125742 45 S211 M5 c4591001 interim ado mth6 compliance

Document text

16.2.5.1 Listing of Subjects Who Received Vaccine Not as Random ized – All Subjects 12 Through 15 Years of Age
Vaccine Group  
(as Randomized) Subject Randomization  
Date Vaccination 
Date Dose 
No. Vaccine Received 
  
No subject meets the reporting criteria.           
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (11:35) Source Dat a: adsl Table Generation: 03NOV2021 (13:12)  
(Data Cutoff Date: 02SEP2021, Database Snapshot Date: 27SEP2021 ) Output File: ./nda2 unblinded/C4591001 SPeds/adsl l001 1ped6 novax
 
090177e1988b7711\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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FDA-CBER-2022-5812-0499805
16.2.5.3 Listing of Study Vaccina tion Errors – All Subjects 12 Through 15 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Dose
No.a Start DateType of Study 
Vaccination Error Action Taken Was a 
Concomitant
Medication
Given 
(Yes/No) Was a 
Nondrug
Treatment
Given 
(Yes/No) Stop DateDiscontinued
From Study
(Yes/No) Associated
With AE
(Yes/No)
  
C4591001 1084 
10841543/ 
Placebo 4 08JUN2021 Expired product 
administered DOSE NOT 
CHANGED N N 08JUN2021 N N 
  
Note: For original placebo group subjects, Dose 3 = first dose of BNT162b2 (30 μg), Dose 4 = se cond dose of BNT162b2 (30 μg). 
a.     Dose No. = the vaccination visit at which the study vacc ination error occurred. 
PFIZER CONFIDENTIAL SDTM Creation: 05OCT2021 (17:29) Source Dat a: adae Table Generation: 09NOV2021 (03:34)  
(Data Cutoff Date: 02SEP2021, Database Snapshot Date: 27SEP2021 ) Output File: ./nda2 _unblinded/C4591001 _S_Peds/adae _l002_me1_ped6
 
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16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1005 
10051328/ 
BNT162b2 (30 μg) Immune system disorders Hypersensitivity 01JAN2010 Y 
  Psychiatric disorders Anxiet y 01JAN2018 Y
  Social circumstances Premenarche 2006 Y
C4591001 1005 
10051410/ 
Placebo Social circumstances Premenarche 2007 Y 
C4591001 1005 
10051412/ 
BNT162b2 (30 μg) Psychiatric disorders Anxiety 01JAN2018 Y 
  Depression 01JAN2018 Y
  Reproductive system and breast 
disordersPolycystic ovaries 01JAN2016 Y 
C4591001 1005 
10051414/ 
Placebo Immune system disorders Hypersensitivity 01JAN2010 Y 
  Psychiatric disorders Autism spectrum disorde r 01JAN2010 Y
C4591001 1005 
10051417/ 
Placebo Skin and subcutaneous tissue disorders Acne 01JAN2019 Y 
C4591001 1005 
10051418/ 
BNT162b2 (30 μg) Respiratory, thoraci c and mediastinal 
disorders Asthma 01JAN2018 Y 
C4591001 1005 
10051419/ 
Placebo Psychiatric disorders Anxiety 01JAN2013 Y 
  Attention deficit h yperactivit y disorde r 01JAN2013 Y
C4591001 1005 
10051420/ 
BNT162b2 (30 μg) Immune system disorders Hypersensitivity 01JAN2019 Y 
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(b) (6)
(b) (6)
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16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2019 Y
  Social circumstances Premenarche 2008 Y
C4591001 1005 
10051422/ 
Placebo Immune system disorders Food allergy 01JAN2014 Y 
  Nervous s ystem disorders Migraine without aura 01JAN2018 Y
C4591001 1005 
10051425/ 
BNT162b2 (30 μg) Immune system disorders Hypersensitivity 01JAN2010 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2017 Y 
C4591001 1005 
10051429/ 
BNT162b2 (30 μg) Musculoskeletal and connective tissue 
disorders Short stature 01OCT2019 Y 
C4591001 1005 
10051431/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2006 Y 
  Psychiatric disorders Depression 01JAN2019 Y
C4591001 1005 
10051436/ 
BNT162b2 (30 μg) Psychiatric disorders Anxiety 01JAN2011 Y 
C4591001 1005 
10051437/ 
Placebo Skin and subcutaneous tissue disorders Acne 01JAN2019 Y 
C4591001 1005 
10051438/ 
Placebo Metabolism and nutrition disorders Lactose intolerance 01JAN2017 Y 
C4591001 1005 
10051439/ 
BNT162b2 (30 μg) Endocrine disorders Hypothyroidism 01JAN2017 Y 
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16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1005 
10051440/ 
Placebo Blood and lymphatic system disorders Immune thrombocytopenia 01JAN2011 31DEC2011 N 
C4591001 1005 
10051441/ 
BNT162b2 (30 μg) Immune system disorders Hypersensitivity 01JAN2005 Y 
  Musculoskeletal and connective tissue 
disordersScoliosis 01JAN2014 31DEC2016 N 
  Psychiatric disorders Anxiet y 01JAN2018 Y
  Surgical and medical procedures Spinal fusion sur gery 01JAN2016 31DEC2016 N
C4591001 1005 
10051444/ 
Placebo Psychiatric disorders Anxiety 01JAN2015 Y 
C4591001 1005 
10051445/ 
Placebo Psychiatric disorders Anxiety 01OCT2020 Y 
C4591001 1005 
10051449/ 
BNT162b2 (30 μg) Immune system disorders Hypersensitivity 01JAN2010 Y 
C4591001 1005 
10051451/ 
BNT162b2 (30 μg) Immune system disorders Hypersensitivity 01JAN2015 Y 
  Psychiatric disorders Anxiet y 01JAN2018 Y
  Attention deficit h yperactivit y disorde r 01JAN2019 Y
  Insomnia 01JAN2019 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2015 Y 
C4591001 1006 
10061183/ 
Placebo Metabolism and nutrition disorders Obesity 01JAN2016 Y 
  Nervous s ystem disorders Headache 01JAN2015 Y
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16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1006 
10061184/ 
BNT162b2 (30 μg) Skin and subcutaneous tissue disorders Acne 01JAN2018 Y 
C4591001 1006 
10061188/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2017 Y 
C4591001 1006 
10061189/ 
BNT162b2 (30 μg) Immune system disorders Hypersensitivity 01JAN2011 Y 
  Infections and infestations Tonsillitis 01JAN2009 31DEC2009 N
  Investi gations Blood pressure increase d 01JAN2019 Y
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2017 Y
  Skin and subcutaneous tissue disorders Urticaria 01JAN2009 Y
  Surgical and medical procedures Adenotonsillectom y 01JAN2009 31DEC2009 N
C4591001 1006 
10061190/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2014 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2019 Y
C4591001 1006 
10061191/ 
BNT162b2 (30 μg) Blood and lymphatic system disorders Immune thrombocytopenia 01JAN2009 Y 
  Immune s ystem disorders Seasonal aller gy 19MAR2012 Y
  Musculoskeletal and connective tissue 
disordersScoliosis 07MAR2017 Y 
  Neoplasms benign, malignant and 
unspecified (incl c ysts and pol yps)Skin papilloma 01APR2020 Y 
  Nervous s ystem disorders Migraine 04NOV2013 Y
  Psychiatric disorders Attention deficit h yperactivit y disorde r 27FEB2013 Y
  Depression 06JUN2019 Y
  Insomnia 02JAN2019 Y
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16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2011 Y 
  Skin and subcutaneous tissue disorders Eczema 21NOV2016 Y
C4591001 1006 
10061196/ 
Placebo Gastrointestinal disorders Toothache 01OCT2020 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2015 Y
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2019 Y
C4591001 1006 
10061200/ 
Placebo Skin and subcutaneous tissue disorders Acne 19JUN2019 Y 
C4591001 1006 
10061201/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2017 Y 
  Nervous s ystem disorders Headache 01JUL2020 Y
C4591001 1006 
10061203/ 
BNT162b2 (30 μg) Immune system disorders Allergy to animal 01JAN2013 Y 
  Hypersensitivit y 01FEB2013 Y
  Seasonal aller gy 01FEB2013 Y
  Nervous s ystem disorders Headache 01AUG2020 Y
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2012 Y
C4591001 1006 
10061206/ 
Placebo Immune system disorders Perennial allergy 01JAN2015 Y 
  Psychiatric disorders Attention defici thyperactivit y disorde r 01JAN2019 Y
  Generalised anxiet y disorde r 01JAN2019 Y
  Insomnia 01JAN2018 Y
  Skin and subcutaneous tissue disorders Eczema 01JAN2012 Y
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16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1006 
10061207/ 
Placebo Psychiatric disorders Anxiety 01JAN2015 Y 
  Attention deficit h yperactivit y disorde r 01JAN2011 Y
  Depression 01JAN2015 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2015 Y 
  Skin and subcutaneous tissue disorders Acne 01JUN2020 Y
C4591001 1006 
10061209/ 
BNT162b2 (30 μg) Musculoskeletal and connective tissue 
disorders Arthralgia 01JAN2018 Y 
C4591001 1006 
10061212/ 
Placebo Skin and subcutaneous tissue disorders Acne 01JAN2016 Y 
C4591001 1006 
10061214/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2006 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 27MAR2013 Y
C4591001 1006 
10061219/ 
Placebo Gastrointestinal disorders Abdominal pain 01JAN2017 Y 
  Immune s ystem disorders Drug hypersensitivit y 01JAN2009 Y
  Neoplasms benign, malignant and 
unspecified (incl c ysts and pol yps)Melanocytic naevus 01JAN2006 Y 
  Psychiatric disorders Insomnia 01JAN2016 Y
  Skin and subcutaneous tissue disorders Acne 01DEC2019 Y
C4591001 1006 
10061220/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2008 Y 
  Seasonal aller gy 01JAN2016 Y
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16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Injury, poisoning and procedural 
complicationsMuscle strain 01NOV2020 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2019 Y
C4591001 1006 
10061221/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2009 Y 
  Musculoskeletal and connective tissue 
disordersScoliosis 20JUL2018 Y 
  Temporomandibular joint s yndrome 12SEP2019 Y
  Reproductive system and breast 
disordersMenstruation irregular 03JAN2019 Y 
C4591001 1006 
10061223/ 
Placebo Immune system disorders Hypersensitivity 01JAN2018 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2015 Y 
C4591001 1006 
10061224/ 
BNT162b2 (30 μg) Immune system disorders Allergy to animal 01JAN2015 Y 
  Infections and infestations Chronic sinusitis 13NOV2019 Y
  Respiratory, thoraci c and mediastinal 
disordersNasal septum deviation 13NOV2019 Y 
  Nasal turbinate h ypertroph y 13NOV2019 Y
  Rhinitis aller gic 01JAN2015 Y
C4591001 1006 
10061227/ 
BNT162b2 (30 μg) Musculoskeletal and connective tissue 
disorders Temporomandibular joint syndrome 01MAR2020 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2016 Y
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16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1006 
10061228/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2013 Y 
  Reproductive system and breast 
disordersDysmenorrhoea 01DEC2019 Y 
C4591001 1006 
10061229/ 
Placebo Blood and lymphatic system disorders Iron deficiency anaemia 01JAN2018 Y 
  Skin and subcutaneous tissue disorders Hyperhidrosis 01APR2017 Y
C4591001 1006 
10061230/ 
BNT162b2 (30 μg) Psychiatric disorders Anxiety 01JAN2018 Y 
  Attention deficit h yperactivit y disorde r 01JAN2018 Y
  Depression 01JAN2018 Y
C4591001 1006 
10061231/ 
BNT162b2 (30 μg) Psychiatric disorders Anxiety 01JAN2012 Y 
  Attention deficit h yperactivit y disorde r 01JAN2017 Y
  Depression 01JAN2013 Y
  Obsessive-compulsive disorde r 01JAN2017 Y
  Respiratory, thoraci c and mediastinal 
disordersSleep apnoea syndrome 01JAN2012 08AUG2014 N 
  Social circumstances Premenarche 2008 Y
  Surgical and medical procedures Adenoidectom y 08AUG2014 08AUG2014 N
  Turbinectom y 08AUG2014 08AUG2014 N
C4591001 1006 
10061232/ 
Placebo Surgical and medical procedures Bone operation 06OCT2019 06OCT2019 N 
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16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1006 
10061234/ 
BNT162b2 (30 μg) Musculoskeletal and connective tissue 
disorders Scoliosis 05FEB2019 Y 
C4591001 1006 
10061235/ 
Placebo Metabolism and nutrition disorders Gluten sensitivity 01JAN2010 Y 
  Psychiatric disorders Insomnia 01JAN2019 Y
C4591001 1006 
10061236/ 
BNT162b2 (30 μg) Gastrointestinal disorders Constipation 01JAN2019 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2016 Y
  Nervous s ystem disorders Migraine 01JAN2018 Y
C4591001 1006 
10061237/ 
Placebo Eye disorders Myopia 01JAN2016 Y 
  Immune s ystem disorders Seasonal aller gy 01SEP2020 Y
  Injury, poisoning and procedural 
complicationsFacial bones fracture 04AUG2013 08AUG2013 N 
  Jaw fracture 04AUG2013 08AUG2013 N
  Nervous s ystem disorders Migraine 01JAN2015 Y
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2016 Y
  Generalised anxiet y disorde r 01MAR2020 Y
  Major depression 01NOV2019 Y
  Surgical and medical procedures Fracture treatmen t 08AUG2013 08AUG2013 N
C4591001 1006 
10061239/ 
Placebo Skin and subcutaneous tissue disorders Acne 01JAN2020 Y 
  Social circumstances Premenarche 2006 12DEC2020 N
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FDA-CBER-2022-5812-0499815
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1006 
10061241/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2018 Y 
  Psychiatric disorders Anxiet y 01JAN2017 Y
C4591001 1006 
10061242/ 
BNT162b2 (30 μg) Skin and subcutaneous tissue disorders Acne 01JAN2018 Y 
C4591001 1006 
10061248/ 
Placebo Immune system disorders Seasonal allergy 01JAN2014 Y 
C4591001 1006 
10061249/ 
BNT162b2 (30 μg) Metabolism and nutrition disorders Obesity 01JAN2016 Y 
C4591001 1006 
10061250/ 
Placebo Nervous system disorders Migraine 01JAN2015 Y 
C4591001 1006 
10061252/ 
BNT162b2 (30 μg) Immune system disorders Allergy to animal 01JAN2008 Y 
  Hypersensitivit y 01JAN2008 Y
  Metabolism and nutrition disorders Food intolerance 01JAN2010 Y
  Psychiatric disorders Anxiet y 01JAN2017 Y
  Depression 01JAN2017 Y
C4591001 1006 
10061253/ 
Placebo Immune system disorders Seasonal allergy 01JAN2018 Y 
  Injury, poisoning and procedural 
complicationsWrist fracture 01MAY2020 31JUL2020 N 
C4591001 1006 
10061254/ 
BNT162b2 (30 μg) Gastrointestinal disorders Abdominal pain upper 06JUN2020 Y 
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FDA-CBER-2022-5812-0499816
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Metabolism and nutrition disorders Obesit y 01JAN2017 Y
  Nervous s ystem disorders Headache 01JUN2020 Y
  Psychiatric disorders Anxiet y 01JUN2020 Y
  Depression 01JUN2020 Y
  Insomnia 01JUL2020 Y
C4591001 1006 
10061256/ 
BNT162b2 (30 μg) Infections and infestations Tonsillitis 01JAN2008 31DEC2008 N 
  Psychiatric disorders Adjustment disorder with depressed moo d 01APR2020 31JUL2020 N
  Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
  Surgical and medical procedures Adenoidectom y 01JAN2008 31DEC2008 N
  Tonsillectom y 01JAN2008 31DEC2008 N
C4591001 1006 
10061257/ 
Placebo Congenital, familial and genetic 
disorders Tourette's disorder 01JAN2016 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2015 Y
  Reproductive system and breast 
disordersDysmenorrhoea 01JAN2017 Y 
C4591001 1006 
10061258/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2018 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2017 Y
C4591001 1006 
10061259/ 
Placebo Injury, poisoning and procedural 
complications Ligament sprain 24AUG2020 Y 
  Nervous s ystem disorders Headache 01JAN2017 Y
C4591001 1006 
10061260/ 
Placebo Social circumstances Premenarche 2008 Y 
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16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1006 
10061261/ 
BNT162b2 (30 μg) Congenital, familial and genetic 
disorders Bicuspid aortic valve 2006 Y 
  Psychiatric disorders Anxiet y 01JAN2019 Y
  Attention deficit h yperactivit y disorde r 01JAN2011 Y
C4591001 1006 
10061262/ 
Placebo Skin and subcutaneous tissue disorders Acne cystic 01JUL2020 Y 
C4591001 1006 
10061263/ 
BNT162b2 (30 μg) Nervous system disorders Headache 01JAN2019 Y 
  Social circumstances Premenarche 2008 Y
C4591001 1006 
10061265/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2012 Y 
  Metabolism and nutrition disorders Food intolerance 01JAN2008 Y
  Musculoskeletal and connective tissue 
disordersGrowth retardation 01JAN2014 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2008 Y 
C4591001 1006 
10061266/ 
Placebo Reproductive system and breast 
disorders Dysmenorrhoea 01JAN2016 Y 
C4591001 1006 
10061269/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2010 Y 
  Musculoskeletal and connective tissue 
disordersKnee deformity 01JAN2008 Y 
  Surgical and medical procedures Epiph ysiodesis 01DEC2020 01DEC2020 N
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16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1006 
10061270/ 
Placebo Immune system disorders Allergy to plants 01JAN2017 Y 
  Rubber sensitivit y 2005 Y
C4591001 1006 
10061271/ 
BNT162b2 (30 μg) Infections and infestations Meningitis 01JAN2011 31DEC2011 N 
  Neoplasms benign, malignant and 
unspecified (incl c ysts and pol yps)Skin papilloma 01NOV2019 Y 
  Psychiatric disorders Anxiet y 01JAN2016 Y
  Attention deficit h yperactivit y disorde r 01JAN2016 Y
C4591001 1006 
10061272/ 
BNT162b2 (30 μg) Psychiatric disorders Aggression 01JAN2017 31DEC2017 N 
  Anxiet y 01JAN2014 Y
  Attention deficit h yperactivit y disorde r 01JAN2010 Y
  Depression 01JAN2014 Y
  Disruptive mood d ysregulation disorde r 01JAN2012 Y
  Insomnia 01JAN2014 Y
  Nightmare 01JAN2015 Y
  Post-traumatic stress disorde r 06NOV2015 Y
  Separation anxiet y disorde r 01JAN2010 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2013 Y 
C4591001 1006 
10061273/ 
Placebo Nervous system disorders Headache 01JAN2016 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2014 31DEC2017 N 
  Skin and subcutaneous tissue disorders Acne 01JAN2019 Y
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16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1006 
10061274/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2010 Y 
  Psychiatric disorders Anxiet y 01JAN2019 Y
  Attention deficit h yperactivit y disorde r 01JAN2014 Y
  Insomnia 01AUG2019 Y
  Skin and subcutaneous tissue disorders Acne 01AUG2020 Y
C4591001 1006 
10061276/ 
Placebo Immune system disorders Seasonal allergy 01JAN2015 Y 
C4591001 1006 
10061277/ 
Placebo Eye disorders Hypermetropia 01JAN2019 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2016 Y
  Nervous s ystem disorders Migraine 01JAN2018 Y
  Psychiatric disorders Anxiet y 01JAN2019 Y
  Attention deficit h yperactivit y disorde r 01JAN2015 Y
C4591001 1006 
10061279/ 
Placebo Immune system disorders Seasonal allergy 01JAN2013 Y 
  Psychiatric disorders Anxiet y 01JAN2014 Y
  Insomnia 01JAN2017 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2011 Y 
  Social circumstances Premenarche 2007 29DEC2020 N
C4591001 1006 
10061280/ 
BNT162b2 (30 μg) Metabolism and nutrition disorders Obesity 01JAN2016 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2010 Y 
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16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1006 
10061282/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2017 Y 
C4591001 1006 
10061283/ 
Placebo Infections and infestations Appendicitis 30SEP2009 30SEP2009 N 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2010 Y
  Surgical and medical procedures Appendicectom y 30SEP2009 30SEP2009 N
C4591001 1006 
10061286/ 
BNT162b2 (30 μg) Eye disorders Eyelid ptosis 01JAN2007 Y 
  Immune s ystem disorders Aller gy to animal 01JAN2015 Y
  Seasonal aller gy 01JAN2014 Y
  Psychiatric disorders Anxiet y 01JAN2018 Y
  Attention deficit h yperactivit y disorde r 01JAN2017 Y
  Insomnia 01JAN2015 Y
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2015 Y 
C4591001 1006 
10061287/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2014 Y 
C4591001 1006 
10061288/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2016 Y 
  Infections and infestations Osteom yelitis 01NOV2007 31DEC2007 N
  Paron ychia 01JAN2017 Y
  Pharyngitis 01JAN2006 31DEC2008 N
  Surgical and medical procedures Adenoidectom y 01JAN2008 31DEC2008 N
  Tonsillectom y 01JAN2008 31DEC2008 N
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 17
FDA-CBER-2022-5812-0499821
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1006 
10061289/ 
BNT162b2 (30 μg) Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2019 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2016 Y
  Psychiatric disorders Anxiet y 01JAN2016 Y
  Attention deficit h yperactivit y disorde r 01OCT2020 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2015 Y 
C4591001 1006 
10061290/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2010 Y 
  Injury, poisoning and procedural 
complicationsContusion 01JAN2019 Y 
  Psychiatric disorders Depression 01JAN2015 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2008 Y 
C4591001 1006 
10061291/ 
Placebo Immune system disorders Hypersensitivity 01JAN2017 Y 
  Neoplasms benign, malignant and 
unspecified (incl c ysts and pol yps)Cholesteatoma 01JAN2011 31DEC2018 N 
  Surgical and medical procedures Ear operation 01JAN2018 31DEC2018 N
C4591001 1006 
10061292/ 
Placebo Injury, poisoning and procedural 
complications Nasal injury 01JUN2020 04JUN2020 N 
  Metabolism and nutrition disorders Dairy intolerance 01AUG2020 Y
  Musculoskeletal and connective tissue 
disordersKyphosis 01AUG2019 14OCT2019 N 
  Psychiatric disorders Anxiet y 01JAN2014 Y
  Depression 01JAN2014 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 18
