125742 S1 M5 CRF c4591001 1080 10801006

Document text

Page 1 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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.
1S l ct appropriate response - Protocol
version24 JUL 2020
.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0955614
Page 2 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Informed Consent
.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/10/2020
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0955615
Page 3 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Demography
1.Subject ID [10801006]
2.Birth Date: 1946
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:
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b  (6) 
   
(b) (4)
FDA-CBER-2021-5683-0955616
Page 4 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/10/2020
2.Erroneous Visit
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0955617
Page 5 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)I   
I   
(b) (4)
FDA-CBER-2021-5683-0955618
Page 6 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/10/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
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(b) (4)
FDA-CBER-2021-5683-0955619
Page 7 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Glaucoma - right eye]
Start Date: UNK/UNK/2014
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroid]
Start Date: UNK/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vaginal Dryness]
Start Date: UNK/UNK/2010
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: UNK/UNK/1995
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Recurrent Panic Attack]
Start Date: UNK/UNK/2014
Ongoing: YES
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955620
Page 8 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vaginal dry Skin]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955621
Page 9 of 307
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Aug/10/2020
.Weight: [76.3]
.Unit: kg
.Height: [169.0]
.Unit: cm
6.Body Mass Index: [26.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)    
(b) (4)
FDA-CBER-2021-5683-0955622
Page 10 of 307
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/10/2020
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
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)   
(b) (4)
FDA-CBER-2021-5683-0955623
Page 11 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/10/2020
2.Randomization Number: [224990]
3.Randomization Group: [ ]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0955624
Page 12 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/10/2020
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 [BP59TT]
5.bSample ID [BP59TV]
5.cSample ID [BP59TW]
5.dSample ID [BPRN5F]
5.eSample ID [BPRN5G]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
     
(b) (4)
FDA-CBER-2021-5683-0955625
Page 13 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/10/2020
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 [BP59FM]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
   
(b) (4)
FDA-CBER-2021-5683-0955626
Page 14 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/10/2020 16:08
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
~--   
(b) (4)
FDA-CBER-2021-5683-0955627
Page 15 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0955628
Page 16 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0955629
Page 17 of 307
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Aug/31/2020
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Aug/31/2020
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955630
Page 18 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Aug/31/2020
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)   
(b) (4)
FDA-CBER-2021-5683-0955631
Page 19 of 307
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0955632
Page 20 of 307
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955633
Page 21 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BP59L6]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
   
(b) (4)
FDA-CBER-2021-5683-0955634
Page 22 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/31/2020 15:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
~--   
(b) (4)
FDA-CBER-2021-5683-0955635
Page 23 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/28/2020
2.Erroneous Visit
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0955636
Page 24 of 307
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Sep/8/2020
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Sep/8/2020
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)   
   
(b) (4)
FDA-CBER-2021-5683-0955637
Page 25 of 307
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)   
   
  
(b) (4)
FDA-CBER-2021-5683-0955638
Page 26 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/28/2020
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 [BPTSPF]
5.bSample ID [BRT45F]
5.cSample ID [BRT45G]
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(b) (4)
FDA-CBER-2021-5683-0955639
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/24/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
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(b) (4)
FDA-CBER-2021-5683-0955640
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/24/2020
2.Date of First Symptom Started: Oct/13/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/25/2020
Symptoms
.aSymptoms: FEVER
Was symptom present? NO
.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
.dSymptoms: CHILLS
Was symptom present? NO
.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
.hSymptoms: DIARRHEA
Was symptom present? YES
4 iSymptoms: VOMITING
Was symptom present? YES
ymptoms - Other
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)   
         
 
(b) (4)
FDA-CBER-2021-5683-0955641
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.aSymptoms - Other Text: [Nausea]
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(b) (4)
FDA-CBER-2021-5683-0955642
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Date of Collectio
nSpecimen Typ
eSpecimen Collection Locati
onAssay Code and Descripti
onDevice Typ
eForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)    
     1-
(b) (4)
FDA-CBER-2021-5683-0955643
Page 31 of 307
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
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(b) (4)
FDA-CBER-2021-5683-0955644
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
.Sample Collected? YES
Date of Collection:
Nov/24/2020
4If no sample was collected or sample
w s not collected according to
pr tocol, please provide reason:[ ]
Aliquot
lease ente  barcode for each aliquot.
.aSam le ID [CV11449]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)     
   
(b) (4)
FDA-CBER-2021-5683-0955645
Page 33 of 307
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3S ple Collected? NO
If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Self-swab was collected]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
 
   
(b) (4)
FDA-CBER-2021-5683-0955646
Page 34 of 307
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 
  
 
(b) (4)
FDA-CBER-2021-5683-0955647
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
 1.          Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0955648
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
.Treatment:
.Treatment: [ ]
.Start Date: //
.Ongoing?
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(b) (4)
FDA-CBER-2021-5683-0955649
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 2
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(b) (4)
FDA-CBER-2021-5683-0955650
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0955651
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)   
(b) (4)
FDA-CBER-2021-5683-0955652
Page 40 of 307
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
 1.       Sponsor-Defined Ident
ifierest
:Resul
t:Repeating
Pages
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)    
    ~    
(b) (4)
FDA-CBER-2021-5683-0955653
Page 41 of 307
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
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(b) (4)
FDA-CBER-2021-5683-0955654
Page 42 of 307
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Category for La
b TestVendor Name (DER
IVED)Collection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0955655
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
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(b) (4)
FDA-CBER-2021-5683-0955656
Page 44 of 307
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)        
(b) (4)
FDA-CBER-2021-5683-0955657
Page 45 of 307
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
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(b) (4)
FDA-CBER-2021-5683-0955658
Page 46 of 307
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Date: Vital Signs Details Form Instance
 1 Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)    
(b) (4)
FDA-CBER-2021-5683-0955659
Page 47 of 307
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
 
