125742 S1 M5 c4591001 S Supp acrf

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Annotated Stud y Book for Stud y Desi gn: C4591001
Stud y Desi gn Version: 14.0
Sponsor: Pfizer
Protocol: C4591001
Sponsor Dru g Name: BLINDED THERAPY
C4591001 - COVID19
Generated by Central Designer TM
January 14, 2021 12:00PMAnnotated Study Book - C4591001
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Visits  
SCR 
MAIN INFORMED CONSENT  
DEMOGRAPHY  
DATE OF VISIT  
INCLUSION/EXCLUSION CRITE
RIA (INC EXC S)  
INCLUSION/EXCLUSION CRITERIA (INC EXC S)  
INCLUSION/EXCLUSION CRITERIA (INC EXC S)  
INCLUSION/EXCLUSION CRITERIA (INC EXC)  
DISPOSITION - SCREENING  
GENERAL MEDICAL HISTORY  
CONCOMITANT MEDICATIONS - BASELINE  
PHYSICAL EXAMINATION  
VITAL SIGNS - BASELINE  
ELECTRONIC SAMPLE TRACKING - PRIOR COVID -19 INFECTION  
MICROBIOLOGY SPECIMEN (COV19 SITE)  
CENTRAL LAB SAMPLE COLLECTION – BASELINE  
LAB URINALYSIS - PREGNANCY TEST  
V1_DAY1_VAX1_S  
DATE OF VISIT  
PHYSICAL EXAMINATION  
VITAL SIGNS  
LAB URINALYSIS - PREGNANCY TEST  
ELECTRONIC SAMPLE TRACKING - NASAL SWAB  
MICROBIOLOGY SPECIMEN (SWAB SITE)  
RANDOMIZATION  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICI TY 
VACCINATION  
VACCINATION DIARY  
V2_DAY2_POSTVAX1_S  
DATE OF VISIT  
PHYSICAL EXAMINATION  
VITAL SIGNS  
CENTRAL LAB SAMPLE COLLECTION  
V3_WEEK1_POSTVAX1_S  
DATE OF VISIT  
PHYSICAL EXAMINATION  
VITAL SIGNS  
CENTRAL LAB SAMPLE COLLECTION  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
V4_WEEK3_VAX2_S  
DATE OF VISIT  
VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES  
PHYSICAL EXAMINATION  
VITAL SIGNS  
LAB URINALYSIS - PREGNANCY TEST  
ELECTRONIC SAMPLE TRACKING - NASAL SWAB  
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MICROBIOLOGY SPECIMEN (SWAB SITE)  
CENTRAL LAB SAMPLE COLLECTION  
ELE
CTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
VACCINATION  
VACCINATION DIARY  
V5_WEEK1_POSTVAX2_S  
DATE OF VISIT  
PHYSICAL EXAMINATION  
VITAL SIGNS  
CENTRAL LAB SAMPLE COLLECTION  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
V6_WEEK2_PO STVAX2_S  
DATE OF VISIT  
VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES  
PHYSICAL EXAMINATION  
VITAL SIGNS  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
VACCINATION DIARY  
V7_MONTH1_S  
DATE OF VISIT  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
V4_WEEK3_VAX2_S_R  
DATE OF VISIT  
VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES  
PHYSICAL EXAMINATION  
VITAL SIGNS  
LAB URINALYSIS - PREGNANCY TEST  
ELECTRONIC SAMPLE TRACKING - NASAL SWAB  
MICROBIOLOGY SPECIMEN (SWAB SITE)  
CENTRAL LAB SAMPLE COLLECTION  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
VACCINATION  
VACCINATION DIARY  
V5_WEEK1_POSTVAX2_S_R  
DATE OF VISIT  
PHYSICAL EXAMINATION  
VITAL SIGNS  
CENTRAL LAB SAMPLE COLLECTION  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
V6_WEEK2_POSTVAX2_S_R  
DATE O F VISIT  
VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES  
PHYSICAL EXAMINATION  
VITAL SIGNS  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
VACCINATION DIARY  
V7_MONTH1_S_R  
DATE OF VISIT  
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ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
V8_MONTH6_S  
DATE OF VISIT  
EL
ECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
V9_MONTH12_S  
DATE OF VISIT  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
V10_MONTH24_S  
DATE OF VISIT  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
V1_DAY1_VAX1_NS  
DATE OF VISIT  
INCLUSION/EXCLUSION CRITERIA (INC  EXC NS)  
INCLUSION/EXCLUSION CRITERIA (INC EXC NS)  
INCLUSION/EXCLUSION CRITERIA (INC EXC NS)  
DISPOSITION - SCREENING  
GENERAL MEDICAL HISTORY  
PHYSICAL EXAMINATION  
VITAL SIGNS - BASELINE  
LAB URINALYSIS - PREGNANCY TEST  
RANDOMIZATION  
ELECTRONIC SAMPLE TRACKIN G - IMMUNOGENICITY  
ELECTRONIC SAMPLE TRACKING - NASAL SWAB  
VACCINATION  
V2_VAX2_NS  
DATE OF VISIT  
VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES  
VITAL SIGNS - TEMP  
LAB URINALYSIS - PREGNANCY TEST  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
ELECTRONIC SAMPLE TRACKING - NASAL SWAB  
VACCINATION  
V3_WEEK2_POSTVAX2_NS  
DATE OF VISIT  
VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
V4_MONTH1_NS  
DATE OF VISIT  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
V5_MONTH6_NS  
DATE OF VISIT  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
V6_MONTH12_NS  
DATE OF VISIT  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
V7_MONTH24_NS  
DATE OF VISIT  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
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V1_DAY1_VAX1_L  
DATE OF VIS IT 
INCLUSION/EXCLUSION CRITERIA (IN EX STG3)  
INCLU
SION/EXCLUSION CRITERIA (IN EX STG3)  
INCLUSION/EXCLUSION CRITERIA (IN EX STG3)  
INCLUSION/EXCLUSION CRITERIA (INC EXC)  
DISPOSITION - SCREENING  
GENERAL MEDICAL HISTORY  
PHYSICAL EXAMINATION  
LAB CHEMISTRY  
LABORATORY DATA -  HEMATOLOGY  
VITAL SIGNS - BASELINE  
VITAL SIGNS - BASELINE  
LAB URINALYSIS - PREGNANCY TEST  
RANDOMIZATION  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
ELECTRONIC SAMPLE TRACKING - NASAL SWAB  
VACCINATION  
VACCINATION DIARY  
V2_VAX2_L  
DATE OF VISIT  
VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES  
VITAL SIGNS - TEMP  
LAB URINALYSIS - PREGNANCY TEST  
ELECTRONIC SAMPLE TRACKING - NASAL SWAB  
VACCINATION  
VACCINATION DIARY  
V3_MONTH1_POSTVAX2_L  
DATE OF VISIT  
VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES  
LAB CHEMISTRY  
LABORATORY DATA -  HEMATOLOGY  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
VACCINATION DIARY  
V4_MONTH6_L  
DATE OF VISIT  
CONTACT OUTCOME  
LAB CHEMISTRY  
LABORATORY DATA -  HEMATOLOGY  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
V5_MONTH12_L  
DATE OF VISIT  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
LAB CHEMISTRY  
LABORATORY DATA -  HEMATOLOGY  
V6_MONTH24_L  
DATE OF VISIT  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
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LAB CHEMISTRY  
LABORATORY D ATA -  HEMATOLOGY  
POT_COVID_ILL  
DATE OF VISIT - ILLN
ESS 
CONTACT OUTCOME - MONTH 1  
SIGNS AND SYMPTOMS OF POTENTIAL COVID -19 
SIGNS AND SYMPTOMS OF POTENTIAL COVID -19 
MICROBIOLOGY SPECIMEN (COVID TEST)  
ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF  
ELECTRONIC SAMPLE TRACKING - NASAL SWAB  
HEALTH CARE UTILIZATION  
HOSPITALIZATION DETAILS  
RESPIRATORY TREATMENT  
RESPIRATORY TREATMENT  
ILLNESS DETAILS  
ILLNESS DETAILS - SEVERE 
ILLNESS DETAILS - SEVERE 
LOCAL LABORATORY DATA - REPEATING CHEMISTRY  
LOCAL LABORATO RY DATA - REPEATING CHEMISTRY  
LOCAL LABORATORY DATA - REPEATING HEMATOLOGY  
VITAL SIGNS - COVID  
VITAL SIGNS - PULSE OX ROOM AIR  
OXYGENATION PARAMETERS  
CONCOMITANT MEDICATIONS - VASOPRESSORS 
IMAGING  
VACCINATION DIARY  
POT_COVID_CONVA 
DATE OF VISIT - ILLNESS CONVALESCENT  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
VACCINATION DIARY  
POT_COVID_REPEAT_SWAB  
DATE OF VISIT - REPEAT SWAB  
ELECTRONIC SAMPLE TRACKING - REPEAT SWAB  
VACCINATION DIARY  
LOGS  
ADVERSE EVENT REPORT  
MEDICATION ERROR 
CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS  
CONCOMITANT MEDICATIONS - PROHIBITED 
RADIATION TREATMENT TRANSFUSIONS  
UNPL  
DATE OF VISIT  
CONTACT OUTCOME - UNPLANNED  
VITAL SIGNS - TEMP  
UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC EVENT  
UNPLANNED_VACCINATION 
DATE OF VISIT  
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VITAL SIGNS - TEMP  
LAB URINALYSIS - PREGNANCY TEST  
VACCINATION  
CONTACT OU
TCOME - MONTH 1  
CONTACT OUTCOME - MONTH 6  
V201_SURVEIL_CONSENT  
DATE OF VISIT  
INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
ELECTRONIC SAMPLE TRACKING - NASAL SWAB  
V202_SURVEIL_SWAB  
DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE  
ELECTRONIC SAMPLE TRACKING - REPEAT SWAB  
DISP  
TREATMENT UNBLINDED  
WITHDRAWAL OF CONSENT  
DEATH DETAILS CODED 
END_OF_TRT  
DISPOSITION – TREATMENT 
REVAX_CONTACT  
DATE OF VISIT  
V101_VAX3 
DATE OF VISIT  
INFORMED CONSENT - FURTHER VACCINATION  
INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION(REVAX IE)  
DISPOSITION - SCREENING FOR FURTHER VACCINATION  
LAB CHEMISTRY  
LABORATORY DATA -  HEMATOLOGY  
LAB URINALYSIS - PREGNANCY TEST  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
ELECTRONIC SAMPLE TRACKING - NASAL SWAB  
VACCINATION  
V102_VAX4 
DATE OF VISIT  
LAB URINALYSIS - PREGNANCY TEST  
ELECTRONIC SAMPLE TRACKING - NASAL SWAB  
VACCINATION  
V103_MONTH1 
DATE OF VISIT  
CONTACT OUTCOME  
LAB CHEMISTRY  
LABORATORY DATA -  HEMATOLOGY  
V104_MONTH6 
DATE OF VISIT  
CONTACT OUTCOME  
LAB CHEMISTRY  
LABORATORY DATA -  HEMATOLOGY  
V105_MONTH18 
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DATE OF VISIT  
CONTACT OUTCOME  
LAB CHEMISTRY  
LABORATORY DATA -  HEMATOLOGY  
FURTHER_VACCINATION_EOT  
DISPOSITION - TREATMENT  
FOLLOW_UP  
DISPOSITION - FOLLOW -UP 
Domains  
 
AE=ADVERSE EVENTS  
VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES  
ADVERSE EVENT REPORT  
MEDICATION ERROR  
CE=CLINICAL EVENTS  
VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES  
SIGNS AND SYMPTOMS OF POTENTIAL COVID -19 
SIGNS AND SYMPTOMS OF POTENTIAL COVID -19 
ILLNESS DETAILS  
ILLNESS DETAILS - SEVER E 
ILLNESS DETAILS - SEVERE  
CM=CONCOMITANT MEDICATIONS  
CONCOMITANT MEDICATIONS - BASELINE  
CONCOMITANT MEDICATIONS - VASOPRESSORS  
CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS  
CONCOMITANT MEDICATIONS - PROHIBITED  
CO=COMMENTS  
ELECTRONIC SAMPLE TRACKING - PRIOR COVID -19 INFECTION  
MICROBIOLOGY SPECIMEN (COV19 SITE)  
ELECTRO NIC SAMPLE TRACKING - NASAL SWAB  
MICROBIOLOGY SPECIMEN (SWAB SITE)  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
MICROBIOLOGY SPECIMEN (COVID TEST)  
ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF  
ELECTRONIC SAMPLE TRACKING - REPEAT SWAB  
DD=DEATH DETAILS  
DEATH DETAILS CODED  
DI=DEVICE IDENTIFIERS  
MICROBIOLOGY SPECIMEN (COV19 SITE)  
MICROBIOLOGY SPECIMEN (SWAB SITE)  
MICROBIOLOGY SPECIMEN (COVID TEST)  
DM=DEMOGRAPHICS  
DEMOGRAPHY  
REACTOGENICITY DIARY  
DS=DISPOSITION  
MAIN INFORMED CONSENT  
DISPOSITION - SCREENING  
RANDOMIZATION  
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TREATMENT UNBLINDED  
WITHDRAWAL OF CONSENT  
DISPOSITION - TREATMENT  
DISPOSITION - FOLLOW -UP 
INFORMED CONSENT - FURTHER VACCINATION  
DISPOSITION - SCREENING FOR FURTHER VACCINATION  
INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE  
EC=EXPOSURE AS COLLECTED  
VACCINATION  
VACCINATION  
EX=EXPOSURE  
VACCINATION  
VACCINATION  
FA=FINDINGS ABOUT EVENTS OR INTERVENTIONS  
VACCINATION DIARY  
VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES  
SIGNS AND SYMPTOMS OF POTENTIAL COVID -19 
SIGNS AND SYMPTOMS OF POTENTIAL COVID -19 
HEALTH CARE UTILIZATION  
UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC EVENT  
HO=HEALTHCARE ENCOUNTERS  
HEALTH CARE UTILIZATION  
HOSPITALIZATION DETAILS  
IE=INCLUSION/EXCLUSION CRITERIA NOT MET  
INCLUSION/EXC LUSION CRITERIA (INC EXC S)  
INCLUSION/EXCLUSION CRITERIA (INC EXC S)  
INCLUSION/EXCLUSION CRITERIA (INC EXC S)  
INCLUSION/EXCLUSION CRITERIA (INC EXC NS)  
INCLUSION/EXCLUSION CRITERIA (INC EXC NS)  
INCLUSION/EXCLUSION CRITERIA (INC EXC NS)  
INCLUSION/EXCLUSION CRITERIA (IN EX STG3)  
INCLUSION/EXCLUSION CRITERIA (IN EX STG3)  
INCLUSION/EXCLUSION CRITERIA (IN EX STG3)  
INCLUSION/EXCLUSION CRITERIA (INC EXC)  
INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION (REVAX IE)  
IS=IMMUNOGENICITY SPECIMEN ASSESSMENTS  
ELECTRONIC SAMPLE TRACKING - PRIOR COVID -19 INFECTION  
ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY  
LB=LABORATORY TEST RESULTS  
CENTRAL LAB SAMPLE COLLECTION - BASELINE  
LAB URINALYSIS - PREGNANCY TEST  
CENTRAL LAB SAMPLE COLLECTION  
LAB CHEMISTRY  
LABORATORY DATA - HEMATOLOGY  
LOCAL LABORATORY DATA - REPEATING CHEMISTRY  
LOCAL LABORATORY DATA - REPEATING CHEMISTRY  
LOCAL LABORATORY DATA - REPEATING HEMATOLOGY  
OXYGENATION PARAMETERS  
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MB=MICROBIOLOGY SPECIMEN  
MICROBIOLOGY SPECIMEN (COV19 SITE)  
CENTRAL LAB SAMPLE COLLECTION - BASELINE  
ELECTRONIC SAMPLE TRACKING - NASAL SWAB  
MICROBIOLOGY SPECIMEN (SWAB SITE)  
CENTRAL LAB SAMPLE COLLECTION  
MICROBIOLOGY SPECIMEN (COVID TEST)  
ELECTRONIC SAMPLE TRACKING - NASAL SWAB S ELF 
ELECTRONIC SAMPLE TRACKING - REPEAT SWAB  
MH=MEDICAL HISTORY  
GENERAL MEDICAL HISTORY  
MO=MORPHOLOGY  
IMAGING  
PE=PHYSICAL EXAMINATION  
PHYSICAL EXAMINATION  
PR=PROCEDURES  
RESPIRATORY TREATMENT  
RESPIRATORY TREATMENT  
RADIATION TREATMENT  
TRANSFUSIONS  
SV=SUBJECT  VISITS  
DATE OF VISIT  
CONTACT OUTCOME  
DATE OF VISIT - ILLNESS ONSET  
CONTACT OUTCOME - MONTH 1  
DATE OF VISIT - ILLNESS CONVALESCENT  
DATE OF VISIT - REPEAT SWAB  
CONTACT OUTCOME - UNPLANNED  
CONTACT OUTCOME - MONTH 6  
DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE  
VS=VITAL SIGNS  
VITAL SIGNS - BASELINE  
VITAL SIGNS  
VACCINATION DIARY  
VITAL SIGNS - BASELINE  
VITAL SIGNS - TEMP  
VITAL SIGNS - COVID  
VITAL SIGNS - PULSE OX ROOM AIR  
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C4591001: ADVERSE EVENT REPORT (AE) - Repeating Form
#C a t e g o r y A E  
IdentifierAdverse 
EventStart 
DateIs the 
Adverse 
Event 
Still 
OngoingToxicity 
GradeSerious Is AE a 
Result of a 
Medication 
ErrorRelationship 
to Study 
TreatmentAction 
Taken 
with 
Study 
TreatmentConcomitant 
Medication 
GivenNon-Drug 
Treatment 
GivenOutcome Caused Study 
DiscontinuationSerious 
Adverse 
Event 
Number
1
Adverse Event Report
1. Category:
[Category] 
ADVERSE EVEN T
2. AE ID:
[AE Identifier] 
3. Adverse Event: 
(If possible specify 
diagnosis, not 
individual 
symptoms) 
[Adverse Event] 
4. Start Date Time:
[Start Date] 
/ 
  / 
: 
  24-hour clock
5. Is the adverse event 
still ongoing?
[Is the Adverse 
Event Still Ongoing] 
YES
NO
End Date Time:
 / 
  / 
 : 
  24-hour clock
6. Toxicity Grade:
[Toxicity Grade] 
1
2
3
4
7. Is the adverse event 
ser ous? 
If Yes, NOTIFY 
PFIZER 
IMMEDIATELY.
Fatal; Life-
threatening; 
Inpatient 
hosp talization or 
prolongat on of 
existing 
hosp talization; 
Persistent or 
signif cant 
disabil ty/incapac ty; 
Congenital 
anomaly/birth 
defect; Important 
med cal event (i.e. 
may jeopardize 
subject and may require 
med cal/surgical 
intervention to 
prevent above 
outcomes).
[Serious] 
YES
Is this ser ous event associated with con genital anomal y or birth defect ?
YES
NO
Did this serious event result in death ?
YES
NO
Did this serious event re quire or prolong hospitalization ?
YES
NO
Did this serious event result in persistent or si gnificant disabil t y/incapac ty?
YES
NO
Is this ser ous event life threatenin g?
