Document text
16.2.7.1 Adverse Events Legend Page
Category Abbreviation Text
Action - Stud y Vaccine Dose NA Not applicable
P Investigational product withdrawn
Action - Sub ject TC Concomitant dru g treatment given
TCN Concomitant non-dru g treatment given
W Withdrawn from stud y
Cause of AE CD Concomitant dru g treatment
CND Concomitant non-dru g treatment
O Other
Outcome F Fatal
N Not recovered/not resolve d
R Recovered/resolve d
RS Recovered/resolved with sequelae
RG Recoverin g/resolving
UNK Unknown
Toxicity Grade 1 Mild
2 Moderate
3 Severe
4 Life-threatenin g
System Organ Class BLOOD Blood and l ymphatic s ystem disorders
CARD Cardiac disorders
CONG Congenital, familial and genetic disorders
EAR Ear and lab yrinth disorders
ENDO Endocrine disorders
EYE Eye disorders
GASTR Gastrointestinal disorders
GENRL General disorders and administration site conditions
HEPAT Hepatobiliar y disorders
090177e196ac915e\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 1
FDA-CBER-2022-5812-0220992
16.2.7.1 Adverse Events Legend Page
Category Abbreviation Text
IMMUN Immune s ystem disorders
INFEC Infections and infestations
INJ&P Injury poisoning and procedural complications
INV Investigations
METAB Metabolism and nutrition disorders
MUSC Musculoskeletal and connective tissue disorders
NEOPL Neoplasms beni gn, malignant and unspecified (incl c ysts and pol yps)
NERV Nervous system disorders
PREG Pregnancy, puerperium and perinatal conditions
PSYCH Psychiatric disorders
RENAL Renal and urinar y disorders
REPRO Reproductive s ystem and breast disorders
RESP Respirator y, thoracic and mediastinal disorders
SKIN Skin and subcutaneous tissue disorders
SOCCI Social circumstances
SURG Surgical and medical procedures
VASC Vascular disorders
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (20:15) Source Data: adae Table Generation: 27MAR2021 (01:37)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unblinded/C4591001 BLA/aelegend
090177e196ac915e\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 2
FDA-CBER-2022-5812-0220993
16.2.7.2.1.1 Listing of Severe and Grade 4 Local Reactions – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Local Reactionb1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
12-15 C4591001 1009
10091288 1 04DEC2020 Pain at the
injection siteMild Sev Mild N N N N 06DEC2020 3
C4591001 1009
10091396 2 26JAN2021 Pain at the
injection siteMild Sev Mild N N N N 28JAN2021 3
C4591001 1013
10131845 1 03DEC2020 Pain at the
injection siteSev Mod N 04DEC2020 2
C4591001 1057
10571438 1 04JAN2021 Pain at the
injection siteN Sev Mild Mild N N N 07JAN2021 3
C4591001 1066
10661408 1 08DEC2020 Pain at the
injection siteMod Sev Mild Mild N N N 11DEC2020 4
C4591001 1091
10911406 2 28DEC2020 Pain at the
injection siteSev Mod Mild N N N N 30DEC2020 3
C4591001 1091
10911428 1 16DEC2020 Pain at the
injection siteMod Sev Mild Mild N N 19DEC2020 4
C4591001 1140
11401359 1 23DEC2020 Pain at the
injection siteN Sev N N N N N 24DEC2020 1
C4591001 1140
11401376 1 29DEC2020 Pain at the
injection siteMild Sev Mild Mild N N N 01JAN2021 4
2 20JAN2021 Pain at the
injection siteMild Sev Mod Mild N N N 23JAN2021 4
C4591001 1142
11421340 2 28DEC2020 Pain at the
injection siteMod Sev Mild N N N N 30DEC2020 3
C4591001 1142
11421369 2 15JAN2021 Pain at the
injection siteMod Sev N N N N N 16JAN2021 2
C4591001 1147
11471320 2 27JAN2021 Pain at the
injection siteMod Sev Mod Mild Mild 06FEB2021 11
C4591001 1150
11501124 2 10NOV2020 Pain at the
injection siteMod Sev Mod Mild N N 13NOV2020 4
090177e196ac915f\Final\Final On: 31-Mar-2021 13:06 (GMT)
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FDA-CBER-2022-5812-0220994
16.2.7.2.1.1 Listing of Severe and Grade 4 Local Reactions – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Local Reactionb1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
C4591001 1150
11501250 1 29DEC2020 Pain at the
injection siteMod Sev Mild N N N N 31DEC2020 3
C4591001 1152
11521697 1 18DEC2020 Pain at the
injection siteMod Sev Mild Mild N N N 21DEC2020 4
C4591001 1156
11561249 1 16OCT2020 Redness (cu) 21 17OCT2020 1
Redness (svt) N Sev N N N N
C4591001 1156
11561310 1 01DEC2020 Pain at the
injection siteN Sev Mild Mild N 04DEC2020 3
C4591001 1235
12351253 1 08JAN2021 Pain at the
injection siteMild Sev Mild N N N N 10JAN2021 3
16-25 C4591001 1008
10081782 2 30DEC2020 Redness (cu) 21 21 02JAN2021 2
Redness (svt) N N Sev Sev N N
C4591001 1057
10571368 1 23NOV2020 Pain at the
injection siteMild Sev N N N N N 24NOV2020 2
C4591001 1090
10901043 2 24AUG2020 Pain at the
injection siteSev Sev Mild N N Mild 01NOV2020 70
C4591001 1120
11201130 2 03SEP2020 Pain at the
injection siteSev Mod Mild Mild Mild N 07SEP2020 5
C4591001 1125
11251243 1 08DEC2020 Pain at the
injection siteMild Sev Sev Mild N N 11DEC2020 4
C4591001 1142
11421316 1 24NOV2020 Pain at the
injection siteMild Sev N N N N N 25NOV2020 2
C4591001 1150
11501152 2 23DEC2020 Pain at the
injection siteSev Mod Mild N 25DEC2020 3
C4591001 1162
11621019 1 03AUG2020 Pain at the
injection siteN Sev N N N N 04AUG2020 1
090177e196ac915f\Final\Final On: 31-Mar-2021 13:06 (GMT)
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FDA-CBER-2022-5812-0220995
16.2.7.2.1.1 Listing of Severe and Grade 4 Local Reactions – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Local Reactionb1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
C4591001 1194
11941069 1 20OCT2020 Pain at the
injection siteSev Mod Mild N N N N 22OCT2020 3
C4591001 1194
11941091 1 22OCT2020 Pain at the
injection siteMod Sev Mild Mild Mild N 26OCT2020 5
C4591001 1205
12051079 1 11NOV2020 Pain at the
injection siteSev Mod Mild N N N N 13NOV2020 3
2 02DEC2020 Pain at the
injection siteMod Sev Mod Mild Mild Mild Mild 09DEC2020 8
C4591001 1212
12121007 2 17NOV2020 Pain at the
injection siteMod Sev Mild Mild N N N 20NOV2020 4
C4591001 1217
12171012 1 23OCT2020 Pain at the
injection siteMild Sev Mild N N N N 25OCT2020 3
C4591001 1226
12261096 1 11AUG2020 Pain at the
injection siteMild Sev Mild N N Mild N 16AUG2020 6
C4591001 1230
12301018 1 24SEP2020 Pain at the
injection siteSev Sev Mild N N N N 26SEP2020 3
C4591001 1230
12301133 1 05OCT2020 Redness (cu) 2 21 07OCT2020 1
Redness (svt) N Sev N N N N
C4591001 1231
12311018 2 27AUG2020 Pain at the
injection siteN Sev Mild Mild Mild N N 31AUG2020 4
C4591001 1231
12311055 1 11AUG2020 Pain at the
injection siteMild Sev Mod Mild Mild Mild Mild 17AUG2020 7
C4591001 1231
12311162 1 13AUG2020 Pain at the
injection siteMild Sev Mild N N N N 15AUG2020 3
C4591001 1247
12471033 2 15OCT2020 Pain at the
injection siteN Sev Sev N N 19OCT2020 2
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FDA-CBER-2022-5812-0220996
16.2.7.2.1.1 Listing of Severe and Grade 4 Local Reactions – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Local Reactionb1 2 3 4 5 6 7 Stop Datec Dur
(Days)d
C4591001 1247
12471199 1 06OCT2020 Redness (cu) 21 21 07OCT2020 2
Redness (svt) Sev Sev N N
Swellin g (cu) 21 06OCT2020 1
Swelling (svt) Sev N N N
Abbreviations: cu = caliper units ; Dur = duration; Mod = modera te; N = none; Sev = se vere; svt = severity.
