Document text
16.2.7.1 Adverse Events Legend Page
Category Abbreviation Text
Action - Stud y Vaccine Dose NA Not applicable
P Investi gational product withdrawn
Action - Sub ject TC Concomitant dru g treatment given
TCN Concomitant non-dru g treatment given
Cause of AE CD Concomitant dru g treatmen t
CND Concomitant non-dru g treatmen t
O Othe r
Outcome N Not recovered/not resolve d
R Recovered/resolve d
RS Recovered/resolved with sequelae
RG Recoverin g/resolvin g
Toxicit y Grade 1 Mild
2 Moderate
3 Severe
4 Life-threatenin g
System Or gan Class BLOOD Blood and l ymphatic s ystem disorders
CARD Cardiac disorders
CONG Congenital, familial and genetic disorders
EAR Ear and lab yrinth disorders
ENDO Endocrine disorders
EYE Eye disorders
GASTR Gastrointestinal disorders
GENRL General disorders and administration site conditions
HEPAT Hepatobiliar y disorders
IMMUN Immune s ystem disorders
INFEC Infections and infestations
INJ&P Injury poisonin g and procedural complications
INV Investi gations
METAB Metabolism and nutrition disorders
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Page 1
FDA-CBER-2022-5812-0224087
16.2.7.1 Adverse Events Legend Page
Category Abbreviation Text
MUSC Musculoskeletal and connective tissue disorders
NEOPL Neoplasms beni gn, mali gnant and unspecified (incl c ysts and pol yps)
NERV Nervous s ystem disorders
PREG Pregnanc y, puerperium and perinatal conditions
PSYCH Psychiatric disorders
RENAL Renal and urinar y disorders
REPRO Reproductive s ystem and breast disorders
RESP Respirator y, thoracic and mediastinal disorders
SKIN Skin and subcutaneous tissue disorders
SOCCI Social circumstances
SURG Surgical and medical procedures
VASC Vascular disorders
PFIZER CONFIDENTIAL SDTM Creation: 05OCT2021 (17:29) Source Dat a: adae Table Generation: 08NOV2021 (19:56)
(Data Cutoff Date: 02SEP2021, Database Snapshot Date: 27SEP2021 ) Output File: ./nda2 unblinded/C4591001 SPeds/ae legend
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FDA-CBER-2022-5812-0224088
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1005
10051317/
BNT162b2 (30
μg) 12/F/
WHITE GENRL Chills/
CHILLS 1 21OCT2020 2/2 2 Yes NA/TC R
(22OCT2020)N/N
C4591001
1005
10051328/
BNT162b2 (30
μg) 14/F/
WHITE GASTR Nausea/
NAUSEA 2 12NOV2020 2/2 2 Yes NA R
(13NOV2020)N/N
C4591001
1005
10051339/
Placebo 14/F/
WHITE PSYCH Anxiety/
anxiety 2 21APR2021 162/C 1 No O NA/TC N N/N
MUSC Myalgia/
generalized
myalgia#3 19MAY2021 3/5 1 Yes NA R
(23MAY2021)N/N
C4591001
1005
10051417/
Placebo 13/F/
WHITE GENRL Pyrexia/
fever# 4 13AUG2021 1/2 2 Yes NA R
(14AUG2021)N/N
C4591001
1005
10051420/
BNT162b2 (30
μg) 12/F/
WHITE PSYCH Anxiety/
Anxiety 2 03MAY2021 120/C 1 No O NA/TC N N/N
Depression/
Depression2 03MAY2021 120/C 1 No O NA/TC N N/N
C4591001
1005
10051424/ 13/M/
WHITE GASTR Nausea/
NAUSEA 2 08JAN2021 1/4 1 Yes NA/TC R
(11JAN2021)N/N
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FDA-CBER-2022-5812-0224089
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
BNT162b2 (30
μg)
GENRL Fatigue/
FATIGUE2 08JAN2021 1/4 2 Yes NA R
(11JAN2021)N/N
Injection site pain/
INJECTION SITE
PAIN2 08JAN2021 1/4 2 Yes NA R
(11JAN2021)N/N
MUSC Myalgia/
GENERALIZED
MYALGIA2 08JAN2021 1/4 2 Yes NA R
(11JAN2021)N/N
NERV Headache/
HEADACHE2 08JAN2021 1/4 2 Yes NA/TC R
(11JAN2021)N/N
C4591001
1005
10051427/
Placebo 14/F/
WHITE GENRL Chills/
chills# 4 07JUN2021 1/3 2 Yes NA R
(09JUN2021)N/N
MUSC Myalgia/
generalized
myalgia#4 07JUN2021 1/3 2 Yes NA R
(09JUN2021)N/N
C4591001
1005
10051437/
Placebo 15/F/
WHITE GENRL Fatigue/
Fatigue# 4 17JUN2021 1/10 2 Yes NA R
(26JUN2021)N/N
MUSC Myalgia/
Generalized
myalgia#4 17JUN2021 1/10 2 Yes NA R
(26JUN2021)N/N
C4591001
1005
10051449/
BNT162b2 (30
μg) 14/M/
WHITE INFEC Appendicitis/
Appendicitis# 2 28JUN2021 148/2 2 No O NA/TCN R
(29JUN2021)Y/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1005
10051450/
Placebo 14/M/
ASIAN INJ&P Hand fracture/
Broken left thumb#3 10JUN2021 18/37 2 No O NA R
(16JUL2021)N/N
C4591001
1006
10061183/
Placebo 14/M/
MULTIPLE INJ&P Hand fracture/
Broken thumb- left2 12MAY2021 126/36 2 No O NA R
(16JUN2021)N/N
GENRL Injection site pain/
Injection Site
Tenderness#3 20MAY2021 1/3 1 Yes NA R
(22MAY2021)N/N
C4591001
1006
10061196/
Placebo 12/M/
WHITE GENRL Injection site pain/
Injection site
tenderness# 3 19MAY2021 1/8 1 Yes NA R
(26MAY2021)N/N
C4591001
1006
10061203/
BNT162b2 (30
μg) 13/F/
WHITE GASTR Nausea/
Nausea 1 04DEC2020 2/1 1 Yes NA R
(04DEC2020)N/N
GENRL Fatigue/
Fatigue1 04DEC2020 2/1 1 Yes NA R
(04DEC2020)N/N
Injection site pain/
Injection site pain1 04DEC2020 2/5 1 Yes NA R
(08DEC2020)N/N
NERV Headache/
Headache1 04DEC2020 2/2 1 Yes NA R
(05DEC2020)N/N
GENRL Fatigue/
Fatigue2 22DEC2020 1/3 1 Yes NA R
(24DEC2020)N/N
Injection site pain/
Injection Site Pain2 22DEC2020 1/3 2 Yes NA R
(24DEC2020)N/N
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Page 5
FDA-CBER-2022-5812-0224091
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
NERV Headache/
Headache2 22DEC2020 1/3 2 Yes NA/TC R
(24DEC2020)N/N
C4591001
1006
10061209/
BNT162b2 (30
μg) 13/M/
WHITE NERV Syncope/
Syncope Vasovagal
response 2 12MAR2021 80/1 1 No O NA/TCN R
(12MAR2021)N/N
C4591001
1006
10061223/
Placebo 15/M/
WHITE GENRL Injection site pain/
Injection Site Pain#3 18MAY2021 2/4 1 Yes NA/TC R
(21MAY2021)N/N
C4591001
1006
10061226/
Placebo 15/F/
WHITE PSYCH Attention deficit
hyperactivity
disorder/
Attention Deficit
Hyperactivity
Disorde r2 24MAR2021 87/C 2 No O NA/TC N N/N
C4591001
1006
10061228/
Placebo 12/F/
WHITE PSYCH Attention deficit
hyperactivity
disorder/
Attention Deficit
Hyperactivity
Disorde r2 24MAR2021 86/C 2 No O NA/TC N N/N
C4591001
1006
10061245/
Placebo 15/M/
WHITE SKIN Urticaria/
Hives face 1 12DEC2020 3/20 1 Yes NA/TC R
(31DEC2020)N/N
Urticaria/
Hives trun k1 12DEC2020 3/4 1 Yes NA/TC R
(15DEC2020)N/N
C4591001
1006 14/M/
WHITE INJ&P Facial bones
fracture/3 02JUN2021 17/5 1 No O NA/TC R
(06JUN2021)N/N
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FDA-CBER-2022-5812-0224092
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
10061253/
Placebo Fractured Nasal
Septum#
C4591001
1006
10061258/
BNT162b2 (30
μg) 14/M/
NATIVE
HAWAIIAN
OR OTHER
PACIFIC
ISLANDER GASTR Aphthous ulcer/
ORAL CANKERS#2 27JUN2021 174/9 2 No O NA/TC R
(05JUL2021)N/N
C4591001
1006
10061266/
Placebo 15/F/
MULTIPLE GENRL Chills/
CHILLS# 3 24FEB2021 1/3 2 Yes NA/TC R
(26FEB2021)N/N
C4591001
1006
10061272/
BNT162b2 (30
μg) 13/F/
BLACK OR
AFRICAN
AMERICAN PSYCH Anxiety/
Worsening of
anxiety 1 23DEC2020 8/27 3 No O NA/TC/TCN R
(18JAN2021)Y/N
Depression/
Worsening of
Depression1 23DEC2020 8/27 3 No O NA/TC/TCN R
(18JAN2021)Y/N
INJ&P Contusion/
Contusion left elbow1 05FEB2021 52/29 1 No O NA R
(05MAR2021)N/N
Fall/
Fall1 05FEB2021 52/1 1 No O NA R
(05FEB2021)N/N
GENRL Injection site pain/
Injection site
soreness#2 17MAY2021 1/4 1 Yes NA R
(20MAY2021)N/N
C4591001
1006
10061274/ 14/F/
WHITE NERV Migraine/
MIGRAINE
HEADACHES2 APR2021 84/C 2 No O NA/TC N N/N
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FDA-CBER-2022-5812-0224093
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
BNT162b2 (30
μg)
C4591001
1006
10061279/
Placebo 13/F/
WHITE PSYCH Anxiety/
Worsening of
Anxiety 2 MAR2021 56/C 2 No O NA/TC N N/N
INJ&P Ligament sprain/
Left Sprained Ankle2 26MAR2021 81/C 1 No O NA/TC/TCN N N/N
NEOPL Skin papilloma/
Left Foot Plantar
Wart#4 09JUN2021 3/9 2 No O NA/TCN R
(17JUN2021)N/N
C4591001
1006
10061285/
Placebo 14/F/
WHITE RENAL Dysuria/
dysuria 2 31MAY2021 140/51 1 No O NA R
(20JUL2021)N/N
GENRL Injection site pain/
Injection site pain#3 04JUN2021 2/2 2 Yes NA R
(05JUN2021)N/N
C4591001
1006
10061286/
BNT162b2 (30
μg) 14/M/
WHITE GENRL Fatigue/
FATIGUE 2 16JAN2021 6/4 2 Yes NA R
(19JAN2021)N/N
INJ&P Bone contusion/
CONTUSION
RIGHT
CALCANEUS2 08MAR2021 57/C 2 No O NA/TCN N N/N
C4591001
1006
10061290/
BNT162b2 (30
μg) 15/F/
WHITE INJ&P Concussion/
Concussion 1 12JAN2021 22/32 2 No O NA/TC R
(12FEB2021)N/N
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Page 8
FDA-CBER-2022-5812-0224094
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1006
10061292/
Placebo 15/F/
WHITE EAR Cerumen impaction/
Earwax Impaction
Left Ear 2 24JAN2021 13/5 2 No O NA/TCN R
(28JAN2021)N/N
INJ&P Procedural pain/
Post Surgical pain
Spinal hardware
removal2 30MAR2021 78/6 3 No O NA/TC R
(04APR2021)N/N
C4591001
1007
10071409/
BNT162b2 (30
μg) 13/M/
ASIAN GENRL Fatigue/
fatigue# 2 28MAY2021 2/3 2 Yes NA R
(30MAY2021)N/N
Injection site pain/
pain at injection
site#2 28MAY2021 2/4 1 Yes NA R
(31MAY2021)N/N
Pyrexia/
fever#2 28MAY2021 2/3 3 Yes NA/TC R
(30MAY2021)N/N
NERV Headache/
headache#2 28MAY2021 2/3 1 Yes NA R
(30MAY2021)N/N
C4591001
1007
10071414/
Placebo 14/M/
WHITE GENRL Chills/
chills# 3 20MAY2021 2/3 2 Yes NA R
(22MAY2021)N/N
Fatigue/
Fatigue#3 20MAY2021 2/3 3 Yes NA R
(22MAY2021)N/N
C4591001
1007
10071476/
BNT162b2 (30
μg) 13/F/
WHITE NERV Syncope/
Vasovagal syncope
without collapse* 30NOV2020 1/1 1 No O NA/TC/TCN R
(30NOV2020)N/N
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FDA-CBER-2022-5812-0224095
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
NERV Dizziness/
lightheadness after
vaccination2 21DEC2020 1/1 1 No O NA R
(21DEC2020)N/Y
C4591001
1007
10071480/
Placebo 14/M/
WHITE GENRL Injection site pain/
Injection site pain#3 17MAY2021 1/8 1 Yes NA R
(24MAY2021)N/N
GENRL Injection site pain/
Injection site pain#4 08JUN2021 1/3 1 Yes NA R
(10JUN2021)N/N
GENRL Pyrexia/
fever#4 09JUN2021 2/2 2 Yes NA/TC R
(10JUN2021)N/N
NERV Headache/
headache#4 09JUN2021 2/2 2 Yes NA/TC R
(10JUN2021)N/N
MUSC Neck pain/
neck pain#4 11JUN2021 4/C 2 No O NA N N/N
INFEC Herpes zoster/
shingles#4 18JUN2021 11/13 2 No O NA R
(30JUN2021)N/N
MUSC Pain in extremity/
Deltoid of left arm
pain#4 20JUN2021 13/4 2 No O NA R
(23JUN2021)N/N
C4591001
1007
10071483/
Placebo 15/F/
WHITE GENRL Injection site pain/
Injection site pain#3 30MAR2021 1/5 1 Yes NA R
(03APR2021)N/N
C4591001
1007
10071484/
Placebo 13/F/
WHITE GENRL Fatigue/
fatigue# 3 20MAY2021 2/34 1 Yes NA R
(22JUN2021)N/N
Injection site pain/
injection site pain#3 20MAY2021 2/1 1 Yes NA R
(20MAY2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 10
FDA-CBER-2022-5812-0224096
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Pyrexia/
subjective fever#3 20MAY2021 2/3 1 Yes NA R
(22MAY2021)N/N
MUSC Myalgia/
generalized muscle
aches#3 20MAY2021 2/3 1 Yes NA R
(22MAY2021)N/N
C4591001
1007
10071497/
BNT162b2 (30
μg) 12/M/
ASIAN BLOOD Lymphadenopathy/
swollen lymph node
left axilla 2 25DEC2020 4/27 1 Yes NA R
(20JAN2021)N/N
C4591001
1007
10071499/
Placebo 14/M/
WHITE MUSC Arthralgia/
left wrist pain+ 2 01MAY2021 131/3 1 No O NA/TC/TCN R
(03MAY2021)N/N
C4591001
1007
10071500/
BNT162b2 (30
μg) 15/F/
WHITE PSYCH Sleep terror/
Night Terror 2 23DEC2020 2/1 1 No O NA R
(23DEC2020)N/N
C4591001
1007
10071505/
Placebo 12/F/
WHITE GENRL Fatigue/
Fatigue# 3 03JUN2021 2/2 1 Yes NA R
(04JUN2021)N/N
MUSC Pain in extremity/
Right Arm Pain#3 03JUN2021 2/4 1 Yes NA R
(06JUN2021)N/N
GENRL Injection site pain/
injection site pain#4 23JUN2021 1/3 1 Yes NA R
(25JUN2021)N/N
GASTR Nausea/
nausea#4 24JUN2021 2/2 1 Yes NA R
(25JUN2021)N/N
GENRL Pyrexia/
fever 101#4 24JUN2021 2/2 2 Yes NA/TC R
(25JUN2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 11
FDA-CBER-2022-5812-0224097
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
NERV Dizziness/
lightheadedness#4 24JUN2021 2/2 1 Yes NA/TCN R
(25JUN2021)N/N
Headache/
headache#4 24JUN2021 2/2 2 Yes NA/TC R
(25JUN2021)N/N
NERV Somnolence/
Excessive
Sleepiness#4 08JUL2021 16/15 3 No O NA R
(22JUL2021)Y/N
C4591001
1007
10071509/
Placebo 15/F/
WHITE MUSC Pain in extremity/
Right Arm Pain# 3 21MAY2021 2/3 1 Yes NA/TC R
(23MAY2021)N/N
C4591001
1007
10071511/
Placebo 15/M/
WHITE NERV Headache/
Headache# 3 18MAY2021 1/2 1 Yes NA R
(19MAY2021)N/N
MUSC Pain in extremity/
Left arm pain#3 19MAY2021 2/2 1 Yes NA R
(20MAY2021)N/N
C4591001
1007
10071516/
Placebo 15/M/
WHITE GENRL Chills/
Chills# 3 19MAY2021 2/2 1 Yes NA R
(20MAY2021)N/N
Pyrexia/
Fever#3 19MAY2021 2/2 1 Yes NA R
(20MAY2021)N/N
C4591001
1007
10071519/
Placebo 15/M/
WHITE GENRL Injection site pain/
Pain at injection
site# 3 31MAR2021 1/2 2 Yes NA R
(01APR2021)N/N
C4591001
1007
10071524/
Placebo 15/M/
WHITE INFEC Candida infection/
thrush 2 01FEB2021 35/2 2 No CD NA R
(02FEB2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 12
FDA-CBER-2022-5812-0224098
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1007
10071531/
Placebo 14/F/
WHITE NERV Headache/
Headache# 3 26MAY2021 2/1 2 Yes NA/TC R
(26MAY2021)N/N
GENRL Injection site pain/
injection site pain#3 22JUN2021 29/3 1 Yes NA R
(24JUN2021)N/N
MUSC Myalgia/
muscle aches to
legs#4 22JUN2021 1/3 1 Yes NA R
(24JUN2021)N/N
C4591001
1007
10071533/
Placebo 14/M/
WHITE MUSC Myalgia/
abdominal muscle
pain 2 06JAN2021 8/2 1 No O NA/TC R
(07JAN2021)N/N
C4591001
1007
10071547/
Placebo 14/M/
WHITE GENRL Injection site pain/
Injection site pain#3 20MAY2021 1/3 1 Yes NA R
(22MAY2021)N/N
GENRL Injection site
erythema/
Injection site
redness#3 21MAY2021 2/4 1 Yes NA R
(24MAY2021)N/N
C4591001
1007
10071559/
Placebo 14/F/
WHITE GENRL Fatigue/
fatigue# 3 28MAY2021 2/3 2 Yes NA R
(30MAY2021)N/N
NERV Dizziness/
dizziness#3 28MAY2021 2/3 1 Yes NA R
(30MAY2021)N/N
Headache/
headache#3 28MAY2021 2/3 2 Yes NA R
(30MAY2021)N/N
NERV Headache/
headache#3 05JUN2021 10/1 2 No O NA/TC R
(05JUN2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 13
FDA-CBER-2022-5812-0224099
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GENRL Chills/
chills#4 17JUN2021 1/2 1 Yes NA/TC R
(18JUN2021)N/N
Injection site pain/
injection site pain#4 17JUN2021 1/3 1 Yes NA R
(19JUN2021)N/N
Pyrexia/
fever 101.9#4 17JUN2021 1/2 2 Yes NA/TC R
(18JUN2021)N/N
MUSC Myalgia/
generalized muscle
pain#4 17JUN2021 1/2 2 Yes NA/TC R
(18JUN2021)N/N
NERV Headache/
headache#4 17JUN2021 1/2 1 Yes NA R
(18JUN2021)N/N
C4591001
1007
10071562/
Placebo 12/F/
WHITE GENRL Fatigue/
fatigue# 3 18MAY2021 2/1 1 Yes NA R
(18MAY2021)N/N
INV Body temperature
increased/
elevated bod y temp#3 18MAY2021 2/1 2 Yes NA/TC R
(18MAY2021)N/N
MUSC Myalgia/
generalized muscle
aches#3 18MAY2021 2/1 1 Yes NA R
(18MAY2021)N/N
INV Body temperature
increased/
elevated body temp
100.0#4 07JUN2021 1/2 2 Yes NA/TC R
(08JUN2021)N/N
GENRL Fatigue/
fatigue#4 08JUN2021 2/1 2 Yes NA R
(08JUN2021)N/N
MUSC Myalgia/
generalized muscle
aches#4 08JUN2021 2/1 1 Yes NA R
(08JUN2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 14
FDA-CBER-2022-5812-0224100
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1007
10071563/
Placebo 12/M/
WHITE NERV Dizziness/
lightheadness 1 14DEC2020 1/1 1 Yes NA/TCN R
(14DEC2020)N/Y
C4591001
1007
10071568/
Placebo 14/M/
WHITE GENRL Injection site pain/
injection site
soreness 1 15DEC2020 1/1 1 Yes NA R
(15DEC2020)N/Y
SKIN Rash maculo-
papular/
maculopapular rash2 05JAN2021 1/29 1 Yes NA R
(02FEB2021)N/Y
C4591001
1007
10071575/
BNT162b2 (30
μg) 15/M/
WHITE INJ&P Contusion/
Contusion of Left
Arm 1 03JAN2021 19/11 2 No O NA/TC R
(13JAN2021)N/N
C4591001
1007
10071581/
Placebo 15/M/
WHITE INFEC Appendicitis/
Appendicitis 2 10MAR2021 63/20 3 No O NA/TC R
(29MAR2021)Y/N
GENRL Fatigue/
fatigue#4 15JUN2021 2/2 2 Yes NA R
(16JUN2021)N/N
Injection site pain/
injection site pain#4 15JUN2021 2/2 1 Yes NA R
(16JUN2021)N/N
MUSC Myalgia/
generalized muscle
aches#4 15JUN2021 2/2 2 Yes NA/TC R
(16JUN2021)N/N
C4591001
1007
10071583/
Placebo 15/M/
WHITE GENRL Injection site pain/
injection site pain#4 09JUN2021 1/3 2 Yes NA R
(11JUN2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 15
FDA-CBER-2022-5812-0224101
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
NERV Headache/
headache#4 10JUN2021 2/1 1 Yes NA R
(10JUN2021)N/N
C4591001
1007
10071584/
BNT162b2 (30
μg) 15/M/
WHITE GENRL Injection site pain/
Soreness at injection
site 2 07JAN2021 1/4 1 Yes NA R
(10JAN2021)N/Y
C4591001
1007
10071585/
Placebo 12/M/
WHITE SKIN Urticaria/
hives; trunk,
abdomen, back 2 16JAN2021 10/18 2 Yes NA/TC R
(02FEB2021)N/N
C4591001
1007
10071586/
Placebo 13/M/
WHITE GENRL Injection site pain/
Injection site pain#3 02JUN2021 2/3 1 Yes NA R
(04JUN2021)N/N
C4591001
1007
10071593/
Placebo 15/M/
WHITE INJ&P Ligament sprain/
left Ankle sprain 1 30DEC2020 3/17 2 No O NA/TCN R
(15JAN2021)N/N
C4591001
1007
10071595/
Placebo 13/F/
WHITE NERV Presyncope/
Vaso-vagal response2 30MAR2021 71/1 1 No O NA/TCN R
(30MAR2021)N/N
C4591001
1007
10071596/
Placebo 13/M/
WHITE GENRL Fatigue/
fatigue# 3 24MAY2021 1/5 2 Yes NA R
(28MAY2021)N/N
NERV Headache/
headache#3 24MAY2021 1/5 2 Yes NA R
(28MAY2021)N/N
GENRL Pyrexia/
fever#3 25MAY2021 2/4 1 Yes NA R
(28MAY2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 16
FDA-CBER-2022-5812-0224102
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
MUSC Myalgia/
muscle aches#3 25MAY2021 2/4 2 Yes NA R
(28MAY2021)N/N
C4591001
1007
10071600/
Placebo 12/F/
WHITE PSYCH Depression/
depression# 2 17MAY2021 119/C 2 No O NA/TC RG Y/N
Suicidal ideation/
Suicidal Ideation#2 17MAY2021 119/5 3 No O NA/TC/TCN R
(21MAY2021)Y/N
C4591001
1007
10071613/
Placebo 13/M/
WHITE GENRL Injection site pain/
Pain at injection site1 29DEC2020 1/1 1 Yes NA R
(29DEC2020)N/N
C4591001
1007
10071614/
Placebo 14/M/
WHITE GENRL Injection site pain/
injection site
soreness# 4 28JUN2021 1/4 1 Yes NA R
(01JUL2021)N/N
GENRL Chills/
chills#4 29JUN2021 2/1 1 Yes NA R
(29JUN2021)N/N
Fatigue/
fatigue#4 29JUN2021 2/3 1 Yes NA R
(01JUL2021)N/N
Pyrexia/
fever 101.9#4 29JUN2021 2/3 2 Yes NA R
(01JUL2021)N/N
NERV Headache/
headache#4 29JUN2021 2/1 1 Yes NA R
(29JUN2021)N/N
C4591001
1007
10071615/
BNT162b2 (30
μg) 12/M/
WHITE BLOOD Lymphadenopathy/
left axillary lymph
node swelling 2 20JAN2021 2/4 1 Yes NA R
(23JAN2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 17
FDA-CBER-2022-5812-0224103