YES
NO
Other med call y important ser ous even t
YES
NO
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. 
[Is AE a Result of a Medication Error] 
YES
NO
9. Is this event related 
to study treatment:[Relat onship to 
Study Treatment] 
NOT RELATE D
If Not Related to stud y treatment (s), this event is due to:
CONCOMITANT DRUG TREATMEN T
CONCOMITANT NON-DRUG TREATMENT
OTHER
If Other, specify:
RELATE D
10. Latest Action Taken 
with Study 
DRUG WITHDRAW N
NOT APPLICABL EAnnotated Study Book - C4591001
STUDYID
AESTDTC
AECAT
AE=Adverse Events
AESPID
AETERM
AETOXGR
AEENDTC
AEENRTPT= ONGOING
AEMERES in SUPPAE
AEREL
AERELTXT in SUPPAE
AERELNST
AEACN
AESER
AESCONG
AESDTH
AESHOSP
AESDISAB
AESLIFE
AESMIE
AEENTPT= LAST SUBJECT ENCOUNTER
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Treatment:
[Act on Taken with 
Study Treatment] 
11. Was a Concomitant 
Medication given?[Concom tant 
Med cat on Given] 
YES
NO
12. Was a Non-Drug 
Treatment given?
[Non-Drug 
Treatment Given] 
YES
NO
13. What was the 
outcome of this adverse event?:
[Outcome] 
FATAL
NOT RECOVERED/NOT RESOLVE D
RECOVERED/RESOLVE D
RECOVERED/RESOLVED WITH SEQUELA E
RECOVERING/RESOLVING
UNKNOW N
14. D d the adverse 
event cause the 
subject to be 
discontinued from the study?
[Caused Study 
Discontinuat on] 
YES
NO
15. Ser ous Adverse 
Event Number: For Pfizer Use Only
[Serious Adverse 
Event Number] 
16. Comparison Term 
[hidden][Comparison Term] 
17. Lowest Level Term 
[hidden][Lowest Level Term] 
18. Lowest Level Term 
Code [hidden]
[Lowest Level Term 
Code] 
19. D ctionary-Derived 
Term [hidden]
[D ctionary-Derived Term] 
20. Preferred Term 
Code [hidden]
[Preferred Term 
Code] 
21. High Level Term 
[hidden][High Level Term] 
22. High Level Term 
Code [hidden]
[High Level Term 
Code] 
23. High Level Group 
Term [hidden]
[High Level Group Term] 
24. High Level Group 
Term Code [hidden]
[High Level Group 
Term Code] 
25. Primary System 
Organ Class [hidden]
[Primary System 
Organ Class] 
26. Primary System 
Organ Class Code 
[hidden]
[Primary System 
Organ Class Code] Annotated Study Book - C4591001
AE=Adverse Events
AECONTRT
AECONTRT
AEOUT
AECMGIV in SUPPAE
AENDGIV in SUPPAE
AESUBJDC in SUPPAE
Linked to related DS record via RELREC
AEREFID
NOT SUBMITTED
AELLT
AEPTCD
AEDECOD
AELLTCD
AEHLGT
AEHLTCD
AEHLT
AEHLGTCD
AEBODSYS
AEBDSYCD
AESOC
AESOCCD
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C4591001: LABORATORY DATA - HEMATOLOGY (CD4)
Laboratory Data Hematology
1. Lab Panel:
[Category for Lab Test] 
HEMATOLOG Y
2. Laboratory Name and Address
[Vendor Name (DERIVED)] 
3. Collection Date:
[Collect on Date:] 
 / 
 / 
4. Specimen Type:
[Specimen Type] 
BLOO D
Lab Result
# Sponsor-Defined Identifier Test: Result: Not Done: Lab Normal Range
5.a CD4_PX4722
Lab Result Entry5.1 Sponsor ID:
[Sponsor-Defined Identifier] 
5.2 Test:
[Test:] 
CD4_PX4722
5.3 Result:
[Result:] 
5.4 Not Done: [hidden]
[Not Done:] 
NOT DONE
5.5 LNMT
[Lab Normal Range] Low
High
Un t
10^3/mm3
/uL
%Annotated Study Book - C4591001
STUDYID
LBCAT
LB=Laboratory Test Results
LBNAM
LBDTC
LBSPEC
LBSPID
LBTEST
LBORRES
LBSTAT
LBORNRLO
LBORNRHI
LBORRESU
Page 13 of 131
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FDA-CBER-2021-5683-0058050
C4591001: COHORT SELECTION (COHORT SEL)
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is equivalent  to PHASE 2/3.
1. Select appropriate response -
Protocol version
[Trigger Response 1] 
2. Select appropriate response -
What cohort does the subject belong to?
[Trigger Response 10] 
STAGE 1 SENTINEL COHORTS
STAGE 1 NONSENTINEL COHORTS
STAGE 2 COHORTS
STAGE 3 COHORTSAnnotated Study Book - C4591001
NOT SUBMITTED
Page 14 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058051
C4591001: CONCOMITANT MEDICATIONS - BASELINE (CONMED BSL) - Repeating Form
#S p o n s o r - D e f i n e d  
IdentifierCategory for 
MedicationConcomitant Medications Pre-
specifiedName of 
MedicationDose 
DescriptionDose 
UnitDose 
FrequencyRoute Start 
Date
1
Concomitant Medications
1. What is the medication dentifier?
[Sponsor-Defined Identifier] 
2. Category:
[Category for Medication] 
GENERAL CONCOMITANT MEDICATIONS
3. Concomitant Medications Pre-specified:
[Concom tant Medications Pre-specified] 
NO
4. Med cation:
Prov de the complete gener c drug name 
(including salt form, where applicable). Where 
generic name is unknown, enter the full trade or 
proprietary name. Include clarifying information in the Med cat on text (e.g., Ingredient(s), 
route, use, formulation).
[Name of Medication] 
5. Dose:
[Dose Description] 
6. Dose Unit:
[Dose Unit] 
7. Dose Frequency:
[Dose Frequency] 
8. Route:
[Route] 
9. Start Date:
[Start Date] 
 / 
 / 
10. Comparison Term [hidden]
[Comparison Term] 
11. Standardized Med cat on Name - Dict onary 
derived. [hidden]
[Standardized Med cat on Name] 
12. Standardized Med cat on Code - D ctionary 
derived [hidden]
[Standardized Med cat on Code] Annotated Study Book - C4591001
CM=Concomitant Medications
STUDYID
CMSPID
CMCAT
NOT SUBMITTED
CMTRT
CMDOSE
CMDOSTXT
CMDOSU
CMDOSFRQ
CMROUTE
CMSTDTC
NOT SUBMITTED
CMDECOD
CMCODE in SUPPCM
Page 15 of 131
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FDA-CBER-2021-5683-0058052
C4591001: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS (CONMED VAX) - Repeating Form
# Sponsor-Defined Identifier Category for Medication Concomitant Medications Pre-specified Name of Medication Start Date
1
Concomitant Medications
1. What is the medication identifier?
[Sponsor-Defined Identifier] 
2. Category:
[Category for Med cat on] 
VACCINATIONS
3. Concomitant Medications Pre-specified:
[Concomitant Medications Pre-specified] 
NO
4. Medication:
Provide the complete gener c drug name 
(including salt form, where applicable). Where 
generic name is unknown, enter the full trade 
or proprietary name. Include clarifying 
information in the Med cat on text (e.g., Ingredient(s), route, use, formulation).
[Name of Medication] 
5. Date:
[Start Date] 
 / 
 / 
6. Comparison Term [hidden]
[Comparison Term] 
7. Standardized Medicat on Name - Dict onary 
derived. [hidden]
[Standardized Med cat on Name] 
8. Standardized Med cat on Code - Dictionary 
derived [hidden]
[Standardized Med cat on Code] Annotated Study Book - C4591001
STUDYID
CM=Concomitant Medications
CMSPID
CMCAT
CMTRT
CMSTDTC
NOT SUBMITTED
NOT SUBMITTED
CMDECOD
CMCODE in SUPPCM
Page 16 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058053
C4591001: MAIN INFORMED CONSENT (CONSENT)
Informed Consent
1. Consent Was:
[Consent Was:] 
OBTAINE D
Date Written Consent Obtained
/ 
  / 
Annotated Study Book - C4591001
DSCAT=PROTOCOL MILESTONE
STUDYID
DSSTDTC when 
DSTERM/DSDECOD=INFORMED CONSENT 
OBTAINED
DS=Disposition
Page 17 of 131
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FDA-CBER-2021-5683-0058054
C4591001: CONTACT OUTCOME - MONTH 1 (CONTACT 1M)
Contact Outcome
1. Follow-Up Contact Category 
[hidden]
[Follow Up Contact Category] 
CONTACT OUTCOM E
2. Contact Type:
[Type of Contact/Visit] 
CLINIC VISIT
TELEHEALTH VISIT
3. Was contact made?
[Was Contact Made] 
YES
Date of Contact:
 / 
 / 
NO
If No, why?
4. Comments:
[Comments/Findings/Details] Annotated Study Book - C4591001
STUDYID
NOT SUBMITTED
SVSTDTC
SV=Subject Visits
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
SVREFID
SVENDTC when UNPLANNED VISITS
Page 18 of 131
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FDA-CBER-2021-5683-0058055
C4591001: CONTACT OUTCOME - MONTH 6 (CONTACT 6M)
Contact Outcome
1. Follow-Up Contact Category 
[hidden]
[Follow Up Contact Category] 
CONTACT OUTCOM E
2. Contact Type:
[Type of Contact/Visit] 
CLINIC VISIT
TELEHEALTH VISIT
3. Was contact made?
[Was Contact Made] 
YES
Date of Contact:
 / 
 / 
NO
If No, why?
4. Comments:
[Comments/Findings/Details] Annotated Study Book - C4591001
STUDYID
NOT SUBMITTED
SVSTDTC
SV=Subject Visits
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
SVREFID
SVENDTC when UNPLANNED VISITS
Page 19 of 131
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FDA-CBER-2021-5683-0058056
C4591001: CONTACT OUTCOME (CONTACT SV)
Contact Outcome
1. Follow-Up Contact Category 
[hidden]
[Follow Up Contact Category] 
CONTACT OUTCOM E
2. Contact Type:
[Type of Contact/Visit] 
TELEPHONE VISIT
3. Was contact made?
[Was Contact Made] 
YES
Date of Contact:
 / 
 / 
NOIf No, why?
4. Comments:
[Comments/Findings/Details] Annotated Study Book - C4591001
STUDYID
NOT SUBMITTED
SVSTDTC
SV=Subject Visits
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
SVREFID
Page 20 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058057
C4591001: CONTACT OUTCOME - UNPLANNED (CONTACT UV)
Contact Outcome
1. Follow-Up Contact Category 
[hidden]
[Follow Up Contact Category] 
CONTACT OUTCOM E
2. Contact Type:
[Type of Contact/Visit] 
TELEPHONE VISIT
3. Was contact made?
[Was Contact Made] 
YES
Date of Contact:
 / 
 / 
Contact Outcome:
VISIT ARRANGE D
VISIT ARRANGED, BUT NOT ATTENDE D
VISIT NOT ARRANGED, REACTION NO LONGER PRESEN T
VISIT NOT ARRANGED, UNABLE TO ATTEN D
VISIT NOT REQUIRED, DATA ENTRY ERROR IN E-DIAR Y
VISIT NOT REQUIRED, INVESTIGATOR DECISIO N
NOIf No, why?
4. Comments:
[Comments/Findings/Details] Annotated Study Book - C4591001
NOT SUBMITTED
STUDYID
SVSTDTC
SV=Subject Visits
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
SVREFID
SVENDTC when UNPLANNED VISITS
Page 21 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058058
C4591001: MICROBIOLOGY SPECIMEN (COV19 SITE) - Repeating Form
# Date of Collection Specimen Type Assay Code and Description Device Type Result Comments:
1
Microbiology Specimen
1. Actual Date of Collection:
[Date of Collection] 
 / 
  / 
2. Specimen Type:
[Specimen Type] 
SERUM
BLOOD
PLASMA
3. Assay Code and Description:
[Assay Code and Description] 
SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
4. Device Type:
[Device Type] 
SARS-COV-2 DIAGNOSTIC TEST
5. Test Result:
[Result] 
POSITIVE
NEGATIV E
INDETERMINATE
6. Comments/Findings/Details:
[Comments:] Annotated Study Book - C4591001
STUDYID
DI=Device Identifiers
MB=Microbiology Specimen
CO=Comments
MBDTC
MBTEST
MBSPEC
MBORRES when MBTESTCD = SARSCOV2
DIVAL when DIPARMCD = DEVTYPE
COVAL when RDOMAIN = MB
MBCAT=CONFIRMATION OF INFECTION
Page 22 of 131
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FDA-CBER-2021-5683-0058059
C4591001: MICROBIOLOGY SPECIMEN (COVID TEST) - Repeating Form
#D a t e  o f  
CollectionSpecimen 
TypeSpecimen Collection 
LocationAssay Code and 
DescriptionDevice 
TypeTrade 
NameResult Comments: Trade Name Other, 
Specify
1
Microbiology Specimen
1. Actual Date of Collection:
[Date of Collection] 
 / 
  / 
2. Specimen Type:
[Specimen Type] 
SWABBED MATERIA L
RESPIRATORY SECRETIONS
3. Specimen Collection Location:
[Specimen Collection Location] 
NASOPHARYNX
LOWER RESPIRATORY SYSTEM
THROAT
4. Assay Code and Description:
[Assay Code and Description] 
SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5. Device Type:
[Device Type] 
SARS-COV-2 DIAGNOSTIC TEST
6. Trade Name:
[Trade Name] 
7. Test Result:
[Result] 
POSITIV E
NEGATIVE
INDETERMINATE
8. Comments/Findings/Details:
[Comments:] 
9. Trade Name Other, Specify:
[Trade Name Other, Specify] Annotated Study Book - C4591001
STUDYID
MBCAT=CONFIRMATION OF INFECTION
MB=Microbiology Specimen
MBDTC
MBTEST
MBSPEC
MBLOC
MBORRES when MBTESTCD = SARSCOV2
DIVAL when DIPARMCD = DEVTYPE
DIVAL when DIPARMCD = TRADENAM
COVAL when RDOMAIN = MB
DI=Device Identifiers
CO=Comments
SUPPMB in TRADEOTH
Page 23 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058060
C4591001: DEATH DETAILS CODED (DEATH DTL)
Death Details
1. Date of Collect on / Notification 
of Death:
[Date of Collect on / Notif cat on 
of Death] 
 / 
  / 
Cause of Death Status Cause of Death
2.
Cause of Death Entry
2.1 Cause of Death Status:
[Cause of Death Status] 
PRIMARY CAUSE OF DEATH
SECONDARY CAUSE OF DEATH
2.2 Cause of Death:
[Cause of Death] 
2.3 Comparison Term [hidden]
[Comparison Term] 
2.4 Lowest Level Term [hidden]
[Lowest Level Term] 
2.5 Lowest Level Term Code 
[hidden]
[Lowest Level Term Code] 
2.6 Dict onary-Derived Term 
[hidden][Dictionary-Derived Term] 
2.7 Preferred Term Code [hidden]
[Preferred Term Code] 
2.8 High Level Term [hidden]
[High Level Term] 
2.9 High Level Term Code 
[hidden]
[High Level Term Code] 
2.10 High Level Group Term 
[hidden][High Level Group Term] 
2.11 High Level Group Term Code 
[hidden][High Level Group Term Code] 
2.12 Primary System Organ Class 
[hidden][Primary System Organ Class] 
2.13 Primary System Organ Class 
Code [hidden]
[Primary System Organ Class Code] Annotated Study Book - C4591001
STUDYID
DDCAT = DEATH DETAILS CODED
DDDTC
DD=Death Details
DDTEST
DDORRES
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
DDSTRESC
Page 24 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058061
C4591001: DEMOGRAPHY (DEMOG)
Demography
1. Subject ID
[Subject ID] 
2. Birth Date:
[Birth Date] 
 / 
 / 
3. Sex:
[Sex] 
FEMAL E
MALE
4. Ethnicity:
[Ethnicity] 
HISPANIC OR LATINO (A) OR OF SPANISH ORIGI N
NOT HISPANIC OR LATINO (A) OR OF SPANISH ORIGI N
NOT REPORTE D
5. Race: (Check X all that apply):
[Race Of Subject] 
BLACK OR AFRICAN AMERICA N
AMERICAN INDIAN OR ALASKA NATIV E
ASIAN
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
WHIT E
NOT REPORTE D
6. Racial Designation:
[Racial Designat on] 
JAPANES E
OTHERAnnotated Study Book - C4591001
STUDYID
BRTHDTC
DM=Demographics
SUBJID
SEX
RACE,  when more than one 
selected,  RACE=MULTIPLE and 
individual responses are RACE1, 
RACE2, etc. in SUPPDM 
ETHNIC
RACIALD in SUPPDM
Page 25 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058062
C4591001: DISPOSITION - FOLLOW-UP (DISP FUP)
Disposition - Follow-Up
1. Date of Complet on/Discontinuation/Death :
[Date of Completion/Discontinuation/Death :] 
/ 
 / 
2. Phase of Disposition:
[Disposition Phase] 
FOLLO W-UP
3. Status:
[Status] 
4. Specify Status:
[Specify Status] Annotated Study Book - C4591001
STUDYID
DSCAT = DISPOSITION EVENT
Linked to related AE record via RELREC
DS=Disposition
DSSTDTC
DSPHASE in SUPPDS
DSDECOD
DSTERM
Page 26 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058063
C4591001: DISPOSITION - SCREENING FOR FURTHER VACCINATION (DISP RESCR)
Disposition - Screening for Further Vaccination
1. Date of Complet on/Discontinuation/Death :
[Date of Completion/Discontinuation/Death :] 
/ 
 / 
2. Phase of Disposition:
[Disposition Phase] 
REPEAT SCREENING 1
3. Status:
[Status] 
4. Specify Status:
[Specify Status] Annotated Study Book - C4591001
Linked to related AE record via RELREC
DSCAT = DISPOSITION EVENT
STUDYID
DS=Disposition
DSSTDTC
DSPHASE in SUPPDS
DSDECOD
DSTERM
Page 27 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058064
C4591001: DISPOSITION - SCREENING (DISP SCR)
Disposition - Screening
1. Date of Complet on/Discontinuation/Death
[Date of Completion/Discontinuation/Death] 
/ 
 / 
2. Phase of Disposition:
[Disposition Phase] 
SCREENING
3. Status:
[Status] 
4. Specify Status:
[Specify Status] Annotated Study Book - C4591001
DSCAT = DISPOSITION EVENT
STUDYID
DS=Disposition
DSSTDTC
DSPHASE in SUPPDS
DSDECOD
DSTERM
Linked to related AE record via RELREC
Page 28 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058065
C4591001: DISPOSITION - TREATMENT (DISP TRT)
Disposition - Treatment
1. Date of Complet on/Discontinuation/Death :
[Date of Completion/Discontinuation/Death :] 
/ 
 / 
2. Phase of Disposition:
[Disposition Phase] 
VACCINATIO N
OPEN LABEL TREATMEN T
3. Status:
[Status] 
4. Specify Status:
[Specify Status] Annotated Study Book - C4591001
DSCAT = DISPOSITION EVENT
STUDYID
DS=Disposition
DSSTDTC
DSPHASE in SUPPDS
DSDECOD
DSTERM
Linked to related AE record via RELREC
Page 29 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058066
C4591001: DATE OF VISIT (DOV)
Date of Visit
1. Date of Visit
[Date of Visit] 
 / 
  / 
2. Erroneous Visit
[Visit Error] 
ERRONEOUS VISITAnnotated Study Book - C4591001
NOT SUBMITTED
SVSTDTC
STUDYID
SV=Subject Visits
SVENDTC when UNPLANNED VISITS
Page 30 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058067
C4591001: DATE OF VISIT - ILLNESS CONVALESCENT (DOV CONV)
Date of Visit
1. Date of Visit
[Date of Visit] 
 / 
  / 
2. Erroneous Visit
[Visit Error] 
ERRONEOUS VISIT
COVID-19 Illness Visit3. COVID-19 Illness Visit:
[COVID-19 Illness Vis t] 
Annotated Study Book - C4591001
NOT SUBMITTED
STUDYID
SVSTDTC
SV=Subject Visits
VISIT
Page 31 of 131
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FDA-CBER-2021-5683-0058068
C4591001: DATE OF VISIT - ILLNESS ONSET (DOV ILL)
Date of Visit
1. Date of Visit
[Date of Visit] 
 / 
  / 
2. Erroneous Visit
[Visit Error] 
ERRONEOUS VISIT
COVID-19 Illness Visit3. COVID-19 Illness Visit:
[COVID-19 Illness Vis t] 
Annotated Study Book - C4591001
SVSTDTC
STUDYID
VISIT
SV=Subject Visits
NOT SUBMITTED
Page 32 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058069
C4591001: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE (DOV SURV)
Date of Visit
1. Date of Visit
[Date of Visit] 
 / 
  / 
2. Erroneous Visit
[Visit Error] 
ERRONEOUS VISIT
COVID-19 Surveillance Visit3. COVID-19 Surveillance Vis t:
[COVID-19 Surveillance Visit] 
Annotated Study Book - C4591001
NOT SUBMITTED
SVSTDTC
STUDYID
SV=Subject Visits
SVENDTC when UNPLANNED VISITS
NOT SUBMITTED
Page 33 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058070
C4591001: DATE OF VISIT - REPEAT SWAB (DOV SWAB)
Date of Visit
1. Date of Visit
[Date of Visit] 
 / 
  / 
2. Erroneous Visit
[Visit Error] 
ERRONEOUS VISIT
COVID-19 Repeat Swab3. COVID-19 Repeat Swab:
[COVID-19 Repeat Swab] 
Annotated Study Book - C4591001
SVSTDTC
STUDYID
VISIT
SV=Subject Visits
NOT SUBMITTED
Page 34 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058071
C4591001: INFORM ENROLLMENT (ENROLL)
InForm Enrollment
1. Subject ID
[Subject ID] Annotated Study Book - C4591001
NOT SUBMITTED
Page 35 of 131
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FDA-CBER-2021-5683-0058072
C4591001: HIV STATUS (HIV)
HIV Status
1. Select appropriate response -
What is the subject HIV status?