FDA-CBER-2022-5812-0499822
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Insomnia 01JAN2010 Y
  Surgical and medical procedures Rhinoplast y 04JUN2020 04JUN2020 N
  Spinal fusion sur gery 14OCT2019 14OCT2019 N
C4591001 1006 
10061293/ 
BNT162b2 (30 μg) Psychiatric disorders Insomnia 01JAN2010 Y 
C4591001 1006 
10061294/ 
Placebo Nervous system disorders Headache 01JAN2018 Y 
C4591001 1006 
10061295/ 
Placebo Immune system disorders Allergy to animal 01JAN2015 Y 
  Seasonal aller gy 01JAN2014 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2015 Y 
C4591001 1006 
10061296/ 
Placebo Gastrointestinal disorders Oral pain 01OCT2020 Y 
  Infections and infestations Appendicitis 18NOV2016 18NOV2016 N
  Surgical and medical procedures Appendicectom y 18NOV2016 18NOV2016 N
C4591001 1006 
10061298/ 
Placebo Immune system disorders Food allergy 01JAN2009 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2013 Y 
C4591001 1006 
10061299/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2018 Y 
C4591001 1006 
10061300/ 
BNT162b2 (30 μg) Skin and subcutaneous tissue disorders Acne 01JAN2017 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 19
FDA-CBER-2022-5812-0499823
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1007 
10071409/ 
BNT162b2 (30 μg) Nervous system disorders Febrile convulsion 2007 31DEC2014 N 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2009 31DEC2009 N 
C4591001 1007 
10071417/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2007 Y 
C4591001 1007 
10071429/ 
Placebo Immune system disorders Seasonal allergy 01JAN2018 Y 
C4591001 1007 
10071469/ 
BNT162b2 (30 μg) Congenital, familial and genetic 
disorders Chondrodystrophy 01JAN2006 Y 
  Immune s ystem disorders Drug hypersensitivit y 01JAN2018 Y
C4591001 1007 
10071471/ 
BNT162b2 (30 μg) Respiratory, thoraci c and mediastinal 
disorders Tonsillar hypertrophy 01JAN2006 31DEC2011 N 
  Surgical and medical procedures Tonsillectom y 01JAN2011 31DEC2011 N
C4591001 1007 
10071472/ 
Placebo Nervous system disorders Migraine 01JAN2017 Y 
C4591001 1007 
10071480/ 
Placebo Congenital, familial and genetic 
disorders Thalassaemia minor 01JAN2006 Y 
C4591001 1007 
10071483/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2017 Y 
  Skin and subcutaneous tissue disorders Eczema 01JAN2008 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 20
(b) (6)
FDA-CBER-2022-5812-0499824
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1007 
10071484/ 
Placebo Immune system disorders Drug hypersensitivity 2007 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2017 Y
C4591001 1007 
10071485/ 
BNT162b2 (30 μg) Immune system disorders Serum sickness 01JAN2013 Y 
  Reproductive system and breast 
disordersMenstruation irregular 01JAN2019 Y 
C4591001 1007 
10071488/ 
BNT162b2 (30 μg) Eye disorders Blepharitis 01JAN2006 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2010 Y
C4591001 1007 
10071492/ 
Placebo Cardiac disorders Postural orthostatic tachycardia syndrome 01JAN2020 Y 
  Ear and lab yrinth disorders Vestibular disorde r 01JAN2013 Y
  Nervous s ystem disorders Migraine 01JAN2012 Y
C4591001 1007 
10071495/ 
Placebo Immune system disorders Seasonal allergy 01JAN2006 Y 
C4591001 1007 
10071497/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2017 Y 
C4591001 1007 
10071499/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2009 Y 
C4591001 1007 
10071500/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2014 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2011 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 21
(b) (6)
FDA-CBER-2022-5812-0499825
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1007 
10071504/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 2005 Y 
C4591001 1007 
10071505/ 
Placebo Congenital, familial and genetic 
disorders Cerebral palsy 2008 Y 
  Nervous s ystem disorders Hydrocephalus 2008 Y
  Migraine 01JAN2015 Y
  Seizure 01JAN2015 Y
  Psychiatric disorders Anxiet y 01JAN2010 Y
  Reproductive system and breast 
disordersHeavy menstrual bleeding 01JAN2019 Y 
  Surgical and medical procedures Portal shunt procedure 01JAN2019 Y
C4591001 1007 
10071511/ 
Placebo Infections and infestations Appendicitis 01JAN2011 31DEC2011 N 
  Chronic tonsillitis 01JAN2012 31DEC2012 N
  Surgical and medical procedures Adenoidectom y 01JAN2012 31DEC2012 N
  Appendicectom y 01JAN2011 31DEC2011 N
C4591001 1007 
10071512/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2014 Y 
C4591001 1007 
10071514/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2012 Y 
C4591001 1007 
10071515/ 
Placebo Immune system disorders Drug hypersensitivity 2008 Y 
  Seasonal aller gy 01JAN2011 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 22
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499826
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1007 
10071516/ 
Placebo Immune system disorders Seasonal allergy 01JAN2010 Y 
C4591001 1007 
10071517/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2010 Y 
C4591001 1007 
10071518/ 
BNT162b2 (30 μg) Nervous system disorders Headache 12OCT2020 Y 
C4591001 1007 
10071520/ 
Placebo Immune system disorders Seasonal allergy 01JAN2009 Y 
C4591001 1007 
10071521/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2016 Y 
C4591001 1007 
10071522/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2019 Y 
C4591001 1007 
10071524/ 
Placebo Congenital, familial and genetic 
disorders Factor V Leiden carrier 01JAN2015 Y 
C4591001 1007 
10071525/ 
BNT162b2 (30 μg) Congenital, familial and genetic 
disorders Factor V Leiden carrier 01JAN2012 Y 
C4591001 1007 
10071527/ 
Placebo Respiratory, thoraci c and mediastinal 
disorders Asthma 01JAN2012 Y 
C4591001 1007 
10071531/ 
Placebo Ear and labyrinth disorders Ear pain 05DEC2020 Y 
  Gastrointestinal disorders Gastrooesopha geal reflux disease 01JAN2018 Y
  Immune s ystem disorders Seasonal aller gy 01JAN2016 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 23
FDA-CBER-2022-5812-0499827
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1007 
10071533/ 
Placebo Immune system disorders Seasonal allergy 01JAN2010 Y 
C4591001 1007 
10071535/ 
BNT162b2 (30 μg) Skin and subcutaneous tissue disorders Acne 01JAN2018 Y 
C4591001 1007 
10071536/ 
BNT162b2 (30 μg) Nervous system disorders Migraine 01JAN2011 Y 
C4591001 1007 
10071537/ 
BNT162b2 (30 μg) Nervous system disorders Migraine 01JAN2017 Y 
C4591001 1007 
10071539/ 
Placebo Gastrointestinal disorders Eosinophilic oesophagitis 01JAN2005 Y 
  Immune s ystem disorders Food aller gy 01JAN2006 Y
  Milk aller gy 01JAN2006 Y
C4591001 1007 
10071541/ 
Placebo Immune system disorders Seasonal allergy 01JAN2010 Y 
C4591001 1007 
10071542/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2016 Y 
C4591001 1007 
10071543/ 
Placebo Neoplasms benign, malignant and 
unspecified (incl cysts and polyps) Nephroblastoma 01JAN2007 31DEC2007 N 
  Surgical and medical procedures Nephrectom y 01JAN2007 Y
C4591001 1007 
10071544/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2018 Y 
  Psychiatric disorders Anxiet y 01JAN2019 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 24
FDA-CBER-2022-5812-0499828
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1007 
10071546/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 2005 Y 
  Seasonal aller gy 2005 Y
  Infections and infestations Sinusitis 09NOV2020 13NOV2020 N
C4591001 1007 
10071547/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2011 Y 
C4591001 1007 
10071550/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 2007 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2018 Y 
C4591001 1007 
10071551/ 
Placebo Immune system disorders Seasonal allergy 01JAN2012 Y 
C4591001 1007 
10071552/ 
Placebo Immune system disorders Allergy to animal 01JAN2008 Y 
  Drug hypersensitivit y 01JAN2007 Y
  Hypersensitivit y 01JAN2008 Y
C4591001 1007 
10071557/ 
BNT162b2 (30 μg) Skin and subcutaneous tissue disorders Acne cosmetica 01JAN2019 Y 
C4591001 1007 
10071558/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2012 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2012 Y
C4591001 1007 
10071560/ 
Placebo Immune system disorders Seasonal allergy 01JAN2014 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 25
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499829
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Skin and subcutaneous tissue disorders Acne 01MAY2019 Y
C4591001 1007 
10071561/ 
BNT162b2 (30 μg) Metabolism and nutrition disorders Hyperlipidaemia 01JAN2018 Y 
C4591001 1007 
10071563/ 
Placebo Immune system disorders Food allergy 01JAN2011 Y 
C4591001 1007 
10071567/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2011 Y 
C4591001 1007 
10071570/ 
Placebo Metabolism and nutrition disorders Obesity 01JAN2020 Y 
  Psychiatric disorders Anxiet y 01MAR2020 Y
  Depression 01MAR2019 Y
  Impulsive behaviou r 01AUG2019 Y
  Insomnia 01MAR2019 Y
C4591001 1007 
10071573/ 
Placebo Skin and subcutaneous tissue disorders Eczema 01JAN2012 Y 
C4591001 1007 
10071574/ 
BNT162b2 (30 μg) Injury, poisoning and procedural 
complications Lower limb fracture 01AUG2020 30SEP2020 N 
C4591001 1007 
10071575/ 
BNT162b2 (30 μg) Immune system disorders Food allergy 01JAN2008 Y 
C4591001 1007 
10071577/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2011 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2008 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 26
FDA-CBER-2022-5812-0499830
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1007 
10071581/ 
Placebo Nervous system disorders Migraine 01JAN2018 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2012 Y
C4591001 1007 
10071583/ 
Placebo Immune system disorders Seasonal allergy 01JAN2014 Y 
C4591001 1007 
10071584/ 
BNT162b2 (30 μg) Immune system disorders Allergy to animal 01JAN2010 Y 
C4591001 1007 
10071585/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2018 Y 
C4591001 1007 
10071586/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2018 Y 
C4591001 1007 
10071587/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2012 Y 
C4591001 1007 
10071590/ 
BNT162b2 (30 μg) Congenital, familial and genetic 
disorders Tourette's disorder 01JAN2017 Y 
  Endocrine disorders Precocious pubert y 01JAN2017 Y
C4591001 1007 
10071591/ 
Placebo Congenital, familial and genetic 
disorders Tourette's disorder 01JAN2017 Y 
C4591001 1007 
10071592/ 
BNT162b2 (30 μg) Ear and labyrinth disorders Deafness 01JAN2017 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2013 Y
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2013 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 27
FDA-CBER-2022-5812-0499831
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1007 
10071593/ 
Placebo Metabolism and nutrition disorders Type 1 diabetes mellitus 01JAN2011 Y 
C4591001 1007 
10071594/ 
BNT162b2 (30 μg) Nervous system disorders Migraine 01JAN2019 Y 
C4591001 1007 
10071596/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2015 Y 
C4591001 1007 
10071599/ 
BNT162b2 (30 μg) Immune system disorders Allergy to animal 01JAN2012 Y 
  Psychiatric disorders Anxiet y 01JAN2018 Y
  Attention deficit h yperactivit y disorde r 01JAN2012 Y
  Depression 01JAN2018 Y
C4591001 1007 
10071600/ 
Placebo Renal and urinary disorders Renal cyst 01JUN2020 Y 
C4591001 1007 
10071601/ 
Placebo Immune system disorders Seasonal allergy 01JAN2010 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2017 Y
C4591001 1007 
10071603/ 
Placebo Endocrine disorders Hypothyroidism 30NOV2020 Y 
  Metabolism and nutrition disorders Type 1 diabetes mellitus 17DEC2018 Y
  Psychiatric disorders Anxiet y 01JAN2017 Y
C4591001 1007 
10071605/ 
BNT162b2 (30 μg) Immune system disorders Food allergy 01JAN2012 Y 
  01MAR2020 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 28
FDA-CBER-2022-5812-0499832
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1007 
10071606/ 
BNT162b2 (30 μg) Psychiatric disorders Anxiety 01SEP2020 Y 
C4591001 1007 
10071608/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2015 Y 
C4591001 1007 
10071609/ 
BNT162b2 (30 μg) Endocrine disorders Hypothyroidism 01JAN2017 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2015 Y
C4591001 1007 
10071613/ 
Placebo Renal and urinary disorders Single functional kidney 2007 Y 
C4591001 1007 
10071617/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2005 Y 
  Psychiatric disorders Anxiet y 01JAN2018 Y
  Obsessive-compulsive disorde r 01JAN2018 Y
C4591001 1007 
10071618/ 
Placebo Psychiatric disorders Anxiety 01JAN2017 Y 
  Attention deficit h yperactivit y disorde r 01JAN2017 Y
C4591001 1007 
10071619/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2018 Y 
C4591001 1007 
10071620/ 
BNT162b2 (30 μg) Psychiatric disorders Anxiety 01JAN2018 Y 
  Attention deficit h yperactivit y disorde r 01JAN2018 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 29
(b) (6)
FDA-CBER-2022-5812-0499833
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1007 
10071621/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01DEC2016 Y 
C4591001 1007 
10071622/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01DEC2015 Y 
C4591001 1007 
10071623/ 
Placebo Musculoskeletal and connective tissue 
disorders Juvenile idiopathic arthritis 22DEC2020 Y 
C4591001 1007 
10071624/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2019 Y 
C4591001 1007 
10071625/ 
Placebo Immune system disorders Drug hypersensitivity 01NOV2007 Y 
C4591001 1007 
10071627/ 
BNT162b2 (30 μg) Respiratory, thoraci c and mediastinal 
disorders Asthma 01DEC2008 Y 
C4591001 1007 
10071628/ 
BNT162b2 (30 μg) Psychiatric disorders Depression 01OCT2019 Y 
C4591001 1007 
10071629/ 
Placebo Immune system disorders Seasonal allergy 01JAN2010 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma exercise induced 01JAN2018 Y 
  Skin and subcutaneous tissue disorders Eczema 01JAN2006 Y
C4591001 1007 
10071630/ 
Placebo Immune system disorders Seasonal allergy 01DEC2014 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01DEC2014 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 30
FDA-CBER-2022-5812-0499834
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1007 
10071634/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2017 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2018 Y
C4591001 1007 
10071635/ 
Placebo Immune system disorders Seasonal allergy 01JAN2018 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2015 Y 
C4591001 1007 
10071638/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2009 Y 
C4591001 1007 
10071641/ 
BNT162b2 (30 μg) Immune system disorders Milk allergy 01JAN2017 Y 
  Skin and subcutaneous tissue disorders Eczema 01JAN2016 Y
C4591001 1007 
10071642/ 
BNT162b2 (30 μg) Nervous system disorders Migraine 01JAN2018 Y 
C4591001 1007 
10071647/ 
BNT162b2 (30 μg) Respiratory, thoraci c and mediastinal 
disorders Asthma 01JAN2010 Y 
C4591001 1007 
10071650/ 
Placebo Psychiatric disorders Anxiety 01JAN2020 Y 
  Attention deficit h yperactivit y disorde r 01JAN2013 Y
C4591001 1007 
10071651/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2010 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 31
FDA-CBER-2022-5812-0499835
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1007 
10071653/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2008 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2011 Y
C4591001 1007 
10071654/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2019 Y 
C4591001 1007 
10071656/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2014 Y 
C4591001 1007 
10071658/ 
Placebo Immune system disorders Allergy to animal 01APR2020 Y 
  Psychiatric disorders Anxiet y 11NOV2020 Y
  Depression 24DEC2020 Y
C4591001 1008 
10081751/ 
Placebo Gastrointestinal disorders Gastrooesophageal reflux disease 2007 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2012 Y
  Nervous s ystem disorders Headache 01JAN2013 Y
  Psychiatric disorders Anxiet y 01JAN2008 Y
  Skin and subcutaneous tissue disorders Acne 01JAN2019 Y
  Hyperhidrosis 01JUN2020 Y
C4591001 1008 
10081752/ 
Placebo Immune system disorders Seasonal allergy 01JAN2007 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
C4591001 1008 
10081753/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2007 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 32
(b) (6)
FDA-CBER-2022-5812-0499836
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1008 
10081755/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2019 Y 
  Seasonal aller gy 01JAN2006 Y
  Nervous s ystem disorders Migraine 01JAN2018 Y
  Psychiatric disorders Anxiet y 01AUG2020 Y
  Depression 01AUG2020 Y
  Skin and subcutaneous tissue disorders Dermatitis contact 01JAN2019 Y
C4591001 1008 
10081756/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2007 Y 
  Seasonal aller gy 01JAN2013 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2013 Y 
C4591001 1008 
10081757/ 
Placebo Immune system disorders Seasonal allergy 01JAN2018 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2018 Y
C4591001 1008 
10081758/ 
BNT162b2 (30 μg) Skin and subcutaneous tissue disorders Acne 01JAN2017 Y 
C4591001 1008 
10081761/ 
Placebo Immune system disorders Seasonal allergy 01JAN2010 Y 
C4591001 1008 
10081763/ 
Placebo Immune system disorders Seasonal allergy 01JAN2010 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2013 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 33
FDA-CBER-2022-5812-0499837
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1008 
10081764/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2010 Y 
C4591001 1008 
10081767/ 
Placebo Congenital, familial and genetic 
disorders Von Willebrand's disease 01JAN2009 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2011 Y
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2011 Y
C4591001 1008 
10081768/ 
Placebo Psychiatric disorders Anxiety 01JAN2015 Y 
  Depression 01JAN2016 Y
  Obsessive-compulsive disorde r 01JAN2015 Y
C4591001 1008 
10081769/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2008 Y 
  Seasonal aller gy 01JAN2009 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2006 Y 
  Skin and subcutaneous tissue disorders Eczema 01JAN2006 Y
C4591001 1008 
10081770/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2016 Y 
  Psychiatric disorders Anxiet y 01JAN2013 Y
  Attention deficit h yperactivit y disorde r 01JAN2014 Y
C4591001 1008 
10081771/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2017 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 34
FDA-CBER-2022-5812-0499838
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1008 
10081777/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2006 Y 
  Seasonal aller gy 01JAN2015 Y
C4591001 1008 
10081780/ 
Placebo Skin and subcutaneous tissue disorders Acne 01JAN2019 Y 
C4591001 1008 
10081781/ 
Placebo Immune system disorders Seasonal allergy 01JAN2018 Y 
C4591001 1008 
10081785/ 
BNT162b2 (30 μg) Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2015 Y 
C4591001 1008 
10081788/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2017 Y 
C4591001 1008 
10081789/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2014 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2013 Y
  Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
C4591001 1008 
10081790/ 
Placebo Respiratory, thoraci c and mediastinal 
disorders Bronchial hyperreactivity 01JAN2010 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
  Social circumstances Premenarche 2008 12JUN2021 N
C4591001 1008 
10081791/ 
BNT162b2 (30 μg) Psychiatric disorders Anxiety 01JAN2016 Y 
  Attention deficit h yperactivit y disorde r 01JAN2016 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 35
(b) (6)
FDA-CBER-2022-5812-0499839
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1008 
10081792/ 
BNT162b2 (30 μg) Psychiatric disorders Anxiety 01JAN2015 Y 
  Attention deficit h yperactivit y disorde r 01JAN2015 Y
C4591001 1008 
10081794/ 
Placebo Social circumstances Premenarche 2008 Y 
C4591001 1008 
10081795/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2011 Y 
  Investi gations Body height decrease d 01JAN2019 Y
  Weight decrease d 01JAN2019 Y
C4591001 1008 
10081798/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2016 Y 
  Seasonal aller gy 01JAN2014 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2009 Y 
C4591001 1008 
10081799/ 
BNT162b2 (30 μg) Skin and subcutaneous tissue disorders Acne 01SEP2020 Y 
  Social circumstances Premenarche 2007 11MAR2021 N
C4591001 1008 
10081800/ 
BNT162b2 (30 μg) Psychiatric disorders Anxiety 01JAN2015 Y 
  Attention deficit h yperactivit y disorde r 01JAN2019 Y
  Depression 01JAN2015 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2016 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 36
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499840
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1008 
10081801/ 
Placebo Cardiac disorders Supraventricular tachycardia 01JAN2014 31DEC2019 N 
