125742 45 S211 M5 c4591001 interim ado compliance

Document text

16.2.5.2.1 Listing of Medication Errors – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication 
Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug 
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study 
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
16-25 C4591001 
1011 
10111215 1 19OCT2020 Product 
administration 
error DOSE NOT 
CHANGED N N 19OCT2020 N N 
  C4591001 
1024 
10241091 1 28AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 28AUG2020 N N 
  C4591001 
1044 
10441034 1 26AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 26AUG2020 N N 
  C4591001 
1068 
10681002 1 18AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 18AUG2020 N N 
  C4591001 
1068 
10681010 1 19AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 19AUG2020 N N 
  C4591001 
1068 
10681018 1 20AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 20AUG2020 N N 
  C4591001 
1068 
10681037 1 24AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 24AUG2020 N N 
  C4591001 
1068 
10681047 1 26AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 26AUG2020 N N 
  C4591001 
1079 
10791170 3 25FEB2021 Product 
administration 
error DOSE NOT 
CHANGED N N 25FEB2021 N N 
090177e196ac915c\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 1
FDA-CBER-2022-5812-0499131
16.2.5.2.1 Listing of Medication Errors – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication 
Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug 
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study 
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1096 
10961027 3 26FEB2021 Product storage 
error DOSE NOT 
CHANGED N N 26FEB2021 N N 
  C4591001 
1096 
10961195 2 21SEP2020 Product 
administration 
error DOSE NOT 
CHANGED N N 21SEP2020 N N 
  C4591001 
1096 
10961245 4 26FEB2021 Product storage 
error DOSE NOT 
CHANGED N N 26FEB2021 N N 
  C4591001 
1126 
11261053 1 20AUG2020 Expired product 
administered DOSE NOT 
CHANGED N N 20AUG2020 N N 
  C4591001 
1141 
11411065 1 12AUG2020 Incorrect dose 
administered DOSE NOT 
CHANGED N N 12AUG2020 N N 
  C4591001 
1141 
11411139 1 27AUG2020 Incorrect dose 
administered DOSE NOT 
CHANGED N N 27AUG2020 N N 
  C4591001 
1146 
11461338 2 13NOV2020 Product 
administration 
error DOSE NOT 
CHANGED N N 13NOV2020 N N 
  C4591001 
1161 
11611010 1 31JUL2020 Product 
administration 
error DOSE NOT 
CHANGED N N 31JUL2020 N N 
  C4591001 
1161 
11611015 1 01AUG2020 Wrong product 
administered DOSE NOT 
CHANGED N N 01AUG2020 N N 
090177e196ac915c\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 2
FDA-CBER-2022-5812-0499132
16.2.5.2.1 Listing of Medication Errors – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication 
Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug 
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study 
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1212 
12121013 3 25JAN2021 Product 
preparation error DOSE NOT 
CHANGED N N 25JAN2021 N N 
  C4591001 
1230 
12301157 2 28OCT2020 Product 
administration 
error DOSE NOT 
CHANGED N N 28OCT2020 N N 
  C4591001 
1231 
12313467 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313498 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313505 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313515 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313519 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313533 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313542 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
090177e196ac915c\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 3
FDA-CBER-2022-5812-0499133
16.2.5.2.1 Listing of Medication Errors – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication 
Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug 
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study 
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1231 
12313546 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313553 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  
a.     Dose No. = the vaccination vis it at which the medication error occurred. 
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (20:15) Source Data: adae Table Generation: 27MAR2021 (01:37)  
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unblinded/C4591001 BLA/adae l002 meallped  
 
090177e196ac915c\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 4
FDA-CBER-2022-5812-0499134
16.2.5.2.2 Listing of Medication Errors – Phase 2/3 Subjects 16 -55 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
16-55 C4591001 
1011 
10111215 1 19OCT2020 Product 
administration errorDOSE NOT 
CHANGED N N 19OCT2020 N N 
  C4591001 
1012 
10121103 2 22SEP2020 Product 
administration errorDOSE NOT 
CHANGED N N 22SEP2020 Y N 
  C4591001 
1024 
10241002 2 01SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 01SEP2020 N N 
  C4591001 
1024 
10241004 2 02SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 02SEP2020 N N 
  C4591001 
1024 
10241006 2 02SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 02SEP2020 N N 
  C4591001 
1024 
10241014 2 01SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 01SEP2020 N N 
  C4591001 
1024 
10241023 2 02SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 02SEP2020 N N 
  C4591001 
1024 
10241032 1 17AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 17AUG2020 N N 
  C4591001 
1024 
10241033 1 18AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 18AUG2020 N N 
  C4591001 
1024 
10241039 1 18AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 18AUG2020 N N 
090177e196ac9179\Final\Final On: 31-Mar-2021 13:07 (GMT) 
Page 5
FDA-CBER-2022-5812-0499135
16.2.5.2.2 Listing of Medication Errors – Phase 2/3 Subjects 16 -55 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1024 
10241040 1 18AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 18AUG2020 N N 
  C4591001 
1024 
10241042 1 19AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 19AUG2020 N N 
  C4591001 
1024 
10241044 1 19AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 19AUG2020 N N 
  C4591001 
1024 
10241046 1 19AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 19AUG2020 N N 
  C4591001 
1024 
10241054 1 20AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 20AUG2020 N N 
  C4591001 
1024 
10241055 1 20AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 20AUG2020 N N 
  C4591001 
1024 
10241061 1 21AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 21AUG2020 N N 
  C4591001 
1024 
10241066 1 24AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 24AUG2020 N N 
  C4591001 
1024 
10241067 1 24AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 24AUG2020 N N 
  C4591001 
1024 
10241071 1 24AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 24AUG2020 N N 
090177e196ac9179\Final\Final On: 31-Mar-2021 13:07 (GMT) 
Page 6
FDA-CBER-2022-5812-0499136
16.2.5.2.2 Listing of Medication Errors – Phase 2/3 Subjects 16 -55 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1024 
10241072 1 25AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 25AUG2020 N N 
  C4591001 
1024 
10241074 1 25AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 25AUG2020 N N 
  C4591001 
1024 
10241078 1 26AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 26AUG2020 N N 
  C4591001 
1024 
10241084 1 27AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 27AUG2020 N N 
  C4591001 
1024 
10241085 1 27AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 27AUG2020 N N 
  C4591001 
1024 
10241091 1 28AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 28AUG2020 N N 
  C4591001 
1024 
10241094 1 28AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 28AUG2020 N N 
  C4591001 
1024 
10241100 1 31AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 31AUG2020 N N 
  C4591001 
1024 
10241102 1 31AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 31AUG2020 N N 
  C4591001 
1024 
10241104 1 01SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 01SEP2020 N N 
090177e196ac9179\Final\Final On: 31-Mar-2021 13:07 (GMT) 
Page 7
FDA-CBER-2022-5812-0499137
16.2.5.2.2 Listing of Medication Errors – Phase 2/3 Subjects 16 -55 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1024 
10241108 1 02SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 02SEP2020 N N 
  C4591001 
1044 
10441001 2 02SEP2020 Product 
temperature 
excursion issueDOSE NOT 
CHANGED N N 02SEP2020 N N 
  C4591001 
1044 
10441015 2 08SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 08SEP2020 N N 
  C4591001 
1044 
10441028 24AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 24AUG2020 N N 
  C4591001 
1044 
10441029 1 25AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 25AUG2020 N N 
  C4591001 
1044 
10441031 1 25AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 25AUG2020 N N 
  C4591001 
1044 
10441034 1 26AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 26AUG2020 N N 
  C4591001 
1044 
10441037 1 26AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 26AUG2020 N N 
  C4591001 
1044 
10441045 1 27AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 27AUG2020 N N 
  C4591001 
1044 
10441048  
27AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 27AUG2020 N N 
090177e196ac9179\Final\Final On: 31-Mar-2021 13:07 (GMT) 
Page 8
FDA-CBER-2022-5812-0499138
16.2.5.2.2 Listing of Medication Errors – Phase 2/3 Subjects 16 -55 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1044 
10441050 1 27AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 27AUG2020 N N 
  C4591001 
1044 
10441052 1 28AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 28AUG2020 N N 
  C4591001 
1044 
10441054 1 28AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 28AUG2020 N N 
  C4591001 
1044 
10441060 1 31AUG2020 Product storage 
error DOSE NOT 
CHANGED N N 31AUG2020 N N 
  C4591001 
1044 
10441063 1 01SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 01SEP2020 N N 
  C4591001 
1044 
10441068 1 01SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 01SEP2020 N N 
  C4591001 
1044 
10441071 1 02SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 02SEP2020 N N 
  C4591001 
1044 
10441076 1 03SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 03SEP2020 N N 
  C4591001 
1044 
10441079 1 04SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 04SEP2020 N N 
  C4591001 
1044 
10441088 1 06SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 06SEP2020 N N 
090177e196ac9179\Final\Final On: 31-Mar-2021 13:07 (GMT) 
Page 9
FDA-CBER-2022-5812-0499139
16.2.5.2.2 Listing of Medication Errors – Phase 2/3 Subjects 16 -55 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1044 
10441089 1 06SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 06SEP2020 N N 
  C4591001 
1068 
10681002 1 18AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 18AUG2020 N N 
  C4591001 
1068 
10681003 1 19AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 19AUG2020 N N 
  C4591001 
1068 
10681006 1 19AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 19AUG2020 N N 
  C4591001 
1068 
10681010 1 19AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 19AUG2020 N N 
  C4591001 
1068 
10681011 1 19AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 19AUG2020 N N 
  C4591001 
1068 
10681012 1 20AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 20AUG2020 N N 
  C4591001 
1068 
10681013 1 20AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 20AUG2020 N N 
  C4591001 
1068 
10681016 1 20AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 20AUG2020 N N 
  C4591001 
1068 
10681017 1 20AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 20AUG2020 N N 
090177e196ac9179\Final\Final On: 31-Mar-2021 13:07 (GMT) 
Page 10
FDA-CBER-2022-5812-0499140
16.2.5.2.2 Listing of Medication Errors – Phase 2/3 Subjects 16 -55 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
    4 08JAN2021 Product 
administration erro rDOSE NOT 
CHANGEDN N 08JAN2021 N N 
  C4591001 
1068 
10681018 1 20AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 20AUG2020 N N 
  C4591001 
1068 
10681021 1 21AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 21AUG2020 N N 
  C4591001 
1068 
10681024 1 21AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 21AUG2020 N N 
  C4591001 
1068 
10681025 1 21AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 21AUG2020 N N 
  C4591001 
1068 
10681026 1 21AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 21AUG2020 N N 
  C4591001 
1068 
10681027 1 21AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 21AUG2020 N N 
  C4591001 
1068 
10681028 1 24AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 24AUG2020 N N 
  C4591001 
1068 
10681031 1 24AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 24AUG2020 N N 
  C4591001 
1068 
10681034 1 24AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 24AUG2020 N N 
090177e196ac9179\Final\Final On: 31-Mar-2021 13:07 (GMT) 
Page 11
FDA-CBER-2022-5812-0499141
16.2.5.2.2 Listing of Medication Errors – Phase 2/3 Subjects 16 -55 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1068 
10681035 1 24AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 24AUG2020 N N 
  C4591001 
1068 
10681036 1 24AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 24AUG2020 N N 
    4 08JAN2021 Product 
administration erro rDOSE NOT 
CHANGEDN N 08JAN2021 N N 
  C4591001 
1068 
10681037 1 24AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 24AUG2020 N N 
  C4591001 
1068 
10681038 1 26AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 26AUG2020 N N 
  C4591001 
1068 
10681042 1 26AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 26AUG2020 N N 
  C4591001 
1068 
10681046 1 26AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 26AUG2020 N N 
  C4591001 
1068 
10681047 1 26AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 26AUG2020 N N 
  C4591001 
1068 
10681052 1 27AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 27AUG2020 N N 
  C4591001 
1068 
10681053 1 27AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 27AUG2020 N N 
090177e196ac9179\Final\Final On: 31-Mar-2021 13:07 (GMT) 
Page 12
FDA-CBER-2022-5812-0499142
16.2.5.2.2 Listing of Medication Errors – Phase 2/3 Subjects 16 -55 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1068 
10681058 1 27AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 27AUG2020 N N 
  C4591001 
1068 
10681060 1 28AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 28AUG2020 N N 
  C4591001 
1068 
10681061 1 28AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 28AUG2020 N N 
  C4591001 
1068 
10681064 1 28AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 28AUG2020 N N 
  C4591001 
1068 
10681066 1 28AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 28AUG2020 N N 
  C4591001 
1068 
10681071 1 31AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 31AUG2020 N N 
  C4591001 
1068 
10681072 1 31AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 31AUG2020 N N 
  C4591001 
1068 
10681073 1 31AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 31AUG2020 N N 
  C4591001 
1068 
10681074 1 31AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 31AUG2020 N N 
  C4591001 
1068 
10681076 1 31AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 31AUG2020 N N 
090177e196ac9179\Final\Final On: 31-Mar-2021 13:07 (GMT) 
Page 13
FDA-CBER-2022-5812-0499143
16.2.5.2.2 Listing of Medication Errors – Phase 2/3 Subjects 16 -55 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1068 
10681077 1 31AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 31AUG2020 N N 
  C4591001 
1068 
10681080 1 31AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 31AUG2020 N N 
  C4591001 
1068 
10681081 1 31AUG2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 31AUG2020 N N 
  C4591001 
1068 
10681083 1 01SEP2020 Incorrect dosage 
administered DOSE NOT 
CHANGED N N 01SEP2020 N N 
  C4591001 
1079 
10791039 1 03AUG2020 Product 
administration errorDOSE NOT 
CHANGED N N 03AUG2020 N N 
  C4591001 
1079 
10791130 1 17AUG2020 Wrong product 
administered DRUG 
WITHDRAWNN N 17AUG2020 N N 
  C4591001 
1079 
10791170 3 25FEB2021 Product 
administration errorDOSE NOT 
CHANGED N N 25FEB2021 N N 
  C4591001 
1079 
10791206 1 28AUG2020 Product 
administration errorDOSE NOT 
CHANGED N N 28AUG2020 N N 
  C4591001 
1088 
10881077 2 11SEP2020 Wrong product 
administered DOSE NOT 
CHANGED N N 11SEP2020 N N 
  C4591001 
1090 
10901334 1 03SEP2020 Wrong product 
administered DOSE NOT 
CHANGED N N 03SEP2020 N N 
090177e196ac9179\Final\Final On: 31-Mar-2021 13:07 (GMT) 
Page 14
FDA-CBER-2022-5812-0499144
16.2.5.2.2 Listing of Medication Errors – Phase 2/3 Subjects 16 -55 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1091 
10911005 1 30JUL2020 Incorrect dose 
administered DOSE NOT 
CHANGED N N 30JUL2020 N N 
  C4591001 
1091 
10911008 1 31JUL2020 Incorrect dose 
administered DOSE NOT 
CHANGED N N 31JUL2020 N N 
  C4591001 
1091 
10911014 1 31JUL2020 Incorrect dose 
administered DOSE NOT 
CHANGED N N 31JUL2020 N N 
  C4591001 
1091 
10911015 1 31JUL2020 Incorrect dose 
administered DOSE NOT 
CHANGED N N 31JUL2020 N N 
  C4591001 
1096 
10961011 3 26FEB2021 Product storage 
error DOSE NOT 
CHANGED N N 26FEB2021 N N 
  C4591001 
1096 
10961027 3 26FEB2021 Product storage 
error DOSE NOT 
CHANGED N N 26FEB2021 N N 
  C4591001 
1096 
10961059 4 26FEB2021 Product storage 
error DOSE NOT 
CHANGED N N 26FEB2021 N N 
  C4591001 
1096 
10961195 2 21SEP2020 Product 
administration errorDOSE NOT 
CHANGED N N 21SEP2020 N N 
  C4591001 
1096 
10961197 2 21SEP2020 Product 
administration errorDOSE NOT 
CHANGED N N 21SEP2020 N N 
  C4591001 
1096 
10961209 4 26FEB2021 Product storage 
error DOSE NOT 
CHANGED N N 26FEB2021 N N 
090177e196ac9179\Final\Final On: 31-Mar-2021 13:07 (GMT) 
Page 15
FDA-CBER-2022-5812-0499145
16.2.5.2.2 Listing of Medication Errors – Phase 2/3 Subjects 16 -55 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1096 
10961245 4 26FEB2021 Product storage 
error DOSE NOT 
CHANGED N N 26FEB2021 N N 
  C4591001 
1096 
10961246 4 26FEB2021 Product storage 
error DOSE NOT 
CHANGED N N 26FEB2021 N N 
  C4591001 
1101 
11011024 3 28DEC2020 Expired product 
administered DOSE NOT 
CHANGED N N 28DEC2020 N N 
  C4591001 
1116 
11161226 1 11SEP2020 Wrong product 
administered DOSE NOT 
CHANGED N N 11SEP2020 N N 
  C4591001 
1126 
11261053 1 20AUG2020 Expired product 
administered DOSE NOT 
CHANGED N N 20AUG2020 N N 
  C4591001 
1129 
11291129 2 08SEP2020 Product 
administration errorDOSE NOT 
CHANGED N N 08SEP2020 N N 
  C4591001 
1136 
11361027 4 25FEB2021 Incorrect dose 
administered DOSE NOT 
CHANGED N N 25FEB2021 N N 
  C4591001 
1136 
11361039 4 24FEB2021 Incorrect dose 
administered DOSE NOT 
CHANGED N N 24FEB2021 N N 
  C4591001 
1136 
11361083 4 24FEB2021 Incorrect dose 
administered DOSE NOT 
CHANGED N N 24FEB2021 N N 
  C4591001 
1136 
11361084 4 25FEB2021 Incorrect dose 