[Trigger Response 2] 
The sub ject is known to be HIV POSITIV E
The subject is NOT known to be HIV POSITIVEAnnotated Study Book - C4591001
NOT SUBMITTED
Page 36 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058073
C4591001: LAB CHEMISTRY (HIV RNA)
Lab Chemistry Details
1. Lab Panel:
[Category for Lab Test] 
CLINICAL CHEMISTR Y
2. Laboratory Name and Address
[Vendor Name] 
3. Collection Date:
[Collect on Date:] 
 / 
 / 
4. Specimen Type:
[Specimen Type] 
BLOO D
Lab Result
# Sponsor-Defined Identifier Test: Result: Not Done: Lab Normal Range
5.a HIV RNA (Ultrasensitive)
Lab Result Entry5.1 Sponsor ID:
[Sponsor-Defined Identifier] 
5.2 Test:
[Test:] 
HIV RNA (Ultrasens tive)
5.3 Result:
[Result:] 
5.4 Not Done: [hidden]
[Not Done:] 
NOT DONE
5.5 LNMT
[Lab Normal Range] Low
High
Un t
/mLAnnotated Study Book - C4591001
STUDYID
LBSTAT
LBCAT
LBNAM
LBTEST
LBSPID
LBDTC
LBSPEC
LBORRES
LBORNRLO
LBORNRHI
LBORRESU
LB=Laboratory Test Results
Page 37 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058074
C4591001: HEALTH CARE UTILIZATION (HLTHCARE)
Health Care Utilization
1. Evaluation Interval: [hidden]
[Evaluation Interval] 
SINCE THE START OF THE RESPIRATORY ILLNESS EPISOD E
2. Disease Name: [hidden]
[Disease Name] 
RESPIRATORY ILLNESS
Health Care Utilization
#
Pre-Specified Type of Practitioner Occurrence of Visits or Contacts
3.a YES SPECIALIST3.b YES EMERGENCY ROOM3.c YES PRIMARY CARE PHYSICIAN3.d YES URGENT CARE3.e YES TELEPHONE CONSULTATION3.f YES OTHER
Health Care Utilization Entry3.1 Pre-Specified: [hidden]
[Pre-Specified] 
YES
3.2 Physician or Healthcare 
Professional:
[Type of Practitioner] 
SPECIALIS T
EMERGENCY ROOM
PRIMARY CARE PHYSICIA N
URGENT CARE
TELEPHONE CONSULTATION
OTHER
3.3 Occurrence of Visits or 
Contacts:
[Occurrence of Vis ts or 
Contacts] 
YES
Number of Vis ts or Contacts:
NO
Health Care Utilization Other
4. Other Type of Pract tioner 
Specify:
[Other Type of Pract t oner 
Specify] 
Health Care Utilization
5. Has the subject been 
hospitalized due to potential 
COVID-19 illness?
[Been Hospitalized] 
YES
Has the subject been in intensive care due to potential COVID-19 illness?
YES
NO
NOAnnotated Study Book - C4591001
HOCAT=HEALTHCARE 
UTILIZATION ASSESSMENT
STUDYID
HCUIDIS in SUPPHO
HO=Healthcare Encounters
FA=Findings About Events or Interventions
FACAT=HEALTHCARE 
UTILIZATION
HOEVINTX
FAEVINTX
HOPRESP
HOOCCUR
HOTERM
FAORRES when FATESTCD=NUMBER
HOTERM
HCUICU in SUPPHO
HCUHSP in SUPPHO
Page 38 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058075
C4591001: HOSPITALIZATION DETAILS (HOSP) - Repeating Form
# Hospitalization Category Hospitalization Term Admission Date Ongoing
1
Hospitalization Details
1. Hosp talization Category:
[Hospitalization Category] 
HOSPITALIZATION STATUS
2. Hosp talization Term:
[Hospitalization Term] 
ICU
HOSPITAL 
3. Admission Date:
[Admission Date] 
 / 
  / 
4. Ongoing?
[Ongoing] 
YES
NO
Dischar ge Date:
 / 
 / 
Annotated Study Book - C4591001
STUDYID
HO=Healthcare Encounters
HOCAT
HOENDTC
HOTERM
HOSTDTC
HOENRTPT= ONGOING
HOENTPT= ONGOING AT CURRENT VISIT
Page 39 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058076
C4591001: ILLNESS DETAILS (ILL POTEN)
Illness Details
1. Category of Clinical Event:
[Category of Clin cal Event:] 
POTENTIAL COVI D-19 ILLNESS
2. Was a diagnosis obtained for 
Potential COVID-19 Illness? 
[Diagnosis Obtained] 
YES
Respirator y Illness Dia gnosis:
Date of Dia gnosis:
/ 
  / 
NO
3. Toxicity Grade:
[Toxicity Grade] 
0
1
2
3
4
5
4. Comparison Term: [hidden]
[Comparison Term] 
5. Lowest Level Term [hidden]
[Lowest Level Term] 
6. Lowest Level Term Code 
[hidden]
[Lowest Level Term Code] 
7. D ctionary Derived Term 
[hidden][D ctionary Derived Term] 
8. Preferred Term Code [hidden]
[Preferred Term Code] 
9. High Level Term [hidden]
[High Level Term] 
10. High Level Term Code [hidden]
[High Level Term Code] 
11. High Level Group Term 
[hidden][High Level Group Term] 
12. High Level Group Term Code 
[hidden][High Level Group Term Code] 
13. Primary System Organ Class 
[hidden][Primary System Organ Class] 
14. Primary System Organ Class 
Code [hidden]
[Primary System Organ Class 
Code] Annotated Study Book - C4591001
STUDYID
NOT SUBMITTED
CE=Clinical Events
CECAT = EFFICACY
CEDTC
CETERM
CETOXGR
NOT SUBMITTED
NOT SUBMITTED
CESOCCD
CEBDSYCD
CESOC
CEBODSYS
CEHLGTCD
CEHLGT
CEHLTCD
CEHLT
CEPTCD
CEDECOD
CELLTCD
CELLT
Page 40 of 131
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FDA-CBER-2021-5683-0058077
C4591001: ILLNESS DETAILS - SEVERE (ILL SEVERE)
Illness Details
1. Category of Clinical Event:
[Category of Clin cal Event:] 
SEVERE COVI D-19 ILLNESS
2. Subcategory of Clin cal Event:
[Subcategory of Clin cal Event] 
SIGNIFICANT ACUTE RENAL DYSFUNCTIO N
SIGNIFICANT ACUTE HEPATIC DYSFUNCTIO N
SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTIO N
3. Was a diagnosis obtained? 
[Diagnosis Obtained] 
YES
Diagnosis:
Start Date:
/ 
  / 
Ongoing?:
YES
NO
End Date:
 / 
 / 
NO
4. Toxicity Grade:
[Toxicity Grade] 
1
2
3
4
5
5. Comparison Term: [hidden]
[Comparison Term] 
6. Lowest Level Term [hidden]
[Lowest Level Term] 
7. Lowest Level Term Code 
[hidden]
[Lowest Level Term Code] 
8. D ctionary Derived Term 
[hidden][D ctionary Derived Term] 
9. Preferred Term Code [hidden]
[Preferred Term Code] 
10. High Level Term [hidden]
[High Level Term] 
11. High Level Term Code [hidden]
[High Level Term Code] 
12. High Level Group Term 
[hidden][High Level Group Term] 
13. High Level Group Term Code 
[hidden][High Level Group Term Code] 
14. Primary System Organ Class 
[hidden][Primary System Organ Class] 
15. Primary System Organ Class 
Code [hidden]
[Primary System Organ Class 
Code] Annotated Study Book - C4591001
CECAT
STUDYID
CE=Clinical Events
CESCAT
CETERM
CESTDTC
NOT SUBMITTED
CEENDTC
CETOXGR
NOT SUBMITTED
CELLT
CELLTCD
CEDECOD
CEPTCD
CEHLT
CEHLTCD
CEHLGT
CEHLGTCD
CEBODSYS
CESOC
CEBDSYCD
CESOCCD
CEENRTPT= ONGOING/BEFORE
CEENTPT= LAST SUBJECT ENCOUNTER
Page 41 of 131
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C4591001: ILLNESS DETAILS - SEVERE (ILL SEVERE) - Repeating Form
# Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade
1
Illness Details
1. Category of Clinical Event:
[Category of Clin cal Event:] 
SEVERE COVI D-19 ILLNESS
2. Subcategory of Clin cal Event:
[Subcategory of Clin cal Event] 
SIGNIFICANT ACUTE RENAL DYSFUNCTIO N
SIGNIFICANT ACUTE HEPATIC DYSFUNCTIO N
SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTIO N
3. Was a diagnosis obtained? 
[Diagnosis Obtained] 
YES
Diagnosis:
Start Date:
/ 
  / 
Ongoing?:
YES
NO
End Date:
 / 
 / 
NO
4. Toxicity Grade:
[Toxicity Grade] 
1
2
3
4
5
5. Comparison Term: [hidden]
[Comparison Term] 
6. Lowest Level Term [hidden]
[Lowest Level Term] 
7. Lowest Level Term Code 
[hidden]
[Lowest Level Term Code] 
8. D ctionary Derived Term 
[hidden][D ctionary Derived Term] 
9. Preferred Term Code [hidden]
[Preferred Term Code] 
10. High Level Term [hidden]
[High Level Term] 
11. High Level Term Code [hidden]
[High Level Term Code] 
12. High Level Group Term 
[hidden][High Level Group Term] 
13. High Level Group Term Code 
[hidden][High Level Group Term Code] 
14. Primary System Organ Class 
[hidden][Primary System Organ Class] 
15. Primary System Organ Class 
Code [hidden]
[Primary System Organ Class Code] Annotated Study Book - C4591001
CECAT
STUDYID
CESCAT
CE=Clinical Events
CETERM
CESTDTC
NOT SUBMITTED
CEENDTC
CETOXGR
NOT SUBMITTED
CELLT
CELLTCD
CEDECOD
CEPTCD
CEHLT
CEHLTCD
CEHLGT
CEHLGTCD
CEBODSYS
CESOC
CEBDSYCD
CESOCCD
CEENRTPT= ONGOING/BEFORE
CEENTPT= LAST SUBJECT ENCOUNTER
Page 42 of 131
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FDA-CBER-2021-5683-0058079
C4591001: IMAGING (IMAGING) - Repeating Form
# Date of Assessment Location of Assessment Imaging Method Overall Assessment
1
Imaging
1. Date of Assessment:
[Date of Assessment] 
 / 
  / 
2. Locat on of Assessment:
[Location of Assessment] 
CHEST
HEAD
OTHER
If other, specify:
3. Type of Imaging Exam:
[Imaging Method] 
CT SCA N
X-RAY
ULTRASOUN D
MRI
OTHERIf other, specify:
4. Assessment:
[Overall Assessment] 
ABNORMAL
If abnormal, specify findings:
INDETERMINATE
NORMA L
UNKNOWN
NOT EVALUABLEAnnotated Study Book - C4591001
MOCAT=CLINICAL ASSESSMENT OF RADIOGRAPHS - IMAGING
STUDYID
MO=Morphology
MODTC
LOCOTH in SUPPMO
MOLOC
MOMETHOD
METHOTH in SUPPMO
MOORRES
MOTEST
MOORRES
ASPECIFY IN SUPPMO
Page 43 of 131
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C4591001: INCLUSION/EXCLUSION CRITERIA (IN EX STG3)
Study eligibility requires subjects to meet all inclus on criteria (YES) and Not meet exclusion criteria (NO). 
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants between the ages of 18 and 55 years, inclusive, 65 and 85 
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study 
stage)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled vis ts, vaccination plan, 
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and 
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed  consent, which includes compliance with the 
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number] 
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on] 
1.3 Cr terion met?
[Criter on met?] 
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal 
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or 
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s)EX03A00
2.d 4 Receipt of medicat ons intended to prevent COVID-19 EX04A00
2.e 8 Immunocompromised indiv duals w th kn own or suspected immunodeficiency, as 
determined by history and/or laboratory/phys cal examinationEX08A00
2.f 9 Individuals with a history of autoimmune disease or an active autoimmune disease 
requiring therapeutic interventionEX09A00
2.g 10 Bleeding diathesis or condition associated  w th prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.h 11 Women who are pregnant or breastfeeding EX11A00
2.i 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.j 13 Individuals who receive immunosuppressive therapy, such as cytotoxic agents or 
systemic corticosteroids. Inhaled/nebulized, Intra-art cular, intrabursal, or topical 
cort costeroids are permittedEX13A00
2.k 14 Receipt of blood/plasma products or immunoglobulin, from 60 days before study 
intervention administrat on or planned receipt throughout the studyEX14A00
2.l 15 Participation in other studies involving study intervention w thin 28 days pr or to study 
entry and/or during study participationEX15A00
2.m 16 Previous part cipation in other studies involving study intervent on containing lip d 
nanopart clesEX16A00
2.n 21 Investigator s te staff or Pfizer employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family membersEX21A00
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number] 
2.2 Cr terion Description:
[Criter on Descript on] 
2.3 Cr terion met?
[Criter on met?] 
YES
Describe details if relevan tAnnotated Study Book - C4591001
IE=Inclusion/Exclusion Criteria Not Met
STUDYID
IESPID
IECAT = INCLUSION
IETEST
IETESTCD
IEDESC in SUPPIE
IEORRES
IETEST
IESPID
IECAT = EXCLUSION
IEDESC in SUPPIE
IEORRES
Page 44 of 131
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FDA-CBER-2021-5683-0058081
NO
2.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use only)] 
Annotated Study Book - C4591001
IETESTCD
IE=Inclusion/Exclusion Criteria Not Met
Page 45 of 131
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FDA-CBER-2021-5683-0058082
C4591001: INCLUSION/EXCLUSION CRITERIA (IN EX STG3)
Study eligibility requires subjects to meet all inclus on criteria (YES) and Not meet exclusion criteria (NO). 
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants between the ages of 18 and 55 years, inclusive, 65 and 85 
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study 
stage)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled vis ts, vaccination plan, 
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and 
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed  consent, which includes compliance with the 
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number] 
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on] 
1.3 Cr terion met?
[Criter on met?] 
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal 
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or 
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s)EX03A00
2.d 4 Receipt of medicat ons intended to prevent COVID-19 EX04A00
2.e 8 Immunocompromised indiv duals w th kn own or suspected immunodeficiency, as 
determined by history and/or laboratory/phys cal examinationEX08A00
2.f 10 Bleeding diathesis or condition associated  w th prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.g 11 Women who are pregnant or breastfeeding EX11A00
2.h 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.i 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or systemic 
cort costeroidsEX13A01
2.j 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study 
intervention administrat on or planned receipt throughout the studyEX14A01
2.k 16 Participation in other studies involving study intervention w thin 28 days pr or to study 
entry and/or during study participationEX15A01
2.l 17 Previous part cipation in other studies involving study intervent on containing lip d 
nanopart clesEX16A01
2.m 22 Investigator s te staff or Pfizer employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number] 
2.2 Cr terion Description:
[Criter on Descript on] 
2.3 Cr terion met?
[Criter on met?] 
YES
Describe details if relevant
NO
2.4 Cr terion ID: (For Pfizer use Annotated Study Book - C4591001
STUDYID
IE=Inclusion/Exclusion Criteria Not Met
IECAT = INCLUSION
IESPID
IETEST
IEORRES
IEDESC in SUPPIE
IETESTCD
IECAT = EXCLUSION
IESPID
IETEST
IEORRES
IEDESC in SUPPIE
IETESTCD
Page 46 of 131
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FDA-CBER-2021-5683-0058083
only)
[Criter on ID: (For Pfizer use 
only)] 
Annotated Study Book - C4591001
IE=Inclusion/Exclusion Criteria Not Met
Page 47 of 131
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FDA-CBER-2021-5683-0058084
C4591001: INCLUSION/EXCLUSION CRITERIA (IN EX STG3)
Study eligibility requires subjects to meet all inclus on criteria (YES) and Not meet exclusion criteria (NO). 
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants between the ages of 18 and 55 years, inclusive, 65 and 85 
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study 
stage)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled vis ts, vaccination plan, 
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and 
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed  consent, which includes compliance with the 
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number] 
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on] 
1.3 Cr terion met?
[Criter on met?] 
