of 184
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/23/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979368
Page 18 of 184
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
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 [BP41FN]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979369
Page 19 of 184
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/23/2020 15:44
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979370
Page 20 of 184
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979371
Page 21 of 184
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/21/2020
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 [BNNRSF]
5.bSample ID [BNNRSG]
5.cSample ID [BP4106]
5.dSample ID [BP4107]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979372
Page 22 of 184
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979373
Page 23 of 184
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979374
Page 24 of 184
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979375
Page 25 of 184
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979376
Page 26 of 184
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979377
Page 27 of 184
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979378
Page 28 of 184
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979379
Page 29 of 184
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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: [ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979380
Page 30 of 184
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979381
Page 31 of 184
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979382
Page 32 of 184
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979383
Page 33 of 184
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979384
Page 34 of 184
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979385
Page 35 of 184
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979386
Page 36 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979387
Page 37 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979388
Page 38 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Sep/17/2020
Contact Outcome:
VISIT ARRANGED
3.Comments: [ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979389
Page 39 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979390
Page 40 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: UNPLANNED ASSESSMENT OF LOCAL
REACTION - SYSTEMIC EVENT
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Unplanned Assessment Of Local Reaction
1.Date of Assessment: Sep/17/2020
2.Injection Site Location DELTOID MUSCLE
3.Injection Site Body Side: LEFT
Reaction
4.aReaction: REDNESS
Reaction Present: NO
4.bReaction: SWELLING
Reaction Present: NO
Symptom
5.aSymptom: PAIN AT INJECTION SITE
Symptom Present: YES
Symptom Grade:
2
Event related to Study Treament?
YES
5.bSymptom: FATIGUE/TIREDNESS
Symptom Present: NO
5.cSymptom: HEADACHE
Symptom Present: NO
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979391
Page 41 of 184
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: UNPLANNED ASSESSMENT OF LOCAL
REACTION - SYSTEMIC EVENT
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.dSymptom: VOMITING
Symptom Present: NO
5.eSymptom: DIARRHEA
Symptom Present: NO
5.fSymptom: NEW OR WORSENED MUSCLE PAIN
Symptom Present: YES
Symptom Grade:
2
Event related to Study Treament?
YES
5.gSymptom: NEW OR WORSENED JOINT PAIN
Symptom Present: NO
5.hSymptom: CHILLS
Symptom Present: NO
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979392
Page 42 of 184
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979393
Page 43 of 184
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979394
Page 44 of 184
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979395
Page 45 of 184
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979396
Page 46 of 184
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Left Axillary swollen l
ymp node Sep/10/2020
00:00 NO
End Date Time:
Sep/14/2020 00:0
0
 Repeating
Pages
 2.ADVERSE
EVENT 2  Muscle Pain @ injectio
n site Sep/10/2020
00:00 NO
End Date Time:
Sep/14/2020 00:0
0
 Repeating
Pages
 3.ADVERSE
EVENT 3  Generalized Muscle Pai
n Sep/10/2020
UNK:UNK NO
End Date Time:
Sep/14/2020 UNK
:UNK
 Repeating
Pages
 4.ADVERSE
EVENT 4  Muscle Pain @ Chest
Wall to Upper Back Sep/10/2020
UNK:UNK NO
End Date Time:
Sep/14/2020 UNK
:UNK
 Repeating
Pages
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979397
Page 47 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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)[Left Axillary swollen lymp node]
4.Start Date Time: Sep/10/2020 00:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/14/2020 00:00
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
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979398
Page 48 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
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[ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979399
Page 49 of 184
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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)[Muscle Pain @ injection site]
4.Start Date Time: Sep/10/2020 00:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/14/2020 00:00
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
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979400
Page 50 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
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[ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979401
Page 51 of 184
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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)[Generalized Muscle Pain]
4.Start Date Time: Sep/10/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/14/2020 UNK:UNK
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
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979402
Page 52 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
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[ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979403
Page 53 of 184
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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)[Muscle Pain @ Chest Wall to Upper Back]
4.Start Date Time: Sep/10/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/14/2020 UNK:UNK
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
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979404
Page 54 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
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[ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979405
Page 55 of 184
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categ
oryMedication
ErrorStart D
ateIs the medication error S
till OngoingStudy Medication Err
ors ActionForm Instanc
e
 1.         Repeating
Pages
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979406
Page 56 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979407
Page 57 of 184
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979408
Page 58 of 184
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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: //
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979409
Page 59 of 184