(b) (4)
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Page 48 of 307
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0955661
Page 49 of 307
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)   
(b) (4)
FDA-CBER-2021-5683-0955662
Page 50 of 307
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)      
     -
(b) (4)
FDA-CBER-2021-5683-0955663
Page 51 of 307
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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.Start Date: //
6.Ongoing?
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(b) (4)
FDA-CBER-2021-5683-0955664
Page 52 of 307
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0955665
Page 53 of 307
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)   
(b) (4)
FDA-CBER-2021-5683-0955666
Page 54 of 307
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/22/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/22/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 
(b) (4)
FDA-CBER-2021-5683-0955667
Page 55 of 307
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/22/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
.Sample Collected? YES
Date of Collection:
Dec/22/2020
4If no sample was collected or sample
w s not collected according to
pr tocol, please provide reason:[ ]
Aliquot
lease ente  barcode for each aliquot.
.aSam le ID [BPTSLS]
5.bSample ID [BPRCBC]
5.cSample ID [BPRCBD]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)     
   1   1   
(b) (4)
FDA-CBER-2021-5683-0955668
Page 56 of 307
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/17/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/17/2020
2.Erroneous Visit
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0955669
Page 57 of 307
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/17/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0955670
Page 58 of 307
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/17/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/17/2020
Contact Outcome:
VISIT NOT ARRANGED, REACTION NO LONGER PRESENT
3.Comments: [Called patient, Grade 3 temperature reaction no longer present.]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 
(b) (4)
FDA-CBER-2021-5683-0955671
Page 59 of 307
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Aug/19/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/19/2020
2.Erroneous Visit
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0955672
Page 60 of 307
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Aug/19/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0955673
Page 61 of 307
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Aug/19/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/19/2020
Contact Outcome:
VISIT ARRANGED
3.Comments: [ ]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 
(b) (4)
FDA-CBER-2021-5683-0955674
Page 62 of 307
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Aug/19/2020Form: VITAL SIGNS - TEMP
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Aug/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: FOREHEAD
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0955675
Page 63 of 307
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Aug/19/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Unplanned Assessment Of Local Reaction
1.Date of Assessment: Aug/19/2020
2.Injection Site Location DELTOID MUSCLE
3.Injection Site Body Side: RIGHT
Reaction
.aReaction: REDNESS
Reaction Present: NO
.bReaction: SWELLING
Reaction Present: NO
Symptom
5 aSymptom: PAIN AT INJECTION SITE
Symptom Present: NO
.bSymptom: FATIGUE/TIREDNESS
Symptom Present: NO
.cSymptom: HEADACHE
Symptom Present: NO
.dSymptom: VOMITING
Symptom Present: NO
5.eSymptom: DIARRHEA
Symptom Present: YES
Symptom Grade:
1
Event related to Study Treament?
NO
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
  
    
(b) (4)
FDA-CBER-2021-5683-0955676
Page 64 of 307
***Confidential***
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Aug/19/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5 fSymptom: NEW OR WORSENED MUSCLE PAIN
Symptom Present: YES
Symptom Grade:
1
Event related to Study Treament?
NO
5.gSymptom: NEW OR WORSENED JOINT PAIN
Symptom Present: NO
5.hSymptom: CHILLS
Symptom Present: NO
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955677
Page 65 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/28/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)   
(b) (4)
FDA-CBER-2021-5683-0955678
Page 66 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0955679
Page 67 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0955680
Page 68 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4If no sample was collected or sample
w s not collected according to
pr tocol, please provide reason:[ ]
Aliquot
lease ente  barcode for each aliquot.
5.Sam le ID [ ]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)    
   
(b) (4)
FDA-CBER-2021-5683-0955681
Page 69 of 307
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
 1.ADVERSE EVE
NT 1  Redness at injection
site Aug/10/2020 16:08  NO
End Date Time:
Aug/10/2020 17:08
 Repeating
Pages
 2.ADVERSE EVE
NT 2  Swelling at injection
site Aug/10/2020 16:08  NO
End Date Time:
Aug/10/2020 17:08
 Repeating
Pages
 3.ADVERSE EVE
NT 3  Lower Back Pain  Aug/14/2020 08:00  NO
End Date Time:
Aug/17/2020 UNK:UNK
 Repeating
Pages
 4.ADVERSE EVE
NT 4  Nausea  Aug/10/2020 16:37  NO
End Date Time:
Aug/10/2020 17:08
 Repeating
Pages
 5.ADVERSE EVE
NT 5  Intermittent Diarrhea
 Aug/12/2020 UNK:
UNK NO
End Date Time:
Aug/19/2020 UNK:UNK
 Repeating
Pages
 6.ADVERSE EVE
NT 6  Chills  Aug/13/2020 UNK:
UNK NO
End Date Time:
Aug/14/2020 UNK:UNK
 Repeating
Pages
 7.ADVERSE EVE
NT 7  Headache  Sep/8/2020 UNK:U
NK NO
End Date Time:
Sep/28/2020 UNK:UNK
 Repeating
Pages
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)      
(b) (4)
FDA-CBER-2021-5683-0955682
Page 70 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
C tegory: ADVERSE EVENT
.AE ID: [1]
.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Redness at injection site]
4.Start Date Time: Aug/10/2020 16:08
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/10/2020 17:08
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8Is 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
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)F  
   