a. Relative day (Rel Day) = date of reaction - date of last vaccination + 1.
b. The maximum measurable s ize for redness and swelling in the electronic diary (e-diary) was 21 caliper units. Redness an d swelling exceeding 21
caliper units are reported as > 21. Study sites recorded injecti on site redness or swelling in centimeters. These were converte d to caliper units (1 caliper
unit = 0.5 centimeters).
c. Stop date is the date the reaction was last reported.
d. Duration (days) was calculated as the difference from th e start of the first reported re action to resolution of the las t reported reaction, inclusive. If the
reaction continued beyond Day 7 , the calculation includes all d ays from the last e-diary day until the date of resolution coll ected on the case report form. If
the reaction was ongoing at the time of the subsequent vaccinat ion, the end date/day for the reaction is the date/day that the next vaccine was administered,
which was used for the duration calculation.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:22) Source Dat a: adfacevd Table Generation: 27MAR2021 (01:55)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 _unblinded/C4591001 _BLA/adce _l004_sevlr _ped
090177e196ac915f\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 6
FDA-CBER-2022-5812-0220997
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
12-15 C4591001 1005
10051317 2 12NOV2020 Oral temperature
(°C)36.7 39.1 37.5 37.1 36.6 36.8 36.6 13NOV2020 1
C4591001 1005
10051328 2 11NOV2020 Headache N Sev N N N N N 12NOV2020 1
C4591001 1006
10061189 1 01DEC2020 Oral temperature
(°C)37.1 39.9 36.8 36.9 35.8 37.1 37.4 02DEC2020 1
2 22DEC2020 Oral temperature
(°C)37.3 39.3 37.3 37.1 36.9 23DEC2020 1
C4591001 1006
10061220 2 28DEC2020 Headache N Sev Mild N N N 30DEC2020 2
C4591001 1006
10061297 1 29DEC2020 Oral temperature
(°C)36.7 39.4 37.1 37.1 36.8 37.1 36.8 30DEC2020 1
Fatigue N Sev N N N N N 30DEC2020 1
C4591001 1007
10071544 2 30DEC2020 Fatigue N Sev N N N N N 31DEC2020 1
C4591001 1007
10071546 2 30DEC2020 Chills Sev N N N N N N 30DEC2020 1
C4591001 1007
10071620 2 20JAN2021 Fatigue N Sev Mod Mod Mod Mod Mod
Headache N Sev Mod Sev MildModMod
Chills N Sev N Mod N N Mod27JAN2021 7
New or worsened
muscle painN Sev Mod Sev Mod Mod Mod
New or worsened
joint painN Sev Mod Sev Mod Mod Mod
C4591001 1007
10071626 2 20JAN2021 Oral temperature
(°C)36.8 39.1 36.7 36.6 36.7 36.9 21JAN2021 1
090177e196ac9160\Final\Final On: 31-Mar-2021 13:06 (GMT)
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FDA-CBER-2022-5812-0220998
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1007
10071639 2 25JAN2021 Fatigue Mild Sev Mild N N N N 27JAN2021 3
C4591001 1007
10071642 1 04JAN2021 Fatigue N Sev N N N Mild Mild 01FEB2021 28
C4591001 1007
10071659 2 27JAN2021 Fatigue N Sev Mild N N N N 29JAN2021 2
C4591001 1008
10081802 1 17DEC2020 Oral temperature
(°C)36.6 39.1 36.3 36.4 35.7 36.9 35.8 18DEC2020 1
C4591001 1008
10081809 1 18DEC2020 Headache Sev N N N 18DEC2020 1
C4591001 1008
10081827 1 21DEC2020 Fatigue N Sev N N N N N 22DEC2020 1
Headache N Sev N N N N N 22DEC2020 1
C4591001 1008
10081846 2 11JAN2021 Oral temperature
(°C)37.3 39.3 36.4 36.2 36.1 36.2 12JAN2021 1
C4591001 1008
10081908 2 27JAN2021 Oral temperature
(°C)36.8 39.7 37.3 37.1 36.9 37 37.1 28JAN2021 1
C4591001 1009
10091220 1 19OCT2020 Fatigue Mod Sev N Mod N 24OCT2020 6
C4591001 1009
10091221 1 19OCT2020 New or worsened
joint painSev N N N 19OCT2020 1
C4591001 1009
10091288 2 23DEC2020 Chills N Sev N N N N N 24DEC2020 1
C4591001 1009
10091310 2 29DEC2020 Headache Mild Sev N N N 30DEC2020 2
C4591001 1009
10091317 1 10DEC2020 Oral temperature
(°C)37.3 39 36.6 37.4 36.9 36.8 36.9 11DEC2020 1
Headache N Sev N N N N N 11DEC2020 1
090177e196ac9160\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 8
FDA-CBER-2022-5812-0220999
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1009
10091318 2 29DEC2020 Oral temperature
(°C)36.6 39 37.1 37 36.6 36.3 36.9 30DEC2020 1
C4591001 1009
10091321 2 30DEC2020 Fatigue N Sev Mild N N N N 01JAN2021 2
Chills N Sev N N N N N 31DEC2020 1
C4591001 1009
10091326 1 11DEC2020 Headache N Sev N N N N N 12DEC2020 1
C4591001 1009
10091328 2 30DEC2020 Headache N Sev N Mild N N N 02JAN2021 3
C4591001 1009
10091355 2 08JAN2021 Headache Sev N N N N 09JAN2021 1
C4591001 1009
10091358 1 17DEC2020 Headache N N N N N N Sev 23DEC2020 1
C4591001 1009
10091361 1 17DEC2020 Fatigue Mod Mod Sev Mild N N N 20DEC2020 4
Headache MildSev Mod MildMildMildN 22DEC2020 6
C4591001 1009
10091362 1 17DEC2020 Chills Sev Mod N N Mod Mild 24DEC2020 8
C4591001 1013
10131841 1 02DEC2020 Fatigue Sev N 03DEC2020 1
Headache Sev N 03DEC2020 1
C4591001 1013
10131859 1 09DEC2020 Fatigue N Sev N N N N N 10DEC2020 1
Headache N Sev N N N N N 10DEC2020 1
C4591001 1013
10131866 2 06JAN2021 Fatigue N Sev N N N N 07JAN2021 1
Chills N Sev N N N N 07JAN2021 1
090177e196ac9160\Final\Final On: 31-Mar-2021 13:06 (GMT)