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979410
Page 60 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979411
Page 61 of 184
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Catego
ryTreatment Ident
ifierCon Non-Drug Treatments Pre-
specifiedTreatme
ntStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979412
Page 62 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979413
Page 63 of 184
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979414
Page 64 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979415
Page 65 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979416
Page 66 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979417
Page 67 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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:
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979418
Page 68 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979419
Page 69 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979420
Page 70 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979421
Page 71 of 184
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979422
Page 72 of 184
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979423
Page 73 of 184
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979424
Page 74 of 184
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979425
Page 75 of 184
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979426
Page 76 of 184
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979427
Page 77 of 184
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/12/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979428
Page 78 of 184
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979429
Page 79 of 184
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979430
Page 80 of 184
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/21/2020
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979431
Page 81 of 184
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979432
Page 82 of 184
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Paul
Matherne Approved Mar-04-2021 15:22:54 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulMatherne, 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.
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979433
Page 83 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormSep-04-2020 16:33:38 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979434
Page 84 of 184
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Paul
Matherne Approved Mar-04-2021 15:22:54 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulMatherne, 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-23-2021 12:35:02 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul
Matherne Approved Nov-13-2020 19:54:31 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulMatherne, 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.
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979435
Page 85 of 184
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
 N/A Nov-11-2020 15:26:54 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul
Matherne Approved Nov-05-2020 16:46:12 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulMatherne, 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.
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979436
Page 86 of 184
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-04-2020
16:32:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-04-2020
16:32:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979437
Page 87 of 184
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-04-2020
16:32:46
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent
Obtained
Sep/4/2020Initial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979438
Page 88 of 184
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-04-2020
16:32:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11161131Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-04-2020
16:32:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1955Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-04-2020
16:33:15
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-04-2020
16:33:15
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LA
TINO(A) OR OF SPANI
SH ORIGINInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979439
Page 89 of 184
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-04-2020
16:33:15
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979440
Page 90 of 184
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-04-2020
16:33:32
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979441
Page 91 of 184
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-04-2020
16:34:06
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-04-2020
16:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-04-2020
16:34:06
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979442
Page 92 of 184
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.a
Date Location User Value Reason
Sep-04-2020
16:34:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histo
ry Term:Hypertensi
on
Start Date: UNK/UN
K/2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-04-2020
16:34:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-04-2020
16:34:27
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979443
Page 93 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-04-2020
16:34:27
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-04-2020
16:34:27
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-04-2020
16:35:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histo
ry Term:High Chol
esterol
Start Date: UNK/UN
K/2019
Ongoing: YESInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979444
Page 94 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.b Line/MH Number:
Date Location User Value Reason
Sep-04-2020
16:35:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-04-2020
16:35:21
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
High CholesterolInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-04-2020
16:35:21
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-04-2020
16:35:21
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979445
Page 95 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Sep-04-2020
16:36:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Histo
ry Term:Heart Palpi
tations
Start Date: Sep/4/2018
Ongoing: YESInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979446
Page 96 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.c Line/MH Number:
Date Location User Value Reason
Sep-04-2020
16:36:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-04-2020
16:36:19
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Heart PalpitationsInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-04-2020
16:36:19
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-04-2020
16:36:19
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979447
Page 97 of 184
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020
17:00:32
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-04-2020
17:00:32
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
135.1Initial Entry
3. Unit:
Date Location User Value Reason
Sep-04-2020
17:00:32
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-04-2020