  
(b) (4)
FDA-CBER-2021-5683-0955683
Page 71 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
14Did the adverse event cause the
subject to be discontinued from the
study?NO
5.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0955684
Page 72 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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)[Swelling at injection site]
4.Start Date Time: Aug/10/2020 16:08
.Is the adverse event still ongoing? NO
End Date Time:
Aug/10/2020 17:08
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9I  his event related to study
treatment:RELATED
0.Latest Action Taken with Study
Treatment:NOT APPLICABLE
1.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
   
(b) (4)
FDA-CBER-2021-5683-0955685
Page 73 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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[ ]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)   
(b) (4)
FDA-CBER-2021-5683-0955686
Page 74 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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)[Lower Back Pain]
4.Start Date Time: Aug/14/2020 08:00
.Is the adverse event still ongoing? NO
End Date Time:
Aug/17/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
  
(b) (4)
FDA-CBER-2021-5683-0955687
Page 75 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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[ ]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0955688
Page 76 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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)[Nausea]
4.Start Date Time: Aug/10/2020 16:37
.Is the adverse event still ongoing? NO
End Date Time:
Aug/10/2020 17:08
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9I  his event related to study
treatment:RELATED
0.Latest Action Taken with Study
Treatment:NOT APPLICABLE
1.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
   
(b) (4)
FDA-CBER-2021-5683-0955689
Page 77 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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[ ]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)   
(b) (4)
FDA-CBER-2021-5683-0955690
Page 78 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Intermittent Diarrhea]
4.Start Date Time: Aug/12/2020 UNK:UNK
.Is the adverse event still ongoing? NO
End Date Time:
Aug/19/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
  
(b) (4)
FDA-CBER-2021-5683-0955691
Page 79 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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[ ]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0955692
Page 80 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Chills]
4.Start Date Time: Aug/13/2020 UNK:UNK
.Is the adverse event still ongoing? NO
End Date Time:
Aug/14/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
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***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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[ ]
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***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Headache]
4.Start Date Time: Sep/8/2020 UNK:UNK
.Is the adverse event still ongoing? NO
End Date Time:
Sep/28/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9I  his event related to study
treatment:RELATED
0.Latest Action Taken with Study
Treatment:NOT APPLICABLE
1.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
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(b) (4)
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***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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[ ]
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(b) (4)
FDA-CBER-2021-5683-0955696
Page 84 of 307
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
 1.          Repeating
Pages
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  -
(b) (4)
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
.Did the Medication Error cause the
subject to be discontinued from the
study?
9W  this medication error associated
with any adverse events?
0.Serious Adverse Event Number: For
Pfizer Use Only[ ]
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(b) (4)
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Page 86 of 307
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)      
     -
(b) (4)
FDA-CBER-2021-5683-0955699
Page 87 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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: //
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(b) (4)
FDA-CBER-2021-5683-0955700
Page 88 of 307
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationse Des i
ptionForm Instanc
e
 1.          Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0955701
Page 89 of 307
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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:
.Dose Frequency:
.Route:
.Start Date: //
0.Ongoing?
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***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
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(b) (4)
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
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FDA-CBER-2021-5683-0955704
Page 92 of 307
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0955705
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
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Page 94 of 307
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
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(b) (4)
FDA-CBER-2021-5683-0955707
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***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
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FDA-CBER-2021-5683-0955708
Page 96 of 307
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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:
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***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
.Body Side:
.Route:
.Actual Dose: [ ]
.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
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***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
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(b) (4)
FDA-CBER-2021-5683-0955711
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***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
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(b) (4)
FDA-CBER-2021-5683-0955712
Page 100 of 307
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
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(b) (4)
FDA-CBER-2021-5683-0955713
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***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Further Vaccination Confirmation
Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
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FDA-CBER-2021-5683-0955714
Page 102 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/25/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
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FDA-CBER-2021-5683-0955715
Page 103 of 307
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
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***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
.Cause of Death Status:
Cause of Death: [ ]
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FDA-CBER-2021-5683-0955717
Page 105 of 307
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/26/2021
2.Erroneous Visit
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(b) (4)
FDA-CBER-2021-5683-0955718
Page 106 of 307
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Informed Consent - Further Vaccination
.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/26/2021
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FDA-CBER-2021-5683-0955719
Page 107 of 307
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
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I   
(b) (4)
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Page 108 of 307
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Jan/26/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
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(b) (4)
FDA-CBER-2021-5683-0955721
Page 109 of 307
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/26/2021
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
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(b) (4)
FDA-CBER-2021-5683-0955722
Page 110 of 307
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/26/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9R85]
5.bSample ID [BRT3W9]
5.cSample ID [BRT3W8]
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(b) (4)
FDA-CBER-2021-5683-0955723
Page 111 of 307
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/26/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9R8C]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
   
(b) (4)
FDA-CBER-2021-5683-0955724
Page 112 of 307
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/26/2021 10:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
~--   
(b) (4)
FDA-CBER-2021-5683-0955725
Page 113 of 307
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/16/2021
2.Erroneous Visit
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0955726
Page 114 of 307
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/16/2021
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
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)   
(b) (4)
FDA-CBER-2021-5683-0955727
Page 115 of 307
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/16/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9RCN]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
   
(b) (4)
FDA-CBER-2021-5683-0955728
Page 116 of 307
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/16/2021 09:57
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
~--   
(b) (4)
FDA-CBER-2021-5683-0955729
Page 117 of 307
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0955730
Page 118 of 307
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0955731
Page 119 of 307
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0955732
Page 120 of 307
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0955733
Page 121 of 307
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0955734
Page 122 of 307
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0955735
Page 123 of 307
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)   
(b) (4)
FDA-CBER-2021-5683-0955736
Page 124 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/28/2020
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0955737
Page 125 of 307
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0955738
Page 126 of 307
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
  