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1007
10071617/
Placebo 15/F/
WHITE PSYCH Anxiety/
worsening of
Anxiety 2 15FEB2021 27/C 2 No O NA/TC N N/N
Obsessive-
compulsive disorder/
worsening of
Obsessive
Compulsive
Disorde r2 15FEB2021 27/C 2 No O NA/TC N N/N
C4591001
1007
10071618/
Placebo 13/M/
WHITE GENRL Injection site pain/
Pain at injection
nsite 1 29DEC2020 1/2 1 Yes NA R
(30DEC2020)N/Y
C4591001
1007
10071620/
BNT162b2 (30
μg) 12/F/
WHITE GASTR Abdominal pain/
Abdominal pain 2 21JAN2021 2/20 2 Yes NA/TC R
(09FEB2021)N/N
PSYCH Conversion disorder/
generalized
Functional
neurolo gic disorde r2 21JAN2021 2/C 2 No O NA/TC N Y/N
INFEC Vulval abscess/
Vulvar boil2 24JAN2021 5/3 1 No O NA/TC R
(26JAN2021)N/N
GASTR Gastritis/
Gastritis2 30JAN2021 11/ 2 No CD NA/TC R N/N
PSYCH Anxiety/
worsenin g anxiet y2 30JAN2021 11/C 2 No O NA/TC/TCN N N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 18
FDA-CBER-2022-5812-0224104
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
SKIN Dermatitis contact/
contact dermatitis
bilateral arms2 12FEB2021 24/ 1 No O NA/TC R N/N
GASTR Abdominal pain/
Functional
Abdominal Pain2 28FEB2021 40/C 3 No O NA/TC N Y/N
Constipation/
Constipation2 28FEB2021 40/14 3 No O NA/TC R
(13MAR2021)Y/N
GASTR Constipation/
constipation2 13MAR2021 53/C 2 No O NA/TC RG N/N
C4591001
1007
10071623/
Placebo 13/M/
WHITE GASTR Toothache/
teeth pain 2 27JAN2021 7/2 2 No CND NA/TC R
(28JAN2021)N/N
MUSC Tendonitis/
right wrist tendonitis2 15FEB2021 26/176 2 No O NA/TC RS
(09AUG2021)N/N
GENRL Fatigue/
Fatigue#3 01JUN2021 1/2 1 Yes NA R
(02JUN2021)N/N
Injection site pain/
Injection site pain#3 01JUN2021 1/3 1 Yes NA R
(03JUN2021)N/N
C4591001
1007
10071624/
Placebo 13/M/
WHITE MUSC Pain in extremity/
left Arm Pain# 3 20MAY2021 2/2 1 Yes NA R
(21MAY2021)N/N
C4591001
1007
10071625/
Placebo 13/F/
WHITE GENRL Injection site pain/
Injection Site Arm
Pain# 3 20MAY2021 2/2 1 Yes NA R
(21MAY2021)N/N
Pyrexia/
fever#3 20MAY2021 2/1 1 Yes NA/TC R
(20MAY2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 19
FDA-CBER-2022-5812-0224105
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1007
10071632/
Placebo 13/F/
WHITE GENRL Injection site pain/
tenderness at
injection site 1 30DEC2020 1/2 1 Yes NA R
(31DEC2020)N/Y
Vessel puncture site
pain/
pain at blood draw
site1 30DEC2020 1/2 1 No O NA R
(31DEC2020)N/Y
NERV Headache/
headache1 30DEC2020 1/1 1 Yes NA R
(30DEC2020)N/Y
SKIN Rash/
rash to chest and
back2 22JAN2021 2/5 2 Yes NA R
(26JAN2021)N/N
GASTR Nausea/
Nausea#3 19MAY2021 2/1 1 Yes NA R
(19MAY2021)N/N
GENRL Pain/
Body ache#3 19MAY2021 2/1 1 Yes NA R
(19MAY2021)N/N
MUSC Pain in extremity/
Arm pain#3 19MAY2021 2/4 1 Yes NA R
(22MAY2021)N/N
NERV Headache/
Headache#3 19MAY2021 2/1 1 Yes NA R
(19MAY2021)N/N
GASTR Nausea/
nausea#4 09JUN2021 2/1 1 Yes NA R
(09JUN2021)N/N
GENRL Pain/
generalized body
aches#4 09JUN2021 2/1 2 Yes NA/TC R
(09JUN2021)N/N
C4591001
1007
10071634/
BNT162b2 (30
μg) 14/M/
WHITE RESP Rhinorrhoea/
Rhinorrhea 2 18FEB2021 25/C 1 No O NA RG N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 20
FDA-CBER-2022-5812-0224106
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
NERV Presyncope/
vasova gal response2 22FEB2021 29/1 1 No O NA R
(22FEB2021)N/N
C4591001
1007
10071640/
Placebo 14/F/
WHITE GENRL Injection site pain/
Injection site pain#3 03JUN2021 1/2 1 Yes NA R
(04JUN2021)N/N
GENRL Chills/
Chills#4 22JUN2021 1/2 1 Yes NA R
(23JUN2021)N/N
Pyrexia/
fever#4 22JUN2021 1/2 1 Yes NA/TC/TCN R
(23JUN2021)N/N
NERV Headache/
headache#4 22JUN2021 1/2 2 Yes NA/TC R
(23JUN2021)N/N
C4591001
1007
10071642/
BNT162b2 (30
μg) 15/M/
WHITE GENRL Fatigue/
fatigue# 2 28MAY2021 2/2 2 Yes NA R
(29MAY2021)N/N
Pain/
body aches#2 28MAY2021 2/2 2 Yes NA R
(29MAY2021)N/N
Pyrexia/
fever 103.5#2 28MAY2021 2/2 3 Yes NA/TC R
(29MAY2021)N/N
NERV Dizziness/
dizziness#2 28MAY2021 2/2 1 Yes NA R
(29MAY2021)N/N
Headache/
headache#2 28MAY2021 2/2 1 Yes NA R
(29MAY2021)N/N
C4591001
1007
10071648/
Placebo 15/M/
ASIAN GENRL Injection site pain/
Injection site pain 2 26JAN2021 1/2 1 Yes NA R
(27JAN2021)N/Y
C4591001
1007 13/M/
WHITE NERV Headache/
Headache#4 15JUN2021 1/2 2 Yes NA/TC R
(16JUN2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 21
FDA-CBER-2022-5812-0224107
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
10071650/
Placebo
GENRL Chest discomfort/
chest ti ghtness#4 16JUN2021 2/1 1 No O NA/TC R
(16JUN2021)N/N
Chills/
chills#4 16JUN2021 2/1 1 Yes NA/TC R
(16JUN2021)N/N
Fatigue/
fatigue#4 16JUN2021 2/1 1 Yes NA/TC R
(16JUN2021)N/N
Injection site pain/
injection site pain#4 16JUN2021 2/1 1 Yes NA/TC R
(16JUN2021)N/N
INV Body temperature
increased/
elevated body
temperature
unknown temp#4 16JUN2021 2/1 1 Yes NA/TC R
(16JUN2021)N/N
MUSC Myalgia/
generalized muscle
aches#4 16JUN2021 2/1 2 Yes NA/TC R
(16JUN2021)N/N
C4591001
1007
10071651/
BNT162b2 (30
μg) 12/M/
WHITE BLOOD Lymphadenopathy/
Left deep cervical
chain lymph node
swelling 1 12JAN2021 8/29 1 Yes NA R
(09FEB2021)N/N
BLOOD Lymphadenopathy/
left Cervical
lymphadenopath y2 23FEB2021 29/15 1 No O NA R
(09MAR2021)N/N
C4591001
1007
10071652/
Placebo 12/F/
WHITE GENRL Injection site
erythema/
Erythema at
injection site#4 21JUN2021 1/2 1 Yes NA R
(22JUN2021)N/Y
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 22
FDA-CBER-2022-5812-0224108
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1007
10071658/
Placebo 13/F/
WHITE GENRL Injection site pain/
injection site pain#4 07JUN2021 1/4 1 Yes NA/TC R
(10JUN2021)N/N
Malaise/
malaise#4 07JUN2021 1/4 3 Yes NA/TC R
(10JUN2021)N/N
Pyrexia/
fever#4 07JUN2021 1/3 1 Yes NA/TC R
(09JUN2021)N/N
MUSC Myalgia/
generalized
myalgia#4 07JUN2021 1/4 3 Yes NA/TC R
(10JUN2021)N/N
MUSC Musculoskeletal
chest pain/
anterior chest wall
pain#4 08JUN2021 2/1 3 Yes NA/TC R
(08JUN2021)N/N
NERV Headache/
headache#4 08JUN2021 2/3 2 Yes NA/TC R
(10JUN2021)N/N
C4591001
1007
10071660/
Placebo 12/M/
WHITE GENRL Injection site pain/
injection site pain#3 02JUN2021 1/3 2 Yes NA R
(04JUN2021)N/N
GENRL Chills/
chills#3 03JUN2021 2/2 1 Yes NA R
(04JUN2021)N/N
Pyrexia/
fever 101.4#3 03JUN2021 2/2 2 Yes NA R
(04JUN2021)N/N
GENRL Injection site pain/
injection site pain#4 24JUN2021 1/2 1 Yes NA R
(25JUN2021)N/Y
GENRL Fatigue/
fatigue#4 25JUN2021 2/2 2 Yes NA R
(26JUN2021)N/N
C4591001
1008 15/F/
WHITE GENRL Fatigue/
Fatigue#3 05APR2021 1/2 1 Yes NA R
(06APR2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 23
FDA-CBER-2022-5812-0224109
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
10081761/
Placebo
C4591001
1008
10081781/
Placebo 13/F/
WHITE GENRL Injection site pain/
injection site pain#4 10JUN2021 2/3 1 Yes NA R
(12JUN2021)N/N
Injection site
reaction/
injection site
fatigue#4 10JUN2021 2/3 1 Yes NA R
(12JUN2021)N/N
C4591001
1008
10081788/
Placebo 13/F/
WHITE GENRL Injection site pain/
injection site pain#3 13MAY2021 1/2 1 Yes NA R
(14MAY2021)N/N
C4591001
1008
10081801/
Placebo 15/F/
WHITE GENRL Fatigue/
Fatigue# 4 08JUN2021 2/2 1 Yes NA R
(09JUN2021)N/N
C4591001
1008
10081808/
Placebo 13/M/
ASIAN GENRL Fatigue/
Fatigue# 3 18MAY2021 2/2 1 Yes NA R
(19MAY2021)N/N
GENRL Fatigue/
Fatigue#4 08JUN2021 2/2 1 Yes NA R
(09JUN2021)N/N
C4591001
1008
10081812/
Placebo 14/M/
WHITE NERV Headache/
headache# 3 14MAY2021 2/2 2 Yes NA/TC R
(15MAY2021)N/N
C4591001
1008 12/M/
WHITE GENRL Fatigue/
Fatigue#3 20MAY2021 2/2 2 Yes NA R
(21MAY2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 24
FDA-CBER-2022-5812-0224110
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
10081837/
Placebo
Pain/
body aches#3 20MAY2021 2/2 2 Yes NA/TC R
(21MAY2021)N/N
NERV Headache/
headache#3 20MAY2021 2/2 2 Yes NA/TC R
(21MAY2021)N/N
C4591001
1008
10081844/
Placebo 12/M/
WHITE GASTR Nausea/
nausea# 3 19MAY2021 1/2 1 Yes NA R
(20MAY2021)N/N
GENRL Pain/
body aches#3 20MAY2021 2/1 1 Yes NA R
(20MAY2021)N/N
NERV Headache/
headache#3 20MAY2021 2/1 1 Yes NA/TC R
(20MAY2021)N/N
C4591001
1008
10081863/
Placebo 13/F/
ASIAN GENRL Pain/
Body Aches# 4 08JUN2021 2/2 1 Yes NA R
(09JUN2021)N/N
NERV Headache/
Headache#4 08JUN2021 2/2 1 Yes NA R
(09JUN2021)N/N
C4591001
1008
10081877/
Placebo 14/M/
WHITE GENRL Fatigue/
fatigue# 3 17MAY2021 1/3 2 Yes NA R
(19MAY2021)N/N
GENRL Pain/
body aches#3 18MAY2021 2/2 2 Yes NA R
(19MAY2021)N/N
C4591001
1008
10081887/
Placebo 12/F/
WHITE GENRL Chills/
chills# 3 14MAY2021 2/4 1 Yes NA R
(17MAY2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 25
FDA-CBER-2022-5812-0224111
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
NERV Headache/
headache#3 14MAY2021 2/4 2 Yes NA R
(17MAY2021)N/N
SKIN Hyperhidrosis/
sweatin g#3 14MAY2021 2/4 1 Yes NA R
(17MAY2021)N/N
C4591001
1008
10081892/
Placebo 14/M/
AMERICAN
INDIAN OR
ALASKA
NATIVE GENRL Injection site pain/
injection site pain#3 25MAY2021 1/5 1 Yes NA R
(29MAY2021)N/N
C4591001
1008
10081913/
Placebo 13/M/
WHITE GENRL Injection site pain/
injection site pain#2 16MAY2021 109/4 1 Yes NA R
(19MAY2021)N/N
C4591001
1008
10081928/
BNT162b2 (30
μg) 13/F/
WHITE SKIN Urticaria/
urticaria multiple
sites 1 10JAN2021 3/13 1 Yes NA/TC R
(22JAN2021)N/N
C4591001
1008
10081931/
Placebo 12/M/
ASIAN INFEC Cellulitis/
Cellulitis left leg 2 15MAR2021 43/5 1 No O NA/TC R
(19MAR2021)N/N
C4591001
1008
10081933/
Placebo 12/M/
WHITE GENRL Injection site pain/
injection site pain#4 08JUN2021 2/2 1 Yes NA R
(09JUN2021)N/N
C4591001
1009
10091220/
Placebo 15/M/
WHITE INJ&P Procedural pain/
POST SURGICAL
PAIN, ORAL 2 20NOV2020 14/11 2 No O NA/TC R
(30NOV2020)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 26
FDA-CBER-2022-5812-0224112
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1009
10091221/
BNT162b2 (30
μg) 14/F/
WHITE MUSC Arthralgia/
worsening right
ankle pain 1 19OCT2020 1/1 3 No O NA/TCN R
(19OCT2020)N/N
C4591001
1009
10091229/
Placebo 12/F/
WHITE GENRL Pain/
Body Aches
following
vaccination#3 22MAY2021 2/2 2 Yes NA/TC R
(23MAY2021)N/N
C4591001
1009
10091231/
BNT162b2 (30
μg) 15/M/
ASIAN BLOOD Lymphadenopathy/
left swollen axillary
lymph node 2 10NOV2020 2/1 1 Yes NA R
(10NOV2020)N/N
C4591001
1009
10091267/
Placebo 13/M/
WHITE RESP Rhinorrhoea/
RUNNY NOSE 2 27DEC2020 6/6 1 No O NA/TC R
(01JAN2021)N/N
C4591001
1009
10091294/
Placebo 15/F/
WHITE MUSC Arthralgia/
bilateral shoulder
pain 1 22DEC2020 16/3 1 No O NA R
(24DEC2020)N/N
GENRL Pain/
body aches#3 06APR2021 1/2 1 Yes NA R
(07APR2021)N/N
C4591001
1009
10091301/
Placebo 15/F/
WHITE INJ&P Arthropod bite/
spider bite# 4 22JUL2021 32/15 2 No O NA/TC R
(05AUG2021)N/N
C4591001
1009
10091305/
Placebo 15/F/
WHITE BLOOD Lymphadenitis/
Right Axillary
Adenitis# 3 24MAR2021 6/24 2 Yes NA/TC R
(16APR2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 27
FDA-CBER-2022-5812-0224113
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1009
10091319/
BNT162b2 (30
μg) 15/M/
WHITE NERV Headache/
headache 2 22JAN2021 25/1 2 No O NA R
(22JAN2021)N/N
C4591001
1009
10091323/
Placebo 15/F/
WHITE GASTR Nausea/
nausea 2 08JAN2021 10/1 1 No O NA R
(08JAN2021)N/N
GENRL Fatigue/
fatigue2 08JAN2021 10/1 1 No O NA R
(08JAN2021)N/N
C4591001
1009
10091326/
Placebo 12/F/
WHITE GENRL Injection site pain/
Sore (pain) left
deltoid- at injection
site#4 26JUN2021 2/1 1 Yes NA R
(26JUN2021)N/N
NERV Headache/
headache#4 26JUN2021 2/1 1 Yes NA R
(26JUN2021)N/N
C4591001
1009
10091334/
Placebo 13/F/
WHITE RESP Rhinorrhoea/
runny nose 2 11JAN2021 12/1 1 No O NA R
(11JAN2021)N/N
C4591001
1009
10091338/
Placebo 15/F/
WHITE SURG Wisdom teeth
removal/
Wisdom Teeth
Removal1 08JUN2021 177/1 2 No O NA/TC R
(08JUN2021)N/N
GASTR Mouth ulceration/
Mouth Ulce r1 16JUN2021 185/6 2 No O NA/TC R
(21JUN2021)N/N
C4591001
1009
10091341/
Placebo 13/M/
WHITE GENRL Pain/
body aches# 3 03JUL2021 2/1 1 Yes NA R
(03JUL2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 28
FDA-CBER-2022-5812-0224114
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1009
10091342/
BNT162b2 (30
μg) 15/M/
WHITE BLOOD Lymphadenopathy/
swollen cervical
lymph nodes
bilateral 2 31JAN2021 28/3 1 No O NA R
(02FEB2021)N/N
C4591001
1009
10091357/
Placebo 15/M/
WHITE CONG Spine malformation/
congenital vertebral
pedicle hypoplasia 2 12FEB2021 39/C 1 No O NA N N/N
GENRL Pain/
body aches#4 06APR2021 2/2 1 Yes NA R
(07APR2021)N/N
NERV Headache/
headache#4 06APR2021 2/2 1 Yes NA R
(07APR2021)N/N
C4591001
1009
10091361/
Placebo 13/F/
WHITE INJ&P Ligament sprain/
sprained right thumb1 02JAN2021 17/30 2 No O NA R
(31JAN2021)N/N
C4591001
1009
10091363/
Placebo 14/M/
WHITE NERV Presyncope/
Vasovagal Reaction1 09FEB2021 55/1 1 No O NA R
(09FEB2021)N/N
C4591001
1009
10091365/
Placebo 12/M/
WHITE INJ&P Upper limb fracture/
right arm fracture 2 19MAR2021 60/C 2 No O NA/TC RG N/N
C4591001
1009
10091366/
Placebo 14/F/
WHITE GENRL Injection site pain/
Mild Injection Site
Pain 2 26FEB2021 1/2 1 Yes NA R
(27FEB2021)N/N
C4591001
1009 13/F/
WHITE NERV Headache/
headache1 06JAN2021 20/1 3 No O NA/TC R
(06JAN2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 29
FDA-CBER-2022-5812-0224115
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
10091370/
BNT162b2 (30
μg)
C4591001
1009
10091379/
Placebo 13/F/
WHITE INJ&P Fall/
GROUND LEVEL
FALL 2 26FEB2021 44/1 2 No O NA R
(26FEB2021)N/N
INJ&P Contusion/
BRUISED KNEE,
LEFT2 22MAR2021 68/19 2 No O NA/TC R
(09APR2021)N/N
SKIN Ingrowing nail/
bilateral great toe
ingrown toenail#3 03JUN2021 16/C 1 No O NA/TC N N/N
C4591001
1009
10091380/
Placebo 14/M/
WHITE INJ&P Clavicle fracture/
Right Clavicle
Fracture 1 18JAN2021 21/36 2 No O NA/TC R
(22FEB2021)N/N
INJ&P Procedural pain/
pain after wisdom
teeth removal2 11FEB2021 24/5 1 No O NA/TC R
(15FEB2021)N/N
C4591001
1009
10091382/
Placebo 14/F/
WHITE MUSC Arthralgia/
RIGHT KNEE
PAIN 1 10JAN2021 7/16 2 No O NA R
(25JAN2021)N/N
GASTR Nausea/
nausea#3 15MAY2021 2/3 1 Yes NA R
(17MAY2021)N/N
MUSC Myalgia/
generalized muscle
pain#3 15MAY2021 2/6 1 Yes NA R
(20MAY2021)N/N
NERV Dizziness/
dizziness#3 15MAY2021 2/2 1 Yes NA R
(16MAY2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 30
FDA-CBER-2022-5812-0224116
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
RESP Rhinorrhoea/
rhinorrhea#3 15MAY2021 2/3 1 Yes NA R
(17MAY2021)N/N
GENRL Chills/
chills#4 03JUN2021 2/1 1 Yes NA R
(03JUN2021)N/N
C4591001
1009
10091399/
Placebo 12/F/
WHITE INJ&P Foot fracture/
Left Fifth Metatarsal
Fracture 2 23FEB2021 26/82 2 No O NA/TC R
(15MAY2021)N/N
C4591001
1009
10091400/
Placebo 12/M/
WHITE SKIN Eczema/
Eczema generalized2 02APR2021 50/3 2 No O NA R
(04APR2021)N/N
SKIN Urticaria/
Urticaria generalized2 07APR2021 55/8 3 No O NA/TC R
(14APR2021)N/N
C4591001
1009
10091401/
Placebo 12/M/
WHITE EAR Motion sickness/
motion sickness# 3 08AUG2021 7/1 1 No O NA R
(08AUG2021)N/N
C4591001
1009
10091403/
Placebo 15/F/
WHITE RESP Rhinorrhoea/
runny nose 1 10JAN2021 3/4 1 Yes NA R
(13JAN2021)N/N
C4591001
1009
10091405/
Placebo 15/F/
WHITE BLOOD Lymphadenopathy/
left axillary
adenopathy# 4 20AUG2021 2/C 1 Yes NA N N/N
GENRL Fatigue/
fatigue#4 20AUG2021 2/2 2 Yes NA R
(21AUG2021)N/N
Pyrexia/
fever#4 20AUG2021 2/1 1 Yes NA/TC R
(20AUG2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 31
FDA-CBER-2022-5812-0224117
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
NERV Headache/
headache#4 20AUG2021 2/2 1 Yes NA R
(21AUG2021)N/N
C4591001
1009
10091406/
Placebo 15/M/
WHITE MUSC Joint swelling/
Swilling in bilateral
knees 1 25JAN2021 18/36 1 No O NA/TC R
(01MAR2021)N/N
GENRL Fatigue/
fatigue#4 20AUG2021 2/2 2 Yes NA R
(21AUG2021)N/N
Pyrexia/
fever#4 20AUG2021 2/2 1 Yes NA R
(21AUG2021)N/N
NERV Headache/
headache#4 20AUG2021 2/2 1 Yes NA R
(21AUG2021)N/N
C4591001
1009
10091409/
BNT162b2 (30
μg) 14/F/
WHITE INJ&P Procedural pain/
Post Surgical Pain 2 22JUL2021 171/C 2 No O NA/TC N N/N
C4591001
1009
10091410/
BNT162b2 (30
μg) 12/F/
WHITE GENRL Fatigue/
FATIGUE 2 01FEB2021 1/3 2 Yes NA R
(03FEB2021)N/N
Injection site pain/
INJECTION SITE
PAIN2 01FEB2021 1/3 2 Yes NA R
(03FEB2021)N/N
C4591001
1009
10091413/
BNT162b2 (30
μg) 13/F/
WHITE MUSC Musculoskeletal
chest pain/
bilateral rib pain 2 05FEB2021 3/1 2 Yes NA/TC R
(05FEB2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 32
FDA-CBER-2022-5812-0224118
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
INJ&P Femur fracture/
Right
Intertrochanteric
Femur Fracture2 13MAR2021 39/4 3 No O NA/TC/TCN R
(16MAR2021)Y/N
INJ&P Procedural pain/
Post Surgical Right
Leg Pain2 16MAR2021 42/15 2 No O NA/TC R
(30MAR2021)N/N
C4591001
1013
10131824/
BNT162b2 (30
μg) 14/F/
BLACK OR
AFRICAN
AMERICAN GENRL Peripheral swelling/
SWELLING LEFT
ARM 1 05DEC2020 5/2 1 Yes NA R
(06DEC2020)N/N
C4591001
1013
10131839/
Placebo 14/F/
WHITE INJ&P Concussion/
SPORTS RELATED
CONCUSSION 2 01MAR2021 69/C 2 No O NA RG N/N
C4591001
1016
10161316/
Placebo 15/M/
WHITE GENRL Chills/
chills# 3 26FEB2021 2/1 2 Yes NA R
(26FEB2021)N/N
MUSC Myalgia/
muscle pain#3 26FEB2021 2/1 2 Yes NA/TC R
(26FEB2021)N/N
C4591001
1016
10161327/
Placebo 12/M/
WHITE NERV Syncope/
syncope 2 09APR2021 151/1 2 No O NA R
(09APR2021)N/N
NERV Epilepsy/
epileps y#4 29JUN2021 8/C 2 No O NA N Y/N
C4591001
1016 14/M/
WHITE INJ&P Wound/
left foot puncture
would#4 04JUL2021 26/21 1 No O NA R
(24JUL2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 33
FDA-CBER-2022-5812-0224119
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
10161329/
Placebo
INFEC Cellulitis/
cellulitis of left foot#4 06JUL2021 28/11 1 No O NA/TC R
(16JUL2021)N/N
C4591001
1016
10161344/
Placebo 15/F/
WHITE BLOOD Lymphadenopathy/
enlarged lymph
nodes, right anterior
cervical nodes2 25NOV2020 15/43 1 No O NA R
(06JAN2021)N/N
INFEC Infectious
mononucleosis/
infectious
mononuclesosis2 25NOV2020 15/43 1 No O NA R
(06JAN2021)N/N
C4591001
1016
10161353/
Placebo 13/F/
WHITE GENRL Chills/
chills# 3 25MAY2021 2/2 2 Yes NA R
(26MAY2021)N/N
Fatigue/
fatigue#3 25MAY2021 2/2 2 Yes NA R
(26MAY2021)N/N
Injection site pain/
left deltoid injection
site soreness#3 25MAY2021 2/2 1 Yes NA R
(26MAY2021)N/N