administered DOSE NOT 
CHANGED N N 25FEB2021 N N 
090177e196ac9179\Final\Final On: 31-Mar-2021 13:07 (GMT) 
Page 16
FDA-CBER-2022-5812-0499146
16.2.5.2.2 Listing of Medication Errors – Phase 2/3 Subjects 16 -55 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1136 
11361109 4 24FEB2021 Incorrect dose 
administered DOSE NOT 
CHANGED N N 24FEB2021 N N 
  C4591001 
1141 
11411011 2 21AUG2020 Incorrect dose 
administered DOSE NOT 
CHANGED N N 21AUG2020 N N 
  C4591001 
1141 
11411014 1 03AUG2020 Incorrect dose 
administered DOSE NOT 
CHANGED N N 03AUG2020 N N 
  C4591001 
1141 
11411023 2 25AUG2020 Incorrect dose 
administered DOSE NOT 
CHANGED N N 25AUG2020 N N 
  C4591001 
1141 
11411065 1 12AUG2020 Incorrect dose 
administered DOSE NOT 
CHANGED N N 12AUG2020 N N 
  C4591001 
1141 
11411068 1 12AUG2020 Incorrect dose 
administered DOSE NOT 
CHANGED N N 12AUG2020 N N 
  C4591001 
1141 
11411080 1 14AUG2020 Incorrect dose 
administered DOSE NOT 
CHANGED N N 14AUG2020 N N 
  C4591001 
1141 
11411093 1 18AUG2020 Incorrect dose 
administered DOSE NOT 
CHANGED N N 18AUG2020 N N 
  C4591001 
1141 
11411139 1 27AUG2020 Incorrect dose 
administered DOSE NOT 
CHANGED N N 27AUG2020 N N 
  C4591001 
1146 
11461196 1 03SEP2020 Product 
administration errorDOSE NOT 
CHANGED N N 03SEP2020 N N 
090177e196ac9179\Final\Final On: 31-Mar-2021 13:07 (GMT) 
Page 17
FDA-CBER-2022-5812-0499147
16.2.5.2.2 Listing of Medication Errors – Phase 2/3 Subjects 16 -55 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1146 
11461338 2 13NOV2020 Product 
administration errorDOSE NOT 
CHANGED N N 13NOV2020 N N 
  C4591001 
1161 
11611010 1 31JUL2020 Product 
administration errorDOSE NOT 
CHANGED N N 31JUL2020 N N 
  C4591001 
1161 
11611015 1 01AUG2020 Wrong product 
administered DOSE NOT 
CHANGED N N 01AUG2020 N N 
  C4591001 
1163 
11631006 1 31JUL2020 Product 
administration errorDRUG 
WITHDRAWNN N 31JUL2020 N N 
  C4591001 
1163 
11631039 1 06AUG2020 Expired product 
administered DOSE NOT 
CHANGED N N 06AUG2020 N N 
  C4591001 
1163 
11631064 1 07AUG2020 Expired product 
administered DOSE NOT 
CHANGED N N 07AUG2020 N N 
  C4591001 
1163 
11631096 1 12AUG2020 Product 
administration errorDOSE NOT 
CHANGED N N 12AUG2020 N N 
  C4591001 
1163 
11631117 2 08SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 08SEP2020 N N 
  C4591001 
1163 
11631121 2 09SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 09SEP2020 N N 
  C4591001 
1163 
11631124 2 08SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 08SEP2020 N N 
090177e196ac9179\Final\Final On: 31-Mar-2021 13:07 (GMT) 
Page 18
FDA-CBER-2022-5812-0499148
16.2.5.2.2 Listing of Medication Errors – Phase 2/3 Subjects 16 -55 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1163 
11631127 2 08SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 08SEP2020 N N 
  C4591001 
1163 
11631136 2 08SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 08SEP2020 N N 
  C4591001 
1163 
11631142 2 09SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 09SEP2020 N N 
  C4591001 
1163 
11631145 2 09SEP2020 Product storage 
error DOSE NOT 
CHANGED N N 09SEP2020 N N 
  C4591001 
1169 
11691033 3 07JAN2021 Underdose DOSE NOT 
CHANGED N N 07JAN2021 N N 
  C4591001 
1169 
11691049 2 05OCT2020 Product 
administration errorDOSE NOT 
CHANGED N N 05OCT2020 N N 
  C4591001 
1185 
11851017 2 16NOV2020 Product 
administration errorDOSE NOT 
CHANGED N N 16NOV2020 N N 
  C4591001 
1185 
11851037 2 16NOV2020 Product 
administration errorDOSE NOT 
CHANGED N N 16NOV2020 N N 
  C4591001 
1212 
12121005 3 25JAN2021 Product preparation 
error DOSE NOT 
CHANGED N N 25JAN2021 N N 
  C4591001 
1212 
12121008 3 25JAN2021 Product preparation 
error DOSE NOT 
CHANGED N N 25JAN2021 N N 
090177e196ac9179\Final\Final On: 31-Mar-2021 13:07 (GMT) 
Page 19
FDA-CBER-2022-5812-0499149
16.2.5.2.2 Listing of Medication Errors – Phase 2/3 Subjects 16 -55 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1212 
12121013 3 25JAN2021 Product preparation 
error DOSE NOT 
CHANGED N N 25JAN2021 N N 
  C4591001 
1212 
12121022 3 25JAN2021 Product preparation 
error DOSE NOT 
CHANGED N N 25JAN2021 N N 
  C4591001 
1212 
12121031 3 25JAN2021 Product preparation 
error DOSE NOT 
CHANGED N N 25JAN2021 N N 
  C4591001 
1221 
12211079 1 02DEC2020 Expired product 
administered DOSE NOT 
CHANGED N N 02DEC2020 N N 
  C4591001 
1230 
12301157 2 28OCT2020 Product 
administration errorDOSE NOT 
CHANGED N N 28OCT2020 N N 
  C4591001 
1231 
12313428 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313429 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313449 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313456 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313459 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
090177e196ac9179\Final\Final On: 31-Mar-2021 13:07 (GMT) 
Page 20
FDA-CBER-2022-5812-0499150
16.2.5.2.2 Listing of Medication Errors – Phase 2/3 Subjects 16 -55 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1231 
12313467 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313469 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313479 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313483 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313486 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313487 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313492 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313497 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313498 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313501 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
090177e196ac9179\Final\Final On: 31-Mar-2021 13:07 (GMT) 
Page 21
FDA-CBER-2022-5812-0499151
16.2.5.2.2 Listing of Medication Errors – Phase 2/3 Subjects 16 -55 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1231 
12313505 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313506 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313508 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313509 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313512 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313514 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313515 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313517 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313518 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313519 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
090177e196ac9179\Final\Final On: 31-Mar-2021 13:07 (GMT) 
Page 22
FDA-CBER-2022-5812-0499152
16.2.5.2.2 Listing of Medication Errors – Phase 2/3 Subjects 16 -55 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1231 
12313528 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313533 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313534 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313537 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313541 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313542 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313546 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313551 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313553 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313554 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
090177e196ac9179\Final\Final On: 31-Mar-2021 13:07 (GMT) 
Page 23
FDA-CBER-2022-5812-0499153
16.2.5.2.2 Listing of Medication Errors – Phase 2/3 Subjects 16 -55 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1231 
12313556 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313564 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1231 
12313567 1 23AUG2020 Wrong dose DOSE NOT 
CHANGED N N 23AUG2020 N N 
  C4591001 
1232 
12321354 2 13NOV2020 Product storage 
error DOSE NOT 
CHANGED N N 13NOV2020 N N 
  C4591001 
1232 
12321373 2 13NOV2020 Product storage 
error DOSE NOT 
CHANGED N N 13NOV2020 N N 
  C4591001 
1232 
12321382 2 12NOV2020 Product storage 
error DOSE NOT 
CHANGED N N 12NOV2020 N N 
  C4591001 
1232 
12321385 2 13NOV2020 Product storage 
error DOSE NOT 
CHANGED N N 13NOV2020 N N 
  C4591001 
1232 
12321394 2 12NOV2020 Product storage 
error DOSE NOT 
CHANGED N N 12NOV2020 N N 
  C4591001 
1232 
12321395 2 12NOV2020 Product storage 
error DOSE NOT 
CHANGED N N 12NOV2020 N N 
  C4591001 
1269 
12691004 1 17AUG2020 Product 
administration errorDOSE NOT 
CHANGED N N 17AUG2020 N N 
090177e196ac9179\Final\Final On: 31-Mar-2021 13:07 (GMT) 
Page 24
FDA-CBER-2022-5812-0499154
16.2.5.2.2 Listing of Medication Errors – Phase 2/3 Subjects 16 -55 Years of Age 
Age 
Group 
(Years) Subject Dose
No.a Start 
Date Type of 
Medication Error Action Taken Was a 
Concomitant 
Medication 
Given 
(Yes/No) Was the 
Nondrug
Treatment 
Given 
(Yes/No) Stop 
Date Discontinued
From Study
(Yes/No) Medication 
Error– 
Associated 
AE 
(Yes/No) 
  
  C4591001 
1269 
12691011 1 20AUG2020 Product 
administration errorDOSE NOT 
CHANGED N N 20AUG2020 N N 
  C4591001 
1269 
12691016 1 20AUG2020 Product 
administration errorDOSE NOT 
CHANGED N N 20AUG2020 N N 
  
a.     Dose No. = the vaccination  visit at which the medication  error occurred. 
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (20:15) Source Dat a: adae Table Generation: 30MAR2021 (13:33)  
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File:  ./nda2 unblinded/C4591001 EUA 1655/adae l002 me1655
 
090177e196ac9179\Final\Final On: 31-Mar-2021 13:07 (GMT) 
Page 25
FDA-CBER-2022-5812-0499155
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
12-15 C4591001 1005 
10051328 Immune system disorders Hypersensitivity 01JAN2010 Y 
    Psychiatric disorders Anxiet y 01JAN2018 Y
    Social circumstances Premenarche 2006 Y
  C4591001 1005 
10051410 Social circumstances Premenarche 2007 Y 
  C4591001 1005 
10051412 Psychiatric disorders Anxiety 01JAN2018 Y 
    Depression 01JAN2018 Y
    Reproductive system and breast 
disordersPolycystic ovaries 01JAN2016 Y 
  C4591001 1005 
10051414 Immune system disorders Hypersensitivity 01JAN2010 Y 
    Psychiatric disorders Autism spectrum disorde r 01JAN2010 Y
  C4591001 1005 
10051418 Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2018 Y 
  C4591001 1005 
10051419 Psychiatric disorders Anxiety 01JAN2013 Y 
    Attention deficit h yperactivit y disorde r 01JAN2013 Y
  C4591001 1005 
10051420 Immune system disorders Hypersensitivity 01JAN2019 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2019 Y
    Social circumstances Premenarche 2008 Y
  C4591001 1005 
10051422 Immune system disorders Food allergy 01JAN2014 Y 
    Nervous s ystem disorders Migraine without aura 01JAN2018 Y
  C4591001 1005 
10051425 Immune system disorders Hypersensitivity 01JAN2010 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2017 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 26
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499156
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1005 
10051429 Musculoskeletal and connective 
tissue disordersShort stature 01OCT2019 Y 
  C4591001 1005 
10051431 Immune system disorders Drug hypersensitivity 01JAN2006 Y 
    Psychiatric disorders Depression 01JAN2019 Y
  C4591001 1005 
10051436 Psychiatric disorders Anxiety 01JAN2011 Y 
  C4591001 1005 
10051437 Skin and subcutaneous tissue 
disordersAcne 01JAN2019 Y 
  C4591001 1005 
10051438 Metabolism and nutrition disorders Lactose intolerance 01JAN2017 Y 
  C4591001 1005 
10051439 Endocrine disorders Hypothyroidism 01JAN2017 Y 
  C4591001 1005 
10051440 Blood and lymphatic system 
disordersImmune thrombocytopenia 01JAN2011 31DEC2011 N 
  C4591001 1005 
10051441 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 Psychiatric disorders Anxiety 01JAN2015 Y 
  C4591001 1005 
10051445 Psychiatric disorders Anxiety 01OCT2020 Y 
  C4591001 1005 
10051449 Immune system disorders Hypersensitivity 01JAN2010 Y 
  C4591001 1005 
10051451 Immune system disorders Hypersensitivity 01JAN2015 Y 
    Psychiatric disorders Anxiet y 01JAN2018 Y
    Attention deficit h yperactivit y disorde r 01JAN2019 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 27
FDA-CBER-2022-5812-0499157
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Insomnia 01JAN2019 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2015 Y 
  C4591001 1006 
10061183 Metabolism and nutrition disorders Obesity 01JAN2016 Y 
    Nervous s ystem disorders Headache 01JAN2015 Y
  C4591001 1006 
10061184 Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
  C4591001 1006 
10061188 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2017 Y 
  C4591001 1006 
10061189 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 
disordersUrticaria 01JAN2009 Y 
    Surgical and medical procedures Adenotonsillectom y 01JAN2009 31DEC2009 N
  C4591001 1006 
10061190 Immune system disorders Seasonal allergy 01JAN2014 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2019 Y 
  C4591001 1006 
10061191 Immune system disorders Seasonal allergy 19MAR2012 Y 
    Musculoskeletal and connective 
tissue disordersScoliosis 07MAR2017 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
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 28
FDA-CBER-2022-5812-0499158
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2011 Y 
    Skin and subcutaneous tissue 
disordersEczema 21NOV2016 Y 
  C4591001 1006 
10061196 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 Skin and subcutaneous tissue 
disordersAcne 19JUN2019 Y 
  C4591001 1006 
10061201 Immune system disorders Seasonal allergy 01JAN2017 Y 
    Nervous s ystem disorders Headache 01JUL2020 Y
  C4591001 1006 
10061203 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 Immune system disorders Perennial allergy 01JAN2015 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2019 Y
    Generalised anxiet y disorde r 01JAN2019 Y
    Insomnia 01JAN2018 Y
    Skin and subcutaneous tissue 
disordersEczema 01JAN2012 Y 
  C4591001 1006 
10061207 Psychiatric disorders Anxiety 01JAN2015 Y 
    Attention deficit h yperactivit y disorde r 01JAN2011 Y
    Depression 01JAN2015 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 29
FDA-CBER-2022-5812-0499159
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2015 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JUN2020 Y 
  C4591001 1006 
10061209 Musculoskeletal and connective 
tissue disordersArthralgia 01JAN2018 Y 
  C4591001 1006 
10061212 Skin and subcutaneous tissue 
disordersAcne 01JAN2016 Y 
  C4591001 1006 
10061214 Immune system disorders Drug hypersensitivity 01JAN2006 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 27MAR2013 Y
  C4591001 1006 
10061219 Immune system disorders Drug hypersensitivity 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 
disordersAcne 01DEC2019 Y 
  C4591001 1006 
10061220 Immune system disorders Drug hypersensitivity 01JAN2008 Y 
    Seasonal aller gy 01JAN2016 Y
    Injury, poisoning and procedural 
complicationsMuscle strain 01NOV2020 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2019 Y 
  C4591001 1006 
10061221 Immune system disorders Seasonal allergy 01JAN2009 Y 
    Musculoskeletal and connective 
tissue disordersScoliosis 20JUL2018 Y 
    Temporomandibular joint s yndrome 12SEP2019 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 30
FDA-CBER-2022-5812-0499160
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Reproductive system and breast 
disordersMenstruation irregular 03JAN2019 Y 
  C4591001 1006 
10061223 Immune system disorders Hypersensitivity 01JAN2018 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2015 Y 
  C4591001 1006 
10061224 Immune system disorders Allergy to animal 01JAN2015 Y 
    Infections and infestations Chronic sinusitis 13NOV2019 Y
    Respiratory, thoracic and 
mediastinal disordersNasal septum deviation 13NOV2019 Y 
    Nasal turbinate h ypertroph y 13NOV2019 Y
    Rhinitis aller gic 01JAN2015 Y
  C4591001 1006 
10061227 Musculoskeletal and connective 
tissue disordersTemporomandibular joint syndrome 01MAR2020 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2016 Y 
  C4591001 1006 
10061228 Immune system disorders Drug hypersensitivity 01JAN2013 Y 
    Reproductive system and breast 
disordersDysmenorrhoea 01DEC2019 Y 
  C4591001 1006 
10061229 Blood and lymphatic system 
disordersIron deficiency anaemia 01JAN2018 Y 
    Skin and subcutaneous tissue 
disordersHyperhidrosis 01APR2017 Y 
  C4591001 1006 
10061230 Psychiatric disorders Anxiety 01JAN2018 Y 
    Attention deficit h yperactivit y disorde r 01JAN2018 Y
    Depression 01JAN2018 Y
  C4591001 1006 
10061231 Psychiatric disorders Anxiety 01JAN2012 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 31
FDA-CBER-2022-5812-0499161
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Attention deficit h yperactivit y disorde r 01JAN2017 Y
    Depression 01JAN2013 Y
    Obsessive-compulsive disorde r 01JAN2017 Y
    Respiratory, thoracic 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 Surgical and medical procedures Bone operation 06OCT2019 06OCT2019 N 
  C4591001 1006 
10061234 Musculoskeletal and connective 
tissue disordersScoliosis 05FEB2019 Y 
  C4591001 1006 
10061235 Metabolism and nutrition disorders Gluten sensitivity 01JAN2010 Y 
    Psychiatric disorders Insomnia 01JAN2019 Y
  C4591001 1006 
10061236 Gastrointestinal disorders Constipation 01JAN2019 Y 
    Immune s ystem disorders Seasonal aller gy 01JAN2016 Y
    Nervous s ystem disorders Migraine 01JAN2018 Y
  C4591001 1006 
10061237 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 Generalised anxiet y disorde r 01MAR2020 Y
    Major depression 01NOV2019 Y
    Surgical and medical procedures Fracture treatmen t 08AUG2013 08AUG2013 N
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 32
(b) (6)
FDA-CBER-2022-5812-0499162
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1006 
10061239 Skin and subcutaneous tissue 
disordersAcne 01JAN2020 Y 
    Social circumstances Premenarche 2006 Y
  C4591001 1006 
10061241 Immune system disorders Seasonal allergy 01JAN2018 Y 
    Psychiatric disorders Anxiet y 01JAN2017 Y
  C4591001 1006 
10061242 Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
  C4591001 1006 
10061248 Immune system disorders Seasonal allergy 01JAN2014 Y 
  C4591001 1006 
10061249 Metabolism and nutrition disorders Obesity 01JAN2016 Y 
  C4591001 1006 
10061250 Nervous system disorders Migraine 01JAN2015 Y 
  C4591001 1006 
10061252 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 Immune system disorders Seasonal allergy 01JAN2018 Y 
    Injury, poisoning and procedural 
complicationsWrist fracture 01MAY2020 31JUL2020 N 
  C4591001 1006 
10061254 Gastrointestinal disorders Abdominal pain upper 06JUN2020 Y 
    Metabolism and nutrition disorders Obesit y 01JAN2017 Y
    Nervous s ystem disorders Headache 01JUN2020 Y
    Psychiatric disorders Anxiet y 01JUN2020 Y
    Depression 01JUN2020 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 33
(b) (6)
FDA-CBER-2022-5812-0499163
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Insomnia 01JUL2020 Y