     
(b) (4)
FDA-CBER-2021-5683-0955739
Page 127 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
temDate User Comment
ormAug-11-2020 18:08:45 (UTC-05:00) Eastern Time
(US & Canada)Met all criteria
Not Applicable
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)   
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955740
Page 128 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormAug-31-2020 21:11:43 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) I 
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955741
Page 129 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Aug-31-2020 21:11:43 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955742
Page 130 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Aug-31-2020 21:11:43 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955743
Page 131 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Aug-31-2020 21:11:43 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955744
Page 132 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Aug-31-2020 21:11:43 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955745
Page 133 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5Aug-31-2020 21:11:43 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955746
Page 134 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6.aAug-31-2020 21:11:43 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955747
Page 135 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6.aAug-31-2020 21:11:43 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955748
Page 136 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6.aAug-31-2020 21:11:43 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955749
Page 137 of 307
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormDec-01-2020 14:20:41 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) I 
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955750
Page 138 of 307
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Dec-01-2020 14:20:41 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955751
Page 139 of 307
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Dec-01-2020 14:20:41 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955752
Page 140 of 307
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Dec-01-2020 14:20:41 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955753
Page 141 of 307
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Dec-01-2020 14:20:41 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955754
Page 142 of 307
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5Dec-01-2020 14:20:41 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955755
Page 143 of 307
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6Dec-01-2020 14:20:41 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955756
Page 144 of 307
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
7Dec-01-2020 14:20:41 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955757
Page 145 of 307
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
8Dec-01-2020 14:20:41 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955758
Page 146 of 307
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
9Dec-01-2020 14:20:41 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955759
Page 147 of 307
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
- Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormJan-27-2021 13:32:29 (UTC-05:00) Eastern Time
(US & Canada)Mollie Maples Not Applicable
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  I 
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0955760
Page 148 of 307
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
Mo  aples  N/A Jan-27-2021 13:31:11 (UTC-05:00) Eastern Time
(US & Canada)Edit - A
signatur
invalida
Affidavit:
N/A
Sylvia Shoffner  Approved Jan-21-2021 16:28:02 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SylviaShoffner, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-01-2020 14:17:06 (UTC-05:00) Eastern Time
(US & Canada)Edit - A
signatur
invalida
Affidavit:
N/A
Sylvia Shoffner  Approved Oct-13-2020 20:12:53 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SylviaShoffner, 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 Oct-13-2020 16:45:33 (UTC-05:00) Eastern Time
(US & Canada)Edit - Al
signature
invalidat
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 
      
     
  
     
  
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955761
Page 149 of 307
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Affidavit:
N/A
Sylvia Shoffner  Approved Oct-12-2020 12:47:23 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SylviaShoffner, 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.
 A Sep-28-2020 17:15:27 (UTC-05:00) Eastern Time
(US & Canada)Edit - A
signatur
invalida
Affidavit:
N/A
Sylvia Shoffner  Approved Sep-14-2020 11:03:29 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SylviaShoffner, 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.
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)     
  
    
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955762
Page 150 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-11-2020 08:06:39
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020nitial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-10-2020 18:17:30
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSnitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
    I    
 
    I    
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955763
Page 151 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-10-2020 18:15:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/10/2020Initial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955764
Page 152 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-10-2020 18:14:53
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a  calc
(au ocalcData Entry:
10801006Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-10-2020 18:14:48
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  auto c lc
( utocalc)Data Entry:
/1946Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-10-2020 18:15:31
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-10-2020 18:15:31
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-10-2020 18:15:34
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6) 
    I  1  
 
    I  - 
 
    I    
 
    I    
 
    I    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955765
Page 153 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-10-2020 18:18:11
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/10/2020nitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
    I    
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955766
Page 154 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-10-2020 18:20:02
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-10-2020 18:20:02
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a  calc
(a ocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-10-2020 18:20:02
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
    I    
 
   I    
 
    I    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955767
Page 155 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.a
Date Location User Value Reason
Aug-10-2020 18:59:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:Glaucoma - right
eye
Start Date: UNK/UNK/2014
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-10-2020 18:59:58
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a to calc
( utocalc)Data Entry:
1nitial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-10-2020 18:59:58
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
Glaucoma - right eyenitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-10-2020 18:59:58
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014nitial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-10-2020 18:59:58
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
YESnitial Entry
1.b
Date Location User Value Reason
Aug-10-2020 19:00:39 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 
 
 
    
 
    
    
 
    
    
 
    
    
 
 
 I   
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955768
Page 156 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00) Eastern Time
(US & Canada)(autocalc) Line/MH Number: 2
Medical History Ter
m:Hypothyroid
Start Date: UNK/UNK/20
10
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Aug-10-2020 19:00:39
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a  calc
(au ocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-10-2020 19:00:39
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
Hypothyroidnitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-10-2020 19:00:39
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010In tial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-10-2020 19:00:39
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
YESnitial Entry
1.c
Date Location User Value Reason
Aug-10-2020 19:01:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:Vaginal Drynes
s
Start Date: UNK/UNK/20
10Initial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 I   1 
 
    I  I  
 
    I  11  
 
    I  1  
 
 
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955769
Page 157 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Aug-10-2020 19:01:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-10-2020 19:01:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Vaginal DrynessInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-10-2020 19:01:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  ata Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-10-2020 19:01:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-10-2020 19:02:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:Depression
Start Date: UNK/UNK/19
95
Ongoing: YESInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)     
 
    
 