  Immune s ystem disorders Drug hypersensitivit y 01JAN2016 Y
  Seasonal aller gy 01JAN2014 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2014 Y 
  Surgical and medical procedures Cardiac ablation 01JAN2019 31DEC2019 N
C4591001 1008 
10081803/ 
Placebo Immune system disorders Seasonal allergy 01JAN2010 Y 
  Metabolism and nutrition disorders Obesit y 01JAN2018 Y
C4591001 1008 
10081804/ 
Placebo Immune system disorders Seasonal allergy 01JAN2014 Y 
C4591001 1008 
10081805/ 
BNT162b2 (30 μg) Social circumstances Premenarche 2008 04FEB2021 N 
C4591001 1008 
10081806/ 
BNT162b2 (30 μg) Nervous system disorders Migraine 01JAN2018 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2017 Y
C4591001 1008 
10081807/ 
Placebo Immune system disorders Seasonal allergy 01JAN2015 Y 
C4591001 1008 
10081808/ 
Placebo Immune system disorders Seasonal allergy 01JAN2019 Y 
C4591001 1008 
10081809/ 
Placebo Gastrointestinal disorders Constipation 01OCT2020 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 37
(b) (6)
FDA-CBER-2022-5812-0499841
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Gastrooesopha geal reflux disease 01OCT2020 Y
  Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
C4591001 1008 
10081810/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01SEP2020 Y 
C4591001 1008 
10081812/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2016 Y 
C4591001 1008 
10081814/ 
BNT162b2 (30 μg) Congenital, familial and genetic 
disorders Metabolic myopathy 01JAN2019 Y 
  Immune s ystem disorders Rubber sensitivit y 01JAN2010 Y
  Nervous s ystem disorders Syncope 01OCT2020 Y
C4591001 1008 
10081816/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2016 Y 
C4591001 1008 
10081818/ 
BNT162b2 (30 μg) Psychiatric disorders Anxiety 01JAN2014 Y 
  Attention deficit h yperactivit y disorde r 01JAN2014 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2007 Y 
C4591001 1008 
10081819/ 
Placebo Immune system disorders Seasonal allergy 01MAR2020 Y 
C4591001 1008 
10081820/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2012 Y 
C4591001 1008 
10081821/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2008 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 38
FDA-CBER-2022-5812-0499842
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1008 
10081822/ 
Placebo Immune system disorders Seasonal allergy 01JAN2012 Y 
  Psychiatric disorders Anxiet y 01JAN2019 Y
  Depression 01JAN2019 Y
C4591001 1008 
10081823/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2008 Y 
C4591001 1008 
10081824/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2017 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2019 Y
C4591001 1008 
10081825/ 
Placebo Social circumstances Premenarche 2008 Y 
C4591001 1008 
10081826/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2008 Y 
C4591001 1008 
10081827/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2010 Y 
C4591001 1008 
10081828/ 
Placebo Immune system disorders Seasonal allergy 01JAN2010 Y 
  Skin and subcutaneous tissue disorders Hand dermatitis 01JAN2010 Y
C4591001 1008 
10081830/ 
Placebo Immune system disorders Seasonal allergy 01JAN2019 Y 
C4591001 1008 
10081831/ 
BNT162b2 (30 μg) Skin and subcutaneous tissue disorders Acne 01JUN2020 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 39
(b) (6)
FDA-CBER-2022-5812-0499843
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1008 
10081832/ 
BNT162b2 (30 μg) Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2017 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2015 Y
  Psychiatric disorders Anxiet y 01JAN2020 Y
  Insomnia 01JAN2018 Y
  Reproductive system and breast 
disordersPolycystic ovaries 01JAN2018 Y 
C4591001 1008 
10081836/ 
Placebo Skin and subcutaneous tissue disorders Acne 01JAN2018 Y 
C4591001 1008 
10081837/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2016 Y 
C4591001 1008 
10081838/ 
BNT162b2 (30 μg) Psychiatric disorders Anxiety 01JAN2013 Y 
  Attention deficit h yperactivit y disorde r 01JAN2013 Y
  Autism spectrum disorde r 01JAN2013 Y
  Depression 01JAN2013 Y
C4591001 1008 
10081839/ 
BNT162b2 (30 μg) Skin and subcutaneous tissue disorders Acne 01JAN2020 Y 
C4591001 1008 
10081841/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2018 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2013 Y
C4591001 1008 
10081842/ 
Placebo Congenital, familial and genetic 
disorders Neurofibromatosis 01JAN2012 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 40
FDA-CBER-2022-5812-0499844
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Immune s ystem disorders Seasonal aller gy 01JAN2017 Y
  Social circumstances Premenarche 2008 Y
C4591001 1008 
10081843/ 
BNT162b2 (30 μg) Immune system disorders Food allergy 01JAN2015 Y 
  Seasonal aller gy 01JAN2010 Y
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2010 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2007 Y 
C4591001 1008 
10081846/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2013 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2017 Y
C4591001 1008 
10081847/ 
BNT162b2 (30 μg) Psychiatric disorders Anxiety 01JAN2018 Y 
  Depression 01JAN2018 Y
  Tic 01OCT2020 Y
C4591001 1008 
10081850/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2015 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2019 Y 
C4591001 1008 
10081851/ 
Placebo Psychiatric disorders Anxiety 01OCT2018 Y 
  Autism spectrum disorde r 01JAN2009 Y
C4591001 1008 
10081852/ 
Placebo Psychiatric disorders Autism spectrum disorder 01JAN2007 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 41
(b) (6)
FDA-CBER-2022-5812-0499845
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Depression 01JAN2017 Y
C4591001 1008 
10081853/ 
Placebo Congenital, familial and genetic 
disorders Gilbert's syndrome 01MAR2019 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2018 Y
C4591001 1008 
10081854/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2011 Y 
C4591001 1008 
10081855/ 
BNT162b2 (30 μg) Nervous system disorders Migraine 01JAN2016 Y 
  Skin and subcutaneous tissue disorders Eczema 01JAN2011 Y
  Psoriasis 01JAN2015 Y
C4591001 1008 
10081856/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2009 Y 
  Seasonal aller gy 01JAN2015 Y
  Psychiatric disorders Anxiet y 01JAN2015 Y
  Obsessive-compulsive disorde r 01JAN2015 Y
C4591001 1008 
10081857/ 
BNT162b2 (30 μg) Social circumstances Premenarche 2007 Y 
C4591001 1008 
10081858/ 
Placebo Immune system disorders Seasonal allergy 01JAN2013 Y 
C4591001 1008 
10081860/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2010 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2010 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 42
(b) (6)
FDA-CBER-2022-5812-0499846
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Skin and subcutaneous tissue disorders Eczema 01JAN2007 Y
C4591001 1008 
10081864/ 
BNT162b2 (30 μg) Social circumstances Premenarche 2008 Y 
C4591001 1008 
10081865/ 
BNT162b2 (30 μg) Respiratory, thoraci c and mediastinal 
disorders Asthma 01JAN2009 Y 
  Skin and subcutaneous tissue disorders Eczema 01JAN2008 Y
  Hand dermatitis 01JAN2008 Y
C4591001 1008 
10081866/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2014 Y 
C4591001 1008 
10081867/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2017 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2019 Y
C4591001 1008 
10081869/ 
Placebo Immune system disorders Seasonal allergy 01JAN2015 Y 
  Nervous s ystem disorders Migraine 01JAN2018 Y
  Psychiatric disorders Anxiet y 01JAN2016 Y
  Attention deficit h yperactivit y disorde r 01JAN2016 Y
  Skin and subcutaneous tissue disorders Acne 01JAN2020 Y
  01JUN2020 Y
C4591001 1008 
10081870/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2016 Y 
C4591001 1008 
10081871/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2015 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 43
(b) (6)
FDA-CBER-2022-5812-0499847
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Nervous s ystem disorders Migraine 01JAN2018 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2016 Y 
C4591001 1008 
10081872/ 
Placebo Immune system disorders Seasonal allergy 01JAN2020 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2014 Y
C4591001 1008 
10081873/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2015 Y 
C4591001 1008 
10081875/ 
Placebo Infections and infestations Appendicitis 01JUL2020 31JUL2020 N 
  Surgical and medical procedures Appendicectom y 01JUL2020 31JUL2020 N
C4591001 1008 
10081877/ 
Placebo Immune system disorders Seasonal allergy 01JAN2017 Y 
  Psychiatric disorders Anxiet y 01MAR2020 Y
  Depression 01MAR2020 Y
C4591001 1008 
10081878/ 
BNT162b2 (30 μg) Skin and subcutaneous tissue disorders Acne 01JAN2019 Y 
C4591001 1008 
10081879/ 
Placebo Endocrine disorders Growth hormone deficiency 01JUL2020 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2008 Y
  Psychiatric disorders Anxiet y 01JUN2020 Y
  Depression 01JUN2020 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 44
FDA-CBER-2022-5812-0499848
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1008 
10081880/ 
Placebo Social circumstances Premenarche 2006 Y 
C4591001 1008 
10081881/ 
Placebo Social circumstances Premenarche 2008 Y 
C4591001 1008 
10081883/ 
BNT162b2 (30 μg) Endocrine disorders Hypothyroidism 01AUG2018 Y 
  Immune s ystem disorders Drug hypersensitivit y 01JAN2006 Y
  01JAN2017 Y
  Psychiatric disorders Anxiet y 01JAN2019 Y
  Attention deficit h yperactivit y disorde r 01AUG2010 Y
  Autism spectrum disorde r 01JAN2019 Y
  Depression 01JAN2019 Y
  Insomnia 01JAN2019 Y
  Skin and subcutaneous tissue disorders Acne 01APR2020 Y
C4591001 1008 
10081884/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2006 Y 
  Skin and subcutaneous tissue disorders Hand dermatitis 01JAN2018 Y
C4591001 1008 
10081886/ 
BNT162b2 (30 μg) Social circumstances Premenarche 2008 Y 
C4591001 1008 
10081887/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2017 Y 
  Social circumstances Premenarche 2008 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 45
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499849
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1008 
10081889/ 
BNT162b2 (30 μg) Musculoskeletal and connective tissue 
disorders Scoliosis 01JUN2020 Y 
C4591001 1008 
10081890/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2017 Y 
  Skin and subcutaneous tissue disorders Eczema 01JAN2012 Y
  Hand dermatitis 01JAN2012 Y
C4591001 1008 
10081891/ 
Placebo Immune system disorders Seasonal allergy 01JAN2011 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2014 Y
  Skin and subcutaneous tissue disorders Acne 01JUN2020 Y
C4591001 1008 
10081892/ 
Placebo Psychiatric disorders Anxiety 01JAN2018 Y 
  Attention deficit h yperactivit y disorde r 01JAN2014 Y
  Skin and subcutaneous tissue disorders Dermatitis contact 01JAN2014 Y
C4591001 1008 
10081893/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2008 Y 
  Seasonal aller gy 01JAN2009 Y
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2020 Y
  Reproductive system and breast 
disordersAbnormal uterine bleeding 01JAN2020 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2016 Y 
  Skin and subcutaneous tissue disorders Hand dermatitis 01JAN2007 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 46
FDA-CBER-2022-5812-0499850
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1008 
10081894/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2011 Y 
C4591001 1008 
10081895/ 
BNT162b2 (30 μg) Social circumstances Premenarche 2006 Y 
C4591001 1008 
10081897/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2016 Y 
C4591001 1008 
10081898/ 
Placebo Psychiatric disorders Anxiety 01JAN2019 Y 
  Social circumstances Premenarche 2008 Y
C4591001 1008 
10081901/ 
Placebo Immune system disorders Drug hypersensitivity 2005 Y 
C4591001 1008 
10081902/ 
Placebo Immune system disorders Seasonal allergy 01JAN2010 Y 
C4591001 1008 
10081903/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2010 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2017 Y
  Skin and subcutaneous tissue disorders Eczema 2008 Y
C4591001 1008 
10081904/ 
Placebo Immune system disorders Seasonal allergy 01JAN2009 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2015 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 47
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499851
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1008 
10081905/ 
BNT162b2 (30 μg) Skin and subcutaneous tissue disorders Acne 01JAN2020 Y 
C4591001 1008 
10081906/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2017 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
C4591001 1008 
10081907/ 
Placebo Reproductive system and breast 
disorders Dysmenorrhoea 01SEP2020 Y 
C4591001 1008 
10081908/ 
BNT162b2 (30 μg) Social circumstances Premenarche 2008 Y 
C4591001 1008 
10081910/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2008 Y 
C4591001 1008 
10081911/ 
Placebo Immune system disorders Seasonal allergy 01JAN2014 Y 
C4591001 1008 
10081912/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2013 Y 
  Respiratory, thoraci c and mediastinal 
disordersSleep apnoea syndrome 01JAN2018 Y 
C4591001 1008 
10081913/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2008 Y 
  Seasonal aller gy 01JAN2016 Y
C4591001 1008 
10081914/ 
Placebo Immune system disorders Seasonal allergy 01JAN2010 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 48
(b) (6)
FDA-CBER-2022-5812-0499852
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2009 Y 
  Skin and subcutaneous tissue disorders Acanthosis ni gricans 01JUL2020 Y
C4591001 1008 
10081915/ 
BNT162b2 (30 μg) Respiratory, thoraci c and mediastinal 
disorders Asthma 01JAN2009 Y 
C4591001 1008 
10081916/ 
BNT162b2 (30 μg) Skin and subcutaneous tissue disorders Acne 01JUL2020 Y 
C4591001 1008 
10081917/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2015 Y 
  Skin and subcutaneous tissue disorders Psoriasis 01JAN2012 Y
C4591001 1008 
10081918/ 
BNT162b2 (30 μg) Social circumstances Premenarche 2008 Y 
C4591001 1008 
10081919/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2016 Y 
  Psychiatric disorders Anxiet y 01OCT2020 Y
C4591001 1008 
10081920/ 
BNT162b2 (30 μg) Psychiatric disorders Enuresis 01JAN2016 Y 
C4591001 1008 
10081921/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2012 Y 
  Respiratory, thoraci c and mediastinal 
disordersEpistaxis 01JAN2017 Y 
C4591001 1008 
10081922/ 
BNT162b2 (30 μg) Nervous system disorders Migraine 01JAN2016 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 49
(b) (6)
FDA-CBER-2022-5812-0499853
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2013 Y
C4591001 1008 
10081923/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2014 Y 
  Social circumstances Premenarche 2008 Y
C4591001 1008 
10081924/ 
Placebo Congenital, familial and genetic 
disorders Bicuspid aortic valve 01JAN2017 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2014 Y
C4591001 1008 
10081928/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2014 Y 
  Psychiatric disorders Anxiet y 01JAN2018 Y
  Attention deficit h yperactivit y disorde r 01JAN2016 Y
C4591001 1008 
10081929/ 
BNT162b2 (30 μg) Social circumstances Premenarche 2008 Y 
C4591001 1008 
10081930/ 
Placebo Respiratory, thoraci c and mediastinal 
disorders Asthma 01JAN2011 Y 
  Social circumstances Premenarche 2008 Y
C4591001 1008 
10081931/ 
Placebo Immune system disorders Seasonal allergy 01JAN2013 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2016 Y 
C4591001 1008 
10081932/ 
Placebo Psychiatric disorders Anxiety 01FEB2019 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 50
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499854
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1008 
10081934/ 
BNT162b2 (30 μg) Gastrointestinal disorders Coeliac disease 01JAN2019 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2019 Y
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2016 Y
  Skin and subcutaneous tissue disorders Alopecia areata 01JAN2020 Y
  Social circumstances Premenarche 2007 Y
C4591001 1008 
10081935/ 
BNT162b2 (30 μg) Psychiatric disorders Anxiety 01JAN2015 Y 
C4591001 1008 
10081937/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2010 Y 
C4591001 1008 
10081938/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2015 Y 
  Seasonal aller gy 01JAN2009 Y
C4591001 1008 
10081940/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2012 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2007 Y 
C4591001 1008 
10081941/ 
Placebo Immune system disorders Seasonal allergy 01JAN2011 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2011 Y 
  Social circumstances Premenarche 2008 Y
C4591001 1008 
10081942/ 
Placebo Immune system disorders Seasonal allergy 01JAN2007 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499855
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2007 Y 
  Skin and subcutaneous tissue disorders Acne 01AUG2020 Y
C4591001 1008 
10081943/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2008 Y 
C4591001 1009 
10091204/ 
Placebo Immune system disorders Seasonal allergy 01JAN2018 Y 
C4591001 1009 
10091208/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2006 Y 
  Seasonal aller gy 01JAN2012 Y
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2012 Y 
C4591001 1009 
10091209/ 
BNT162b2 (30 μg) Psychiatric disorders Anxiety 01SEP2018 Y 
  Attention deficit h yperactivit y disorde r 01SEP2017 Y
  Social circumstances Premenarche 2007 Y
C4591001 1009 
10091212/ 
Placebo Infections and infestations Tinea infection 06SEP2020 Y 
C4591001 1009 
10091218/ 
BNT162b2 (30 μg) Eye disorders Amblyopia 2007 Y 
  Strabismus 2007 Y
  General disorders and administration 
site conditionsDrug intolerance 01JAN2008 Y 
  Immune s ystem disorders Drug hypersensitivit y 01JAN2008 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499856
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Musculoskeletal and connective tissue 
disordersJoint instability 01JAN2007 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2014 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 16SEP2011 Y 
  Rhinitis aller gic 01JAN2009 Y
C4591001 1009 
10091220/ 
Placebo Immune system disorders Seasonal allergy 12JUN2017 Y 
  Injury, poisoning and procedural 
complicationsPost concussion syndrome 01JUN2019 Y 
  Nervous s ystem disorders Headache 05MAY2017 Y
  Migraine 05MAY2017 Y
  Psychiatric disorders Anxiet y 01JAN2018 Y
  Depression 01JAN2018 Y
C4591001 1009 
10091221/ 
BNT162b2 (30 μg) Infections and infestations Tonsillitis 10AUG2017 30APR2019 N 
  Musculoskeletal and connective tissue 
disordersArthralgia 01JAN2018 Y 
  Skin and subcutaneous tissue disorders Acne 01FEB2020 Y
  Social circumstances Premenarche 2006 Y
C4591001 1009 
10091223/ 
BNT162b2 (30 μg) Nervous system disorders Benign rolandic epilepsy 01JAN2014 31DEC2016 N 
C4591001 1009 
10091226/ 
Placebo Psychiatric disorders Depression 01JAN2019 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499857
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1009 
10091227/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2010 Y 
  Skin and subcutaneous tissue disorders Urticaria 01JAN2018 Y
C4591001 1009 
10091229/ 
Placebo Immune system disorders Seasonal allergy 01JAN2013 Y 
  Infections and infestations Ear infection 01JAN2016 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma exercise induced 19AUG2020 Y 
C4591001 1009 
10091233/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2017 Y 
C4591001 1009 
10091234/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2017 Y 
C4591001 1009 
10091237/ 
Placebo Immune system disorders Seasonal allergy 01JAN2015 Y 
  Metabolism and nutrition disorders Lactose intolerance 01JAN2007 Y
  Musculoskeletal and connective tissue 
disordersArthralgia 01JAN2016 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2017 Y
C4591001 1009 
10091238/ 
Placebo Skin and subcutaneous tissue disorders Acne 01JAN2017 Y 
C4591001 1009 
10091247/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2009 Y 
  Seasonal aller gy 01JAN2019 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 54
FDA-CBER-2022-5812-0499858
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1009 
10091249/ 
Placebo Skin and subcutaneous tissue disorders Acne 01JAN2015 Y 
C4591001 1009 
10091265/ 
BNT162b2 (30 μg) Metabolism and nutrition disorders Obesity 01JAN2017 Y 
C4591001 1009 
10091266/ 
Placebo Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2008 Y 
  Nervous s ystem disorders Migraine 01JAN2018 Y
  Psychiatric disorders Anxiet y 01JAN2016 Y
  Attention deficit h yperactivit y disorde r 01JAN2015 Y
  Insomnia 01JAN2017 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2008 Y 
C4591001 1009 
10091267/ 
Placebo Immune system disorders Allergy to plants 21AUG2017 Y 
  Psychiatric disorders Anxiet y 01JAN2009 Y
  Attention deficit h yperactivit y disorde r 01JAN2019 Y
C4591001 1009 