GENRL Chills/
chills#4 14JUN2021 1/2 2 Yes NA/TC R
(15JUN2021)N/N
Injection site pain/
injection site pain#4 14JUN2021 1/4 1 Yes NA/TC R
(17JUN2021)N/N
Pain/
body aches#4 14JUN2021 1/2 1 Yes NA/TC R
(15JUN2021)N/N
Pyrexia/
fever#4 14JUN2021 1/2 1 Yes NA/TC R
(15JUN2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 34
FDA-CBER-2022-5812-0224120
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
NERV Headache/
headache#4 14JUN2021 1/2 1 Yes NA/TC R
(15JUN2021)N/N
C4591001
1016
10161366/
Placebo 12/M/
WHITE GASTR Vomiting/
vomiting# 4 08JUL2021 2/2 1 Yes NA R
(09JUL2021)N/N
C4591001
1016
10161371/
Placebo 12/F/
WHITE GENRL Fatigue/
fatigue# 4 15JUN2021 2/3 1 Yes NA R
(17JUN2021)N/N
Pyrexia/
fever, low grade#4 15JUN2021 2/1 1 Yes NA/TC R
(15JUN2021)N/N
C4591001
1039
10391246/
Placebo 15/M/
WHITE GENRL Fatigue/
fatigue# 3 27FEB2021 2/3 2 Yes NA R
(01MAR2021)N/N
Pain/
generalized
achiness#3 27FEB2021 2/4 2 Yes NA R
(02MAR2021)N/N
Pyrexia/
fever#3 27FEB2021 2/2 1 Yes NA R
(28FEB2021)N/N
NERV Headache/
headache#3 27FEB2021 2/3 1 Yes NA R
(01MAR2021)N/N
GENRL Fatigue/
fatigue#4 19MAR2021 2/2 1 Yes NA R
(20MAR2021)N/N
Pyrexia/
fever#4 19MAR2021 2/2 1 Yes NA R
(20MAR2021)N/N
C4591001
1039
10391250/ 14/F/
WHITE PSYCH Tic/
exacerbation of tic
disorde r2 09JAN2021 13/C 1 No O NA RG N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 35
FDA-CBER-2022-5812-0224121
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
BNT162b2 (30
μg)
C4591001
1039
10391251/
Placebo 15/F/
ASIAN GENRL Fatigue/
Fatigue# 4 25FEB2021 1/3 1 Yes NA R
(27FEB2021)N/N
NERV Headache/
Headache#4 25FEB2021 1/3 1 Yes NA R
(27FEB2021)N/N
C4591001
1039
10391258/
Placebo 13/F/
WHITE GENRL Pyrexia/
Fever# 4 01JUN2021 1/2 1 Yes NA/TC R
(02JUN2021)N/N
NERV Headache/
Headache#4 01JUN2021 1/2 1 Yes NA/TC R
(02JUN2021)N/N
GENRL Fatigue/
Fatigue#4 02JUN2021 2/2 1 Yes NA/TC R
(03JUN2021)N/N
C4591001
1039
10391259/
Placebo 13/M/
WHITE GENRL Injection site pain/
injection site pain#3 14MAY2021 1/8 1 Yes NA/TC R
(21MAY2021)N/N
GENRL Fatigue/
fatigue#3 15MAY2021 2/1 1 Yes NA/TC R
(15MAY2021)N/N
GENRL Injection site pain/
injection site pain#4 04JUN2021 1/2 1 Yes NA R
(05JUN2021)N/Y
GENRL Pyrexia/
fever#4 05JUN2021 2/3 1 Yes NA/TC R
(07JUN2021)N/N
GENRL Fatigue/
fatigue#4 06JUN2021 3/1 1 Yes NA/TC R
(06JUN2021)N/N
NERV Headache/
headache#4 06JUN2021 3/1 1 Yes NA/TC R
(06JUN2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 36
FDA-CBER-2022-5812-0224122
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1039
10391264/
Placebo 12/F/
ASIAN MUSC Myalgia/
General muscle
aches# 3 25MAY2021 2/3 1 Yes NA R
(27MAY2021)N/N
C4591001
1039
10391266/
Placebo 12/M/
WHITE GENRL Fatigue/
Fatigue# 4 04JUN2021 2/2 1 Yes NA R
(05JUN2021)N/N
Pain/
Body ache#4 04JUN2021 2/2 1 Yes NA/TC R
(05JUN2021)N/N
Pyrexia/
Fever - max 100F#4 04JUN2021 2/2 1 Yes NA/TC R
(05JUN2021)N/N
MUSC Myalgia/
Left arm muscle
ache#4 04JUN2021 2/2 1 Yes NA R
(05JUN2021)N/N
C4591001
1039
10391268/
Placebo 13/F/
WHITE GENRL Pyrexia/
Fever - up to 102.5#3 14MAY2021 2/2 3 Yes NA R
(15MAY2021)N/N
C4591001
1039
10391270/
Placebo 13/F/
WHITE RESP Epistaxis/
Epistaxis 1 23DEC2020 15/1 1 No O NA R
(23DEC2020)N/N
GENRL Injection site pain/
Injection site pain#3 13MAY2021 1/2 1 Yes NA/TC R
(14MAY2021)N/N
GENRL Fatigue/
fatigue#3 14MAY2021 2/3 1 Yes NA R
(16MAY2021)N/N
Pyrexia/
Fever#3 14MAY2021 2/1 1 Yes NA/TC R
(14MAY2021)N/N
GENRL Fatigue/
fatigue#4 04JUN2021 2/3 1 Yes NA/TC R
(06JUN2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 37
FDA-CBER-2022-5812-0224123
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Pyrexia/
fever#4 04JUN2021 2/2 1 Yes NA/TC R
(05JUN2021)N/N
C4591001
1039
10391271/
Placebo 14/F/
WHITE NERV Headache/
Headache# 3 14MAY2021 2/1 2 Yes NA/TC R
(14MAY2021)N/N
NERV Headache/
headache#4 04JUN2021 2/1 2 Yes NA/TC R
(04JUN2021)N/N
C4591001
1039
10391273/
Placebo 12/F/
WHITE GENRL Fatigue/
Fatigue# 3 14MAY2021 2/1 1 Yes NA R
(14MAY2021)N/N
Injection site pain/
Injection site
soreness#3 14MAY2021 2/2 1 Yes NA R
(15MAY2021)N/N
C4591001
1039
10391274/
Placebo 13/M/
WHITE IMMUN Food allergy/
exacerbation of
pineapple food
allergy#4 01JUL2021 28/1 1 No O NA/TC R
(01JUL2021)N/N
RESP Upper-airway cough
syndrome/
post nasal drip#4 01JUL2021 28/6 1 No O NA/TC R
(06JUL2021)N/N
C4591001
1039
10391279/
Placebo 14/F/
WHITE GENRL Injection site pain/
injection site pain#3 17MAY2021 1/3 1 Yes NA/TC R
(19MAY2021)N/N
GENRL Fatigue/
fatigue#3 18MAY2021 2/2 1 Yes NA R
(19MAY2021)N/N
GENRL Chills/
Chills#4 07JUN2021 1/2 1 Yes NA/TC R
(08JUN2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 38
FDA-CBER-2022-5812-0224124
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Fatigue/
Fatigue#4 07JUN2021 1/2 1 Yes NA/TC/TCN R
(08JUN2021)N/N
Injection site pain/
Injection site pain#4 07JUN2021 1/2 1 Yes NA R
(08JUN2021)N/N
Pain/
Body aches#4 07JUN2021 1/2 1 Yes NA/TC R
(08JUN2021)N/N
C4591001
1039
10391280/
Placebo 13/F/
WHITE NERV Presyncope/
Vasovagal episode 2 04FEB2021 29/1 1 No O NA R
(04FEB2021)N/N
GENRL Injection site pain/
Injection site
soreness#3 15MAY2021 2/4 1 Yes NA R
(18MAY2021)N/N
C4591001
1039
10391283/
Placebo 15/M/
WHITE GENRL Injection site pain/
Injection site
soreness# 3 13MAY2021 1/3 1 Yes NA R
(15MAY2021)N/N
GENRL Fatigue/
Fatigue#3 14MAY2021 2/3 2 Yes NA R
(16MAY2021)N/N
NERV Headache/
Headache#3 14MAY2021 2/3 2 Yes NA R
(16MAY2021)N/N
C4591001
1039
10391285/
Placebo 13/F/
WHITE GASTR Nausea/
nausea# 3 14MAY2021 1/2 1 Yes NA R
(15MAY2021)N/N
GENRL Fatigue/
fatigue#3 14MAY2021 1/2 1 Yes NA R
(15MAY2021)N/N
GENRL Injection site pain/
injection site pain#3 15MAY2021 2/1 1 Yes NA R
(15MAY2021)N/N
GASTR Nausea/
nausea#4 04JUN2021 1/2 1 Yes NA R
(05JUN2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 39
FDA-CBER-2022-5812-0224125
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GENRL Pyrexia/
fever#4 04JUN2021 1/2 1 Yes NA R
(05JUN2021)N/N
MUSC Arthralgia/
Generalized
Arthral gia#+4 04JUN2021 1/2 1 Yes NA R
(05JUN2021)N/N
Myalgia/
muscle aches#4 04JUN2021 1/2 1 Yes NA R
(05JUN2021)N/N
C4591001
1039
10391287/
Placebo 14/F/
WHITE GENRL Fatigue/
fatigue# 3 13MAY2021 1/2 1 Yes NA R
(14MAY2021)N/N
GENRL Injection site pain/
injection site pain#3 14MAY2021 2/2 1 Yes NA R
(15MAY2021)N/N
GENRL Fatigue/
fatigue#4 03JUN2021 1/2 1 Yes NA R
(04JUN2021)N/N
GENRL Injection site pain/
injection site
soreness#4 04JUN2021 2/1 1 Yes NA R
(04JUN2021)N/N
NERV Headache/
headache#4 04JUN2021 2/2 1 Yes NA R
(05JUN2021)N/N
C4591001
1039
10391290/
BNT162b2 (30
μg) 12/F/
WHITE NERV Presyncope/
Vasovagal episode#2 13JUL2021 187/1 2 No O NA R
(13JUL2021)N/N
C4591001
1039
10391292/
Placebo 13/F/
WHITE GENRL Fatigue/
Fatigue# 3 14MAY2021 1/3 1 Yes NA R
(16MAY2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 40
FDA-CBER-2022-5812-0224126
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Injection site pain/
Injection site
soreness#3 14MAY2021 1/9 1 Yes NA R
(22MAY2021)N/N
GASTR Nausea/
Nausea#4 04JUN2021 1/3 1 Yes NA/TC R
(06JUN2021)N/N
GENRL Fatigue/
Fatigue#4 04JUN2021 1/3 1 Yes NA/TC R
(06JUN2021)N/N
Injection site pain/
Injection arm
soreness#4 04JUN2021 1/7 1 Yes NA/TC R
(10JUN2021)N/N
C4591001
1039
10391294/
Placebo 13/M/
ASIAN GENRL Injection site pain/
Injection site pain#3 14MAY2021 1/3 1 Yes NA R
(16MAY2021)N/N
GENRL Injection site pain/
Injection arm
soreness#4 04JUN2021 1/2 1 Yes NA R
(05JUN2021)N/N
C4591001
1039
10391296/
Placebo 13/M/
WHITE GENRL Injection site pain/
Injection site
soreness# 3 14MAY2021 1/2 1 Yes NA R
(15MAY2021)N/N
GASTR Nausea/
nausea#4 04JUN2021 1/3 1 Yes NA R
(06JUN2021)N/N
GENRL Axillary pain/
Left armpit
soreness#4 04JUN2021 1/3 1 Yes NA R
(06JUN2021)N/N
Chills/
Chills#4 04JUN2021 1/2 1 Yes NA/TC R
(05JUN2021)N/N
GENRL Pyrexia/
Fever 102#4 05JUN2021 2/1 2 Yes NA/TC R
(05JUN2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 41
FDA-CBER-2022-5812-0224127
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1039
10391301/
Placebo 14/M/
WHITE GENRL Injection site pain/
Injection site pain#3 13MAY2021 1/6 1 Yes NA R
(18MAY2021)N/N
NERV Presyncope/
vasova gal episode#2 13MAY2021 113/1 1 No O NA R
(13MAY2021)N/N
MUSC Myalgia/
General muscle
aches#3 14MAY2021 2/3 1 Yes NA R
(16MAY2021)N/N
NERV Headache/
Headache#3 14MAY2021 2/3 1 Yes NA R
(16MAY2021)N/N
GENRL Chills/
chills#4 05JUN2021 2/2 1 Yes NA R
(06JUN2021)N/N
Injection site pain/
injection site
soreness#4 05JUN2021 2/4 1 Yes NA R
(08JUN2021)N/N
Pain/
body aches#4 05JUN2021 2/2 1 Yes NA R
(06JUN2021)N/N
Pyrexia/
fever#4 05JUN2021 2/2 1 Yes NA R
(06JUN2021)N/N
NERV Headache/
headache#4 05JUN2021 2/2 1 Yes NA R
(06JUN2021)N/N
C4591001
1039
10391303/
Placebo 13/M/
WHITE GENRL Chills/
chills# 4 04JUN2021 1/2 1 Yes NA R
(05JUN2021)N/N
C4591001
1039
10391305/
Placebo 13/M/
WHITE GENRL Fatigue/
Fatigue# 3 15MAY2021 2/2 1 Yes NA R
(16MAY2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 42
FDA-CBER-2022-5812-0224128
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1039
10391307/
Placebo 15/F/
WHITE INJ&P Muscle strain/
exacerbation of neck
muscle strain# 3 14MAY2021 1/C 3 No O NA/TC RG N/N
ENDO Thyroid mass/
thyroid nodule#3 01JUN2021 19/C 1 No O NA N N/N
GENRL Chills/
chills#4 04JUN2021 1/3 2 Yes NA/TC R
(06JUN2021)N/N
Injection site pain/
injection site
soreness#4 04JUN2021 1/4 2 Yes NA R
(07JUN2021)N/Y
Pyrexia/
fever#4 04JUN2021 1/3 1 Yes NA/TC R
(06JUN2021)N/N
MUSC Myalgia/
muscle aches#4 04JUN2021 1/3 2 Yes NA/TC R
(06JUN2021)N/N
NERV Headache/
headache#4 04JUN2021 1/3 2 Yes NA/TC R
(06JUN2021)N/N
GASTR Vomiting/
vomitin g#4 05JUN2021 2/2 1 Yes NA R
(06JUN2021)N/N
METAB Vitamin D
deficiency/
Vitamin D
deficienc y#4 11JUN2021 8/C 1 No O NA/TC RG N/N
ENDO Autoimmune
thyroiditis/
Hashimoto's
thyroiditis#4 14JUN2021 11/C 1 No O NA N N/N
C4591001
1039
10391309/
Placebo 14/M/
ASIAN GENRL Fatigue/
fatigue# 2 17MAY2021 111/2 1 Yes NA R
(18MAY2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 43
FDA-CBER-2022-5812-0224129
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Injection site pain/
injection site pain#2 17MAY2021 111/2 1 Yes NA R
(18MAY2021)N/N
GENRL Fatigue/
fatigue#4 09JUN2021 2/4 1 Yes NA R
(12JUN2021)N/N
C4591001
1039
10391310/
Placebo 13/M/
WHITE GENRL Fatigue/
fatigue# 2 14MAY2021 109/2 1 Yes NA R
(15MAY2021)N/N
Injection site
bruising/
bruise at injection
site#3 14MAY2021 1/5 1 Yes NA R
(18MAY2021)N/N
NERV Headache/
headache#2 14MAY2021 109/1 1 Yes NA/TC R
(14MAY2021)N/N
GENRL Injection site
swelling/
swelling at injection
site#3 18MAY2021 5/14 1 Yes NA R
(31MAY2021)N/N
GENRL Injection site
bruising/
bruising at injection
site#4 07JUN2021 1/8 1 Yes NA R
(14JUN2021)N/N
GENRL Fatigue/
fatigue#4 08JUN2021 2/2 1 Yes NA R
(09JUN2021)N/N
NERV Headache/
headache#4 08JUN2021 2/2 1 Yes NA/TC R
(09JUN2021)N/N
C4591001
1039
10391313/
Placebo 14/M/
WHITE GENRL Pain/
General Body
aches# 3 15MAY2021 2/1 2 Yes NA/TC R
(15MAY2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 44
FDA-CBER-2022-5812-0224130
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GENRL Injection site pain/
Injection site
soreness#4 03JUN2021 1/3 1 Yes NA R
(05JUN2021)N/N
Pain/
General Body
aches#4 03JUN2021 1/3 2 Yes NA/TC R
(05JUN2021)N/N
GENRL Fatigue/
Fatigue#4 04JUN2021 2/2 2 Yes NA R
(05JUN2021)N/N
C4591001
1039
10391314/
Placebo 14/F/
ASIAN NEOPL Fibroadenoma of
breast/
Exacerbation of
fibroadenoma of
right breas t2 06FEB2021 10/60 1 No O NA/TCN R
(06APR2021)N/N
GENRL Injection site pain/
Injection Site Pain#3 17MAY2021 1/3 1 Yes NA R
(19MAY2021)N/N
C4591001
1039
10391315/
BNT162b2 (30
μg) 14/M/
WHITE NERV Presyncope/
vasovagal episode#2 22JUL2021 177/1 2 No O NA R
(22JUL2021)N/N
C4591001
1039
10391317/
Placebo 12/M/
ASIAN GASTR Vomiting/
vomiting* 07JAN2021 1/1 1 No O NA R
(07JAN2021)N/N
NERV Presyncope/
pre-syncope*07JAN2021 1/1 1 No O NA R
(07JAN2021)N/N
GENRL Chills/
chills#3 15MAY2021 2/1 1 Yes NA/TC R
(15MAY2021)N/N
Fatigue/
fatigue#3 15MAY2021 2/1 1 Yes NA R
(15MAY2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 45
FDA-CBER-2022-5812-0224131
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1039
10391319/
Placebo 12/M/
WHITE GENRL Chills/
chills# 3 21MAY2021 2/2 2 Yes NA/TC R
(22MAY2021)N/N
Injection site pain/
injection site pain#3 21MAY2021 2/3 2 Yes NA/TC R
(23MAY2021)N/N
Pyrexia/
fever - max temp
102.3#3 21MAY2021 2/3 3 Yes NA/TC R
(23MAY2021)N/N
C4591001
1039
10391321/
Placebo 12/F/
WHITE GENRL Chills/
Chills# 3 17MAY2021 1/2 2 Yes NA/TC R
(18MAY2021)N/N
GENRL Injection site pain/
Injection arm
soreness#4 08JUN2021 1/2 1 Yes NA/TC R
(09JUN2021)N/N
C4591001
1039
10391325/
Placebo 13/F/
ASIAN GENRL Chills/
Chills# 3 13MAY2021 1/3 2 Yes NA/TC R
(15MAY2021)N/N
Fatigue/
fatigue#3 13MAY2021 1/3 2 Yes NA R
(15MAY2021)N/N
Pyrexia/
Fever - up to 103.4#3 13MAY2021 1/2 3 Yes NA/TC R
(14MAY2021)N/N
GENRL Chills/
chills#4 03JUN2021 1/3 1 Yes NA/TC R
(05JUN2021)N/N
Fatigue/
fatigue#4 03JUN2021 1/2 1 Yes NA R
(04JUN2021)N/N
GENRL Fatigue/
fatigue#4 04JUN2021 2/4 2 Yes NA R
(07JUN2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 46
FDA-CBER-2022-5812-0224132
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Injection site
bruising/
bruise at injection
site#4 04JUN2021 2/8 1 Yes NA R
(11JUN2021)N/N
Pain/
generalized aches#4 04JUN2021 2/2 1 Yes NA/TC R
(05JUN2021)N/N
C4591001
1039
10391326/
BNT162b2 (30
μg) 15/M/
ASIAN PSYCH Depression/
Depression
Exacerbation 1 26JAN2021 16/5 3 No O NA/TC/TCN R
(30JAN2021)Y/N
PSYCH Depression/
Depression
Exacerbation2 29MAR2021 57/5 3 No O NA/TC/TCN R
(02APR2021)Y/N
C4591001
1039
10391327/
Placebo 15/M/
WHITE GENRL Fatigue/
Fatigue# 2 06JUN2021 126/3 1 Yes NA R
(08JUN2021)N/N
C4591001
1039
10391328/
Placebo 14/F/
WHITE GENRL Fatigue/
fatigue# 3 14MAY2021 1/4 1 Yes NA R
(17MAY2021)N/N
Injection site pain/
Injection site pain#3 14MAY2021 1/4 1 Yes NA/TC R
(17MAY2021)N/N
GENRL Fatigue/
Fatigue#4 04JUN2021 1/2 1 Yes NA R
(05JUN2021)N/N
Injection site pain/
Injection arm
soreness#4 04JUN2021 1/2 1 Yes NA R
(05JUN2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
Page 47
FDA-CBER-2022-5812-0224133
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1039
10391329/
Placebo 13/M/
WHITE GENRL Injection site pain/
Injection site
soreness# 3 21MAY2021 2/3 1 Yes NA R
(23MAY2021)N/N
GENRL Fatigue/
fatigue#4 11JUN2021 2/3 1 Yes NA R
(13JUN2021)N/N
Injection site pain/
injection arm
soreness#4 11JUN2021 2/3 1 Yes NA R
(13JUN2021)N/N
C4591001
1039
10391330/
BNT162b2 (30
μg) 15/M/
WHITE GASTR Abdominal pain
upper/
stomach pain# 2 25JUN2021 144/1 1 No O NA R
(25JUN2021)N/N
Nausea/
nausea#2 25JUN2021 144/1 1 No O NA R
(25JUN2021)N/N
C4591001
1039
10391332/
BNT162b2 (30
μg) 13/F/
WHITE PSYCH Suicidal ideation/
Active Suicidal
Ideation 2 12APR2021 70/10 4 No O NA/TC/TCN R
(21APR2021)Y/N
C4591001
1039
10391333/
Placebo 15/M/
WHITE GENRL Fatigue/
fatigue# 4 12JUN2021 2/2 1 Yes NA R
(13JUN2021)N/N
C4591001
1039
10391337/
Placebo 15/M/
WHITE SKIN Urticaria/
urticaria, both hands2 04FEB2021 2/3 1 Yes NA R
(06FEB2021)N/N
GENRL Chills/
chills#3 14MAY2021 1/2 2 Yes NA/TC R
(15MAY2021)N/N
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FDA-CBER-2022-5812-0224134
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GASTR Vomiting/
vomit#3 15MAY2021 2/1 1 Yes NA/TC R
(15MAY2021)N/N
GENRL Pyrexia/
Fever#4 05JUN2021 2/2 1 Yes NA/TC R
(06JUN2021)N/N
C4591001
1039
10391339/
Placebo 12/F/
WHITE GASTR Nausea/
Nausea 1 12JAN2021 1/1 1 Yes NA R
(12JAN2021)N/N
Vomiting/
Vomitin g1 12JAN2021 1/1 1 Yes NA R
(12JAN2021)N/N
C4591001
1044
10441265/
Placebo 14/M/
WHITE INFEC Sinusitis/
sinusitis# 4 16JUN2021 8/12 1 No O NA/TC R
(27JUN2021)N/N
C4591001
1044
10441266/
BNT162b2 (30
μg) 14/F/
WHITE SKIN Acne/
Worsening of acne2 07JAN2021 11/26 1 No O NA/TC R
(01FEB2021)N/N
C4591001
1044
10441267/
Placebo 14/M/
WHITE INJ&P Fall/
Accidental fall 2 29APR2021 123/35 2 No O NA/TC R
(02JUN2021)N/N
Hand fracture/
thumb fracture2 29APR2021 123/35 2 No O NA/TC R
(02JUN2021)N/N
C4591001
1044
10441275/
Placebo 12/F/
WHITE MUSC Myalgia/
myalgia 2 04JAN2021 7/1 1 Yes NA/TC R
(04JAN2021)N/N
C4591001
1044 15/M/
WHITE GENRL Injection site pain/
injection site pain#4 25MAR2021 2/1 1 Yes NA R
(25MAR2021)N/N
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FDA-CBER-2022-5812-0224135
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
10441282/
Placebo
C4591001
1044
10441284/
Placebo 15/M/
WHITE PSYCH Depression/
depression 2 01FEB2021 35/C 1 No O NA/TC RG N/N
PSYCH Anxiety/
Anxiet y2 27APR2021 120/C 2 No O NA/TC RG N/N
C4591001
1044
10441285/
BNT162b2 (30
μg) 15/F/
WHITE SURG Wisdom teeth
removal/
Wisdom teeth
extraction 2 22JUN2021 175/1 2 No O NA R
(22JUN2021)N/N
C4591001
1044
10441292/
Placebo 15/M/
WHITE GENRL Oedema peripheral/
Edema Toes
(Bilateral) 1 17DEC2020 1/3 1 No O NA/TC R
(19DEC2020)N/N
C4591001
1044
10441300/
BNT162b2 (30
μg) 15/M/
WHITE GASTR Abdominal pain
upper/
Stomach pain# 2 31AUG2021 226/2 1 No O NA R
(01SEP2021)N/N
C4591001
1044
10441303/
Placebo 15/M/
WHITE GENRL Injection site pain/
Injection site pain#3 20APR2021 1/4 1 Yes NA R
(23APR2021)N/N
MUSC Myalgia/
generlized Muscle
aches#3 20APR2021 1/3 1 Yes NA R
(22APR2021)N/N
C4591001
1044 15/F/
WHITE SKIN Rash/
generalized rash2 25FEB2021 38/3 1 No O NA/TC R
(27FEB2021)N/N
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FDA-CBER-2022-5812-0224136
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
10441304/
BNT162b2 (30
μg)
C4591001
1044
10441309/
BNT162b2 (30
μg) 12/M/
WHITE EYE Eye pain/
Ocular Pain in Right
Eye 2 12MAY2021 115/3 2 No O NA R
(14MAY2021)N/N
C4591001
1044
10441320/
Placebo 15/M/
WHITE GENRL Chills/
chills# 4 04JUN2021 1/2 1 Yes NA R
(05JUN2021)N/N
NERV Headache/
headache#4 04JUN2021 1/2 1 Yes NA R
(05JUN2021)N/N
C4591001
1044
10441328/
BNT162b2 (30
μg) 15/F/
WHITE INFEC Pilonidal cyst/
Pilonidal cyst 2 22APR2021 87/C 2 No O NA/TCN RG N/N
C4591001
1044
10441335/