17:00:32
(UTC-06:00)
Central Time (US &ACV0PFEINFP6000  Data Entry:
61.0Initial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979448
Page 98 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Canada)
5. Unit:
Date Location User Value Reason
Sep-04-2020
17:00:32
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-04-2020
17:00:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
25.5Initial Entry
7.a
Date Location User Value Reason
Sep-04-2020
17:00:32
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Record Ident
ifier::1
Temperature
:97.8
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-04-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0979449
Page 99 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
17:00:32
(UTC-06:00)
Central Time (US &
Canada)1
7.a Temperature:
Date Location User Value Reason
Sep-04-2020
17:00:32
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
97.8Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-04-2020
17:00:32
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-04-2020
17:00:32
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979450
Page 100 of 184
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-04-2020
17:00:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-04-2020
17:00:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-04-2020
17:00:59
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-04-2020
17:00:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979451
Page 101 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5. Specimen Type:
Date Location User Value Reason
Sep-04-2020
17:00:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-04-2020
17:00:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-De
fined Identi
fier:113
Test:: Choriogonado
tropin Beta_P
X113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-04-2020
17:00:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-04-2020
17:00:59
(UTC-06:00)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Bet
a_PX113Initial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979452
Page 102 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Central Time (US &
Canada)
6.a Not Done:
Date Location User Value Reason
Sep-04-2020
17:00:59
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979453
Page 103 of 184
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-04-2020
17:01:48
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-04-2020
17:01:48
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
253146Initial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979454
Page 104 of 184
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020
17:02:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020
17:02:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020
17:59:13
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-04-2020
17:02:01
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979455
Page 105 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-04-2020
17:02:01
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020
17:59:13
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Heather
LambertData Entry:
Sample ID: BN65BHInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-04-2020
17:59:13
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Heather
LambertData Entry:
BN65BHInitial Entry
5.b
Date Location User Value Reason
Sep-04-2020
17:59:21
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Heather
LambertData Entry:
Sample ID: BN65BJInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979456
Page 106 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.b Sample ID
Date Location User Value Reason
Sep-04-2020
17:59:21
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Heather
LambertData Entry:
BN65BJInitial Entry
5.c
Date Location User Value Reason
Sep-04-2020
17:59:27
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Heather
LambertData Entry:
Sample ID: BLBFG5Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-04-2020
17:59:27
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Heather
LambertData Entry:
BLBFG5Initial Entry
5.d
Date Location User Value Reason
Sep-04-2020
17:59:33
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Heather
LambertData Entry:
Sample ID: BLBFG6Initial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979457
Page 107 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.d Sample ID
Date Location User Value Reason
Sep-04-2020
17:59:33
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Heather
LambertData Entry:
BLBFG6Initial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979458
Page 108 of 184
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020
17:02:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020
17:02:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020
17:59:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-04-2020
17:02:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979459
Page 109 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-04-2020
17:02:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020
17:59:45
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Heather
LambertData Entry:
Sample ID: BN65NTInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-04-2020
17:59:45
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Heather
LambertData Entry:
BN65NTInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979460
Page 110 of 184
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-04-2020
17:02:50
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020
17:02:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020
17:02:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-04-2020
17:02:50
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020 14:40Initial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979461
Page 111 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020
17:02:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-04-2020
17:02:50
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-04-2020
17:02:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-04-2020
17:02:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERI
ODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979462
Page 112 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-04-2020
17:02:50
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979463
Page 113 of 184
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-04-2020
17:03:38
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICI
TY E-DIARY NOT CO
LLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979464
Page 114 of 184
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-15-2020
05:49:06
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 2: Closed Per site
confirmation
Not COVID
ILLNESS
Oct-13-2020
09:53:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 2: Answered Subject was
brought in for an
unplanned visit,
but it did not
meet criteria for
Covid illness
visit
Oct-01-2020
15:12:33
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 2: Opened As per Illness
ediary records,
subject reported
"Yes" for the
question "Have
you experienced
any of the
following?” for
the COVID-19
symptoms or
diagnosis on
17SEP2020. But
there is no
COVID Illness
visit reported in
the database.