    
    
 
    
    
 
    
  i  
 
 
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955770
Page 158 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.d Line/MH Number:
Date Location User Value Reason
Aug-10-2020 19:02:33
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a to calc
( utocalc)Data Entry:
4nitial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-10-2020 19:02:33
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
Depressionnitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-10-2020 19:02:33
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-10-2020 19:02:33
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-11-2020 08:16:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numb
er:5
Medical History
Term:Recurrent Panic
Attack
Start Date: UNK/UNK/201
4
Ongoing: YESSubject did not
express having panic
attack within 48
hours of vaccination.
Aug-10-2020 19:03:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Te
rm:Panic AttackInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
  I    
 
  I  I  
 
  I  i  
 
  I  1  
 
 
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955771
Page 159 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Start Date: UNK/UNK/2
014
Ongoing: YES
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955772
Page 160 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.e Line/MH Number:
Date Location User Value Reason
Aug-10-2020 19:03:17
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a to calc
( utocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020 10:51:58
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Hayley Wype Query 1: Closed Response satisfies
query
Aug-11-2020 08:16:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  au o que y
(autoque y)Query 1: Answered Subject did not
express having panic
attack within 48 hours
of vaccination.
Aug-11-2020 08:16:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Recurrent Panic AttackSubject did not
express having panic
attack within 48 hours
of vaccination.
Aug-11-2020 07:29:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened GPD Clin: Panic
Attack is reported to
be ongoing since
2014. Please clarify in
event term if this is a
RECURRENT event
since 2014 and, if so,
confirm symptoms not
present within 48h of
vaccination if
symptoms could meet
delaying criteria.
Aug-10-2020 19:03:17
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
Panic AttackInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-10-2020 19:03:17
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.e Ongoing:
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
  
    
 
 
   I 
 1  
  
    
 
    
    
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0955773
Page 161 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Aug-10-2020 19:03:17
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
YESnitial Entry
1.f
Date Location User Value Reason
Aug-10-2020 19:03:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Ter
m:Vaginal dry Ski
n
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
1.f Line/MH Number:
Date Location User Value Reason
Aug-10-2020 19:03:56
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a to calc
( utocalc)Data Entry:
6nitial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-10-2020 19:03:56
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  D ta Entry:
V ginal dry SkinIn tial Entry
1.f Start Date:
Date Location User Value Reason
Aug-10-2020 19:03:56
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  D ta Entry:
UNK/UNK/2010nitial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-10-2020 19:03:56
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
YESnitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)     I  I  
 
 
 
 I    
 
    I  1  
 
    I    
 
    I  I  
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955774
Page 162 of 307
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date:
Date Location User Value Reason
Aug-10-2020 19:10:28
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/10/2020In tial Entry
2. Weight:
Date Location User Value Reason
Aug-10-2020 19:10:28
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
76.3In tial Entry
3. Unit:
Date Location User Value Reason
Aug-10-2020 19:10:28
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
kgnitial Entry
4. Height:
Date Location User Value Reason
Aug-10-2020 19:10:28
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
169.0In tial Entry
5. Unit:
Date Location User Value Reason
Aug-10-2020 19:10:28
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
cmnitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-10-2020 19:10:28
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a to calc
( utocalc)Data Entry:
26.7nitial Entry
7.a
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
    I    
 
    I    
 
    I    
 
    I    
 
    I    
 
   I    
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955775
Page 163 of 307
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Aug-10-2020 19:10:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.4
Temperature Unit: F
Temperature Locatio
n::FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-10-2020 19:10:28
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-10-2020 19:10:28
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
9 .4Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-10-2020 19:10:28
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry: nitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-10-2020 19:10:28
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 
 I    
 
 I  1 1 
 
 I  I  
 
 I  11 1 
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955776
Page 164 of 307
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-10-2020 19:08:15
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a  calc
(au ocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-10-2020 19:08:15
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a  calc
(au ocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-10-2020 19:08:15
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/10/2020nitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-10-2020 19:08:15
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a  calc
(au ocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-10-2020 19:08:15
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a to calc
( utocalc)Data Entry:
URINEnitial Entry
6.a
Date Location User Value Reason
Aug-10-2020 19:08:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 I    
 
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    I    
 
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 I    
 
 
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955777
Page 165 of 307
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Test:: Choriogonadotropi
n Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Aug-10-2020 19:08:15
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a  calc
(au ocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-10-2020 19:08:15
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-12-2020 09:12:16
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Query N/A due to age
Aug-12-2020 06:41:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened GPD Clin: Please
confirm why a
pregnancy test was
not done. There is
nothing in her
medical history to
indicate she is not a
woman of child
bearing potential.
Please update MedHx
as appropriate.
Aug-10-2020 19:08:15
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEnitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 I    
 
  I    
 
 I    
I    
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0955778
Page 166 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-11-2020 08:31:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/10/2020Initial Entry
2. Randomization Number:
Date Location User ValueReason
Aug-12-2020
14:59:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check: VC_DS001_07
Aug-12-2020
07:38:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Ans
weredTranscription Error
Aug-12-2020
07:38:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
22499
0Transcription Error
Aug-12-2020
04:24:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW4174932;Randomization
Number appears to be a
duplicate with Subject
10801007. Please confirm the
number has been entered
correctly or clarify.
Aug-11-2020
08:31:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
22499
1Initial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
    
    
 
  
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0955779
Page 167 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-10-2020 18:47:52
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a  calc
(au ocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-10-2020 18:47:52
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a to calc
( utocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-10-2020 18:48:02
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a o query
( toqueryQuery 1: Deleted Close Auto Query
Aug-10-2020 18:47:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-10-2020 18:47:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/10/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Aug-10-2020 18:48:59
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Aug-10-2020 18:48:38
(UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
BPRN5GInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
  