  C4591001 1006 
10061256 Infections and infestations Tonsillitis 01JAN2008 31DEC2008 N 
    Psychiatric disorders Adjustment disorder with depressed moo d 01APR2020 31JUL2020 N
    Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
    Surgical and medical procedures Adenoidectom y 01JAN2008 31DEC2008 N
    Tonsillectom y 01JAN2008 31DEC2008 N
  C4591001 1006 
10061257 Congenital, familial and genetic 
disordersTourette'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 Immune system disorders Seasonal allergy 01JAN2018 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2017 Y
  C4591001 1006 
10061259 Injury, poisoning and procedural 
complicationsLigament sprain 24AUG2020 Y 
    Nervous s ystem disorders Headache 01JAN2017 Y
  C4591001 1006 
10061260 Social circumstances Premenarche 2008 Y 
  C4591001 1006 
10061261 Congenital, familial and genetic 
disordersBicuspid aortic valve 2006 Y 
    Psychiatric disorders Anxiet y 01JAN2019 Y
    Attention deficit h yperactivit y disorde r 01JAN2011 Y
  C4591001 1006 
10061262 Skin and subcutaneous tissue 
disordersAcne cystic 01JUL2020 Y 
  C4591001 1006 
10061263 Nervous system disorders Headache 01JAN2019 Y 
    Social circumstances Premenarche 2008 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 34
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499164
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1006 
10061265 Immune system disorders Seasonal allergy 01JAN2012 Y 
    Metabolism and nutrition disorders Food intolerance 01JAN2008 Y
    Musculoskeletal and connective 
tissue disordersGrowth retardation 01JAN2014 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2008 Y 
  C4591001 1006 
10061266 Reproductive system and breast 
disordersDysmenorrhoea 01JAN2016 Y 
  C4591001 1006 
10061269 Immune system disorders Seasonal allergy 01JAN2010 Y 
    Musculoskeletal and connective 
tissue disordersKnee deformity 01JAN2008 Y 
    Surgical and medical procedures Epiph ysiodesis 01DEC2020 01DEC2020 N
  C4591001 1006 
10061270 Immune system disorders Allergy to plants 01JAN2017 Y 
    Rubber sensitivit y 2005 Y
  C4591001 1006 
10061271 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 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
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 35
(b) (6)
FDA-CBER-2022-5812-0499165
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Nightmare 01JAN2015 Y
    Post-traumatic stress disorde r 06NOV2015 Y
    Separation anxiet y disorde r 01JAN2010 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2013 Y 
  C4591001 1006 
10061273 Nervous system disorders Headache 01JAN2016 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2014 31DEC2017 N 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2019 Y 
  C4591001 1006 
10061274 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 
disordersAcne 01AUG2020 Y 
  C4591001 1006 
10061276 Immune system disorders Seasonal allergy 01JAN2015 Y 
  C4591001 1006 
10061277 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 Immune system disorders Seasonal allergy 01JAN2013 Y 
    Psychiatric disorders Anxiet y 01JAN2014 Y
    Insomnia 01JAN2017 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 36
FDA-CBER-2022-5812-0499166
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2011 Y 
    Social circumstances Premenarche 2007 29DEC2020 N
  C4591001 1006 
10061280 Metabolism and nutrition disorders Obesity 01JAN2016 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2010 Y 
  C4591001 1006 
10061282 Immune system disorders Seasonal allergy 01JAN2017 Y 
  C4591001 1006 
10061283 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 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, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2015 Y 
  C4591001 1006 
10061287 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2014 Y 
  C4591001 1006 
10061288 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
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 37
(b) (6)
FDA-CBER-2022-5812-0499167
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Tonsillectom y 01JAN2008 31DEC2008 N
  C4591001 1006 
10061289 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, thoracic and 
mediastinal disordersAsthma 01JAN2015 Y 
  C4591001 1006 
10061290 Immune system disorders Seasonal allergy 01JAN2010 Y 
    Injury, poisoning and procedural 
complicationsContusion 01JAN2019 Y 
    Psychiatric disorders Depression 01JAN2015 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2008 Y 
  C4591001 1006 
10061291 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 Injury, poisoning and procedural 
complicationsNasal 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
    Insomnia 01JAN2010 Y
    Surgical and medical procedures Rhinoplast y 04JUN2020 04JUN2020 N
    Spinal fusion sur gery 14OCT2019 14OCT2019 N
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 38
FDA-CBER-2022-5812-0499168
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1006 
10061293 Psychiatric disorders Insomnia 01JAN2010 Y 
  C4591001 1006 
10061294 Nervous system disorders Headache 01JAN2018 Y 
  C4591001 1006 
10061295 Immune system disorders Allergy to animal 01JAN2015 Y 
    Seasonal aller gy 01JAN2014 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2015 Y 
  C4591001 1006 
10061296 Infections and infestations Appendicitis 18NOV2016 18NOV2016 N 
    Surgical and medical procedures Appendicectom y 18NOV2016 18NOV2016 N
  C4591001 1006 
10061298 Immune system disorders Food allergy 01JAN2009 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2013 Y 
  C4591001 1006 
10061299 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2018 Y 
  C4591001 1006 
10061300 Skin and subcutaneous tissue 
disordersAcne 01JAN2017 Y 
  C4591001 1007 
10071409 Nervous system disorders Febrile convulsion 2007 31DEC2014 N 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2009 31DEC2009 N 
  C4591001 1007 
10071417 Immune system disorders Seasonal allergy 01JAN2007 Y 
  C4591001 1007 
10071429 Immune system disorders Seasonal allergy 01JAN2018 Y 
  C4591001 1007 
10071469 Congenital, familial and genetic 
disordersChondrodystrophy 01JAN2006 Y 
    Immune s ystem disorders Drug hypersensitivit y 01JAN2018 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 39
(b) (6)
FDA-CBER-2022-5812-0499169
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1007 
10071471 Respiratory, thoracic and 
mediastinal disordersTonsillar hypertrophy 01JAN2006 31DEC2011 N 
    Surgical and medical procedures Tonsillectom y 01JAN2011 31DEC2011 N
  C4591001 1007 
10071472 Nervous system disorders Migraine 01JAN2017 Y 
  C4591001 1007 
10071480 Congenital, familial and genetic 
disordersThalassaemia minor 01JAN2006 Y 
  C4591001 1007 
10071483 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2017 Y 
    Skin and subcutaneous tissue 
disordersEczema 01JAN2008 Y 
  C4591001 1007 
10071484 Immune system disorders Drug hypersensitivity 2007 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2017 Y
  C4591001 1007 
10071485 Immune system disorders Serum sickness 01JAN2013 Y 
    Reproductive system and breast 
disordersMenstruation irregular 01JAN2019 Y 
  C4591001 1007 
10071488 Eye disorders Blepharitis 01JAN2006 Y 
    Immune s ystem disorders Seasonal aller gy 01JAN2010 Y
  C4591001 1007 
10071492 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 Immune system disorders Seasonal allergy 01JAN2006 Y 
  C4591001 1007 
10071497 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2017 Y 
  C4591001 1007 
10071499 Immune system disorders Drug hypersensitivity 01JAN2009 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 40
(b) (6)
FDA-CBER-2022-5812-0499170
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1007 
10071500 Immune system disorders Seasonal allergy 01JAN2014 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2011 Y
  C4591001 1007 
10071504 Immune system disorders Drug hypersensitivity 2005 Y 
  C4591001 1007 
10071505 Congenital, familial and genetic 
disordersCerebral 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 
disordersMenorrhagia 01JAN2019 Y 
    Surgical and medical procedures Portal shunt procedure 01JAN2019 Y
  C4591001 1007 
10071511 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 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2014 Y 
  C4591001 1007 
10071514 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2012 Y 
  C4591001 1007 
10071515 Immune system disorders Drug hypersensitivity 2008 Y 
    Seasonal aller gy 01JAN2011 Y
  C4591001 1007 
10071516 Immune system disorders Seasonal allergy 01JAN2010 Y 
  C4591001 1007 
10071517 Immune system disorders Drug hypersensitivity 01JAN2010 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 41
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499171
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1007 
10071518 Nervous system disorders Headache 12OCT2020 Y 
  C4591001 1007 
10071520 Immune system disorders Seasonal allergy 01JAN2009 Y 
  C4591001 1007 
10071521 Immune system disorders Seasonal allergy 01JAN2016 Y 
  C4591001 1007 
10071522 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2019 Y 
  C4591001 1007 
10071524 Congenital, familial and genetic 
disordersFactor V Leiden carrier 01JAN2015 Y 
  C4591001 1007 
10071525 Congenital, familial and genetic 
disordersFactor V Leiden carrier 01JAN2012 Y 
  C4591001 1007 
10071527 Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2012 Y 
  C4591001 1007 
10071531 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
  C4591001 1007 
10071533 Immune system disorders Seasonal allergy 01JAN2010 Y 
  C4591001 1007 
10071535 Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
  C4591001 1007 
10071536 Nervous system disorders Migraine 01JAN2011 Y 
  C4591001 1007 
10071537 Nervous system disorders Migraine 01JAN2017 Y 
  C4591001 1007 
10071539 Gastrointestinal disorders Eosinophilic oesophagitis 01JAN2005 Y 
    Immune s ystem disorders Food aller gy 01JAN2006 Y
    Milk aller gy 01JAN2006 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 42
FDA-CBER-2022-5812-0499172
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1007 
10071541 Immune system disorders Seasonal allergy 01JAN2010 Y 
  C4591001 1007 
10071542 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2016 Y 
  C4591001 1007 
10071543 Neoplasms benign, malignant and 
unspecified (incl c ysts and pol yps)Nephroblastoma 01JAN2007 31DEC2007 N 
    Surgical and medical procedures Nephrectom y 01JAN2007 Y
  C4591001 1007 
10071544 Immune system disorders Seasonal allergy 01JAN2018 Y 
    Psychiatric disorders Anxiet y 01JAN2019 Y
  C4591001 1007 
10071546 Immune system disorders Drug hypersensitivity 2005 Y 
    Seasonal aller gy 2005 Y
    Infections and infestations Sinusitis 09NOV2020 13NOV2020 N
  C4591001 1007 
10071547 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2011 Y 
  C4591001 1007 
10071550 Immune system disorders Seasonal allergy 2007 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2018 Y 
  C4591001 1007 
10071551 Immune system disorders Seasonal allergy 01JAN2012 Y 
  C4591001 1007 
10071552 Immune system disorders Allergy to animal 01JAN2008 Y 
    Drug hypersensitivit y 01JAN2007 Y
    Hypersensitivit y 01JAN2008 Y
  C4591001 1007 
10071557 Skin and subcutaneous tissue 
disordersAcne cosmetica 01JAN2019 Y 
  C4591001 1007 
10071558 Immune system disorders Seasonal allergy 01JAN2012 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2012 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 43
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499173
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1007 
10071560 Immune system disorders Seasonal allergy 01JAN2014 Y 
    Skin and subcutaneous tissue 
disordersAcne 01MAY2019 Y 
  C4591001 1007 
10071561 Metabolism and nutrition disorders Hyperlipidaemia 01JAN2018 Y 
  C4591001 1007 
10071563 Immune system disorders Food allergy 01JAN2011 Y 
  C4591001 1007 
10071567 Immune system disorders Seasonal allergy 01JAN2011 Y 
  C4591001 1007 
10071570 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 Skin and subcutaneous tissue 
disordersEczema 01JAN2012 Y 
  C4591001 1007 
10071574 Injury, poisoning and procedural 
complicationsLower limb fracture 01AUG2020 30SEP2020 N 
  C4591001 1007 
10071575 Immune system disorders Food allergy 01JAN2008 Y 
  C4591001 1007 
10071577 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2011 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2008 Y 
  C4591001 1007 
10071581 Nervous system disorders Migraine 01JAN2018 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2012 Y
  C4591001 1007 
10071583 Immune system disorders Seasonal allergy 01JAN2014 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 44
FDA-CBER-2022-5812-0499174
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1007 
10071584 Immune system disorders Allergy to animal 01JAN2010 Y 
  C4591001 1007 
10071585 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2018 Y 
  C4591001 1007 
10071586 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2018 Y 
  C4591001 1007 
10071587 Immune system disorders Seasonal allergy 01JAN2012 Y 
  C4591001 1007 
10071590 Congenital, familial and genetic 
disordersTourette's disorder 01JAN2017 Y 
    Endocrine disorders Precocious pubert y 01JAN2017 Y
  C4591001 1007 
10071591 Congenital, familial and genetic 
disordersTourette's disorder 01JAN2017 Y 
  C4591001 1007 
10071592 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
  C4591001 1007 
10071593 Metabolism and nutrition disorders Type 1 diabetes mellitus 01JAN2011 Y 
  C4591001 1007 
10071594 Nervous system disorders Migraine 01JAN2019 Y 
  C4591001 1007 
10071596 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2015 Y 
  C4591001 1007 
10071599 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 Renal and urinary disorders Renal cyst 01JUN2020 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 45
FDA-CBER-2022-5812-0499175
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1007 
10071601 Immune system disorders Seasonal allergy 01JAN2010 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2017 Y
  C4591001 1007 
10071603 Endocrine disorders Hypothyroidism 30NOV2020 Y 
    Metabolism and nutrition disorders Type 1 diabetes mellitus 17DEC2018 Y
    Psychiatric disorders Anxiet y 01JAN2017 Y
  C4591001 1007 
10071605 Immune system disorders Food allergy 01JAN2012 Y 
      01MAR2020 Y
  C4591001 1007 
10071606 Psychiatric disorders Anxiety 01SEP2020 Y 
  C4591001 1007 
10071608 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2015 Y 
  C4591001 1007 
10071609 Endocrine disorders Hypothyroidism 01JAN2017 Y 
    Immune s ystem disorders Seasonal aller gy 01JAN2015 Y
  C4591001 1007 
10071613 Renal and urinary disorders Single functional kidney 2007 Y 
  C4591001 1007 
10071617 Immune system disorders Drug hypersensitivity 01JAN2005 Y 
  C4591001 1007 
10071618 Psychiatric disorders Anxiety 01JAN2017 Y 
    Attention deficit h yperactivit y disorde r 01JAN2017 Y
  C4591001 1007 
10071619 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2018 Y 
  C4591001 1007 
10071620 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2018 Y 
  C4591001 1007 
10071621 Psychiatric disorders Attention deficit hyperactivity disorder 01DEC2016 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 46
(b) (6)
FDA-CBER-2022-5812-0499176
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1007 
10071622 Psychiatric disorders Attention deficit hyperactivity disorder 01DEC2015 Y 
  C4591001 1007 
10071624 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2019 Y 
  C4591001 1007 
10071625 Immune system disorders Drug hypersensitivity 01NOV2007 Y 
  C4591001 1007 
10071627 Respiratory, thoracic and 
mediastinal disordersAsthma 01DEC2008 Y 
  C4591001 1007 
10071629 Immune system disorders Seasonal allergy 01JAN2010 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma exercise induced 01JAN2018 Y 
    Skin and subcutaneous tissue 
disordersEczema 01JAN2006 Y 
  C4591001 1007 
10071630 Immune system disorders Seasonal allergy 01DEC2014 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01DEC2014 Y
  C4591001 1007 
10071634 Immune system disorders Seasonal allergy 01JAN2017 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2018 Y
  C4591001 1007 
10071635 Immune system disorders Seasonal allergy 01JAN2018 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2015 Y 
  C4591001 1007 
10071638 Immune system disorders Seasonal allergy 01JAN2009 Y 
  C4591001 1007 
10071641 Immune system disorders Milk allergy 01JAN2017 Y 
    Skin and subcutaneous tissue 
disordersEczema 01JAN2016 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 47
FDA-CBER-2022-5812-0499177
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1007 
10071642 Nervous system disorders Migraine 01JAN2018 Y 
  C4591001 1007 
10071647 Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2010 Y 
  C4591001 1007 
10071650 Psychiatric disorders Anxiety 01JAN2020 Y 
    Attention deficit h yperactivit y disorde r 01JAN2013 Y
  C4591001 1007 
10071651 Immune system disorders Drug hypersensitivity 01JAN2010 Y 
  C4591001 1007 
10071653 Immune system disorders Seasonal allergy 01JAN2008 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2011 Y
  C4591001 1007 
10071654 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2019 Y 
  C4591001 1007 
10071656 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2014 Y 
  C4591001 1007 
10071658 Immune system disorders Allergy to animal 01APR2020 Y 
    Psychiatric disorders Depression 24DEC2020 Y
  C4591001 1008 
10081751 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 
disordersAcne 01JAN2019 Y 
    Hyperhidrosis 01JUN2020 Y
  C4591001 1008 
10081752 Immune system disorders Seasonal allergy 01JAN2007 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 48
(b) (6)
FDA-CBER-2022-5812-0499178
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1008 
10081753 Immune system disorders Seasonal allergy 01JAN2007 Y 
  C4591001 1008 
10081755 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 
disordersDermatitis contact 01JAN2019 Y 
  C4591001 1008 
10081756 Immune system disorders Drug hypersensitivity 01JAN2007 Y 
    Seasonal aller gy 01JAN2013 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2013 Y 
  C4591001 1008 
10081757 Immune system disorders Seasonal allergy 01JAN2018 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2018 Y
  C4591001 1008 
10081758 Skin and subcutaneous tissue 
disordersAcne 01JAN2017 Y 
  C4591001 1008 
10081761 Immune system disorders Seasonal allergy 01JAN2010 Y 
  C4591001 1008 
10081763 Immune system disorders Seasonal allergy 01JAN2010 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2013 Y
  C4591001 1008 
10081764 Immune system disorders Seasonal allergy 01JAN2010 Y 
  C4591001 1008 