Placebo 15/F/
WHITE SKIN Acne/
Worsening of acne2 27FEB2021 30/C 1 No O NA/TC RG N/N
C4591001
1044
10441337/
Placebo 13/M/
WHITE INJ&P Humerus fracture/
Broken humerus
(right arm) 1 10JAN2021 3/34 2 No O NA/TC R
(12FEB2021)N/N
C4591001
1044
10441338/
Placebo 13/F/
WHITE NEOPL Skin papilloma/
Wart on second toe
(left) 2 01FEB2021 4/7 1 No O NA/TC R
(07FEB2021)N/N
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FDA-CBER-2022-5812-0224137
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1044
10441345/
Placebo 12/F/
WHITE GASTR Nausea/
nausea# 4 07JUN2021 1/2 1 Yes NA/TC R
(08JUN2021)N/N
Vomiting/
vomittin g#4 07JUN2021 1/2 1 Yes NA R
(08JUN2021)N/N
MUSC Myalgia/
generalized
myalgia#4 07JUN2021 1/C 2 Yes NA/TC RG N/N
NERV Dizziness/
dizziness#4 07JUN2021 1/1 2 Yes NA R
(07JUN2021)N/N
C4591001
1044
10441351/
Placebo 15/M/
WHITE INJ&P Muscle strain/
Left hip flexor strain2 11FEB2021 11/17 2 No O NA/TC R
(27FEB2021)N/N
C4591001
1044
10441354/
Placebo 13/F/
WHITE PSYCH Attention deficit
hyperactivity
disorder/
Worsening of
ADHD2 24APR2021 86/C 1 No O NA/TC N N/N
C4591001
1044
10441361/
BNT162b2 (30
μg) 15/M/
WHITE INJ&P Concussion/
Concussion 1 23JAN2021 13/22 1 No O NA R
(13FEB2021)N/N
SKIN Dermatitis contact/
allergic contact
dermatitis involving
all extremities
(contact with poison
sumac)2 24APR2021 81/C 1 No O NA/TC RG N/N
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FDA-CBER-2022-5812-0224138
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1044
10441364/
BNT162b2 (30
μg) 15/F/
WHITE PSYCH Attention deficit
hyperactivity
disorder/
attention deficit
hyperactivity
disorde r2 29APR2021 86/ 1 No O NA/TC R N/N
CARD Tachycardia/
Tach ycardia#2 19AUG2021 198/C 1 No O NA RG N/N
NERV Dizziness/
Lightheadedness#2 19AUG2021 198/C 1 No O NA RG N/N
C4591001
1044
10441373/
Placebo 14/F/
WHITE SKIN Urticaria/
hives forehead 1 12JAN2021 1/1 1 Yes NA R
(12JAN2021)N/N
PSYCH Anxiety/
Worsening of
Anxiet y2 05MAR2021 30/C 2 No O NA/TC RG N/N
C4591001
1044
10441384/
Placebo 13/M/
WHITE MUSC Tendonitis/
Achilles tendinitis 2 08MAR2021 33/C 2 No O NA/TC RG N/N
RESP Nasal congestion/
nasal con gestion2 07MAY2021 93/C 1 No O NA/TC RG N/N
C4591001
1057
10571387/
Placebo 14/F/
WHITE MUSC Pain in extremity/
ARM SORENESS#4 23JUN2021 1/2 1 Yes NA R
(24JUN2021)N/N
C4591001
1057
10571389/
Placebo 12/F/
WHITE GENRL Fatigue/
FATIGUE# 2 24MAY2021 141/1 1 Yes NA R
(24MAY2021)N/N
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FDA-CBER-2022-5812-0224139
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Injection site pain/
LEFT ARM
INJECTION SITE
SORNESS#2 24MAY2021 141/1 1 Yes NA R
(24MAY2021)N/N
C4591001
1057
10571407/
Placebo 15/M/
WHITE GENRL Fatigue/
FATIGUE# 4 02APR2021 1/3 1 Yes NA R
(04APR2021)N/N
Injection site pain/
RIGHT ARM
INJECTION SITE
SORENESS#4 02APR2021 1/3 1 Yes NA R
(04APR2021)N/N
C4591001
1057
10571408/
Placebo 14/M/
WHITE GASTR Nausea/
NAUSEA# 3 25MAY2021 1/2 1 Yes NA R
(26MAY2021)N/N
NERV Headache/
HEADACHE#3 25MAY2021 1/2 1 Yes NA R
(26MAY2021)N/N
C4591001
1057
10571431/
Placebo 13/M/
WHITE GENRL Pain/
BODY ACHES# 4 21JUN2021 1/3 1 Yes NA R
(23JUN2021)N/N
C4591001
1057
10571432/
Placebo 12/F/
WHITE GENRL Fatigue/
FATIGUE# 4 01JUN2021 1/2 1 Yes NA R
(02JUN2021)N/N
Injection site pain/
LEFT ARM
INJECTION SITE
SORENESS#4 01JUN2021 1/2 1 Yes NA R
(02JUN2021)N/N
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FDA-CBER-2022-5812-0224140
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1057
10571434/
Placebo 13/M/
MULTIPLE GENRL Injection site pain/
PAIN AT
INJECTION SITE
LEFT DELTOID#4 29JUN2021 1/3 1 Yes NA R
(01JUL2021)N/N
MUSC Pain in extremity/
LEFT UPPER ARM
PAIN#4 29JUN2021 1/3 1 Yes NA R
(01JUL2021)N/N
C4591001
1057
10571441/
Placebo 13/M/
ASIAN MUSC Myalgia/
MUSCLE ACHES#4 09JUN2021 1/3 1 Yes NA R
(11JUN2021)N/N
C4591001
1057
10571451/
BNT162b2 (30
μg) 12/F/
WHITE INFEC Vulvovaginal
mycotic infection/
VAGINAL YEAST
INFECTION 1 13JAN2021 2/22 2 No O NA/TC R
(03FEB2021)N/N
C4591001
1066
10661410/
Placebo 13/F/
WHITE GENRL Injection site pain/
pain at injection
site# 4 09JUN2021 2/3 1 Yes NA R
(11JUN2021)N/N
C4591001
1066
10661422/
BNT162b2 (30
μg) 12/M/
WHITE SKIN Rash/
rash on torso 1 24DEC2020 3/5 1 No O NA R
(28DEC2020)N/N
C4591001
1077
10771275/
Placebo 13/M/
WHITE INJ&P Fall/
FALL 2 07MAY2021 137/1 1 No O NA R
(07MAY2021)N/N
Ligament sprain/
RIGHT WRIST
SPRAIN2 07MAY2021 137/19 1 No O NA/TC R
(25MAY2021)N/N
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FDA-CBER-2022-5812-0224141
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1077
10771278/
BNT162b2 (30
μg) 13/M/
WHITE GASTR Diarrhoea/
DIARRHEA 2 23DEC2020 1/2 2 Yes NA R
(24DEC2020)N/N
Vomiting/
VOMITING2 23DEC2020 1/1 1 Yes NA R
(23DEC2020)N/N
GENRL Fatigue/
FATIGUE2 23DEC2020 1/2 2 Yes NA R
(24DEC2020)N/N
Injection site pain/
RIGHT ARM
INJECTION SITE
PAIN2 23DEC2020 1/2 1 Yes NA R
(24DEC2020)N/N
Injection site
swelling/
INJECTION SITE
SWELLING2 23DEC2020 1/2 2 Yes NA R
(24DEC2020)N/N
Pyrexia/
FEVER2 23DEC2020 1/2 3 Yes NA/TC R
(24DEC2020)N/N
PSYCH Disorientation/
DISORIENTATION2 23DEC2020 1/1 2 Yes NA R
(23DEC2020)N/N
C4591001
1077
10771279/
BNT162b2 (30
μg) 13/M/
WHITE GASTR Oral mucosal
blistering/
ORAL/BUCCAL
BLISTERS 2 07JAN2021 4/4 2 Yes NA R
(10JAN2021)N/N
INJ&P Hand fracture/
RIGHT 5TH
METACARPAL
FRACTURE#2 18MAY2021 135/30 1 No O NA R
(16JUN2021)N/N
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FDA-CBER-2022-5812-0224142
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1077
10771280/
Placebo 14/F/
WHITE INJ&P Concussion/
CONCUSSION 2 08APR2021 95/14 1 No O NA R
(21APR2021)N/N
Fall/
FALL2 08APR2021 95/1 1 No O NA R
(08APR2021)N/N
C4591001
1077
10771285/
Placebo 14/F/
WHITE GENRL Injection site pain/
PAIN AT
INJECTION SITE#3 19MAY2021 2/3 1 Yes NA/TC R
(21MAY2021)N/N
C4591001
1077
10771295/
Placebo 15/M/
WHITE INJ&P Ligament rupture/
RIGHT KNEE ACL
TEAR# 4 29MAR2021 13/29 2 No O NA/TCN R
(26APR2021)N/N
Meniscus injury/
RIGHT KNEE
MENISCUS TEAR#4 29MAR2021 13/29 2 No O NA R
(26APR2021)N/N
Sports injury/
FOOTBALL
INJURY#4 29MAR2021 13/1 2 No O NA R
(29MAR2021)N/N
C4591001
1077
10771298/
Placebo 14/M/
WHITE GENRL Fatigue/
FATIGUE# 4 04JUN2021 1/2 1 Yes NA R
(05JUN2021)N/N
C4591001
1077
10771300/
BNT162b2 (30
μg) 15/F/
WHITE REPRO Amenorrhoea/
AMENORRHEA 1 12JAN2021 6/80 1 No O NA R
(01APR2021)N/N
C4591001
1084 15/F/
WHITE INFEC Ear infection/
L Ear infection2 28JAN2021 11/9 2 No O NA/TC R
(05FEB2021)N/N
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FDA-CBER-2022-5812-0224143
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
10841556/
BNT162b2 (30
μg)
C4591001
1084
10841558/
BNT162b2 (30
μg) 15/F/
WHITE INJ&P Ligament sprain/
left sprained ankle 2 27JAN2021 10/2 2 No O NA/TC R
(28JAN2021)N/N
C4591001
1084
10841560/
Placebo 15/M/
WHITE PSYCH Obsessive-
compulsive disorder/
Obsessive
compulsive disorde r2 09FEB2021 19/C 2 No O NA/TC N N/N
C4591001
1084
10841569/
Placebo 14/F/
WHITE NERV Headache/
Headache 2 29JAN2021 8/15 1 No O NA R
(12FEB2021)N/N
C4591001
1091
10911406/
BNT162b2 (30
μg) 14/M/
WHITE PSYCH Panic attack/
Panic attacks 2 25FEB2021 60/C 2 No O NA N N/N
INJ&P Upper limb fracture/
Broken ri ght arm2 25MAY2021 149/C 3 No O NA/TCN RG N/N
C4591001
1091
10911411/
Placebo 15/M/
WHITE GASTR Tooth impacted/
Tooth impaction# 4 15JUL2021 22/1 2 No O NA R
(15JUL2021)N/N
C4591001
1091
10911414/
BNT162b2 (30
μg) 14/M/
WHITE GENRL Injection site pain/
Injection site pain#2 26MAY2021 2/2 1 Yes NA R
(27MAY2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1091
10911417/
Placebo 13/F/
WHITE GENRL Injection site pain/
Injection site pain
left arm# 3 18MAY2021 1/1 1 Yes NA R
(18MAY2021)N/N
Pyrexia/
Fever#3 18MAY2021 1/1 1 Yes NA/TC R
(18MAY2021)N/N
C4591001
1091
10911422/
BNT162b2 (30
μg) 15/F/
WHITE INFEC Ear infection/
left ear infection 1 23DEC2020 10/8 1 No O NA/TC R
(30DEC2020)N/N
Otitis externa/
outer ear infection
left ea r1 23DEC2020 10/8 1 No O NA/TC R
(30DEC2020)N/N
Otitis media/
middle ear infection
left ea r1 23DEC2020 10/8 1 No O NA/TC R
(30DEC2020)N/N
C4591001
1091
10911423/
Placebo 14/F/
BLACK OR
AFRICAN
AMERICAN GASTR Diarrhoea/
Diarrhea# 4 22JUL2021 2/2 1 Yes NA R
(23JUL2021)N/N
Vomiting/
Vomittin g#4 22JUL2021 2/2 1 Yes NA R
(23JUL2021)N/N
MUSC Myalgia/
Myalgia#4 22JUL2021 2/2 1 Yes NA RS
(23JUL2021)N/N
NERV Headache/
Headache#4 22JUL2021 2/2 1 Yes NA R
(23JUL2021)N/N
C4591001
1091
10911433/
Placebo 14/M/
WHITE SKIN Rash/
intermittent rash on
wrist 1 19DEC2020 3/C 1 No O NA N N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1091
10911447/
BNT162b2 (30
μg) 15/M/
WHITE INFEC Appendicitis/
Appendicitis# 2 09JUL2021 177/2 2 No O NA/TCN R
(10JUL2021)Y/N
C4591001
1091
10911463/
Placebo 15/M/
WHITE GASTR Tooth impacted/
Wisdom teethth
impaction 2 27APR2021 91/11 1 No O NA/TCN R
(07MAY2021)N/N
C4591001
1123
11231440/
BNT162b2 (30
μg) 13/M/
WHITE INFEC Otitis media/
Left otitis media# 2 13AUG2021 229/9 2 No O NA/TC R
(21AUG2021)N/N
C4591001
1123
11231442/
Placebo 12/M/
WHITE NERV Headache/
headache 1 16DEC2020 8/2 1 No O NA/TC R
(17DEC2020)N/N
PSYCH Depression/
Depression1 23DEC2020 15/164 2 No O NA/TC R
(04JUN2021)N/N
PSYCH Depression/
worsening of
depression2 MAR2021 57/ 1 No O NA/TC R
(04JUN2021)N/N
C4591001
1123
11231448/
Placebo 13/M/
BLACK OR
AFRICAN
AMERICAN GASTR Diarrhoea/
Diarrhea 1 16DEC2020 6/3 1 Yes NA R
(18DEC2020)N/N
C4591001
1123
11231472/
BNT162b2 (30
μg) 15/F/
WHITE INFEC Tinea capitis/
Tinea capitis 1 01JAN2021 12/43 1 No O NA/TC R
(12FEB2021)N/N
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Page 60
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
SKIN Acne/
worsening of acne
vulgaris1 07JAN2021 18/C 1 No O NA/TC N N/N
C4591001
1123
11231473/
Placebo 15/F/
WHITE INJ&P Hand fracture/
avulsion fracture
right middle finger2 11APR2021 90/C 2 No O NA/TC/TCN RG N/N
C4591001
1123
11231489/
BNT162b2 (30
μg) 13/M/
WHITE INJ&P Meniscus injury/
Torn medial and
lateral left knee
menisci 2 MAR2021 50/C 1 No O NA/TC RG N/N
C4591001
1123
11231507/
BNT162b2 (30
μg) 14/F/
WHITE PSYCH Depression/
Worsening of
Depression 2 19JAN2021 2/5 2 No O NA/TC R
(23JAN2021)Y/N
PSYCH Attention deficit
hyperactivity
disorder/
WORSENING
Attention Deficit
Hyper Activity
Disorde r2 01MAR2021 43/C 1 No O NA/TC N N/N
C4591001
1123
11231520/
Placebo 12/M/
WHITE INFEC Conjunctivitis/
Bilateral
conjunctivitis 1 12JAN2021 14/6 1 No O NA/TC R
(17JAN2021)N/N
C4591001
1123
11231523/
Placebo 12/M/
WHITE EYE Retinal
haemorrhage/
INTRA RETINAL 2 16FEB2021 22/C 2 No O NA RG N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
HEMORRHAGE
OD
C4591001
1124
11241245/
BNT162b2 (30
μg) 14/F/
WHITE PSYCH Anxiety/
Anxiety 2 MAR2021 55/C 2 No O NA/TC RG N/N
Depression/
Depression2 MAR2021 55/C 2 No O NA/TC RG N/N
C4591001
1124
11241251/
BNT162b2 (30
μg) 15/F/
WHITE GENRL Pyrexia/
Fever (102.2 degrees
F) 2 09JAN2021 2/1 3 Yes NA/TC R
(09JAN2021)N/N
C4591001
1125
11251248/
Placebo 15/M/
WHITE GENRL Fatigue/
Fatigue 2 05JAN2021 7/4 1 Yes NA/TC R
(08JAN2021)N/N
C4591001
1126
11261233/
Placebo 14/M/
WHITE GENRL Fatigue/
Fatigue# 3 19MAY2021 1/2 1 Yes NA R
(20MAY2021)N/N
Injection site pain/
Left Upper Arm
Injection Site Pain#3 19MAY2021 1/3 2 Yes NA R
(21MAY2021)N/N
MUSC Myalgia/
Muscle Aches#3 20MAY2021 2/2 2 Yes NA R
(21MAY2021)N/N
GENRL Fatigue/
Fatigue#4 09JUN2021 1/4 2 Yes NA R
(12JUN2021)N/N
C4591001
1126 12/F/
WHITE SKIN Photosensitivity
reaction/3 23MAY2021 6/4 2 No O NA/TC/TCN R
(26MAY2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
11261235/
Placebo Phyto
photodermatitis,
bilateral hands#
GENRL Pain/
Generalized body
aches#4 09JUN2021 2/1 1 Yes NA/TC R
(09JUN2021)N/N
Pyrexia/
Fever#4 09JUN2021 2/1 1 Yes NA/TC R
(09JUN2021)N/N
C4591001
1126
11261239/
Placebo 15/F/
WHITE GENRL Injection site pain/
Left arm injection
site pain# 3 17MAY2021 1/3 2 Yes NA R
(19MAY2021)N/N
GENRL Fatigue/
Fatigue#4 07JUN2021 1/2 2 Yes NA R
(08JUN2021)N/N
Injection site pain/
Pain, in jection site#4 07JUN2021 1/2 2 Yes NA R
(08JUN2021)N/N
Pain/
Generalized body
aches#4 07JUN2021 1/2 2 Yes NA R
(08JUN2021)N/N
Pyrexia/
Fever#4 07JUN2021 1/2 2 Yes NA/TC R
(08JUN2021)N/N
C4591001
1126
11261240/
Placebo 15/M/
WHITE GENRL Injection site pain/
Pain, injection site#3 21MAY2021 1/2 2 Yes NA R
(22MAY2021)N/N
GENRL Fatigue/
Fatigue#4 10JUN2021 1/2 1 Yes NA R
(11JUN2021)N/N
Injection site pain/
Pain, in jection site#4 10JUN2021 1/2 1 Yes NA R
(11JUN2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Pain/
Generalized body
aches#4 10JUN2021 1/2 1 Yes NA R
(11JUN2021)N/N
C4591001
1126
11261246/
BNT162b2 (30
μg) 13/M/
WHITE MUSC Pain in extremity/
Right leg pain 2 31DEC2020 9/C 1 No O NA N N/N
GASTR Aphthous ulcer/
Canker sore under
tongue2 12JAN2021 21/4 1 No O NA R
(15JAN2021)N/N
GENRL Nodule/
Red bump on right
index finger at
cuticle2 13JAN2021 22/50 1 No O NA R
(03MAR2021)N/N
C4591001
1126
11261250/
Placebo 12/M/
WHITE GENRL Injection site pain/
Pain, Injection Site#3 19MAY2021 1/2 1 Yes NA R
(20MAY2021)N/N
GENRL Fatigue/
Fatigue#4 15JUN2021 1/2 1 Yes NA R
(16JUN2021)N/N
Injection site pain/
Pain, in jection site#4 15JUN2021 1/2 1 Yes NA R
(16JUN2021)N/N
C4591001
1126
11261253/
Placebo 13/M/
WHITE GENRL Chills/
Chills# 3 17MAY2021 1/1 2 Yes NA R
(17MAY2021)N/N
Injection site pain/
Left arm injection
site pain#3 17MAY2021 1/3 1 Yes NA/TC R
(19MAY2021)N/N
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Page 64
FDA-CBER-2022-5812-0224150
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
MUSC Myalgia/
Muscle aches#3 17MAY2021 1/3 2 Yes NA/TC R
(19MAY2021)N/N
GENRL Fatigue/
Fatigue#3 18MAY2021 2/2 2 Yes NA R
(19MAY2021)N/N
GENRL Fatigue/
Fatigue#4 08JUN2021 1/2 1 Yes NA R
(09JUN2021)N/N
C4591001
1126
11261254/
Placebo 15/M/
WHITE IMMUN Food allergy/
Allergic reaction,
nuts 1 09DEC2020 7/1 2 No O NA/TC R
(09DEC2020)N/N
GENRL Chills/
Chills#3 23JUN2021 2/1 1 Yes NA R
(23JUN2021)N/N
Injection site pain/
Injection site pain#3 23JUN2021 2/3 1 Yes NA R
(25JUN2021)N/N
Malaise/
Malaise#3 23JUN2021 2/1 1 Yes NA R
(23JUN2021)N/N
NERV Headache/
Headache#3 23JUN2021 2/1 1 Yes NA R
(23JUN2021)N/N
GENRL Fatigue/
Fatigue#4 12JUL2021 1/2 1 Yes NA R
(13JUL2021)N/N
NERV Headache/
Headache#4 12JUL2021 1/2 1 Yes NA R
(13JUL2021)N/N
C4591001
1126
11261262/
Placebo 15/F/
WHITE GENRL Injection site pain/
Left upper arm
injection site pain#3 10FEB2021 1/3 1 Yes NA R
(12FEB2021)N/N
GENRL Malaise/
Malaise#4 03MAR2021 1/2 2 Yes NA R
(04MAR2021)N/N
NERV Headache/
Headache#4 03MAR2021 1/2 1 Yes NA R
(04MAR2021)N/N
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Page 65
FDA-CBER-2022-5812-0224151
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GENRL Injection site pain/
Injection site pain#4 04MAR2021 2/3 1 Yes NA R
(06MAR2021)N/N
C4591001
1126
11261263/
BNT162b2 (30
μg) 15/M/
WHITE BLOOD Lymphadenopathy/
LEFT AXILLA
LYMPH NODE
SWELLING 1 10DEC2020 7/4 1 Yes NA R
(13DEC2020)N/N
INJ&P Fall/
Mechanical Fall1 20DEC2020 17/1 2 No O NA R
(20DEC2020)N/N
Radius fracture/
RIGHT DISTAL
RADIUS TORUS
FRACTURE1 20DEC2020 17/32 2 No O NA/TC R
(20JAN2021)N/N
C4591001
1126
11261265/
Placebo 14/M/
WHITE GENRL Injection site pain/
Pain, injection site#3 20MAY2021 2/4 1 Yes NA R
(23MAY2021)N/N
GENRL Injection site pain/
Pain, in jection site#4 14JUN2021 1/2 1 Yes NA R
(15JUN2021)N/N
C4591001
1126
11261266/
Placebo 12/F/
WHITE GENRL Injection site pain/
Pain, Injection site#3 19MAY2021 1/2 1 Yes NA R
(20MAY2021)N/N
GENRL Injection site pain/
Pain, in jection site#4 15JUN2021 2/1 1 Yes NA R
(15JUN2021)N/N
C4591001
1126
11261267/
Placebo 13/M/
WHITE GENRL Injection site pain/
Left upper arm
injection site pain#3 21MAY2021 1/3 2 Yes NA/TC R
(23MAY2021)N/N
GENRL Fatigue/
Fatigue#3 22MAY2021 2/1 2 Yes NA R
(22MAY2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GENRL Fatigue/
Fatigue#4 11JUN2021 1/3 2 Yes NA R
(13JUN2021)N/N
Injection site pain/
PAIN, INJECTION
SITE#4 11JUN2021 1/3 2 Yes NA/TC R
(13JUN2021)N/N
Pain/
GENERALIZED
BODY ACHES#4 11JUN2021 1/3 2 Yes NA/TC R
(13JUN2021)N/N
Pyrexia/
Fever#4 11JUN2021 1/2 2 Yes NA/TC R
(12JUN2021)N/N
C4591001
1126
11261268/
BNT162b2 (30
μg) 13/F/
WHITE SKIN Urticaria/
Facial Urticaria,
worsening 1 18DEC2020 5/14 1 No O NA R
(31DEC2020)N/N
MUSC Osteochondrosis/
Juvenile
Osteochondrosis of
bilateral fifth
metatarsals1 28DEC2020 15/C 2 No O NA/TC/TCN RG N/N
C4591001
1126
11261270/
Placebo 15/M/
WHITE GENRL Injection site pain/
Left upper arm
injection site pain#2 20MAY2021 135/2 1 Yes NA R
(21MAY2021)N/N
GENRL Fatigue/
Fatigue#4 11JUN2021 2/2 1 Yes NA R
(12JUN2021)N/N
C4591001
1126
11261271/
BNT162b2 (30
μg) 15/M/
WHITE INV SARS-CoV-2
antibody test
positive/
SARS-COV-2 IGG,
QL, IA - Positive2 21JAN2021 16/C 1 Yes NA N N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1126
11261274/
Placebo 15/F/
WHITE GENRL Injection site pain/
Left upper arm
injection site pain#3 20MAY2021 1/3 2 Yes NA/TC R
(22MAY2021)N/N
NERV Headache/
Headache#3 21MAY2021 2/1 2 Yes NA/TC R
(21MAY2021)N/N
GENRL Injection site pain/
Pain, in jection site#4 11JUN2021 2/3 1 Yes NA R
(13JUN2021)N/N
C4591001
1126
11261275/
Placebo 15/F/
WHITE GENRL Injection site pain/
Left upper arm
injection site pain#3 08FEB2021 1/3 1 Yes NA/TC R
(10FEB2021)N/N
GENRL Chills/
Chills#3 09FEB2021 2/1 2 Yes NA/TC R
(09FEB2021)N/N
NERV Headache/
Headache#3 09FEB2021 2/1 2 Yes NA/TC R
(09FEB2021)N/N
C4591001
1126
11261276/
Placebo 15/M/
WHITE GENRL Injection site pain/
Left upper arm
injection site pain#3 08FEB2021 1/3 2 Yes NA/TC R
(10FEB2021)N/N
GENRL Pyrexia/
Fever#3 09FEB2021 2/1 1 Yes NA/TC R
(09FEB2021)N/N
NERV Headache/
Headache#3 09FEB2021 2/1 2 Yes NA/TC R
(09FEB2021)N/N
GENRL Malaise/
Malaise#4 03MAR2021 1/2 1 Yes NA R
(04MAR2021)N/N
NERV Headache/
Headache#4 03MAR2021 1/2 1 Yes NA R
(04MAR2021)N/N
C4591001
1126 15/M/
WHITE GENRL Injection site pain/
Left upper arm
injection site pain#3 20MAY2021 1/4 1 Yes NA/TC R