    
 
  
    
 
 
    
 
 
    
    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955780
Page 168 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a
Date Location User Value Reason
Aug-10-2020 18:48:02
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP59TTnitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-10-2020 18:48:02
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  D a Entry:
BP 9TTnitial Entry
5.b
Date Location User Value Reason
Aug-10-2020 18:48:10
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  D a Entry:
S mple ID: BP59TVInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-10-2020 18:48:10
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  D a Entry:
BP 9TVInitial Entry
5.c
Date Location User Value Reason
Aug-10-2020 18:48:19
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP59TWnitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-10-2020 18:48:19
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  D a Entry:
BP 9TWnitial Entry
5.d
Date Location User Value Reason
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
    
I    
 
    
I  1  
 
    
I  1  
 
    
I  1  
 
    
I    
 
    
I  1  
 
    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955781
Page 169 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-10-2020 18:48:29
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  D a Entry:
S mple ID: BPRN5FInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-10-2020 18:48:29
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
BPRN5Fnitial Entry
5.e
Date Location User Value Reason
Aug-10-2020 18:49:07
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRN5Gnitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-10-2020 18:49:07
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
BPRN5GInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)I  1  
 
    I    
 
    I    
    I    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955782
Page 170 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-10-2020 18:49:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  a  calc
(au ocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-10-2020 18:49:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  a to calc
( utocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-10-2020 18:49:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  a o query
( toqueryQuery 1: Deleted Close Auto Query
Aug-10-2020 18:49:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-10-2020 18:49:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/10/2020Initial Entry
5.a
Date Location User Value Reason
Aug-10-2020 18:49:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP59FMInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
  
    
 
  
    
 
 
    
 
  
    
 
  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955783
Page 171 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-10-2020 18:49:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP59FMInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955784
Page 172 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-10-2020 19:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-10-2020 19:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  a  calc
(au ocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-10-2020 19:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  a to calc
( utocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-21-2020
07:30:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Cl
osedResponse satisfies
query
Aug-20-2020
17:24:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: An
sweredForm updated
Aug-20-2020
09:12:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Re
issued:Open
edDM 1: Please
update "Contact
Outcome" form
under unplanned
visit.
Aug-18-2020
1 :31:25
(UTC-05:00)ACV0PFEINFP6000  Query 1: An
sweredSubject was
contacted. Please
confirm if
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (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-2021-5683-0955785
Page 173 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Eastern Time
(US & Canada)unplanned contact is
the same as
unplanned visit form
Aug-18-2020
03:15:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1: Op
enedSubject has reported
with Severe
symptoms/reactions
on '2020-08-14'. Per
protocol, subjects
experiencing Grade
3 local reactions
should be contacted.
Please confirm if an
UNPLANNED
CONTACT was
made and update the
corresponding form
as appropriate.
Aug-10-2020
19:06:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/10/202
0 16:08Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-10-2020 19:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
( utocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-10-2020 19:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-10-2020 19:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  a to calc
( utocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
   
    
 
  
  1  
 
   
    
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0955786
Page 174 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-10-2020 19:06:41
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a to calc
( utocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODnitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-10-2020 19:06:41
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
YESnitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
   I    
 
    I  I  
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955787
Page 175 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-10-2020 19:05:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DIA
RY COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
  I  
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955788
Page 176 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-31-2020 21:10:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
   
   
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955789
Page 177 of 307
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
ep-12-2020 03:07:40
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Query 1: Closed Data updated per
uery
ep-11-2020 16:56:02
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  auto query
( oquery)Query 1: Answered ubject did not have
fever on day of
Vaccination day 2.
Sep-11-2020 16:56:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Aug/31/2020Subject did not have
fever on day of
Vaccination day 2.
Sep-10-2020 12:09:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened RQ: Per Diary
records, Medication
for fever or pain is not
ongoing on 31Aug20
which is Day 1 of
VAX2. Please
reconcile and update
as stop data. Else,
clarify in query
response. Thanks.
ep-09-2020 13:15:47
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Query 1: Answered ever and pain is
ngoing
Sep-07-2020 13:24:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sagaya Mythili Query 1: Opened eDiary: Vaccination 2
is given for the
subject, however
FEVER/PAIN MED
associated with
Vaccination 1 is still
ongoing. Please
review and update as
appropriate. Else,
clarify in query
response.
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
    I   ~  I 
    
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0955790
Page 178 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
YESInitial Entry
2.a
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
l L   
  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955791
Page 179 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.b Symptom:
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-01-2020 17:52:30 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)      
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0955792
Page 180 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00) Eastern Time
(US & Canada)Symptom:: CH
ILL
S
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
  l 
  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0955793
Page 181 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.e Symptom:
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-09-2020 19:27:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIARRH
EA
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:YES
Ongoing
?
NO
Stop
Date:
Aug
/31/
202
0Subject reported that
AE's were not present
during vaccination 2.
They were gone by
morning of
vaccination.
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIAR
RHEA
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:YES
Ongo
ing?
YE
SInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 
  
 
  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955794
Page 182 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.f Symptom:
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-10-2020 12:00:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-09-2020 19:27:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Subject reported that
AE's were not present
during vaccination 2.
They were gone by
morning of
vaccination.
Sep-09-2020 19:27:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Aug/31/2020Subject reported that
AE's were not present
during vaccination 2.
They were gone by
morning of
vaccination.
Sep-07-2020 13:25:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sagaya Mythili Query 1: Opened eDiary: Vaccination 2
is given for the
subject, however
DIARRHEA
associated with
Vaccination 1 is still
ongoing. Please
review and update as
appropriate. Else,
clarify in query
response.
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
YESInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
 