10091272/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 10SEP2009 Y 
  Food aller gy 01JAN2010 Y
  Seasonal aller gy 01JAN2011 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma exercise induced 01JUL2020 Y 
C4591001 1009 
10091273/ 
Placebo Respiratory, thoraci c and mediastinal 
disorders Tracheomalacia 01DEC2005 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 55
FDA-CBER-2022-5812-0499859
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1009 
10091274/ 
Placebo Skin and subcutaneous tissue disorders Eczema 01JAN2015 Y 
C4591001 1009 
10091277/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2008 Y 
  Skin and subcutaneous tissue disorders Keratosis pilaris 19FEB2020 Y
C4591001 1009 
10091280/ 
BNT162b2 (30 μg) Psychiatric disorders Enuresis 01JAN2011 Y 
  Social circumstances Premenarche 2008 Y
C4591001 1009 
10091282/ 
Placebo Skin and subcutaneous tissue disorders Acne 01JUN2019 Y 
C4591001 1009 
10091283/ 
Placebo Immune system disorders Allergy to animal 01JAN2015 Y 
  Milk aller gy 01JAN2010 Y
  Metabolism and nutrition disorders Food intolerance 01JAN2018 Y
  Musculoskeletal and connective tissue 
disordersShoulder deformity 01JAN2018 Y 
  Psychiatric disorders Anxiet y 01JAN2018 Y
  Attention deficit h yperactivit y disorde r 01JAN2018 Y
  Insomnia 01JAN2017 Y
  Reproductive system and breast 
disordersDysmenorrhoea 01OCT2017 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma exercise induced 01JAN2016 Y 
  Skin and subcutaneous tissue disorders Eczema 01JAN2007 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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FDA-CBER-2022-5812-0499860
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1009 
10091287/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2018 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2016 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2017 Y
  Eczema 2005 Y
C4591001 1009 
10091288/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2017 Y 
  Skin and subcutaneous tissue disorders Eczema 01JAN2008 Y
C4591001 1009 
10091289/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2014 Y 
C4591001 1009 
10091292/ 
Placebo Immune system disorders Seasonal allergy 01JAN2018 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2017 Y
C4591001 1009 
10091293/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2011 Y 
  Skin and subcutaneous tissue disorders Eczema 01JAN2008 Y
C4591001 1009 
10091294/ 
Placebo Reproductive system and breast 
disorders Heavy menstrual bleeding 01JAN2018 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2017 Y
  Dermatitis atopic 01JAN2018 Y
C4591001 1009 
10091295/ 
BNT162b2 (30 μg) Social circumstances Premenarche 2008 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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FDA-CBER-2022-5812-0499861
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1009 
10091297/ 
BNT162b2 (30 μg) Immune system disorders Food allergy 01JAN2008 Y 
  Nervous s ystem disorders Headache 01JAN2014 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2014 Y 
C4591001 1009 
10091300/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2016 Y 
C4591001 1009 
10091301/ 
Placebo Immune system disorders Allergy to animal 01JAN2016 Y 
  Food aller gy 01JAN2016 Y
  Oral aller gy syndrome 01JAN2016 Y
  Seasonal aller gy 01JAN2016 Y
  Nervous s ystem disorders Migraine 01JAN2015 Y
  Psychiatric disorders Anxiet y 01JAN2017 Y
  Attention deficit h yperactivit y disorde r 01JAN2017 Y
  Depression 01JAN2017 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2016 Y 
C4591001 1009 
10091304/ 
BNT162b2 (30 μg) Investigations Cardiac murmur 01JAN2007 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2010 Y 
C4591001 1009 
10091305/ 
Placebo Immune system disorders Seasonal allergy 01JAN2012 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2011 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 58
FDA-CBER-2022-5812-0499862
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1009 
10091307/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2008 Y 
  Skin and subcutaneous tissue disorders Hand dermatitis 01JAN2015 Y
C4591001 1009 
10091308/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2010 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2019 Y
C4591001 1009 
10091309/ 
BNT162b2 (30 μg) Nervous system disorders Arachnoid cyst 01JAN2006 Y 
  Febrile convulsion 01JUL2008 31JUL2008 N
  Surgical and medical procedures Cerebral c yst excision 01OCT2018 01OCT2018 N
C4591001 1009 
10091310/ 
BNT162b2 (30 μg) Cardiac disorders Postural orthostatic tachycardia syndrome 01JAN2018 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2012 Y
  Nervous s ystem disorders Migraine 01JAN2011 Y
C4591001 1009 
10091311/ 
Placebo Congenital, familial and genetic 
disorders Bicuspid aortic valve 2007 Y 
  Renal and urinar y disorders Dysuria 20NOV2020 23NOV2020 N
C4591001 1009 
10091312/ 
Placebo Immune system disorders Seasonal allergy 01JAN2011 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2015 Y 
  Rhinitis aller gic 01JAN2011 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499863
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1009 
10091314/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2007 Y 
  Seasonal aller gy 01JAN2013 Y
C4591001 1009 
10091315/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2008 Y 
  Nervous s ystem disorders Headache 01JAN2012 Y
  Skin and subcutaneous tissue disorders Acne 01FEB2020 Y
C4591001 1009 
10091316/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2006 Y 
  Psychiatric disorders Anxiet y 01JAN2008 Y
  Attention deficit h yperactivit y disorde r 01JAN2015 Y
  Depression 01JAN2008 Y
  Insomnia 01DEC2010 Y
C4591001 1009 
10091318/ 
BNT162b2 (30 μg) Immune system disorders Hypersensitivity 01JAN2012 Y 
  Social circumstances Premenarche 2006 Y
C4591001 1009 
10091319/ 
BNT162b2 (30 μg) Immune system disorders Food allergy 01JAN2014 Y 
  Seasonal aller gy 01JAN2014 Y
C4591001 1009 
10091320/ 
Placebo Psychiatric disorders Major depression 01SEP2020 Y 
  Suicidal ideation 01SEP2020 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499864
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1009 
10091321/ 
BNT162b2 (30 μg) Investigations Cardiac murmur 10DEC2020 Y 
  Nervous s ystem disorders Migraine 01JAN2016 Y
  Skin and subcutaneous tissue disorders Nail psoriasis 01JAN2016 Y
C4591001 1009 
10091323/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2013 Y 
  01JAN2015 Y
C4591001 1009 
10091324/ 
Placebo Immune system disorders Seasonal allergy 01JAN2015 Y 
C4591001 1009 
10091326/ 
Placebo Immune system disorders Seasonal allergy 01JAN2017 Y 
  Psychiatric disorders Generalised anxiet y disorde r 01JAN2018 Y
  Skin and subcutaneous tissue disorders Eczema 2008 Y
  Social circumstances Premenarche 2008 Y
C4591001 1009 
10091328/ 
BNT162b2 (30 μg) Congenital, familial and genetic 
disorders Pectus excavatum 2007 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2016 Y
  Social circumstances Premenarche 2007 Y
C4591001 1009 
10091330/ 
Placebo Metabolism and nutrition disorders Food intolerance 01JAN2015 Y 
  Lactose intolerance 01JAN2019 Y
  Social circumstances Premenarche 2007 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499865
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1009 
10091331/ 
BNT162b2 (30 μg) Musculoskeletal and connective tissue 
disorders Pain in jaw 01JAN2014 Y 
  Nervous s ystem disorders Headache 01JAN2020 Y
  Social circumstances Premenarche 2007 Y
C4591001 1009 
10091333/ 
BNT162b2 (30 μg) Cardiac disorders Aortic valve disease 01JAN2008 Y 
C4591001 1009 
10091334/ 
Placebo General disorders and administration 
site conditions Drug intolerance 01JAN2018 Y 
  Immune s ystem disorders Aller gy to animal 01JAN2015 Y
  Seasonal aller gy 01JAN2015 Y
  Nervous s ystem disorders Headache 01JAN2018 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2017 Y 
  Skin and subcutaneous tissue disorders Eczema 01JUN2020 Y
  Social circumstances Premenarche 2007 Y
C4591001 1009 
10091335/ 
BNT162b2 (30 μg) Skin and subcutaneous tissue disorders Acne 01JAN2018 Y 
C4591001 1009 
10091336/ 
Placebo Immune system disorders Food allergy 01JAN2011 Y 
  Seasonal aller gy 01JAN2011 Y
C4591001 1009 
10091338/ 
Placebo Cardiac disorders Ventricular extrasystoles 30OCT2019 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499866
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1009 
10091340/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2007 Y 
  Metabolism and nutrition disorders Obesit y 01JAN2016 Y
C4591001 1009 
10091341/ 
Placebo Psychiatric disorders Anxiety 01DEC2019 Y 
C4591001 1009 
10091342/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2007 Y 
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2007 Y 
  Skin and subcutaneous tissue disorders Hand dermatitis 01JAN2018 Y
C4591001 1009 
10091343/ 
BNT162b2 (30 μg) Social circumstances Premenarche 2007 Y 
C4591001 1009 
10091344/ 
Placebo Reproductive system and breast 
disorders Varicocele 01JAN2019 Y 
C4591001 1009 
10091345/ 
BNT162b2 (30 μg) Respiratory, thoraci c and mediastinal 
disorders Asthma 01JAN2014 Y 
C4591001 1009 
10091346/ 
Placebo Eye disorders Strabismus 01JAN2010 Y 
  Immune s ystem disorders Aller gy to animal 01FEB2020 Y
  Oral aller gy syndrome 01FEB2020 Y
  Psychiatric disorders Anxiet y 01JAN2011 Y
  Skin and subcutaneous tissue disorders Eczema 01FEB2020 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499867
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1009 
10091347/ 
Placebo Investigations Cardiac murmur 15DEC2020 Y 
  Social circumstances Premenarche 2007 Y
C4591001 1009 
10091349/ 
Placebo Congenital, familial and genetic 
disorders Imperforate hymen 06JUL2020 Y 
  Reproductive system and breast 
disordersDysmenorrhoea 01AUG2019 Y 
C4591001 1009 
10091350/ 
Placebo Immune system disorders Allergy to animal 2006 Y 
C4591001 1009 
10091351/ 
BNT162b2 (30 μg) Social circumstances Premenarche 2008 31JAN2021 N 
C4591001 1009 
10091353/ 
BNT162b2 (30 μg) Social circumstances Premenarche 2008 Y 
C4591001 1009 
10091354/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2008 Y 
  Psychiatric disorders Attention deficit h yperactivi ty disorde r 01JAN2018 Y
C4591001 1009 
10091355/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2019 Y 
  Insomnia 01JAN2017 Y
  Oppositional defiant disorde r 01JAN2019 Y
C4591001 1009 
10091356/ 
Placebo Social circumstances Premenarche 2007 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499868
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1009 
10091357/ 
Placebo Musculoskeletal and connective tissue 
disorders Arthralgia 01JAN2017 Y 
  Back pain 01JAN2018 Y
  Nervous s ystem disorders Headache 01JAN2018 Y
  Psychiatric disorders Insomnia 01JAN2017 Y
C4591001 1009 
10091358/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2007 Y 
  Nervous s ystem disorders Migraine 01JAN2018 Y
C4591001 1009 
10091359/ 
Placebo Congenital, familial and genetic 
disorders Transposition of the great vessels 2007 2007 N 
  Investi gations Cardiac murmu r 2007 Y
  Nervous s ystem disorders Headache 01JAN2018 Y
  Psychiatric disorders Insomnia 01JAN2015 Y
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2012 Y 
  Surgical and medical procedures Arterial switch operation 2007 2007 N
C4591001 1009 
10091360/ 
BNT162b2 (30 μg) Musculoskeletal and connective tissue 
disorders Scoliosis 01MAY2019 31JUL2019 N 
  Psychiatric disorders Insomnia 01JAN2010 Y
  Surgical and medical procedures Spinal fusion sur gery 01JUL2019 31JUL2019 N
C4591001 1009 
10091361/ 
Placebo Psychiatric disorders Insomnia 01JAN2019 Y 
C4591001 1009 
10091362/ 
BNT162b2 (30 μg) Congenital, familial and genetic 
disorders Bicuspid aortic valve 2008 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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FDA-CBER-2022-5812-0499869
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Psychiatric disorders Anxiet y 01JAN2018 Y
  Attention deficit h yperactivit y disorde r 01JAN2017 Y
  Insomnia 01JAN2016 Y
C4591001 1009 
10091363/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2016 Y 
  Insomnia 01JAN2016 Y
  Skin and subcutaneous tissue disorders Acne 01JAN2019 Y
C4591001 1009 
10091364/ 
BNT162b2 (30 μg) Metabolism and nutrition disorders Obesity 01JAN2016 Y 
C4591001 1009 
10091365/ 
Placebo Psychiatric disorders Anxiety 01JAN2014 Y 
C4591001 1009 
10091366/ 
Placebo Congenital, familial and genetic 
disorders Atrial septal defect 2006 2009 N 
  Immune s ystem disorders Food aller gy 01JAN2015 Y
  Seasonal aller gy 01JAN2010 Y
  Surgical and medical procedures Atrial septal defect repai r 01AUG2009 31AUG2009 N
C4591001 1009 
10091369/ 
Placebo Immune system disorders Perennial allergy 01JAN2014 Y 
  Injury, poisoning and procedural 
complicationsLigament sprain 01JAN2019 30SEP2019 N 
  Nervous s ystem disorders Headache 01JAN2019 Y
  Skin and subcutaneous tissue disorders Acne 19FEB2019 Y
  Dry skin 18FEB2018 Y
  Social circumstances Premenarche 2008 31MAR2021 N
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499870
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1009 
10091370/ 
BNT162b2 (30 μg) Social circumstances Premenarche 2007 Y 
C4591001 1009 
10091371/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2017 Y 
C4591001 1009 
10091372/ 
BNT162b2 (30 μg) Metabolism and nutrition disorders Type 1 diabetes mellitus 01JUN2019 Y 
C4591001 1009 
10091376/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2014 Y 
  Insomnia 01JAN2020 Y
C4591001 1009 
10091380/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2007 Y 
C4591001 1009 
10091381/ 
BNT162b2 (30 μg) Nervous system disorders Migraine 01JAN2016 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2016 Y
  Skin and subcutaneous tissue disorders Urticaria 01JAN2012 Y
  Social circumstances Premenarche 2008 Y
C4591001 1009 
10091382/ 
Placebo Gastrointestinal disorders Coeliac disease 01JAN2013 Y 
  Psychiatric disorders Anxiet y 01JAN2018 Y
C4591001 1009 
10091383/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2008 Y 
  Nervous s ystem disorders Nystagmus 2005 Y
  Psychiatric disorders Obsessive-compulsive disorde r 01JAN2017 Y
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(b) (6)
FDA-CBER-2022-5812-0499871
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2009 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
C4591001 1009 
10091384/ 
Placebo Skin and subcutaneous tissue disorders Acne 01JAN2018 Y 
C4591001 1009 
10091386/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2008 Y 
  Seasonal aller gy 01JAN2020 Y
  Skin and subcutaneous tissue disorders Psoriasis 01JAN2015 Y
C4591001 1009 
10091387/ 
BNT162b2 (30 μg) Injury, poisoning and procedural 
complications Wrist fracture 01JAN2021 Y 
C4591001 1009 
10091388/ 
Placebo Immune system disorders Drug hypersensitivity 01DEC2018 Y 
  Seasonal aller gy 01JAN2018 Y
  Injury, poisoning and procedural 
complicationsRadius fracture 26DEC2020 Y 
  Psychiatric disorders Anxiet y 01JAN2017 Y
  Skin and subcutaneous tissue disorders Eczema 01JAN2008 Y
C4591001 1009 
10091391/ 
BNT162b2 (30 μg) Immune system disorders Anaphylactic reaction 01JAN2007 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2014 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2017 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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FDA-CBER-2022-5812-0499872
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1009 
10091392/ 
Placebo Immune system disorders Food allergy 01FEB2010 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2012 Y 
  Social circumstances Premenarche 2008 Y
C4591001 1009 
10091396/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2013 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
C4591001 1009 
10091398/ 
BNT162b2 (30 μg) Injury, poisoning and procedural 
complications Meniscus injury 31DEC2020 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma exercise induced 01SEP2020 Y 
C4591001 1009 
10091399/ 
Placebo Social circumstances Premenarche 2008 Y 
C4591001 1009 
10091400/ 
Placebo Infections and infestations Otitis media 01JAN2008 31DEC2017 N 
  Skin and subcutaneous tissue disorders Drug eruption 01JAN2008 Y
  Surgical and medical procedures Adenoidectom y 01JAN2016 31DEC2016 N
  Ear tube insertion 01JAN2014 31DEC2014 N
C4591001 1009 
10091402/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2015 Y 
C4591001 1009 
10091403/ 
Placebo Immune system disorders Hypersensitivity 01JAN2012 Y 
  Metabolism and nutrition disorders Obesit y 01JAN2017 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499873
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Skin and subcutaneous tissue disorders Acne 01JAN2017 Y
C4591001 1009 
10091404/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2014 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2016 Y 
  Social circumstances Premenarche 2008 Y
C4591001 1009 
10091405/ 
Placebo Immune system disorders Seasonal allergy 01JAN2005 Y 
C4591001 1009 
10091406/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2018 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
C4591001 1009 
10091407/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2008 Y 
  01SEP2019 Y
  Skin and subcutaneous tissue disorders Acne 01JAN2019 Y
C4591001 1009 
10091408/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JUN2020 Y 
  Social circumstances Premenarche 2007 Y
C4591001 1009 
10091409/ 
BNT162b2 (30 μg) Musculoskeletal and connective tissue 
disorders Kyphosis 2006 Y 
  Psychiatric disorders Depression 01JAN2020 Y
C4591001 1009 
10091410/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2015 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499874
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Social circumstances Premenarche 2008 Y
C4591001 1009 
10091411/ 
Placebo Congenital, familial and genetic 
disorders Microgenia 2005 24MAR2021 N 
  Gastrointestinal disorders Tooth impacte d 2005 24MAR2021 N
  Immune s ystem disorders Food aller gy 01JAN2010 Y
C4591001 1009 
10091412/ 
Placebo Immune system disorders Seasonal allergy 01JAN2010 Y 
  Psychiatric disorders Anxiet y 01JAN2015 Y
  Attention deficit h yperactivit y disorde r 30OCT2018 Y
  Autism spectrum disorde r 01JAN2018 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2010 Y 
C4591001 1009 
10091413/ 
BNT162b2 (30 μg) Respiratory, thoraci c and mediastinal 
disorders Asthma exercise induced 01JAN2017 Y 
  Skin and subcutaneous tissue disorders Acne 01MAY2020 Y
  Social circumstances Premenarche 2007 Y
C4591001 1009 
10091414/ 
BNT162b2 (30 μg) Immune system disorders Allergy to animal 01JAN2017 Y 
  Drug hypersensitivit y 01JAN2012 Y
  Seasonal aller gy 01JAN2017 Y
C4591001 1013 
10131821/ 
BNT162b2 (30 μg) Hepatobiliary disorders Cholelithiasis 01JUN2020 30JUN2020 N 
  Surgical and medical procedures Cholec ystectom y 01SEP2020 30SEP2020 N
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499875
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1013 
10131823/ 
Placebo Congenital, familial and genetic 
disorders Sickle cell trait 2005 Y 
  Metabolism and nutrition disorders Obesit y 01JAN2013 Y
C4591001 1013 
10131824/ 
BNT162b2 (30 μg) Congenital, familial and genetic 
disorders Sickle cell anaemia 01JAN2007 Y 
  Surgical and medical procedures Central venous catheterisation 01JAN2018 Y
C4591001 1013 
10131826/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2018 Y 
C4591001 1013 
10131828/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2006 Y 
  Seasonal aller gy 01JAN2008 Y
C4591001 1013 
10131830/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2012 Y 
C4591001 1013 
10131839/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2019 Y 
C4591001 1013 
10131841/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2013 Y 
C4591001 1013 
10131842/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2011 Y 
C4591001 1013 
10131843/ 
BNT162b2 (30 μg) Immune system disorders Hypersensitivity 01JAN2018 Y 
  Metabolism and nutrition disorders Decreased appetite 01JAN2018 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499876
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Psychiatric disorders Attention deficit h yperactivit y disorde r 02DEC2016 Y
  Insomnia 01JAN2018 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2016 Y 
C4591001 1013 
10131844/ 
Placebo Immune system disorders Hypersensitivity 01JAN2018 Y 
  Metabolism and nutrition disorders Decreased appetite 01JAN2018 Y
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2016 Y
C4591001 1013 
10131845/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2015 Y 
C4591001 1013 
10131846/ 
BNT162b2 (30 μg) Immune system disorders Hypersensitivity 01JAN2007 Y 
C4591001 1013 
10131850/ 
BNT162b2 (30 μg) Eye disorders Myopia 01JAN2014 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2011 Y
C4591001 1013 
10131852/ 