10081767 Congenital, familial and genetic 
disordersVon Willebrand's disease 01JAN2009 Y 
    Immune s ystem disorders Seasonal aller gy 01JAN2011 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 49
FDA-CBER-2022-5812-0499179
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2011 Y
  C4591001 1008 
10081768 Psychiatric disorders Anxiety 01JAN2015 Y 
    Depression 01JAN2016 Y
    Obsessive-compulsive disorde r 01JAN2015 Y
  C4591001 1008 
10081769 Immune system disorders Drug hypersensitivity 01JAN2008 Y 
    Seasonal aller gy 01JAN2009 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2006 Y 
    Skin and subcutaneous tissue 
disordersEczema 01JAN2006 Y 
  C4591001 1008 
10081770 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 Immune system disorders Seasonal allergy 01JAN2017 Y 
  C4591001 1008 
10081777 Immune system disorders Drug hypersensitivity 01JAN2006 Y 
    Seasonal aller gy 01JAN2015 Y
  C4591001 1008 
10081780 Skin and subcutaneous tissue 
disordersAcne 01JAN2019 Y 
  C4591001 1008 
10081781 Immune system disorders Seasonal allergy 01JAN2018 Y 
  C4591001 1008 
10081785 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2015 Y 
  C4591001 1008 
10081788 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2017 Y 
  C4591001 1008 
10081789 Immune system disorders Drug hypersensitivity 01JAN2014 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 50
FDA-CBER-2022-5812-0499180
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2013 Y
    Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
  C4591001 1008 
10081790 Respiratory, thoracic and 
mediastinal disordersBronchial hyperreactivity 01JAN2010 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
    Social circumstances Premenarche 2008 Y
  C4591001 1008 
10081791 Psychiatric disorders Anxiety 01JAN2016 Y 
    Attention deficit h yperactivit y disorde r 01JAN2016 Y
  C4591001 1008 
10081792 Psychiatric disorders Anxiety 01JAN2015 Y 
    Attention deficit h yperactivit y disorde r 01JAN2015 Y
  C4591001 1008 
10081794 Social circumstances Premenarche 2008 Y 
  C4591001 1008 
10081795 Immune system disorders Seasonal allergy 01JAN2011 Y 
    Investi gations Body height decrease d 01JAN2019 Y
    Weight decrease d 01JAN2019 Y
  C4591001 1008 
10081798 Immune system disorders Drug hypersensitivity 01JAN2016 Y 
    Seasonal aller gy 01JAN2014 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2009 Y 
  C4591001 1008 
10081799 Skin and subcutaneous tissue 
disordersAcne 01SEP2020 Y 
    Social circumstances Premenarche 2007 11MAR2021 N
  C4591001 1008 
10081800 Psychiatric disorders Anxiety 01JAN2015 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 51
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499181
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Attention deficit h yperactivit y disorde r 01JAN2019 Y
    Depression 01JAN2015 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2016 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
  C4591001 1008 
10081801 Cardiac disorders Supraventricular tachycardia 01JAN2014 31DEC2019 N 
    Immune s ystem disorders Drug hypersensitivit y 01JAN2016 Y
    Seasonal aller gy 01JAN2014 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2014 Y 
    Surgical and medical procedures Cardiac ablation 01JAN2019 31DEC2019 N
  C4591001 1008 
10081803 Immune system disorders Seasonal allergy 01JAN2010 Y 
    Metabolism and nutrition disorders Obesit y 01JAN2018 Y
  C4591001 1008 
10081804 Immune system disorders Seasonal allergy 01JAN2014 Y 
  C4591001 1008 
10081805 Social circumstances Premenarche 2008 04FEB2021 N 
  C4591001 1008 
10081806 Nervous system disorders Migraine 01JAN2018 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2017 Y 
  C4591001 1008 
10081807 Immune system disorders Seasonal allergy 01JAN2015 Y 
  C4591001 1008 
10081809 Gastrointestinal disorders Constipation 01OCT2020 Y 
    Gastrooesopha geal reflux disease 01OCT2020 Y
    Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 52
(b) (6)
FDA-CBER-2022-5812-0499182
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1008 
10081810 Psychiatric disorders Attention deficit hyperactivity disorder 01SEP2020 Y 
  C4591001 1008 
10081812 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2016 Y 
  C4591001 1008 
10081814 Congenital, familial and genetic 
disordersMetabolic myopathy 01JAN2019 Y 
    Immune s ystem disorders Rubber sensitivit y 01JAN2010 Y
    Nervous s ystem disorders Syncope 01OCT2020 Y
  C4591001 1008 
10081816 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2016 Y 
  C4591001 1008 
10081818 Psychiatric disorders Anxiety 01JAN2014 Y 
    Attention deficit h yperactivit y disorde r 01JAN2014 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2007 Y 
  C4591001 1008 
10081819 Immune system disorders Seasonal allergy 01MAR2020 Y 
  C4591001 1008 
10081820 Immune system disorders Drug hypersensitivity 01JAN2012 Y 
  C4591001 1008 
10081821 Immune system disorders Seasonal allergy 01JAN2008 Y 
  C4591001 1008 
10081822 Immune system disorders Seasonal allergy 01JAN2012 Y 
    Psychiatric disorders Anxiet y 01JAN2019 Y
    Depression 01JAN2019 Y
  C4591001 1008 
10081823 Immune system disorders Drug hypersensitivity 01JAN2008 Y 
  C4591001 1008 
10081824 Immune system disorders Seasonal allergy 01JAN2017 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2019 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 53
FDA-CBER-2022-5812-0499183
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1008 
10081825 Social circumstances Premenarche 2008 Y 
  C4591001 1008 
10081826 Immune system disorders Drug hypersensitivity 01JAN2008 Y 
  C4591001 1008 
10081827 Immune system disorders Drug hypersensitivity 01JAN2010 Y 
  C4591001 1008 
10081828 Immune system disorders Seasonal allergy 01JAN2010 Y 
    Skin and subcutaneous tissue 
disordersHand dermatitis 01JAN2010 Y 
  C4591001 1008 
10081830 Immune system disorders Seasonal allergy 01JAN2019 Y 
  C4591001 1008 
10081831 Skin and subcutaneous tissue 
disordersAcne 01JUN2020 Y 
  C4591001 1008 
10081832 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 Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
  C4591001 1008 
10081837 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2016 Y 
  C4591001 1008 
10081838 Psychiatric disorders Anxiety 01JAN2013 Y 
    Attention deficit h yperactivit y disorde r 01JAN2013 Y
    Autism spectrum disorde r 01JAN2013 Y
    Depression 01JAN2013 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 54
(b) (6)
FDA-CBER-2022-5812-0499184
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1008 
10081839 Skin and subcutaneous tissue 
disordersAcne 01JAN2020 Y 
  C4591001 1008 
10081841 Immune system disorders Seasonal allergy 01JAN2018 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2013 Y
  C4591001 1008 
10081842 Congenital, familial and genetic 
disordersNeurofibromatosis 01JAN2012 Y 
    Immune s ystem disorders Seasonal aller gy 01JAN2017 Y
    Social circumstances Premenarche 2008 Y
  C4591001 1008 
10081843 Immune system disorders Food allergy 01JAN2015 Y 
    Seasonal aller gy 01JAN2010 Y
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2010 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2007 Y 
  C4591001 1008 
10081846 Immune system disorders Seasonal allergy 01JAN2013 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2017 Y 
  C4591001 1008 
10081847 Psychiatric disorders Anxiety 01JAN2018 Y 
    Depression 01JAN2018 Y
    Tic 01OCT2020 Y
  C4591001 1008 
10081850 Immune system disorders Seasonal allergy 01JAN2015 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2019 Y 
  C4591001 1008 
10081851 Psychiatric disorders Anxiety 01OCT2018 Y 
    Autism spectrum disorde r 01JAN2009 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 55
(b) (6)
FDA-CBER-2022-5812-0499185
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1008 
10081852 Psychiatric disorders Autism spectrum disorder 01JAN2007 Y 
    Depression 01JAN2017 Y
  C4591001 1008 
10081853 Congenital, familial and genetic 
disordersGilbert's syndrome 01MAR2019 Y 
    Immune s ystem disorders Seasonal aller gy 01JAN2018 Y
  C4591001 1008 
10081854 Immune system disorders Seasonal allergy 01JAN2011 Y 
  C4591001 1008 
10081855 Nervous system disorders Migraine 01JAN2016 Y 
    Skin and subcutaneous tissue 
disordersEczema 01JAN2011 Y 
    Psoriasis 01JAN2015 Y
  C4591001 1008 
10081856 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 Social circumstances Premenarche 2007 Y 
  C4591001 1008 
10081858 Immune system disorders Seasonal allergy 01JAN2013 Y 
  C4591001 1008 
10081860 Immune system disorders Seasonal allergy 01JAN2010 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2010 Y 
    Skin and subcutaneous tissue 
disordersEczema 01JAN2007 Y 
  C4591001 1008 
10081864 Social circumstances Premenarche 2008 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 56
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499186
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1008 
10081865 Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2009 Y 
    Skin and subcutaneous tissue 
disordersEczema 01JAN2008 Y 
    Hand dermatitis 01JAN2008 Y
  C4591001 1008 
10081866 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2014 Y 
  C4591001 1008 
10081867 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2017 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2019 Y 
  C4591001 1008 
10081869 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 
disordersAcne 01JAN2020 Y 
      01JUN2020 Y
  C4591001 1008 
10081870 Immune system disorders Drug hypersensitivity 01JAN2016 Y 
  C4591001 1008 
10081871 Immune system disorders Drug hypersensitivity 01JAN2015 Y 
    Nervous s ystem disorders Migraine 01JAN2018 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2016 Y 
  C4591001 1008 
10081872 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2014 Y 
  C4591001 1008 
10081873 Immune system disorders Seasonal allergy 01JAN2015 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 57
FDA-CBER-2022-5812-0499187
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1008 
10081875 Infections and infestations Appendicitis 01JUL2020 31JUL2020 N 
    Surgical and medical procedures Appendicectom y 01JUL2020 31JUL2020 N
  C4591001 1008 
10081877 Immune system disorders Seasonal allergy 01JAN2017 Y 
    Psychiatric disorders Anxiet y 01MAR2020 Y
    Depression 01MAR2020 Y
  C4591001 1008 
10081878 Skin and subcutaneous tissue 
disordersAcne 01JAN2019 Y 
  C4591001 1008 
10081879 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
  C4591001 1008 
10081880 Social circumstances Premenarche 2006 Y 
  C4591001 1008 
10081881 Social circumstances Premenarche 2008 Y 
  C4591001 1008 
10081883 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 
disordersAcne 01APR2020 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 58
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499188
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1008 
10081884 Immune system disorders Drug hypersensitivity 01JAN2006 Y 
    Skin and subcutaneous tissue 
disordersHand dermatitis 01JAN2018 Y 
  C4591001 1008 
10081886 Social circumstances Premenarche 2008 Y 
  C4591001 1008 
10081887 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2017 Y 
    Social circumstances Premenarche 2008 Y
  C4591001 1008 
10081889 Musculoskeletal and connective 
tissue disordersScoliosis 01JUN2020 Y 
  C4591001 1008 
10081890 Immune system disorders Seasonal allergy 01JAN2017 Y 
    Skin and subcutaneous tissue 
disordersEczema 01JAN2012 Y 
    Hand dermatitis 01JAN2012 Y
  C4591001 1008 
10081891 Immune system disorders Seasonal allergy 01JAN2011 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2014 Y
    Skin and subcutaneous tissue 
disordersAcne 01JUN2020 Y 
  C4591001 1008 
10081892 Psychiatric disorders Anxiety 01JAN2018 Y 
    Attention deficit h yperactivit y disorde r 01JAN2014 Y
    Skin and subcutaneous tissue 
disordersDermatitis contact 01JAN2014 Y 
  C4591001 1008 
10081893 Immune system disorders Drug hypersensitivity 01JAN2008 Y 
    Seasonal aller gy 01JAN2009 Y
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2020 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 59
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499189
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Reproductive system and breast 
disordersDysfunctional uterine bleeding 01JAN2020 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2016 Y 
    Skin and subcutaneous tissue 
disordersHand dermatitis 01JAN2007 Y 
  C4591001 1008 
10081894 Immune system disorders Seasonal allergy 01JAN2011 Y 
  C4591001 1008 
10081895 Social circumstances Premenarche 2006 Y 
  C4591001 1008 
10081897 Immune system disorders Seasonal allergy 01JAN2016 Y 
  C4591001 1008 
10081898 Psychiatric disorders Anxiety 01JAN2019 Y 
    Social circumstances Premenarche 2008 Y
  C4591001 1008 
10081901 Immune system disorders Drug hypersensitivity 2005 Y 
  C4591001 1008 
10081902 Immune system disorders Seasonal allergy 01JAN2010 Y 
  C4591001 1008 
10081903 Immune system disorders Seasonal allergy 01JAN2010 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2017 Y
    Skin and subcutaneous tissue 
disordersEczema 2008 Y 
  C4591001 1008 
10081904 Immune system disorders Seasonal allergy 01JAN2009 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2015 Y 
  C4591001 1008 
10081905 Skin and subcutaneous tissue 
disordersAcne 01JAN2020 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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FDA-CBER-2022-5812-0499190
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1008 
10081906 Immune system disorders Drug hypersensitivity 01JAN2017 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
  C4591001 1008 
10081907 Reproductive system and breast 
disordersDysmenorrhoea 01SEP2020 Y 
  C4591001 1008 
10081908 Social circumstances Premenarche 2008 Y 
  C4591001 1008 
10081910 Immune system disorders Seasonal allergy 01JAN2008 Y 
  C4591001 1008 
10081911 Immune system disorders Seasonal allergy 01JAN2014 Y 
  C4591001 1008 
10081912 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2013 Y 
    Respiratory, thoracic and 
mediastinal disordersSleep apnoea syndrome 01JAN2018 Y 
  C4591001 1008 
10081913 Immune system disorders Drug hypersensitivity 01JAN2008 Y 
    Seasonal aller gy 01JAN2016 Y
  C4591001 1008 
10081914 Immune system disorders Seasonal allergy 01JAN2010 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2009 Y 
    Skin and subcutaneous tissue 
disordersAcanthosis nigricans 01JUL2020 Y 
  C4591001 1008 
10081915 Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2009 Y 
  C4591001 1008 
10081916 Skin and subcutaneous tissue 
disordersAcne 01JUL2020 Y 
  C4591001 1008 
10081917 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2015 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499191
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Skin and subcutaneous tissue 
disordersPsoriasis 01JAN2012 Y 
  C4591001 1008 
10081918 Social circumstances Premenarche 2008 Y 
  C4591001 1008 
10081919 Immune system disorders Drug hypersensitivity 01JAN2016 Y 
  C4591001 1008 
10081920 Psychiatric disorders Enuresis 01JAN2016 Y 
  C4591001 1008 
10081921 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2012 Y 
    Respiratory, thoracic and 
mediastinal disordersEpistaxis 01JAN2017 Y 
  C4591001 1008 
10081922 Nervous system disorders Migraine 01JAN2016 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2013 Y
  C4591001 1008 
10081923 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2014 Y 
    Social circumstances Premenarche 2008 Y
  C4591001 1008 
10081924 Congenital, familial and genetic 
disordersBicuspid aortic valve 01JAN2017 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2014 Y
  C4591001 1008 
10081928 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 Social circumstances Premenarche 2008 Y 
  C4591001 1008 
10081930 Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2011 Y 
    Social circumstances Premenarche 2008 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499192
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1008 
10081931 Immune system disorders Seasonal allergy 01JAN2013 Y 
  C4591001 1008 
10081932 Psychiatric disorders Anxiety 01FEB2019 Y 
  C4591001 1008 
10081934 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 
disordersAlopecia areata 01JAN2020 Y 
    Social circumstances Premenarche 2007 Y
  C4591001 1008 
10081935 Psychiatric disorders Anxiety 01JAN2015 Y 
  C4591001 1008 
10081937 Immune system disorders Seasonal allergy 01JAN2010 Y 
  C4591001 1008 
10081938 Immune system disorders Drug hypersensitivity 01JAN2015 Y 
    Seasonal aller gy 01JAN2009 Y
  C4591001 1008 
10081940 Immune system disorders Seasonal allergy 01JAN2012 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2007 Y 
  C4591001 1008 
10081941 Immune system disorders Seasonal allergy 01JAN2011 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2011 Y 
    Social circumstances Premenarche 2008 Y
  C4591001 1008 
10081942 Immune system disorders Seasonal allergy 01JAN2007 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2007 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 63
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499193
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Skin and subcutaneous tissue 
disordersAcne 01AUG2020 Y 
  C4591001 1008 
10081943 Immune system disorders Drug hypersensitivity 01JAN2008 Y 
  C4591001 1009 
10091204 Immune system disorders Seasonal allergy 01JAN2018 Y 
  C4591001 1009 
10091208 Immune system disorders Drug hypersensitivity 01JAN2006 Y 
    Seasonal aller gy 01JAN2012 Y
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2012 Y 
  C4591001 1009 
10091209 Psychiatric disorders Anxiety 01SEP2018 Y 
    Attention deficit h yperactivit y disorde r 01SEP2017 Y
    Social circumstances Premenarche 2007 Y
  C4591001 1009 
10091212 Infections and infestations Tinea infection 06SEP2020 Y 
  C4591001 1009 
10091218 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
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2014 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 16SEP2011 Y 
    Rhinitis aller gic 01JAN2009 Y
  C4591001 1009 
10091220 Immune system disorders Seasonal allergy 12JUN2017 Y 
    Injury, poisoning and procedural 
complicationsPost concussion syndrome 01JUN2019 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499194
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Nervous s ystem disorders Headache 05MAY2017 Y
    Migraine 05MAY2017 Y
    Psychiatric disorders Anxiet y 01JAN2018 Y
    Depression 01JAN2018 Y
  C4591001 1009 
10091221 Infections and infestations Tonsillitis 10AUG2017 30APR2019 N 
    Musculoskeletal and connective 
tissue disordersArthralgia 01JAN2018 Y 