(23MAY2021)N/N
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FDA-CBER-2022-5812-0224154
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
11261279/
Placebo
GENRL Chills/
Chills#3 21MAY2021 2/1 2 Yes NA R
(21MAY2021)N/N
GENRL Fatigue/
Fatigue#4 11JUN2021 1/3 2 Yes NA R
(13JUN2021)N/N
Pain/
Body aches#4 11JUN2021 1/3 2 Yes NA R
(13JUN2021)N/N
Pyrexia/
Fever#4 11JUN2021 1/1 1 Yes NA R
(11JUN2021)N/N
C4591001
1126
11261280/
Placebo 12/M/
WHITE GENRL Injection site pain/
Left upper arm
injection site pain#3 20MAY2021 1/3 2 Yes NA/TC R
(22MAY2021)N/N
MUSC Myalgia/
Muscle aches#3 21MAY2021 2/1 2 Yes NA/TC R
(21MAY2021)N/N
GENRL Fatigue/
Fatigue#4 11JUN2021 1/3 2 Yes NA R
(13JUN2021)N/N
Pain/
Body aches#4 11JUN2021 1/3 2 Yes NA R
(13JUN2021)N/N
Pyrexia/
Fever#4 11JUN2021 1/1 1 Yes NA R
(11JUN2021)N/N
C4591001
1126
11261283/
Placebo 13/F/
ASIAN GENRL Fatigue/
Fatigue# 3 18MAY2021 2/2 2 Yes NA R
(19MAY2021)N/N
Injection site pain/
Right Arm Injection
Site Pain#3 18MAY2021 2/2 2 Yes NA/TC R
(19MAY2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
NERV Headache/
Headache#3 18MAY2021 2/1 2 Yes NA/TC R
(18MAY2021)N/N
GENRL Fatigue/
Fatigue#4 10JUN2021 2/1 1 Yes NA R
(10JUN2021)N/N
C4591001
1126
11261284/
Placebo 13/F/
ASIAN GENRL Injection site pain/
Pain, injection site 2 07JAN2021 2/153 2 Yes NA R
(08JUN2021)N/N
GENRL Fatigue/
Fatigue#3 18MAY2021 2/3 1 Yes NA R
(20MAY2021)N/N
Injection site pain/
Injection site pain#3 18MAY2021 2/3 1 Yes NA R
(20MAY2021)N/N
Pyrexia/
Fever, 101F#3 18MAY2021 2/1 2 Yes NA/TC R
(18MAY2021)N/N
C4591001
1126
11261287/
Placebo 15/M/
WHITE GENRL Injection site
hypoaesthesia/
Injection Site
numbness#3 20MAY2021 1/2 1 Yes NA R
(21MAY2021)N/N
GENRL Injection site pain/
Pain, in jection site#4 11JUN2021 2/1 2 Yes NA R
(11JUN2021)N/N
Injection site
swelling/
Swelling, injection
site#4 11JUN2021 2/1 2 Yes NA R
(11JUN2021)N/N
C4591001
1126
11261289/
Placebo 14/F/
WHITE GENRL Fatigue/
Fatigue# 3 17MAY2021 1/2 2 Yes NA R
(18MAY2021)N/N
Injection site pain/
Pain, In jection Site#3 17MAY2021 1/3 2 Yes NA R
(19MAY2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1126
11261290/
Placebo 12/M/
NOT
REPORTED SKIN Pityriasis rosea/
Worsening Pityriasis
Rosea 1 23DEC2020 7/28 2 No O NA/TC R
(19JAN2021)N/N
GENRL Fatigue/
Fatigue#3 18MAY2021 1/4 2 Yes NA/TC R
(21MAY2021)N/N
GENRL Chills/
Chills#3 19MAY2021 2/3 1 Yes NA/TC R
(21MAY2021)N/N
Injection site pain/
Injection Site Pain#3 19MAY2021 2/3 1 Yes NA/TC R
(21MAY2021)N/N
GENRL Fatigue/
Fatigue#4 09JUN2021 1/2 1 Yes NA R
(10JUN2021)N/N
Injection site pain/
Pain, in jection site#4 09JUN2021 1/4 1 Yes NA R
(12JUN2021)N/N
C4591001
1126
11261292/
Placebo 12/F/
ASIAN GENRL Chills/
Chills# 3 17MAY2021 1/1 2 Yes NA/TC R
(17MAY2021)N/N
Injection site pain/
Left arm injection
site pain#3 17MAY2021 1/3 2 Yes NA/TC R
(19MAY2021)N/N
GENRL Fatigue/
Fatigue#3 18MAY2021 2/2 2 Yes NA R
(19MAY2021)N/N
MUSC Myalgia/
Muscle aches#3 18MAY2021 2/2 2 Yes NA/TC R
(19MAY2021)N/N
NERV Headache/
Headache#3 18MAY2021 2/2 1 Yes NA/TC R
(19MAY2021)N/N
GENRL Chills/
Chills#4 07JUN2021 1/2 2 Yes NA R
(08JUN2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Pain/
Generalized body
aches#4 07JUN2021 1/2 2 Yes NA R
(08JUN2021)N/N
Pyrexia/
Fever#4 07JUN2021 1/2 1 Yes NA R
(08JUN2021)N/N
GENRL Fatigue/
Fatigue#4 08JUN2021 2/2 2 Yes NA R
(09JUN2021)N/N
NERV Headache/
Headache#4 08JUN2021 2/2 1 Yes NA R
(09JUN2021)N/N
C4591001
1126
11261294/
Placebo 13/F/
WHITE GENRL Fatigue/
Fatigue# 3 17JUL2021 2/2 2 Yes NA R
(18JUL2021)N/N
Injection site pain/
Injection Site Pain#3 17JUL2021 2/3 1 Yes NA R
(19JUL2021)N/N
GENRL Injection site pain/
Injection site pain#4 07AUG2021 2/2 1 Yes NA R
(08AUG2021)N/N
C4591001
1126
11261296/
Placebo 15/M/
WHITE INJ&P Accident/
Dirt bike nontraffic
accident 2 24JAN2021 17/1 2 No O NA/TC/TCN R
(24JAN2021)N/N
Contusion/
Left elbow contusion2 24JAN2021 17/8 1 No O NA/TCN R
(31JAN2021)N/N
Lip injury/
Lower lip laceration2 24JAN2021 17/13 1 No O NA/TC/TCN R
(05FEB2021)N/N
Tooth fracture/
Three teeth fractures2 24JAN2021 17/1 2 No O NA/TC/TCN R
(24JAN2021)N/N
GENRL Injection site pain/
Pain in jection site#3 08APR2021 2/2 1 Yes NA R
(09APR2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GENRL Injection site pain/
Injection site pain#4 27APR2021 2/2 1 Yes NA R
(28APR2021)N/N
C4591001
1126
11261297/
Placebo 13/M/
WHITE GENRL Injection site pain/
Left Upper Arm
Injection Site Pain#3 19MAY2021 1/3 2 Yes NA R
(21MAY2021)N/N
GENRL Injection site pain/
Injection site pain#4 09JUN2021 1/2 1 Yes NA R
(10JUN2021)N/N
C4591001
1126
11261300/
Placebo 13/M/
ASIAN GENRL Injection site pain/
Left upper arm
injection site pain#3 19MAY2021 1/2 2 Yes NA/TC R
(20MAY2021)N/N
GENRL Pain/
Generalized body
aches#4 12JUN2021 2/2 1 Yes NA/TC R
(13JUN2021)N/N
C4591001
1126
11261301/
BNT162b2 (30
μg) 15/F/
WHITE GASTR Nausea/
Nausea 1 24DEC2020 3/2 2 Yes NA R
(25DEC2020)N/N
C4591001
1126
11261302/
Placebo 14/M/
WHITE GENRL Injection site pain/
Left upper arm
injection site pain#3 21MAY2021 1/2 1 Yes NA R
(22MAY2021)N/N
GENRL Injection site pain/
Injection site pain#4 11JUN2021 1/3 1 Yes NA R
(13JUN2021)N/N
C4591001
1126
11261305/
Placebo 15/M/
WHITE GENRL Injection site pain/
Left Upper Arm
Injection Site Pain#3 24FEB2021 1/2 2 Yes NA R
(25FEB2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GENRL Injection site pain/
Injection site pain#4 17MAR2021 1/2 1 Yes NA R
(18MAR2021)N/N
C4591001
1126
11261306/
Placebo 12/M/
WHITE GENRL Injection site pain/
Left upper arm
injection site pain#3 18MAY2021 1/3 2 Yes NA R
(20MAY2021)N/N
C4591001
1126
11261307/
BNT162b2 (30
μg) 14/F/
WHITE NERV Migraine/
Migraine headache,
worsening 1 24JAN2021 21/C 2 No O NA/TC RG N/N
C4591001
1126
11261308/
Placebo 12/M/
WHITE GENRL Pyrexia/
Fever 101`F# 3 19JUN2021 2/1 2 Yes NA/TC R
(19JUN2021)N/N
GENRL Injection site pain/
Injection Site Pain#4 10JUL2021 2/3 1 Yes NA R
(12JUL2021)N/N
C4591001
1126
11261309/
BNT162b2 (30
μg) 12/M/
WHITE GASTR Lip swelling/
Swollen lips 2 26JAN2021 2/2 1 Yes NA R
(27JAN2021)N/N
Mouth swelling/
Swollen mouth2 26JAN2021 2/2 1 Yes NA R
(27JAN2021)N/N
C4591001
1126
11261311/
Placebo 13/M/
WHITE GENRL Injection site pain/
Injection site pain#3 02JUN2021 1/2 1 Yes NA R
(03JUN2021)N/N
GENRL Malaise/
Malaise#4 22JUN2021 2/2 1 Yes NA R
(23JUN2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1126
11261312/
Placebo 14/F/
WHITE NERV Headache/
Headache 1 17JAN2021 13/5 2 No O NA R
(21JAN2021)N/N
GENRL Injection site pain/
Left upper arm
injection site pain#3 18MAY2021 1/3 1 Yes NA R
(20MAY2021)N/N
GENRL Injection site pain/
Pain, in jection site#4 09JUN2021 1/3 2 Yes NA/TC R
(11JUN2021)N/N
Pain/
Generalized body
aches#4 09JUN2021 1/3 2 Yes NA/TC R
(11JUN2021)N/N
Pyrexia/
Fever#4 09JUN2021 1/3 2 Yes NA/TC R
(11JUN2021)N/N
C4591001
1126
11261314/
Placebo 13/M/
WHITE SKIN Rash/
Skin rash L side of
neck to L scapula 2 01FEB2021 4/3 1 Yes NA/TC R
(03FEB2021)N/N
GENRL Fatigue/
Fatigue#3 19MAY2021 1/1 2 Yes NA R
(19MAY2021)N/N
Injection site pain/
Pain, in jection site#3 19MAY2021 1/3 2 Yes NA R
(21MAY2021)N/N
GENRL Pyrexia/
Fever#3 20MAY2021 2/1 2 Yes NA/TC R
(20MAY2021)N/N
NERV Headache/
Headache#3 20MAY2021 2/1 2 Yes NA R
(20MAY2021)N/N
C4591001
1126
11261317/
Placebo 12/F/
WHITE GENRL Injection site pain/
Injection Site Pain#3 17MAY2021 1/3 1 Yes NA R
(19MAY2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GENRL Injection site pain/
Injection site pain#4 09JUN2021 1/3 1 Yes NA R
(11JUN2021)N/N
GENRL Malaise/
Malaise#4 10JUN2021 2/3 1 Yes NA R
(12JUN2021)N/N
C4591001
1126
11261318/
Placebo 12/F/
WHITE GENRL Chills/
Chills# 3 05AUG2021 1/3 1 Yes NA R
(07AUG2021)N/N
Injection site pain/
Injection site pain#3 05AUG2021 1/3 1 Yes NA R
(07AUG2021)N/N
C4591001
1126
11261320/
Placebo 12/F/
WHITE GENRL Fatigue/
Fatigue# 3 18MAY2021 1/2 1 Yes NA R
(19MAY2021)N/N
Injection site pain/
Pain, in jection site#3 18MAY2021 1/2 1 Yes NA R
(19MAY2021)N/N
GENRL Injection site pain/
Pain, in jection site#4 09JUN2021 2/1 1 Yes NA R
(09JUN2021)N/N
C4591001
1126
11261322/
Placebo 13/M/
ASIAN GENRL Injection site pain/
Pain, Injection site#3 25MAY2021 2/4 2 Yes NA R
(28MAY2021)N/N
GENRL Fatigue/
Fatigue#4 14JUN2021 1/2 1 Yes NA R
(15JUN2021)N/N
Pain/
Generalized body
aches#4 14JUN2021 1/2 1 Yes NA R
(15JUN2021)N/N
NERV Headache/
Headache#4 14JUN2021 1/2 1 Yes NA R
(15JUN2021)N/N
C4591001
1126 12/F/
WHITE GENRL Chills/
Chills#3 18MAY2021 1/1 2 Yes NA R
(18MAY2021)N/N
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
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FDA-CBER-2022-5812-0224162
16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
11261325/
Placebo
Injection site pain/
Left upper arm
injection site pain#3 18MAY2021 1/3 1 Yes NA/TC R
(20MAY2021)N/N
GENRL Fatigue/
Fatigue#3 19MAY2021 2/1 1 Yes NA R
(19MAY2021)N/N
NERV Headache/
Headache#3 19MAY2021 2/1 1 Yes NA/TC R
(19MAY2021)N/N
GENRL Chills/
Body Chills#4 09JUN2021 2/1 1 Yes NA R
(09JUN2021)N/N
C4591001
1131
11311280/
Placebo 13/F/
WHITE NERV Presyncope/
vasovagal reaction
secondary to vaccine1 17DEC2020 1/1 2 Yes NA R
(17DEC2020)N/N
C4591001
1131
11311283/
Placebo 15/M/
WHITE INFEC Pilonidal cyst/
pilonidal cyst 1 29DEC2020 8/52 2 No O NA/TC R
(18FEB2021)N/N
C4591001
1131
11311285/
Placebo 14/F/
WHITE GENRL Injection site pain/
injection site pain#3 15JUN2021 2/2 1 Yes NA R
(16JUN2021)N/N
Pain/
body aches#3 15JUN2021 2/2 1 Yes NA R
(16JUN2021)N/N
NERV Headache/
headache#3 15JUN2021 2/2 1 Yes NA R
(16JUN2021)N/N
C4591001
1131
11311287/
Placebo 12/F/
BLACK OR
AFRICAN
AMERICAN RESP Rhinorrhoea/
rhinorrhea 1 17JAN2021 20/18 1 No O NA R
(03FEB2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
BLOOD Lymphadenopathy/
enlarge lymph nods-
neck(bilateral)2 27JAN2021 10/8 1 Yes NA R
(03FEB2021)N/N
INFEC Ear infection/
ear infection#4 01JUL2021 16/11 1 No O NA R
(11JUL2021)N/N
C4591001
1131
11311288/
Placebo 12/F/
BLACK OR
AFRICAN
AMERICAN GASTR Vomiting/
vomiting# 4 17JUN2021 2/1 1 No O NA R
(17JUN2021)N/N
GENRL Chest pain/
chest pain#4 17JUN2021 2/2 2 No O NA R
(18JUN2021)N/N
Pyrexia/
fever#4 17JUN2021 2/1 1 No O NA R
(17JUN2021)N/N
INFEC Pharyngitis
streptococcal/
strep throat#4 17JUN2021 2/3 1 No O NA R
(19JUN2021)N/N
MUSC Myalgia/
general m yalgia#4 17JUN2021 2/2 1 No O NA R
(18JUN2021)N/N
NERV Headache/
headache#4 17JUN2021 2/3 1 No O NA R
(19JUN2021)N/N
RESP Cough/
cough#4 17JUN2021 2/1 1 No O NA R
(17JUN2021)N/N
Nasal congestion/
nasal con gestion#4 17JUN2021 2/4 1 No O NA R
(20JUN2021)N/N
C4591001
1131
11311293/
Placebo 12/F/
WHITE GASTR Abdominal pain
upper/
Stomach ache# 4 03AUG2021 1/2 2 Yes NA/TC R
(04AUG2021)N/N
GENRL Pyrexia/
Low grade 4 03AUG2021 1/1 1 Yes NA/TC R
(03AUG2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
temperature
elevation#
C4591001
1131
11311299/
Placebo 15/M/
WHITE GENRL Injection site pain/
injection site pain#3 20MAY2021 1/3 1 Yes NA R
(22MAY2021)N/N
GASTR Nausea/
nausea#4 11JUN2021 2/1 1 Yes NA R
(11JUN2021)N/N
GENRL Pyrexia/
febrile#4 11JUN2021 2/1 2 Yes NA/TC R
(11JUN2021)N/N
C4591001
1131
11311300/
Placebo 13/F/
WHITE GENRL Injection site pain/
injection site pain#3 20MAY2021 1/4 2 Yes NA/TC R
(23MAY2021)N/N
INJ&P Sunburn/
sun burn(face and
shoulders)#3 07JUN2021 19/C 3 No O NA/TC RG N/N
GENRL Chills/
chills#4 10JUN2021 1/2 2 Yes NA/TC R
(11JUN2021)N/N
Pyrexia/
fever#4 10JUN2021 1/2 2 Yes NA/TC R
(11JUN2021)N/N
C4591001
1131
11311301/
BNT162b2 (30
μg) 13/M/
WHITE MUSC Arthralgia/
sacroiliac joint pain1 15JAN2021 5/25 2 No O NA R
(08FEB2021)N/N
INJ&P Accident/
skiin g acciden t2 18FEB2021 14/2 2 No O NA/TC/TCN R
(19FEB2021)N/N
INJ&P Clavicle fracture/
right clavicle
fracture2 19FEB2021 15/64 2 No O NA/TC/TCN R
(23APR2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1139
11391171/
Placebo 15/M/
WHITE INJ&P Skin laceration/
laceration of
forehead 2 10MAR2021 65/7 2 No O NA R
(16MAR2021)N/N
C4591001
1139
11391179/
BNT162b2 (30
μg) 15/M/
WHITE NERV Syncope/
syncope# 2 12JUL2021 186/1 2 No O NA R
(12JUL2021)N/N
C4591001
1139
11391210/
Placebo 14/M/
WHITE INJ&P Concussion/
Concussion# 3 08JUN2021 14/18 3 No O NA/TC R
(25JUN2021)N/N
Hyphaema/
traumatic hyphema
of left e ye#3 08JUN2021 14/18 2 No O NA/TC R
(25JUN2021)N/N
C4591001
1139
11391217/
Placebo 13/M/
WHITE INFEC Otitis externa/
Otitis Externa# 4 29JUN2021 22/8 1 No O NA/TC R
(06JUL2021)N/N
C4591001
1139
11391225/
BNT162b2 (30
μg) 12/F/
WHITE INJ&P Concussion/
concussion 2 01FEB2021 5/9 2 No O NA/TC R
(09FEB2021)N/N
C4591001
1139
11391246/
Placebo 15/M/
WHITE MUSC Arthralgia/
Bilateral knee pain1 11JAN2021 4/36 2 No O NA/TC R
(15FEB2021)N/N
C4591001
1139
11391248/ 15/M/
WHITE INJ&P Muscle strain/
Abdominal Muscle
Strain2 10MAR2021 41/4 1 No O NA R
(13MAR2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
BNT162b2 (30
μg)
C4591001
1140
11401330/
Placebo 12/M/
WHITE GENRL Injection site pain/
pain at injection
site# 3 17MAY2021 1/2 1 Yes NA R
(18MAY2021)N/N
GENRL Fatigue/
fatigue#4 09JUN2021 2/2 1 Yes NA R
(10JUN2021)N/N
Pyrexia/
fever#4 09JUN2021 2/2 1 Yes NA R
(10JUN2021)N/N
C4591001
1140
11401335/
Placebo 14/F/
WHITE GENRL Pyrexia/
fever# 3 17MAY2021 1/2 1 Yes NA R
(18MAY2021)N/N
C4591001
1140
11401338/
Placebo 15/F/
WHITE GENRL Injection site pain/
Pain at the injection
site# 3 17MAY2021 1/3 1 Yes NA RS
(19MAY2021)N/N
MUSC Myalgia/
Mayalgias#3 18MAY2021 2/2 1 Yes NA R
(19MAY2021)N/N
NERV Headache/
Headache#3 18MAY2021 2/2 1 Yes NA R
(19MAY2021)N/N
GENRL Injection site pain/
pain at injection
site#4 07JUN2021 1/C 1 Yes NA RG N/Y
C4591001
1140
11401343/
BNT162b2 (30
μg) 13/F/
AMERICAN
INDIAN OR
ALASKA
NATIVE NERV Migraine/
complex migraine 1 23DEC2020 3/1 3 Yes NA/TC/TCN R
(23DEC2020)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1140
11401353/
Placebo 12/M/
WHITE MUSC Neck pain/
neck pain 2 03FEB2021 23/3 2 No O NA/TC R
(05FEB2021)N/N
GENRL Injection site pain/
Pain at the injection
site#3 21MAY2021 1/3 1 Yes NA R
(23MAY2021)N/N
GENRL Pyrexia/
Fever#3 22MAY2021 2/2 1 Yes NA R
(23MAY2021)N/N
C4591001
1140
11401354/
BNT162b2 (30
μg) 15/F/
WHITE CONG Syringomyelia/
Thoracic spinal
syrinx# 2 JUN2021 140/C 3 No O NA/TC/TCN N Y/N
C4591001
1140
11401356/
Placebo 14/F/
MULTIPLE GENRL Fatigue/
Fatigue# 3 20MAY2021 1/2 1 Yes NA R
(21MAY2021)N/N
Injection site pain/
Pain at injection
site#3 20MAY2021 1/2 1 Yes NA R
(21MAY2021)N/N
Pyrexia/
Fever#3 20MAY2021 1/3 1 Yes NA R
(22MAY2021)N/N
NERV Headache/
Headache#3 20MAY2021 1/2 1 Yes NA R
(21MAY2021)N/N
C4591001
1140
11401357/
Placebo 15/F/
WHITE GENRL Chills/
Mild Chills 2 11JAN2021 1/2 1 Yes NA R
(12JAN2021)N/Y
Fatigue/
Mild Fati gue2 11JAN2021 1/2 1 Yes NA R
(12JAN2021)N/Y
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Injection site pain/
mild injection site
pain2 11JAN2021 1/2 1 Yes NA R
(12JAN2021)N/Y
C4591001
1140
11401362/
Placebo 14/M/
WHITE GENRL Injection site pain/
pain at injection
site# 3 17MAY2021 1/2 1 Yes NA R
(18MAY2021)N/N
C4591001
1140
11401364/
Placebo 14/M/
WHITE GENRL Injection site pain/
Pain at injection
site# 3 22MAY2021 2/3 1 Yes NA R
(24MAY2021)N/N
C4591001
1140
11401365/
BNT162b2 (30
μg) 15/M/
WHITE PSYCH Suicidal ideation/
Suicidal Ideation 2 04APR2021 76/2 3 No O NA/TC/TCN R
(05APR2021)Y/N
C4591001
1140
11401366/
Placebo 13/F/
WHITE GENRL Injection site pain/
Pain at injection
site# 3 22MAY2021 2/3 1 Yes NA R
(24MAY2021)N/N
C4591001
1140
11401372/
Placebo 13/F/
WHITE GENRL Injection site pain/
pain at injection
site# 3 18MAY2021 1/C 1 Yes NA RG N/Y
C4591001
1140
11401374/
Placebo 14/F/
WHITE GENRL Pain/
body aches# 3 28MAY2021 1/3 1 Yes NA/TC R
(30MAY2021)N/N
GASTR Vomiting/
vomitin g#3 30MAY2021 3/1 1 Yes NA R
(30MAY2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1140
11401383/
Placebo 14/M/
WHITE GENRL Injection site pain/
Pain at injection
site# 3 21MAY2021 1/3 1 Yes NA R
(23MAY2021)N/N
C4591001
1140
11401384/
Placebo 14/F/
WHITE GENRL Injection site pain/
Pain at injection
site# 3 18MAY2021 2/3 1 Yes NA R
(20MAY2021)N/N
C4591001
1140
11401385/
BNT162b2 (30
μg) 12/F/
WHITE IMMUN Seasonal allergy/
Seasonal Allergies 2 MAR2021 34/C 2 No O NA RG N/N
C4591001
1140
11401387/
Placebo 12/M/
WHITE INJ&P Contusion/
Left arm contusion#2 16MAY2021 109/8 1 No O NA/TCN R
(23MAY2021)N/N
C4591001
1140
11401388/
Placebo 15/M/
WHITE GENRL Fatigue/
fatigue# 3 19MAY2021 1/2 1 Yes NA R
(20MAY2021)N/N
Injection site pain/
pain at injection
site#3 19MAY2021 1/3 1 Yes NA R
(21MAY2021)N/N
NERV Headache/
headache#3 20MAY2021 2/1 1 Yes NA R
(20MAY2021)N/N
C4591001
1140
11401389/
Placebo 13/F/
WHITE GENRL Injection site pain/
pain at injection
site# 3 19MAY2021 1/3 1 Yes NA R
(21MAY2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1140
11401392/
Placebo 15/M/
WHITE GENRL Fatigue/
Fatigue# 3 19MAY2021 1/2 1 Yes NA R
(20MAY2021)N/N
Injection site pain/
Pain at injection
site#3 19MAY2021 1/1 1 Yes NA R
(19MAY2021)N/N
C4591001
1140
11401395/
Placebo 12/F/
WHITE GENRL Fatigue/
Fatigue# 3 20MAY2021 1/1 1 Yes NA R
(20MAY2021)N/N
NERV Headache/
Headache#3 20MAY2021 1/1 1 Yes NA R
(20MAY2021)N/N
C4591001
1142
11421326/
Placebo 12/F/
WHITE GENRL Injection site
erythema/
injection site
redness#3 25MAY2021 2/6 1 Yes NA R
(30MAY2021)N/N
Injection site pain/
injection site pain#3 25MAY2021 2/6 1 Yes NA R
(30MAY2021)N/N
Injection site
swelling/
injection site
swellin g#3 25MAY2021 2/6 1 Yes NA R
(30MAY2021)N/N
C4591001
1142
11421335/
Placebo 13/F/
WHITE GENRL Fatigue/
fatigue# 3 30JUL2021 1/2 2 Yes NA R
(31JUL2021)N/N
Injection site pain/
injection site pain#3 30JUL2021 1/2 2 Yes NA R
(31JUL2021)N/N
Malaise/
malaise#3 30JUL2021 1/2 2 Yes NA R
(31JUL2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1142
11421352/
Placebo 13/M/
WHITE INJ&P Patella fracture/
Fracture of left
patella 2 31JAN2021 28/C 3 No O NA RG N/N
C4591001
1142
11421355/
Placebo 12/M/
MULTIPLE GENRL Injection site pain/