Placebo Nervous system disorders Headache 01JAN2016 Y 
  Migraine 01JAN2015 Y
C4591001 1013 
10131855/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2011 Y 
  Depression 01JAN2019 Y
  Insomnia 01JAN2019 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 73
FDA-CBER-2022-5812-0499877
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1013 
10131858/ 
Placebo Social circumstances Premenarche 2007 Y 
C4591001 1013 
10131859/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JUN2020 Y 
C4591001 1013 
10131860/ 
Placebo Immune system disorders Seasonal allergy 01JAN2017 Y 
C4591001 1013 
10131861/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2016 Y 
C4591001 1013 
10131867/ 
Placebo Immune system disorders Hypersensitivity 01JAN2015 Y 
  Infections and infestations Tonsillitis 01JAN2016 31DEC2016 N
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2014 Y 
  Surgical and medical procedures Tonsillectom y 01JAN2016 31DEC2016 N
C4591001 1013 
10131868/ 
Placebo Immune system disorders Seasonal allergy 01JAN2018 Y 
  Musculoskeletal and connective tissue 
disordersScoliosis 01JUL2018 Y 
C4591001 1013 
10131869/ 
Placebo Immune system disorders Seasonal allergy 2006 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01MAR2016 Y
C4591001 1013 
10131870/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2012 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499878
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1013 
10131871/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2013 Y 
C4591001 1013 
10131872/ 
BNT162b2 (30 μg) Immune system disorders Food allergy 01JAN2010 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2017 Y
C4591001 1013 
10131873/ 
BNT162 b2 (30 μg) Eye disorders Myopia 01JAN2014 Y 
C4591001 1013 
10131874/ 
Placebo Eye disorders Myopia 01JAN2016 Y 
  Surgical and medical procedures Myringotom y 01JAN2009 31DEC2009 N
C4591001 1013 
10131875/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2015 Y 
  Musculoskeletal and connective tissue 
disordersTendonitis 01JAN2019 Y 
C4591001 1013 
10131876/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2013 Y 
C4591001 1013 
10131877/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01NOV2013 Y 
C4591001 1013 
10131879/ 
Placebo Endocrine disorders Growth hormone deficiency 01JAN2019 Y 
C4591001 1013 
10131881/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2008 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 75
FDA-CBER-2022-5812-0499879
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2007 Y 
C4591001 1016 
10161307/ 
Placebo Immune system disorders Seasonal allergy 04FEB2016 Y 
  Psychiatric disorders Depression 15JUN2020 Y
C4591001 1016 
10161308/ 
Placebo Immune system disorders Seasonal allergy 30MAR2010 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 30MAR2010 Y 
  Skin and subcutaneous tissue disorders Eczema 08JAN2013 Y
  Psoriasis 16DEC2014 Y
C4591001 1016 
10161310/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01APR2016 Y 
C4591001 1016 
10161311/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 18DEC2015 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 07MAR2012 Y 
C4591001 1016 
10161314/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JUN2007 Y 
C4591001 1016 
10161315/ 
Placebo Immune system disorders Seasonal allergy 01APR2014 Y 
C4591001 1016 
10161316/ 
Placebo Immune system disorders Seasonal allergy 08MAR2007 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 76
FDA-CBER-2022-5812-0499880
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1016 
10161318/ 
Placebo Gastrointestinal disorders Constipation 01FEB2009 Y 
  Immune s ystem disorders Seasonal aller gy 01MAR2008 Y
C4591001 1016 
10161319/ 
Placebo Immune system disorders Seasonal allergy 01OCT2015 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01OCT2015 30NOV2017 N 
  Orophar yngeal pain 12OCT2020 15OCT2020 N
C4591001 1016 
10161320/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01FEB2012 Y 
C4591001 1016 
10161322/ 
BNT162b2 (30 μg) Gastrointestinal disorders Abdominal pain 01OCT2019 Y 
  Nervous s ystem disorders Febrile convulsion 08APR2008 08APR2008 N
  20AUG2010 20AUG2010 N
  Psychiatric disorders Attention deficit h yperactivit y disorde r 26JUN2014 Y
  Skin and subcutaneous tissue disorders Psoriasis 06JAN2020 Y
C4591001 1016 
10161323/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 18SEP2012 Y 
C4591001 1016 
10161324/ 
Placebo Immune system disorders Seasonal allergy 01MAY2015 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01SEP2015 31DEC2015 N 
C4591001 1016 
10161326/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 24APR2009 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 77
FDA-CBER-2022-5812-0499881
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Respiratory, thoraci c and mediastinal 
disordersAsthma 11MAY2007 Y 
C4591001 1016 
10161327/ 
Placebo Immune system disorders Seasonal allergy 24APR2009 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 24APR2009 Y 
C4591001 1016 
10161329/ 
Placebo Gastrointestinal disorders Constipation 01FEB2013 Y 
  Immune s ystem disorders Seasonal aller gy 01MAY2012 Y
  Psychiatric disorders Anxiet y 01AUG2019 Y
  Attention deficit h yperactivit y disorde r 01MAR2018 Y
  Chronic tic disorde r 01SEP2015 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01DEC2010 Y 
C4591001 1016 
10161330/ 
BNT162b2 (30 μg) Nervous system disorders Migraine 01JUN2009 Y 
  Psychiatric disorders Anxiet y 01AUG2019 Y
C4591001 1016 
10161331/ 
Placebo Immune system disorders Seasonal allergy 01AUG2016 Y 
  Injury, poisoning and procedural 
complicationsClavicle fracture 01AUG2018 31OCT2018 N 
  Nervous s ystem disorders Migraine 01APR2016 Y
C4591001 1016 
10161332/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01APR2011 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 78
FDA-CBER-2022-5812-0499882
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1016 
10161334/ 
Placebo Respiratory, thoraci c and mediastinal 
disorders Asthma 23OCT2009 Y 
C4591001 1016 
10161335/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01AUG2010 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 28AUG2015 30SEP2018 N
  Insomnia 01JUN2017 Y
  Surgical and medical procedures Adenoidectom y 28MAY2020 28MAY2020 N
  Tonsillectom y 28MAY2020 28MAY2020 N
C4591001 1016 
10161336/ 
Placebo Nervous system disorders Headache 01APR2015 Y 
  Psychiatric disorders Aggression 23JUL2012 Y
  Anxiet y 01APR2012 Y
  Attention deficit h yperactivit y disorde r 24APR2014 Y
  Behaviour disorde r 07AUG2007 Y
  Post-traumatic stress disorde r 27JUL2020 Y
C4591001 1016 
10161337/ 
Placebo Psychiatric disorders Depression 01JUL2020 Y 
C4591001 1016 
10161338/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 20NOV2013 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01MAR2015 Y
C4591001 1016 
10161339/ 
BNT162b2 (30 μg) Gastrointestinal disorders Constipation 01APR2020 Y 
  Immune s ystem disorders Seasonal aller gy 01APR2016 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 79
FDA-CBER-2022-5812-0499883
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Musculoskeletal and connective tissue 
disordersPain in extremity 01SEP2020 09SEP2020 N 
  Nervous s ystem disorders Headache 11FEB2020 Y
  Psychiatric disorders Attention deficit h yperactivit y disorde r 10NOV2016 Y
  Insomnia 12FEB2020 Y
C4591001 1016 
10161340/ 
Placebo Immune system disorders Seasonal allergy 01MAY2019 Y 
  Infections and infestations Infectious mononucleosis 01SEP2017 31OCT2017 N
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01APR2018 Y
  Disruptive mood d ysregulation disorde r 10SEP2020 Y
  Insomnia 01JAN2013 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01FEB2010 Y 
C4591001 1016 
10161343/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 30JAN2012 Y 
  Oppositional defiant disorde r 30MAR2017 Y
  Tic 14JUN2017 05JUL2017 N
C4591001 1016 
10161344/ 
Placebo Immune system disorders Seasonal allergy 01FEB2010 Y 
  Psychiatric disorders Anger 01NOV2018 30JUN2019 N
  Anxiet y 01AUG2017 Y
  Attention deficit h yperactivit y disorde r 01SEP2014 Y
  Chronic tic disorde r 01MAY2020 Y
  Depression 01MAY2019 Y
  Oppositional defiant disorde r 01NOV2018 30JUN2019 N
  Skin and subcutaneous tissue disorders Acne 01JUN2017 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 80
FDA-CBER-2022-5812-0499884
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Vascular disorders Hypotension 01MAY2017 Y
C4591001 1016 
10161350/ 
BNT162b2 (30 μg) Ear and labyrinth disorders Deafness unilateral 24MAY2010 Y 
  Immune s ystem disorders Seasonal aller gy 31AUG2007 Y
  Reproductive system and breast 
disordersVaricocele 24SEP2020 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 06SEP2012 31DEC2018 N 
  Skin and subcutaneous tissue disorders Acne 17SEP2020 Y
C4591001 1016 
10161351/ 
Placebo Immune system disorders Seasonal allergy 01OCT2007 Y 
  Psychiatric disorders Oppositional defiant disorde r 01MAY2009 31MAY2010 N
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JUN2012 31JUL2017 N 
C4591001 1016 
10161352/ 
Placebo Immune system disorders Seasonal allergy 01OCT2015 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 04OCT2010 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 14APR2017 Y 
C4591001 1016 
10161353/ 
Placebo Immune system disorders Seasonal allergy 01MAY2011 Y 
C4591001 1016 
10161354/ 
BNT162b2 (30 μg) Renal and urinary disorders Vesicoureteric reflux 01SEP2006 31JAN2011 N 
C4591001 1016 
10161356/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 18SEP2012 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 81
FDA-CBER-2022-5812-0499885
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Impulse-control disorde r 20APR2016 Y
C4591001 1016 
10161358/ 
Placebo Immune system disorders Seasonal allergy 01MAR2017 Y 
C4591001 1016 
10161361/ 
Placebo Immune system disorders Seasonal allergy 01JAN2010 Y 
  Infections and infestations Abscess limb 01JUN2015 30JUN2015 N
C4591001 1016 
10161362/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01MAY2013 31OCT2015 N 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 09AUG2011 31MAR2016 N 
C4591001 1016 
10161363/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01MAY2009 Y 
C4591001 1016 
10161364/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2005 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 06MAR2012 Y
  Bipolar disorde r 24JUL2018 Y
  Reproductive system and breast 
disordersDysmenorrhoea 03AUG2020 Y 
C4591001 1016 
10161365/ 
Placebo Psychiatric disorders Anxiety 01MAR2020 Y 
  Depression 01MAR2020 Y
  Skin and subcutaneous tissue disorders Eczema 06JAN2009 30APR2016 N
C4591001 1016 
10161366/ 
Placebo Nervous system disorders Headache 01DEC2018 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 82
FDA-CBER-2022-5812-0499886
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1016 
10161367/ 
Placebo Gastrointestinal disorders Gastrooesophageal reflux disease 01SEP2008 Y 
  Immune s ystem disorders Seasonal aller gy 01NOV2008 Y
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01DEC2014 Y
  Reproductive system and breast 
disordersAbnormal uterine bleeding 01JUL2020 Y 
C4591001 1016 
10161368/ 
Placebo Social circumstances Premenarche 2008 Y 
C4591001 1016 
10161369/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JUN2019 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JUN2015 Y
  Skin and subcutaneous tissue disorders Miliaria 01JUN2019 Y
  Social circumstances Premenarche 2008 Y
C4591001 1016 
10161372/ 
Placebo Immune system disorders Seasonal allergy 01APR2019 Y 
C4591001 1016 
10161373/ 
BNT162b2 (30 μg) Congenital, familial and genetic 
disorders Spina bifida occulta 01FEB2020 Y 
  Immune s ystem disorders Seasonal aller gy 01JUN2019 Y
  Musculoskeletal and connective tissue 
disordersKyphosis 01FEB2020 Y 
  Lordosis 01FEB2020 Y
C4591001 1016 
10161374/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01APR2013 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 83
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499887
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1016 
10161375/ 
Placebo Immune system disorders Seasonal allergy 01APR2010 Y 
  Nervous s ystem disorders Migraine 01JUN2019 Y
C4591001 1016 
10161376/ 
BNT162b2 (30 μg) Skin and subcutaneous tissue disorders Acne 01MAR2019 Y 
  Surgical and medical procedures Chondroplast y 01FEB2020 14FEB2020 N
C4591001 1016 
10161377/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01APR2016 Y 
  Musculoskeletal and connective tissue 
disordersOsteochondrosis 01FEB2016 Y 
  Skin and subcutaneous tissue disorders Acne 01JUN2019 Y
C4591001 1016 
10161378/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01MAY2018 Y 
  Skin and subcutaneous tissue disorders Eczema 03MAR2010 Y
C4591001 1016 
10161379/ 
Placebo Immune system disorders Seasonal allergy 01APR2012 Y 
C4591001 1016 
10161381/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01APR2006 Y 
C4591001 1016 
10161382/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01AUG2014 Y 
  Skin and subcutaneous tissue disorders Eczema 01NOV2010 Y
C4591001 1016 
10161383/ 
Placebo Immune system disorders Seasonal allergy 01APR2011 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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FDA-CBER-2022-5812-0499888
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Skin and subcutaneous tissue disorders Eczema 01DEC2010 Y
C4591001 1016 
10161384/ 
BNT162b2 (30 μg) Immune system disorders Food allergy 01MAY2009 Y 
  Seasonal aller gy 01OCT2009 Y
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01AUG2016 Y
C4591001 1016 
10161385/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 15AUG2011 Y 
  Skin and subcutaneous tissue disorders Eczema 14NOV2006 Y
C4591001 1016 
10161386/ 
Placebo Immune system disorders Seasonal allergy 01APR2011 Y 
  Respiratory, thoraci c and mediastinal 
disordersBronchial hyperreactivity 01APR2011 Y 
  Social circumstances Premenarche 2007 Y
C4591001 1016 
10161387/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01APR2009 Y 
  Neoplasms benign, malignant and 
unspecified (incl c ysts and pol yps)Skin papilloma 01MAY2019 Y 
  Psychiatric disorders Gender d ysphoria 01SEP2016 Y
  Social circumstances Premenarche 2006 Y
C4591001 1016 
10161388/ 
Placebo Immune system disorders Seasonal allergy 01APR2006 Y 
  Nervous s ystem disorders Headache 01MAY2012 Y
  Reproductive system and breast 
disordersHeavy menstrual bleeding 01JUN2017 Y 
  Skin and subcutaneous tissue disorders Eczema 01MAR2006 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499889
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1039 
10391246/ 
Placebo Eye disorders Myopia 01JAN2010 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2011 Y
  Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
  Social circumstances Corrective lens use r 01JAN2011 Y
C4591001 1039 
10391247/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2008 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2020 Y
C4591001 1039 
10391250/ 
BNT162b2 (30 μg) General disorders and administration 
site conditions Cyst 01JAN2015 31DEC2015 N 
  Psychiatric disorders Tic 01JAN2019 Y
  Social circumstances Menarche 01JAN2018 Y
C4591001 1039 
10391251/ 
Placebo Psychiatric disorders Anxiety 01JAN2017 Y 
  Reproductive system and breast 
disordersHeavy menstrual bleeding 01JAN2018 Y 
  Skin and subcutaneous tissue disorders Eczema 01JUN2020 Y
  Social circumstances Menarche 01JAN2016 Y
  Vegetarian 2005 Y
C4591001 1039 
10391252/ 
Placebo Eye disorders Strabismus 01JAN2008 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
  Social circumstances Corrective lens use r 01JAN2008 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499890
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1039 
10391253/ 
BNT162b2 (30 μg) Social circumstances Premenarche 2008 Y 
C4591001 1039 
10391255/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2014 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
  Social circumstances Vegan 01JUN2020 Y
C4591001 1039 
10391256/ 
Placebo Nervous system disorders Epilepsy 01JAN2017 30SEP2020 N 
  Social circumstances Vegetarian 2008 Y
C4591001 1039 
10391258/ 
Placebo Immune system disorders Seasonal allergy 01JAN2009 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2016 Y 
  Sleep apnoea s yndrome 01JAN2013 31DEC2013 N
  Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
  Social circumstances Menarche 01JAN2017 Y
  Surgical and medical procedures Adenoidectom y 01JAN2013 31DEC2013 N
  Tonsillectom y 01JAN2013 31DEC2013 N
C4591001 1039 
10391259/ 
Placebo Eye disorders Amblyopia 01JAN2011 Y 
  Myopia 01JAN2011 Y
  Immune s ystem disorders Seasonal aller gy 01JAN2012 Y
  Social circumstances Corrective lens use r 01JAN2011 Y
  Surgical and medical procedures Circumcision 2007 31DEC2007 N
  Myringotom y 01APR2008 30APR2008 N
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499891
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1039 
10391260/ 
BNT162b2 (30 μg) Eye disorders Myopia 01JAN2019 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2014 Y
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2018 Y 
  Social circumstances Corrective lens use r 01JAN2019 Y
C4591001 1039 
10391262/ 
BNT162b2 (30 μg) Eye disorders Myopia 01JAN2016 Y 
  Immune s ystem disorders Food aller gy 01JAN2007 Y
  Social circumstances Corrective lens use r 01JAN2016 Y
  Premenarche 2006 Y
C4591001 1039 
10391263/ 
BNT162b2 (30 μg) Respiratory, thoraci c and mediastinal 
disorders Rhinitis perennial 01JAN2007 Y 
C4591001 1039 
10391264/ 
Placebo Skin and subcutaneous tissue disorders Eczema 01JAN2011 Y 
  Social circumstances Premenarche 2008 Y
C4591001 1039 
10391265/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2011 Y 
  Seasonal aller gy 01JAN2011 Y
  Infections and infestations Ear infection 01JAN2010 31DEC2014 N
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2015 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2008 Y 
  Skin and subcutaneous tissue disorders Actinic keratosis 01JAN2011 Y
  Surgical and medical procedures Adenoidectom y 01JAN2014 31DEC2014 N
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499892
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Myringotom y 01JAN2010 31DEC2010 N
C4591001 1039 
10391266/ 
Placebo Musculoskeletal and connective tissue 
disorders Scoliosis 01JAN2019 Y 
  Surgical and medical procedures Circumcision 01JAN2008 31DEC2008 N
  Ear tube insertion 01JAN2009 31DEC2009 N
  01JAN2013 31DEC2013 N
C4591001 1039 
10391267/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2010 Y 
  Seasonal aller gy 01JAN2013 Y
  Psychiatric disorders Anxiet y 01JAN2013 Y
  Social circumstances Menarche 01JAN2018 Y
  Vegetarian 01JAN2019 Y
C4591001 1039 
10391268/ 
Placebo Social circumstances Menarche 01JAN2018 Y 
C4591001 1039 
10391269/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2013 Y 
  Infections and infestations Ear infection 2008 31DEC2010 N
  Surgical and medical procedures Adenoidectom y 01APR2009 30APR2009 N
  Ear tube insertion 01JAN2010 31DEC2010 N
  Myringotom y 01JAN2010 31DEC2010 N
C4591001 1039 
10391270/ 
Placebo Eye disorders Astigmatism 01JAN2010 Y 
  Immune s ystem disorders Drug hypersensitivit y 01JAN2009 Y
  Infections and infestations Ear infection 01JAN2008 31DEC2011 N
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499893
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Psychiatric disorders Anxiet y 01JAN2016 Y
  Attention deficit h yperactivit y disorde r 01JAN2016 Y
  Social circumstances Corrective lens use r 01JAN2010 Y
  Menarche 01APR2020 Y
  Surgical and medical procedures Myringotom y 01JAN2011 31DEC2011 N
C4591001 1039 
10391271/ 
Placebo Immune system disorders Seasonal allergy 01JAN2018 Y 
  Skin and subcutaneous tissue disorders Eczema 01JAN2018 Y
  Social circumstances Menarche 01MAR2020 Y
C4591001 1039 
10391272/ 
BNT162b2 (30 μg) Immune system disorders Food allergy 01JAN2010 Y 
  Seasonal aller gy 01JAN2019 Y
  Skin and subcutaneous tissue disorders Eczema 01JAN2011 Y
  Surgical and medical procedures Myringotom y 01JAN2010 31DEC2010 N
C4591001 1039 
10391273/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01NOV2020 Y 
  Depression 01OCT2020 Y
  Social circumstances Menarche 01JAN2020 Y
C4591001 1039 
10391274/ 
Placebo Immune system disorders Food allergy 01JAN2013 Y 
  Seasonal aller gy 01JAN2007 Y
C4591001 1039 
10391276/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2009 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2019 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 90
FDA-CBER-2022-5812-0499894
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Idiopathic urticaria 01JAN2018 Y
C4591001 1039 
10391277/ 
Placebo Social circumstances Menarche 01JAN2019 Y 
  Vegetarian 2006 Y
C4591001 1039 
10391278/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2011 Y 