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955795
Page 183 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.g
Date Location User Value Reason
Sep-09-2020 19:28:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR WO
RSENED MU
SCLE PAIN
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:YES
Ongoing?
NO
Stop Date
:
Aug/31/
2020Subject reported that
AE's were not present
during vaccination 2.
They were gone by
morning of
vaccination.
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR W
ORSENED
MUSCLE P
AIN
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:YES
Ongoing?
YESInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955796
Page 184 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.g Symptom:
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE PA
INInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-10-2020 11:58:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-09-2020 19:28:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Subject reported that
AE's were not present
during vaccination 2.
They were gone by
morning of
vaccination.
Sep-09-2020 19:28:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Aug/31/2020Subject reported that
AE's were not present
during vaccination 2.
They were gone by
morning of
vaccination.
Sep-07-2020 13:25:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sagaya Mythili Query 1: Opened eDiary: Vaccination 2
is given for the
subject, however
NEW OR
WORSENED
MUSCLE PAIN
associated with
Vaccination 1 is still
ongoing. Please
review and update as
appropriate. Else,
clarify in query
response.
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?Initial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
 
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955797
Page 185 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
YES
2.h
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
ep-01-2020 17:52:30
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PAINnitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
ep-01-2020 17:52:30
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
NOnitial Entry
3. Injection Site Location:
Date Location User Value Reason
ep-01-2020 17:52:30
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a  calc
(au ocalcData Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
ep-01-2020 17:52:30
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTnitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)     
 
 
 
     
 
     
 
   1  
 
     
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955798
Page 186 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions
present on the last day the Su
bject Diary was completed?:NOInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955799
Page 187 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SIT
E
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 17:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (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-2021-5683-0955800
Page 188 of 307
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020 21:11:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
2.a
Date Location User Value Reason
Aug-31-2020 21:11:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.8
Temperature Unit: F
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-31-2020 21:11:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-31-2020 21:11:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
97.8Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-31-2020 21:11:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Aug-31-2020 21:11:23 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 
   
 
 
 
 
   
 
 
   
 
 
   
 
 
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0955801
Page 189 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00) Eastern Time
(US & Canada)ORAL CAVITY
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)  
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0955802
Page 190 of 307
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-31-2020 21:11:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-31-2020 21:11:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-31-2020 21:11:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-31-2020 21:11:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-31-2020 21:11:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Aug-31-2020 21:11:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined Ident
ifier:Not Applica
bleInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955803
Page 191 of 307
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Test:: Not Applica
ble
Result:: Not Applica
ble
Not Done:: Not Applica
ble
6.a Sponsor ID:
Date Location User Value Reason
Aug-31-2020 21:11:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Aug-31-2020 21:11:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Aug-31-2020 21:11:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Aug-31-2020 21:11:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 
   
 
 
   
 
 
   
 
 
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955804
Page 192 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 21:12:18
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a  calc
(au ocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 21:12:18
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a to calc
( utocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 21:12:37
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  auto query
(autoqueryQuery 1: Deleted Close Auto Query
Aug-31-2020 21:12:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-31-2020 21:12:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020 21:12:37
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP59L6Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 
    
 
 
    
 
 
    
 
 
   
 
 
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955805
Page 193 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-31-2020 21:12:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP59L6Initial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955806
Page 194 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-31-2020 21:13:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020 21:13:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  a  calc
(au ocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020 21:13:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  uto calc
autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-31-2020 21:13:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/31/2020 15:36Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020 21:13:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  uto calc
autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-31-2020 21:13:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
   
   
 
   
    
 
   
    
 
   
   
 
   
    
 
   
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955807
Page 195 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Aug-31-2020 21:13:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  uto calc
autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-31-2020 21:13:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  uto calc
autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-31-2020 21:13:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)    
    
 
   
    
 
   
   
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955808
Page 196 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-08-2020 05:50:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Oct-07-2020 15:00:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered Changed data per
query
Oct-07-2020 05:39:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened DM: Kindly consider
to update details on
SYMPRDATE form
or else clarify. Thank
you.
Sep-29-2020 12:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Sep-29-2020 12:54:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered EOT tab is complete
Sep-29-2020 10:30:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened CLINQUERY: Since
subject has now
completed V3 and the
treatment period of
the study, please
complete the EOT tab
to indicate
'Completed'
Sep-28-2020 17:15:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/28/2020Initial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 
   
   
    
   
   
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0955809
Page 197 of 307
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-09-2020 03:25:23
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-08-2020 16:58:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/8/2020Transcription Error
Oct-08-2020 16:51:29
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  au  query
(a oquery)Query 1: Answered Transcription Error
Oct-08-2020 16:51:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/28/2020Transcription Error
Oct-08-2020 00:58:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened eDiary: Per diary
records,
FEVER/PAIN MED
present on Last day
however inform
entered with 'No' for
the same. Please
verify and update. If
diary entered in error,
please enter stop date
as last date of diary.
Thanks.
Oct-07-2020 15:00:09
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
NInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 I   I 
I    
I  1  
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955810
Page 198 of 307
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.a
Date Location User Value Reason
Oct-09-2020 13:49:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOChanged Information
Oct-07-2020 15:00:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FEVER
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:YES
Ongoing
?
NO
Stop
Date:
Sep
/28/
202
0Initial Entry
2.a Symptom:
Date Location User Value Reason
Oct-07-2020 15:00:09
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERnitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-09-2020 15:14:10
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
uery
Oct-09-2020 13:49:20
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  uto query
autoquery)Query 1: Answered Changed Information
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 
 