Please clarify.
Sep-30-2020
06:18:35ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0979465
Page 115 of 184
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00)
Central Time (US &
Canada)
Sep-29-2020
13:13:09
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Sep-29-2020
13:13:09
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
Sep-29-2020
08:32:51
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly
review and
complete ‘Date
of Visit, Nasal
Swab,
Pregnancy Test,
Vaccination,
Vital Signs'
forms at this
visit. Thank you.
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0979466
Page 116 of 184
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Sep-29-2020
13:15:47
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
2.a
Date Location User Value Reason
Sep-29-2020
13:15:47
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Record Ident
ifier::1
Temperature
:97.3
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-29-2020
13:15:47
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979467
Page 117 of 184
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-29-2020
13:15:47
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
97.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-29-2020
13:15:47
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-29-2020
13:15:47
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979468
Page 118 of 184
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-29-2020
13:16:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-29-2020
13:16:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-29-2020
13:16:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-29-2020
13:16:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979469
Page 119 of 184
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5. Specimen Type:
Date Location User Value Reason
Sep-29-2020
13:16:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-29-2020
13:16:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-De
fined Identi
fier:113
Test:: Choriogonado
tropin Beta_P
X113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-29-2020
13:16:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-29-2020
13:16:35
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta
_PX113Initial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979470
Page 120 of 184
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US &
Canada)
6.a Not Done:
Date Location User Value Reason
Sep-29-2020
13:16:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979471
Page 121 of 184
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-29-2020
13:17:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-29-2020
13:17:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020
10:31:46
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-30-2020
03:28:44
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0979472
Page 122 of 184
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-29-2020
13:17:29
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-29-2020
13:17:29
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Oct-01-2020
10:31:46
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP41FNInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-01-2020
10:31:46
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BP41FNInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979473
Page 123 of 184
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-29-2020
13:18:14
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-29-2020
13:18:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-29-2020
13:18:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-29-2020
13:18:14
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020 15:44Initial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979474
Page 124 of 184
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5. Anatomical Location:
Date Location User Value Reason
Sep-29-2020
13:18:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-29-2020
13:18:14
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-29-2020
13:18:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-29-2020
13:18:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERI
ODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979475
Page 125 of 184
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-29-2020
13:18:14
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979476
Page 126 of 184
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-27-2020
06:48:14
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-26-2020
13:23:57
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 1: Answered EOT does match
V3 Date. Please
clarify if further
action is
required
Oct-24-2020
10:25:26
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened As per CRF
guidelines, the
treatment period
is defined as 1st
vaccination visit
through the
1-month post
vaccination visit
after the 2nd
vaccination.
Hence, please
complete
treatment
disposition CRF
and update date
of EOT to match
the date the Visit
3.
Oct-22-2020
08:47:18
(UTC-06:00)ACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0979477
Page 127 of 184
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Central Time (US &
Canada)
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979478
Page 128 of 184
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020
08:47:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-24-2020
09:39:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Balaji
Prabu RQuery 1: Closed Query raised in
hidden items
Oct-24-2020
04:12:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened As per CRF
guidelines, the
treatment period
is defined as 1st
vaccination visit
through the
1-month post
vaccination visit
after the 2nd
vaccination.
Hence, please
complete
treatment
disposition CRF
and update date
of EOT to match
the date the Visit
3.