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal 
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or 
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s)EX03A00
2.d 4 Receipt of medicat ons intended to prevent COVID-19 EX04A00
2.e 8 Immunocompromised indiv duals w th kn own or suspected immunodeficiency, as 
determined by history and/or laboratory/phys cal examinationEX08A00
2.f 9 Individuals with a history of autoimmune disease or an active autoimmune disease 
requiring therapeutic interventionEX09A00
2.g 10 Bleeding diathesis or condition associated  w th prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.h 11 Women who are pregnant or breastfeeding EX11A00
2.i 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.j 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or systemic 
cort costeroidsEX13A01
2.k 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study 
intervention administrat on or planned receipt throughout the studyEX14A01
2.l 16 Participation in other studies involving study intervention w thin 28 days pr or to study 
entry and/or during study participationEX15A01
2.m 17 Previous part cipation in other studies involving study intervent on containing lip d 
nanopart clesEX16A01
2.n 22 Investigator s te staff or Pfizer employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number] 
2.2 Cr terion Description:
[Criter on Descript on] 
2.3 Cr terion met?
[Criter on met?] 
YES
Describe details if relevantAnnotated Study Book - C4591001
IE=Inclusion/Exclusion Criteria Not Met
STUDYID
IECAT = INCLUSION
IESPID
IETEST
IETESTCD
IEDESC in SUPPIE
IEORRES
IETEST
IESPID
IECAT = EXCLUSION
IEDESC in SUPPIE
IEORRES
Page 48 of 131
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FDA-CBER-2021-5683-0058085
NO
2.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
Annotated Study Book - C4591001
IETESTCD
IE=Inclusion/Exclusion Criteria Not Met
Page 49 of 131
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FDA-CBER-2021-5683-0058086
C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC)
Criterion Description
1.
Inclusion Criteria Not Met Entry
1.1 Description of Inclusion 
Cr terion Not Met
[Criter on Descript on] 
Criterion Description
2.
Exclusion Criteria Met Entry
2.1 Description of Exclusion 
Cr terion Met
[Criter on Descript on] 
Annotated Study Book - C4591001
STUDYID
IE=Inclusion/Exclusion Criteria Not Met
IETEST when IEORRES=N
IETEST when IEORRES=Y
Page 50 of 131
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FDA-CBER-2021-5683-0058087
C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC NS)
Study eligibility requires subjects to meet all inclus on criteria (YES) and Not meet exclusion criteria (NO). 
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants between the ages of 18 and 55 years, inclusive, 65 and 85 
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study 
stage)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled vis ts, vaccination plan, 
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and 
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed  consent, which includes compliance with the 
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number] 
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on] 
1.3 Cr terion met?
[Criter on met?] 
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal 
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or 
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s)EX03A00
2.d 4 Receipt of medicat ons intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Prev ous clinical or microbiolog cal diagnosis of COVID-19 EX05A00
2.f 8 Immunocompromised indiv duals w th kn own or suspected immunodeficiency, as 
determined by history and/or laboratory/phys cal examinationEX08A00
2.g 10 Bleeding diathesis or condition associated  w th prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.h 11 Women who are pregnant or breastfeeding EX11A00
2.i 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.j 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or systemic 
cort costeroidsEX13A01
2.k 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study 
intervention administrat on or planned receipt throughout the studyEX14A01
2.l 16 Participation in other studies involving study intervention w thin 28 days pr or to study 
entry and/or during study participationEX15A01
2.m 17 Previous part cipation in other studies involving study intervent on containing lip d 
nanopart clesEX16A01
2.n 22 Investigator s te staff or Pfizer employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number] 
2.2 Cr terion Description:
[Criter on Descript on] 
2.3 Cr terion met?
[Criter on met?] 
YES
Describe details if relevant
NOAnnotated Study Book - C4591001
STUDYID
IE=Inclusion/Exclusion Criteria Not Met
IESPID
IECAT = INCLUSION
IETEST
IETESTCD
IEDESC in SUPPIE
IEORRES
IESPID
IECAT = EXCLUSION
IETEST
IEORRES
IEDESC in SUPPIE
Page 51 of 131
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FDA-CBER-2021-5683-0058088
2.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
Annotated Study Book - C4591001
IETESTCD
IE=Inclusion/Exclusion Criteria Not Met
Page 52 of 131
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FDA-CBER-2021-5683-0058089
C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC NS)
Study eligibility requires subjects to meet all inclus on criteria (YES) and Not meet exclusion criteria (NO). 
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants between the ages of 18 and 55 years, inclusive, 65 and 85 
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study 
stage)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled vis ts, vaccination plan, 
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and 
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed  consent, which includes compliance with the 
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number] 
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on] 
1.3 Cr terion met?
[Criter on met?] 
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal 
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or 
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s)EX03A00
2.d 4 Receipt of medicat ons intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Prev ous clinical or microbiolog cal diagnosis of COVID-19 EX05A00
2.f 8 Immunocompromised indiv duals w th kn own or suspected immunodeficiency, as 
determined by history and/or laboratory/phys cal examinationEX08A00
2.g 9 Individuals with a history of autoimmune disease or an active autoimmune disease 
requiring therapeutic interventionEX09A00
2.h 10 Bleeding diathesis or condition associated  w th prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.i 11 Women who are pregnant or breastfeeding EX11A00
2.j 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.k 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or systemic 
cort costeroidsEX13A01
2.l 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study 
intervention administrat on or planned receipt throughout the studyEX14A01
2.m 16 Participation in other studies involving study intervention w thin 28 days pr or to study 
entry and/or during study participationEX15A01
2.n 17 Previous part cipation in other studies involving study intervent on containing lip d 
nanopart clesEX16A01
2.o 22 Investigator s te staff or Pfizer employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number] 
2.2 Cr terion Description:
[Criter on Descript on] 
2.3 Cr terion met?
[Criter on met?] 
YES
Describe details if relevan tAnnotated Study Book - C4591001
STUDYID
IE=Inclusion/Exclusion Criteria Not Met
IEDESC in SUPPIE
IESPID
IECAT = INCLUSION
IETEST
IETESTCD
IEDESC in SUPPIE
IEORRES
IETEST
IESPID
IECAT = EXCLUSION
IEORRES
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NO
2.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
Annotated Study Book - C4591001
IE=Inclusion/Exclusion Criteria Not Met
IETESTCD
Page 54 of 131
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FDA-CBER-2021-5683-0058091
C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC NS)
Study eligibility requires subjects to meet all inclus on criteria (YES) and Not meet exclusion criteria (NO). 
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants between the ages of 18 and 55 years, inclusive, 65 and 85 
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study 
stage)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled vis ts, vaccination plan, 
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and 
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed  consent, which includes compliance with the 
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number] 
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on] 
1.3 Cr terion met?
[Criter on met?] 
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal 
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or 
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s)EX03A00
2.d 4 Receipt of medicat ons intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Prev ous clinical or microbiolog cal diagnosis of COVID-19 EX05A00
2.f 8 Immunocompromised indiv duals w th kn own or suspected immunodeficiency, as 
determined by history and/or laboratory/phys cal examinationEX08A00
2.g 9 Individuals with a history of autoimmune disease or an active autoimmune disease 
requiring therapeutic interventionEX09A00
2.h 10 Bleeding diathesis or condition associated  w th prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.i 11 Women who are pregnant or breastfeeding EX11A00
2.j 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.k 13 Individuals who receive immunosuppressive therapy, such as cytotoxic agents or 
systemic corticosteroids. Inhaled/nebulized, Intra-art cular, intrabursal, or topical 
cort costeroids are permittedEX13A00
2.l 14 Receipt of blood/plasma products or immunoglobulin, from 60 days before study 
intervention administrat on or planned receipt throughout the studyEX14A00
2.m 15 Participation in other studies involving study intervention w thin 28 days pr or to study 
entry and/or during study participationEX15A00
2.n 16 Previous part cipation in other studies involving study intervent on containing lip d 
nanopart clesEX16A00
2.o 21 Investigator s te staff or Pfizer employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family membersEX21A00
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number] 
2.2 Cr terion Description:
[Criter on Descript on] 
2.3 Cr terion met?
[Criter on met?] 
YES
Describe details if relevantAnnotated Study Book - C4591001
IE=Inclusion/Exclusion Criteria Not Met
STUDYID
IEDESC in SUPPIE
IESPID
IECAT = INCLUSION
IETEST
IETESTCD
IEDESC in SUPPIE
IEORRES
IETEST
IESPID
IECAT = EXCLUSION
IEORRES
Page 55 of 131
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NO
2.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
Annotated Study Book - C4591001
IE=Inclusion/Exclusion Criteria Not Met
IETESTCD
Page 56 of 131
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C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC S)
Study eligibility requires subjects to meet all inclus on criteria (YES) and Not meet exclusion criteria (NO). 
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants between the ages of 18 and 55 years, inclusive, 65 and 85 
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study 
stage)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled vis ts, vaccination plan, 
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and 
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed  consent, which includes compliance with the 
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number] 
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on] 
1.3 Cr terion met?
[Criter on met?] 
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal 
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or 
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s)EX03A00
2.d 4 Receipt of medicat ons intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Prev ous clinical or microbiolog cal diagnosis of COVID-19 EX05A00
2.f 6 Sentinel participants in Stage 1 only: Individuals at high risk for severe COVID-19 (full 
details in protocol)EX06A01
2.g 7 Sentinel participants in Stage 1 only: Individuals currently working in occupations with 
high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response 
personnel)EX07A00
2.h 8 Immunocompromised indiv duals w th kn own or suspected immunodeficiency, as 
determined by history and/or laboratory/phys cal examinat onEX08A00
2.i 9 Sentinel participants in Stage 1 only: Individuals w th a history of autoimmune disease or 
an active autoimmune disease requiring therapeut c interventionEX09A04
2.j 10 Bleeding diathesis or condition associated  w th prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.k 11 Women who are pregnant or breastfeeding EX11A00
2.l 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.m 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or systemic 
cort costeroidsEX13A01
2.n 14 Sentinel participants in Stage 1 only: Regular receipt of inhaled/nebulized corticosteroids EX22A01
2.o 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study 
intervention administrat on or planned receipt throughout the studyEX14A01
2.p 16 Participation in other studies involving study intervention w thin 28 days pr or to study 
entry and/or during study participationEX15A01
2.q 17 Previous part cipation in other studies involving study intervent on containing lip d 
nanopart clesEX16A01
2.r 18 Sentinel part cipants in Stage 1 only: Posi tive serological test for SARS-CoV-2 IgM and/or 
IgG antibodies at the screening visitEX17A01
2.s 19 Sentinel part cipants in Stage 1 only: Screening hematology/blood chemistry lab 
>=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be considered eligible by InvestigatorEX18A01
2.t 20 Sentinel part cipants in Stage 1 only: Positive test for HIV, hepat tis B surface antigen EX19A01Annotated Study Book - C4591001
STUDYID
IE=Inclusion/Exclusion Criteria Not Met
IESPID
IECAT = INCLUSION
IETEST
IETESTCD
IEDESC in SUPPIE
IEORRES
Page 57 of 131
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FDA-CBER-2021-5683-0058094
(HBsAg), hepat tis B core antibodies (HBc Abs) , or hepatitis C virus antibodies (HCV Abs) 
at screening vis t
2.u 21 Sentinel participants in Stage 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 
hours before receipt of study interventionEX20A01
2.v 22 Investigator s te staff or Pfizer employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number] 
2.2 Cr terion Description:
[Criter on Descript on] 
2.3 Cr terion met?
[Criter on met?] 
YES
Describe details if relevant
NO
2.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
Annotated Study Book - C4591001
IE=Inclusion/Exclusion Criteria Not Met
IECAT = EXCLUSION
IESPID
IETEST
IEORRES
IEDESC in SUPPIE
IETESTCD
Page 58 of 131
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FDA-CBER-2021-5683-0058095
C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC S)
Study eligibility requires subjects to meet all inclus on criteria (YES) and Not meet exclusion criteria (NO). 
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants between the ages of 18 and 55 years, inclusive, 65 and 85 
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study 
stage)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled vis ts, vaccination plan, 
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and 
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed  consent, which includes compliance with the 
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number] 
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on] 
1.3 Cr terion met?
[Criter on met?] 
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal 
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or 
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s)EX03A00
2.d 4 Receipt of medicat ons intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Prev ous clinical or microbiolog cal diagnosis of COVID-19 EX05A00
2.f 6 Sentinel participants in Stage 1 only: Individuals at high risk for severe COVID-19 EX06A00
2.g 7 Sentinel participants in Stage 1 only: Individuals currently working in occupations with 
high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel)EX07A00
2.h 8 Immunocompromised indiv duals w th kn own or suspected immunodeficiency, as 
determined by history and/or laboratory/phys cal examinat onEX08A00
2.i 9 Individuals w th a history of autoimmune disease or an active autoimmune disease 
requiring therapeutic interventionEX09A00
2.j 10 Bleeding diathesis or condition associated  w th prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.k 11 Women who are pregnant or breastfeeding EX11A00
2.l 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.m 13 Individuals who receive immunosuppressive therapy, such as cytotoxic agents or 
systemic corticosteroids. Inhaled/nebulized, Intra-art cular, intrabursal, or topical cort costeroids are permittedEX13A00
2.n 14 Receipt of blood/plasma products or immunoglobulin, from 60 days before study 
intervention administrat on or planned receipt throughout the studyEX14A00
2.o 15 Participation in other studies involving study intervention w thin 28 days pr or to study 
entry and/or during study participationEX15A00
2.p 16 Previous part cipation in other studies involving study intervent on containing lip d 
nanopart clesEX16A00
2.q 17 Sentinel part cipants in Stage 1 only: Posi tive serological test for SARS-CoV-2 IgM and/or 
IgG antibodies at the screening visitEX17A00
2.r 18 Sentinel part cipants in Stage 1 only: Screening hematology/blood chemistry lab 
>=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be 
considered eligible by InvestigatorEX18A00
2.s 19 Sentinel part cipants in Stage 1 only: Positive test for HIV, hepat tis B surface antigen 
(HBsAg), hepat tis B core antibodies (HBc Abs) , or hepatitis C virus antibodies (HCV Abs) 
at screening vis tEX19A00Annotated Study Book - C4591001
STUDYID
IE=Inclusion/Exclusion Criteria Not Met
IESPID
IECAT = INCLUSION
IETEST
IETESTCD
IEDESC in SUPPIE
IEORRES
Page 59 of 131
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FDA-CBER-2021-5683-0058096
2.t 20 Sentinel participants in Stage 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 
hours before receipt of study interventionEX20A00
2.u 21 Investigator s te staff or Pfizer employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family membersEX21A00
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number] 
2.2 Cr terion Description:
[Criter on Descript on] 
2.3 Cr terion met?
[Criter on met?] 
YES
Describe details if relevan t
NO
2.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
Annotated Study Book - C4591001
IECAT = EXCLUSION
IE=Inclusion/Exclusion Criteria Not Met
IEDESC in SUPPIE
IESPID
IETEST
IEORRES
IETESTCD
Page 60 of 131
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FDA-CBER-2021-5683-0058097
C4591001: INCLUSION/EXCLUSION CRITERIA (INC EXC S)
Study eligibility requires subjects to meet all inclus on criteria (YES) and Not meet exclusion criteria (NO). 
Inclusion Criteria
# Inclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
1.a 1 Male or female part cipants between the ages of 18 and 55 years, inclusive, 65 and 85 
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study 
stage)IN01A00
1.b 2 Participants who are willing and able to comply w th all scheduled vis ts, vaccination plan, 
laboratory tests, lifestyle cons derat ons, and other study proceduresIN02A00
1.c 3 Healthy participants who are determined by medical history, physical examination, and 
clinical judgment of the investigator to be eligible for inclusion in the studyIN03A00
1.d 4 Capable of giving personal signed informed  consent, which includes compliance with the 
requirements and restr ctions listed in the ICD and in this protocolIN04A00
Inclusion Criteria Entry
1.1 Inclusion Number:
[Inclusion Number] 
1
2
3
4
1.2 Cr terion Description:
[Criter on Descript on] 
1.3 Cr terion met?
[Criter on met?] 
YES
NO
Describe details if relevan t
1.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
IN01A00
IN02A0 0
IN03A00
IN04A00
Exclusion Criteria
# Exclusion Number Criterion Description Criterion met? Criterion ID: (For Pfizer use only)
2.a 1 Other medical or psychiatric condition incl. recent (within past year) or active suicidal 
deation/behavior/lab abnormal ty that may increase the risk of study participationEX01A00
2.b 2 Known infection w th human immunodeficiency virus (HIV), hepatitis C virus (HCV), or 
hepatitis B virus (HBV)EX02A00
2.c 3 History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s)EX03A00
2.d 4 Receipt of medicat ons intended to prevent COVID-19 EX04A00
2.e 5 Stages 1 and 2 only: Prev ous clinical or microbiolog cal diagnosis of COVID-19 EX05A00
2.f 6 Sentinel participants in Stage 1 only: Individuals at high risk for severe COVID-19 (full 
details in protocol)EX06A01
2.g 7 Sentinel participants in Stage 1 only: Individuals currently working in occupations with 
high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response 
personnel)EX07A00
2.h 8 Immunocompromised indiv duals w th kn own or suspected immunodeficiency, as 
determined by history and/or laboratory/phys cal examinat onEX08A00
2.i 9 Individuals w th a history of autoimmune disease or an active autoimmune disease 
requiring therapeutic interventionEX09A00
2.j 10 Bleeding diathesis or condition associated  w th prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular inject onEX10A00
2.k 11 Women who are pregnant or breastfeeding EX11A00
2.l 12 Previous vaccinat on with any coronavirus vaccine EX12A00
2.m 13 Subjects who receive immunosuppressive therapy, such as cytotox c agents or systemic 
cort costeroidsEX13A01
2.n 14 Sentinel participants in Stage 1 only: Regular receipt of inhaled/nebulized corticosteroids EX22A01
2.o 15 Receipt of blood/plasma products or immunoglobulin, from 60 days before study 
intervention administrat on or planned receipt throughout the studyEX14A01
2.p 16 Participation in other studies involving study intervention w thin 28 days pr or to study 
entry and/or during study participationEX15A01
2.q 17 Previous part cipation in other studies involving study intervent on containing lip d 
nanopart clesEX16A01
2.r 18 Sentinel part cipants in Stage 1 only: Posi tive serological test for SARS-CoV-2 IgM and/or 
IgG antibodies at the screening visitEX17A01
2.s 19 Sentinel part cipants in Stage 1 only: Screening hematology/blood chemistry lab 
>=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be considered eligible by InvestigatorEX18A01
2.t 20 Sentinel part cipants in Stage 1 only: Positive test for HIV, hepat tis B surface antigen EX19A01Annotated Study Book - C4591001
STUDYID
IE=Inclusion/Exclusion Criteria Not Met
IESPID
IECAT = INCLUSION
IETEST
IETESTCD
IEDESC in SUPPIE
IEORRES
Page 61 of 131
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FDA-CBER-2021-5683-0058098
(HBsAg), hepat tis B core antibodies (HBc Abs) , or hepatitis C virus antibodies (HCV Abs) 
at screening vis t
2.u 21 Sentinel participants in Stage 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 
hours before receipt of study interventionEX20A01
2.v 22 Investigator s te staff or Pfizer employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family membersEX21A01
Exclusion Criteria Entry
2.1 Exclusion Number:
[Exclusion Number] 
2.2 Cr terion Description:
[Criter on Descript on] 
2.3 Cr terion met?
[Criter on met?] 