injection site pain#3 27JUL2021 1/2 2 Yes NA R
(28JUL2021)N/N
C4591001
1142
11421356/
Placebo 14/F/
BLACK OR
AFRICAN
AMERICAN GENRL Injection site pain/
injection site pain#3 27JUL2021 1/2 2 Yes NA R
(28JUL2021)N/N
C4591001
1142
11421385/
BNT162b2 (30
μg) 15/M/
NOT
REPORTED BLOOD Lymphadenopathy/
left supraclavicular
lymph node swelling1 07JAN2021 8/8 1 Yes NA R
(14JAN2021)N/N
C4591001
1142
11421393/
Placebo 13/M/
WHITE GENRL Injection site pain/
injection site pain#3 31AUG2021 1/3 1 Yes NA R
(02SEP2021)N/N
C4591001
1142
11421394/
BNT162b2 (30
μg) 14/M/
NOT
REPORTED NERV Paraesthesia/
transient feeling of
pins and needles to
torso 1 18JAN2021 8/C 1 No O NA RG N/N
C4591001
1147
11471262/
BNT162b2 (30
μg) 14/F/
WHITE PSYCH Generalised anxiety
disorder/
Generalized anxiety
disorder (worsening)2 25JAN2021 22/C 1 No O NA/TC N N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1147
11471263/
BNT162b2 (30
μg) 12/M/
WHITE NEOPL Hair follicle tumour
benign/
Pilomatrixoma 1 2020 1/ 1 No O NA/TC/TCN R
(09FEB2021)N/N
C4591001
1147
11471270/
Placebo 15/F/
WHITE INV Body temperature
increased/
Increased body
temperature#3 25FEB2021 2/2 1 Yes NA R
(26FEB2021)N/N
MUSC Myalgia/
Myalgia#3 25FEB2021 2/2 1 Yes NA R
(26FEB2021)N/N
NERV Headache/
Headache#3 25FEB2021 2/2 1 Yes NA R
(26FEB2021)N/N
C4591001
1147
11471281/
Placebo 13/M/
WHITE INFEC Appendicitis/
Acute appendicitis 2 22JAN2021 19/2 4 No O NA/TC/TCN R
(23JAN2021)Y/N
Focal peritonitis/
localized peritonitis,
without perforation
or gangrene2 22JAN2021 19/2 4 No O NA/TC/TCN R
(23JAN2021)Y/N
C4591001
1147
11471292/
Placebo 14/M/
ASIAN SKIN Acne/
Acne vulgaris (new
diagnosis) 2 25JAN2021 17/C 1 No O NA/TC N N/N
C4591001
1147
11471302/
BNT162b2 (30
μg) 15/F/
WHITE RESP Nasal congestion/
Nasal congestion 2 19MAR2021 70/3 1 No O NA/TC R
(21MAR2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Rhinorrhoea/
Runn y nose2 19MAR2021 70/3 1 No O NA/TC R
(21MAR2021)N/N
Sneezing/
Sneezin g2 19MAR2021 70/3 1 No O NA/TC R
(21MAR2021)N/N
C4591001
1147
11471307/
Placebo 13/M/
WHITE GENRL Injection site
erythema/
Redness at injection
site#3 13MAY2021 1/4 1 Yes NA R
(16MAY2021)N/N
Injection site pain/
Pain at injection
site#3 13MAY2021 1/4 1 Yes NA R
(16MAY2021)N/N
NERV Headache/
Headache#3 13MAY2021 1/4 1 Yes NA R
(16MAY2021)N/N
C4591001
1147
11471310/
BNT162b2 (30
μg) 15/F/
WHITE RESP Nasal congestion/
Nasal congestion 1 02JAN2021 13/8 1 No O NA/TC R
(09JAN2021)N/N
EAR Ear pain/
Left ear pain2 JAN2021 1/C 1 No O NA/TC RG N/N
C4591001
1147
11471320/
BNT162b2 (30
μg) 15/F/
WHITE PSYCH Anxiety/
Anxiety# 2 MAY2021 95/C 2 No O NA/TC N N/N
C4591001
1147
11471321/
Placebo 15/M/
BLACK OR
AFRICAN
AMERICAN METAB Glucose tolerance
impaired/
pre-diabetes# 4 02JUL2021 26/C 1 No O NA N N/N
Vitamin D
deficienc y/4 02JUL2021 26/C 1 No O NA/TC N N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
vitamin D
deficienc y#
C4591001
1147
11471322/
Placebo 12/M/
WHITE EAR Ear pain/
Right ear pain 1 25JAN2021 21/7 1 No O NA/TC R
(31JAN2021)N/N
INFEC Conjunctivitis/
Acute conjunctivitis,
left2 25FEB2021 30/C 1 No O NA/TC RG N/N
C4591001
1147
11471323/
Placebo 14/M/
WHITE SKIN Dermatitis contact/
Allergic reaction to
surgical dressings. 2 09FEB2021 14/C 2 No O NA/TC RG N/N
C4591001
1147
11471327/
BNT162b2 (30
μg) 14/M/
WHITE GENRL Pyrexia/
Fever (104.7) 1 06JAN2021 2/3 4 Yes P/TC R
(08JAN2021)N/N
C4591001
1147
11471331/
BNT162b2 (30
μg) 13/F/
WHITE INJ&P Hand fracture/
Fracture of middle
phalanx of left index
finger 2 24FEB2021 28/C 1 No O NA RG N/N
C4591001
1147
11471336/
Placebo 15/F/
WHITE GASTR Nausea/
Nausea 2 11APR2021 75/C 1 No O NA N N/N
C4591001
1147
11471345/
Placebo 15/M/
WHITE MUSC Myalgia/
Generalized muscle
pain# 3 20MAY2021 2/2 1 Yes NA R
(21MAY2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1150
11501120/
Placebo 15/M/
WHITE MUSC Tendonitis/
Tendonitis 2 MAR2021 116/ 1 No O NA R N/N
GENRL Injection site pain/
Pain at injection
site#3 21MAY2021 2/1 1 Yes NA R
(21MAY2021)N/N
C4591001
1150
11501121/
Placebo 15/F/
WHITE GENRL Pyrexia/
Fever# 4 10JUN2021 1/2 1 Yes NA R
(11JUN2021)N/N
MUSC Myalgia/
Muscle Pain#4 10JUN2021 1/2 1 Yes NA R
(11JUN2021)N/N
C4591001
1150
11501125/
Placebo 14/M/
BLACK OR
AFRICAN
AMERICAN GENRL Injection site pain/
Injection Site pain#3 18MAY2021 1/2 1 Yes NA R
(19MAY2021)N/N
GENRL Fatigue/
Fatigue#4 10JUN2021 1/2 1 Yes NA R
(11JUN2021)N/N
C4591001
1150
11501127/
BNT162b2 (30
μg) 15/M/
WHITE GENRL Fatigue/
Fatigue 2 12NOV2020 2/1 1 Yes NA R
(12NOV2020)N/N
C4591001
1150
11501129/
Placebo 12/F/
WHITE INJ&P Concussion/
Concussion 2 11JAN2021 63/60 2 No O NA R
(11MAR2021)N/N
GENRL Fatigue/
Fatigue#3 14MAY2021 2/3 2 Yes NA R
(16MAY2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Injection site pain/
Pain at injection
site#3 14MAY2021 2/3 2 Yes NA R
(16MAY2021)N/N
Pain/
Body Aches#3 14MAY2021 2/3 2 Yes NA R
(16MAY2021)N/N
Pyrexia/
Fever#3 14MAY2021 2/1 1 Yes NA R
(14MAY2021)N/N
C4591001
1150
11501130/
BNT162b2 (30
μg) 12/F/
WHITE GASTR Nausea/
Nausea 2 09NOV2020 1/3 2 Yes NA R
(11NOV2020)N/N
NERV Dizziness/
Dizziness2 09NOV2020 1/3 1 Yes NA R
(11NOV2020)N/N
C4591001
1150
11501131/
Placebo 15/M/
WHITE GENRL Fatigue/
Fatigue# 3 23FEB2021 1/3 2 Yes NA R
(25FEB2021)N/N
Injection site pain/
Pain at injection
site#3 23FEB2021 1/3 2 Yes NA R
(25FEB2021)N/N
Pain/
Generalized Body
Aches#3 23FEB2021 1/3 2 Yes NA R
(25FEB2021)N/N
NERV Headache/
Headache#3 23FEB2021 1/3 2 Yes NA R
(25FEB2021)N/N
GENRL Fatigue/
Fatigue#4 15MAR2021 1/2 2 Yes NA R
(16MAR2021)N/N
Injection site pain/
Pain at injection
site#4 15MAR2021 1/2 2 Yes NA R
(16MAR2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Pain/
Generalized Body
Aches#4 15MAR2021 1/2 2 Yes NA R
(16MAR2021)N/N
NERV Headache/
Headache#4 15MAR2021 1/2 2 Yes NA R
(16MAR2021)N/N
PSYCH Major depression/
Current severe
episode of major
depressive disorder
without psychotic
features without
prior episode#4 MAR2021 1/ 3 No O NA/TC R
(10AUG2021)Y/N
C4591001
1150
11501132/
BNT162b2 (30
μg) 14/M/
WHITE GASTR Diarrhoea/
Diarrhea 2 09NOV2020 1/2 2 Yes NA R
(10NOV2020)N/N
C4591001
1150
11501134/
Placebo 15/M/
WHITE GENRL Chills/
Chills# 3 18MAY2021 2/2 1 Yes NA R
(19MAY2021)N/N
C4591001
1150
11501166/
Placebo 14/F/
WHITE GENRL Fatigue/
Fatigue# 3 21MAY2021 2/2 1 Yes NA R
(22MAY2021)N/N
MUSC Myalgia/
Muscle Pain#4 09JUN2021 2/2 2 Yes NA R
(10JUN2021)N/N
C4591001
1150
11501168/
BNT162b2 (30
μg) 13/M/
WHITE PSYCH Depression/
Depression 2 MAR2021 69/C 2 No O NA RG N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1150
11501176/
Placebo 14/F/
WHITE GENRL Injection site pain/
Pain at injection
site# 3 18MAY2021 1/3 2 Yes NA R
(20MAY2021)N/N
GENRL Chills/
Chills#3 19MAY2021 2/1 1 Yes NA R
(19MAY2021)N/N
Fatigue/
Fatigue#3 19MAY2021 2/1 2 Yes NA R
(19MAY2021)N/N
NERV Syncope/
Faintin g#3 19MAY2021 2/1 2 Yes NA R
(19MAY2021)N/N
C4591001
1150
11501182/
Placebo 15/F/
WHITE GENRL Injection site pain/
Injection Site Pain#3 25FEB2021 1/2 1 Yes NA R
(26FEB2021)N/N
C4591001
1150
11501185/
Placebo 14/F/
WHITE GENRL Fatigue/
Fatigue# 3 13MAY2021 1/2 1 Yes NA R
(14MAY2021)N/N
Injection site
bruising/
Bruise at injection
site#3 13MAY2021 1/5 1 Yes NA R
(17MAY2021)N/N
Injection site pain/
Pain at injection
site#3 13MAY2021 1/2 1 Yes NA R
(14MAY2021)N/N
C4591001
1150
11501189/
Placebo 15/F/
WHITE GASTR Nausea/
Nausea# 3 17MAY2021 1/2 1 Yes NA R
(18MAY2021)N/N
GENRL Fatigue/
Fatigue#3 17MAY2021 1/2 1 Yes NA R
(18MAY2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Injection site pain/
Pain at injection
site#3 17MAY2021 1/2 2 Yes NA R
(18MAY2021)N/N
C4591001
1150
11501190/
Placebo 13/F/
WHITE GENRL Injection site pain/
Pain at injection
site# 3 17MAY2021 1/2 1 Yes NA R
(18MAY2021)N/N
GENRL Fatigue/
Fatigue#3 18MAY2021 2/1 1 Yes NA R
(18MAY2021)N/N
C4591001
1150
11501193/
Placebo 14/F/
WHITE PSYCH Attention deficit
hyperactivity
disorder/
ADHD1 DEC2020 1/C 1 No O NA RG N/N
C4591001
1150
11501204/
Placebo 14/M/
WHITE GENRL Fatigue/
Fatigue# 3 17MAY2021 1/2 1 Yes NA R
(18MAY2021)N/N
C4591001
1150
11501207/
Placebo 14/M/
WHITE GENRL Injection site pain/
Pain at injection
site# 3 18MAY2021 1/2 1 Yes NA R
(19MAY2021)N/N
C4591001
1150
11501210/
Placebo 12/F/
WHITE GENRL Injection site pain/
Pain at injection
site# 3 24MAY2021 1/3 2 Yes NA R
(26MAY2021)N/N
GENRL Fatigue/
Fatigue#4 14JUN2021 1/3 2 Yes NA R
(16JUN2021)N/N
Injection site pain/
Pain at injection
site#4 14JUN2021 1/3 2 Yes NA R
(16JUN2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
MUSC Arthralgia/
Generalized joint
Pain#+4 14JUN2021 1/3 1 Yes NA R
(16JUN2021)N/N
Myalgia/
Muscle Pain#4 14JUN2021 1/3 1 Yes NA R
(16JUN2021)N/N
GENRL Pyrexia/
Fever#4 15JUN2021 2/1 1 Yes NA R
(15JUN2021)N/N
C4591001
1150
11501212/
Placebo 12/F/
WHITE GENRL Injection site pain/
Pain at injection
site# 3 13MAY2021 1/2 1 Yes NA R
(14MAY2021)N/N
C4591001
1150
11501214/
Placebo 12/M/
WHITE GENRL Injection site pain/
Injection Site pain#3 19MAY2021 2/3 1 Yes NA R
(21MAY2021)N/N
NERV Headache/
Headache#4 11JUN2021 2/2 1 Yes NA R
(12JUN2021)N/N
C4591001
1150
11501215/
Placebo 14/F/
WHITE GENRL Injection site pain/
Injection Site pain#3 19MAY2021 2/2 1 Yes NA R
(20MAY2021)N/N
C4591001
1150
11501218/
Placebo 15/F/
WHITE GENRL Injection site pain/
Injection site pain#3 18MAY2021 2/2 2 Yes NA RS
(19MAY2021)N/N
NERV Headache/
Headache#4 09JUN2021 2/1 1 Yes NA R
(09JUN2021)N/N
C4591001
1150
11501222/
Placebo 14/M/
WHITE GENRL Injection site pain/
Pain at injection
site# 4 01JUN2021 1/3 1 Yes NA R
(03JUN2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GENRL Fatigue/
Fatigue#4 02JUN2021 2/2 1 Yes NA R
(03JUN2021)N/N
NERV Headache/
Headache#4 02JUN2021 2/2 1 Yes NA R
(03JUN2021)N/N
C4591001
1150
11501224/
Placebo 12/M/
WHITE GENRL Injection site pain/
Pain at injection
site# 3 18MAY2021 1/3 1 Yes NA R
(20MAY2021)N/N
GENRL Chills/
Chills#4 07JUN2021 1/2 1 Yes NA R
(08JUN2021)N/N
Fatigue/
Fatigue#4 07JUN2021 1/2 1 Yes NA R
(08JUN2021)N/N
C4591001
1150
11501229/
Placebo 14/F/
WHITE GENRL Fatigue/
Fatigue# 3 14MAY2021 1/2 2 Yes NA R
(15MAY2021)N/N
Injection site pain/
Pain at injection
site#3 14MAY2021 1/3 2 Yes NA R
(16MAY2021)N/N
Pyrexia/
Fever#3 14MAY2021 1/2 1 Yes NA R
(15MAY2021)N/N
GENRL Chills/
Chills#4 02JUN2021 1/2 2 Yes NA R
(03JUN2021)N/N
Fatigue/
Fatigue#4 02JUN2021 1/3 2 Yes NA R
(04JUN2021)N/N
Injection site
erythema/
Redness at injection
site#4 02JUN2021 1/3 2 Yes NA R
(04JUN2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Injection site pain/
Pain at injection
site#4 02JUN2021 1/3 2 Yes NA R
(04JUN2021)N/N
Pyrexia/
Fever#4 02JUN2021 1/2 2 Yes NA R
(03JUN2021)N/N
NERV Headache/
Headache#4 02JUN2021 1/3 2 Yes NA R
(04JUN2021)N/N
INFEC Hand-foot-and-
mouth disease/
Hand, foot and
mouth disease#4 10JUN2021 9/8 2 No O NA R
(17JUN2021)N/N
C4591001
1150
11501231/
Placebo 14/F/
ASIAN GENRL Fatigue/
Fatigue# 3 17MAY2021 1/2 1 Yes NA R
(18MAY2021)N/N
Injection site pain/
Pain at injection
site#3 17MAY2021 1/2 1 Yes NA R
(18MAY2021)N/N
Pain/
Body Aches#3 17MAY2021 1/2 1 Yes NA R
(18MAY2021)N/N
Pyrexia/
Fever#3 17MAY2021 1/1 1 Yes NA R
(17MAY2021)N/N
C4591001
1150
11501232/
Placebo 14/M/
WHITE GENRL Chills/
Chills# 3 19MAY2021 2/1 1 Yes NA R
(19MAY2021)N/N
GENRL Pyrexia/
Fever (101.0)#4 08JUN2021 2/1 1 Yes NA R
(08JUN2021)N/N
C4591001
1150 15/M/
WHITE GENRL Injection site pain/
Injection Site Pain#4 08JUN2021 2/2 2 Yes NA R
(09JUN2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
11501235/
Placebo
C4591001
1150
11501242/
Placebo 15/M/
WHITE GENRL Fatigue/
Fatigue# 3 11MAR2021 2/2 1 Yes NA R
(12MAR2021)N/N
GENRL Fatigue/
Fatigue#4 06APR2021 2/2 1 Yes NA R
(07APR2021)N/N
Injection site pain/
Injection Site Pain#4 06APR2021 2/2 1 Yes NA R
(07APR2021)N/N
INJ&P Traumatic renal
injury/
Laceration of Left
Kidne y#4 17JUL2021 104/C 2 No O NA RG Y/N
C4591001
1150
11501243/
Placebo 12/F/
WHITE GENRL Fatigue/
Fatigue# 3 15MAY2021 2/2 1 Yes NA R
(16MAY2021)N/N
Injection site pain/
Injection Site Pain#3 15MAY2021 2/2 1 Yes NA R
(16MAY2021)N/N
GENRL Injection site pain/
Injection Site Pain#4 04JUN2021 2/2 1 Yes NA R
(05JUN2021)N/N
C4591001
1150
11501248/
Placebo 13/M/
WHITE INJ&P Tibia fracture/
Broken Left Tibia 2 07APR2021 79/C 2 No O NA RG N/N
GENRL Injection site pain/
Pain at injection
site#3 19MAY2021 1/3 1 Yes NA R
(21MAY2021)N/N
GENRL Fatigue/
Fatigue#3 20MAY2021 2/2 1 Yes NA R
(21MAY2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1150
11501249/
Placebo 15/M/
WHITE GENRL Injection site pain/
Injection Site Pain#4 05JUN2021 2/2 2 Yes NA R
(06JUN2021)N/N
Pyrexia/
Fever (100.7)#4 05JUN2021 2/2 1 Yes NA R
(06JUN2021)N/N
C4591001
1150
11501250/
BNT162b2 (30
μg) 13/F/
NOT
REPORTED PSYCH Suicidal ideation/
Suicidal Ideation 2 03MAR2021 44/5 2 No O NA/TC/TCN R
(07MAR2021)Y/N
C4591001
1150
11501257/
Placebo 15/F/
WHITE GENRL Injection site pain/
Injection site pain#3 15MAY2021 2/2 1 Yes NA R
(16MAY2021)N/N
C4591001
1150
11501261/
Placebo 13/M/
WHITE GENRL Fatigue/
Fatigue# 4 04JUN2021 2/1 2 Yes NA R
(04JUN2021)N/N
NERV Headache/
Headache#4 04JUN2021 2/1 1 Yes NA R
(04JUN2021)N/N
C4591001
1150
11501263/
Placebo 12/M/
WHITE GENRL Injection site pain/
Injection Site Pain#3 20MAY2021 2/2 1 Yes NA R
(21MAY2021)N/N
NERV Headache/
Headache#3 20MAY2021 2/2 1 Yes NA R
(21MAY2021)N/N
GENRL Injection site pain/
Injection Site Pain#4 12JUN2021 2/2 2 Yes NA R
(13JUN2021)N/N
C4591001
1150 12/M/
WHITE GENRL Chills/
Chills#3 15MAY2021 2/2 1 Yes NA R
(16MAY2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
11501271/
Placebo
Fatigue/
Fatigue#3 15MAY2021 2/2 1 Yes NA R
(16MAY2021)N/N
MUSC Myalgia/
Muscle Pain#4 03JUN2021 2/2 1 Yes NA R
(04JUN2021)N/N
C4591001
1150
11501272/
Placebo 14/F/
WHITE GENRL Fatigue/
Fatigue# 3 15MAY2021 2/1 1 Yes NA R
(15MAY2021)N/N
C4591001
1150
11501280/
Placebo 14/F/
WHITE GENRL Injection site pain/
Pain at injection
site# 3 19MAY2021 1/2 1 Yes NA R
(20MAY2021)N/N
NERV Headache/
Headache#3 20MAY2021 2/1 2 Yes NA R
(20MAY2021)N/N
MUSC Myalgia/
Muscle Aches#4 11JUN2021 2/1 1 Yes NA R
(11JUN2021)N/N
C4591001
1150
11501282/
Placebo 14/M/
WHITE GENRL Injection site pain/
Pain at injection
site# 3 17MAY2021 1/3 1 Yes NA R
(19MAY2021)N/N
INFEC Tinea infection/
Ringworm#3 07JUN2021 22/C 1 No O NA RG N/N
C4591001
1150
11501284/
Placebo 14/F/
WHITE GENRL Fatigue/
Fatigue# 3 17MAY2021 1/3 2 Yes NA R
(19MAY2021)N/N
Injection site pain/
Pain at injection
site#3 17MAY2021 1/3 2 Yes NA R
(19MAY2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Pain/
Body Aches#3 17MAY2021 1/2 2 Yes NA R
(18MAY2021)N/N
Pyrexia/
Fever#3 17MAY2021 1/2 1 Yes NA R
(18MAY2021)N/N
NERV Headache/
Headache#3 17MAY2021 1/2 1 Yes NA R
(18MAY2021)N/N
GENRL Pyrexia/
Fever (100.7)#4 07JUN2021 1/4 1 Yes NA R
(10JUN2021)N/N
MUSC Myalgia/
Muscle Aches#4 07JUN2021 1/4 2 Yes NA R
(10JUN2021)N/N
C4591001
1150
11501287/
BNT162b2 (30
μg) 12/M/
WHITE GENRL Injection site pain/
Injection Site Pain 1 08JAN2021 2/1 1 Yes NA/TC R
(08JAN2021)N/N
C4591001
1150
11501291/
Placebo 15/M/
WHITE GENRL Injection site pain/
Pain at injection
site# 3 19MAY2021 1/4 2 Yes NA R
(22MAY2021)N/Y
GENRL Fatigue/
Fatigue#3 20MAY2021 2/3 2 Yes NA R
(22MAY2021)N/N
NERV Headache/
Headache#3 20MAY2021 2/2 2 Yes NA R
(21MAY2021)N/N
C4591001
1150
11501294/
Placebo 12/F/
BLACK OR
AFRICAN
AMERICAN EAR Conductive
deafness/
Left sided mild
conductive hearing
loss1 14JAN2021 4/ 2 Yes NA R N/N
GENRL Injection site pain/
Pain at injection
site#3 27MAY2021 1/3 1 Yes NA R
(29MAY2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Injection site
swelling/
Swollen at injection
site#3 27MAY2021 1/3 1 Yes NA R
(29MAY2021)N/N
GENRL Injection site pain/
Pain at injection
site#4 16JUN2021 1/2 1 Yes NA R
(17JUN2021)N/N
C4591001
1150
11501298/
Placebo 13/M/
ASIAN GENRL Chills/
Chills# 3 14MAY2021 2/1 1 Yes NA R
(14MAY2021)N/N
Pyrexia/
Fever#3 14MAY2021 2/1 1 Yes NA R
(14MAY2021)N/N
NERV Headache/
Headache#3 14MAY2021 2/1 1 Yes NA R
(14MAY2021)N/N
GENRL Chills/
Chills#4 01JUN2021 1/1 1 Yes NA R
(01JUN2021)N/N
Pyrexia/
Fever#4 01JUN2021 1/1 1 Yes NA R
(01JUN2021)N/N
C4591001
1152
11521615/
Placebo 15/M/
WHITE SKIN Rash/
generalized rash
upper body 1 03DEC2020 1/8 1 No O NA R
(10DEC2020)N/N
C4591001
1152
11521617/
BNT162b2 (30
μg) 13/M/
WHITE INJ&P Upper limb fracture/
Elbow Fracture# 2 01AUG2021 217/C 2 No O NA/TC/TCN N Y/N
C4591001
1152
11521640/ 15/M/
WHITE INFEC Ear infection/
right ear infection,
NFI1 20DEC2020 14/7 2 No O NA/TC R
(26DEC2020)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
BNT162b2 (30
μg)
C4591001
1152
11521641/
BNT162b2 (30
μg) 12/M/
WHITE EYE Eyelid rash/
rash right eyelid 1 07DEC2020 1/2 1 Yes NA R
(08DEC2020)N/N
SKIN Rash/
rash bilateral
extremities1 08DEC2020 2/1 1 Yes NA R
(08DEC2020)N/N
C4591001
1152
11521654/
Placebo 14/F/
WHITE PSYCH Depression/
Worsened
Depression 1 26DEC2020 18/C 2 No O NA/TC N N/N
C4591001
1152
11521664/
Placebo 13/F/
WHITE INJ&P Ankle fracture/
FRACTURED
LEFT ANKLE 2 18JUN2021 171/C 2 No O NA/TC/TCN N N/N
Fall/
FALL2 18JUN2021 171/1 2 No O NA R
(18JUN2021)N/N
C4591001
1152
11521669/
Placebo 15/F/
ASIAN NERV Headache/
headache 2 30MAR2021 91/1 1 No O NA R
(30MAR2021)N/N
C4591001
1152
11521683/
BNT162b2 (30
μg) 14/F/
WHITE BLOOD Lymphadenopathy/
Swollen Lymph
Node (Left Clavicle)1 26DEC2020 12/C 1 No O NA N N/N
C4591001
1152 15/F/
WHITE RESP Nasal congestion/
Nasal Con gestion2 03MAY2021 118/C 2 No O NA/TC N N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
11521687/
Placebo
C4591001
1152
11521688/
Placebo 12/F/
WHITE RESP Nasal congestion/
Nasal Congestion 2 01MAY2021 116/C 2 No O NA/TC N N/N
GENRL Chills/
Chills#4 15JUN2021 2/2 2 Yes NA/TC R
(16JUN2021)N/N
Fatigue/
fatigue#4 15JUN2021 2/C 2 Yes NA/TC RG N/N
NERV Headache/
headache#4 15JUN2021 2/C 2 Yes NA/TC RG N/N
C4591001
1152
11521690/
Placebo 14/F/
WHITE INFEC Ear infection/
Left ear infection# 3 11JUN2021 15/C 2 No O NA/TC/TCN N N/N
C4591001