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FDA-CBER-2022-5812-0221000
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1013
10131871 1 21DEC2020 Oral temperature
(°C)36.8 39 36.7 36.7 38.9 37.2 25DEC2020 4
Fatigue MildSev N N N N 22DEC2020 2
C4591001 1016
10161307 1 15OCT2020 Fatigue Mod Sev Mild Mod Mild N Mild 22OCT2020 8
C4591001 1016
10161326 2 10NOV2020 New or worsened
joint painN Sev N N N N 11NOV2020 1
C4591001 1016
10161330 1 20OCT2020 Headache N N N N N N Sev 27OCT2020 2
C4591001 1016
10161373 2 27JAN2021 Headache N Sev N N N N N 28JAN2021 1
Chills N Sev N N N MildN 01FEB2021 5
C4591001 1039
10391304 2 19JAN2021 Fatigue N Sev N N N N N 20JAN2021 1
C4591001 1039
10391318 2 29JAN2021 Fatigue Mod Sev Mild Mild Mild 04FEB2021 7
C4591001 1044
10441266 1 08DEC2020 Fatigue Mod Sev N Mild N N N 11DEC2020 4
2 28DEC2020 Chills Sev N N N N N 29DEC2020 1
C4591001 1044
10441291 2 06JAN2021 Oral temperature
(°C)36.1 39.6 37.2 36.1 36.9 36.4 36.6 07JAN2021 1
C4591001 1044
10441300 2 18JAN2021 Fatigue Sev N N N N 19JAN2021 1
C4591001 1044
10441316 1 04JAN2021 Chills N Sev N N N N N 05JAN2021 1
C4591001 1044
10441322 2 27JAN2021 Headache N Sev N N N N N 28JAN2021 1
090177e196ac9160\Final\Final On: 31-Mar-2021 13:06 (GMT)
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FDA-CBER-2022-5812-0221001
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1044
10441331 2 27JAN2021 Fatigue N Sev N N N N N 28JAN2021 1
C4591001 1044
10441343 2 29JAN2021 Oral temperature
(°C)37.3 39.5 37.7 37.5 36.2 36.6 36.5 30JAN2021 1
Fatigue ModSev Mod ModModModMod
Chills N Sev Mod N N N N 31JAN2021 2
C4591001 1044
10441355 2 29JAN2021 Headache N Sev Mild Mild N Mild N 03FEB2021 5
C4591001 1044
10441379 2 04FEB2021 Fatigue Mild Sev N N N N N 05FEB2021 2
C4591001 1057
10571382 1 08DEC2020 Oral temperature
(°C)35.9 39.1 36.9 36.8 37.4 37.1 36.5 09DEC2020 1
Fatigue N Sev N N N N N 09DEC2020 1
C4591001 1057
10571411 2 06JAN2021 Fatigue N Sev Mod Mild N N N 09JAN2021 3
C4591001 1057
10571424 1 24DEC2020 Chills N Mod Sev Mod Mod Mild 01JAN2021 8
C4591001 1057
10571428 1 24DEC2020 Fatigue N N N N Sev Sev 31DEC2020 3
Headache N N N N ModSev 31DEC2020 3
Chills N N N ModSev N 29DEC2020 2
C4591001 1057
10571438 2 25JAN2021 Oral temperature
(°C)36.8 39.2 36.6 36.7 36.9 37.1 26JAN2021 1
C4591001 1057
10571451 1 12JAN2021 Oral temperature
(°C)36.5 39.2 38.1 37.1 37.3 36.3 36.6 14JAN2021 2
C4591001 1066
10661408 2 28DEC2020 Headache Mild Sev Mild N N 30DEC2020 3
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FDA-CBER-2022-5812-0221002
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1077
10771280 2 04JAN2021 Fatigue Sev Sev N N N 05JAN2021 2
New or worsened
muscle painSev Sev Mild N N 06JAN2021 3
C4591001 1084
10841546 1 18DEC2020 Fatigue Mild Sev Mild Mild N N N 21DEC2020 4
Headache MildSev Mild MildN N Mild24DEC2020 7
C4591001 1084
10841571 1 30DEC2020 Fatigue Mild Mild Sev 05JAN2021 6
C4591001 1084
10841580 1 06JAN2021 Oral temperature
(°C)37.5 39.9 37.7 36.4 36.8 36.8 37 07JAN2021 1
C4591001 1084
10841593 2 29JAN2021 Headache N Sev Mild N N N 31JAN2021 2
C4591001 1091
10911457 1 29DEC2020 Fatigue Sev Mod Mod Sev Mod N Mod 05JAN2021 8
2 18JAN2021 Fatigue Sev Mod ModMildN N 22JAN2021 4
Headache Sev Mod MildN N N 21JAN2021 3
C4591001 1123
11231440 2 28DEC2020 Headache N Sev N N N N 29DEC2020 1
C4591001 1123
11231442 1 09DEC2020 Oral temperature
(°C)39.7 33.4 33.4 34.6 34.1 34.1 09DEC2020 1
C4591001 1123
11231461 2 05JAN2021 Oral temperature
(°C)37.8 39.3 37.6 37.1 36.4 36.7 06JAN2021 1
C4591001 1123
11231475 2 11JAN2021 Oral temperature
(°C)36.8 39.4 36.8 36.8 37.5 37.1 12JAN2021 1
C4591001 1123
11231481 2 12JAN2021 Headache N Sev Mild N N N 14JAN2021 2
090177e196ac9160\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 12
FDA-CBER-2022-5812-0221003
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1123
11231484 2 12JAN2021 Oral temperature
(°C) 39.4 37.5 37.1 36.6 36.3 13JAN2021 1
Headache Sev Mild ModMod N 16JAN2021 4
C4591001 1123
11231495 2 13JAN2021 Fatigue Mod Sev N N N N 14JAN2021 2
C4591001 1123
11231513 1 30DEC2020 Headache N N N N Sev Mild N 04JAN2021 2
C4591001 1124
11241251 2 08JAN2021 Oral temperature
(°C)37.6 39 36.9 36.7 36.7 09JAN2021 1
C4591001 1125
11251248 1 11DEC2020 Fatigue Mod Sev Mod Mod Mild Mild Mild 17DEC2020 7
C4591001 1125
11251252 1 16DEC2020 Fatigue Sev N 17DEC2020 1
C4591001 1126
11261263 1 04DEC2020 Chills N Sev N N N N 05DEC2020 1
C4591001 1126
11261273 2 06JAN2021 Headache N Sev Mild Mild N N N 09JAN2021 3
C4591001 1126
11261281 1 16DEC2020 Headache N Mild Sev N N N N 18DEC2020 2
C4591001 1126
11261286 1 16DEC2020 Oral temperature
(°C)37.2 39 36.8 36.9 36.6 36.8 36.4 17DEC2020 1
C4591001 1126
11261299 2 12JAN2021 New or worsened
muscle painN N Sev N N N N 14JAN2021 1
C4591001 1126
11261307 1 04JAN2021 Chills N Sev N N N N N 05JAN2021 1
C4591001 1126
11261309 1 04JAN2021 New or worsened
muscle painN Sev N N N N 05JAN2021 1