YES
Describe details if relevant
NO
2.4 Cr terion ID: (For Pfizer use 
only)
[Criter on ID: (For Pfizer use 
only)] 
Annotated Study Book - C4591001
IESPID
IECAT = EXCLUSION
IE=Inclusion/Exclusion Criteria Not Met
IEDESC in SUPPIE
IETEST
IEORRES
IETESTCD
Page 62 of 131
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FDA-CBER-2021-5683-0058099
C4591001: CASEBOOK SIGNATURE FORM (INVSIG)
Casebook Signature Form
1. Casebook Signature
[Casebook Signature] 
Click Here to EnableAnnotated Study Book - C4591001
NOT SUBMITTED
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FDA-CBER-2021-5683-0058100
C4591001: CENTRAL LAB SAMPLE COLLECTION (LAB)
Central Lab Sample Collection
1. Collection Date:
[Collect on Date:] 
 / 
 / 
2. Specimen Type:
[Specimen Type] 
BLOO D
Lab Test
# Category for Lab Test Subcategory for Lab Test Lab Sub-Panel Collected
3.a CLINICAL CHEMISTRY BLOOD CHEMISTRY
3.b HEMATOLOGY DIFFERENTIAL
Lab Test Entry3.1 Lab Panel:
[Category for Lab Test] 
HEMATOLOGY
CLINICAL CHEMISTR Y
3.2 Lab Sub-Panel:
[Subcategory for Lab Test] 
DIFFERENTIAL
BLOOD CHEMISTRY
3.3 Was the lab sub-panel collected?:
[Lab Sub-Panel Collected] 
YES
NOAnnotated Study Book - C4591001
LB=Laboratory Test Results
STUDYID
MB=Microbiology Specimen
LBCAT
MBDTC
LBDTC
LBSPEC
LBSCATYN in SUPPLB
MBSPEC
MBCAT
MBSCATYN in SUPPMB
NOT SUBMITTED
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FDA-CBER-2021-5683-0058101
C4591001: CENTRAL LAB SAMPLE COLLECTION - BASELINE (LAB BSL)
Central Lab Sample Collection
1. Collection Date:
[Collect on Date:] 
 / 
 / 
2. Specimen Type:
[Specimen Type] 
BLOO D
Lab Test
# Category for Lab Test Subcategory for Lab Test Lab Sub-Panel Collected
3.a CLINICAL CHEMISTRY BLOOD CHEMISTRY
3.b CLINICAL CHEMISTRY VIROLOGY
3.c HEMATOLOGY DIFFERENTIAL
Lab Test Entry3.1 Lab Panel:
[Category for Lab Test] 
HEMATOLOGY
CLINICAL CHEMISTRY
3.2 Lab Sub-Panel:
[Subcategory for Lab Test] 
DIFFERENTIAL
BLOOD CHEMISTRY
VIROLOGY
3.3 Was the lab sub-panel collected?:
[Lab Sub-Panel Collected] 
YES
NOAnnotated Study Book - C4591001
STUDYID
LB=Laboratory Test Results
MBSPEC
MB=Microbiology Specimen
LBCAT
MBDTC
LBDTC
LBSPEC
MBCAT
LBSCATYN in SUPPLB
MBSCATYN in SUPPMB
NOT SUBMITTED
Page 65 of 131
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FDA-CBER-2021-5683-0058102
C4591001: LOCAL LABORATORY DATA - REPEATING CHEMISTRY (LAB CHEM) - Repeating Form
# Category for Lab Test Vendor Name Collection Date: Specimen Type Lab Result
1
Lab Chemistry Details
1. Lab Panel:
[Category for Lab Test] 
CLINICAL CHEMISTR Y
2. Laboratory Name and Address
[Vendor Name] 
3. Collection Date:
[Collect on Date:] 
 / 
 / 
4. Specimen Type:
[Specimen Type] 
BLOO D
Lab Result
#
Sponsor-Defined Identifier Test: Result: Not Done: Lab Normal Range
5.a C Reactive Protein_PX329
Lab Result Entry5.1 Sponsor ID:
[Sponsor-Defined Identifier] 
5.2 Test:
[Test:] 
C Reactive Protein_PX329
5.3 Result:
[Result:] 
5.4 Not Done: [hidden]
[Not Done:] 
NOT DONE
5.5 LNMT
[Lab Normal Range] Low
High
Un t
Annotated Study Book - C4591001
STUDYID
LBDTC
LBCAT
LB=Laboratory Test Results
LBNAM
LBSPEC
LBSPID
LBTEST
LBORRES
LBSTAT
LBORNRLO
LBORNRHI
LBORRESU
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FDA-CBER-2021-5683-0058103
C4591001: LOCAL LABORATORY DATA - REPEATING CHEMISTRY (LAB CHEM) - Repeating Form
# Category for Lab Test Vendor Name Collection Date: Specimen Type Lab Result
1
Lab Chemistry Details
1. Lab Panel:
[Category for Lab Test] 
CLINICAL CHEMISTR Y
2. Laboratory Name and Address
[Vendor Name] 
3. Collection Date:
[Collect on Date:] 
 / 
 / 
4. Specimen Type:
[Specimen Type] 
BLOO D
Lab Result
#
Sponsor-Defined Identifier Test: Result: Not Done: Lab Normal Range
5.a C Reactive Protein_PX329
5.b Alanine Aminotransferase_PX30
5.c Aspartate Aminotransferase_PX28
5.d Alkaline Phosphatase_PX35
5.e Bilirubin_PX21
5.f Blood Urea Nitrogen_PX47
5.g Creatinine_PX48
Lab Result Entry5.1 Sponsor ID:
[Sponsor-Defined Identifier] 
5.2 Test:
[Test:] 
5.3 Result:
[Result:] 
5.4 Not Done:
[Not Done:] 
NOT DON E
5.5 LNMT
[Lab Normal Range] Low
High
Un t
Annotated Study Book - C4591001
STUDYID
LBSPID
LB=Laboratory Test Results
LBCAT
LBNAM
LBTEST
LBDTC
LBSPEC
LBORRES
LBSTAT
LBORNRLO
LBORNRHI
LBORRESU
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FDA-CBER-2021-5683-0058104
C4591001: LOCAL LABORATORY DATA - REPEATING Hematology (LAB HEM) - Repeating Form
# Category for Lab Test Vendor Name (DERIVED) Collection Date: Specimen Type Lab Result
1
Laboratory Data Hematology
1. Lab Panel:
[Category for Lab Test] 
HEMATOLOG Y
2. Laboratory Name and Address
[Vendor Name (DERIVED)] 
3. Collection Date:
[Collect on Date:] 
 / 
 / 
4. Specimen Type:
[Specimen Type] 
BLOO D
Lab Result
#
Sponsor-Defined Identifier Test: Result: Not Done: Lab Normal Range
5.a Hemoglobin_PX1
5.b Hematocrit_PX2
5.c Erythrocytes_PX3
5.d Platelets_PX5
5.e Leukocytes_PX7
5.f Neutrophils_PX608
5.g Eosinophils_PX609
5.h Monocytes_PX612
5.i Basophils_PX610
5.j Lymphocytes_PX611
Lab Result Entry5.1 Sponsor ID:
[Sponsor-Defined Identifier] 
5.2 Test:
[Test:] 
5.3 Result:
[Result:] 
5.4 Not Done:
[Not Done:] 
NOT DONE
5.5 LNMT
[Lab Normal Range] Low
High
Unt
Annotated Study Book - C4591001
STUDYID
LBSPEC
LBCAT
LB=Laboratory Test Results
LBNAM
LBDTC
LBSPID
LBTEST
LBORRES
LBSTAT
LBORNRLO
LBORNRHI
LBORRESU
Page 68 of 131
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FDA-CBER-2021-5683-0058105
C4591001: LAB URINALYSIS - PREGNANCY TEST (LAB PREG)
Lab Urinalysis
1. Lab Panel:
[Category for Lab Test] 
URINALYSIS
2. Lab Sub-Panel:
[Subcategory for Lab Test] 
PREGNANC Y
3. Collection Date:
[Collect on Date:] 
 / 
 / 
4. Laboratory Name and Address (Derived) 
[Vendor Name (DERIVED)] 
5. Specimen Type:
[Specimen Type] 
URINE
Lab Result
# Sponsor-Defined Identifier Test: Result: Not Done:
6.a Chor ogonadotropin Beta_PX113
Lab Result Entry6.1 Sponsor ID:
[Sponsor-Defined Identifier] 
6.2 Test:
[Test:] 
Chor o gonadotro pin Beta_PX11 3
6.3 Result:
[Result:] 
NEGATIVE
POSITIV E
6.4 Not Done:
[Not Done:] 
NOT DONEAnnotated Study Book - C4591001
LB=Laboratory Test Results
LBCAT
STUDYID
LBNAM
LBDTC
LBSPEC
LBSPID
LBTEST
LBORRES
LBSTAT
LBSCAT
Page 69 of 131
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FDA-CBER-2021-5683-0058106
C4591001: MEDICATION ERROR (MED ERROR) - Repeating Form
# Category Medication 
ErrorStart 
DateIs the medication 
error Still 
OngoingStudy 
Medication 
Errors ActionConcomitant 
Medication GivenNon-Drug 
Treatment 
GivenCaused Study 
DiscontinuationMedication Error 
Associated With 
AESerious 
Adverse Event 
Number
1
Medication Error
1. Category:
[Category] 
MEDICATION ERROR
2. Medication Error (Type 
of Medication Error):
[Med cat on Error] 
3. If this is a dispensing 
error, record the incorrect container 
number that was 
dispensed/administered 
to the subject: [hidden]
[Incorrect package ID] 
4. Start Date:
[Start Date] 
/ 
  / 
5. Is the med cation error 
still ongoing?
[Is the med cat on error 
Still Ongoing] 
YES
NO
End Date:
 / 
 / 
6. Latest Action Taken 
with Study Treatment:
[Study Medication 
Errors Act on] 
NO ACTION TAKEN
PERMANENTLY DISCONTINUED
7. Was a Concomitant 
Med cation given?[Concom tant 
Med cat on Given] 
YES
NO
8. Was a Non-Drug 
Treatment given?[Non-Drug Treatment 
Given] 
YES
NO
9. D d the Medication Error 
cause the subject to be 
discontinued from the 
study?
[Caused Study 
Discontinuat on] 
YES
NO
10. Was this medication 
error associated with any adverse events?
[Med cat on Error 
Associated With AE] 
YES
AE ID:
AE ID:
AE ID:
AE ID:
AE ID:
NO
11. Ser ous Adverse Event 
Number: For Pfizer Use 
Only
[Serious Adverse Event 
Number] 
12. Comparison Term 
[hidden]
[Comparison Term] 
13. Lowest Level Term 
[hidden]
[Lowest Level Term] 
14. Lowest Level Term 
Code [hidden]
[Lowest Level Term Code] 
15. D ctionary-Derived 
Term [hidden]
[D ctionary-Derived 
Term] Annotated Study Book - C4591001
AE=Adverse Events
STUDYID
AETERM
AECAT
AEIPKGID in SUPPAE
AESTDTC
AEACN
AECONTRT
AESUBJDC in SUPPAE
AEENDTC
AECMGIV in SUPPAE
AENDGIV in SUPPAE
AEMEFL in SUPPAE
Linked to related DS record via RELREC
AECONTRT
AEAENO in SUPPAE
AEAENO in SUPPAE
AEAENO in SUPPAE
AEAENO in SUPPAE
AEAENO in SUPPAE
AEREFID
NOT SUBMITTED
AELLT
AELLTCD
AEDECOD
AEENRTPT= ONGOING
AEENTPT= LAST SUBJECT ENCOUNTER
Page 70 of 131
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FDA-CBER-2021-5683-0058107
16. Preferred Term Code 
[hidden]
[Preferred Term Code] 
17. High Level Term 
[hidden][High Level Term] 
18. High Level Term Code 
[hidden]
[High Level Term Code] 
19. High Level Group Term 
[hidden][High Level Group 
Term] 
20. High Level Group Term 
Code [hidden]
[High Level Group Term 
Code] 
21. Primary System Organ 
Class [hidden]
[Primary System Organ 
Class] 
22. Primary System Organ 
Class Code [hidden]
[Primary System Organ Class Code] Annotated Study Book - C4591001
AEHLTCD
AEPTCD
AE=Adverse Events
AEHLT
AEHLGT
AEHLGTCD
AEBODSYS
AESOC
AEBDSYCD
AESOCCD
Page 71 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058108
C4591001: GENERAL MEDICAL HISTORY (MEDHX)
Line/MH Number Medical History Term Start Date Ongoing
1.
Medical History Details Entry
1.1 Line/MH Number:
[Line/MH Number] 
1.2 Disease/Syndrome/Surgery/Non-
Drug Allergies/Drug Allergies:
[Medical History Term] 
1.3 Start Date:
[Start Date] 
/ 
  / 
1.4 Ongoing:
[Ongoing] 
YES
NO
End Date:
 / 
 / 
1.5 Comparison Term [hidden]
[Comparison Term] 
1.6 Lowest Level Term [hidden]
[Lowest Level Term] 
1.7 Lowest Level Term Code 
[hidden]
[Lowest Level Term Code] 
1.8 Dict onary Derived Term 
[hidden][Dictionary Derived Term] 
1.9 Preferred Term Code [hidden]
[Preferred Term Code] 
1.10 High Level Term [hidden]
[High Level Term] 
1.11 High Level Term Code [hidden]
[High Level Term Code] 
1.12 High Level Group Term [hidden]
[High Level Group Term] 
1.13 High Level Group Term Code 
[hidden]
[High Level Group Term Code] 
1.14 Primary System Organ Class 
[hidden][Primary System Organ Class] 
1.15 Primary System Organ Class 
Code [hidden]
[Primary System Organ Class 
Code] Annotated Study Book - C4591001
STUDYID
MHCAT=GENERAL MEDICAL HISTORY
MHSPID
MHTERM
MHSTDTC
MH=Medical History
MHENDTC
NOT SUBMITTED
MHLLT
MHLLTCD
MHDECOD
MHPTCD
MHHLT
MHHLTCD
MHHLGT
MHHLGTCD
MHBODSYS
MHBDSYCD
MHSOC
MHSOCCD
MHENRTPT= ONGOING/BEFORE
MHENTPT= LAST SUBJECT ENCOUNTER
Page 72 of 131
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FDA-CBER-2021-5683-0058109
C4591001: OXYGENATION PARAMETERS (OXYGEN) - Repeating Form
# Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen)
1
Oxygenation Parameters
1. Date Time of Assessment:
[Date Time of Assessment] 
 / 
  / 
 : 
  24-hour clock
2. Arterial Blood Gases PaO2 
(mmHg):
[Arterial Blood Gases PaO2] 
3. FiO2 (Fract on of Inhaled 
Oxygen):[FiO2 (Fraction of Inhaled 
Oxygen)] Annotated Study Book - C4591001
STUDYID
LBCAT= OXYGENATION PARAMETERS
LB=Laboratory Test Results
LBDTC
LBORRES  when LBTESTCD = PO2
LBORRES  when LBTESTCD = FIO2
LBSCAT= BLOOD CHEMISTRY
Page 73 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058110
C4591001: PHYSICAL EXAMINATION (PHYS EXAM)
Physical Examination
1. Exam Date:
[Exam Date] 
 / 
  / 
Physical Examination Result
# Body System Examined Result
2.a GENERAL APPEARANCE2.b SKIN2.c HEAD2.d EYES2.e EARS2.f NOSE2.g THROAT2.h HEART2.i LUNGS2.j ABDOMEN2.k MUSCULOSKELETAL2.l EXTREMITIES2.m NEUROLOGICAL
2.n LYMPH NODES
Physical Examination Result Entry
2.1 Body System Examined:
[Body System Examined] 
2.2 Result:
[Result] 
NORMAL
ABNORMAL
If abnormal findings, specify: (If clinically signif cant, record on the Medical History or Adverse Event CRF as appropriate).
Are there clinically signif cant findings?
YES
NO
NOT DONEAnnotated Study Book - C4591001
PECAT=PHYSICAL EXAMINATION
STUDYID
PE=Physical Examination
PEDTC
PEORRES
PETEST
PECLSIG in SUPPPE
PESTAT
Page 74 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058111
C4591001: ELECTRONIC SAMPLE TRACKING - PRIOR COVID-19 INFECTION (PRIORCOV19)
Electronic Sample Tracking
1. Data Origin
[Data Origin] 
SITE
2. Sample Type
[Sample Type] 
SERUM
3. Sample Collected?
[Sample Collected] 
NO
YES
Date of Collect on:
 / 
 / 
4. If no sample was collected or 
sample was not collected 
according to protocol, please 
provide reason:
[Reason sample not collected] 
Sample ID
5.
Aliquot Entry
Please enter barcode for each aliquot.5.1 Sample ID
[Sample ID] Annotated Study Book - C4591001
STUDYID
IS=Immunogenicity Specimen Assessment
CO=Comments
ETRKDOR in SUPPIS
ISSPEC
ISDTC
COVAL when RDOMAIN = IS
NOT SUBMITTED
ISCAT=SEROLOGY
COVAL when COREF=SAMPLE COLLECTED
CODTC
Page 75 of 131
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FDA-CBER-2021-5683-0058112
C4591001: CONCOMITANT MEDICATIONS - PROHIBITED (PROHIB CM) - Repeating Form
# Sponsor-Defined 
IdentifierCategory for 
MedicationConcomitant Medications Pre-
specifiedName of 
MedicationDose 
DescriptionDose 
UnitDose 
FrequencyRoute Start 
DateOngoing
1
Concomitant Medications
1. What is the medication dentifier?
[Sponsor-Defined Identifier] 
2. Category:
[Category for Medication] 
CONCOMITANT IMMUNOSUPPRESSIVE THERAP Y
CORTICOSTEROIDS
IMMUNOGLOBULINS
3. Concomitant Medications Pre-specified:
[Concom tant Medications Pre-specified] 
NO
4. Med cation:
Prov de the complete gener c drug name 
(including salt form, where applicable). Where 
generic name is unknown, enter the full trade or 
proprietary name. Include clarifying information 
in the Med cat on text (e.g., Ingredient(s), 
route, use, formulation).
[Name of Medication] 
5. Dose:
[Dose Description] 
6. Dose Unit:
[Dose Unit] 
7. Dose Frequency:
[Dose Frequency] 
8. Route:
[Route] 
9. Start Date:
[Start Date] 
 / 
 / 
10. Ongoing?
[Ongoing] 
YES
NO
End Date:
/ 
  / 
11. Comparison Term [hidden]
[Comparison Term] 
12. Standardized Med cat on Name - Dict onary 
derived. [hidden]
[Standardized Med cat on Name] 
13. Standardized Med cat on Code - D ctionary 
derived [hidden]
[Standardized Med cat on Code] Annotated Study Book - C4591001
CM=Concomitant Medications
STUDYID
CMCAT
CMSPID
CMSTDTC
CMROUTE
CMDOSFRQ
CMDOSU
CMDOSE
CMTRT
CMENDTC
NOT SUBMITTED
CMDOSTXT
NOT SUBMITTED
CMDECOD
CMCODE in SUPPCM
CMENRTPT= ONGOING
CMENTPT= LAST SUBJECT ENCOUNTER
Page 76 of 131
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FDA-CBER-2021-5683-0058113
C4591001: RADIATION TREATMENT (PROHIB ND) - Repeating Form
# Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Ongoing?