  Infections and infestations Pharyngitis streptococcal 01JAN2010 31DEC2012 N
  Surgical and medical procedures Tonsillectom y 01JAN2012 31DEC2012 N
C4591001 1039 
10391279/ 
Placebo Social circumstances Menarche 01FEB2019 Y 
C4591001 1039 
10391280/ 
Placebo Eye disorders Blindness unilateral 01JAN2014 Y 
  Metabolism and nutrition disorders Vitamin D deficienc y 01JAN2019 Y
  Nervous s ystem disorders Headache 01JAN2019 Y
  Psychiatric disorders Anxiet y 01JAN2014 Y
  Attention deficit h yperactivit y disorde r 01JAN2014 Y
  Depression 01JAN2014 Y
  Insomnia 01JAN2016 Y
  Post-traumatic stress disorde r 01JAN2016 Y
  Skin and subcutaneous tissue disorders Rash 01MAR2020 Y
  Social circumstances Menarche 01JAN2017 Y
  Surgical and medical procedures Cataract operation 01JAN2013 31DEC2013 N
  Vitrectom y 01JAN2012 31DEC2012 N
  01JAN2014 31DEC2014 N
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499895
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1039 
10391281/ 
BNT162b2 (30 μg) Psychiatric disorders Anxiety 01NOV2020 Y 
  Skin and subcutaneous tissue disorders Rosacea 01JAN2017 Y
C4591001 1039 
10391282/ 
BNT162b2 (30 μg) Immune system disorders Food allergy 01JAN2012 Y 
C4591001 1039 
10391283/ 
Placebo Eye disorders Myopia 01JAN2019 Y 
  Immune s ystem disorders Food aller gy 01JAN2005 Y
  Seasonal aller gy 01JAN2017 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2018 Y 
  Asthma exercise induce d 01JAN2018 Y
  Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
  Drug eruption 01JAN2005 Y
  Surgical and medical procedures Dacr yocystorhinostom y 01JAN2007 31DEC2007 N
C4591001 1039 
10391284/ 
BNT162b2 (30 μg) Gastrointestinal disorders Dyspepsia 01JAN2019 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2012 Y
  Nervous s ystem disorders Migraine 01JAN2013 Y
  Reproductive system and breast 
disordersEpididymal cyst 01JAN2018 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma exercise induced 01JAN2013 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
  Eczema 01JAN2013 Y
  Hand dermatitis 01JAN2013 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 92
FDA-CBER-2022-5812-0499896
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1039 
10391285/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2010 Y 
  Social circumstances Premenarche 2007 Y
  Vegetarian 01JAN2019 Y
C4591001 1039 
10391286/ 
BNT162b2 (30 μg) Social circumstances Premenarche 2007 Y 
C4591001 1039 
10391287/ 
Placebo Gastrointestinal disorders Umbilical hernia 01JAN2013 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2009 Y
  Psychiatric disorders Anxiet y 01JAN2017 Y
  Reproductive system and breast 
disordersDysmenorrhoea 01JAN2018 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2011 Y 
  Skin and subcutaneous tissue disorders Eczema 01JAN2016 Y
C4591001 1039 
10391289/ 
BNT162b2 (30 μg) Gastrointestinal disorders Dyspepsia 01JAN2019 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2010 Y
  Musculoskeletal and connective tissue 
disordersArthralgia 01JAN2020 Y 
  Social circumstances Premenarche 2005 Y
C4591001 1039 
10391290/ 
BNT162b2 (30 μg) Eye disorders Myopia 01JAN2019 Y 
  Social circumstances Corrective lens use r 01JAN2019 Y
  Menarche 30JUN2020 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499897
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1039 
10391291/ 
Placebo Eye disorders Hypermetropia 01JAN2019 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
  Social circumstances Corrective lens use r 01JAN2019 Y
  Vegetarian 01JAN2004 Y
  Surgical and medical procedures Trans gender hormonal therap y 01JAN2019 Y
C4591001 1039 
10391292/ 
Placebo Immune system disorders Seasonal allergy 01JAN2018 Y 
  Social circumstances Menarche 01JUN2018 Y
C4591001 1039 
10391293/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2013 Y 
C4591001 1039 
10391294/ 
Placebo Skin and subcutaneous tissue disorders Acne 01AUG2020 Y 
C4591001 1039 
10391295/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2018 Y 
  Seasonal aller gy 01JAN2018 Y
  Injury, poisoning and procedural 
complicationsUpper limb fracture 01NOV2020 Y 
  Psychiatric disorders Anxiet y 01JAN2018 Y
  Depression 01JAN2018 Y
  Social circumstances Menarche 01JAN2017 Y
  Surgical and medical procedures Tonsillectom y 01JAN2013 31DEC2013 N
  Wisdom teeth removal 01JUL2020 31JUL2020 N
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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FDA-CBER-2022-5812-0499898
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1039 
10391296/ 
Placebo Nervous system disorders Dyslexia 01JAN2017 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2017 Y
C4591001 1039 
10391298/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2015 Y 
  Psychiatric disorders Insomnia 01JAN2017 Y
C4591001 1039 
10391299/ 
Placebo Immune system disorders Seasonal allergy 01JAN2010 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2018 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma exercise induced 01JAN2016 Y 
C4591001 1039 
10391300/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2017 Y 
C4591001 1039 
10391301/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2016 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2016 Y 
  Rhinitis aller gic 01JAN2016 Y
C4591001 1039 
10391302/ 
BNT162b2 (30 μg) Psychiatric disorders Anxiety 01JAN2016 Y 
  Depression 01JAN2016 Y
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2015 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 95
FDA-CBER-2022-5812-0499899
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1039 
10391303/ 
Placebo Congenital, familial and genetic 
disorders Developmental hip dysplasia 01APR2008 30APR2008 N 
  Eye disorders Myopia 01JAN2017 Y
  Immune s ystem disorders Seasonal aller gy 01JAN2017 Y
  Social circumstances Corrective lens use r 01JAN2017 Y
C4591001 1039 
10391304/ 
BNT162b2 (30 μg) General disorders and administration 
site conditions Pain 01JAN2018 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2017 Y
  Metabolism and nutrition disorders Dehydration 01JUN2020 30JUN2020 N
  Psychiatric disorders Depression 01JAN2017 31DEC2017 N
  Renal and urinar y disorders Haematuria 01JUN2020 30JUN2020 N
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2018 Y 
C4591001 1039 
10391306/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 2008 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2017 Y
  Surgical and medical procedures Appendicectom y 01JAN2018 31DEC2018 N
C4591001 1039 
10391307/ 
Placebo Immune system disorders Seasonal allergy 01JAN2005 Y 
  Social circumstances Menarche 01SEP2019 Y
C4591001 1039 
10391308/ 
BNT162b2 (30 μg) Congenital, familial and genetic 
disorders Pectus excavatum 01JAN2008 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2007 Y
  Respiratory, thoraci c and mediastinal 
disordersEpistaxis 01JAN2015 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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FDA-CBER-2022-5812-0499900
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Social circumstances Premenarche 2007 Y
  Surgical and medical procedures Tonsillectom y 01JAN2013 31DEC2013 N
C4591001 1039 
10391309/ 
Placebo Eye disorders Myopia 01JAN2016 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2011 Y
  Social circumstances Corrective lens use r 01JAN2016 Y
C4591001 1039 
10391310/ 
Placebo Immune system disorders Seasonal allergy 2007 Y 
C4591001 1039 
10391314/ 
Placebo Neoplasms benign, malignant and 
unspecified (incl cysts and polyps) Fibroadenoma of breast 01FEB2020 Y 
  Psychiatric disorders Anxiet y 01JAN2018 Y
  Attention deficit h yperactivit y disorde r 01JAN2015 Y
  Reproductive system and breast 
disordersDysmenorrhoea 01JAN2018 Y 
  Heav y menstrual bleedin g 01JAN2018 Y
  Social circumstances Menarche 01JAN2018 Y
C4591001 1039 
10391315/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2008 Y 
C4591001 1039 
10391316/ 
BNT162b2 (30 μg) Respiratory, thoraci c and mediastinal 
disorders Rhinitis allergic 01JAN2018 Y 
  Social circumstances Premenarche 2008 Y
C4591001 1039 
10391317/ 
Placebo Eye disorders Astigmatism 01JAN2013 Y 
  Gastrointes tinal disorders Diarrhoea 01JAN2011 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499901
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Social circumstances Corrective lens use r 01JAN2013 Y
C4591001 1039 
10391318/ 
BNT162b2 (30 μg) Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2018 31DEC2018 N 
  Psychiatric disorders Anxiet y 01JAN2017 Y
  Depression 01JAN2017 Y
  Insomnia 01JAN2017 Y
  Skin and subcutaneous tissue disorders Idiopathic urticaria 01JAN2018 Y
  Social circumstances Menarche 01JAN2016 Y
  Surgical and medical procedures Adenoidectom y 01JAN2012 31DEC2012 N
  Tonsillectom y 01JAN2012 31DEC2012 N
C4591001 1039 
10391319/ 
Placebo Immune system disorders Seasonal allergy 01JAN2012 Y 
  Social circumstances Vegetarian 01JAN2018 Y
C4591001 1039 
10391320/ 
Placebo Immune system disorders Seasonal allergy 01JAN2012 Y 
  Social circumstances Menarche 01SEP2020 Y
C4591001 1039 
10391321/ 
Placebo Social circumstances Menarche 01SEP2020 Y 
C4591001 1039 
10391322/ 
BNT162b2 (30 μg) Eye disorders Myopia 01JAN2016 Y 
  Immune s ystem disorders Drug hypersensitivit y 2005 Y
  Psychiatric disorders Anxiet y 01MAR2020 Y
  Reproductive system and breast 
disordersHeavy menstrual bleeding 01JAN2018 Y 
  Social circumstances Menarche 01JAN2017 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499902
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1039 
10391323/ 
BNT162b2 (30 μg) Gastrointestinal disorders Abdominal hernia 2008 Y 
  Immune s ystem disorders Drug hypersensitivit y 01JAN2015 Y
C4591001 1039 
10391324/ 
BNT162b2 (30 μg) Social circumstances Corrective lens user 01OCT2020 Y 
  Menarche 02SEP2020 Y
C4591001 1039 
10391325/ 
Placebo Social circumstances Corrective lens user 01JAN2013 Y 
  Menarche 01SEP2020 Y
C4591001 1039 
10391326/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2016 Y 
  Psychiatric disorders Anxiet y 01JAN2018 Y
  Attention deficit h yperactivit y disorde r 01JAN2018 Y
  Depression 01JAN2018 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2006 31DEC2018 N 
  Social circumstances Corrective lens use r 01JAN2012 Y
C4591001 1039 
10391327/ 
Placebo Eye disorders Myopia 01JAN2018 Y 
  Psychiatric disorders Anxiet y 01NOV2020 Y
  Depression 01NOV2020 Y
  Surgical and medical procedures Limb reconstructive sur gery 31JUL2020 31JUL2020 N
C4591001 1039 
10391328/ 
Placebo Psychiatric disorders Depression 01JAN2018 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499903
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2016 Y 
  Social circumstances Menarche 01JAN2017 Y
C4591001 1039 
10391329/ 
Placebo Immune system disorders Seasonal allergy 01JAN2016 Y 
  Surgical and medical procedures Tonsillectom y 01JAN2011 31DEC2011 N
C4591001 1039 
10391330/ 
BNT162b2 (30 μg) Eye disorders Presbyopia 01JAN2011 Y 
  Psychiatric disorders Anxiet y 01JAN2016 Y
  Attention deficit h yperactivit y disorde r 01JAN2018 Y
  Depression 01JAN2016 Y
  Social circumstances Corrective lens use r 01JAN2011 Y
  Surgical and medical procedures Wisdom teeth removal 01JAN2019 31DEC2019 N
C4591001 1039 
10391331/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2009 Y 
  Seasonal aller gy 01JAN2016 Y
C4591001 1039 
10391332/ 
BNT162b2 (30 μg) Nervous system disorders Migraine 01SEP2020 Y 
  Psychiatric disorders Anxiet y 01JAN2018 Y
  Depression 01NOV2020 30NOV2020 N
  Major depression 01JAN2018 Y
  Post-traumatic stress disorde r 01NOV2020 30NOV2020 N
  Reproductive system and breast 
disordersHeavy menstrual bleeding 01JAN2018 Y 
  Social circumstances Menarche 01JAN2018 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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FDA-CBER-2022-5812-0499904
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1039 
10391333/ 
Placebo Skin and subcutaneous tissue disorders Actinic keratosis 01JAN2019 31DEC2020 N 
C4591001 1039 
10391334/ 
Placebo Endocrine disorders Growth hormone deficiency 01JAN2010 Y 
  Surgical and medical procedures Lipoma excision 01JAN2012 Y
C4591001 1039 
10391336/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2018 Y 
  Seasonal aller gy 01JAN2015 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2014 Y 
C4591001 1039 
10391337/ 
Placebo Gastrointestinal disorders Diarrhoea 01JAN2010 Y 
  Immune s ystem disorders Drug hypersensitivit y 01JAN2007 Y
  Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
  Eczema 01JAN2012 31DEC2012 N
  Surgical and medical procedures Tonsillectom y 01JAN2011 31DEC2011 N
C4591001 1039 
10391338/ 
BNT162b2 (30 μg) Psychiatric disorders Depression 01JAN2018 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
  Social circumstances Menarche 01DEC2016 Y
  Vegetarian 01JAN2018 Y
C4591001 1039 
10391339/ 
Placebo Social circumstances Premenarche 2008 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499905
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1044 
10441256/ 
Placebo Respiratory, thoraci c and mediastinal 
disorders Rhinitis allergic 01JAN2009 Y 
C4591001 1044 
10441260/ 
Placebo Immune system disorders Drug hypersensitivity 01FEB2020 Y 
  01JAN2008 Y
C4591001 1044 
10441263/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01NOV2019 Y 
C4591001 1044 
10441266/ 
BNT162b2 (30 μg) Nervous system disorders Migraine 01JAN2010 Y 
  Reproductive system and breast 
disordersDysmenorrhoea 01JAN2018 Y 
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2008 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2019 Y
C4591001 1044 
10441267/ 
Placebo Skin and subcutaneous tissue disorders Eczema 01JAN2009 Y 
C4591001 1044 
10441268/ 
BNT162b2 (30 μg) Ear and labyrinth disorders Deafness bilateral 01JAN2010 Y 
C4591001 1044 
10441273/ 
BNT162b2 (30 μg) Gastrointestinal disorders Gastrooesophageal reflux disease 2008 Y 
  Social circumstances Premenarche 01NOV2020 Y
C4591001 1044 
10441274/ 
Placebo Respiratory, thoraci c and mediastinal 
disorders Rhinitis allergic 01JAN2009 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 102
(b) (6)
FDA-CBER-2022-5812-0499906
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1044 
10441276/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2013 Y 
C4591001 1044 
10441279/ 
BNT162b2 (30 μg) Respiratory, thoraci c and mediastinal 
disorders Rhinitis allergic 01JAN2012 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2016 Y
C4591001 1044 
10441280/ 
Placebo Metabolism and nutrition disorders Type 1 diabetes mellitus 01JUL2010 Y 
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2008 Y 
C4591001 1044 
10441281/ 
BNT162b2 (30 μg) Skin and subcutaneous tissue disorders Acne 01JUN2020 Y 
C4591001 1044 
10441282/ 
Placebo General disorders and administration 
site conditions Drug intolerance 01JAN2006 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma exercise induced 01JAN2018 Y 
  Rhinitis aller gic 01JAN2008 Y
C4591001 1044 
10441284/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2015 Y 
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2005 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2015 Y
C4591001 1044 
10441285/ 
BNT162b2 (30 μg) Psychiatric disorders Anxiety 01AUG2019 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 103
FDA-CBER-2022-5812-0499907
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1044 
10441286/ 
Placebo Reproductive system and breast 
disorders Menstruation irregular 01MAR2018 Y 
C4591001 1044 
10441288/ 
BNT162b2 (30 μg) Social circumstances Premenarche 01NOV2020 Y 
C4591001 1044 
10441289/ 
Placebo Immune system disorders Allergy to animal 01JAN2009 Y 
  Food aller gy 01JAN2009 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2009 Y 
  Social circumstances Premenarche 2007 Y
C4591001 1044 
10441290/ 
BNT162b2 (30 μg) Psychiatric disorders Insomnia 01JAN2018 Y 
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2019 Y 
  Social circumstances Premenarche 01NOV2020 Y
C4591001 1044 
10441292/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2012 Y 
C4591001 1044 
10441293/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2015 Y 
C4591001 1044 
10441294/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2015 Y 
C4591001 1044 
10441295/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2009 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499908
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  01JAN2015 Y
C4591001 1044 
10441296/ 
BNT162b2 (30 μg) Injury, poisoning and procedural 
complications Radius fracture 01SEP2020 18SEP2020 N 
C4591001 1044 
10441297/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2012 Y 
C4591001 1044 
10441298/ 
Placebo Immune system disorders Seasonal allergy 01JAN2018 Y 
  Social circumstances Premenarche 01NOV2020 Y
C4591001 1044 
10441299/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2006 Y 
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2010 Y 
C4591001 1044 
10441300/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2005 Y 
  01JAN2010 Y
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2007 Y 
C4591001 1044 
10441302/ 
Placebo Skin and subcutaneous tissue disorders Acne 01JAN2019 Y 
C4591001 1044 
10441303/ 
Placebo Skin and subcutaneous tissue disorders Acne 01JAN2019 Y 
C4591001 1044 
10441304/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01AUG2018 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 105
FDA-CBER-2022-5812-0499909
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1044 
10441306/ 
BNT162b2 (30 μg) Respiratory, thoraci c and mediastinal 
disorders Rhinitis allergic 01JAN2017 Y 
C4591001 1044 
10441308/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2016 Y 
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2014 Y 
C4591001 1044 
10441309/ 
BNT162b2 (30 μg) Respiratory, thoraci c and mediastinal 
disorders Rhinitis allergic 01JAN2015 Y 
C4591001 1044 
10441310/ 
BNT162b2 (30 μg) Respiratory, thoraci c and mediastinal 
disorders Rhinitis allergic 01JUL2020 Y 
C4591001 1044 
10441311/ 
BNT162b2 (30 μg) Reproductive system and breast 
disorders Dysmenorrhoea 01JAN2020 Y 
C4591001 1044 
10441312/ 
Placebo Respiratory, thoraci c and mediastinal 
disorders Asthma 01JAN2008 Y 
C4591001 1044 
10441313/ 
Placebo Skin and subcutaneous tissue disorders Acne 01JAN2009 Y 
C4591001 1044 
10441316/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2007 Y 
C4591001 1044 
10441317/ 
Placebo Immune system disorders Seasonal allergy 01JAN2018 Y 
C4591001 1044 
10441319/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2009 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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FDA-CBER-2022-5812-0499910
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1044 
10441321/ 
BNT162b2 (30 μg) Congenital, familial and genetic 
disorders Atrial septal defect 01JAN2007 30SEP2007 N 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2015 Y
  Surgical and medical procedures Atrial septal defect repai r 01JAN2007 30SEP2007 N
C4591001 1044 
10441322/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2017 Y 
  Skin and subcutaneous tissue disorders Acne 01SEP2020 Y
C4591001 1044 
10441324/ 
Placebo Respiratory, thoraci c and mediastinal 
disorders Asthma 01JAN2007 Y 
C4591001 1044 
10441326/ 
Placebo Social circumstances Premenarche 2007 Y 
C4591001 1044 
10441327/ 
Placebo Reproductive system and breast 
disorders Menstruation irregular 01JAN2019 Y 
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2019 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2019 Y
C4591001 1044 
10441330/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01NOV2020 Y 
C4591001 1044 
10441331/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2016 Y 
C4591001 1044 
10441332/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2014 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499911
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1044 
10441333/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2010 Y 
C4591001 1044 
10441334/ 
BNT162b2 (30 μg) Social circumstances Premenarche 2008 Y 
C4591001 1044 
10441335/ 
Placebo Musculoskeletal and connective tissue 
disorders Osteochondrosis 01OCT2019 Y 
  Psychiatric disorders Anxiet y 01JAN2017 Y
  Depression 01JAN2017 Y
  Skin and subcutaneous tissue disorders Acne 01JAN2019 Y
  Dry skin 01JAN2020 Y
C4591001 1044 
10441338/ 
Placebo Respiratory, thoraci c and mediastinal 
disorders Rhinitis allergic 01JAN2018 Y 
C4591001 1044 
10441341/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01OCT2018 Y 
C4591001 1044 
10441343/ 
BNT162b2 (30 μg) Eye disorders Punctate keratitis 15AUG2013 Y 
C4591001 1044 
10441345/ 
Placebo Immune system disorders Food allergy 01JAN2017 Y 
  Seasonal aller gy 01JAN2016 Y
  Social circumstances Premenarche 2008 Y
C4591001 1044 
10441347/ 