1152
11521696/
Placebo 14/M/
WHITE GENRL Injection site pain/
site injection arm
pain# 3 25MAY2021 2/2 2 Yes NA/TC R
(26MAY2021)N/N
MUSC Myalgia/
Myalgias#3 25MAY2021 2/2 2 Yes NA/TC R
(26MAY2021)N/N
C4591001
1152
11521697/
BNT162b2 (30
μg) 12/F/
ASIAN GENRL Injection site pain/
Injection Site Pain 1 18DEC2020 1/4 2 Yes NA/TC R
(21DEC2020)N/N
GENRL Chills/
Chills1 19DEC2020 2/1 2 Yes NA R
(19DEC2020)N/N
Fatigue/
Fatigue1 19DEC2020 2/1 2 Yes NA R
(19DEC2020)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Injection site
swelling/
Injection Site
Swellin g1 19DEC2020 2/2 2 Yes NA R
(20DEC2020)N/N
Pyrexia/
Feve r1 19DEC2020 2/1 1 Yes NA/TC R
(19DEC2020)N/N
C4591001
1152
11521704/
BNT162b2 (30
μg) 14/M/
WHITE BLOOD Lymphadenopathy/
swollen lymph node
left axilla 1 26DEC2020 6/10 2 Yes NA R
(04JAN2021)N/N
C4591001
1152
11521706/
Placebo 13/M/
WHITE GENRL Fatigue/
Fatigue 1 21DEC2020 1/7 3 Yes NA/TC R
(27DEC2020)N/N
NERV Headache/
HEADACHE1 26DEC2020 6/2 3 Yes NA/TC R
(27DEC2020)N/N
C4591001
1152
11521739/
Placebo 12/M/
WHITE MUSC Musculoskeletal
stiffness/
Left arm stiffness#3 22MAY2021 2/7 1 Yes NA R
(28MAY2021)N/N
C4591001
1152
11521740/
Placebo 15/F/
WHITE INJ&P Tooth fracture/
Chipped baby tooth2 17FEB2021 22/1 1 No O NA R
(17FEB2021)N/N
GENRL Fatigue/
fatigue#3 25MAY2021 2/2 2 Yes NA/TC R
(26MAY2021)N/N
Injection site pain/
site injection arm
pain#3 25MAY2021 2/C 2 Yes NA/TC RG N/N
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Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1152
11521749/
BNT162b2 (30
μg) 13/F/
ASIAN GASTR Abdominal pain/
ABDOMINAL
CRAMPS 1 09JAN2021 2/1 1 Yes NA R
(09JAN2021)N/N
C4591001
1152
11521752/
Placebo 15/M/
ASIAN INJ&P Joint injury/
left wrist joint
injured# 3 26MAY2021 2/C 1 No O NA/TCN RG N/N
C4591001
1152
11521756/
BNT162b2 (30
μg) 12/F/
WHITE GASTR Diarrhoea/
Diarrhea 2 06FEB2021 6/3 1 No O NA R
(08FEB2021)N/N
C4591001
1156
11561310/
BNT162b2 (30
μg) 12/F/
BLACK OR
AFRICAN
AMERICAN INFEC Body tinea/
TINEA CORPORIS1 08DEC2020 8/18 1 No O NA R
(25DEC2020)N/N
C4591001
1156
11561357/
Placebo 12/F/
WHITE INFEC Appendicitis/
APPENDICITIS# 4 10JUN2021 4/1 2 Yes NA/TC R
(10JUN2021)Y/N
C4591001
1223
12231267/
BNT162b2 (30
μg) 12/M/
WHITE GENRL Fatigue/
fatigue 2 27JAN2021 1/3 2 Yes NA R
(29JAN2021)N/N
Pyrexia/
fever1 27JAN2021 21/3 1 Yes NA/TC R
(29JAN2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
MUSC Myalgia/
generalized muscle
aches2 27JAN2021 1/3 1 Yes NA R
(29JAN2021)N/N
C4591001
1223
12231269/
Placebo 15/F/
WHITE GENRL Fatigue/
fatigue# 3 21MAY2021 2/2 1 Yes NA/TCN R
(22MAY2021)N/N
C4591001
1223
12231271/
BNT162b2 (30
μg) 12/M/
WHITE GENRL Injection site pain/
injection site pain 1 29JAN2021 22/4 1 Yes NA R
(01FEB2021)N/N
C4591001
1223
12231273/
Placebo 15/M/
WHITE CARD Myocarditis/
Myopericarditis# 4 12JUN2021 3/2 3 No O NA/TC R
(13JUN2021)Y/N
C4591001
1223
12231277/
Placebo 12/M/
WHITE GENRL Injection site pain/
injection site pain#3 26MAY2021 2/2 1 Yes NA R
(27MAY2021)N/N
GENRL Pyrexia/
fever#4 14JUN2021 1/3 1 Yes NA/TC R
(16JUN2021)N/N
NERV Headache/
headache#4 14JUN2021 1/3 1 Yes NA R
(16JUN2021)N/N
C4591001
1223
12231279/
Placebo 13/F/
WHITE GENRL Fatigue/
fatigue# 4 11JUN2021 1/3 1 Yes NA R
(13JUN2021)N/N
MUSC Pain in extremity/
sore arm#4 11JUN2021 1/3 1 Yes NA/TC R
(13JUN2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1223
12231281/
BNT162b2 (30
μg) 14/F/
WHITE GENRL Pyrexia/
fever 2 03FEB2021 2/2 1 Yes NA R
(04FEB2021)N/N
MUSC Myalgia/
muscle ache
generalize d2 03FEB2021 2/3 1 Yes NA R
(05FEB2021)N/N
NERV Headache/
headache2 03FEB2021 2/3 1 Yes NA/TC R
(05FEB2021)N/N
C4591001
1223
12231283/
Placebo 14/M/
WHITE GENRL Fatigue/
fatigue# 3 20MAY2021 1/2 1 Yes NA R
(21MAY2021)N/N
Injection site pain/
injection site pain#3 20MAY2021 1/3 1 Yes NA R
(22MAY2021)N/N
C4591001
1223
12231286/
Placebo 15/F/
WHITE NERV Headache/
headache 2 05FEB2021 3/3 1 Yes NA/TC R
(07FEB2021)N/N
GENRL Fatigue/
fatigue#3 21MAY2021 1/3 1 Yes NA R
(23MAY2021)N/N
Pyrexia/
fever#3 21MAY2021 1/2 1 Yes NA/TC R
(22MAY2021)N/N
GENRL Fatigue/
fatigue#4 11JUN2021 1/2 1 Yes NA R
(12JUN2021)N/N
Injection site pain/
injection site pain#4 11JUN2021 1/2 1 Yes NA R
(12JUN2021)N/N
C4591001
1235 13/M/
WHITE INFEC Paronychia/
ingrown toenail
infection#3 24MAY2021 7/15 2 No O NA/TC/TCN R
(07JUN2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
12351235/
Placebo
Skin candida/
cutaneous
candidiasis#3 24MAY2021 7/15 2 No O NA/TC R
(07JUN2021)N/N
GENRL Adverse drug
reaction/
antibiotic side
effect#3 02JUN2021 16/4 2 No O NA R
(05JUN2021)N/N
C4591001
1235
12351252/
Placebo 13/M/
WHITE SKIN Urticaria/
allergic urticaria# 4 27JUN2021 20/3 2 No O NA/TC R
(29JUN2021)N/N
C4591001
1270
12701173/
Placebo 15/F/
WHITE GENRL Fatigue/
Fatigue# 3 13MAY2021 1/3 1 Yes NA R
(15MAY2021)N/N
Injection site pain/
Injection Site Pain#3 13MAY2021 1/2 1 Yes NA R
(14MAY2021)N/N
Pain/
Generalized Body
Aches#3 13MAY2021 1/3 1 Yes NA R
(15MAY2021)N/N
C4591001
1270
12701181/
Placebo 15/F/
WHITE MUSC Back pain/
Low Back Pain 2 22FEB2021 63/36 1 No O NA R
(29MAR2021)N/N
C4591001
1270
12701188/
Placebo 13/M/
ASIAN GENRL Fatigue/
Fatigue# 3 18MAY2021 1/2 1 Yes NA R
(19MAY2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
NERV Headache/
Headache#3 18MAY2021 1/2 1 Yes NA R
(19MAY2021)N/N
C4591001
1270
12701200/
BNT162b2 (30
μg) 13/M/
WHITE INFEC Anal abscess/
PERIANAL
ABSCESS 2 16MAR2021 78/C 3 No O NA/TC/TCN RG Y/N
C4591001
1270
12701202/
BNT162b2 (30
μg) 15/M/
WHITE INFEC Paronychia/
Left finger
paronychia 2 17MAR2021 77/9 1 No O NA/TC R
(25MAR2021)N/N
C4591001
1270
12701204/
Placebo 12/M/
NOT
REPORTED GENRL Chills/
Chills# 3 18MAY2021 2/1 1 Yes NA/TC R
(18MAY2021)N/N
Injection site pain/
Injection site pain#3 18MAY2021 2/1 1 Yes NA/TC R
(18MAY2021)N/N
Pyrexia/
Fever#3 18MAY2021 2/1 2 Yes NA/TC R
(18MAY2021)N/N
C4591001
1270
12701205/
Placebo 13/F/
MULTIPLE INFEC Subcutaneous
abscess/
Subcutaneous Tissue
Abcess Right
Earlobe1 19DEC2020 5/17 1 No O NA/TCN R
(04JAN2021)N/N
GENRL Injection site pain/
Injection site pain#3 17MAY2021 1/4 1 Yes NA/TC R
(20MAY2021)N/N
SKIN Ingrowing nail/
Right Ingrown
Toenail#3 09JUN2021 24/22 1 No O NA/TC R
(30JUN2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1270
12701206/
Placebo 15/F/
WHITE GENRL Fatigue/
FATIGUE# 3 27MAY2021 2/1 2 Yes NA R
(27MAY2021)N/N
Injection site pain/
Injection site pain#3 27MAY2021 2/1 1 Yes NA R
(27MAY2021)N/N
INJ&P Ligament sprain/
RIHT WRIST
SPRAIN#4 14JUL2021 29/C 1 No O NA/TC/TCN RG N/N
C4591001
1270
12701208/
Placebo 14/F/
WHITE INJ&P Concussion/
Concussion without
loss of conciousness2 11MAR2021 65/ 2 No O NA/TCN R N/N
Hand fracture/
Left Middle Finger
Middle Phalanx
Fracture2 11MAR2021 65/70 2 No O NA/TCN R
(19MAY2021)N/N
Hand fracture/
Right Middle Finger
Phalanx Fracture2 11MAR2021 65/70 2 No O NA/TCN R
(19MAY2021)N/N
C4591001
1270
12701213/
Placebo 12/F/
WHITE GASTR Abdominal pain/
Chronic Abdominal
Pain 2 JAN2021 1/C 1 No O NA/TC N N/N
MUSC Tendonitis/
tendinitis of Left
Ankle2 JAN2021 1/C 1 No O NA/TC/TCN RG N/N
GENRL Fatigue/
Fatigue#3 17MAY2021 1/2 1 Yes NA R
(18MAY2021)N/N
Injection site pain/
Injection site pain#3 17MAY2021 1/2 1 Yes NA R
(18MAY2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
NERV Headache/
Headache#3 17MAY2021 1/2 1 Yes NA R
(18MAY2021)N/N
C4591001
1270
12701216/
Placebo 12/F/
MULTIPLE NERV Syncope/
Syncope# 2 17MAY2021 132/1 2 No O NA/TCN R
(17MAY2021)N/N
C4591001
1270
12701217/
Placebo 12/F/
WHITE NEOPL Melanocytic naevus/
Melanocytic Nevus2 10FEB2021 34/C 1 No O NA N N/N
SKIN Acne/
Acne Vul garis2 10FEB2021 34/C 1 No O NA/TC RG N/N
Seborrhoeic
dermatitis/
Seborrheic
Dermatitis to scalp2 10FEB2021 34/C 1 No O NA/TC RG N/N
GENRL Injection site pain/
Injection site pain#3 17MAY2021 1/3 1 Yes NA R
(19MAY2021)N/N
C4591001
1270
12701221/
Placebo 12/F/
WHITE GENRL Chills/
Chills# 3 26MAY2021 1/2 1 Yes NA R
(27MAY2021)N/N
EAR Ear pain/
Right otal gia#4 02JUL2021 19/7 1 No O NA/TC R
(08JUL2021)N/N
C4591001
1270
12701222/
BNT162b2 (30
μg) 14/F/
WHITE PSYCH Suicidal ideation/
SUICIDAL
IDEATION 2 16FEB2021 40/28 3 No O NA/TC/TCN R
(15MAR2021)Y/N
C4591001
1270 13/M/
WHITE GENRL Pain/
Body Aches#3 21MAY2021 2/2 1 Yes NA R
(22MAY2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
12701223/
Placebo
Pyrexia/
Fever#3 21MAY2021 2/2 1 Yes NA R
(22MAY2021)N/N
C4591001
1270
12701227/
Placebo 13/M/
ASIAN MUSC Myalgia/
Generalized
Myalgia# 3 19MAY2021 2/1 1 Yes NA/TC R
(19MAY2021)N/N
NERV Headache/
Headache#3 19MAY2021 2/1 1 Yes NA/TC R
(19MAY2021)N/N
C4591001
1270
12701228/
Placebo 12/F/
WHITE RENAL Dysuria/
Dysuria# 4 09JUN2021 7/3 1 No O NA R
(11JUN2021)N/N
C4591001
1270
12701233/
BNT162b2 (30
μg) 14/F/
WHITE GASTR Rectal prolapse/
Rectal Prolapse 2 22FEB2021 28/C 1 No O NA/TC RG N/N
C4591001
1270
12701236/
Placebo 14/F/
WHITE PSYCH Anxiety/
Anxiety 1 11JAN2021 6/C 1 No O NA RG N/N
C4591001
1270
12701237/
Placebo 13/F/
AMERICAN
INDIAN OR
ALASKA
NATIVE MUSC Musculoskeletal
chest pain/
Rib pain on right
side 1 10FEB2021 35/29 1 No O NA R
(10MAR2021)N/N
SKIN Rash/
Rash on Ri ght Foo t1 05APR2021 89/4 1 No O NA/TC R
(08APR2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GASTR Nausea/
INTERMITTENT
NAUSEA#3 19MAY2021 1/56 2 Yes NA R
(13JUL2021)N/N
GENRL Chills/
CHILLS#3 19MAY2021 1/3 1 Yes NA/TC R
(21MAY2021)N/N
Non-cardiac chest
pain/
INTERMITTENT
NON-CARDIAC
CHEST
DISCOMFORT#3 19MAY2021 1/56 2 Yes NA/TC R
(13JUL2021)N/N
NERV Headache/
INTERMITTENT
HEADACHES#3 19MAY2021 1/56 2 Yes NA/TC R
(13JUL2021)N/N
GENRL Pyrexia/
Fever#3 20MAY2021 2/2 1 Yes NA/TC R
(21MAY2021)N/N
GASTR Abdominal pain
upper/
INTERMITTENT
STOMACH PAIN#3 25MAY2021 7/50 2 Yes NA R
(13JUL2021)N/N
GENRL Fatigue/
FATIGUE#3 25MAY2021 7/50 3 Yes NA R
(13JUL2021)N/N
Thirst/
INCREASED
THIRST#3 25MAY2021 7/19 1 Yes NA R
(12JUN2021)N/N
METAB Decreased appetite/
LOSS OF
APPETITE#3 25MAY2021 7/50 2 Yes NA R
(13JUL2021)N/N
INFEC Otitis media/
LEFT OTITIS
MEDIA#3 29JUN2021 42/8 1 No O NA/TC R
(06JUL2021)N/N
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16.2.7.2.1 Listing of Adverse Events – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1270
12701241/
Placebo 13/M/
WHITE GENRL Chills/
Chills# 3 19MAY2021 1/2 1 Yes NA R
(20MAY2021)N/N
Pyrexia/
Fever#3 19MAY2021 1/2 1 Yes NA/TC R
(20MAY2021)N/N
NERV Headache/
Headache#3 19MAY2021 1/2 1 Yes NA/TC R
(20MAY2021)N/N
C4591001
1270
12701244/
Placebo 14/F/
WHITE GENRL Injection site pain/
Injection site pain#3 18MAY2021 1/2 1 Yes NA/TC R
(19MAY2021)N/N
Abbreviations: C = continuing; Du r = duration; Imm = immediate. Refer to the AE legend page (Li sting 16.2.7.1) for additional definitions.
Note: MedDRA (v24.0) coding dictionary applied.
Note: * = prevaccination AE, # = AE occurring on or after subjec t unblinding, + = new arthralgia after the EUA snapshot.
Note: For original placebo group subjects, Dose 3 = first dose of BNT162b2 (30 μg), Dose 4 = se cond dose of BNT162b2 (30 μg).
a. Relative day (Rel Day) = da te of AE - date of last vacci nation + 1. For an AE that occurred before the date of the firs t study vaccination, + 1 was not
added to compute relative day.
b. Duration (days) was calculated as the difference from th e start of the first reported ev ent to resolution of the last r eported event, inclusive.
c. Vaccine related (Vax Rel) : relationship to investigation al vaccine as assessed by the investigator.
PFIZER CONFIDENTIAL SDTM Creation: 05OCT2021 (17:29) Source Dat a: adae Table Generation: 08NOV2021 (19:56)
(Data Cutoff Date: 02SEP2021, Da tabase Snapshot Date: 27SEP2021) Output File: ./nda2 unblinded/C4591001 SPeds/adae l002 1ped6
090177e1988b5492\Final\Final On: 09-Nov-2021 04:12 (GMT)
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16.2.7.2.2 Listing of Adverse Events Updated After the EUA Snapshot – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)Updates
from
EUA to
sBLAd
C4591001
1006
10061272/
BNT162b2 (30
μg) 13/F/
BLACK OR
AFRICAN
AMERICANPSYCH Anxiety/
Worsening of
anxiety 1 23DEC2020 8/27 3 No O NA/TC/TCN R
(18JAN2021)Y/N C3
Depression/
Worsening of
Depression1 23DEC2020 8/27 3 No O NA/TC/TCN R
(18JAN2021)Y/N C3
INJ&P Contusion/
Contusion left
elbow1 05FEB2021 52/29 1 No O NA R
(05MAR2021)N/N C2
C4591001
1006
10061290/
BNT162b2 (30
μg) 15/F/
WHITE INJ&P Concussion/
Concussion 1 12JAN2021 22/32 2 No O NA/TC R
(12FEB2021)N/N C2
C4591001
1007
10071497/
BNT162b2 (30
μg) 12/M/
ASIAN BLOOD Lymphadenopathy /
swollen lymph
node left axilla 2 25DEC2020 4/27 1 Yes NA R
(20JAN2021)N/N C2
C4591001
1007
10071575/
BNT162b2 (30
μg) 15/M/
WHITE INJ&P Contusion/
Contusion of Left
Arm 1 03JAN2021 19/11 2 No O NA/TC R
(13JAN2021)N/N C1, C2
C4591001
1007
10071581/
Placebo 15/M/
WHITE INFEC Appendicitis/
Appendicitis 2 10MAR2021 63/20 3 No O NA/TC R
(29MAR2021)Y/N C2, C5
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16.2.7.2.2 Listing of Adverse Events Updated After the EUA Snapshot – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)Updates
from
EUA to
sBLAd
C4591001
1007
10071585/
Placebo 12/M/
WHITE SKIN Urticaria/
hives; trunk,
abdomen, back 2 16JAN2021 10/18 2 Yes NA/TC R
(02FEB2021)N/N C2
C4591001
1007
10071620/
BNT162b2 (30
μg) 12/F/
WHITE PSYCH Conversion
disorder/
generalized
Functional
neurologic
disorde r2 21JAN2021 2/C 2 No O NA/TC N Y/N C1, C2,
C4
GASTR Gastritis/
Gastritis2 30JAN2021 11/ 2 No CD NA/TC R N/N C2
SKIN Dermatitis contact/
contact dermatitis
bilateral arms2 12FEB2021 24/ 1 No O NA/TC R N/N C2
GASTR Abdominal pain/
Functional
Abdominal Pain2 28FEB2021 40/C 3 No O NA/TC N Y/N C4
Constipation/
Constipation2 28FEB2021 40/14 3 No O NA/TC R
(13MAR2021)Y/N C2
C4591001
1007
10071651/
BNT162b2 (30
μg) 12/M/
WHITE BLOOD Lymphadenopathy /
left Cervical
lymphadenopathy2 23FEB2021 29/15 1 No O NA R
(09MAR2021)N/N C2
C4591001
1009
10091366/
Placebo 14/F/
WHITE GENRL Injection site pain/
Mild Injection Site
Pain 2 26FEB2021 1/2 1 Yes NA R
(27FEB2021)N/N C5
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16.2.7.2.2 Listing of Adverse Events Updated After the EUA Snapshot – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)Updates
from
EUA to
sBLAd
C4591001
1009
10091380/
Placebo 14/M/
WHITE INJ&P Clavicle fracture/
Right Clavicle
Fracture 1 18JAN2021 21/36 2 No O NA/TC R
(22FEB2021)N/N C2
C4591001
1009
10091399/
Placebo 12/F/
WHITE INJ&P Foot fracture/
Left Fifth
Metatarsal
Fracture2 23FEB2021 26/82 2 No O NA/TC R
(15MAY2021)N/N C2
C4591001
1009
10091406/
Placebo 15/M/
WHITE MUSC Joint swelling/
Swilling in
bilateral knees 1 25JAN2021 18/36 1 No O NA/TC R
(01MAR2021)N/N C2
C4591001
1013
10131839/
Placebo 14/F/
WHITE INJ&P Concussion/
SPORTS
RELATED
CONCUSSION2 01MAR2021 69/C 2 No O NA RG N/N C6
C4591001
1039
10391314/
Placebo 14/F/
ASIAN NEOPL Fibroadenoma of
breast/
Exacerbation of
fibroadenoma of
right breas t2 06FEB2021 10/60 1 No O NA/TCN R
(06APR2021)N/N C2, C3,
C4
C4591001
1039
10391326/
BNT162b2 (30
μg) 15/M/
ASIAN PSYCH Depression/
Depression
Exacerbation 1 26JAN2021 16/5 3 No O NA/TC/TCN R
(30JAN2021)Y/N C4
C4591001
1044
10441304/
BNT162b2 (30
μg) 15/F/
WHITE SKIN Rash/
generalized rash 2 25FEB2021 38/3 1 No O NA/TC R
(27FEB2021)N/N C4, C6
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16.2.7.2.2 Listing of Adverse Events Updated After the EUA Snapshot – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)Updates
from
EUA to
sBLAd
C4591001
1044
10441337/
Placebo 13/M/
WHITE INJ&P Humerus fracture/
Broken humerus
(right arm) 1 10JAN2021 3/34 2 No O NA/TC R
(12FEB2021)N/N C2
C4591001
1057
10571451/
BNT162b2 (30
μg) 12/F/
WHITE INFEC Vulvovaginal
mycotic infection/
VAGINAL
YEAST
INFECTION1 13JAN2021 2/22 2 No O NA/TC R
(03FEB2021)N/N C2
C4591001
1066
10661422/
BNT162b2 (30
μg) 12/M/
WHITE SKIN Rash/
rash on torso 1 24DEC2020 3/5 1 No O NA R
(28DEC2020)N/N C2
C4591001
1123
11231442/
Placebo 12/M/
WHITE PSYCH Depression/
Depression 1 23DEC2020 15/164 2 No O NA/TC R
(04JUN2021)N/N C2
C4591001
1126
11261246/
BNT162b2 (30
μg) 13/M/
WHITE GENRL Nodule/
Red bump on right
index finger at
cuticle 2 13JAN2021 22/50 1 No O NA R
(03MAR2021)N/N C2
C4591001
1131
11311301/
BNT162b2 (30
μg) 13/M/
WHITE MUSC Arthralgia/
sacroiliac joint
pain 1 15JAN2021 5/25 2 No O NA R
(08FEB2021)N/N C2
INJ&P Accident/
skiin g acciden t2 18FEB2021 14/2 2 No O NA/TC/TCN R
(19FEB2021)N/N C2
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16.2.7.2.2 Listing of Adverse Events Updated After the EUA Snapshot – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)Updates
from
EUA to
sBLAd
INJ&P Clavicle fracture/
right clavicle
fracture2 19FEB2021 15/64 2 No O NA/TC/TCN R
(23APR2021)N/N C2
C4591001
1139
11391246/
Placebo 15/M/
WHITE MUSC Arthralgia/
Bilateral knee pain1 11JAN2021 4/36 2 No O NA/TC R
(15FEB2021)N/N C2
C4591001
1139
11391248/
BNT162b2 (30
μg) 15/M/
WHITE INJ&P Muscle strain/
Abdominal Muscle
Strain 2 10MAR2021 41/4 1 No O NA R
(13MAR2021)N/N C2, C6
C4591001
1142
11421385/
BNT162b2 (30
μg) 15/M/
NOT
REPORTED BLOOD Lymphadenopathy /
left supraclavicular
lymph node
swelling 1 07JAN2021 8/8 1 Yes NA R
(14JAN2021)N/N C2
C4591001
1147
11471263/
BNT162b2 (30
μg) 12/M/
WHITE NEOPL Hair follicle
tumour benign/
Pilomatrixoma 1 2020 1/ 1 No O NA/TC/TCN R
(09FEB2021)N/N C1, C2,
C3, C4
C4591001
1150
11501129/
Placebo 12/F/
WHITE INJ&P Concussion/
Concussion 2 11JAN2021 63/60 2 No O NA R
(11MAR2021)N/N C4
C4591001
1270
12701222/
BNT162b2 (30
μg) 14/F/
WHITE PSYCH Suicidal ideation/
SUICIDAL
IDEATION 2 16FEB2021 40/28 3 No O NA/TC/TCN R
(15MAR2021)Y/N C2, C3
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16.2.7.2.2 Listing of Adverse Events Updated After the EUA Snapshot – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)Updates
from
EUA to
sBLAd
Abbreviations: C = continuing; Du r = duration; Imm = immediate; EUA = emergency use authorizatio n. Refer to the AE legend page (Listing 16.2.7.1) for
additional definitions.