1
Radiation Treatment
1. Category:
[Category] 
RADIATION THERAP Y
2. What is the treatment Identifier?
[Treatment Identifier] 
3. Concomitant Non-drug Treatment Pre-specified:
[Con Non-Drug Treatments Pre-specified] 
YES
4. Treatment:
[Treatment] 
5. Start Date:
[Start Date] 
 / 
  / 
6. Ongoing?
[Ongoing?] 
YES
NO
End Date:
/ 
  / 
7. Comparison Term [hidden]
[Comparison Term] 
8. Lowest Level Term [hidden]
[Lowest Level Term] 
9. Lowest Level Term Code [hidden]
[Lowest Level Term Code] 
10. D ctionary Derived Term [hidden]
[D ctionary Derived Term] 
11. Preferred Term Code [hidden]
[Preferred Term Code] 
12. High Level Term [hidden]
[High Level Term] 
13. High Level Term Code [hidden]
[High Level Term Code] 
14. High Level Group Term [hidden]
[High Level Group Term] 
15. High Level Group Term Code [hidden]
[High Level Group Term Code] 
16. Primary System Organ Class [hidden]
[Primary System Organ Class] 
17. Primary System Organ Class Code [hidden]
[Primary System Organ Class Code] Annotated Study Book - C4591001
STUDYID
PR=Procedures
PRCAT
PRSPID
PRPRESP
PRTRT
PRSTDTC
PRENDTC
NOT SUBMITTED
PRLLT in SUPPPR 
PRLLTCD in SUPPPR 
PRHLT in SUPPPR
PRPTCD in SUPPPR
PRDECOD
PRHLTCD in SUPPPR
PRHLGT in SUPPPR 
PRHLGTCD in SUPPPR
PRBODSYS in SUPPPR
 PRBDSYCD in SUPPPR
PRSOC in SUPPPR 
PRSOCCD in SUPPPR
PRENRTPT= ONGOING
PRENTPT= LAST SUBJECT ENCOUNTER
Page 77 of 131
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FDA-CBER-2021-5683-0058114
C4591001: VITAL SIGNS - PULSE OX ROOM AIR (PULSE OX) - Repeating Form
#D ate: Vital Signs Details
1
Vital Signs
1. Date:
[Date:] 
 / 
  / 
Vital Signs Details
#
Record Identifier: Oxygen Saturation
2.a 1
Vital Signs Details Entry2.1 Record Identifier:
[Record Identifier:] 
1
2.2 SPO2 Pulse Oximetry %
[Oxygen Saturation] Annotated Study Book - C4591001
STUDYID
VS=Vital Signs
VSCAT=GENERAL VITAL SIGNS
VSDTC
VSSPID
VSORRES when VSTESTCD = OXYSAT
Page 78 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058115
C4591001: RANDOMIZATION (RAND)
Disposition
1. Randomizat on Date :
[Randomization Date :] 
/ 
 / 
2. Randomizat on Number:
[Randomization Number] 
3. Randomizat on Group:
[Randomization Group] Annotated Study Book - C4591001
STUDYID
DSCAT=PROTOCOL MILESTONE
DS=Disposition
DSSTDTC when DSTERM/DSDECOD=RANDOMIZED
DSREFID
DSRANGRP in SUPPDS
Page 79 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058116
C4591001: REACTOGENICITY DIARY (REAC DIARY)
Reactogenicity Diary
1. Select appropriate response -
Reactogen c ty diary collection
[Trigger Response 9] 
YES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJEC T
NO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECTAnnotated Study Book - C4591001
STUDYID
DM=Demographics
REACTOFL='N' in SUPPDM
REACTOFL='Y' in SUPPDM when non-missing 
of vaccination start date
Page 80 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058117
C4591001: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC EVENT (REACTION)
Unplanned Assessment Of Local Reaction
1. CISR Category [hidden]
[CISR Category] 
UNPLANNED ASSESSMENT OF LOCAL REACTION/SYSTEMIC EVEN T
2. Date of Assessment:
[Date of Assessment] 
 / 
  / 
3. Injection Site Location
[Injection S te Location] 
DELTOID MUSCL E
4. Injection Site Body S de:
[Injection S te Body Side] 
LEFT
RIGH T
Reaction
#R eaction: Reaction Present:
5.a REDNESS5.b SWELLING
Reaction Entry5.1 Reaction:
[React on:] 
REDNESS
SWELLING
5.2 Reaction Present:
[React on Present:] 
YES
Maximum Diameter (cm):
Minimum Diameter (cm):
Meets Grade 4 Reaction Cr teria:
YES
NO
NO
Symptom
#S ymptom: Symptom Present:
6.a PAIN AT INJECTION SITE
6.b FATIGUE/TIREDNESS6.c HEADACHE6.d VOMITING6.e DIARRHEA6.f NEW OR WORSENED MUSCLE PAIN6.g NEW OR WORSENED JOINT PAIN6.h CHILLS
Symptom Entry6.1 Symptom:
[Symptom:] 
6.2 Symptom Present:
[Symptom Present:] 
YES
Symptom Grade:
1
2
3
4
Event related to Stud y Treament ?
YES
NO
NOAnnotated Study Book - C4591001
FACAT=REACTOGENICITY -UNPLANNED ASSESSMENT
STUDYID
FA=Findings About Events or Interventions
NOT SUBMITTED
FADTC
FALOC
FALAT
FAOBJ
FAORRES when FATESTCD=OCCUR
FAORRES when FATESTCD=MAXDIAM
FAORRES when FATESTCD=MINDIAM
FAOBJ
FAORRES when FATESTCD=OCCUR
FAORRES when FATESTCD=REL
FAORRES when FATESTCD=G4CRIMET
FAORRES when FATESTCD=SEV
Page 81 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058118
C4591001: RESPIRATORY TREATMENT (RESP TX) - Repeating Form
# Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Ongoing?
1
Respiratory Treatment
1. What is the treatment Identifier?
[Treatment Identifier] 
2. Concomitant Non-drug Treatment Pre-specified:
[Con Non-Drug Treatments Pre-specified] 
YES
3. Treatment:
[Treatment] 
NON-INVASIVE POSITIVE PRESSURE VENTILATION
CPAP
MECHANICAL VENTILATIO N
EXTRACORPOREAL MEMBRANE OXYGENATIO N
HIGH FLOW OXYGEN THERAP Y
4. Treatment:
[Treatment] 
5. Start Date:
[Start Date] 
 / 
 / 
6. Ongoing?
[Ongoing?] 
YES
NO
End Date:
/ 
  / 
7. Comparison Term [hidden]
[Comparison Term] 
8. Lowest Level Term [hidden]
[Lowest Level Term] 
9. Lowest Level Term Code [hidden]
[Lowest Level Term Code] 
10. D ctionary Derived Term [hidden]
[D ctionary Derived Term] 
11. Preferred Term Code [hidden]
[Preferred Term Code] 
12. High Level Term [hidden]
[High Level Term] 
13. High Level Term Code [hidden]
[High Level Term Code] 
14. High Level Group Term [hidden]
[High Level Group Term] 
15. High Level Group Term Code [hidden]
[High Level Group Term Code] 
16. Primary System Organ Class [hidden]
[Primary System Organ Class] 
17. Primary System Organ Class Code [hidden]
[Primary System Organ Class Code] Annotated Study Book - C4591001
PRCAT=GENERAL NON-DRUG TREATMENT
STUDYID
PR=Procedures
PRSPID
PRPRESP
PRTRT
PRTRT
PRSTDTC
PRENDTC
NOT SUBMITTED
PRENRTPT= ONGOING
PRENTPT= LAST SUBJECT ENCOUNTER
PRLLT in SUPPPR 
PRLLTCD in SUPPPR 
PRDECOD
PRPTCD in SUPPPR
PRHLT in SUPPPR
PRHLTCD in SUPPPR
PRHLGT in SUPPPR 
PRSOCCD in SUPPPR
 PRBDSYCD in SUPPPR
PRSOC in SUPPPR 
PRBODSYS in SUPPPR
PRHLGTCD in SUPPPR
Page 82 of 131
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FDA-CBER-2021-5683-0058119
C4591001: RESPIRATORY TREATMENT (RESP TX) - Repeating Form
# Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Ongoing?
1
Respiratory Treatment
1. What is the treatment Identifier?
[Treatment Identifier] 
2. Concomitant Non-drug Treatment Pre-specified:
[Con Non-Drug Treatments Pre-specified] 
YES
3. Treatment:
[Treatment] 
INTUBATIO N
NON-INVASIVE POSITIVE PRESSURE VENTILATION
CPAP
OXYGEN THERAP Y
4. Treatment:
[Treatment] 
5. Start Date:
[Start Date] 
 / 
  / 
6. Ongoing?
[Ongoing?] 
YES
NO
End Date:
/ 
 / 
7. Comparison Term [hidden]
[Comparison Term] 
8. Lowest Level Term [hidden]
[Lowest Level Term] 
9. Lowest Level Term Code [hidden]
[Lowest Level Term Code] 
10. D ctionary Derived Term [hidden]
[D ctionary Derived Term] 
11. Preferred Term Code [hidden]
[Preferred Term Code] 
12. High Level Term [hidden]
[High Level Term] 
13. High Level Term Code [hidden]
[High Level Term Code] 
14. High Level Group Term [hidden]
[High Level Group Term] 
15. High Level Group Term Code [hidden]
[High Level Group Term Code] 
16. Primary System Organ Class [hidden]
[Primary System Organ Class] 
17. Primary System Organ Class Code [hidden]
[Primary System Organ Class Code] Annotated Study Book - C4591001
STUDYID
PRCAT=GENERAL NON-DRUG TREATMENT
PR=Procedures
PRSPID
PRPRESP
PRTRT
PRTRT
PRSTDTC
PRENDTC
NOT SUBMITTED
PRDECOD
PRENRTPT= ONGOING
PRENTPT= LAST SUBJECT ENCOUNTER
PRLLT in SUPPPR 
PRLLTCD in SUPPPR 
PRPTCD in SUPPPR
PRHLT in SUPPPR
PRHLTCD in SUPPPR
PRHLGT in SUPPPR 
PRSOCCD in SUPPPR
 PRBDSYCD in SUPPPR
PRSOC in SUPPPR 
PRBODSYS in SUPPPR
PRHLGTCD in SUPPPR
Page 83 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058120
C4591001: FURTHER VACCINATION CONFIRMATION (REVAX CONF)
Further Vaccination Confirmation
1. Select appropriate response - Is 
part cipant willing to return for 
Vaccination 3?
[Trigger Response 1] 
Partici pant is willin g to return for Vaccinat on 3
Participant is:
eligible per local/national recommendations and confirmed to have received onl y placebo at Vaccination 1/ 2
eligible per other protocol allowance (s) and confirmed to have received onl y placebo at Vaccination 1/ 2
eligible and NOT confirmed to have received onl y placebo at Vaccination 1/2 
Participant is NOT willing to return for Vaccination 3 OR otherwise not eligibleAnnotated Study Book - C4591001
NOT SUBMITTED
Page 84 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058121
C4591001: INFORMED CONSENT - FURTHER VACCINATION (REVAX CONS)
Informed Consent - Further Vaccination
1. Consent Was:
[Consent Was:] 
OBTAINE D
Date Written Consent Obtained
/ 
  / 
Annotated Study Book - C4591001
DSCAT=PROTOCOL MILESTONE
STUDYID
DSSTDTC when 
DSTERM/DSDECOD=INFORMED 
CONSENT OBTAINED
DS=Disposition
Page 85 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058122
C4591001: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION (REVAX IE)
Criterion Description
1.
Inclusion Criteria Not Met Entry
1.1 Description of Inclusion 
Cr terion Not Met
[Criter on Descript on] 
Criterion Description
2.
Exclusion Criteria Met Entry
2.1 Description of Exclusion 
Cr terion Met
[Criter on Descript on] 
Annotated Study Book - C4591001
IETEST when IEORRES=N
IE=Inclusion/Exclusion Criteria Not Met
STUDYID
IETEST when IEORRES=Y
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C4591001: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB (RSWAB)
Electronic Sample Tracking
1. Data Origin
[Data Origin] 
SITE
2. Sample Type
[Sample Type] 
NASAL_SWAB
NASAL_SWAB_SEL F
3. Sample Collected?
[Sample Collected] 
NO
YES
Date of Collect on:
 / 
 / 
4. If no sample was collected or 
sample was not collected 
according to protocol, please 
provide reason:
[Reason sample not collected] 
Sample ID
5.
Aliquot Entry
Please enter barcode for each aliquot.5.1 Sample ID
[Sample ID] Annotated Study Book - C4591001
MBCAT=VIROLOGY
ETRKDOR in SUPPMB
STUDYID
MB=Microbiology Specimen
CO=Comments
MBSPEC
MBDTC
NOT SUBMITTED
NOT SUBMITTED
COVAL when RDOMAIN = MB
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FDA-CBER-2021-5683-0058124
C4591001: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY (SAMP TRK)
Electronic Sample Tracking
1. Data Origin
[Data Origin] 
SITE
2. Sample Type
[Sample Type] 
SERUM
3. Sample Collected?
[Sample Collected] 
NO
YES
Date of Collect on:
 / 
 / 
4. If no sample was collected or 
sample was not collected 
according to protocol, please 
provide reason:
[Reason sample not collected] 
Sample ID
5.
Aliquot Entry
Please enter barcode for each aliquot.5.1 Sample ID
[Sample ID] Annotated Study Book - C4591001
IS=Immunogenicity Specimen Assessment
STUDYID
CO=Comments
ISCAT=SEROLOGY
ETRKDOR in SUPPIS
ISSPEC
ISDTC
NOT SUBMITTED
COVAL when RDOMAIN = IS
COVAL when COREF=SAMPLE COLLECTED
CODTC
Page 88 of 131
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FDA-CBER-2021-5683-0058125
C4591001: INFORM SCREENING (SCREEN)
InForm Screening
1. InForm Initials [hidden]
[InForm Initials] 
2. Birth Date:
[Birth Year] 
 / 
  / 
Annotated Study Book - C4591001
NOT SUBMITTED
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FDA-CBER-2021-5683-0058126
C4591001: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF (SELF SWAB)
Electronic Sample Tracking
1. Data Origin
[Data Origin] 
SITE
2. Sample Type
[Sample Type] 
NASAL_SWAB_SELF
3. Sample Collected?
[Sample Collected] 
NO
YES
Date of Collect on:
 / 
 / 
4. If no sample was collected or 
sample was not collected 
according to protocol, please 
provide reason:
[Reason sample not collected] 
Sample ID
5.
Aliquot Entry
Please enter barcode for each aliquot.5.1 Sample ID
[Sample ID] Annotated Study Book - C4591001
MBCAT=VIROLOGY
STUDYID
MB=Microbiology Specimen
CO=Comments
ETRKDOR in SUPPMB
MBDTC
NOT SUBMITTED
COVAL when RDOMAIN = MB
MBSPEC
NOT SUBMITTED
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FDA-CBER-2021-5683-0058127
C4591001: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 (SOD)
Signs and Symptoms
1. Date of Assessment:
[Date of assessment] 
 / 
  / 
2. Date of First Symptom Started:
[First Symptom Started Date] 
 / 
  / 
3. Symptoms Ongoing?
[Symptoms Ongoing] 
YES
NO
Date of Last Symptom Resolved:
 / 
 / 
Symptoms
#
Event Pre-specified Symptoms Symptom Present
4.a YES FEVER
4.b YES NEW OR INCREASED COUGH 4.c YES NEW OR INCREASED SHORTNESS OF BREATH4.d YES CHILLS4.e YES NEW OR INCREASED MUSCLE PAIN4.f YES NEW LOSS OF TASTE OR SMELL4.g YES NEW OR INCREASED SORE THROAT4.h YES DIARRHEA4.i YES VOMITING
Symptoms Entry4.1 Event Pre-specified: [hidden]
[Event Pre-specified] 
YES
4.2 Symptoms:
[Symptoms] 
4.3 Was symptom present?
[Symptom Present] 
YES
NO
Symptoms - Other
5.

Symptoms - Other Entry5.1 Symptoms - Other Text:
[Symptoms - Other] 
5.2 Comparison Term: [hidden]
[Comparison Term] 
5.3 Lowest Level Term [hidden]
[Lowest Level Term] 
5.4 Lowest Level Term Code 
[hidden]
[Lowest Level Term Code] 
5.5 Dict onary Derived Term 
[hidden][Dictionary Derived Term] 
5.6 Preferred Term Code [hidden]
[Preferred Term Code] 
5.7 High Level Term [hidden]
[High Level Term] 
5.8 High Level Term Code 
[hidden][High Level Term Code] 
5.9 High Level Group Term 
[hidden][High Level Group Term] 
5.10 High Level Group Term Code 
[hidden]
[High Level Group Term Code] 
5.11 Primary System Organ Class 
[hidden][Primary System Organ Class] 
5.12 Primary System Organ Class 
Code [hidden]
[Primary System Organ Class Annotated Study Book - C4591001
CESCAT=SIGNS AND SYMPTOMS OF DISEASE
Original version: VERSION 1: USED PRIOR TO JULY 6, 2020
New version: VERSION 2: USED AFTER JULY 6, 2020
STUDYID
FACAT=EFFICACY
FASCAT=RESPIRATORY ILLNESS
FADTC
FAORRES when FATESTCD=FSYMDATE
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
FA=Findings About 
Events or Interventions
FAORRES when FATESTCD=SYMONGO
FAORRES when FATESTCD=LSYMDATE
NOT SUBMITTED
FAOBJ
FAORRES when FATESTCD=OCCUR
FAOBJ
NOT SUBMITTED
CE=Clinical Events
CETERM
CESTDTC
CEENDTC
CECAT=EFFICACY
CEDTC
CEENRTPT= ONGOING
CEENTPT= ONGOING 
AT CURRENT VISIT
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Code] Annotated Study Book - C4591001
FA=Findings About Events or Interventions
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C4591001: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 (SOD)
Signs and Symptoms
1. Date of Assessment:
[Date of assessment] 
 / 
  / 
2. Date of First Symptom Started:
[First Symptom Started Date] 
 / 
  / 
3. Symptoms Ongoing?
[Symptoms Ongoing] 
YES
NO
Date of Last Symptom Resolved:
 / 
 / 
Symptoms
#
Event Pre-specified Symptoms Symptom Present
4.a YES FEVER
4.b YES LOSS OF TASTE/SMELL4.c YES NEW OR INCREASED COUGH 4.d YES NEW OR INCREASED NASAL CONGESTION4.e YES NEW OR INCREASED NASAL DISCHARGE4.f YES NEW OR INCREASED SHORTNESS OF BREATH4.g YES NEW OR INCREASED SORE THROAT4.h YES NEW OR INCREASED SPUTUM PRODUCTION4.i YES NEW OR INCREASED WHEEZING
Symptoms Entry4.1 Event Pre-specified: [hidden]
[Event Pre-specified] 
YES
4.2 Symptoms:
[Symptoms] 
4.3 Was symptom present?
[Symptom Present] 
YES
NO
Symptoms - Other
5.