2 25JAN2021 Fatigue MildSev N N N N N 26JAN2021 2
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FDA-CBER-2022-5812-0221004
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
Chills MildSev N N N N N 26JAN2021 2
C4591001 1126
11261310 2 26JAN2021 Headache N Sev N N N N 27JAN2021 1
C4591001 1126
11261315 1 06JAN2021 Oral temperature
(°C)36.9 39.3 36.3 36.8 36.6 36.9 36.8 07JAN2021 1
C4591001 1126
11261324 2 28JAN2021 Oral temperature
(°C)36.4 39.2 36.6 36.2 36.5 36.3 35.8 29JAN2021 1
C4591001 1131
11311290 2 20JAN2021 Fatigue Mod Sev N N N N 21JAN2021 2
Headache N Sev N N N N 21JAN2021 1
C4591001 1131
11311302 2 01FEB2021 Oral temperature
(°C)36.2 39.6 36.5 36.4 36.3 36.3 02FEB2021 1
C4591001 1139
11391155 2 28DEC2020 Fatigue N Sev Mild N N N N 30DEC2020 2
C4591001 1139
11391238 1 07JAN2021 Headache Mild Sev Mod Mild Mild N Mild 14JAN2021 8
C4591001 1140
11401328 2 05JAN2021 Oral temperature
(°C)36.7 39.5 37.1 37 37.1 37 37 06JAN2021 1
C4591001 1140
11401329 2 05JAN2021 Oral temperature
(°C)36.8 40 36.9 36.5 36.6 36.7 36.7 06JAN2021 1
C4591001 1140
11401343 1 21DEC2020 Headache N N Sev N N N N 23DEC2020 1
Vomitin g N N Sev N N N N 23DEC2020 1
C4591001 1140
11401345 2 11JAN2021 Oral temperature
(°C)36.2 38.9 36.4 35.7 36.8 12JAN2021 1
C4591001 1140
11401352 2 13JAN2021 Headache Mild Sev N N N N Mild 17FEB2021 36
090177e196ac9160\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 14
FDA-CBER-2022-5812-0221005
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1140
11401359 1 23DEC2020 Fatigue N Sev N N N N N 24DEC2020 1
C4591001 1140
11401378 2 20JAN2021 Fatigue Mod Sev N N N 21JAN2021 2
C4591001 1140
11401380 2 19JAN2021 Chills Sev N N N N N 20JAN2021 1
C4591001 1140
11401391 2 28JAN2021 Headache Sev N Mod N N 01FEB2021 3
C4591001 1140
11401400 1 08JAN2021 Headache N N N Mod N Sev 20JAN2021 9
C4591001 1142
11421340 1 07DEC2020 Fatigue N Sev N N N N N 08DEC2020 1
Headache N Sev N N N N N 08DEC2020 1
2 28DEC2020 Headache ModSev N N N N N 29DEC2020 2
C4591001 1142
11421369 2 15JAN2021 Fatigue Mod Sev Mild N N N N 17JAN2021 3
Chills MildSev Mild N N N N 17JAN2021 3
New or worsened
muscle painN Sev N N N N N 16JAN2021 1
New or worsened
joint painN Sev N N N N N 16JAN2021 1
C4591001 1142
11421375 1 22DEC2020 Fatigue Sev N N N N N 22DEC2020 1
C4591001 1142
11421392 2 29JAN2021 Chills Sev N N N N N 30JAN2021 1
C4591001 1147
11471277 2 28DEC2020 New or worsened
muscle pain N N N N Sev Sev 07JAN2021 6
090177e196ac9160\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 15
FDA-CBER-2022-5812-0221006
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1147
11471285 2 04JAN2021 Fatigue Sev N 09JAN2021 1
C4591001 1147
11471301 1 19DEC2020 Fatigue N Sev Mild N N N 21DEC2020 2
C4591001 1147
11471312 2 09JAN2021 Fatigue Mild N N N N Sev N 14JAN2021 6
C4591001 1147
11471327 1 05JAN2021 Oral temperature
(°C)35.6 40.4 38 35.8 35.9 36.4 07JAN2021 2
C4591001 1147
11471334 2 27JAN2021 Chills Sev Mild N N N N N 28JAN2021 2
C4591001 1147
11471337 2 27JAN2021 Chills N Sev N N N N N 28JAN2021 1
New or worsened
muscle painN Sev N N N N N 28JAN2021 1
C4591001 1147
11471347 2 28JAN2021 Chills N Sev Mild N N N 30JAN2021 2
C4591001 1150
11501198 2 30DEC2020 Fatigue N Sev 31DEC2020 1
C4591001 1150
11501245 1 28DEC2020 Headache N Sev N N N N 29DEC2020 1
2 19JAN2021 Headache N Sev N N N N N 20JAN2021 1
C4591001 1150
11501260 2 20JAN2021 Oral temperature
(°C)37.2 39.1 37.2 36.7 37.1 37 36.4 21JAN2021 1
C4591001 1150
11501274 2 25JAN2021 New or worsened
muscle pain Sev N 26JAN2021 1
New or worsened
joint pain Sev N 26JAN2021 1
090177e196ac9160\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 16
FDA-CBER-2022-5812-0221007
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1150
11501297 1 11JAN2021 Oral temperature
(°C)37.2 39.1 37.4 37.1 36.9 36.9 37.1 12JAN2021 1
2 02FEB2021 Oral temperature
(°C)36.8 39.7 38.4 36.8 37.1 04FEB2021 2
Fatigue N Sev Mod N N 04FEB2021 2
Chills N Sev N N N 03FEB2021 1
C4591001 1150
11501299 1 12JAN2021 Chills N Sev Mild N N N N 14JAN2021 2
2 01FEB2021 Chills N Sev Mild N N N 03FEB2021 2
C4591001 1152
11521619 2 22DEC2020 Oral temperature
(°C)36.7 39.3 37.9 37.2 36.9 37 36.8 23DEC2020 1
C4591001 1152
11521670 2 30DEC2020 Chills N Sev N N N N N 31DEC2020 1
C4591001 1152
11521706 1 21DEC2020 Fatigue Mod Mod Mild N Sev Mild 27DEC2020 7
Headache N N N N Sev Mod27DEC2020 2
C4591001 1156
11561340 2 19JAN2021 Fatigue Sev Mod N N N 20JAN2021 2
C4591001 1156
11561342 2 19JAN2021 Oral temperature
(°C)36.8 39.9 37.1 37 37 37 37 20JAN2021 1
C4591001 1156
11561349 2 26JAN2021 Chills N Sev N N N N N 27JAN2021 1
C4591001 1156
11561356 1 07JAN2021 Fatigue Mild Sev Mod Mild N N N 10JAN2021 4
New or worsened
muscle painN Sev N N N N N 08JAN2021 1
C4591001 1156
11561358 2 29JAN2021 Fatigue N Sev Mild N N N N 31JAN2021 2
090177e196ac9160\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 17
FDA-CBER-2022-5812-0221008