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979479
Page 129 of 184
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-22-2020
08:47:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020
10:45:45
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-22-2020
08:47:28
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-22-2020
08:47:28
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020
10:45:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNNRSFInitial Entry
5.a Sample ID
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0979480
Page 130 of 184
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Oct-22-2020
10:45:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNNRSFInitial Entry
5.b
Date Location User Value Reason
Oct-22-2020
10:45:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNNRSGInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-22-2020
10:45:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNNRSGInitial Entry
5.c
Date Location User Value Reason
Oct-22-2020
10:46:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP4106Initial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0979481
Page 131 of 184
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.c Sample ID
Date Location User Value Reason
Oct-22-2020
10:46:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP4106Initial Entry
5.d
Date Location User Value Reason
Oct-22-2020
10:46:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP4107Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-22-2020
10:46:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP4107Initial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0979482
Page 132 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-30-2020
12:31:33
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979483
Page 133 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Assessments
Date Location User Value Reason
Sep-30-2020
12:32:19
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-30-2020
12:31:42
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Contact
Outcome is
ticked however
'CONTACT
OUTCOME'
form is not
entered. Please
review and
update as
appropriate.
Sep-30-2020
12:31:42
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
CONTACT OUTCOM
EInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979484
Page 134 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Contact Type:
Date Location User Value Reason
Sep-30-2020
12:31:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Sep-30-2020
12:32:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-30-2020
12:32:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Sep/17/2020
Contact Outcome:
VISIT ARRANGE
DTranscription
Error
Sep-30-2020
12:31:55ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Contact Outcome'
is selected as
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979485
Page 135 of 184
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00)
Central Time (US
& Canada)'VISIT
ARRANGED' but
no 'VITAL
SIGNS' and/or
'UNPLANNED
ASSESSMENT
OF LOCAL
REACTION'
form(s) is/are
entered. Please
review and
update as
appropriate.
Sep-30-2020
12:31:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Response to
"Date of Contact"
is missing.
Sep-30-2020
12:31:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Contact Outcome:
VISIT ARRANGE
DInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979486
Page 136 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Sep-30-2020
12:33:14
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 
)Data Entry:
Sep/17/2020Initial Entry
2.a
Date Location User Value Reason
Sep-30-2020
12:33:14
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Record Ident
ifier::1
Temperature
:98.7
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-30-2020
12:33:14
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979487
Page 137 of 184
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Sep-30-2020
12:33:14
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
98.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-30-2020
12:33:14
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-30-2020
12:33:14
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979488
Page 138 of 184
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: UNPLANNED ASSESSMENT OF LOCAL
REACTION - SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
2. Injection Site Location
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
3. Injection Site Body Side:
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
4.a
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &ACV0PFEINFP6000  Data Entry:
Reaction:: REDNE
SSInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979489
Page 139 of 184
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: UNPLANNED ASSESSMENT OF LOCAL
REACTION - SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Canada) Reaction Pres
ent::NO
4.a Reaction:
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
4.a Reaction Present:
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Reaction:: SWELLI
NG
Reaction Pre
sent::NOInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979490
Page 140 of 184
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: UNPLANNED ASSESSMENT OF LOCAL
REACTION - SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
4.b Reaction:
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
4.b Reaction Present:
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sympto
m::PAIN AT INJE
CTION SITE
Sympto
m Prese
nt::YES
Symptom Gr
ade:
2
Event related
to Study Trea
ment?
YESInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979491
Page 141 of 184
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: UNPLANNED ASSESSMENT OF LOCAL
REACTION - SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Symptom:
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION S
ITEInitial Entry
5.a Symptom Present:
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Symptom Grade:
2
Event related to Study
Treament?