    Skin and subcutaneous tissue 
disordersAcne 01FEB2020 Y 
    Social circumstances Premenarche 2006 Y
  C4591001 1009 
10091223 Nervous system disorders Benign rolandic epilepsy 01JAN2014 31DEC2016 N 
  C4591001 1009 
10091226 Psychiatric disorders Depression 01JAN2019 Y 
  C4591001 1009 
10091227 Immune system disorders Seasonal allergy 01JAN2010 Y 
    Skin and subcutaneous tissue 
disordersUrticaria 01JAN2018 Y 
  C4591001 1009 
10091229 Immune system disorders Seasonal allergy 01JAN2013 Y 
    Infections and infestations Ear infection 01JAN2016 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma exercise induced 19AUG2020 Y 
  C4591001 1009 
10091233 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2017 Y 
  C4591001 1009 
10091234 Immune system disorders Seasonal allergy 01JAN2017 Y 
  C4591001 1009 
10091237 Immune system disorders Seasonal allergy 01JAN2015 Y 
    Metabolism and nutrition disorders Lactose intolerance 01JAN2007 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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FDA-CBER-2022-5812-0499195
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Musculoskeletal and connective 
tissue disordersArthralgia 01JAN2016 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2017 Y 
  C4591001 1009 
10091238 Skin and subcutaneous tissue 
disordersAcne 01JAN2017 Y 
  C4591001 1009 
10091247 Immune system disorders Drug hypersensitivity 01JAN2009 Y 
    Seasonal aller gy 01JAN2019 Y
  C4591001 1009 
10091249 Skin and subcutaneous tissue 
disordersAcne 01JAN2015 Y 
  C4591001 1009 
10091265 Metabolism and nutrition disorders Obesity 01JAN2017 Y 
  C4591001 1009 
10091266 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, thoracic and 
mediastinal disordersAsthma 01JAN2008 Y 
  C4591001 1009 
10091267 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 Respiratory, thoracic and 
mediastinal disordersAsthma exercise induced 01JUL2020 Y 
  C4591001 1009 
10091273 Respiratory, thoracic and 
mediastinal disordersTracheomalacia 01DEC2005 Y 
  C4591001 1009 
10091274 Skin and subcutaneous tissue 
disordersEczema 01JAN2015 Y 
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FDA-CBER-2022-5812-0499196
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1009 
10091277 Immune system disorders Drug hypersensitivity 01JAN2008 Y 
    Skin and subcutaneous tissue 
disordersKeratosis pilaris 19FEB2020 Y 
  C4591001 1009 
10091280 Psychiatric disorders Enuresis 01JAN2011 Y 
    Social circumstances Premenarche 2008 Y
  C4591001 1009 
10091282 Skin and subcutaneous tissue 
disordersAcne 01JUN2019 Y 
  C4591001 1009 
10091283 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, thoracic and 
mediastinal disordersAsthma exercise induced 01JAN2016 Y 
    Skin and subcutaneous tissue 
disordersEczema 01JAN2007 Y 
  C4591001 1009 
10091287 Immune system disorders Seasonal allergy 01JAN2018 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2016 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2017 Y 
    Eczema 2005 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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FDA-CBER-2022-5812-0499197
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1009 
10091288 Immune system disorders Seasonal allergy 01JAN2017 Y 
    Skin and subcutaneous tissue 
disordersEczema 01JAN2008 Y 
  C4591001 1009 
10091289 Immune system disorders Seasonal allergy 01JAN2014 Y 
  C4591001 1009 
10091292 Immune system disorders Seasonal allergy 01JAN2018 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2017 Y 
  C4591001 1009 
10091293 Immune system disorders Drug hypersensitivity 01JAN2011 Y 
    Skin and subcutaneous tissue 
disordersEczema 01JAN2008 Y 
  C4591001 1009 
10091294 Reproductive system and breast 
disordersMenorrhagia 01JAN2018 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2017 Y 
    Dermatitis atopic 01JAN2018 Y
  C4591001 1009 
10091295 Social circumstances Premenarche 2008 Y 
  C4591001 1009 
10091297 Immune system disorders Food allergy 01JAN2008 Y 
    Nervous s ystem disorders Headache 01JAN2014 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2014 Y 
  C4591001 1009 
10091300 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2016 Y 
  C4591001 1009 
10091301 Immune system disorders Allergy to animal 01JAN2016 Y 
    Food aller gy 01JAN2016 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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FDA-CBER-2022-5812-0499198
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    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, thoracic and 
mediastinal disordersAsthma 01JAN2016 Y 
  C4591001 1009 
10091304 Investigations Cardiac murmur 01JAN2007 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2010 Y 
  C4591001 1009 
10091305 Immune system disorders Seasonal allergy 01JAN2012 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2011 Y
  C4591001 1009 
10091307 Immune system disorders Drug hypersensitivity 01JAN2008 Y 
    Skin and subcutaneous tissue 
disordersHand dermatitis 01JAN2015 Y 
  C4591001 1009 
10091308 Immune system disorders Drug hypersensitivity 01JAN2010 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2019 Y
  C4591001 1009 
10091309 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 Cardiac disorders Postural orthostatic tachycardia syndrome 01JAN2018 Y 
    Immune s ystem disorders Seasonal aller gy 01JAN2012 Y
    Nervous s ystem disorders Migraine 01JAN2011 Y
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FDA-CBER-2022-5812-0499199
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1009 
10091311 Congenital, familial and genetic 
disordersBicuspid aortic valve 2007 Y 
    Renal and urinar y disorders Dysuria 20NOV2020 23NOV2020 N
  C4591001 1009 
10091312 Immune system disorders Seasonal allergy 01JAN2011 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2015 Y 
    Rhinitis aller gic 01JAN2011 Y
  C4591001 1009 
10091314 Immune system disorders Drug hypersensitivity 01JAN2007 Y 
    Seasonal aller gy 01JAN2013 Y
  C4591001 1009 
10091315 Immune system disorders Drug hypersensitivity 01JAN2008 Y 
    Nervous s ystem disorders Headache 01JAN2012 Y
    Skin and subcutaneous tissue 
disordersAcne 01FEB2020 Y 
  C4591001 1009 
10091316 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 Immune system disorders Hypersensitivity 01JAN2012 Y 
    Social circumstances Premenarche 2006 Y
  C4591001 1009 
10091319 Immune system disorders Food allergy 01JAN2014 Y 
    Seasonal aller gy 01JAN2014 Y
  C4591001 1009 
10091320 Psychiatric disorders Depression 01SEP2020 Y 
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FDA-CBER-2022-5812-0499200
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Suicidal ideation 01SEP2020 Y
  C4591001 1009 
10091321 Investigations Cardiac murmur 10DEC2020 Y 
    Nervous s ystem disorders Migraine 01JAN2016 Y
    Skin and subcutaneous tissue 
disordersNail psoriasis 01JAN2016 Y 
  C4591001 1009 
10091323 Immune system disorders Drug hypersensitivity 01JAN2013 Y 
      01JAN2015 Y
  C4591001 1009 
10091324 Immune system disorders Seasonal allergy 01JAN2015 Y 
  C4591001 1009 
10091326 Immune system disorders Seasonal allergy 01JAN2017 Y 
    Psychiatric disorders Generalised anxiet y disorde r 01JAN2018 Y
    Skin and subcutaneous tissue 
disordersEczema 2008 Y 
    Social circumstances Premenarche 2008 Y
  C4591001 1009 
10091328 Congenital, familial and genetic 
disordersPectus excavatum 2007 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2016 Y
    Social circumstances Premenarche 2007 Y
  C4591001 1009 
10091330 Metabolism and nutrition disorders Food intolerance 01JAN2015 Y 
    Lactose intolerance 01JAN2019 Y
    Social circumstances Premenarche 2007 Y
  C4591001 1009 
10091331 Musculoskeletal and connective 
tissue disordersPain in jaw 01JAN2014 Y 
    Nervous s ystem disorders Headache 01JAN2020 Y
    Social circumstances Premenarche 2007 Y
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FDA-CBER-2022-5812-0499201
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1009 
10091333 Cardiac disorders Aortic valve disease 01JAN2008 Y 
  C4591001 1009 
10091334 General disorders and 
administration site conditionsDrug 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, thoracic and 
mediastinal disordersAsthma 01JAN2017 Y 
    Skin and subcutaneous tissue 
disordersEczema 01JUN2020 Y 
    Social circumstances Premenarche 2007 Y
  C4591001 1009 
10091335 Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
  C4591001 1009 
10091336 Immune system disorders Food allergy 01JAN2011 Y 
    Seasonal aller gy 01JAN2011 Y
  C4591001 1009 
10091338 Cardiac disorders Ventricular extrasystoles 30OCT2019 Y 
  C4591001 1009 
10091340 Immune system disorders Drug hypersensitivity 01JAN2007 Y 
    Metabolism and nutrition disorders Obesit y 01JAN2016 Y
  C4591001 1009 
10091341 Psychiatric disorders Anxiety 01DEC2019 Y 
  C4591001 1009 
10091342 Immune system disorders Drug hypersensitivity 01JAN2007 Y 
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2007 Y 
    Skin and subcutaneous tissue 
disordersHand dermatitis 01JAN2018 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499202
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1009 
10091343 Social circumstances Premenarche 2007 Y 
  C4591001 1009 
10091344 Reproductive system and breast 
disordersVaricocele 01JAN2019 Y 
  C4591001 1009 
10091345 Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2014 Y 
  C4591001 1009 
10091346 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 
disordersEczema 01FEB2020 Y 
  C4591001 1009 
10091347 Investigations Cardiac murmur 15DEC2020 Y 
    Social circumstances Premenarche 2007 Y
  C4591001 1009 
10091349 Congenital, familial and genetic 
disordersImperforate hymen 06JUL2020 Y 
    Reproductive system and breast 
disordersDysmenorrhoea 01AUG2019 Y 
  C4591001 1009 
10091350 Immune system disorders Allergy to animal 2006 Y 
  C4591001 1009 
10091351 Social circumstances Premenarche 2008 Y 
  C4591001 1009 
10091353 Social circumstances Premenarche 2008 Y 
  C4591001 1009 
10091354 Immune system disorders Drug hypersensitivity 01JAN2008 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2018 Y
  C4591001 1009 
10091355 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2019 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499203
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Insomnia 01JAN2017 Y
    Oppositional defiant disorde r 01JAN2019 Y
  C4591001 1009 
10091356 Social circumstances Premenarche 2007 Y 
  C4591001 1009 
10091357 Musculoskeletal and connective 
tissue disordersArthralgia 01JAN2017 Y 
    Back pain 01JAN2018 Y
    Nervous s ystem disorders Headache 01JAN2018 Y
    Psychiatric disorders Insomnia 01JAN2017 Y
  C4591001 1009 
10091358 Immune system disorders Drug hypersensitivity 01JAN2007 Y 
    Nervous s ystem disorders Migraine 01JAN2018 Y
  C4591001 1009 
10091359 Congenital, familial and genetic 
disordersTransposition 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, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2012 Y 
    Surgical and medical procedures Arterial switch operation 2007 2007 N
  C4591001 1009 
10091360 Musculoskeletal and connective 
tissue disordersScoliosis 01MAY2019 31JUL2019 N 
    Psychiatric disorders Insomnia 01JAN2010 Y
    Surgical and medical procedures Spinal fusion sur gery 01JUL2019 31JUL2019 N
  C4591001 1009 
10091361 Psychiatric disorders Insomnia 01JAN2019 Y 
  C4591001 1009 
10091362 Congenital, familial and genetic 
disordersBicuspid aortic valve 2008 Y 
    Psychiatric disorders Anxiet y 01JAN2018 Y
    Attention deficit h yperactivit y disorde r 01JAN2017 Y
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(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499204
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Insomnia 01JAN2016 Y
  C4591001 1009 
10091363 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2016 Y 
    Insomnia 01JAN2016 Y
    Skin and subcutaneous tissue 
disordersAcne 01JAN2019 Y 
  C4591001 1009 
10091364 Metabolism and nutrition disorders Obesity 01JAN2016 Y 
  C4591001 1009 
10091365 Psychiatric disorders Anxiety 01JAN2014 Y 
  C4591001 1009 
10091366 Congenital, familial and genetic 
disordersAtrial 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 Immune system disorders Perennial allergy 01JAN2014 Y 
    Injury, poisoning and procedural 
complicationsLigament sprain 01JAN2019 Y 
    Nervous s ystem disorders Headache 01JAN2019 Y
    Social circumstances Premenarche 2008 Y
  C4591001 1009 
10091370 Social circumstances Premenarche 2007 Y 
  C4591001 1009 
10091371 Immune system disorders Seasonal allergy 01JAN2017 Y 
  C4591001 1009 
10091372 Metabolism and nutrition disorders Type 1 diabetes mellitus 01JUN2019 Y 
  C4591001 1009 
10091376 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2014 Y 
    Insomnia 01JAN2020 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 75
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499205
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1009 
10091380 Immune system disorders Drug hypersensitivity 01JAN2007 Y 
  C4591001 1009 
10091381 Nervous system disorders Migraine 01JAN2016 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2016 Y
    Skin and subcutaneous tissue 
disordersUrticaria 01JAN2012 Y 
    Social circumstances Premenarche 2008 Y
  C4591001 1009 
10091382 Gastrointestinal disorders Coeliac disease 01JAN2013 Y 
    Psychiatric disorders Anxiet y 01JAN2018 Y
  C4591001 1009 
10091383 Immune system disorders Drug hypersensitivity 01JAN2008 Y 
    Nervous s ystem disorders Nystagmus 2005 Y
    Psychiatric disorders Obsessive-compulsive disorde r 01JAN2017 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2009 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
  C4591001 1009 
10091384 Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
  C4591001 1009 
10091386 Immune system disorders Drug hypersensitivity 01JAN2008 Y 
    Seasonal aller gy 01JAN2020 Y
    Skin and subcutaneous tissue 
disordersPsoriasis 01JAN2015 Y 
  C4591001 1009 
10091387 Injury, poisoning and procedural 
complicationsWrist fracture 01JAN2021 Y 
  C4591001 1009 
10091388 Immune system disorders Drug hypersensitivity 01DEC2018 Y 
    Seasonal aller gy 01JAN2018 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 76
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499206
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Injury, poisoning and procedural 
complicationsRadius fracture 26DEC2020 Y 
    Psychiatric disorders Anxiet y 01JAN2017 Y
    Skin and subcutaneous tissue 
disordersEczema 01JAN2008 Y 
  C4591001 1009 
10091391 Immune system disorders Anaphylactic reaction 01JAN2007 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2014 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2017 Y 
  C4591001 1009 
10091392 Immune system disorders Food allergy 01FEB2010 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2012 Y 
    Social circumstances Premenarche 2008 Y
  C4591001 1009 
10091396 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2013 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
  C4591001 1009 
10091398 Injury, poisoning and procedural 
complicationsMeniscus injury 31DEC2020 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma exercise induced 01SEP2020 Y 
  C4591001 1009 
10091399 Social circumstances Premenarche 2008 Y 
  C4591001 1009 
10091400 Infections and infestations Otitis media 01JAN2008 31DEC2017 N 
    Skin and subcutaneous tissue 
disordersDrug eruption 01JAN2008 Y 
    Surgical and medical procedures Adenoidectom y 01JAN2016 31DEC2016 N
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 77
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499207
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Ear tube insertion 01JAN2014 31DEC2014 N
  C4591001 1009 
10091402 Immune system disorders Drug hypersensitivity 01JAN2015 Y 
  C4591001 1009 
10091403 Immune system disorders Hypersensitivity 01JAN2012 Y 
    Metabolism and nutrition disorders Obesit y 01JAN2017 Y
    Skin and subcutaneous tissue 
disordersAcne 01JAN2017 Y 
  C4591001 1009 
10091404 Immune system disorders Seasonal allergy 01JAN2014 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2016 Y 
    Social circumstances Premenarche 2008 Y
  C4591001 1009 
10091405 Immune system disorders Seasonal allergy 01JAN2005 Y 
  C4591001 1009 
10091406 Immune system disorders Drug hypersensitivity 01JAN2018 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
  C4591001 1009 
10091407 Immune system disorders Drug hypersensitivity 01JAN2008 Y 
      01SEP2019 Y
    Skin and subcutaneous tissue 
disordersAcne 01JAN2019 Y 
  C4591001 1009 
10091408 Psychiatric disorders Attention deficit hyperactivity disorder 01JUN2020 Y 
    Social circumstances Premenarche 2007 Y
  C4591001 1009 
10091409 Psychiatric disorders Depression 01JAN2020 Y 
  C4591001 1009 
10091410 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2015 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 78
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499208
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Social circumstances Premenarche 2008 Y
  C4591001 1009 
10091412 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, thoracic and 
mediastinal disordersAsthma 01JAN2010 Y 
  C4591001 1009 
10091413 Respiratory, thoracic and 
mediastinal disordersAsthma exercise induced 01JAN2017 Y 
    Skin and subcutaneous tissue 
disordersAcne 01MAY2020 Y 
    Social circumstances Premenarche 2007 Y
  C4591001 1009 
10091414 Immune system disorders Allergy to animal 01JAN2017 Y 
    Drug hypersensitivit y 01JAN2012 Y
    Seasonal aller gy 01JAN2017 Y
  C4591001 1013 
10131821 Hepatobiliary disorders Cholelithiasis 01JUN2020 30JUN2020 N 
    Surgical and medical procedures Cholec ystectom y 01SEP2020 30SEP2020 N
  C4591001 1013 
10131823 Congenital, familial and genetic 
disordersSickle cell trait 2005 Y 
    Metabolism and nutrition disorders Obesit y 01JAN2013 Y
  C4591001 1013 
10131824 Congenital, familial and genetic 
disordersSickle cell anaemia 01JAN2007 Y 
    Surgical and medical procedures Central venous catheterisation 01JAN2018 Y
  C4591001 1013 
10131826 Immune system disorders Drug hypersensitivity 01JAN2018 Y 
  C4591001 1013 
10131828 Immune system disorders Drug hypersensitivity 01JAN2006 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 79
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499209
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Seasonal aller gy 01JAN2008 Y
  C4591001 1013 
10131830 Immune system disorders Drug hypersensitivity 01JAN2012 Y 
  C4591001 1013 
10131839 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2019 Y 
  C4591001 1013 
10131841 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2013 Y 
  C4591001 1013 