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1223
12231280 2 28JAN2021 Oral temperature
(°C) 39.2 38.4 30JAN2021 2
C4591001 1235
12351236 2 22DEC2020 New or worsened
muscle painMod Sev N N N N 23DEC2020 2
C4591001 1235
12351249 1 15DEC2020 Headache Sev Mod Mod Sev Mod Mild 04JAN2021 21
2 04JAN2021 Headache Sev Sev Sev Sev Sev 09JAN2021 6
C4591001 1235
12351254 2 28JAN2021 Fatigue Sev Mild N N N N 30JAN2021 2
Chills Sev N N N N N 29JAN2021 1
C4591001 1270
12701191 2 23DEC2020 Fatigue N Sev Mild N N N N 25DEC2020 2
C4591001 1270
12701207 2 05JAN2021 Oral temperature
(°C)37.4 39.5 37.4 37.1 37.2 36.8 37.4 06JAN2021 1
Fatigue N Sev Mod Mod N Mod N 10JAN2021 5
C4591001 1270
12701220 2 08JAN2021 Oral temperature
(°C)37.2 39.1 37.4 37.1 36.2 36.4 09JAN2021 1
C4591001 1270
12701239 2 28JAN2021 Oral temperature
(°C)36.2 39 36.1 36.1 36.3 36.1 36.2 29JAN2021 1
16-25 C4591001 1001
10011125 1 04AUG2020 Fatigue Mod Mod Sev Mild N 07AUG2020 4
Headache ModMod Sev Mod N 07AUG2020 4
New or worsened
muscle painN N Sev N N 06AUG2020 1
New or worsened
joint painN Mild Sev N N 06AUG2020 2
C4591001 1005
10051024 2 31AUG2020 Fatigue Sev N N N N 01SEP2020 1
090177e196ac9160\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 18
FDA-CBER-2022-5812-0221009
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1005
10051434 2 12JAN2021 Chills N Sev N N N 13JAN2021 1
C4591001 1005
10051442 1 22DEC2020 Fatigue N Sev Mild Mild N Mild N 27DEC2020 5
C4591001 1006
10061185 2 21DEC2020 Chills N Sev N N N N N 22DEC2020 1
C4591001 1006
10061192 2 22DEC2020 Headache N Sev N Mild N N N 25DEC2020 3
C4591001 1006
10061210 2 23DEC2020 Headache N Sev N N N N N 24DEC2020 1
C4591001 1006
10061246 1 10DEC2020 Fatigue N N Sev N N N N 12DEC2020 1
C4591001 1007
10071487 1 01DEC2020 Headache N Sev Mild N N 03DEC2020 2
C4591001 1007
10071503 1 03DEC2020 New or worsened
muscle painSev Mod N N 04DEC2020 2
C4591001 1009
10091028 2 31AUG2020 New or worsened
muscle painN Sev N N N N N 01SEP2020 1
C4591001 1013
10131005 1 28JUL2020 Headache N N N N Sev N 01AUG2020 1
C4591001 1013
10131059 2 25AUG2020 Fatigue N Sev Mild N N N N 27AUG2020 2
C4591001 1015
10151035 2 04SEP2020 Fatigue Sev N N N N N 05SEP2020 1
New or worsened
muscle pain Sev N N N N N 05SEP2020 1
New or worsened
joint pain Sev N N N N N 05SEP2020 1
090177e196ac9160\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 19
FDA-CBER-2022-5812-0221010
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1016
10161349 2 25NOV2020 Headache Mod Sev Mild N N N N 27NOV2020 3
C4591001 1044
10441244 2 14DEC2020 Fatigue N Sev Mild Mild Mild Mild N 19DEC2020 5
New or worsened
muscle painN Sev Mild N N N N 16DEC2020 2
C4591001 1044
10441245 2 14DEC2020 Fatigue Sev Mild N N N 16DEC2020 2
C4591001 1044
10441287 1 11DEC2020 Fatigue Mod Sev Mild Mild N Mild Mild
C4591001 1071
10711039 2 04SEP2020 Headache N N Mod Sev Mild Mild 21SEP2020 16
C4591001 1073
10731064 2 01SEP2020 Fatigue Mod Mod Mod Sev N N N 04SEP2020 4
Headache N Mod N Sev N N N 04SEP2020 3
C4591001 1073
10731083 2 02SEP2020 Fatigue Mod Sev N N N N 03SEP2020 2
Chills N Sev N N N N 03SEP2020 1
C4591001 1080
10801009 2 03SEP2020 Headache Sev Mod N N 05SEP2020 2
C4591001 1082
10821036 1 04AUG2020 Headache Mod N Mild N N N Sev 11AUG2020 8
2 25AUG2020 Headache N Sev Sev N N N Mod31AUG2020 6
C4591001 1090
10901043 2 24AUG2020 Headache Mild Sev N N N Mild 30AUG2020 7
Chills N Sev N N N N 25AUG2020 1
C4591001 1107
11071010 2 18AUG2020 Headache Mod N Mod Sev Mod 23AUG2020 6
090177e196ac9160\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 20
FDA-CBER-2022-5812-0221011
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1107
11071055 2 27AUG2020 Headache N Sev N N N N N 28AUG2020 1
C4591001 1109
11091020 2 18AUG2020 Headache Mod Sev N N N N 19AUG2020 2
C4591001 1112
11121045 1 03AUG2020 Oral temperature
(°C)36.9 39 37 37.1 36.9 36.8 36.6 04AUG2020 1
C4591001 1120
11201172 1 13AUG2020 Fatigue N Sev Mild N N N N 15AUG2020 2
C4591001 1120
11201250 2 11SEP2020 Headache N Sev N N N N N 12SEP2020 1
New or worsened
joint painN Sev N N N Mod Mild
C4591001 1125
11251243 1 08DEC2020 Fatigue N Mod Sev N N N 10DEC2020 2
Headache N Sev Sev N N N 10DEC2020 2
C4591001 1126
11261208 2 04DEC2020 Headache N Sev N N N N N 05DEC2020 1
C4591001 1129
11291261 2 14DEC2020 Headache Sev Sev N N N N N 15DEC2020 2
C4591001 1129
11291262 2 14DEC2020 Fatigue Sev Mild Mild N N N N 16DEC2020 3
C4591001 1135
11351088 2 28AUG2020 Fatigue Mild Sev N N N N N 29AUG2020 2
C4591001 1139
11391160 2 29DEC2020 Oral temperature
(°C)36.3 38.9 36.2 36.8 30DEC2020 1
C4591001 1140
11401316 2 14DEC2020 Headache Mild Sev N N N N N 15DEC2020 2
Chills N Sev N N N N N 15DEC2020 1
090177e196ac9160\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 21
FDA-CBER-2022-5812-0221012
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1140
11401320 2 23DEC2020 Fatigue Mild Sev N N N N N 24DEC2020 2
C4591001 1140
11401321 1 04DEC2020 Fatigue Mod Sev Mod N N N N 06DEC2020 3