Note: MedDRA (v24.0) coding dictionary applied.
a. Relative day (Rel Day) = da te of AE - date of last vacci nation + 1. For an AE that occurred before the date of the firs t study vaccination, + 1 was not added
to compute relative day.
b. Duration (days) was calculated as the difference from th e start of the first reported ev ent to resolution of the last r eported event, inclusive.
c. Vaccine related (Vax Rel) : relationship to investigation al vaccine as assessed by the investigator.
d. C1 means AE preferred term changed from EUA to sBLA; C2 means AE resolved date or ongoing status , or outcome changed f rom EUA to sBLA; C3
means AE action changed from EUA to sBLA;
C4 means AE causality changed from EUA to sBLA; C5 means AE onset date changed from EUA to sBLA; C6 means minor AE term change d from EUA to
sBLA and AE dictionary derived remains the same.
PFIZER CONFIDENTIAL SDTM Creation: 05OCT2021 (17:29) Source Dat a: adae Table Generation: 08NOV2021 (19:56)
(Data Cutoff Date: 02SEP2021, Database Snapshot Date: 27SEP2021 ) Output File: ./nda2 _unblinded/C4591001 _S_Peds/adae _l002_1_c_ped6
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16.2.7.2.3 Listing of New Adverse Events After the EUA Snapshot – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1005
10051339/
Placebo 14/F/
WHITE PSYCH Anxiety/
anxiety 2 21APR2021 162/C 1 No O NA/TC N N/N
MUSC Myalgia/
generalized
myalgia#3 19MAY2021 3/5 1 Yes NA R
(23MAY2021)N/N
C4591001
1005
10051417/
Placebo 13/F/
WHITE GENRL Pyrexia/
fever# 4 13AUG2021 1/2 2 Yes NA R
(14AUG2021)N/N
C4591001
1005
10051420/
BNT162b2 (30
μg) 12/F/
WHITE PSYCH Anxiety/
Anxiety 2 03MAY2021 120/C 1 No O NA/TC N N/N
Depression/
Depression2 03MAY2021 120/C 1 No O NA/TC N N/N
C4591001
1005
10051427/
Placebo 14/F/
WHITE GENRL Chills/
chills# 4 07JUN2021 1/3 2 Yes NA R
(09JUN2021)N/N
MUSC Myalgia/
generalized
myalgia#4 07JUN2021 1/3 2 Yes NA R
(09JUN2021)N/N
C4591001
1005
10051437/
Placebo 15/F/
WHITE GENRL Fatigue/
Fatigue# 4 17JUN2021 1/10 2 Yes NA R
(26JUN2021)N/N
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16.2.7.2.3 Listing of New Adverse Events After the EUA Snapshot – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
MUSC Myalgia/
Generalized
myalgia#4 17JUN2021 1/10 2 Yes NA R
(26JUN2021)N/N
C4591001
1005
10051449/
BNT162b2 (30
μg) 14/M/
WHITE INFEC Appendicitis/
Appendicitis# 2 28JUN2021 148/2 2 No O NA/TCN R
(29JUN2021)Y/N
C4591001
1005
10051450/
Placebo 14/M/
ASIAN INJ&P Hand fracture/
Broken left thumb#3 10JUN2021 18/37 2 No O NA R
(16JUL2021)N/N
C4591001
1006
10061183/
Placebo 14/M/
MULTIPLE INJ&P Hand fracture/
Broken thumb- left2 12MAY2021 126/36 2 No O NA R
(16JUN2021)N/N
GENRL Injection site pain/
Injection Site
Tenderness#3 20MAY2021 1/3 1 Yes NA R
(22MAY2021)N/N
C4591001
1006
10061196/
Placebo 12/M/
WHITE GENRL Injection site pain/
Injection site
tenderness# 3 19MAY2021 1/8 1 Yes NA R
(26MAY2021)N/N
C4591001
1006
10061223/
Placebo 15/M/
WHITE GENRL Injection site pain/
Injection Site Pain#3 18MAY2021 2/4 1 Yes NA/TC R
(21MAY2021)N/N
C4591001
1006
10061226/
Placebo 15/F/
WHITE PSYCH Attention deficit
hyperactivity
disorder/
Attention Deficit 2 24MAR2021 87/C 2 No O NA/TC N N/N
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16.2.7.2.3 Listing of New Adverse Events After the EUA Snapshot – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Hyperactivity
Disorde r
C4591001
1006
10061228/
Placebo 12/F/
WHITE PSYCH Attention deficit
hyperactivity
disorder/
Attention Deficit
Hyperactivity
Disorde r2 24MAR2021 86/C 2 No O NA/TC N N/N
C4591001
1006
10061253/
Placebo 14/M/
WHITE INJ&P Facial bones
fracture/
Fractured Nasal
Septum#3 02JUN2021 17/5 1 No O NA/TC R
(06JUN2021)N/N
C4591001
1006
10061258/
BNT162b2 (30
μg) 14/M/
NATIVE
HAWAIIAN
OR OTHER
PACIFIC
ISLANDER GASTR Aphthous ulcer/
ORAL CANKERS#2 27JUN2021 174/9 2 No O NA/TC R
(05JUL2021)N/N
C4591001
1006
10061272/
BNT162b2 (30
μg) 13/F/
BLACK OR
AFRICAN
AMERICAN INJ&P Fall/
Fall 1 05FEB2021 52/1 1 No O NA R
(05FEB2021)N/N
GENRL Injection site pain/
Injection site
soreness#2 17MAY2021 1/4 1 Yes NA R
(20MAY2021)N/N
C4591001
1006
10061274/
BNT162b2 (30
μg) 14/F/
WHITE NERV Migraine/
MIGRAINE
HEADACHES 2 APR2021 84/C 2 No O NA/TC N N/N
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16.2.7.2.3 Listing of New Adverse Events After the EUA Snapshot – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1006
10061279/
Placebo 13/F/
WHITE PSYCH Anxiety/
Worsening of
Anxiety 2 MAR2021 56/C 2 No O NA/TC N N/N
INJ&P Ligament sprain/
Left Sprained Ankle2 26MAR2021 81/C 1 No O NA/TC/TCN N N/N
NEOPL Skin papilloma/
Left Foot Plantar
Wart#4 09JUN2021 3/9 2 No O NA/TCN R
(17JUN2021)N/N
C4591001
1006
10061285/
Placebo 14/F/
WHITE RENAL Dysuria/
dysuria 2 31MAY2021 140/51 1 No O NA R
(20JUL2021)N/N
GENRL Injection site pain/
Injection site pain#3 04JUN2021 2/2 2 Yes NA R
(05JUN2021)N/N
C4591001
1006
10061286/
BNT162b2 (30
μg) 14/M/
WHITE INJ&P Bone contusion/
CONTUSION
RIGHT
CALCANEUS 2 08MAR2021 57/C 2 No O NA/TCN N N/N
C4591001
1006
10061292/
Placebo 15/F/
WHITE INJ&P Procedural pain/
Post Surgical pain
Spinal hardware
removal2 30MAR2021 78/6 3 No O NA/TC R
(04APR2021)N/N
C4591001
1007
10071409/
BNT162b2 (30
μg) 13/M/
ASIAN GENRL Fatigue/
fatigue# 2 28MAY2021 2/3 2 Yes NA R
(30MAY2021)N/N
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16.2.7.2.3 Listing of New Adverse Events After the EUA Snapshot – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Injection site pain/
pain at injection
site#2 28MAY2021 2/4 1 Yes NA R
(31MAY2021)N/N
Pyrexia/
fever#2 28MAY2021 2/3 3 Yes NA/TC R
(30MAY2021)N/N
NERV Headache/
headache#2 28MAY2021 2/3 1 Yes NA R
(30MAY2021)N/N
C4591001
1007
10071414/
Placebo 14/M/
WHITE GENRL Chills/
chills# 3 20MAY2021 2/3 2 Yes NA R
(22MAY2021)N/N
Fatigue/
Fatigue#3 20MAY2021 2/3 3 Yes NA R
(22MAY2021)N/N
C4591001
1007
10071480/
Placebo 14/M/
WHITE GENRL Injection site pain/
Injection site pain#3 17MAY2021 1/8 1 Yes NA R
(24MAY2021)N/N
GENRL Injection site pain/
Injection site pain#4 08JUN2021 1/3 1 Yes NA R
(10JUN2021)N/N
GENRL Pyrexia/
fever#4 09JUN2021 2/2 2 Yes NA/TC R
(10JUN2021)N/N
NERV Headache/
headache#4 09JUN2021 2/2 2 Yes NA/TC R
(10JUN2021)N/N
MUSC Neck pain/
neck pain#4 11JUN2021 4/C 2 No O NA N N/N
INFEC Herpes zoster/
shingles#4 18JUN2021 11/13 2 No O NA R
(30JUN2021)N/N
MUSC Pain in extremity/
Deltoid of left arm
pain#4 20JUN2021 13/4 2 No O NA R
(23JUN2021)N/N
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16.2.7.2.3 Listing of New Adverse Events After the EUA Snapshot – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1007
10071483/
Placebo 15/F/
WHITE GENRL Injection site pain/
Injection site pain#3 30MAR2021 1/5 1 Yes NA R
(03APR2021)N/N
C4591001
1007
10071484/
Placebo 13/F/
WHITE GENRL Fatigue/
fatigue# 3 20MAY2021 2/34 1 Yes NA R
(22JUN2021)N/N
Injection site pain/
injection site pain#3 20MAY2021 2/1 1 Yes NA R
(20MAY2021)N/N
Pyrexia/
subjective fever#3 20MAY2021 2/3 1 Yes NA R
(22MAY2021)N/N
MUSC Myalgia/
generalized muscle
aches#3 20MAY2021 2/3 1 Yes NA R
(22MAY2021)N/N
C4591001
1007
10071499/
Placebo 14/M/
WHITE MUSC Arthralgia/
left wrist pain+ 2 01MAY2021 131/3 1 No O NA/TC/TCN R
(03MAY2021)N/N
C4591001
1007
10071505/
Placebo 12/F/
WHITE GENRL Fatigue/
Fatigue# 3 03JUN2021 2/2 1 Yes NA R
(04JUN2021)N/N
MUSC Pain in extremity/
Right Arm Pain#3 03JUN2021 2/4 1 Yes NA R
(06JUN2021)N/N
GENRL Injection site pain/
injection site pain#4 23JUN2021 1/3 1 Yes NA R
(25JUN2021)N/N
GASTR Nausea/
nausea#4 24JUN2021 2/2 1 Yes NA R
(25JUN2021)N/N
GENRL Pyrexia/
fever 101#4 24JUN2021 2/2 2 Yes NA/TC R
(25JUN2021)N/N
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16.2.7.2.3 Listing of New Adverse Events After the EUA Snapshot – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
NERV Dizziness/
lightheadedness#4 24JUN2021 2/2 1 Yes NA/TCN R
(25JUN2021)N/N
Headache/
headache#4 24JUN2021 2/2 2 Yes NA/TC R
(25JUN2021)N/N
NERV Somnolence/
Excessive
Sleepiness#4 08JUL2021 16/15 3 No O NA R
(22JUL2021)Y/N
C4591001
1007
10071509/
Placebo 15/F/
WHITE MUSC Pain in extremity/
Right Arm Pain# 3 21MAY2021 2/3 1 Yes NA/TC R
(23MAY2021)N/N
C4591001
1007
10071511/
Placebo 15/M/
WHITE NERV Headache/
Headache# 3 18MAY2021 1/2 1 Yes NA R
(19MAY2021)N/N
MUSC Pain in extremity/
Left arm pain#3 19MAY2021 2/2 1 Yes NA R
(20MAY2021)N/N
C4591001
1007
10071516/
Placebo 15/M/
WHITE GENRL Chills/
Chills# 3 19MAY2021 2/2 1 Yes NA R
(20MAY2021)N/N
Pyrexia/
Fever#3 19MAY2021 2/2 1 Yes NA R
(20MAY2021)N/N
C4591001
1007
10071519/
Placebo 15/M/
WHITE GENRL Injection site pain/
Pain at injection
site# 3 31MAR2021 1/2 2 Yes NA R
(01APR2021)N/N
C4591001
1007
10071531/
Placebo 14/F/
WHITE NERV Headache/
Headache# 3 26MAY2021 2/1 2 Yes NA/TC R
(26MAY2021)N/N
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16.2.7.2.3 Listing of New Adverse Events After the EUA Snapshot – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GENRL Injection site pain/
injection site pain#3 22JUN2021 29/3 1 Yes NA R
(24JUN2021)N/N
MUSC Myalgia/
muscle aches to
legs#4 22JUN2021 1/3 1 Yes NA R
(24JUN2021)N/N
C4591001
1007
10071547/
Placebo 14/M/
WHITE GENRL Injection site pain/
Injection site pain#3 20MAY2021 1/3 1 Yes NA R
(22MAY2021)N/N
GENRL Injection site
erythema/
Injection site
redness#3 21MAY2021 2/4 1 Yes NA R
(24MAY2021)N/N
C4591001
1007
10071559/
Placebo 14/F/
WHITE GENRL Fatigue/
fatigue# 3 28MAY2021 2/3 2 Yes NA R
(30MAY2021)N/N
NERV Dizziness/
dizziness#3 28MAY2021 2/3 1 Yes NA R
(30MAY2021)N/N
Headache/
headache#3 28MAY2021 2/3 2 Yes NA R
(30MAY2021)N/N
NERV Headache/
headache#3 05JUN2021 10/1 2 No O NA/TC R
(05JUN2021)N/N
GENRL Chills/
chills#4 17JUN2021 1/2 1 Yes NA/TC R
(18JUN2021)N/N
Injection site pain/
injection site pain#4 17JUN2021 1/3 1 Yes NA R
(19JUN2021)N/N
Pyrexia/
fever 101.9#4 17JUN2021 1/2 2 Yes NA/TC R
(18JUN2021)N/N
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16.2.7.2.3 Listing of New Adverse Events After the EUA Snapshot – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
MUSC Myalgia/
generalized muscle
pain#4 17JUN2021 1/2 2 Yes NA/TC R
(18JUN2021)N/N
NERV Headache/
headache#4 17JUN2021 1/2 1 Yes NA R
(18JUN2021)N/N
C4591001
1007
10071562/
Placebo 12/F/
WHITE GENRL Fatigue/
fatigue# 3 18MAY2021 2/1 1 Yes NA R
(18MAY2021)N/N
INV Body temperature
increased/
elevated body
temp#3 18MAY2021 2/1 2 Yes NA/TC R
(18MAY2021)N/N
MUSC Myalgia/
generalized muscle
aches#3 18MAY2021 2/1 1 Yes NA R
(18MAY2021)N/N
INV Body temperature
increased/
elevated body temp
100.0#4 07JUN2021 1/2 2 Yes NA/TC R
(08JUN2021)N/N
GENRL Fatigue/
fatigue#4 08JUN2021 2/1 2 Yes NA R
(08JUN2021)N/N
MUSC Myalgia/
generalized muscle
aches#4 08JUN2021 2/1 1 Yes NA R
(08JUN2021)N/N
C4591001
1007
10071581/
Placebo 15/M/
WHITE GENRL Fatigue/
fatigue# 4 15JUN2021 2/2 2 Yes NA R
(16JUN2021)N/N
Injection site pain/
injection site pain#4 15JUN2021 2/2 1 Yes NA R
(16JUN2021)N/N
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16.2.7.2.3 Listing of New Adverse Events After the EUA Snapshot – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
MUSC Myalgia/
generalized muscle
aches#4 15JUN2021 2/2 2 Yes NA/TC R
(16JUN2021)N/N
C4591001
1007
10071583/
Placebo 15/M/
WHITE GENRL Injection site pain/
injection site pain#4 09JUN2021 1/3 2 Yes NA R
(11JUN2021)N/N
NERV Headache/
headache#4 10JUN2021 2/1 1 Yes NA R
(10JUN2021)N/N
C4591001
1007
10071586/
Placebo 13/M/
WHITE GENRL Injection site pain/
Injection site pain#3 02JUN2021 2/3 1 Yes NA R
(04JUN2021)N/N
C4591001
1007
10071595/
Placebo 13/F/
WHITE NERV Presyncope/
Vaso-vagal
response 2 30MAR2021 71/1 1 No O NA/TCN R
(30MAR2021)N/N
C4591001
1007
10071596/
Placebo 13/M/
WHITE GENRL Fatigue/
fatigue# 3 24MAY2021 1/5 2 Yes NA R
(28MAY2021)N/N
NERV Headache/
headache#3 24MAY2021 1/5 2 Yes NA R
(28MAY2021)N/N
GENRL Pyrexia/
fever#3 25MAY2021 2/4 1 Yes NA R
(28MAY2021)N/N
MUSC Myalgia/
muscle aches#3 25MAY2021 2/4 2 Yes NA R
(28MAY2021)N/N
C4591001
1007
10071600/
Placebo 12/F/
WHITE PSYCH Depression/
depression# 2 17MAY2021 119/C 2 No O NA/TC RG Y/N
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16.2.7.2.3 Listing of New Adverse Events After the EUA Snapshot – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Suicidal ideation/
Suicidal Ideation#2 17MAY2021 119/5 3 No O NA/TC/TCN R
(21MAY2021)Y/N
C4591001
1007
10071614/
Placebo 14/M/
WHITE GENRL Injection site pain/
injection site
soreness# 4 28JUN2021 1/4 1 Yes NA R
(01JUL2021)N/N
GENRL Chills/
chills#4 29JUN2021 2/1 1 Yes NA R
(29JUN2021)N/N
Fatigue/
fatigue#4 29JUN2021 2/3 1 Yes NA R
(01JUL2021)N/N
Pyrexia/
fever 101.9#4 29JUN2021 2/3 2 Yes NA R
(01JUL2021)N/N
NERV Headache/
headache#4 29JUN2021 2/1 1 Yes NA R
(29JUN2021)N/N
C4591001
1007
10071617/
Placebo 15/F/
WHITE PSYCH Anxiety/
worsening of
Anxiety 2 15FEB2021 27/C 2 No O NA/TC N N/N
Obsessive-
compulsive
disorder/
worsening of
Obsessive
Compulsive
Disorde r2 15FEB2021 27/C 2 No O NA/TC N N/N
C4591001
1007
10071620/
BNT162b2 (30
μg) 12/F/
WHITE PSYCH Anxiety/
worsening anxiety2 30JAN2021 11/C 2 No O NA/TC/TCN N N/N
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FDA-CBER-2022-5812-0224218
16.2.7.2.3 Listing of New Adverse Events After the EUA Snapshot – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GASTR Constipation/
constipation2 13MAR2021 53/C 2 No O NA/TC RG N/N
C4591001
1007
10071623/
Placebo 13/M/
WHITE MUSC Tendonitis/
right wrist
tendonitis 2 15FEB2021 26/176 2 No O NA/TC RS
(09AUG2021)N/N
GENRL Fatigue/
Fatigue#3 01JUN2021 1/2 1 Yes NA R
(02JUN2021)N/N
Injection site pain/
Injection site pain#3 01JUN2021 1/3 1 Yes NA R
(03JUN2021)N/N
C4591001
1007
10071624/
Placebo 13/M/
WHITE MUSC Pain in extremity/
left Arm Pain# 3 20MAY2021 2/2 1 Yes NA R
(21MAY2021)N/N
C4591001
1007
10071625/
Placebo 13/F/
WHITE GENRL Injection site pain/
Injection Site Arm
Pain# 3 20MAY2021 2/2 1 Yes NA R
(21MAY2021)N/N
Pyrexia/
fever#3 20MAY2021 2/1 1 Yes NA/TC R
(20MAY2021)N/N
C4591001
1007
10071632/
Placebo 13/F/
WHITE GASTR Nausea/
Nausea# 3 19MAY2021 2/1 1 Yes NA R
(19MAY2021)N/N
GENRL Pain/
Body ache#3 19MAY2021 2/1 1 Yes NA R
(19MAY2021)N/N
MUSC Pain in extremity/
Arm pain#3 19MAY2021 2/4 1 Yes NA R
(22MAY2021)N/N
NERV Headache/
Headache#3 19MAY2021 2/1 1 Yes NA R
(19MAY2021)N/N
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FDA-CBER-2022-5812-0224219
16.2.7.2.3 Listing of New Adverse Events After the EUA Snapshot – All Subjects 12 Through 15 Years of Age
Subject/
Vaccine
Group (as
Administered) Age(Years)/
Sex/
Race System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GASTR Nausea/
nausea#4 09JUN2021 2/1 1 Yes NA R
(09JUN2021)N/N
GENRL Pain/
generalized body
aches#4 09JUN2021 2/1 2 Yes NA/TC R
(09JUN2021)N/N
C4591001
1007
10071640/
Placebo 14/F/
WHITE GENRL Injection site pain/
Injection site pain#3 03JUN2021 1/2 1 Yes NA R
(04JUN2021)N/N
GENRL Chills/
Chills#4 22JUN2021 1/2 1 Yes NA R
(23JUN2021)N/N
Pyrexia/
fever#4 22JUN2021 1/2 1 Yes NA/TC/TCN R
(23JUN2021)N/N
NERV Headache/
headache#4 22JUN2021 1/2 2 Yes NA/TC R
(23JUN2021)N/N
C4591001
1007
10071642/
BNT162b2 (30
μg) 15/M/
WHITE GENRL Fatigue/
fatigue#
…[truncated]