10131842 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2011 Y 
  C4591001 1013 
10131843 Immune system disorders Hypersensitivity 01JAN2018 Y 
    Metabolism and nutrition disorders Decreased appetite 01JAN2018 Y
    Psychiatric disorders Attention deficit h yperactivit y disorde r 02DEC2016 Y
    Insomnia 01JAN2018 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2016 Y 
  C4591001 1013 
10131844 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 Immune system disorders Drug hypersensitivity 01JAN2015 Y 
  C4591001 1013 
10131846 Immune system disorders Hypersensitivity 01JAN2007 Y 
  C4591001 1013 
10131850 Eye disorders Myopia 01JAN2014 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2011 Y
  C4591001 1013 
10131852 Nervous system disorders Headache 01JAN2016 Y 
    Migraine 01JAN2015 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 80
FDA-CBER-2022-5812-0499210
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1013 
10131855 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2011 Y 
    Depression 01JAN2019 Y
    Insomnia 01JAN2019 Y
  C4591001 1013 
10131858 Social circumstances Premenarche 2007 Y 
  C4591001 1013 
10131859 Psychiatric disorders Attention deficit hyperactivity disorder 01JUN2020 Y 
  C4591001 1013 
10131860 Immune system disorders Seasonal allergy 01JAN2017 Y 
  C4591001 1013 
10131861 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2016 Y 
  C4591001 1013 
10131867 Immune system disorders Hypersensitivity 01JAN2015 Y 
    Infections and infestations Tonsillitis 01JAN2016 31DEC2016 N
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2014 Y 
    Surgical and medical procedures Tonsillectom y 01JAN2016 31DEC2016 N
  C4591001 1013 
10131868 Immune system disorders Seasonal allergy 01JAN2018 Y 
    Musculoskeletal and connective 
tissue disordersScoliosis 01JUL2018 Y 
  C4591001 1013 
10131869 Immune system disorders Seasonal allergy 2006 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01MAR2016 Y
  C4591001 1013 
10131870 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2012 Y 
  C4591001 1013 
10131871 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2013 Y 
  C4591001 1013 
10131872 Immune system disorders Food allergy 01JAN2010 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 81
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499211
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2017 Y
  C4591001 1013 
10131873 Eye disorders Myopia 01JAN2014 Y 
  C4591001 1013 
10131874 Eye disorders Myopia 01JAN2016 Y 
    Surgical and medical procedures Myringotom y 01JAN2009 31DEC2009 N
  C4591001 1013 
10131875 Immune system disorders Drug hypersensitivity 01JAN2015 Y 
    Musculoskeletal and connective 
tissue disordersTendonitis 01JAN2019 Y 
  C4591001 1013 
10131876 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2013 Y 
  C4591001 1013 
10131877 Psychiatric disorders Attention deficit hyperactivity disorder 01NOV2013 Y 
  C4591001 1013 
10131879 Endocrine disorders Growth hormone deficiency 01JAN2019 Y 
  C4591001 1013 
10131881 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2008 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2007 Y 
  C4591001 1016 
10161307 Immune system disorders Seasonal allergy 04FEB2016 Y 
    Psychiatric disorders Depression 15JUN2020 Y
  C4591001 1016 
10161308 Immune system disorders Seasonal allergy 30MAR2010 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 30MAR2010 Y 
    Skin and subcutaneous tissue 
disordersEczema 08JAN2013 Y 
    Psoriasis 16DEC2014 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 82
FDA-CBER-2022-5812-0499212
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1016 
10161310 Immune system disorders Seasonal allergy 01APR2016 Y 
  C4591001 1016 
10161311 Immune system disorders Seasonal allergy 18DEC2015 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 07MAR2012 Y 
  C4591001 1016 
10161314 Immune system disorders Seasonal allergy 01JUN2007 Y 
  C4591001 1016 
10161315 Immune system disorders Seasonal allergy 01APR2014 Y 
  C4591001 1016 
10161316 Immune system disorders Seasonal allergy 08MAR2007 Y 
  C4591001 1016 
10161318 Gastrointestinal disorders Constipation 01FEB2009 Y 
    Immune s ystem disorders Seasonal aller gy 01MAR2008 Y
  C4591001 1016 
10161319 Immune system disorders Seasonal allergy 01OCT2015 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01OCT2015 30NOV2017 N 
    Orophar yngeal pain 12OCT2020 15OCT2020 N
  C4591001 1016 
10161320 Psychiatric disorders Attention deficit hyperactivity disorder 01FEB2012 Y 
  C4591001 1016 
10161322 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 
disordersPsoriasis 06JAN2020 Y 
  C4591001 1016 
10161323 Psychiatric disorders Attention deficit hyperactivity disorder 18SEP2012 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 83
FDA-CBER-2022-5812-0499213
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1016 
10161324 Immune system disorders Seasonal allergy 01MAY2015 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01SEP2015 31DEC2015 N 
  C4591001 1016 
10161326 Immune system disorders Seasonal allergy 24APR2009 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 11MAY2007 Y 
  C4591001 1016 
10161327 Immune system disorders Seasonal allergy 24APR2009 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 24APR2009 Y 
  C4591001 1016 
10161329 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, thoracic and 
mediastinal disordersAsthma 01DEC2010 Y 
  C4591001 1016 
10161330 Nervous system disorders Migraine 01JUN2009 Y 
    Psychiatric disorders Anxiet y 01AUG2019 Y
  C4591001 1016 
10161331 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 Psychiatric disorders Attention deficit hyperactivity disorder 01APR2011 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 84
FDA-CBER-2022-5812-0499214
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1016 
10161334 Respiratory, thoracic and 
mediastinal disordersAsthma 23OCT2009 Y 
  C4591001 1016 
10161335 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 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 
10161338 Immune system disorders Drug hypersensitivity 20NOV2013 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01MAR2015 Y
  C4591001 1016 
10161339 Gastrointestinal disorders Constipation 01APR2020 Y 
    Immune s ystem disorders Seasonal aller gy 01APR2016 Y
    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 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
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 85
FDA-CBER-2022-5812-0499215
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Disruptive mood d ysregulation disorde r 10SEP2020 Y
    Insomnia 01JAN2013 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01FEB2010 Y 
  C4591001 1016 
10161343 Psychiatric disorders Attention deficit hyperactivity disorder 30JAN2012 Y 
    Oppositional defiant disorde r 30MAR2017 Y
    Tic 14JUN2017 05JUL2017 N
  C4591001 1016 
10161344 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 
disordersAcne 01JUN2017 Y 
    Vascular disorders Hypotension 01MAY2017 Y
  C4591001 1016 
10161350 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, thoracic and 
mediastinal disordersAsthma 06SEP2012 31DEC2018 N 
    Skin and subcutaneous tissue 
disordersAcne 17SEP2020 Y 
  C4591001 1016 
10161351 Immune system disorders Seasonal allergy 01OCT2007 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 86
FDA-CBER-2022-5812-0499216
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Psychiatric disorders Oppositional defiant disorde r 01MAY2009 31MAY2010 N
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JUN2012 31JUL2017 N 
  C4591001 1016 
10161352 Immune system disorders Seasonal allergy 01OCT2015 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 04OCT2010 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 14APR2017 Y 
  C4591001 1016 
10161353 Immune system disorders Seasonal allergy 01MAY2011 Y 
  C4591001 1016 
10161354 Renal and urinary disorders Vesicoureteric reflux 01SEP2006 31JAN2011 N 
  C4591001 1016 
10161356 Psychiatric disorders Attention deficit hyperactivity disorder 18SEP2012 Y 
    Impulse-control disorde r 20APR2016 Y
  C4591001 1016 
10161358 Immune system disorders Seasonal allergy 01MAR2017 Y 
  C4591001 1016 
10161361 Immune system disorders Seasonal allergy 01JAN2010 Y 
    Infections and infestations Abscess limb 01JUN2015 30JUN2015 N
  C4591001 1016 
10161362 Immune system disorders Seasonal allergy 01MAY2013 31OCT2015 N 
    Respiratory, thoracic and 
mediastinal disordersAsthma 09AUG2011 31MAR2016 N 
  C4591001 1016 
10161363 Immune system disorders Seasonal allergy 01MAY2009 Y 
  C4591001 1016 
10161364 Immune system disorders Seasonal allergy 01JAN2005 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 06MAR2012 Y
    Bipolar disorde r 24JUL2018 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 87
FDA-CBER-2022-5812-0499217
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Reproductive system and breast 
disordersDysmenorrhoea 03AUG2020 Y 
  C4591001 1016 
10161365 Psychiatric disorders Anxiety 01MAR2020 Y 
    Depression 01MAR2020 Y
    Skin and subcutaneous tissue 
disordersEczema 06JAN2009 30APR2016 N 
  C4591001 1016 
10161366 Nervous system disorders Headache 01DEC2018 Y 
  C4591001 1016 
10161367 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 
disordersDysfunctional uterine bleeding 01JUL2020 Y 
  C4591001 1016 
10161368 Social circumstances Premenarche 2008 Y 
  C4591001 1016 
10161369 Immune system disorders Seasonal allergy 01JUN2019 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JUN2015 Y
    Skin and subcutaneous tissue 
disordersMiliaria 01JUN2019 Y 
    Social circumstances Premenarche 2008 Y
  C4591001 1016 
10161372 Immune system disorders Seasonal allergy 01APR2019 Y 
  C4591001 1016 
10161373 Congenital, familial and genetic 
disordersSpina bifida occulta 01FEB2020 Y 
    Immune s ystem disorders Seasonal aller gy 01JUN2019 Y
    Musculoskeletal and connective 
tissue disordersKyphosis 01FEB2020 Y 
    Lordosis 01FEB2020 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 88
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499218
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1016 
10161374 Immune system disorders Seasonal allergy 01APR2013 Y 
  C4591001 1016 
10161375 Immune system disorders Seasonal allergy 01APR2010 Y 
    Nervous s ystem disorders Migraine 01JUN2019 Y
  C4591001 1016 
10161376 Skin and subcutaneous tissue 
disordersAcne 01MAR2019 Y 
    Surgical and medical procedures Chondroplast y 01FEB2020 14FEB2020 N
  C4591001 1016 
10161377 Immune system disorders Seasonal allergy 01APR2016 Y 
    Musculoskeletal and connective 
tissue disordersOsteochondrosis 01FEB2016 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JUN2019 Y 
  C4591001 1016 
10161378 Psychiatric disorders Attention deficit hyperactivity disorder 01MAY2018 Y 
    Skin and subcutaneous tissue 
disordersEczema 03MAR2010 Y 
  C4591001 1016 
10161379 Immune system disorders Seasonal allergy 01APR2012 Y 
  C4591001 1016 
10161381 Immune system disorders Seasonal allergy 01APR2006 Y 
  C4591001 1016 
10161382 Immune system disorders Seasonal allergy 01AUG2014 Y 
    Skin and subcutaneous tissue 
disordersEczema 01NOV2010 Y 
  C4591001 1016 
10161383 Immune system disorders Seasonal allergy 01APR2011 Y 
    Skin and subcutaneous tissue 
disordersEczema 01DEC2010 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 89
FDA-CBER-2022-5812-0499219
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1016 
10161384 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 Psychiatric disorders Attention deficit hyperactivity disorder 15AUG2011 Y 
    Skin and subcutaneous tissue 
disordersEczema 14NOV2006 Y 
  C4591001 1016 
10161386 Immune system disorders Seasonal allergy 01APR2011 Y 
    Respiratory, thoracic and 
mediastinal disordersBronchial hyperreactivity 01APR2011 Y 
    Social circumstances Premenarche 2007 Y
  C4591001 1016 
10161387 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 Immune system disorders Seasonal allergy 01APR2006 Y 
    Nervous s ystem disorders Headache 01MAY2012 Y
    Reproductive system and breast 
disordersMenorrhagia 01JUN2017 Y 
    Skin and subcutaneous tissue 
disordersEczema 01MAR2006 Y 
  C4591001 1039 
10391246 Eye disorders Myopia 01JAN2010 Y 
    Immune s ystem disorders Seasonal aller gy 01JAN2011 Y
    Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 90
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499220
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Social circumstances Corrective lens use r 01JAN2011 Y
  C4591001 1039 
10391247 Immune system disorders Seasonal allergy 01JAN2008 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2020 Y 
  C4591001 1039 
10391250 General disorders and 
administration site conditionsCyst 01JAN2015 31DEC2015 N 
    Psychiatric disorders Tic 01JAN2019 Y
    Social circumstances Menarche 01JAN2018 Y
  C4591001 1039 
10391251 Psychiatric disorders Anxiety 01JAN2017 Y 
    Reproductive system and breast 
disordersMenorrhagia 01JAN2018 Y 
    Skin and subcutaneous tissue 
disordersEczema 01JUN2020 Y 
    Social circumstances Menarche 01JAN2016 Y
    Vegetarian 2005 Y
  C4591001 1039 
10391252 Eye disorders Strabismus 01JAN2008 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
    Social circumstances Corrective lens use r 01JAN2008 Y
  C4591001 1039 
10391253 Social circumstances Premenarche 2008 Y 
  C4591001 1039 
10391255 Immune system disorders Drug hypersensitivity 01JAN2014 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
    Social circumstances Vegan 01JUN2020 Y
  C4591001 1039 
10391256 Nervous system disorders Epilepsy 01JAN2017 30SEP2020 N 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499221
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Social circumstances Vegetarian 2008 Y
  C4591001 1039 
10391258 Immune system disorders Seasonal allergy 01JAN2009 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2016 Y 
    Sleep apnoea s yndrome 01JAN2013 31DEC2013 N
    Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
    Social circumstances Menarche 01JAN2017 Y
    Surgical and medical procedures Adenoidectom y 01JAN2013 31DEC2013 N
    Tonsillectom y 01JAN2013 31DEC2013 N
  C4591001 1039 
10391259 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
  C4591001 1039 
10391260 Eye disorders Myopia 01JAN2019 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2014 Y
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2018 Y 
    Social circumstances Corrective lens use r 01JAN2019 Y
  C4591001 1039 
10391262 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
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 92
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499222
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1039 
10391263 Respiratory, thoracic and 
mediastinal disordersRhinitis perennial 01JAN2007 Y 
  C4591001 1039 
10391264 Skin and subcutaneous tissue 
disordersEczema 01JAN2011 Y 
    Social circumstances Premenarche 2008 Y
  C4591001 1039 
10391265 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, thoracic and 
mediastinal disordersAsthma 01JAN2008 Y 
    Skin and subcutaneous tissue 
disordersActinic keratosis 01JAN2011 Y 
    Surgical and medical procedures Adenoidectom y 01JAN2014 31DEC2014 N
    Myringotom y 01JAN2010 31DEC2010 N
  C4591001 1039 
10391266 Musculoskeletal and connective 
tissue disordersScoliosis 01JAN2019 Y 
    Surgical and medical procedures Circumcision 01JAN2008 31DEC2008 N
    Ear tube insertion 01JAN2009 31DEC2009 N
      01JAN2013 31DEC2013 N
  C4591001 1039 
10391267 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 Social circumstances Menarche 01JAN2018 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 93
(b) (6)
FDA-CBER-2022-5812-0499223
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1039 
10391269 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 Eye disorders Astigmatism 01JAN2010 Y 
    Immune s ystem disorders Drug hypersensitivit y 01JAN2009 Y
    Infections and infestations Ear infection 01JAN2008 31DEC2011 N
    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 Immune system disorders Seasonal allergy 01JAN2018 Y 
    Skin and subcutaneous tissue 
disordersEczema 01JAN2018 Y 
    Social circumstances Menarche 01MAR2020 Y
  C4591001 1039 
10391272 Immune system disorders Food allergy 01JAN2010 Y 
    Seasonal aller gy 01JAN2019 Y
    Skin and subcutaneous tissue 
disordersEczema 01JAN2011 Y 
    Surgical and medical procedures Myringotom y 01JAN2010 31DEC2010 N
  C4591001 1039 
10391273 Psychiatric disorders Attention deficit hyperactivity disorder 01NOV2020 Y 
    Social circumstances Menarche 01JAN2020 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 94
(b) (6)
FDA-CBER-2022-5812-0499224
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1039 
10391274 Immune system disorders Food allergy 01JAN2013 Y 
    Seasonal aller gy 01JAN2007 Y
  C4591001 1039 
10391276 Immune system disorders Seasonal allergy 01JAN2009 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2019 Y 
    Idiopathic urticaria 01JAN2018 Y
  C4591001 1039 
10391277 Social circumstances Menarche 01JAN2019 Y 
    Vegetarian 2006 Y
  C4591001 1039 
10391278 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 Social circumstances Menarche 01FEB2019 Y 
  C4591001 1039 
10391280 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 
disordersRash 01MAR2020 Y 
    Social circumstances Menarche 01JAN2017 Y
    Surgical and medical procedures Cataract operation 01JAN2013 31DEC2013 N
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 95
(b) (6)
FDA-CBER-2022-5812-0499225
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Vitrectom y 01JAN2012 31DEC2012 N
      01JAN2014 31DEC2014 N
  C4591001 1039 
10391281 Skin and subcutaneous tissue 
disordersRosacea 01JAN2017 Y 
  C4591001 1039 
10391282 Immune system disorders Food allergy 01JAN2012 Y 
  C4591001 1039 
10391283 Eye disorders Myopia 01JAN2019 Y 
    Immune s ystem disorders Food aller gy 01JAN2005 Y
    Seasonal aller gy 01JAN2017 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2018 Y 
    Asthma exercise induce d 01JAN2018 Y
    Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
    Drug eruption 01JAN2005 Y
    Surgical and medical procedures Dacr yocystorhinostom y 01JAN2007 31DEC2007 N
  C4591001 1039 
10391284 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, thoracic and 
mediastinal disordersAsthma exercise induced 01JAN2013 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
    Eczema 01JAN2013 Y
    Hand dermatitis 01JAN2013 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 96
FDA-CBER-2022-5812-0499226
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1039 
10391285 Immune system disorders Drug hypersensitivity 01JAN2010 Y 
    Social circumstances Premenarche 2007 Y
    Vegetarian 01JAN2019 Y