C4591001 1140
11401322 2 23DEC2020 Fatigue Mod Sev Mod Mild N 26DEC2020 4
Headache ModSev Mild N N 25DEC2020 3
C4591001 1141
11411081 1 14AUG2020 Fatigue N Sev N N N N N 15AUG2020 1
C4591001 1142
11421336 2 23DEC2020 Headache N N N N Sev N 28DEC2020 1
C4591001 1147
11471255 2 05DEC2020 Oral temperature
(°C)37.1 39.5 37.1 37.1 37.2 37.1 37 06DEC2020 1
Chills N Sev N N N N N 06DEC2020 1
C4591001 1152
11521072 2 01SEP2020 Diarrhea N N Sev Mild N N 04SEP2020 2
C4591001 1152
11521600 2 15DEC2020 Oral temperature
(°C)36.8 37.3 39 36.7 36.6 36.8 36.9 17DEC2020 1
C4591001 1152
11521630 2 28DEC2020 Headache N Sev N N N N N 29DEC2020 1
C4591001 1152
11521632 1 07DEC2020 Chills Mod Sev Mild N N 09DEC2020 3
2 28DEC2020 Fatigue N Sev Mild N N N 30DEC2020 2
Headache N Sev Mild N N N 30DEC2020 2
C4591001 1156
11561299 1 11NOV2020 Fatigue N Mild Mod N N Sev N 16NOV2020 5
C4591001 1156
11561300 1 17NOV2020 Oral temperature
(°C)36.9 38.9 35.4 36.5 37.1 36.4 18NOV2020 1
090177e196ac9160\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 22
FDA-CBER-2022-5812-0221013
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1162
11621044 1 06AUG2020 Oral temperature
(°C) 36.1 40 37.6 11AUG2020 1
Fatigue N Sev Sev 13AUG2020 3
Headache N Sev Sev 13AUG2020 3
Chills Mild Sev Mod13AUG2020 6
New or worsened
muscle pain N Sev N 11AUG2020 1
C4591001 1162
11621080 2 02SEP2020 Headache N Sev Mod N N N 04SEP2020 2
Chills N Sev Mod N N N 04SEP2020 2
C4591001 1162
11621110 2 02SEP2020 Fatigue Sev N N N N N 03SEP2020 1
C4591001 1171
11711027 1 14AUG2020 Chills N Sev N N N N N 15AUG2020 1
C4591001 1194
11941062 2 11NOV2020 Fatigue Mod Sev Mild Mild N N N 14NOV2020 4
C4591001 1194
11941069 2 11NOV2020 Fatigue Sev Sev Mild N N N N 13NOV2020 3
C4591001 1195
11951100 1 18OCT2020 Vomiting Sev N N N N N 18OCT2020 1
C4591001 1205
12051079 1 11NOV2020 Headache Mild Sev N N Mild N Mod 18NOV2020 8
2 02DEC2020 Headache ModSev N N N N N 03DEC2020 2
Chills MildSev N N N N N 03DEC2020 2
New or worsened
muscle painN Sev N N N N N 03DEC2020 1
New or worsened
joint painN Sev N N N N N 03DEC2020 1
090177e196ac9160\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 23
FDA-CBER-2022-5812-0221014
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1208
12081051 2 01DEC2020 Fatigue Mod Sev Mod N N N 03DEC2020 3
C4591001 1212
12121007 2 17NOV2020 Oral temperature
(°C)36.9 39.5 37.5 36.9 36.8 36.6 37 18NOV2020 1
Fatigue ModSev Mod N N N N 19NOV2020 3
New or worsened
muscle painN Sev Mod N N N N 19NOV2020 2
C4591001 1214
12141053 2 02DEC2020 Headache N N N N N N Sev 08DEC2020 1
C4591001 1217
12171053 1 06NOV2020 Fatigue N Sev N N N N 07NOV2020 1
2 26NOV2020 Fatigue N Sev N N N N 27NOV2020 1
C4591001 1223
12231057 1 01SEP2020 Headache N Sev Mild N N N N 03SEP2020 2
C4591001 1224
12241168 2 10DEC2020 Chills Mod Sev N N N N N 11DEC2020 2
C4591001 1224
12241171 1 23NOV2020 Fatigue N Sev N N N N N 24NOV2020 1
Headache N Sev N N N N N 24NOV2020 1
C4591001 1224
12241173 2 21DEC2020 New or worsened
muscle painN Sev N N N 22DEC2020 1
C4591001 1224
12241176 1 30NOV2020 Chills N Sev N N N N N 01DEC2020 1
C4591001 1224
12241178 1 30NOV2020 Fatigue Mild Sev N N N N N 01DEC2020 2
Chills N Sev N N N N N 01DEC2020 1
2 29DEC2020 Chills MildSev Mild N N N N 31DEC2020 3
090177e196ac9160\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 24
FDA-CBER-2022-5812-0221015
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1226
12261001 2 25AUG2020 New or worsened
muscle painMod Sev N N N 26AUG2020 2
C4591001 1226
12261096 1 11AUG2020 Fatigue N Sev Mod N N N N 13AUG2020 2
Headache N Sev Mod N N N N 13AUG2020 2
New or worsened
muscle painN Sev Mild N N N N 13AUG2020 2
New or worsened
joint painN Sev Mild Mild N N N 14AUG2020 3
2 01SEP2020 Fatigue N Sev N N N N N 02SEP2020 1
C4591001 1226
12261124 2 04SEP2020 Fatigue N Sev N N N N 05SEP2020 1
C4591001 1229
12291065 1 30SEP2020 Chills Mod Mild Mild Mod Sev N N 04OCT2020 5
2 21OCT2020 Fatigue MildN Mod N N Sev N 26OCT2020 6
New or worsened
muscle painN Mild N N N Sev Mod 27OCT2020 6
C4591001 1230
12301018 1 24SEP2020 New or worsened
muscle painMod Sev N N N N N 25SEP2020 2
New or worsened
joint painN Sev N N N N N 25SEP2020 1
C4591001 1230
12301094 1 01OCT2020 Headache N Sev Sev N N N N 03OCT2020 2
C4591001 1230
12301102 2 23OCT2020 Headache N Mod N Mod N Sev N 28OCT2020 5
C4591001 1231
12311018 2 27AUG2020 Headache N Sev N N N N N 28AUG2020 1
090177e196ac9160\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 25
FDA-CBER-2022-5812-0221016
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1231
12311055 2 01SEP2020 Oral temperature
(°C)36.7 39 37.2 36.7 36.5 36.6 02SEP2020 1
Fatigue N Sev N N Mod N 06SEP2020 5
Chills N Sev N N N N 02SEP2020 1
C4591001 1231
12311164 2 02SEP2020 Fatigue N Sev Mild Mild N Mild Mild 09SEP2020 7
Chills N Sev N N N N N 03SEP2020 1
C4591001 1231
12311266 2 02SEP2020 Oral temperature
(°C)37.4 39.1 37.9 36.2 36.4 36.3 36.2 03SEP2020 1