Placebo Psychiatric disorders Depression 01JUN2020 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2019 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499912
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1044 
10441348/ 
Placebo Respiratory, thoraci c and mediastinal 
disorders Rhinitis allergic 01JAN2012 Y 
C4591001 1044 
10441349/ 
BNT162b2 (30 μg) Respiratory, thoraci c and mediastinal 
disorders Rhinitis allergic 01JAN2009 Y 
C4591001 1044 
10441350/ 
BNT162b2 (30 μg) Congenital, familial and genetic 
disorders Von Willebrand's disease 01FEB2019 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2005 Y
  Skin and subcutaneous tissue disorders Acne 01JAN2008 Y
C4591001 1044 
10441352/ 
BNT162b2 (30 μg) Reproductive system and breast 
disorders Dysmenorrhoea 01APR2017 Y 
C4591001 1044 
10441353/ 
BNT162b2 (30 μg) Respiratory, thoraci c and mediastinal 
disorders Rhinitis allergic 01JAN2014 Y 
C4591001 1044 
10441354/ 
Placebo Immune system disorders Seasonal allergy 01JAN2011 Y 
  Nervous s ystem disorders Migraine 01JAN2019 Y
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JUL2020 Y
  Insomnia 01JAN2019 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2009 Y 
  Social circumstances Premenarche 2007 Y
C4591001 1044 
10441355/ 
BNT162b2 (30 μg) Psychiatric disorders Insomnia 01JAN2019 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2012 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 109
(b) (6)
FDA-CBER-2022-5812-0499913
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Rhinitis aller gic 01JAN2012 Y
C4591001 1044 
10441356/ 
Placebo Respiratory, thoraci c and mediastinal 
disorders Asthma 01JAN2010 Y 
  Skin and subcutaneous tissue disorders Rash 01DEC2020 Y
C4591001 1044 
10441357/ 
Placebo Musculoskeletal and connective tissue 
disorders Osteochondrosis 01JAN2020 Y 
  Psychiatric disorders Depression 01MAR2019 Y
  Obsessive-compulsive disorde r 01MAR2019 Y
  Skin and subcutaneous tissue disorders Eczema 01JAN2008 Y
C4591001 1044 
10441358/ 
BNT162b2 (30 μg) Respiratory, thoraci c and mediastinal 
disorders Rhinitis allergic 01JAN2020 Y 
C4591001 1044 
10441361/ 
BNT162b2 (30 μg) Respiratory, thoraci c and mediastinal 
disorders Asthma 01JAN2014 Y 
  Rhinitis aller gic 01JAN2008 Y
  Skin and subcutaneous tissue disorders Dermatitis contact 01JAN2007 Y
C4591001 1044 
10441362/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2012 Y 
  Musculoskeletal and connective tissue 
disordersJuvenile idiopathic arthritis 01JAN2012 Y 
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2017 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2018 Y
C4591001 1044 
10441366/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2015 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 110
FDA-CBER-2022-5812-0499914
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Injury, poisoning and procedural 
complicationsStress fracture 21DEC2020 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2019 Y
C4591001 1044 
10441367/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2008 Y 
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2014 Y 
C4591001 1044 
10441368/ 
Placebo Nervous system disorders Ophthalmic migraine 01JAN2014 Y 
C4591001 1044 
10441371/ 
Placebo Reproductive system and breast 
disorders Menstruation irregular 17NOV2019 Y 
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2012 Y 
C4591001 1044 
10441372/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01OCT2013 Y 
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2012 Y 
C4591001 1044 
10441373/ 
Placebo Gastrointestinal disorders Gastrooesophageal reflux disease 2006 Y 
  Psychiatric disorders Anxiet y 01JAN2018 Y
  Obsessive-compulsive disorde r 01JAN2020 Y
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2011 Y 
C4591001 1044 
10441375/ 
BNT162b2 (30 μg) Respiratory, thoraci c and mediastinal 
disorders Rhinitis allergic 01JAN2011 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499915
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1044 
10441376/ 
BNT162b2 (30 μg) Immune system disorders Food allergy 01JAN2009 Y 
  Hypersensitivit y 01JAN2009 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2007 Y 
C4591001 1044 
10441377/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2012 Y 
  Injury, poisoning and procedural 
complicationsFoot fracture 08JAN2021 Y 
  Nervous s ystem disorders Dizziness 01JAN2019 Y
  Respiratory, thoraci c and mediastinal 
disordersOropharyngeal pain 12JAN2021 22JAN2021 N 
  Vasomotor rhinitis 01JAN2015 Y
  Social circumstances Premenarche 2008 Y
C4591001 1044 
10441378/ 
BNT162b2 (30 μg) Psychiatric disorders Anxiety 01MAR2019 Y 
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2014 Y 
C4591001 1044 
10441379/ 
BNT162b2 (30 μg) Respiratory, thoraci c and mediastinal 
disorders Rhinitis allergic 01JAN2009 Y 
C4591001 1044 
10441380/ 
Placebo Immune system disorders Seasonal allergy 01JAN2011 Y 
C4591001 1044 
10441381/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2015 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2017 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499916
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1044 
10441382/ 
Placebo Respiratory, thoraci c and mediastinal 
disorders Rhinitis allergic 01JAN2011 Y 
C4591001 1044 
10441383/ 
BNT162b2 (30 μg) Injury, poisoning and procedural 
complications Limb fracture 30SEP2020 Y 
C4591001 1044 
10441384/ 
Placebo Endocrine disorders Autoimmune thyroiditis 01JUN2018 Y 
  Immune s ystem disorders Drug hypersensitivit y 01JAN2007 Y
  Milk aller gy 01JAN2009 Y
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2014 Y 
C4591001 1057 
10571377/ 
Placebo Immune system disorders Hypersensitivity 01JAN2008 Y 
  Infections and infestations Adenoiditis 01JAN2010 31DEC2010 N
  Surgical and medical procedures Adenoidectom y 01JAN2010 31DEC2010 N
C4591001 1057 
10571378/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2009 Y 
  Infections and infestations Adenoiditis 01JAN2009 31DEC2009 N
  Tonsillitis 01JAN2011 31DEC2011 N
  Metabolism and nutrition disorders Obesit y 01JAN2019 Y
  Psychiatric disorders Generalised anxiet y disorde r 01JAN2016 Y
  Social circumstances Premenarche 2008 Y
  Surgical and medical procedures Adenoidectom y 01JAN2009 31DEC2009 N
  Tonsillectom y 01JAN2011 31DEC2011 N
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499917
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1057 
10571379/ 
Placebo Skin and subcutaneous tissue disorders Hyperhidrosis 01JAN2014 Y 
C4591001 1057 
10571380/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2015 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01DEC2013 Y
C4591001 1057 
10571382/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2013 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2009 31DEC2012 N 
  Skin and subcutaneous tissue disorders Dermatitis atopic 01JAN2007 Y
C4591001 1057 
10571383/ 
Placebo Immune system disorders Seasonal allergy 01JAN2013 Y 
  Psychiatric disorders Generalised anxiet y disorde r 01JAN2018 Y
  Insomnia 01JAN2018 Y
C4591001 1057 
10571385/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2015 Y 
  Major depression 01JAN2016 31DEC2017 N
C4591001 1057 
10571386/ 
Placebo Metabolism and nutrition disorders Obesity 01JAN2015 Y 
C4591001 1057 
10571388/ 
BNT162b2 (30 μg) Immune system disorders Allergy to animal 01JAN2016 Y 
C4591001 1057 
10571389/ 
Placebo Immune system disorders Allergy to animal 01JAN2016 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 114
FDA-CBER-2022-5812-0499918
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1057 
10571390/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2007 Y 
  Psychiatric disorders Major depression 01JAN2016 Y
  Skin and subcutaneous tissue disorders Acne 01JAN2017 Y
C4591001 1057 
10571391/ 
Placebo Immune system disorders Seasonal allergy 01JAN2007 Y 
C4591001 1057 
10571393/ 
Placebo Psychiatric disorders Major depression 01JUN2018 Y 
C4591001 1057 
10571394/ 
Placebo Infections and infestations Adenoiditis 01JAN2011 31MAR2011 N 
  Musculoskeletal and connective tissue 
disordersHypermobility syndrome 01JUN2020 Y 
  Surgical and medical procedures Adenoidectom y 01MAR2011 31MAR2011 N
C4591001 1057 
10571395/ 
BNT162b2 (30 μg) Immune system disorders Food allergy 01JAN2009 Y 
  Seasonal aller gy 01JAN2009 Y
  01JAN2013 Y
C4591001 1057 
10571396/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2010 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma exercise induced 01JAN2015 Y 
C4591001 1057 
10571397/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2009 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
Page 115
FDA-CBER-2022-5812-0499919
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1057 
10571398/ 
Placebo Gastrointestinal disorders Constipation 01JAN2007 Y 
C4591001 1057 
10571399/ 
BNT162b2 (30 μg) Infections and infestations Adenoiditis 01JAN2013 31DEC2013 N 
  Psychiatric disorders Bipolar disorde r 01JUN2019 Y
  Obsessive-compulsive disorde r 01JUN2019 Y
  Surgical and medical procedures Adenoidectom y 01JAN2013 31DEC2013 N
C4591001 1057 
10571400/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2015 Y 
C4591001 1057 
10571401/ 
BNT162b2 (30 μg) Musculoskeletal and connective tissue 
disorders Knee deformity 01JAN2016 31DEC2018 N 
  Surgical and medical procedures Knee operation 01DEC2018 31DEC2018 N
C4591001 1057 
10571402/ 
Placebo Metabolism and nutrition disorders Obesity 01JAN2013 Y 
C4591001 1057 
10571404/ 
Placebo Immune system disorders Seasonal allergy 01JAN2010 Y 
  Psychiatric disorders Generalised anxiet y disorde r 01JAN2019 Y
  Major depression 01JAN2019 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2010 Y 
  Skin and subcutaneous tissue disorders Dermatitis atopic 01JAN2008 Y
C4591001 1057 
10571405/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01AUG2013 Y 
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16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1057 
10571406/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2012 Y 
C4591001 1057 
10571408/ 
Placebo Immune system disorders Mycotic allergy 01JAN2010 Y 
  Seasonal aller gy 01JAN2010 Y
  Infections and infestations Adenoiditis 01JAN2012 31DEC2012 N
  Surgical and medical procedures Adenoidectom y 01JAN2012 31DEC2012 N
C4591001 1057 
10571411/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2017 Y 
C4591001 1057 
10571413/ 
BNT162b2 (30 μg) Infections and infestations Tonsillitis 01JAN2014 31DEC2014 N 
  Surgical and medical procedures Tonsillectom y 01JAN2014 31DEC2014 N
C4591001 1057 
10571414/ 
Placebo Immune system disorders Rubber sensitivity 01JAN2018 Y 
C4591001 1057 
10571415/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2009 Y 
C4591001 1057 
10571417/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2014 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2019 Y
C4591001 1057 
10571418/ 
BNT162b2 (30 μg) Metabolism and nutrition disorders Obesity 01APR2015 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 27MAR2018 Y
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FDA-CBER-2022-5812-0499921
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Reproductive system and breast 
disordersHeavy menstrual bleeding 01DEC2019 Y 
C4591001 1057 
10571419/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01APR2011 Y 
  Infections and infestations Adenoiditis 01JAN2010 31JAN2010 N
  Psychiatric disorders Autism spectrum disorde r 01MAR2010 Y
  Surgical and medical procedures Adenoidectom y 01JAN2010 31JAN2010 N
C4591001 1057 
10571420/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2013 31DEC2014 N 
C4591001 1057 
10571421/ 
Placebo Immune system disorders Seasonal allergy 01JAN2007 Y 
  Metabolism and nutrition disorders Obesit y 01JAN2014 Y
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01APR2017 31MAR2019 N
  Skin and subcutaneous tissue disorders Eczema 01JAN2010 Y
C4591001 1057 
10571422/ 
BNT162b2 (30 μg) Metabolism and nutrition disorders Obesity 01JAN2010 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2010 Y 
C4591001 1057 
10571423/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 2005 Y 
  Infections and infestations Adenoiditis 01JAN2011 31DEC2011 N
  Tonsillitis 01JAN2011 31DEC2011 N
  Respiratory, thoraci c and mediastinal 
disordersAsthma 2005 Y 
  Surgical and medical procedures Adenoidectom y 01JAN2011 31DEC2011 N
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FDA-CBER-2022-5812-0499922
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Tonsillectom y 01JAN2011 31DEC2011 N
C4591001 1057 
10571424/ 
Placebo Immune system disorders Seasonal allergy 2008 Y 
  Metabolism and nutrition disorders Obesit y 01JAN2015 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 2008 Y 
C4591001 1057 
10571425/ 
Placebo Social circumstances Premenarche 2007 Y 
C4591001 1057 
10571426/ 
BNT162b2 (30 μg) Social circumstances Premenarche 07NOV2008 Y 
C4591001 1057 
10571427/ 
BNT162b2 (30 μg) Social circumstances Premenarche 2008 Y 
C4591001 1057 
10571428/ 
Placebo Congenital, familial and genetic 
disorders Hereditary spherocytosis 01JAN2010 Y 
C4591001 1057 
10571431/ 
Placebo Infections and infestations Tonsillitis 01JAN2014 31DEC2014 N 
  Surgical and medical procedures Tonsillectom y 01JAN2014 31DEC2014 N
C4591001 1057 
10571432/ 
Placebo Eye disorders Optic atrophy 01NOV2019 Y 
  Social circumstances Premenarche 2008 Y
C4591001 1057 
10571433/ 
BNT162b2 (30 μg) Musculoskeletal and connective tissue 
disorders Scoliosis 15OCT2015 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01OCT2014 Y
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(b) (6)
FDA-CBER-2022-5812-0499923
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Surgical and medical procedures Scoliosis sur gery 15OCT2020 15OCT2020 N
C4591001 1057 
10571434/ 
Placebo Metabolism and nutrition disorders Obesity 01JAN2010 Y 
C4591001 1057 
10571435/ 
BNT162b2 (30 μg) Metabolism and nutrition disorders Obesity 01JAN2010 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JA N2015 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2015 Y 
C4591001 1057 
10571436/ 
Placebo Respiratory, thoraci c and mediastinal 
disorders Asthma 01JAN2007 Y 
C4591001 1057 
10571437/ 
Placebo Infections and infestations Adenoiditis 01JAN2008 31DEC2008 N 
  Tonsillitis 01JAN2008 31DEC2008 N
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2014 Y
  Autism spectrum disorde r 01JAN2011 Y
  Generalised anxiet y disorde r 01JAN2018 Y
  Surgical and medical procedures Adenoidectom y 01JAN2008 31DEC2008 N
  Tonsillectom y 01JAN2008 31DEC2008 N
C4591001 1057 
10571438/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2018 Y 
C4591001 1057 
10571439/ 
Placebo Reproductive system and breast 
disorders Intermenstrual bleeding 01JAN2020 Y 
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16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1057 
10571440/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 2008 Y 
C4591001 1057 
10571441/ 
Placebo Psychiatric disorders Generalised anxiety disorder 01MAR2020 Y 
C4591001 1057 
10571442/ 
Placebo Gastrointestinal disorders Umbilical hernia 01JAN2014 31DEC2014 N 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2013 Y
  Surgical and medical procedures Umbilical hernia repai r 01JAN2014 31DEC2014 N
C4591001 1057 
10571443/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2018 Y 
C4591001 1057 
10571446/ 
Placebo Immune system disorders Seasonal allergy 01JAN2015 Y 
  Metabolism and nutrition disorders Type 1 diabetes mellitus 01JAN2015 Y
C4591001 1057 
10571447/ 
Placebo Immune system disorders Seasonal allergy 01JAN2015 Y 
C4591001 1057 
10571448/ 
BNT162b2 (30 μg) Eye disorders Strabismus 01JAN2008 31DEC2018 N 
  Infections and infestations Adenoiditis 01JAN2016 31DEC2016 N
  Tonsillitis 01JAN2016 31DEC2016 N
  Psychiatric disorders Generalised anxiet y disorde r 01JAN2015 Y
  Surgical and medical procedures Adenoidectom y 01JAN2016 31DEC2016 N
  Eye operation 01JAN2008 31DEC2008 N
  01JAN2010 31DEC2010 N
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FDA-CBER-2022-5812-0499925
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  01JAN2015 31DEC2015 N
  01JAN2018 31DEC2018 N
  Tonsillectom y 01JAN2016 31DEC2016 N
C4591001 1057 
10571449/ 
Placebo Psychiatric disorders Attention deficit hyperactivity disorder 01OCT2019 Y 
C4591001 1057 
10571450/ 
Placebo Injury, poisoning and procedural 
complications Foot fracture 01JAN2007 31DEC2007 N 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2018 Y 
C4591001 1057 
10571451/ 
BNT162b2 (30 μg) Infections and infestations Vulvovaginal mycotic infection 01JAN2012 Y 
C4591001 1066 
10661394/ 
Placebo Immune system disorders Seasonal allergy 01JAN2010 Y 
  Infections and infestations Pharyngeal abscess 01JAN2008 31DEC2008 N
  Surgical and medical procedures Abscess draina ge 01JAN2008 31DEC2008 N
C4591001 1066 
10661395/ 
BNT162b2 (30 μg) Nervous system disorders Mental impairment 01JAN2019 Y 
  Psychiatric disorders Anxiet y 01JAN2019 Y
  Autism spectrum disorde r 01JAN2019 Y
C4591001 1066 
10661397/ 
Placebo Nervous system disorders Headache 01NOV2018 Y 
  Psychiatric disorders Anxiet y 01DEC2018 Y
  Insomnia 01DEC2018 Y
  Skin and subcutaneous tissue disorders Acne 01DEC2019 Y
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FDA-CBER-2022-5812-0499926
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1066 
10661401/ 
Placebo Immune system disorders Hypersensitivity 01JAN2017 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2017 Y
C4591001 1066 
10661402/ 
BNT162b2 (30 μg) Psychiatric disorders Anxiety 01JAN2018 Y 
  Eatin g disorde r 01FEB2019 Y
C4591001 1066 
10661404/ 
BNT162b2 (30 μg) Infections and infestations Tonsillitis 01JAN2010 31DEC2010 N 
  Respiratory, thoraci c and mediastinal 
disordersNasal turbinate hypertrophy 01JAN2012 31DEC2012 N 
  Skin and subcutaneous tissue disorders Eczema 01JAN2010 Y
  Social circumstances Premenarche 2008 Y
  Surgical and medical procedures Adenoidectom y 01JAN2010 31DEC2010 N
  Tonsillectom y 01JAN2010 31DEC2010 N
  Turbinoplast y 01JAN2012 31DEC2012 N
C4591001 1066 
10661405/ 
Placebo Psychiatric disorders Anxiety 01JAN2013 Y 
  Depression 01JAN2018 Y
  Sleep disorde r 01JAN2013 Y
C4591001 1066 
10661407/ 
BNT162b2 (30 μg) Infections and infestations Oral herpes 01JAN2017 Y 
C4591001 1066 
10661408/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2005 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2016 Y
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16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Skin and subcutaneous tissue disorders Ingrowin g nail 01JAN2019 31DEC2019 N
  Surgical and medical procedures Nail operation 01JAN2019 31DEC2019 N
C4591001 1066 
10661409/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2013 Y 
C4591001 1066 
10661410/ 
Placebo Infections and infestations Pharyngitis streptococcal 01JAN2014 31DEC2014 N 
  Surgical and medical procedures Tonsillectom y 01JAN2014 31DEC2014 N
C4591001 1066 
10661411/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2017 Y 
C4591001 1066 
10661412/ 
Placebo Infections and infestations Pharyngitis streptococcal 01JAN2014 31DEC2014 N 
  Nervous s ystem disorders Headache 01JAN2014 Y
  Migraine 01JAN2014 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma exercise induced 01JAN2014 Y 
  Surgical and medical procedures Tonsillectom y 01JAN2014 31DEC2014 N
C4591001 1066 
10661414/ 
BNT162b2 (30 μg) Psychiatric disorders Autism spectrum disorder 01JAN2007 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2019 Y
C4591001 1066 
10661415/ 
Placebo Metabolism and nutrition disorders Obesity 01JAN2017 Y 
  Nervous s ystem disorders Headache 01JAN2017 Y
  Pregnancy, puerperium and perinatal 
conditionsPremature baby 2006 2006 N 
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FDA-CBER-2022-5812-0499928
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Psychiatric disorders Depression 01OCT2017 Y
  Reproductive system and breast 
disordersPolycystic ovaries 01JAN2019 Y 
C4591001 1066 
10661416/ 
Placebo Injury, poisoning and procedural 
complications Tibia fracture 01JAN2010 31DEC2010 N 
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2017 31DEC2019 N 
C4591001 1066 
10661417/ 
BNT162b2 (30 μg) Immune system disorders Hypersensitivity 01JAN2010 Y 
C4591001 1066 
10661418/ 
Placebo Skin and subcutaneous tissue disorders Acne 01JAN2018 Y 
C4591001 1066 
10661419/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2018 Y 
  Injury, poisoning and procedural 
complicationsConcussion 01AUG2019 30SEP2019 N 
  Respiratory, thoraci c and mediastinal 
disordersVocal cord disorder 01JAN2018 Y 
C4591001 1066 
10661420/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2006 Y 
  Infections and infestations Appendicitis 01MAR2020 31MAR2020 N
  Surgical and medical procedures Appendicectom y 01MAR2020 31MAR2020 N
C4591001 1066 
10661421/ 