  C4591001 1039 
10391286 Social circumstances Premenarche 2007 Y 
  C4591001 1039 
10391287 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, thoracic and 
mediastinal disordersAsthma 01JAN2011 Y 
    Skin and subcutaneous tissue 
disordersEczema 01JAN2016 Y 
  C4591001 1039 
10391289 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 Eye disorders Myopia 01JAN2019 Y 
    Social circumstances Corrective lens use r 01JAN2019 Y
    Menarche 30JUN2020 Y
  C4591001 1039 
10391291 Eye disorders Hypermetropia 01JAN2019 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 97
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499227
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    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 Immune system disorders Seasonal allergy 01JAN2018 Y 
    Social circumstances Menarche 01JUN2018 Y
  C4591001 1039 
10391293 Immune system disorders Seasonal allergy 01JAN2013 Y 
  C4591001 1039 
10391294 Skin and subcutaneous tissue 
disordersAcne 01AUG2020 Y 
  C4591001 1039 
10391295 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
  C4591001 1039 
10391296 Nervous system disorders Dyslexia 01JAN2017 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2017 Y
  C4591001 1039 
10391298 Immune system disorders Seasonal allergy 01JAN2015 Y 
    Psychiatric disorders Insomnia 01JAN2017 Y
  C4591001 1039 
10391299 Immune system disorders Seasonal allergy 01JAN2010 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2018 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 98
FDA-CBER-2022-5812-0499228
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Respiratory, thoracic and 
mediastinal disordersAsthma exercise induced 01JAN2016 Y 
  C4591001 1039 
10391300 Immune system disorders Seasonal allergy 01JAN2017 Y 
  C4591001 1039 
10391301 Immune system disorders Drug hypersensitivity 01JAN2016 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2016 Y 
    Rhinitis aller gic 01JAN2016 Y
  C4591001 1039 
10391302 Psychiatric disorders Anxiety 01JAN2016 Y 
    Depression 01JAN2016 Y
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2015 Y 
  C4591001 1039 
10391303 Congenital, familial and genetic 
disordersDevelopmental 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 General disorders and 
administration site conditionsPain 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, thoracic and 
mediastinal disordersAsthma 01JAN2018 Y 
  C4591001 1039 
10391306 Immune system disorders Drug hypersensitivity 2008 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2017 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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(b) (4)
FDA-CBER-2022-5812-0499229
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Surgical and medical procedures Appendicectom y 01JAN2018 31DEC2018 N
  C4591001 1039 
10391307 Immune system disorders Seasonal allergy 01JAN2005 Y 
    Social circumstances Menarche 01SEP2019 Y
  C4591001 1039 
10391308 Congenital, familial and genetic 
disordersPectus excavatum 01JAN2008 Y 
    Immune s ystem disorders Seasonal aller gy 01JAN2007 Y
    Respiratory, thoracic and 
mediastinal disordersEpistaxis 01JAN2015 Y 
    Social circumstances Premenarche 2007 Y
    Surgical and medical procedures Tonsillectom y 01JAN2013 31DEC2013 N
  C4591001 1039 
10391309 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 Immune system disorders Seasonal allergy 2007 Y 
  C4591001 1039 
10391314 Neoplasms benign, malignant and 
unspecified (incl c ysts 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 
    Menorrha gia 01JAN2018 Y
    Social circumstances Menarche 01JAN2018 Y
  C4591001 1039 
10391315 Immune system disorders Seasonal allergy 01JAN2008 Y 
  C4591001 1039 
10391316 Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2018 Y 
    Social circumstances Premenarche 2008 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 100
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499230
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1039 
10391317 Eye disorders Astigmatism 01JAN2013 Y 
    Gastrointestinal disorders Diarrhoea 01JAN2011 Y
    Social circumstances Corrective lens use r 01JAN2013 Y
  C4591001 1039 
10391318 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2018 31DEC2018 N 
    Psychiatric disorders Anxiet y 01JAN2017 Y
    Depression 01JAN2017 Y
    Insomnia 01JAN2017 Y
    Skin and subcutaneous tissue 
disordersIdiopathic 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 Immune system disorders Seasonal allergy 01JAN2012 Y 
    Social circumstances Vegetarian 01JAN2018 Y
  C4591001 1039 
10391320 Immune system disorders Seasonal allergy 01JAN2012 Y 
    Social circumstances Menarche 01SEP2020 Y
  C4591001 1039 
10391321 Social circumstances Menarche 01SEP2020 Y 
  C4591001 1039 
10391322 Eye disorders Myopia 01JAN2016 Y 
    Immune s ystem disorders Drug hypersensitivit y 2005 Y
    Psychiatric disorders Anxiet y 01MAR2020 Y
    Reproductive system and breast 
disordersMenorrhagia 01JAN2018 Y 
    Social circumstances Menarche 01JAN2017 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 101
(b) (6)
FDA-CBER-2022-5812-0499231
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1039 
10391323 Gastrointestinal disorders Abdominal hernia 2008 Y 
    Immune s ystem disorders Drug hypersensitivit y 01JAN2015 Y
  C4591001 1039 
10391324 Social circumstances Corrective lens user 01OCT2020 Y 
    Menarche 02SEP2020 Y
  C4591001 1039 
10391325 Social circumstances Corrective lens user 01JAN2013 Y 
    Menarche 01SEP2020 Y
  C4591001 1039 
10391326 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, thoracic and 
mediastinal disordersAsthma 01JAN2006 31DEC2018 N 
    Social circumstances Corrective lens use r 01JAN2012 Y
  C4591001 1039 
10391327 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 Psychiatric disorders Depression 01JAN2018 Y 
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2016 Y 
    Social circumstances Menarche 01JAN2017 Y
  C4591001 1039 
10391329 Immune system disorders Seasonal allergy 01JAN2016 Y 
    Surgical and medical procedures Tonsillectom y 01JAN2011 31DEC2011 N
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499232
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1039 
10391330 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 Immune system disorders Drug hypersensitivity 01JAN2009 Y 
    Seasonal aller gy 01JAN2016 Y
  C4591001 1039 
10391332 Nervous system disorders Migraine 01SEP2020 Y 
    Psychiatric disorders Anxiet y 01JAN2018 Y
    Depression 01JAN2018 Y
      01NOV2020 30NOV2020 N
    Post-traumatic stress disorde r 01NOV2020 30NOV2020 N
    Reproductive system and breast 
disordersMenorrhagia 01JAN2018 Y 
    Social circumstances Menarche 01JAN2018 Y
  C4591001 1039 
10391333 Skin and subcutaneous tissue 
disordersActinic keratosis 01JAN2019 31DEC2020 N 
  C4591001 1039 
10391334 Endocrine disorders Growth hormone deficiency 01JAN2010 Y 
    Surgical and medical procedures Lipoma excision 01JAN2012 Y
  C4591001 1039 
10391336 Immune system disorders Drug hypersensitivity 01JAN2018 Y 
    Seasonal aller gy 01JAN2015 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2014 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 103
FDA-CBER-2022-5812-0499233
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1039 
10391337 Gastrointestinal disorders Diarrhoea 01JAN2010 Y 
    Immune s ystem disorders Drug hypersensitivit y 01JAN2007 Y
    Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
    Eczema 01JAN2012 31DEC2012 N
    Surgical and medical procedures Tonsillectom y 01JAN2011 31DEC2011 N
  C4591001 1039 
10391338 Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
    Social circumstances Menarche 01DEC2016 Y
    Vegetarian 01JAN2018 Y
  C4591001 1039 
10391339 Social circumstances Premenarche 2008 Y 
  C4591001 1044 
10441256 Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2009 Y 
  C4591001 1044 
10441260 Immune system disorders Drug hypersensitivity 01FEB2020 Y 
      01JAN2008 Y
  C4591001 1044 
10441263 Psychiatric disorders Attention deficit hyperactivity disorder 01NOV2019 Y 
  C4591001 1044 
10441266 Nervous system disorders Migraine 01JAN2010 Y 
    Reproductive system and breast 
disordersDysmenorrhoea 01JAN2018 Y 
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2008 Y 
  C4591001 1044 
10441267 Skin and subcutaneous tissue 
disordersEczema 01JAN2009 Y 
  C4591001 1044 
10441268 Ear and labyrinth disorders Deafness bilateral 01JAN2010 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 104
(b) (6)
FDA-CBER-2022-5812-0499234
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1044 
10441273 Gastrointestinal disorders Gastrooesophageal reflux disease 2008 Y 
    Social circumstances Premenarche 01NOV2020 Y
  C4591001 1044 
10441274 Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2009 Y 
  C4591001 1044 
10441276 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2013 Y 
  C4591001 1044 
10441279 Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2012 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2016 Y 
  C4591001 1044 
10441280 Metabolism and nutrition disorders Type 1 diabetes mellitus 01JUL2010 Y 
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2008 Y 
  C4591001 1044 
10441281 Skin and subcutaneous tissue 
disordersAcne 01JUN2020 Y 
  C4591001 1044 
10441282 General disorders and 
administration site conditionsDrug intolerance 01JAN2006 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma exercise induced 01JAN2018 Y 
    Rhinitis aller gic 01JAN2008 Y
  C4591001 1044 
10441284 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2015 Y 
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2005 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2015 Y 
  C4591001 1044 
10441285 Psychiatric disorders Anxiety 01AUG2019 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 105
(b) (6)
FDA-CBER-2022-5812-0499235
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1044 
10441286 Reproductive system and breast 
disordersMenstruation irregular 01MAR2018 Y 
  C4591001 1044 
10441288 Social circumstances Premenarche 01NOV2020 Y 
  C4591001 1044 
10441289 Immune system disorders Allergy to animal 01JAN2009 Y 
    Food aller gy 01JAN2009 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2009 Y 
    Social circumstances Premenarche 2007 Y
  C4591001 1044 
10441290 Psychiatric disorders Insomnia 01JAN2018 Y 
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2019 Y 
    Social circumstances Premenarche 01NOV2020 Y
  C4591001 1044 
10441292 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2012 Y 
  C4591001 1044 
10441293 Immune system disorders Drug hypersensitivity 01JAN2015 Y 
  C4591001 1044 
10441294 Immune system disorders Drug hypersensitivity 01JAN2015 Y 
  C4591001 1044 
10441295 Immune system disorders Drug hypersensitivity 01JAN2009 Y 
      01JAN2015 Y
  C4591001 1044 
10441296 Injury, poisoning and procedural 
complicationsRadius fracture 01SEP2020 18SEP2020 N 
  C4591001 1044 
10441297 Immune system disorders Seasonal allergy 01JAN2012 Y 
  C4591001 1044 
10441298 Immune system disorders Seasonal allergy 01JAN2018 Y 
    Social circumstances Premenarche 01NOV2020 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 106
(b) (6)
FDA-CBER-2022-5812-0499236
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1044 
10441299 Immune system disorders Drug hypersensitivity 01JAN2006 Y 
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2010 Y 
  C4591001 1044 
10441300 Immune system disorders Drug hypersensitivity 01JAN2005 Y 
      01JAN2010 Y
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2007 Y 
  C4591001 1044 
10441302 Skin and subcutaneous tissue 
disordersAcne 01JAN2019 Y 
  C4591001 1044 
10441303 Skin and subcutaneous tissue 
disordersAcne 01JAN2019 Y 
  C4591001 1044 
10441304 Immune system disorders Drug hypersensitivity 01AUG2018 Y 
  C4591001 1044 
10441306 Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2017 Y 
  C4591001 1044 
10441308 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2016 Y 
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2014 Y 
  C4591001 1044 
10441309 Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2015 Y 
  C4591001 1044 
10441310 Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JUL2020 Y 
  C4591001 1044 
10441311 Reproductive system and breast 
disordersDysmenorrhoea 01JAN2020 Y 
  C4591001 1044 
10441312 Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2008 Y 
  C4591001 1044 
10441313 Skin and subcutaneous tissue 
disordersAcne 01JAN2009 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 107
FDA-CBER-2022-5812-0499237
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1044 
10441316 Immune system disorders Drug hypersensitivity 01JAN2007 Y 
  C4591001 1044 
10441317 Immune system disorders Seasonal allergy 01JAN2018 Y 
  C4591001 1044 
10441319 Immune system disorders Drug hypersensitivity 01JAN2009 Y 
  C4591001 1044 
10441321 Congenital, familial and genetic 
disordersAtrial 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 Immune system disorders Seasonal allergy 01JAN2017 Y 
    Skin and subcutaneous tissue 
disordersAcne 01SEP2020 Y 
  C4591001 1044 
10441324 Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2007 Y 
  C4591001 1044 
10441326 Social circumstances Premenarche 2007 Y 
  C4591001 1044 
10441327 Reproductive system and breast 
disordersMenstruation irregular 01JAN2019 Y 
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2019 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2019 Y 
  C4591001 1044 
10441330 Psychiatric disorders Attention deficit hyperactivity disorder 01NOV2020 Y 
  C4591001 1044 
10441331 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2016 Y 
  C4591001 1044 
10441332 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2014 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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FDA-CBER-2022-5812-0499238
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1044 
10441333 Immune system disorders Seasonal allergy 01JAN2010 Y 
  C4591001 1044 
10441334 Social circumstances Premenarche 2008 Y 
  C4591001 1044 
10441335 Musculoskeletal and connective 
tissue disordersOsteochondrosis 01OCT2019 Y 
    Psychiatric disorders Anxiet y 01JAN2017 Y
    Depression 01JAN2017 Y
    Skin and subcutaneous tissue 
disordersAcne 01JAN2019 Y 
    Dry skin 01JAN2020 Y
  C4591001 1044 
10441338 Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2018 Y 
  C4591001 1044 
10441341 Psychiatric disorders Attention deficit hyperactivity disorder 01OCT2018 Y 
  C4591001 1044 
10441343 Eye disorders Punctate keratitis 15AUG2013 Y 
  C4591001 1044 
10441345 Immune system disorders Food allergy 01JAN2017 Y 
    Seasonal aller gy 01JAN2016 Y
    Social circumstances Premenarche 2008 Y
  C4591001 1044 
10441347 Psychiatric disorders Depression 01JUN2020 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2019 Y 
  C4591001 1044 
10441348 Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2012 Y 
  C4591001 1044 
10441349 Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2009 Y 
  C4591001 1044 
10441350 Congenital, familial and genetic 
disordersVon Willebrand's disease 01FEB2019 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499239
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Immune s ystem disorders Seasonal aller gy 01JAN2005 Y
    Skin and subcutaneous tissue 
disordersAcne 01JAN2008 Y 
  C4591001 1044 
10441352 Reproductive system and breast 
disordersDysmenorrhoea 01APR2017 Y 
  C4591001 1044 
10441353 Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2014 Y 
  C4591001 1044 
10441354 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, thoracic and 
mediastinal disordersAsthma 01JAN2009 Y 
    Social circumstances Premenarche 2007 Y
  C4591001 1044 
10441355 Psychiatric disorders Insomnia 01JAN2019 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2012 Y 
    Rhinitis aller gic 01JAN2012 Y
  C4591001 1044 
10441356 Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2010 Y 
    Skin and subcutaneous tissue 
disordersRash 01DEC2020 Y 
  C4591001 1044 
10441357 Musculoskeletal and connective 
tissue disordersOsteochondrosis 01JAN2020 Y 
    Psychiatric disorders Depression 01MAR2019 Y
    Obsessive-compulsive disorde r 01MAR2019 Y
    Skin and subcutaneous tissue 
disordersEczema 01JAN2008 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499240
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1044 
10441358 Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2020 Y 
  C4591001 1044 
10441361 Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2014 Y 
    Rhinitis aller gic 01JAN2008 Y
    Skin and subcutaneous tissue 
disordersDermatitis contact 01JAN2007 Y 
  C4591001 1044 
10441362 Immune system disorders Drug hypersensitivity 01JAN2012 Y 
    Musculoskeletal and connective 
tissue disordersJuvenile idiopathic arthritis 01JAN2012 Y 
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2017 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
  C4591001 1044 
10441366 Immune system disorders Drug hypersensitivity 01JAN2015 Y 
    Injury, poisoning and procedural 
complicationsStress fracture 21DEC2020 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2019 Y
  C4591001 1044 
10441367 Immune system disorders Drug hypersensitivity 01JAN2008 Y 
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2014 Y 
  C4591001 1044 
10441368 Nervous system disorders Migraine with aura 01JAN2014 Y 
  C4591001 1044 
10441371 Reproductive system and breast 
disordersMenstruation irregular 17NOV2019 Y 
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2012 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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FDA-CBER-2022-5812-0499241
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1044 
10441372 Psychiatric disorders Attention deficit hyperactivity disorder 01OCT2013 Y 
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2012 Y 
  C4591001 1044 
10441373 Gastrointestinal disorders Gastrooesophageal reflux disease 2006 Y 
    Psychiatric disorders Anxiet y 01JAN2018 Y
    Obsessive-compulsive disorde r 01JAN2020 Y
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2011 Y 
  C4591001 1044 
10441375 Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2011 Y 
  C4591001 1044 
10441376 Immune system disorders Food allergy 01JAN2009 Y 
    Hypersensitivit y 01JAN2009 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2007 Y 
  C4591001 1044 
10441377 Immune system disorders Drug hypersensitivity 01JAN2012 Y 
    Injury, poisoning and procedural 
complicationsFoot fracture 08JAN2021 Y 
    Nervous s ystem disorders Dizziness 01JAN2019 Y
    Respiratory, thoracic and 
mediastinal disordersOropharyngeal pain 12JAN2021 22JAN2021 N 
    Vasomotor rhinitis 01JAN2015 Y