Symptoms - Other Entry5.1 Symptoms - Other Text:
[Symptoms - Other] 
5.2 Comparison Term: [hidden]
[Comparison Term] 
5.3 Lowest Level Term [hidden]
[Lowest Level Term] 
5.4 Lowest Level Term Code 
[hidden]
[Lowest Level Term Code] 
5.5 Dict onary Derived Term 
[hidden][Dictionary Derived Term] 
5.6 Preferred Term Code [hidden]
[Preferred Term Code] 
5.7 High Level Term [hidden]
[High Level Term] 
5.8 High Level Term Code 
[hidden][High Level Term Code] 
5.9 High Level Group Term 
[hidden][High Level Group Term] 
5.10 High Level Group Term Code 
[hidden]
[High Level Group Term Code] 
5.11 Primary System Organ Class 
[hidden][Primary System Organ Class] 
5.12 Primary System Organ Class 
Code [hidden]
[Primary System Organ Class Annotated Study Book - C4591001
Original version: VERSION 1: USED PRIOR TO JULY 6, 2020
New version: VERSION 2: USED AFTER JULY 6, 2020
STUDYID
FAORRES when FATESTCD=OCCUR
FACAT=EFFICACY
FASCAT=RESPIRATORY ILLNESS
FADTC
FAORRES when FATESTCD=FSYMDATE
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
NOT SUBMITTED
FAORRES when FATESTCD=SYMONGO
FAORRES when FATESTCD=LSYMDATE
NOT SUBMITTED
FAOBJ
FAOBJ
NOT SUBMITTED
CETERM
CEENDTC
CESTDTC
FA=Findings About 
Events or Interventions
CE=Clinical Events
CECAT=EFFICACY
CESCAT=SIGNS AND SYMPTOMS OF DISEASE
CEDTC
CEENRTPT= ONGOING
CEENTPT= ONGOING 
AT CURRENT VISIT
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Code] Annotated Study Book - C4591001
FA=Findings About Events or Interventions
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C4591001: STRATIFICATION (STRAT)
Stratification
1. Select appropriate response -
Randomizat on Stage
[Trigger Response 3] 
Non-Sentinel Sta ge 1
2. Select appropriate response -
Randomizat on Age Group
[Trigger Response 4] 
Age 18 to 55
Age 65 to 85
3. Select appropriate response -
Randomizat on Dose[Trigger Response 5] 
10 mcg
20 mc g
30 mcg
4. Select appropriate response -
Randomizat on Dose Group[Trigger Response 8] 
21 Day
60 Day
5. Select appropriate response -
BNT Number[Trigger Response 7] 
(BNT162b1 or PBO)
(BNT162b2 or PBO)
(BNT162b3 or PBO)Annotated Study Book - C4591001
NOT SUBMITTED
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C4591001: STRATIFICATION (STRAT)
Stratification
1. Select appropriate response -
Randomizat on Stage
[Trigger Response 3] 
Stage 2
2. Select appropriate response -
Randomizat on Age Group
[Trigger Response 4] 
Age 18 to 55
Age 56 to 85
3. Select appropriate response -
Randomizat on Dose[Trigger Response 5] 
10 mcg
20 mc g
30 mcg
4. Select appropriate response -
BNT Number[Trigger Response 7] 
(BNT162b1 or PBO)
(BNT162b2 or PBO)
(BNT162b3 or PBO)Annotated Study Book - C4591001
NOT SUBMITTED
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C4591001: STRATIFICATION (STRAT)
Stratification
1. Select appropriate response -
Randomizat on Stage
[Trigger Response 3] 
Stage 1
Stage 2
2. Select appropriate response -
Randomizat on Age Group
[Trigger Response 4] 
Age 18 to 55
Age 56 to 85
Age 65 to 8 5
3. Select appropriate response -
Randomizat on Dose
[Trigger Response 5] 
Low dose level (3mcg)
Medium dose level (10mcg)
High dose level (30mcg)
Low dose level (10mcg)
Medium dose level (30mc g)
High dose level (100mcg)
Low dose level (0.1mcg)
Medium dose level (0.3mcg)
High dose level (1mcg)
Mid-High dose level (50mc g)
Low-Mid dose level (20mcg)
4. Select appropriate response -
Randomizat on Dose Group 
[hidden]
[Trigger Response 6] 
21 Da y 2-dose group
60 Day 2-dose group
1-dose group
5. Select appropriate response -
Randomizat on Dose Group
[Trigger Response 8] 
21 Da y
60 Day
6. Select appropriate response -
BNT Number[Trigger Response 7] 
(BNT162a1 or PBO)
(BNT162b1 or PBO)
(BNT162b2 or PBO )
(BNT162c2 or PBO)
(BNT162b3 or PBO )Annotated Study Book - C4591001
NOT SUBMITTED
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C4591001: SUBJECT STATUS (SUB STATU)
Subject Status
1. Subject Status
[Subject Status] 
2. Subject Status Date
[Status Date] 
 / 
  / 
Annotated Study Book - C4591001
NOT SUBMITTED
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C4591001: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE (SURV CONS)
Informed Consent - Asymptomatic Surveillance
1. Consent Was:
[Consent Was:] 
OBTAINE D
Date Written Consent Obtained
/ 
  / 
Annotated Study Book - C4591001
DSSTDTC when 
DSTERM/DSDECOD=INFORMED 
CONSENT OBTAINED
STUDYID
DSCAT=PROTOCOL MILESTONE
DS=Disposition
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C4591001: ELECTRONIC SAMPLE TRACKING - NASAL SWAB (SWAB PFE)
Electronic Sample Tracking
1. Data Origin
[Data Origin] 
SITE
2. Sample Type
[Sample Type] 
NASAL_SWAB
3. Sample Collected?
[Sample Collected] 
NO
YES
Date of Collect on:
 / 
 / 
4. If no sample was collected or 
sample was not collected 
according to protocol, please 
provide reason:
[Reason sample not collected] 
Sample ID
5.
Aliquot Entry
Please enter barcode for each aliquot.5.1 Sample ID
[Sample ID] Annotated Study Book - C4591001
ETRKDOR in SUPPMB
MB=Microbiology Specimen
STUDYID
CO=Comments
MBSPEC
MBDTC
NOT SUBMITTED
NOT SUBMITTED
COVAL when RDOMAIN = MB
MBCAT=VIROLOGY
Page 100 of 131
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C4591001: MICROBIOLOGY SPECIMEN (SWAB SITE) - Repeating Form
# Date of Collection Specimen Type Specimen Collection Location Assay Code and Description Device Type Trade Name Result Comments:
1
Microbiology Specimen
1. Actual Date of Collection:
[Date of Collection] 
 / 
  / 
2. Specimen Type:
[Specimen Type] 
SWABBED MATERIAL
3. Specimen Collection Location:
[Specimen Collection Location] 
NASAL CAVITY
4. Assay Code and Description:
[Assay Code and Description] 
SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5. Device Type:
[Device Type] 
SARS-CO V-2 DIAGNOSTIC TES T
6. Trade Name:
[Trade Name] 
CEPHEID XPERT XPRESS SARS-COV-2 TEST
7. Test Result:
[Result] 
POSITIVE
NEGATIVE
INDETERMINATE
8. Comments/Findings/Details:
[Comments:] Annotated Study Book - C4591001
STUDYID
MB=Microbiology Specimen
DI=Device Identifiers
CO=Comments
MBDTC
MBSPEC
MBLOC
MBTEST
MBORRES when MBTESTCD = SARSCOV2
DIVAL when DIPARMCD = DEVTYPE
DIVAL when DIPARMCD = TRADENAM
COVAL when RDOMAIN = MB
MBCAT=CONFIRMATION OF INFECTION
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C4591001: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES (SYMPRDATE)
Vaccination Symptoms Diary - Symptom Resolved Dates
1. Were medications to treat 
fever/pain given on the last day 
the Subject Diary was 
completed?[Fever/Pain Medication on Last 
Diary Day] 
YES
Ongoing?
YES
NO
Stop Date:
/ 
  / 
NO
# Symptom: Were fever or systemic symptoms present on the last day the Subject Diary was completed?
2.a FEVER
2.b FATIGUE2.c HEADACHE2.d CHILLS2.e VOMITING2.f DIARRHEA2.g NEW OR WORSENED MUSCLE PAIN2.h NEW OR WORSENED JOINT PAIN
2.1 Symptom:
[Symptom:] 
2.2 Were fever or system c 
symptoms present on the last 
day the Subject Diary was 
completed?
[Were fever or systemic 
symptoms present on the last 
day the Subject Diary was 
completed?] 
YES
Ongoing?
YES
NOStop Date:
/ 
  / 
NO
3. Injection Site Location:
[Injection S te Location:] 
DELTOID MUSCLE
4. Injection Site Body S de:
[Injection S te Body Side:] 
LEFT
RIGHT
# Injection Site Reaction: Were injection site reactions present on the last day the Subject Diary was completed?
5.a REDNESS
5.b SWELLING5.c PAIN AT INJECTION SITE
5.1 Injection Site React on:
[Injection Site Reaction:] 
REDNESS
SWELLING
PAIN AT INJECTION SITE
5.2 Were injection s te reactions 
present on the last day the 
Subject Diary was completed?
[Were inject on site reactions 
present on the last day the 
Subject Diary was completed?] 
YES
Ongoing?
YES
NOStop Date:
/ 
  / 
NOAnnotated Study Book - C4591001
CE=Clinical Events
STUDYID
AE=Adverse Events
FA=Findings About Events or Interventions
CECAT=REACTOGENICITY
FACAT=REACTOGENICITY
FAORRES
FAORRES when FATESTCD =STPDMEDP
FAENRTPT= ONGOING
CESCAT=SYSTEMIC
FASCAT=SYSTEMIC
AECAT=REACTOGENICITY
AESCAT=SYSTEMIC
CETERM
AETERM
FAOBJ
NOT SUBMITTED
CEENRTPT= 
ONGOING
AEENRTPT
= ONGOING
ONGNXVIS in 
SUPPCE 
CELOC
CELAT
CESCAT=ADMINISTRATION SITE
AESCAT=ADMINISTRATION SITE
FASCAT=ADMINISTRATION SITE
AELOC
AELAT
CETERM
AETERM
FAOBJ
NOT SUBMITTED
RCENDTC in SUPPCE
RCENDTC in SUPPCE
FAENTPT= ONGOING RELATIVE TO LAST DAY OF 
DIARY PERIOD
CEENTPT= ONGOING 
RELATIVE TO LAST 
DAY OF DIARY PERIOD 
AEENTPT= 
ONGOING 
RELATIVE TO LAST 
DAY OF DIARY 
PERIOD 
CEENRTPT= 
ONGOING
CEENTPT= ONGOING 
RELATIVE TO LAST 
DAY OF DIARY PERIOD 
AEENRTPT
= ONGOING
AEENTPT= 
ONGOING 
RELATIVE TO LAST 
DAY OF DIARY 
PERIOD 
ONGNXVIS in 
SUPPCE 
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C4591001: TRANSFUSIONS (TRANSFUSE) - Repeating Form
#T ransfusion Type Date of Transfusion
1
1. Transfus on Type:
[Transfus on Type] 
PACKED RBC
PLATELETS
WHOLE BLOOD
PLASM A
OTHER
Specify:
2. Date of Transfus on:
[Date of Transfusion] 
 / 
  / 
Annotated Study Book - C4591001
PRCAT=TRANSFUSION DETAILS
STUDYID
PR=Procedures
PRTRT
PRSTDTC
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C4591001: TREATMENT UNBLINDED (TRN UNBLN)
Treatment Unblinded
1. Date Treatment Unblinded :
[Date Treatment Unblinded :] 
/ 
 / 
2. Primary Reason for Unblinding:
[Primary Reason for Unblinding] 
SUBJECT SAFETY CONCER N
OTHER 
If other, s pecify:
ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATIO NAnnotated Study Book - C4591001
STUDYID
DS=Disposition
DSCAT=OTHER EVENT
DSSTDTC
DSTERM
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C4591001: UNPLANNED VISIT (UNPL)
Unplanned Assessments
1. Assessments
[Assessments] 
CONTACT OUTCOM EAnnotated Study Book - C4591001
NOT SUBMITTED
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C4591001: VACCINATION (VACIN TRT)
Vaccination
1. Was there a 
temporary 
delay of 
vaccinat on?[Temporary 
Delay of 
Vaccination] 
YES
Date of First Delay:
 / 
  / 
Reason (s) for Tem porary Delay of Vaccination
FEVER OR ACUTE ILLNESS
RECENT SYSTEMIC CORTICOSTEROID TREATMEN T
RECENT NO N-STUDY VACCINATION
ANTICIPATED NO N-STUDY VACCINATION
NO
2. Treatment 
Name
[Treatment 
Name] 
3. Formulat on:
[Formulat on:] 
INJECTION
4. Dose Date 
Time:[Dose Date 
Time:] 
 / 
 / 
 : 
 24-hour clock
5. Anatomical 
Locat on:[Anatomical 
Locat on:] 
DELTOID MUSCLE
6. Body Side:
[Body S de:] 
LEFT
RIGHT
7. Route:
[Route:] 
INTRAMUSCULAR
8. Planned Dose:
[Planned Dose] 
9. Planned Dose 
Unit:[Planned Dose 
Unit] 
ug
10. Actual Dose:
[Actual Dose:] 
11. Unit:
[Unit:] 
ug
12. Was the Actual 
Dose adjusted from planned?
[Dose Adjusted 
From Planned] 
YES
What was the reason the dose was adjusted?
ADVERSE EVENT (S)
INSUFFICIENT CLINICAL RESPONS E
OTHER SPECIF Y
If other, s pecify:
NO
13. Timeframe 
Subject Was 
Observed
[Timeframe 
Subject Was 
Observed] 
THE PROTOCOL SPECIFIED OBSERVATION PERIOD
14. Was the 
subject observed for at 
least the 
protocol 
specified 
observation 
period after 
investigational 
product administration?
[Observed Post 
Dose For 
Specified Time] 
YES
NO
If No, specify reason:
15. Comparison 
Term [hidden]
[Comparison 
Term] 
16. Standardized 
Med cation 
Name -Annotated Study Book - C4591001
EXADJ when more than one 
selected,  EXADJ=MULTIPLE 
and individual responses are 
EXADJ1, EXADJ2, etc. in 
SUPPEX
FDDTC in SUPPEX
EXCAT=INVESTIGATIONAL 
PRODUCT
STUDYID
EX=Exposure
EC=Exposure as Collected
EXSCAT=VACCINATION
ECCAT=INVESTIGATIONAL 
PRODUCT
ECSCAT=VACCINATION
EXTDV in SUPPEX
EXTRT
EXDOSFRM
EXLOC
ECTDV in SUPPEC
FDDTC in SUPPEC
ECADJ when more than one 
selected,  ECADJ=MULTIPLE 
and individual responses are 
ECADJ1, ECADJ2, etc. in 
SUPPEC
ECTRT
ECDOSFRM
EXSTDTC
ECSTDTC
EXENDTC
ECENDTC
ECLOC
EXLAT
ECLAT
EXROUTE
ECROUTE
EXDOSE
EXDOSU
ECOBSVT in SUPPEC
EXOBSVT in SUPPEX
ECDOSE
EXOBSV in SUPPEX
ECOBSV in SUPPEC
EXOBSVD in SUPPEX
ECOBSVD in SUPPEC
NOT SUBMITTED
ECDOSE
ECDOSU
ECDOSU
EXDOSADJ in SUPPEX
ECDOSADJ in SUPPEC
EXADJ when more than one 
selected,  EXADJ=MULTIPLE and 
individual responses are EXADJ1, 
EXADJ2, etc. in SUPPEX
ECADJ when more than one 
selected,  ECADJ=MULTIPLE and 
individual responses are ECADJ1, 
ECADJ2, etc. in SUPPEC
EXDOSAJO in SUPPEX
ECDOSAJO in SUPPEC
EXDECOD in SUPPEX
ECDECOD in SUPPEC
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D ctionary 
Derived. 
[hidden]
[Standardized 
Med cation 
Name] 
17. Standardized 
Med cation 
Code -
D ctionary 
Derived 
[hidden]
[Standardized 
Med cation 
Code] Annotated Study Book - C4591001
EXCD in SUPPEX
EX=Exposure
EC=Exposure as Collected
ECCD in SUPPEC
Page 107 of 131
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FDA-CBER-2021-5683-0058144
C4591001: VACCINATION (VACIN TRT)
Vaccination
1. Was there a 
temporary 
delay of 
vaccinat on?[Temporary 
Delay of 
Vaccination] 
YES
Date of First Delay:
 / 
  / 
Reason (s) for Tem porary Delay of Vaccination
FEVER OR ACUTE ILLNESS
RECENT SYSTEMIC CORTICOSTEROID TREATMEN T
RECENT NO N-STUDY VACCINATION
ANTICIPATED NO N-STUDY VACCINATION
NO
2. Treatment 
Name
[Treatment 
Name] 
3. Formulat on:
[Formulat on:] 
INJECTION
4. Dose Date 
Time:[Dose Date 
Time:] 
 / 
 / 
 : 
 24-hour clock
5. Anatomical 
Locat on:[Anatomical 
Locat on:] 
DELTOID MUSCLE
6. Body Side:
[Body S de:] 
LEFT
RIGHT
7. Route:
[Route:] 
INTRAMUSCULAR
8. Container 
Number: [hidden]
[PAC / K t 
Number:] 
9. Actual Dose:
[Actual Dose:] 
10. Unit:
[Unit:] 
mL
ug
11. Timeframe 
Subject Was 
Observed
[Timeframe 
Subject Was 
Observed] 
THE PROTOCOL SPECIFIED OBSERVATION PERIOD
 
12.
Was the 
subject observed for at 
least the 
protocol 
specified 
observation period after 
investigational 
product 
administration?
[Observed Post 
Dose For 
Specified Time] 
YES
NO
If No, s pecify reason:
13. Comparison 
Term [hidden]
[Comparison 
Term] 
14. Standardized 
Med cation 
Name -
D ctionary 
Derived. 
[hidden]
[Standardized 
Med cation 
Name] 
15. Standardized 
Med cation Code -
D ctionary 
Derived [hidden]Annotated Study Book - C4591001
EXCAT=INVESTIGATIONAL 
PRODUCT
ECDOSE
EXADJ when more than one 
selected,  EXADJ=MULTIPLE 
and individual responses are 
EXADJ1, EXADJ2, etc. in 
SUPPEX
STUDYID
EX=Exposure
EC=Exposure as Collected
EXSCAT=VACCINATION
ECCAT=INVESTIGATIONAL 
PRODUCT
ECSCAT=VACCINATION
EXTDV in SUPPEX
EXTRT
EXDOSFRM
EXLOC
ECTDV in SUPPEC
FDDTC in SUPPEX
FDDTC in SUPPEC
ECADJ when more than one 
selected,  ECADJ=MULTIPLE 
and individual responses are 
ECADJ1, ECADJ2, etc. in 
SUPPEC
ECTRT
ECDOSFRM
EXSTDTC
ECSTDTC
EXENDTC
ECENDTC
ECLOC
EXLAT
ECLAT
EXROUTE
ECROUTE
EXDOSE
ECDOSU
EXDOSU
ECOBSVT in SUPPEC
EXOBSVT in SUPPEX
EXOBSV in SUPPEX
ECOBSV in SUPPEC
EXOBSVD in SUPPEX
ECOBSVD in SUPPEC
NOT SUBMITTED
EXDECOD in SUPPEX
ECDECOD in SUPPEC
EXCD in SUPPEX
ECCD in SUPPEC
NOT SUBMITTED
Page 108 of 131
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FDA-CBER-2021-5683-0058145
[Standardized 
Med cation 
Code] Annotated Study Book - C4591001
EX=Exposure
EC=Exposure as Collected
Page 109 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058146
C4591001: CONCOMITANT MEDICATIONS - VASOPRESSORS (VASOPRESS) - Repeating Form
# Sponsor-Defined Identifier Category for Medication Concomitant Medications Pre-specified Name of Medication Start Date Ongoing
1
Concomitant Medications
1. What is the medication identifier?
[Sponsor-Defined Identifier] 
2. Category:
[Category for Med cat on] 
GENERAL CONCOMITANT MEDICATIONS
3. Concomitant Medications Pre-specified:
[Concomitant Medications Pre-specified] 
NO
4. Medication:
Provide the complete gener c drug name 
(including salt form, where applicable). Where 
generic name is unknown, enter the full trade 
or proprietary name. Include clarifying 
information in the Med cat on text (e.g., Ingredient(s), route, use, formulation).