YESInitial Entry
5.b
Date Location User Value Reason
Sep-30-2020
12:45:32
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Symptom
::FATIGUE/T
IREDNESS
Symptom
Present::NOInitial Entry
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Symptom
::FATIGUE/T
IREDNESSInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979492
Page 142 of 184
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: UNPLANNED ASSESSMENT OF LOCAL
REACTION - SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Symptom
Present::
5.b Symptom:
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
FATIGUE/TIREDNESSInitial Entry
5.b Symptom Present:
Date Location User Value Reason
Sep-30-2020
12:45:32
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-30-2020
12:45:32
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEADA
CHE
Symptom Pr
esent::NOInitial Entry
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEADA
CHE
Symptom Pr
esent::Initial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979493
Page 143 of 184
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: UNPLANNED ASSESSMENT OF LOCAL
REACTION - SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.c Symptom:
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 
)Data Entry:
HEADACHEInitial Entry
5.c Symptom Present:
Date Location User Value Reason
Sep-30-2020
12:45:32
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.d
Date Location User Value Reason
Sep-30-2020
12:45:32
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VOMITI
NG
Symptom Pr
esent::NOInitial Entry
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VOMITI
NG
Symptom Pr
esent::Initial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979494
Page 144 of 184
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: UNPLANNED ASSESSMENT OF LOCAL
REACTION - SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.d Symptom:
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 
)Data Entry:
VOMITINGInitial Entry
5.d Symptom Present:
Date Location User Value Reason
Sep-30-2020
12:45:32
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.e
Date Location User Value Reason
Sep-30-2020
12:45:32
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 
)Data Entry:
Symptom:: DIARR
HEA
Symptom Pr
esent::NOInitial Entry
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIARR
HEA
Symptom Pr
esent::Initial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979495
Page 145 of 184
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: UNPLANNED ASSESSMENT OF LOCAL
REACTION - SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.e Symptom:
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
5.e Symptom Present:
Date Location User Value Reason
Sep-30-2020
12:45:32
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.f
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sympt
om::NEW OR WOR
SENED MUSC
LE PAIN
Sympt
om Pre
sent::YES
Symptom Gra
de:
2
Event related t
o Study Tream
ent?
YESInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979496
Page 146 of 184
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: UNPLANNED ASSESSMENT OF LOCAL
REACTION - SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.f Symptom:
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED
MUSCLE PAINInitial Entry
5.f Symptom Present:
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Symptom Grade:
2
Event related to Study
Treament?
YESInitial Entry
5.g
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sympto
m::NEW OR WO
RSENED JOI
NT PAIN
Sympto
m Prese
nt::NOInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979497
Page 147 of 184
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: UNPLANNED ASSESSMENT OF LOCAL
REACTION - SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.g Symptom:
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED
JOINT PAINInitial Entry
5.g Symptom Present:
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.h
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CHIL
LS
Symptom Pres
ent::NOInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979498
Page 148 of 184
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/17/2020Form: UNPLANNED ASSESSMENT OF LOCAL
REACTION - SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.h Symptom:
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
5.h Symptom Present:
Date Location User Value Reason
Sep-30-2020
12:44:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979499
Page 149 of 184
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-26-2020
13:23:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-26-2020
13:23:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-26-2020
13:23:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979500
Page 150 of 184
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Sep-30-2020
12:59:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979501
Page 151 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Sep-30-2020
13:05:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979502
Page 152 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Nov-02-2020
15:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0979503
Page 153 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Nov-04-2020
10:31:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0979504
Page 154 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Sep-30-2020
12:59:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-30-2020
12:59:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-30-2020
12:59:53
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Left Axillary swollen ly
mp nodeInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-30-2020
12:59:53
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020 00:00Initial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979505
Page 155 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-12-2020
16:57:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-12-2020
16:06:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Oct-12-2020
16:06:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/14/2020 00:00New Information
Oct-12-2020
14:35:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Please determine
if this Adverse
Event is still
ONGOING.
Please update or
clarify.
Sep-30-2020
12:59:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0979506
Page 156 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-30-2020
12:59:53
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent
or significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-30-2020
12:59:53
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-30-2020
12:59:53
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-15-2020
05:12:22
(UTC-06:00)ACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Closed closed per site
response
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979507
Page 157 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Central Time (US &
Canada)
Oct-14-2020
18:23:12
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 1: Answered Per PI, timining
and proxmity to
injection site
suggest a causal
relationship to
administered
vaccine.
Assessed as
likely a local
reaction.
Oct-01-2020
15:02:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Opened GPD Clin: Per
protocol
investigator’s
causality
assessment is the
determination of
whether there is
a reasonable
possibility that
IP caused or
contributed to
AE. Please
kindly provide
the evidence/
arguments to
suggest a causal
relationship?