    Social circumstances Premenarche 2008 Y
  C4591001 1044 
10441378 Psychiatric disorders Anxiety 01MAR2019 Y 
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2014 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499242
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1044 
10441379 Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2009 Y 
  C4591001 1044 
10441380 Immune system disorders Seasonal allergy 01JAN2011 Y 
  C4591001 1044 
10441381 Immune system disorders Drug hypersensitivity 01JAN2015 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2017 Y
  C4591001 1044 
10441382 Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2011 Y 
  C4591001 1044 
10441383 Injury, poisoning and procedural 
complicationsLimb fracture 30SEP2020 Y 
  C4591001 1044 
10441384 Endocrine disorders Autoimmune thyroiditis 01JUN2018 Y 
    Immune s ystem disorders Drug hypersensitivit y 01JAN2007 Y
    Milk aller gy 01JAN2009 Y
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2014 Y 
  C4591001 1057 
10571377 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 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
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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(b) (6)
FDA-CBER-2022-5812-0499243
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1057 
10571379 Skin and subcutaneous tissue 
disordersHyperhidrosis 01JAN2014 Y 
  C4591001 1057 
10571380 Immune system disorders Seasonal allergy 01JAN2015 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01DEC2013 Y
  C4591001 1057 
10571382 Immune system disorders Drug hypersensitivity 01JAN2013 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2009 31DEC2012 N 
    Skin and subcutaneous tissue 
disordersDermatitis atopic 01JAN2007 Y 
  C4591001 1057 
10571383 Immune system disorders Seasonal allergy 01JAN2013 Y 
    Psychiatric disorders Generalised anxiet y disorde r 01JAN2018 Y
    Insomnia 01JAN2018 Y
  C4591001 1057 
10571385 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2015 Y 
    Major depression 01JAN2016 31DEC2017 N
  C4591001 1057 
10571386 Metabolism and nutrition disorders Obesity 01JAN2015 Y 
  C4591001 1057 
10571388 Immune system disorders Allergy to animal 01JAN2016 Y 
  C4591001 1057 
10571389 Immune system disorders Allergy to animal 01JAN2016 Y 
  C4591001 1057 
10571390 Immune system disorders Seasonal allergy 01JAN2007 Y 
    Psychiatric disorders Major depression 01JAN2016 Y
    Skin and subcutaneous tissue 
disordersAcne 01JAN2017 Y 
  C4591001 1057 
10571391 Immune system disorders Seasonal allergy 01JAN2007 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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FDA-CBER-2022-5812-0499244
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1057 
10571393 Psychiatric disorders Major depression 01JUN2018 Y 
  C4591001 1057 
10571394 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 Immune system disorders Food allergy 01JAN2009 Y 
    Seasonal aller gy 01JAN2009 Y
      01JAN2013 Y
  C4591001 1057 
10571396 Immune system disorders Seasonal allergy 01JAN2010 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma exercise induced 01JAN2015 Y 
  C4591001 1057 
10571397 Immune system disorders Seasonal allergy 01JAN2009 Y 
  C4591001 1057 
10571398 Gastrointestinal disorders Constipation 01JAN2007 Y 
  C4591001 1057 
10571399 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 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2015 Y 
  C4591001 1057 
10571401 Musculoskeletal and connective 
tissue disordersKnee deformity 01JAN2016 31DEC2018 N 
    Surgical and medical procedures Knee operation 01DEC2018 31DEC2018 N
  C4591001 1057 
10571402 Metabolism and nutrition disorders Obesity 01JAN2013 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 115
FDA-CBER-2022-5812-0499245
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1057 
10571404 Immune system disorders Seasonal allergy 01JAN2010 Y 
    Psychiatric disorders Generalised anxiet y disorde r 01JAN2019 Y
    Major depression 01JAN2019 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2010 Y 
    Skin and subcutaneous tissue 
disordersDermatitis atopic 01JAN2008 Y 
  C4591001 1057 
10571405 Psychiatric disorders Attention deficit hyperactivity disorder 01AUG2013 Y 
  C4591001 1057 
10571406 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2012 Y 
  C4591001 1057 
10571408 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 Immune system disorders Seasonal allergy 01JAN2017 Y 
  C4591001 1057 
10571413 Infections and infestations Tonsillitis 01JAN2014 31DEC2014 N 
    Surgical and medical procedures Tonsillectom y 01JAN2014 31DEC2014 N
  C4591001 1057 
10571414 Immune system disorders Rubber sensitivity 01JAN2018 Y 
  C4591001 1057 
10571415 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2009 Y 
  C4591001 1057 
10571417 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2014 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2019 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 116
FDA-CBER-2022-5812-0499246
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1057 
10571418 Metabolism and nutrition disorders Obesity 01APR2015 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 27MAR2018 Y
    Reproductive system and breast 
disordersMenorrhagia 01DEC2019 Y 
  C4591001 1057 
10571419 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 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2013 31DEC2014 N 
  C4591001 1057 
10571421 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 
disordersEczema 01JAN2010 Y 
  C4591001 1057 
10571422 Metabolism and nutrition disorders Obesity 01JAN2010 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2010 Y 
  C4591001 1057 
10571423 Immune system disorders Seasonal allergy 2005 Y 
    Infections and infestations Adenoiditis 01JAN2011 31DEC2011 N
    Tonsillitis 01JAN2011 31DEC2011 N
    Respiratory, thoracic and 
mediastinal disordersAsthma 2005 Y 
    Surgical and medical procedures Adenoidectom y 01JAN2011 31DEC2011 N
    Tonsillectom y 01JAN2011 31DEC2011 N
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499247
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1057 
10571424 Immune system disorders Seasonal allergy 2008 Y 
    Metabolism and nutrition disorders Obesit y 01JAN2015 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 2008 Y 
  C4591001 1057 
10571425 Social circumstances Premenarche 2007 Y 
  C4591001 1057 
10571426 Social circumstances Premenarche 07NOV2008 Y 
  C4591001 1057 
10571427 Social circumstances Premenarche 2008 Y 
  C4591001 1057 
10571428 Congenital, familial and genetic 
disordersHereditary spherocytosis 01JAN2010 Y 
  C4591001 1057 
10571431 Infections and infestations Tonsillitis 01JAN2014 31DEC2014 N 
    Surgical and medical procedures Tonsillectom y 01JAN2014 31DEC2014 N
  C4591001 1057 
10571432 Eye disorders Optic atrophy 01NOV2019 Y 
    Social circumstances Premenarche 2008 Y
  C4591001 1057 
10571433 Musculoskeletal and connective 
tissue disordersScoliosis 15OCT2015 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01OCT2014 Y
    Surgical and medical procedures Scoliosis sur gery 15OCT2020 15OCT2020 N
  C4591001 1057 
10571434 Metabolism and nutrition disorders Obesity 01JAN2010 Y 
  C4591001 1057 
10571435 Metabolism and nutrition disorders Obesity 01JAN2010 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2015 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2015 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499248
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1057 
10571436 Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2007 Y 
  C4591001 1057 
10571437 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 Immune system disorders Seasonal allergy 01JAN2018 Y 
  C4591001 1057 
10571439 Reproductive system and breast 
disordersMetrorrhagia 01JAN2020 Y 
  C4591001 1057 
10571440 Immune system disorders Drug hypersensitivity 2008 Y 
  C4591001 1057 
10571441 Psychiatric disorders Generalised anxiety disorder 01MAR2020 Y 
  C4591001 1057 
10571442 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 Immune system disorders Seasonal allergy 01JAN2018 Y 
  C4591001 1057 
10571446 Immune system disorders Seasonal allergy 01JAN2015 Y 
    Metabolism and nutrition disorders Type 1 diabetes mellitus 01JAN2015 Y
  C4591001 1057 
10571447 Immune system disorders Seasonal allergy 01JAN2015 Y 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 119
(b) (6)
FDA-CBER-2022-5812-0499249
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1057 
10571448 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
      01JAN2015 31DEC2015 N
      01JAN2018 31DEC2018 N
    Tonsillectom y 01JAN2016 31DEC2016 N
  C4591001 1057 
10571449 Psychiatric disorders Attention deficit hyperactivity disorder 01OCT2019 Y 
  C4591001 1057 
10571450 Injury, poisoning and procedural 
complicationsFoot fracture 01JAN2007 31DEC2007 N 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2018 Y 
  C4591001 1057 
10571451 Infections and infestations Vulvovaginal mycotic infection 01JAN2012 Y 
  C4591001 1066 
10661394 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 Nervous system disorders Mental impairment 01JAN2019 Y 
    Psychiatric disorders Anxiet y 01JAN2019 Y
    Autism spectrum disorde r 01JAN2019 Y
  C4591001 1066 
10661397 Nervous system disorders Headache 01NOV2018 Y 
    Psychiatric disorders Anxiet y 01DEC2018 Y
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
Page 120
FDA-CBER-2022-5812-0499250
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Insomnia 01DEC2018 Y
    Skin and subcutaneous tissue 
disordersAcne 01DEC2019 Y 
  C4591001 1066 
10661401 Immune system disorders Hypersensitivity 01JAN2017 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2017 Y
  C4591001 1066 
10661402 Psychiatric disorders Anxiety 01JAN2018 Y 
    Eatin g disorde r 01FEB2019 Y
  C4591001 1066 
10661404 Infections and infestations Tonsillitis 01JAN2010 31DEC2010 N 
    Respiratory, thoracic and 
mediastinal disordersNasal turbinate hypertrophy 01JAN2012 31DEC2012 N 
    Skin and subcutaneous tissue 
disordersEczema 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 Psychiatric disorders Anxiety 01JAN2013 Y 
    Depression 01JAN2018 Y
    Sleep disorde r 01JAN2013 Y
  C4591001 1066 
10661407 Infections and infestations Oral herpes 01JAN2017 Y 
  C4591001 1066 
10661408 Immune system disorders Drug hypersensitivity 01JAN2005 Y 
    Psychiatric disorders Attention deficit h yperactivit y disorde r 01JAN2016 Y
    Skin and subcutaneous tissue 
disordersIngrowing nail 01JAN2019 31DEC2019 N 
090177e196ac915d\Final\Final On: 31-Mar-2021 13:05 (GMT) 
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16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Surgical and medical procedures Nail operation 01JAN2019 31DEC2019 N
  C4591001 1066 
10661409 Immune system disorders Seasonal allergy 01JAN2013 Y 
  C4591001 1066 
10661410 Infections and infestations Pharyngitis streptococcal 01JAN2014 31DEC2014 N 
    Surgical and medical procedures Tonsillectom y 01JAN2014 31DEC2014 N
  C4591001 1066 
10661411 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2017 Y 
  C4591001 1066 
10661412 Infections and infestations Pharyngitis streptococcal 01JAN2014 31DEC2014 N 
    Nervous s ystem disorders Headache 01JAN2014 Y
    Migraine 01JAN2014 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma exercise induced 01JAN2014 Y 
    Surgical and medical procedures Tonsillectom y 01JAN2014 31DEC2014 N
  C4591001 1066 
10661414 Psychiatric disorders Autism spectrum disorder 01JAN2007 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2019 Y 
  C4591001 1066 
10661415 Metabolism and nutrition disorders Obesity 01JAN2017 Y 
    Nervous s ystem disorders Headache 01JAN2017 Y
    Pregnancy, puerperium and 
perinatal conditionsPremature baby 2006 2006 N 
    Psychiatric disorders Depression 01OCT2017 Y
    Reproductive system and breast 
disordersPolycystic ovaries 01JAN2019 Y 
  C4591001 1066 
10661416 Injury, poisoning and procedural 
complicationsTibia fracture 01JAN2010 31DEC2010 N 
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2017 31DEC2019 N 
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16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1066 
10661417 Immune system disorders Hypersensitivity 01JAN2010 Y 
  C4591001 1066 
10661418 Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
  C4591001 1066 
10661419 Immune system disorders Seasonal allergy 01JAN2018 Y 
    Injury, poisoning and procedural 
complicationsConcussion 01AUG2019 30SEP2019 N 
    Respiratory, thoracic and 
mediastinal disordersVocal cord disorder 01JAN2018 Y 
  C4591001 1066 
10661420 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 Psychiatric disorders Anxiety 01JAN2013 Y 
    Attention deficit h yperactivit y disorde r 01JAN2013 Y
    Enuresis 01JAN2010 Y
      Reactive attachment disorder of infancy or early 
childhoo d 01JAN2008 Y 
  C4591001 1066 
10661422 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2014 Y 
    Autism spectrum disorde r 01JAN2011 Y
  C4591001 1066 
10661423 Immune system disorders Seasonal allergy 01JAN2016 Y 
  C4591001 1066 
10661424 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
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FDA-CBER-2022-5812-0499253
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    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 Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
    Rosacea 01JAN2018 Y
  C4591001 1066 
10661426 Congenital, familial and genetic 
disordersHypospadias 2005 30APR2006 N 
    Immune s ystem disorders Hypersensitivit y 01JAN2017 Y
    Surgical and medical procedures Urethral repai r 01APR2006 30APR2006 N
  C4591001 1066 
10661428 Immune system disorders Drug hypersensitivity 01JAN2013 Y 
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JUN2020 Y 
  C4591001 1066 
10661430 Skin and subcutaneous tissue 
disordersAcne 01JAN2018 Y 
  C4591001 1066 
10661431 Nervous system disorders Headache 2005 Y 
    Psychiatric disorders Anxiet y 01JAN2019 Y
    Skin and subcutaneous tissue 
disordersAcne 01JAN2017 Y 
  C4591001 1066 
10661432 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 Immune system disorders Drug hypersensitivity 01JAN2010 Y 
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(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499254
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1066 
10661434 Psychiatric disorders Attention deficit hyperactivity disorder 12JAN2015 Y 
    Insomnia 12JAN2019 Y
  C4591001 1066 
10661435 Congenital, familial and genetic 
disordersTalipes 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
    Hallucination, auditor y 01JAN2017 Y
    Neurodevelopmental disorde r 2007 Y
  C4591001 1077 
10771274 Immune system disorders Seasonal allergy 01JAN2015 Y 
    Injury, poisoning and procedural 
complicationsRadius fracture 01JAN2011 31DEC2011 N 
  C4591001 1077 
10771277 Congenital, familial and genetic 
disordersHemivertebra 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 polyps)Lipoma 01JAN2013 Y 
    Surgical and medical procedures Temporomandibular joint sur gery 01JAN2014 31DEC2014 N
  C4591001 1077 
10771279 Immune system disorders Drug hypersensitivity 01JAN2017 Y 
  C4591001 1077 
10771280 Immune system disorders Rubber sensitivity 01JAN2018 Y 
    Psychiatric disorders Depression 01JAN2019 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2018 Y 
  C4591001 1077 
10771281 Psychiatric disorders Anxiety 01JAN2019 Y 
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(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0499255
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1077 
10771282 Immune system disorders Seasonal allergy 01JAN2017 Y 
  C4591001 1077 
10771283 Infections and infestations Sinusitis 01JAN2009 31DEC2009 N 
    Surgical and medical procedures Adenoidectom y 01JAN2009 31DEC2009 N
  C4591001 1077 
10771286 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 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 Psychiatric disorders Attention deficit hyperactivity disorder 30OCT2020 Y 
  C4591001 1077 
10771290 Psychiatric disorders Depression 01JAN2018 Y 
    Skin and subcutaneous tissue 
disordersAcne 01JAN2019 Y 
  C4591001 1077 
10771293 Psychiatric disorders Anxiety 01JAN2018 Y 
    Attention deficit h yperactivit y disorde r 01JAN2014 Y
  C4591001 1077 
10771294 Psychiatric disorders Anxiety 01JAN2014 Y 
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16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
  C4591001 1077 
10771295 Immune system disorders Hypersensitivity 01JAN2012 Y 
  C4591001 1077 
10771300 Psychiatric disorders Anxiety 01MAY2020 Y 
  C4591001 1084 
10841541 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 Immune system disorders Seasonal allergy 01JAN2006 Y 
    Reproductive system and breast 
disordersMenstruation irregular 01SEP2019 Y 
  C4591001 1084 
10841543 Eye disorders Visual acuity reduced 01JAN2018 Y 
    Immune s ystem disorders Seasonal aller gy 01JAN2013 Y
    Injury, poisoning and procedural 
complicationsFoot fracture 01JAN2017 31DEC2017 N 
    Tibia fracture 01JAN2009 31DEC2009 N
  C4591001 1084 
10841544 Psychiatric disorders Attention deficit hyperactivity disorder 01JAN2017 Y 
    Respiratory, thoracic and 
mediastinal disordersRhinitis allergic 01JAN2010 Y 
  C4591001 1084 
10841545 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 Immune system disorders Seasonal allergy 01JAN2018 Y 
  C4591001 1084 
10841547 Immune system disorders Seasonal allergy 01JAN2016 Y 
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FDA-CBER-2022-5812-0499257
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    Psychiatric disorders Anxiet y 01SEP2020 Y
    Respiratory, thoracic and 
mediastinal disordersAsthma 01JAN2010 Y 
    Surgical and medical procedures Myringotom y 01JAN2006 31DEC2006 N
  C4591001 1084 
10841548 Eye disorders Visual acuity reduced 01JAN2014 Y 
    Immune s ystem disorders Seasonal aller gy 01JAN2010 Y
  C4591001 1084 
10841549 Gastrointestinal disorders Gastrooesophageal reflux disease 01JAN2017 Y 
    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, thoracic 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 Congenital, familial and genetic 
disordersRenal 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 Gastrointestinal disorders Inguinal hernia 01JAN2009 31DEC2009 N 
    Umbilical hernia 01JAN2009 31DEC2009 N
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FDA-CBER-2022-5812-0499258
16.2.5.3.1 Listing of Medical Hi story – Subjects 12 Through 25 Years of Age 
Age 
Group 
(Years) Subject System Organ Class Preferred Term Start Date End Date Ongoing
(Yes/No)
  
    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
  C4591001 1084 
10841552 Ear an
…[truncated]