[Name of Medication] 
5. Start Date:
[Start Date] 
 / 
 / 
6. Ongoing?
[Ongoing] 
YES
NO
End Date:
/ 
  / 
7. Comparison Term [hidden]
[Comparison Term] 
8. Standardized Medicat on Name - Dict onary 
derived. [hidden]
[Standardized Med cat on Name] 
9. Standardized Med cat on Code - Dictionary 
derived [hidden]
[Standardized Med cat on Code] Annotated Study Book - C4591001
CM=Concomitant Medications
CMSCAT=VASOPRESSORS 
AGENTS
STUDYID
CMSPID
CMTRT
CMSTDTC
CMENDTC
NOT SUBMITTED
NOT SUBMITTED
CMCAT
CMDECOD
CMCODE in SUPPCM 
CMENRTPT= ONGOING
CMENTPT= LAST SUBJECT ENCOUNTER
Page 110 of 131
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FDA-CBER-2021-5683-0058147
C4591001: VITAL SIGNS - TEMP (VITAL TEMP)
Vital Signs
1. Date:
[Date:] 
 / 
  / 
Vital Signs Details
# Record Identifier: Temperature Temperature Unit Temperature Location:
2.a 1
Vital Signs Details Entry2.1 Record Identifier:
[Record Identifier:] 
1
2.2 Temperature:
[Temperature] 
2.3 Unit:
[Temperature Unit] 
F
C
2.4 Temperature Location:
[Temperature Location:] 
ORAL CAVITY
EAR
RECTU M
AXILLA
FOREHEADAnnotated Study Book - C4591001
VSCAT=REACTOGENICITY - UNPLANNED TEMPERATURE
VSSCAT=SYSTEMIC
STUDYID
VS=Vital Signs
VSDTC
VSSPID
VSORRES when VSTESTCD =TEMP
VSORRESU when VSTESTCD = TEMP
VSLOC when VSTESTCD = TEMP
Page 111 of 131
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FDA-CBER-2021-5683-0058148
C4591001: VITAL SIGNS - BASELINE (VITALS BSL)
Vital Signs
1. Date:
[Date:] 
 / 
  / 
2. Weight:
[Weight] 
3. Un t:
[Weight Unit] 
kg
LB
4. Height:
[Height] 
5. Un t:
[Height Un t] 
cm
in
6. Body Mass Index:
[Body Mass Index] 
Vital Signs Details
# Record Identifier: Temperature Temperature Unit Temperature Location:
7.a 1
Vital Signs Details Entry7.1 Record Identifier:
[Record Identifier:] 
1
7.2 Temperature:
[Temperature] 
7.3 Unit:
[Temperature Unit] 
C
F
7.4 Temperature Location:
[Temperature Location:] 
ORAL CAVITY
EAR
RECTUM
AXILL A
FOREHEADAnnotated Study Book - C4591001
VSCAT=GENERAL VITAL SIGNS
STUDYID
VS=Vital Signs
VSORRES when VSTESTCD = WEIGHT
VSORRESU when VSTESTCD = WEIGHT
VSORRES when VSTESTCD = HEIGHT
VSORRESU when VSTESTCD = HEIGHT
VSORRES when VSTESTCD = BMI
VSSPID
VSORRES when VSTESTCD = TEMP
VSDTC
VSLOC when VSTESTCD = TEMP
VSORRESU when VSTESTCD = TEMP
Page 112 of 131
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FDA-CBER-2021-5683-0058149
C4591001: VITAL SIGNS - BASELINE (VITALS BSL)
Vital Signs
1. Date:
[Date:] 
 / 
  / 
2. Weight:
[Weight] 
3. Un t:
[Weight Unit] 
kg
LB
4. Height:
[Height] 
5. Un t:
[Height Un t] 
cm
in
6. Body Mass Index:
[Body Mass Index] 
Vital Signs Details
# Record Identifier: Temperature Temperature Unit Temperature Location: Systolic: Diastolic: BP Position Pulse:
7.a 1 SITTING
Vital Signs Details Entry7.1 Record Identifier:
[Record Identifier:] 
1
7.2 Temperature:
[Temperature] 
7.3 Unit:
[Temperature Unit] 
C
F
7.4 Temperature Location:
[Temperature Location:] 
ORAL CAVITY
EAR
RECTUM
AXILL A
FOREHEAD
7.5 Systol c:
[Systolic:] 
7.6 Diastol c:
[Diastol c:] 
7.7 BP Posit on:
[BP Position] 
SITTING
7.8 Pulse:
[Pulse:] Annotated Study Book - C4591001
VSCAT=GENERAL VITAL SIGNS
VSORRESU when VSTESTCD = WEIGHT
VSORRES when VSTESTCD = BMI
STUDYID
VS=Vital Signs
VSORRES when VSTESTCD = WEIGHT
VSORRES when VSTESTCD = HEIGHT
VSORRESU when VSTESTCD = HEIGHT
VSSPID
VSORRES when VSTESTCD = TEMP
VSDTC
VSORRES when VSTESTCD = SYSBP
VSLOC when VSTESTCD = TEMP
VSORRESU when VSTESTCD = TEMP
VSORRES when VSTESTCD = DIABP
VSPOS when VSTESTCD = DIABP, SYSBP
VSORRES when VSTESTCD = PULSE
Page 113 of 131
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FDA-CBER-2021-5683-0058150
C4591001: VITAL SIGNS - COVID (VITALS COV) - Repeating Form
#D ate: Vital Signs Details
1
Vital Signs
1. Date:
[Date:] 
 / 
  / 
Vital Signs Details
#
Record Identifier: Systolic: Diastolic: Respiratory Rate in respirations/minute Heart Rate in beats/minute
2.a 1
Vital Signs Details Entry2.1 Record Identifier:
[Record Identifier:] 
1
2.2 Systol c:
[Systolic:] 
2.3 Diastol c:
[Diastol c:] 
2.4 Respiratory Rate in 
respirations/minute:
[Respiratory Rate in 
respirations/minute] 
2.5 Heart Rate in beats/minute:
[Heart Rate in beats/minute] Annotated Study Book - C4591001
VSCAT=GENERAL VITAL SIGNS
STUDYID
VS=Vital Signs
VSSPID
VSDTC
VSORRES when VSTESTCD = DIABP
VSORRES when VSTESTCD = HR
VSORRES when VSTESTCD = RESP
VSORRES when VSTESTCD = SYSBP
Page 114 of 131
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FDA-CBER-2021-5683-0058151
C4591001: VITAL SIGNS (VITALS FUP)
Vital Signs
1. Date:
[Date:] 
 / 
  / 
Vital Signs Details
# Record Identifier: Temperature Temperature Unit Temperature Location: Systolic: Diastolic: BP Position Pulse:
2.a 1 SITTING
Vital Signs Details Entry2.1 Record Identifier:
[Record Identifier:] 
1
2.2 Temperature:
[Temperature] 
2.3 Unit:
[Temperature Unit] 
F
C
2.4 Temperature Location:
[Temperature Location:] 
ORAL CAVITY
EAR
RECTU M
AXILLA
FOREHEAD
2.5 Systol c:
[Systolic:] 
2.6 Diastol c:
[Diastol c:] 
2.7 BP Posit on:
[BP Position] 
SITTING
2.8 Pulse:
[Pulse:] Annotated Study Book - C4591001
VSCAT=GENERAL VITAL SIGNS
STUDYID
VS=Vital Signs
VSSPID
VSORRES when VSTESTCD = TEMP
VSDTC
VSLOC when VSTESTCD = TEMP
VSORRESU when VSTESTCD = TEMP
VSORRES when VSTESTCD = SYSBP
VSORRES when VSTESTCD = PULSE
VSORRES when VSTESTCD = DIABP
VSPOS when VSTESTCD = DIABP, SYSBP
Page 115 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058152
C4591001: WITHDRAWAL OF CONSENT (WOC)
Withdrawal Of Consent
1. Withdrawal of Consent Date :
[Withdrawal of Consent Date :] 
/ 
 / 
Annotated Study Book - C4591001
DSCAT=OTHER EVENT
DS=Disposition
STUDYID
DSSTDTC when DSTERM/DSDECOD=WITHDRAWAL 
OF CONSENT
Page 116 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058153
A-1426 -0086 /  App Subject Facing Screen Report 22-JUN-2020  
C4591001 -Post -12-July-2020  English (USA) enUS  Version 2 
3 Form: Vacci nation Diary  
Screen 1  
[Computed] Text will display “ Hello, welcome to 
the vaccination diary. You will be answering the 
following questions about how you have been 
feeling since your vaccination on {1}. You will 
answer these questions for {2} day(s) .” 
{1} Will display a date  
{2} Will display a number of days.  
Example: Hello, welcome to the vaccination 
diary. You will be answering the following 
questions about how you have been feeling 
since your vaccination on Mar -27-2020. You will 
answer these  questions for 7 day(s).  Message 1  
Screen 3  
VSCAT=REACTOGENICITY
STUDYID
VS=Vital Signs
VSORRES when VSTESTCD = TEMP
VSORRESU when VSTESTCD = TEMP
MAXIMUM in SUPPVS
VSSCAT=SYSTEMIC
Page 117 of 131
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FDA-CBER-2021-5683-0058154
A-1426 -0086 /  App Subject Facing Screen Report 22-JUN-2020  
C4591001 -Post -12-July-2020  English (USA) enUS  Version 2 
Message 1  Message 2  
Message 3  Screen 4  
VS=Vital Signs
VSORRES when VSTESTCD = TEMP
VSORRESU when VSTESTCD = TEMP
MAXIMUM in SUPPVS
Page 118 of 131
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FDA-CBER-2021-5683-0058155
A-1426 -0086 /  App Subject Facing Screen Report 22-JUN-2020  
C4591001 -Post -12-July-2020  English (USA) enUS  Version 2 
Message 3  Screen 5  
[Computed] will display the temperature 
selected on Screen 3 or Screen 4  
Message 1  
Screen 6  
FACAT=REACTOGENICITY
FA=Findings About Events or Interventions
STUDYID
FAORRES when FATESTCD = OCCUR  and FAOBJ = REDNESS
FASCAT = ADMINISTRATION SITE
Page 119 of 131
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FDA-CBER-2021-5683-0058156
A-1426 -0086 /  App Subject Facing Screen Report 22-JUN-2020  
C4591001 -Post -12-July-2020  English (USA) enUS  Version 2 
Message 2  
Screen 7  
Message 2  Screen 8  
[Computed] will display the number selected on 
Screen 7.  
FASCAT = ADMINISTRATION SITE
FAORRES when FATESTCD = DIAMETER and FAOBJ = REDNESS
FA=Findings About Events or Interventions
Page 120 of 131
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FDA-CBER-2021-5683-0058157
A-1426 -0086 /  App Subject Facing Screen Report 22-JUN-2020  
C4591001 -Post -12-July-2020  English (USA) enUS  Version 2 
Screen 9  
Screen 10  
Screen 11  
[Computed] will display the number selected on 
Screen 10.  
Screen 12  
FAORRES when FATESTCD = OCCUR and 
FAOBJ = SWELLING
FAORRES when FATESTCD = DIAMETER and 
FAOBJ = SWELLING
FA=Findings About Events or Interventions
FAORRES when FATESTCD = OCCUR and 
FAOBJ = PAIN AT INJECTION SITE
FASCAT = ADMINISTRATION SITE
FASCAT = ADMINISTRATION SITE
FASCAT = ADMINISTRATION SITE
Page 121 of 131
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FDA-CBER-2021-5683-0058158
A-1426 -0086 /  App Subject Facing Screen Report 22-JUN-2020  
C4591001 -Post -12-July-2020  English (USA) enUS  Version 2 
Screen 13  
Screen 14  
Message 2  Message 4  
FAORRES when FATESTCD = SEV  and 
FAOBJ = PAIN AT INJECTION SITE
FA=Findings About Events or Interventions
FASCAT = ADMINISTRATION SITE
Page 122 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058159
A-1426 -0086 /  App Subject Facing Screen Report 22-JUN-2020  
C4591001 -Post -12-July-2020  English (USA) enUS  Version 2 
Screen 15  Screen 16  
Screen 17  
Screen 18  
FAORRES when FATESTCD = OCCUR and 
FAOBJ = HOSPITALIZED FOR INJECTION SITE 
PAIN
FAORRES when FATESTCD = OCCUR and 
FAOBJ = FATIGUE
FAORRES when FATESTCD = SEV and 
FAOBJ = FATIGUE
FA=Findings About Events or Interventions
FASCAT = ADMINISTRATION SITE
FASCAT = SYSTEMIC
FASCAT = SYSTEMIC
Page 123 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058160
A-1426 -0086 /  App Subject Facing Screen Report 22-JUN-2020  
C4591001 -Post -12-July-2020  English (USA) enUS  Version 2 
Message 2  Screen 19  
Screen 20  
Screen 21  
FAORRES when FATESTCD = OCCUR and 
FAOBJ = HOSPITALIZED FOR TIREDNESS 
(FATIGUE)
FASCAT = SYSTEMIC
FAORRES when FATESTCD = OCCUR and 
FAOBJ = HEADACHE
FA=Findings About Events or Interventions
FASCAT = SYSTEMIC
Page 124 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058161
A-1426 -0086 /  App Subject Facing Screen Report 22-JUN-2020  
C4591001 -Post -12-July-2020  English (USA) enUS  Version 2 
Screen 22  Screen 23  
Screen 24  Screen 25  
FAORRES when FATESTCD = OCCUR and 
FAOBJ = HOSPITALIZED FOR HEADACHE
FAORRES when FATESTCD = SEV and 
FAOBJ = HEADACHE
FAORRES when FATESTCD = OCCUR and 
FAOBJ = VOMITING
FA=Findings About Events or Interventions
FASCAT = SYSTEMIC
FASCAT = SYSTEMIC
FASCAT = SYSTEMIC
Page 125 of 131
090177e196f3882d\Final\Final On: 04-May-2021 20:47 (GMT)
FDA-CBER-2021-5683-0058162
A-1426 -0086 /  App Subject Facing Screen Report 22-JUN-2020  
C4591001 -Post -12-July-2020  English (USA) enUS  Version 2 
Screen 26  Message 2  
Screen 27  Screen 28  
FAORRES when FATESTCD = SEV and 
FAOBJ = VOMITING
FAORRES when FATESTCD = OCCUR and 
FAOBJ = HOSPITALIZED FOR VOMITING
FA=Findings About Events or Interventions
FASCAT = SYSTEMIC
FASCAT = SYSTEMIC
FASCAT = SYSTEMIC
FAORRES when FATESTCD = OCCUR and 
FAOBJ = DIARRHEA
Page 126 of 131
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FDA-CBER-2021-5683-0058163
A-1426 -0086 /  App Subject Facing Screen Report 22-JUN-2020  
C4591001 -Post -12-July-2020  English (USA) enUS  Version 2 
Screen 29  Screen 30  
Message 2  Screen 31  
FASCAT = SYSTEMIC
FAORRES when FATESTCD = SEV and 
FAOBJ = DIARRHEA
FAORRES when FATESTCD = OCCUR and 
FAOBJ = HOSPITALIZED FOR DIARRHEA
FA=Findings About Events or Interventions
FASCAT = SYSTEMIC
Page 127 of 131
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FDA-CBER-2021-5683-0058164
A-1426 -0086 /  App Subject Facing Screen Report 22-JUN-2020  
C4591001 -Post -12-July-2020  English (USA) enUS  Version 2 
Screen 32  
Screen 33  
Screen 34  Screen 35  
FAORRES when FATESTCD = OCCUR and 
FAOBJ = CHILLS
FAORRES when FATESTCD = SEV and 
FAOBJ = CHILLS
FA=Findings About Events or Interventions
FASCAT = SYSTEMIC
FASCAT = SYSTEMIC
FASCAT = SYSTEMIC
FAORRES when FATESTCD = OCCUR and 
FAOBJ = HOSPITALIZED FOR CHILLS
Page 128 of 131
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FDA-CBER-2021-5683-0058165
A-1426 -0086 /  App Subject Facing Screen Report 22-JUN-2020  
C4591001 -Post -12-July-2020  English (USA) enUS  Version 2 
Screen 36  Screen 37  
Screen 38  Screen 39  
FAORRES when FATESTCD = OCCUR and 
FAOBJ = MUSCLE PAIN
FAORRES when FATESTCD = OCCUR and 
FAOBJ = HOSPITALIZED FOR MUSCLE PAIN
FAORRES when FATESTCD = SEV and 
FAOBJ = MUSCLE PAIN
FA=Findings About Events or Interventions
FASCAT = SYSTEMIC
FASCAT = SYSTEMIC
FASCAT = SYSTEMIC
Page 129 of 131
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FDA-CBER-2021-5683-0058166
A-1426 -0086 /  App Subject Facing Screen Report 22-JUN-2020  
C4591001 -Post -12-July-2020  English (USA) enUS  Version 2 
Screen 40  Screen 41  
Screen 42  Screen 43  
FAORRES when FATESTCD = OCCUR and 
FAOBJ = JOINT PAIN
FA=Findings About Events or Interventions
FASCAT = SYSTEMIC
FASCAT = SYSTEMIC
FAORRES when FATESTCD = SEV and 
FAOBJ = JOINT PAIN
FAORRES when FATESTCD = OCCUR and 
FAOBJ = HOSPITALIZED FOR JOINT PAIN
FASCAT = SYSTEMIC
Page 130 of 131
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FDA-CBER-2021-5683-0058167
A-1426 -0086 /  App Subject Facing Screen Report 22-JUN-2020  
C4591001 -Post -12-July-2020  English (USA) enUS  Version 2 
Screen 44  Message 2  
Screen 45  
[Computed] will display “Please continue to fill 
out your diary for the next {1} day(s).”  
Where {1} = a number of days  
Example: Please continue to fill out your diary 
for the next 4 day(s).  Scre en 46  
[Computed] will display “Please continue to fill 
out your diary for the next {1} day(s).”  
Where {1} = a number of days  
Example: Please continue to fill out your diary 
for the next 4 day(s).  
FAORRES when FATESTCD = MEDTFVPN and 
FAOBJ = MEDICATIONS
FA=Findings About Events or Interventions
FASCAT = MEDICATIONS GIVEN
Page 131 of 131
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FDA-CBER-2021-5683-0058168