C4591001 1231
12311281 2 04SEP2020 New or worsened
muscle painMild Sev N N N N N 05SEP2020 2
C4591001 1231
12311306 1 15AUG2020 Headache N Mod N Sev N N N 18AUG2020 3
C4591001 1231
12311368 2 04SEP2020 Oral temperature
(°C)36 39.1 39.2 35.8 35.9 36.6 35.9 06SEP2020 2
C4591001 1231
12311432 1 15AUG2020 Headache N Sev Mild Mild Mild N N 19AUG2020 4
C4591001 1231
12311454 2 03SEP2020 Fatigue Mild Sev N N N N N 04SEP2020 2
C4591001 1231
12311463 1 15AUG2020 Fatigue Mild Mod Mild N N Sev Mild 23AUG2020 9
C4591001 1235
12351237 2 28DEC2020 New or worsened
joint painN Sev N N N N N 29DEC2020 1
C4591001 1235
12351241 2 28DEC2020 Headache Mild Sev Mild Mild Mild N N 01JAN2021 5
C4591001 1246
12461038 2 20OCT2020 Diarrhea N Sev Mild N N 22OCT2020 2
090177e196ac9160\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 26
FDA-CBER-2022-5812-0221017
16.2.7.3.1.1 Listing of Severe and Grade 4 Systemic Events – Su bjects 12 Through 25 Years of Age (Reactogenicity
Subset)
Rel Daya
Age
Group
(Years) Subject Dose
No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur
(Days)c
C4591001 1247
12471010 1 23SEP2020 Headache Mild Mild Mod N Mod Mild Sev 29SEP2020 7
C4591001 1247
12471033 2 15OCT2020 New or worsened
muscle painN Sev Sev N N 19OCT2020 2
C4591001 1247
12471121 1 30SEP2020 Oral temperature
(°C)39.2 39.8 39.1 39.2 39 38.8 38.9 06OCT2020 7
Fatigue ModMod Mod Sev ModModMod06OCT2020 7
Headache ModSev Mod ModModMildMod06OCT2020 7
2 21OCT2020 Oral temperature
(°C)38.9 40 39.6 39.3 38.2 38.9 38.8
Fatigue ModMod Mod ModModModSev
C4591001 1247
12471145 2 22OCT2020 Headache Mild N Sev N N 26OCT2020 4
C4591001 1270
12701165 1 23NOV2020 Fatigue N Sev N N N N N 24NOV2020 1
Abbreviations: Dur = duration; Mod = moderate; N = none; Sev = severe.
Note: Subject C4591001 1077 10771278 (13 years of age) experienc ed systemic events, including a t emperature of 40.4°C, on the d ay of Dose 2. Since
these events were recorded as ad verse events and not in the ele ctronic diary (e-diary), they do not appear in this listing.
a. Relative day (Rel Day) = date of event - date of last va ccination + 1.
b. Stop date is the date the event was last reported.
c. Duration (days) was calcula ted as the difference from the start of the first reported ev ent to resolution of the last reported event, inclusive. If the event
continued beyond Day 7, the calculation includes all days from the last e-diary day until the date of resolution collected on the case report form. If the
event is ongoing at the time of the subsequent vaccination, the end date/day for the event is t he date/day that the next vacci ne was administered, which was
used for the duration calculation.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:22) Source Data: adfacevd Table Generation: 27MAR2021 (01:55)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 _unblinded/C4591001 _BLA/adce _l004_sevse _ped
090177e196ac9160\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 27
FDA-CBER-2022-5812-0221018
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
12-15 C4591001
1005
10051317 GENRL Chills/
CHILLS 1 21OCT2020 2/2 2 Yes NA/TC R
(22OCT2020)N/N
C4591001
1005
10051328 GASTR Nausea/
NAUSEA 2 12NOV2020 2/2 2 Yes NA R
(13NOV2020)N/N
C4591001
1005
10051424 GASTR Nausea/
NAUSEA 2 08JAN2021 1/4 1 Yes NA/TC R
(11JAN2021)N/N
GENRL Fatigue/
FATIGUE2 08JAN2021 1/4 2 Yes NA R
(11JAN2021)N/N
Injection site pain/
INJECTION SITE PAIN2 08JAN2021 1/4 2 Yes NA R
(11JAN2021)N/N
MUSC Myalgia/
GENERALIZED
MYALGIA2 08JAN2021 1/4 2 Yes NA R
(11JAN2021)N/N
NERV Headache/
HEADACHE2 08JAN2021 1/4 2 Yes NA/TC R
(11JAN2021)N/N
C4591001
1006
10061203 GASTR Nausea/
Nausea 1 04DEC2020 2/1 1 Yes NA R
(04DEC2020)N/N
GENRL Fatigue/
Fatigue1 04DEC2020 2/1 1 Yes NA R
(04DEC2020)N/N
Injection site pain/
Injection site pain1 04DEC2020 2/5 1 Yes NA R
(08DEC2020)N/N
NERV Headache/
Headache1 04DEC2020 2/2 1 Yes NA R
(05DEC2020)N/N
GENRL Fatigue/
Fatigue2 22DEC2020 1/3 1 Yes NA R
(24DEC2020)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 28
FDA-CBER-2022-5812-0221019
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Injection site pain/
Injection Site Pain2 22DEC2020 1/3 2 Yes NA R
(24DEC2020)N/N
NERV Headache/
Headache2 22DEC2020 1/3 2 Yes NA/TC R
(24DEC2020)N/N
C4591001
1006
10061209 NERV Syncope/
Syncope Vasovagal
response2 12MAR2021 80/1 1 No O NA/TCN R
(12MAR2021)N/N
C4591001
1006
10061245 SKIN Urticaria/
Hives face 1 12DEC2020 3/20 1 Yes NA/TC R
(31DEC2020)N/N
Urticaria/
Hives trun k1 12DEC2020 3/4 1 Yes NA/TC R
(15DEC2020)N/N
C4591001
1006
10061266# GENRL Chills/
CHILLS 3 24FEB2021 1/3 2 Yes NA/TC R
(26FEB2021)N/N
C4591001
1006
10061272 PSYCH Anxiety/
Worsening of anxiety 1 23DEC2020 8/27 3 No O P/TC/TCN R
(18JAN2021)Y/N
Depression/
Worsenin g of Depression1 23DEC2020 8/27 3 No O P/TC/TCN R
(18JAN2021)Y/N
INJ&P Contusion/
Contusion left elbow1 05FEB2021 52/C 1 No O NA RG N/N
C4591001
1006
10061286 GENRL Fatigue/