Sep-30-2020
12:59:53
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979508
Page 158 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Sep-30-2020
12:59:53
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-30-2020
12:59:53
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-30-2020
12:59:53
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-12-2020
16:06:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-12-2020
16:06:50ACV0PFEINFP6000  Data Entry:
RECOVERED/RENew Information
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979509
Page 159 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00)
Central Time (US
& Canada)SOLVED
Oct-12-2020
16:06:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Left Axillary
swollen lymp node:
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Sep-30-2020
12:59:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/R
ESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-30-2020
12:59:53
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979510
Page 160 of 184
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Sep-30-2020
13:05:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-30-2020
13:05:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-02-2020
16:43:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Nov-02-2020
15:26:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Nov-02-2020
15:26:04
(UTC-06:00)ACV0PFEINFP6000  Data Entry:
Muscle Pain @ injecti
on siteChanged
Information
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979511
Page 161 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Central Time (US
& Canada)
Oct-23-2020
14:07:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
This AE needs to
be split into two
Adverse Event
Records to match
the Unplanned
Assessment of
Local Reactions.
Please update to
include both
PAIN AT
INJECTION
SITE and NEW
OR
WORSENED
MUSCLE PAIN.
Thank you.
Oct-23-2020
11:01:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Candidate CLINQUERY:
This AE needs to
be split into two
Adverse Event
Records to match
the Unplanned
Assessment of
Local Reactions.
Please update to
include both
PAIN AT
INJECTION
SITE and NEW
OR
WORSENED
MUSCLE PAIN.
Thank you.
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0979512
Page 162 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-30-2020
13:05:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Muscle pain extendin
g from injection site t
o chest wall and uppe
r backInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-30-2020
13:05:20
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020 00:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-12-2020
16:57:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-12-2020
16:05:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Oct-12-2020
16:05:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/14/2020 00:00New Information
Oct-12-2020
14:36:04ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Please determine
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0979513
Page 163 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00)
Central Time (US
& Canada)if this Adverse
Event is still
ONGOING.
Please update or
clarify.
Sep-30-2020
13:05:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-30-2020
13:05:20
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent
or significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-30-2020
13:05:20
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979514
Page 164 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-30-2020
13:05:20
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-30-2020
13:05:20
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-30-2020
13:05:20
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-30-2020
13:05:20
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979515
Page 165 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-30-2020
13:05:20
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-12-2020
16:07:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-12-2020
16:07:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RE
SOLVEDTranscription Error
Oct-12-2020
16:05:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Muscle pain
extending from
injection site to chest
wall and upper back:
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Sep-30-2020
13:05:20
(UTC-06:00)ACV0PFEINFP6000  Data Entry:
RECOVERING/R
ESOLVINGInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979516
Page 166 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Central Time (US
& Canada)
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-30-2020
13:05:20
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979517
Page 167 of 184
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Nov-02-2020
15:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-02-2020
15:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Nov-12-2020
19:11:58
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
4: Clo
sedResponse
satisfies
query
Nov-12-2020
15:26:18
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
2: Clo
sedDiscrepancy
has been
closed.
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979518
Page 168 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Nov-12-2020
11:17:57
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
4: An
swere
dTranscription
Error
Nov-12-2020
11:17:57
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: An
swere
dTranscription
Error
Nov-12-2020
11:17:57
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Gener
alized
Muscl
e PainTranscription
Error
Nov-12-2020
05:34:40
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery
1: Clo
sedResponse
satisfies
query
Nov-12-2020
04:27:46
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
4: Op
enedDM: A
trailing or
leading
space is
identified. To
avoid
processing
errors, please
remove the
identified
character by
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979519
Page 169 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
deleting the
entry and
re-entering
the data
(without
using copy
and paste).
Nov-12-2020
04:27:35
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Clo
sedNew query
raised
Nov-12-2020
04:24:33
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Op
enedDM: A
trailing or
trailing space
is identified.
To avoid
processing
errors, please
remove the
identified
character by
deleting the
entry and
re-entering
the data
(without
using copy
and paste).