Placebo Psychiatric disorders Anxiety 01JAN2013 Y 
  Attention deficit h yperactivit y disorde r 01JAN2013 Y
  Enuresis 01JAN2010 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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FDA-CBER-2022-5812-0499929
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Reactive attachment disorder of infancy or early 
childhoo d 01JAN2008 Y 
C4591001 1066 
10661422/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2014 Y 
  Autism spectrum disorde r 01JAN2011 Y
C4591001 1066 
10661423/ 
Placebo Immune system disorders Seasonal allergy 01JAN2016 Y 
C4591001 1066 
10661424/ 
BNT162b2 (30 μg) Gastrointestinal disorders Cyclic vomiting syndrome 01JAN2010 31DEC2018 N 
  Eosinophilic oesopha gitis 01JAN2008 31DEC2018 N
  Immune s ystem disorders Drug hypersensitivit y 01JAN2008 Y
  Hypersensitivit y 01JAN2008 31DEC2018 N
  Infections and infestations Chronic tonsillitis 2006 31JUL2006 N
  Investi gations Endoscop y 01JAN2008 31DEC2008 N
  Surgical and medical procedures Tonsillectom y 01JUL2006 31DEC2006 N
C4591001 1066 
10661425/ 
Placebo Skin and subcutaneous tissue disorders Acne 01JAN2018 Y 
  Rosacea 01JAN2018 Y
C4591001 1066 
10661426/ 
Placebo Congenital, familial and genetic 
disorders Hypospadias 2005 30APR2006 N 
  Immune s ystem disorders Hypersensitivit y 01JAN2017 Y
  Surgical and medical procedures Urethral repai r 01APR2006 30APR2006 N
C4591001 1066 
10661428/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2013 Y 
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16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JUN2020 Y 
C4591001 1066 
10661430/ 
BNT162b2 (30 μg) Skin and subcutaneous tissue disorders Acne 01JAN2018 Y 
C4591001 1066 
10661431/ 
BNT162b2 (30 μg) Nervous system disorders Headache 2005 Y 
  Psychiatric disorders Anxiet y 01JAN2019 Y
  Skin and subcutaneous tissue disorders Acne 01JAN2017 Y
C4591001 1066 
10661432/ 
Placebo Infections and infestations Appendicitis 01MAY2018 31MAY2018 N 
  Tonsillitis 01JAN2009 31DEC2011 N
  Social circumstances Premenarche 2006 Y
  Surgical and medical procedures Appendicectom y 01MAY2018 31MAY2018 N
  Tonsillectom y 01JAN2011 31DEC2011 N
C4591001 1066 
10661433/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2010 Y 
C4591001 1066 
10661434/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 12JAN2015 Y 
  Insomnia 12JAN2019 Y
C4591001 1066 
10661435/ 
BNT162b2 (30 μg) Congenital, familial and genetic 
disorders Talipes 2007 31AUG2007 N 
  Nervous s ystem disorders Mental impairmen t 01JAN2017 Y
  Psychiatric disorders Anxiet y 01JAN2017 Y
  Attention deficit h yperactivit y disorde r 01JAN2017 Y
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(b) (6)
FDA-CBER-2022-5812-0499931
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Hallucination, auditor y 01JAN2017 Y
  Neurodevelopmental disorde r 2007 Y
C4591001 1077 
10771274/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2015 Y 
  Injury, poisoning and procedural 
complicationsRadius fracture 01JAN2011 31DEC2011 N 
C4591001 1077 
10771277/ 
Placebo Congenital, familial and genetic 
disorders Hemivertebra 2007 Y 
  Oculoauriculovertebral d ysplasia 2007 Y
  Ear and lab yrinth disorders Deafness unilateral 2007 Y
  Neoplasms benign, malignant and 
unspecified (incl c ysts and pol yps)Lipoma 01JAN2013 Y 
  Surgical and medical procedures Temporomandibular joint sur gery 01JAN2014 31DEC2014 N
C4591001 1077 
10771279/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2017 Y 
C4591001 1077 
10771280/ 
Placebo Immune system disorders Rubber sensitivity 01JAN2018 Y 
  Nervous s ystem disorders Headache 01JAN2018 Y
  Psychiatric disorders Depression 01JAN2019 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2018 Y 
C4591001 1077 
10771281/ 
BNT162b2 (30 μg) Psychiatric disorders Anxiety 01JAN2019 Y 
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(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499932
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1077 
10771282/ 
Placebo Immune system disorders Seasonal allergy 01JAN2017 Y 
C4591001 1077 
10771283/ 
Placebo Infections and infestations Sinusitis 01JAN2009 31DEC2009 N 
  Surgical and medical procedures Adenoidectom y 01JAN2009 31DEC2009 N
C4591001 1077 
10771286/ 
BNT162b2 (30 μg) Immune system disorders Reaction to colouring 01JAN2014 Y 
  Seasonal aller gy 01JAN2011 Y
  Infections and infestations Tonsillitis 01JAN2017 31DEC2017 N
  Nervous s ystem disorders Epileps y 01JAN2019 Y
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2017 Y
  Surgical and medical procedures Adenoidectom y 01JAN2018 31JAN2018 N
  Strabismus correction 01JAN2009 31DEC2009 N
  01JAN2013 31DEC2013 N
  Tonsillectom y 01JAN2018 31JAN2018 N
C4591001 1077 
10771287/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2010 Y 
  Infections and infestations Appendicitis 01JAN2012 31DEC2012 N
  Surgical and medical procedures Appendicectom y 01JAN2012 31DEC2012 N
C4591001 1077 
10771288/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 30OCT2020 Y 
C4591001 1077 
10771290/ 
Placebo Psychiatric disorders Depression 01JAN2018 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2019 Y
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FDA-CBER-2022-5812-0499933
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1077 
10771293/ 
Placebo Psychiatric disorders Anxiety 01JAN2018 Y 
  Attention deficit h yperactivit y disorde r 01JAN2014 Y
C4591001 1077 
10771294/ 
Placebo Psychiatric disorders Anxiety 01JAN2014 Y 
C4591001 1077 
10771295/ 
Placebo Immune system disorders Hypersensitivity 01JAN2012 Y 
C4591001 1077 
10771296/ 
BNT162b2 (30 μg) Respiratory, thoraci c and mediastinal 
disorders Asthma 01JUL2007 Y 
C4591001 1077 
10771300/ 
BNT162b2 (30 μg) Psychiatric disorders Anxiety 01MAY2020 Y 
C4591001 1084 
10841541/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2018 Y 
  Infections and infestations Ear infection 01JAN2009 31DEC2010 N
  Pharyngitis 01JAN2009 31DEC2010 N
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2011 31DEC2019 N
C4591001 1084 
10841542/ 
Placebo Immune system disorders Seasonal allergy 01JAN2006 Y 
  Reproductive system and breast 
disordersMenstruation irregular 01SEP2019 Y 
C4591001 1084 
10841543/ 
Placebo Eye disorders Visual acuity reduced 01JAN2018 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2013 Y
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FDA-CBER-2022-5812-0499934
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Injury, poisoning and procedural 
complicationsFoot fracture 01JAN2017 31DEC2017 N 
  Tibia fracture 01JAN2009 31DEC2009 N
C4591001 1084 
10841544/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2017 Y 
  Respiratory, thoraci c and mediastinal 
disordersRhinitis allergic 01JAN2010 Y 
C4591001 1084 
10841545/ 
Placebo Immune system disorders Seasonal allergy 01JAN2018 Y 
  Infections and infestations Ear infection 01JAN2016 31JAN2019 N
  Surgical and medical procedures Myringotom y 01JAN2019 31JAN2019 N
C4591001 1084 
10841546/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2018 Y 
C4591001 1084 
10841547/ 
Placebo Immune system disorders Seasonal allergy 01JAN2016 Y 
  Psychiatric disorders Anxiet y 01SEP2020 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2010 Y 
  Surgical and medical procedures Myringotom y 01JAN2006 31DEC2006 N
C4591001 1084 
10841548/ 
BNT162b2 (30 μg) Eye disorders Visual acuity reduced 01JAN2014 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2010 Y
C4591001 1084 
10841549/ 
BNT162b2 (30 μg) Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2017 Y 
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FDA-CBER-2022-5812-0499935
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Immune s ystem disorders Seasonal aller gy 01JAN2007 Y
  Injury, poisoning and procedural 
complicationsHand fracture 01JAN2018 31DEC2018 N 
  Wrist fracture 01JAN2012 31DEC2012 N
  01JUL2019 31DEC2020 N
  Respiratory, thoraci c and mediastinal 
disordersSleep apnoea syndrome 01JAN2009 31DEC2010 N 
  Surgical and medical procedures Adenoidectom y 01JAN2010 31DEC2010 N
  Myringotom y 01JAN2008 31DEC2008 N
  01JAN2010 31DEC2010 N
  Tonsillectom y 01JAN2010 31DEC2010 N
C4591001 1084 
10841550/ 
Placebo Congenital, familial and genetic 
disorders Renal dysplasia 01JAN2013 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2015 Y
  Musculoskeletal and connective tissue 
disordersScoliosis 01JAN2009 Y 
  Neoplasms benign, malignant and 
unspecified (incl c ysts and pol yps)Fibroma 01JAN2013 Y 
C4591001 1084 
10841551/ 
BNT162b2 (30 μg) Gastrointestinal disorders Inguinal hernia 01JAN2009 31DEC2009 N 
  Umbilical hernia 01JAN2009 31DEC2009 N
  Infections and infestations Ear infection 01JAN2010 31DEC2010 N
  Surgical and medical procedures Adenoidectom y 01JAN2010 31DEC2010 N
  Inguinal hernia repai r 01JAN2009 31DEC2009 N
  Myringotom y 01JAN2010 31DEC2010 N
  Umbilical hernia repai r 01JAN2009 31DEC2009 N
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16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1084 
10841552/ 
Placebo Ear and labyrinth disorders Tinnitus 01JAN2019 Y 
  Injury, poisoning and procedural 
complicationsTorus fracture 01JAN2015 Y 
C4591001 1084 
10841553/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2019 Y 
  Nervous s ystem disorders Headache 01JAN2009 Y
C4591001 1084 
10841555/ 
Placebo Immune system disorders Drug hypersensitivity 01JAN2010 Y 
  Skin and subcutaneous tissue disorders Acne 01JUL2020 Y
C4591001 1084 
10841556/ 
BNT162b2 (30 μg) Eye disorders Visual acuity reduced 01JAN2018 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2019 Y
  Infections and infestations Kidne y infection 01JAN2010 31DEC2010 N
  Skin and subcutaneous tissue disorders Acne 01JAN2019 Y
C4591001 1084 
10841557/ 
Placebo Immune system disorders Allergy to animal 01JAN2014 Y 
C4591001 1084 
10841558/ 
BNT162b2 (30 μg) Eye disorders Visual acuity reduced 01JAN2016 Y 
  Gastrointestinal disorders Diarrhoea 2005 Y
  Immune s ystem disorders Seasonal aller gy 01JAN2007 Y
  Musculoskeletal and connective tissue 
disordersArthralgia 01JAN2009 Y 
  Psychiatric disorders Depression 01JAN2020 Y
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(b) (6)
FDA-CBER-2022-5812-0499937
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2017 Y 
C4591001 1084 
10841559/ 
BNT162b2 (30 μg) Eye disorders Visual acuity reduced 01JAN2016 Y 
  Immune s ystem disorders Aller gy to arthropod bite 01JAN2007 Y
  Seasonal aller gy 01JAN2007 Y
  Infections and infestations Respirator y syncytial virus infection 01JAN2007 31DEC2007 N
  Musculoskeletal and connective tissue 
disordersGrowing pains 01JAN2017 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2008 Y 
C4591001 1084 
10841560/ 
Placebo Eye disorders Visual acuity reduced 01JAN2013 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2006 Y
  Infections and infestations Ear infection 01JAN2005 31DEC2008 N
  Molluscum conta giosum 01JAN2008 31DEC2009 N
  Tonsillitis 01JAN2010 31DEC2010 N
  Injury, poisoning and procedural 
complicationsTorus fracture 01JAN2016 31DEC2016 N 
  Neoplasms benign, malignant and 
unspecified (incl c ysts and pol yps)Skin papilloma 01JAN2014 31DEC2014 N 
  Psychiatric disorders Anxiet y 01AUG2020 Y
  Attention deficit h yperactivit y disorde r 01JAN2015 Y
  Surgical and medical procedures Myringotom y 01JAN2008 31DEC2008 N
  Tonsillectom y 01JAN2010 31DEC2010 N
C4591001 1084 
10841561/ 
Placebo Eye disorders Visual acuity reduced 01JAN2013 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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FDA-CBER-2022-5812-0499938
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  General disorders and administration 
site conditionsPain 01JAN2015 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2009 Y
C4591001 1084 
10841562/ 
BNT162b2 (30 μg) General disorders and administration 
site conditions Pain 01JAN2008 Y 
C4591001 1084 
10841563/ 
BNT162b2 (30 μg) Ear and labyrinth disorders Hypoacusis 01JAN2019 Y 
  General disorders and administration 
site conditionsPain 01JAN2018 Y 
  Immune s ystem disorders Drug hypersensitivit y 01JAN2009 Y
  Seasonal aller gy 01JAN2018 Y
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2019 Y
C4591001 1084 
10841564/ 
Placebo Congenital, familial and genetic 
disorders Sickle cell trait 01JAN2008 Y 
  General disorders and administration 
site conditionsPain 01JAN2018 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2018 Y
  Investi gations Cardiac murmu r 01JAN2008 Y
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2018 Y
C4591001 1084 
10841565/ 
Placebo Immune system disorders Seasonal allergy 01JAN2017 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 10SEP2020 Y
C4591001 1084 
10841566/ 
BNT162b2 (30 μg) Eye disorders Visual acuity reduced 01JAN2015 Y 
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FDA-CBER-2022-5812-0499939
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  General disorders and administration 
site conditionsPain 01JAN2010 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2016 Y
  Injury, poisoning and procedural 
complicationsHand fracture 01JAN2012 31DEC2012 N 
  Upper limb fracture 01JAN2009 31DEC2009 N
C4591001 1084 
10841567/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2014 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2019 Y
C4591001 1084 
10841568/ 
Placebo Eye disorders Visual acuity reduced 01JAN2013 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2010 Y
  Injury, poisoning and procedural 
complicationsStress fracture 01JAN2016 31DEC2016 N 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01MAR2019 Y
  Skin and subcutaneous tissue disorders Acne 01JUL2020 Y
C4591001 1084 
10841569/ 
Placebo Eye disorders Visual acuity reduced 01JAN2018 Y 
  Psychiatric disorders Attention deficit h yperactivit y disorde r 01JUN2020 Y
C4591001 1084 
10841570/ 
Placebo General disorders and administration 
site conditions Pain 01JAN2018 Y 
  Immune s ystem disorders Drug hypersensitivit y 01JAN2018 Y
  Hypersensitivit y 01JAN2016 Y
  Injury, poisoning and procedural 
complicationsWrist fracture 01JAN2015 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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FDA-CBER-2022-5812-0499940
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2013 Y 
C4591001 1084 
10841571/ 
Placebo Eye disorders Visual acuity reduced 01JAN2011 Y 
  Gastrointestinal disorders Gastrooesopha geal reflux disease 01JAN2019 Y
  Immune s ystem disorders Seasonal aller gy 01JAN2014 Y
  Metabolism and nutrition disorders Iron deficienc y 01JAN2019 Y
  Psychiatric disorders Anxiet y 01JAN2016 Y
  Autism spectrum disorde r 01MAY2020 Y
  Depression 01JAN2016 Y
  Reproductive system and breast 
disordersPremenstrual dysphoric disorder 01DEC2017 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2014 Y
C4591001 1084 
10841572/ 
Placebo Immune system disorders Seasonal allergy 01JAN2008 Y 
  Infections and infestations Tonsillitis 01JAN2009 31DEC2009 N
  Psychiatric disorders Depression 01NOV2020 Y
  Skin and subcutaneous tissue disorders Eczema 01OCT2020 Y
  Surgical and medical procedures Adenoidectom y 01JAN2009 31DEC2009 N
  Tonsillectom y 01JAN2009 31DEC2009 N
C4591001 1084 
10841573/ 
BNT162b2 (30 μg) Neoplasms benign, malignant and 
unspecified (incl cysts and polyps) Haemangioma 2008 31DEC2011 N 
C4591001 1084 
10841574/ 
BNT162b2 (30 μg) Eye disorders Visual acuity reduced 01JAN2017 Y 
  Infections and infestations Gastrointestinal viral infection 01JAN2015 31DEC2015 N
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(b) (6)
FDA-CBER-2022-5812-0499941
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Otitis media 01JAN2010 Y
  Viral infection 01JAN2009 31DEC2009 N
  Injury, poisoning and procedural 
complicationsFoot fracture 01JAN2014 Y 
  Skin and subcutaneous tissue disorders Hyperkeratosis 01JAN2017 Y
C4591001 1084 
10841576/ 
BNT162b2 (30 μg) Eye disorders Visual acuity reduced 01JUN2016 Y 
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2006 Y 
C4591001 1084 
10841577/ 
Placebo Eye disorders Visual acuity reduced 01JAN2012 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2010 Y
  Injury, poisoning and procedural 
complicationsUpper limb fracture 01JAN2013 Y 
  Psychiatric disorders Anxiet y 01JAN2019 Y
  Attention deficit h yperactivit y disorde r 01JAN2017 Y
  Surgical and medical procedures Open reduction of fracture 01JAN2013 31DEC2013 N
C4591001 1084 
10841578/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2017 Y 
C4591001 1084 
10841581/ 
Placebo Musculoskeletal and connective tissue 
disorders Myalgia 01JAN2019 Y 
C4591001 1084 
10841582/ 
BNT162b2 (30 μg) Immune system disorders Hypersensitivity 01JAN2019 Y 
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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FDA-CBER-2022-5812-0499942
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
C4591001 1084 
10841583/ 
BNT162b2 (30 μg) Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2014 Y 
  Surgical and medical procedures Tonsillectom y 01JAN2010 31DEC2010 N
C4591001 1084 
10841584/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2013 Y 
  Injury, poisoning and procedural 
complicationsHand fracture 01JAN2018 Y 
  Nervous s ystem disorders Dyslexia 01JAN2012 Y
  Respiratory, thoraci c and mediastinal 
disordersEpistaxis 01JAN2010 Y 
  Skin and subcutaneous tissue disorders Acne 01JAN2019 Y
C4591001 1084 
10841586/ 
Placebo Eye disorders Chalazion 01JAN2014 31DEC2014 N 
  Visual acuit y reduce d 01JAN2012 Y
  Immune s ystem disorders Seasonal aller gy 01JAN2019 Y
  Surgical and medical procedures Eye operation 01JAN2014 31DEC2014 N
C4591001 1084 
10841587/ 
Placebo Eye disorders Visual acuity reduced 01JAN2012 Y 
  Nervous s ystem disorders Headache 01JAN2012 Y
C4591001 1084 
10841588/ 
Placebo Ear and labyrinth disorders Tinnitus 01JAN2019 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2012 Y
  Metabolism and nutrition disorders Obesit y 01JAN2018 Y
  Psychiatric disorders Anxiet y 01JAN2019 Y
090177e1988b770f\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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FDA-CBER-2022-5812-0499943
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2018 Y 
  Surgical and medical procedures Tonsillectom y 01JAN2013 31DEC2013 N
C4591001 1084 
10841590/ 
Placebo Eye disorders Visual acuity reduced 01JAN2013 Y 
  Gastrointestinal disorders Dysphagia 01JAN2017 Y
  Immune s ystem disorders Seasonal aller gy 01JAN2009 Y
  Infections and infestations Ear infection 01JAN2006 31DEC2006 N
  Injury, poisoning and procedural 
complicationsLower limb fracture 01JAN2018 31DEC2018 N 
  Musculoskeletal and connective tissue 
disordersPain in extremity 01JAN2010 Y 
C4591001 1084 
10841591/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2008 Y 
  Infections and infestations Ear infection 01JAN2009 31DEC2009 N
  Nervous s ystem disorders Headache 01JAN2019 Y
  Renal and urinar y disorders Nephrolithiasis 01APR2020 30APR2020 N
  Social circumstances Premenarche 2008 Y
  Surgical and medical procedures Myringotom y 01JAN2009 31DEC2009 N
C4591001 1084 
10841592/ 
BNT162b2 (30 μg) Eye disorders Visual acuity reduced 01JAN2016 Y 
  Infections and infestations Adenoiditis 01JAN2012 31DEC2012 N
  Tonsillitis 01JAN2012 31DEC2012 N
  Nervous s ystem disorders Headache 01JAN2018 Y
  Skin and subcutaneous tissue disorders Eczema 01JAN2015 Y
  Surgical and medical procedures Adenoidectom y 01JAN2012 31DEC2012 N
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(b) (6)
FDA-CBER-2022-5812-0499944
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  Tonsillectom y 01JAN2012 31DEC2012 N
C4591001 1084 
10841593/ 
BNT162b2 (30 μg) Immune system disorders Seasonal allergy 01JAN2015 Y 
  Psychiatric disorders Anxiet y 01JAN2016 Y
C4591001 1084 
10841594/ 
BNT162b2 (30 μg) Immune system disorders Drug hypersensitivity 01JAN2012 Y 
C4591001 1084 
10841595/ 
Placebo Immune system disorders Seasonal allergy 01JAN2010 Y 
  Infections and infestations Tonsillitis 01JAN2012 31DEC2012 N
C4591001 1084 
10841596/ 
Placebo Eye disorders Visual acuity reduced 01JAN2013 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2006 Y
  Nervous s ystem disorders Headache 01JAN2012 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2018 Y 
C4591001 1084 
10841597/ 
Placebo Eye disorders Visual acuity reduced 01JAN2011 Y 
  Immune s ystem disorders Seasonal aller gy 01JAN2012 Y
  Injury, poisoning and procedural 
complicationsUpper limb fracture 01JAN2016 31DEC2016 N 
  Nervous s ystem disorders Headache 01JAN2018 Y
  Respiratory, thoraci c and mediastinal 
disordersAsthma 01JAN2016 31DEC2018 N 
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FDA-CBER-2022-5812-0499945
16.2.5.4 Listing of Medical Histo ry – All Subjects 12 Through 1 5 Years of Age 
Subject/ 
Vaccine Group 
(as Randomized) Sy
…[truncated]