  I    
 
 I   I I    
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955811
Page 199 of 307
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Oct-09-2020 13:49:20
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
NOhanged Information
Oct-09-2020 03:38:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened eDiary RQ1: Per
CCG, if eDiary is
missing and if
deemed appropriate
by PI, reactogenicity
events that are not
reported in the e-diary
in error can be moved
to the AE CRF. Please
reconcile and update
as appropriate.
Thanks.
Oct-08-2020 16:52:39
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Query 1: Answered ubject expressed
having a fever in
person.
Oct-08-2020 03:42:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened eDiary: Per diary
records, FEVER not
present on Last day
however inform is
entered with 'Yes' for
the same. Please
verify and update.
Else, clarify. Thanks.
Oct-07-2020 15:00:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/28/2020Initial Entry
2.b
Date Location User Value Reason
Oct-07-2020 15:00:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IG
UEInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)I    
I   I 
 
 
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955812
Page 200 of 307
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Were fever or systemic symp
toms present on the last day t
he Subject Diary was comple
ted?:NO
2.b Symptom:
Date Location User Value Reason
Oct-07-2020 15:00:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 15:00:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-08-2020 16:58:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEADA
CHE
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:YES
Ongoin
g?
NO
Stop
Date
:
Sep
/8/
202
0Transcription Error
Oct-08-2020 16:53:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEADA
CHETranscription Error
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 
    
 
 
    
 
 
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955813
Page 201 of 307
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:YES
Ongoing
?
NO
Stop
Date:
Sep
/28/
202
0
Oct-07-2020 15:00:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:NOInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955814
Page 202 of 307
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.c Symptom:
Date Location User Value Reason
Oct-07-2020 15:00:09
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEnitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-09-2020 07:11:50
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
uery
Oct-08-2020 16:58:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/8/2020Transcription Error
Oct-08-2020 16:53:26
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  au  query
(a oquery)Query 1: Answered ranscription Error
Oct-08-2020 16:53:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/28/2020Transcription Error
Oct-08-2020 00:59:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened eDiary: Per diary
records, HEADACHE
present on Last day
however inform
entered with 'No' for
the same. Please
verify and update. If
diary entered in error,
please enter stop date
as last date of diary.
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
  I    
 
 I    
I 
   
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955815
Page 203 of 307
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Thanks.
Oct-07-2020 15:00:09
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
NOnitial Entry
2.d
Date Location User Value Reason
Oct-07-2020 15:00:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-07-2020 15:00:09
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 15:00:09
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
NOnitial Entry
2.e
Date Location User Value Reason
Oct-07-2020 15:00:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:NOInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)      I    
 
 
 
 I    
 
 I    
 
 
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955816
Page 204 of 307
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.e Symptom:
Date Location User Value Reason
Oct-07-2020 15:00:09
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGnitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 15:00:09
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-07-2020 15:00:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Oct-07-2020 15:00:09
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAnitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 15:00:09
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
NOnitial Entry
2.g
Date Location User Value Reason
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 I    
 
 I    
 
 
 
 I    
 
 I    
 
  
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955817
Page 205 of 307
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Oct-07-2020 15:00:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Oct-07-2020 15:00:09
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE P
AINnitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 15:00:09
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
NOnitial Entry
2.h
Date Location User Value Reason
Oct-07-2020 15:00:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOIN
T PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 I    
 
 I    
 
 
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955818
Page 206 of 307
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.h Symptom:
Date Location User Value Reason
Oct-07-2020 15:00:09
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PAI
Nnitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 15:00:09
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-07-2020 15:00:09
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a  calc
(au ocalcData Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-07-2020 15:00:09
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-07-2020 15:00:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions
present on the last day the S
ubject Diary was completed?
:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-07-2020 15:00:09 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 I    
 
 I    
 
    I  1  
 
 I    
 
 
 
 
   
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955819
Page 207 of 307
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00) Eastern Time
(US & Canada)REDNESS
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 15:00:09
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
NOnitial Entry
5.b
Date Location User Value Reason
Oct-07-2020 15:00:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactions
present on the last day the S
ubject Diary was completed
?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-07-2020 15:00:09
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGnitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 15:00:09
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
NOnitial Entry
5.c
Date Location User Value Reason
Oct-07-2020 15:00:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN A
T INJEC
TION SI
TEInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT)     
 
 I    
 
 
 
 I    
 
 I    
 
 
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955820
Page 208 of 307
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-07-2020 15:00:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 15:00:09
(UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
 
    
 
 
    
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955821
Page 209 of 307
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
ep-28-2020 17:15:39
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a  calc
(au ocalcData Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
ep-28-2020 17:15:39
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a o calc
( tocalcData Entry:
SERUMnitial Entry
3. Sample Collected?
Date Location User Value Reason
ep-29-2020 15:32:55
UTC-05:00) Eastern Time
US & Canada)ACV0PFEINFP6000  a o query
( toqueryQuery 1: Closed lose Auto Query
Sep-29-2020 06:45:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-28-2020 17:15:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-28-2020 17:15:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/28/2020Initial Entry
5.a
Date Location User Value Reason
Sep-29-2020 15:32:55
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
Sample ID: BPTSPFInitial Entry
090177e196ae40ca\Final\Final On: 01-Apr-2021 05:43 (GMT) 
     1  
 
       
 
     
 
   
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955822
Page 210 of 307
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail His
…[truncated]