Nov-12-2020
01:13:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
2: Op
enedSpacing:
Verbatim
Term
contains
leading,
trailing or
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979520
Page 170 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
more than
one
consecutive
space.
Nov-11-2020
15:26:54
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dTranscription
Error
Nov-11-2020
15:26:54
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Gener
alized
Muscl
e PainTranscription
Error
Nov-07-2020
15:34:54
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery
1: Rei
ssued:
Open
edGPD Clin:
page
unlocked,
please
update AE
term
accordingly.
Thanks
Nov-06-2020
13:31:49
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dPlease
Unlock to
change
answer
Nov-06-2020
08:34:40
(UTC-06:00)
Central TimeACV0PFEINFP6000  Svitlana
TonkovydQuery
1: Rei
ssued:
OpenGPD Clin: if
participant
experienced
generalized
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979521
Page 171 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(US &
Canada)edmuscle pain,
please
update AE
term to
"generalized
muscle
pain". If it
was local,
please
update AE
term to
specify
anatomic
location
(example:
neck muscle
pain, low
back muscle
pain).
Thanks
Nov-05-2020
16:30:23
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dPlease
provide
option to
update and
answer to
clarify query
Nov-05-2020
06:26:22
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Op
enedGPD Clin:
can you
please
confirm this
is or is not
generalized
muscle pain?
If yes -
please
update
verbatim,
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0979522
Page 172 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
otherwise
clarify in
query
response.
Thank you
Nov-04-2020
14:01:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery
1: Ca
ndidat
eGPD Clin:
can you
please
confirm this
is or is not
generalized
muscle pain?
If yes -
please
update
verbatim,
otherwise
clarify in
query
response.
Thank you
Nov-02-2020
15:28:50
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Muscl
e PainInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-02-2020
15:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020 UNK:UNKInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979523
Page 173 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-02-2020
15:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/14/2020 UNK:UN
KInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-02-2020
15:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent
or significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-02-2020
15:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0979524
Page 174 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Nov-02-2020
15:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-02-2020
15:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-02-2020
15:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-02-2020
15:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-02-2020
15:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0979525
Page 175 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-02-2020
15:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-02-2020
15:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0979526
Page 176 of 184
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Nov-04-2020
10:31:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-04-2020
10:31:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-04-2020
10:31:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Muscle Pain @ Chest Wall
to Upper BackInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-04-2020
10:31:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020 UNK:UNKInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0979527
Page 177 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-04-2020
10:31:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/14/2020 UNK:UN
KInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-04-2020
10:31:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent
or significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-04-2020
10:31:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0979528
Page 178 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Nov-04-2020
10:31:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-04-2020
10:31:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-04-2020
10:31:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-04-2020
10:31:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-04-2020
10:31:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0979529
Page 179 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-04-2020
10:31:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-04-2020
10:31:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0979530
Page 180 of 184
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-23-2021
12:35:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/12/2021Initial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979531
Page 181 of 184
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-25-2021
11:12:38
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-25-2021
11:12:12
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing in
the DISP visit.
Please complete
this date.
Feb-25-2021
11:12:12
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to r
eturn for Vaccination 3
Participant is:
eligible and NOT con
firmed to have receiv
ed only placebo at Va
ccination 1/2Transcription
Error
Feb-23-2021
12:35:23
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Participant is NOT willi
ng to return for Vaccinat
ion 3 OR otherwise not
eligibleInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979532
Page 182 of 184
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-25-2021
11:12:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/12/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-25-2021
11:12:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY F
OR ADDITIONAL VAC
CINATIONInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979533
Page 183 of 184
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-26-2020
13:23:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-04-2020
17:01:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZ
EDInitial Entry
Sep-04-2020
16:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-26-2020
13:23:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/21/2020Initial Entry
Sep-04-2020
17:01:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
Sep-04-2020
16:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979534
Page 184 of 184
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161131 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-05-2020
16:28:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3f2b\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0979535