FATIGUE 2 16JAN2021 6/4 2 Yes NA R
(19JAN2021)N/N
C4591001
1006
10061290 INJ&P Concussion/
Concussion 1 12JAN2021 22/C 2 No O NA/TC RG N/N
C4591001
1006
10061292 EAR Cerumen impaction/
Earwax Impaction Left Ear2 24JAN2021 13/5 2 No O NA/TCN R
(28JAN2021)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 29
FDA-CBER-2022-5812-0221020
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1007
10071476 NERV Syncope/
Vasovagal syncope without
collapse*30NOV2020 1/1 1 No O NA/TC/TCN R
(30NOV2020)N/N
NERV Dizziness/
lightheadness after
vaccination2 21DEC2020 1/1 1 No O NA R
(21DEC2020)N/Y
C4591001
1007
10071497 BLOOD Lymphadenopathy/
swollen lymph node left
axilla2 25DEC2020 4/C 1 Yes NA RG N/N
C4591001
1007
10071500 PSYCH Sleep terror/
Night Terror 2 23DEC2020 2/1 1 No O NA R
(23DEC2020)N/N
C4591001
1007
10071524 INFEC Candida infection/
thrush 2 01FEB2021 35/2 2 No CD NA R
(02FEB2021)N/N
C4591001
1007
10071533 MUSC Myalgia/
abdominal muscle pain 2 06JAN2021 8/2 1 No O NA/TC R
(07JAN2021)N/N
C4591001
1007
10071563 NERV Dizziness/
lightheadness 1 14DEC2020 1/1 1 Yes NA/TCN R
(14DEC2020)N/Y
C4591001
1007
10071568 GENRL Injection site pain/
injection site soreness 1 15DEC2020 1/1 1 Yes NA R
(15DEC2020)N/Y
SKIN Rash maculo-papular/
maculopapular rash2 05JAN2021 1/29 1 Yes NA R
(02FEB2021)N/Y
C4591001
1007
10071575 MUSC Mobility decreased/
Altered Mobility of Left
upper extremit y1 03JAN2021 19/C 2 No O NA/TC RG N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 30
FDA-CBER-2022-5812-0221021
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1007
10071581 INFEC Appendicitis/
Appendicitis 2 11MAR2021 64/C 3 No O NA/TC RG Y/N
C4591001
1007
10071584 GENRL Injection site pain/
Soreness at injection site 2 07JAN2021 1/4 1 Yes NA R
(10JAN2021)N/Y
C4591001
1007
10071585 SKIN Urticaria/
hives; trunk, abdomen, back2 16JAN2021 10/C 2 Yes NA/TC RG N/N
C4591001
1007
10071593 INJ&P Ligament sprain/
left Ankle sprain 1 30DEC2020 3/17 2 No O NA/TCN R
(15JAN2021)N/N
C4591001
1007
10071613 GENRL Injection site pain/
Pain at injection site 1 29DEC2020 1/1 1 Yes NA R
(29DEC2020)N/N
C4591001
1007
10071615 BLOOD Lymphadenopathy/
left axillary lymph node
swellin g2 20JAN2021 2/4 1 Yes NA R
(23JAN2021)N/N
C4591001
1007
10071618 GENRL Injection site pain/
Pain at injection nsite 1 29DEC2020 1/2 1 Yes NA R
(30DEC2020)N/Y
C4591001
1007
10071620 GASTR Abdominal pain/
Abdominal pain 2 21JAN2021 2/20 2 Yes NA/TC R
(09FEB2021)N/N
NERV Neuralgia/
generalized Functional
neurolo gic pain2 21JAN2021 2/C 2 No O NA/TC RG Y/N
INFEC Vulval abscess/
Vulvar boil2 24JAN2021 5/3 1 No O NA/TC R
(26JAN2021)N/N
GASTR Gastritis/
Gastritis2 30JAN2021 11/C 2 No CD NA/TC RG N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 31
FDA-CBER-2022-5812-0221022
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
SKIN Dermatitis contact/
contact dermatitis bilateral
arms2 12FEB2021 24/C 1 No O NA/TC RG N/N
GASTR Abdominal pain/
Functional Abdominal Pain2 28FEB2021 40/C 3 No O NA/TC N Y/N
Constipation/
Constipation2 28FEB2021 40/C 3 No O NA/TC N Y/N
C4591001
1007
10071623 GASTR Toothache/
teeth pain 2 27JAN2021 7/2 2 No CND NA/TC R
(28JAN2021)N/N
C4591001
1007
10071632 GENRL Injection site pain/
tenderness at injection site1 30DEC2020 1/2 1 Yes NA R
(31DEC2020)N/Y
Vessel puncture site pain/
pain at blood draw site1 30DEC2020 1/2 1 No O NA R
(31DEC2020)N/Y
NERV Headache/
headache1 30DEC2020 1/1 1 Yes NA R
(30DEC2020)N/Y
SKIN Rash/
rash to chest and bac k2 22JAN2021 2/5 2 Yes NA R
(26JAN2021)N/N
C4591001
1007
10071634 RESP Rhinorrhoea/
Rhinorrhea 2 18FEB2021 25/C 1 No O NA RG N/N
NERV Presyncope/
vasova gal response2 22FEB2021 29/1 1 No O NA R
(22FEB2021)N/N
C4591001
1007
10071648 GENRL Injection site pain/
Injection site pain 2 26JAN2021 1/2 1 Yes NA R
(27JAN2021)N/Y
C4591001
1007
10071651 BLOOD Lymphadenopathy/
Left deep cervical chain
lymph node swellin g1 12JAN2021 8/29 1 Yes NA R
(09FEB2021)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 32
FDA-CBER-2022-5812-0221023
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
BLOOD Lymphadenopathy/
left Cervical
lymphadenopath y2 23FEB2021 29/C 1 No O NA RG N/N
C4591001
1008
10081928 SKIN Urticaria/
urticaria multiple sites 1 10JAN2021 3/13 1 Yes NA/TC R
(22JAN2021)N/N
C4591001
1009
10091220 INJ&P Procedural pain/
POST SURGICAL PAIN,
ORAL2 20NOV2020 14/11 2 No O NA/TC R
(30NOV2020)N/N
C4591001
1009
10091221 MUSC Arthralgia/
worsening right ankle pain1 19OCT2020 1/1 3 No O NA/TCN R
(19OCT2020)N/N
C4591001
1009
10091231 BLOOD Lymphadenopathy/
left swollen axillary lymph
node2 10NOV2020 2/1 1 Yes NA R
(10NOV2020)N/N
C4591001
1009
10091267 RESP Rhinorrhoea/
RUNNY NOSE 2 27DEC2020 6/6 1 No O NA/TC R
(01JAN2021)N/N
C4591001
1009
10091294 MUSC Arthralgia/
bilateral shoulder pain 1 22DEC2020 16/3 1 No O NA R
(24DEC2020)N/N
C4591001
1009
10091319 NERV Headache/
headache 2 22JAN2021 25/1 2 No O NA R
(22JAN2021)N/N
C4591001
1009
10091323 GASTR Nausea/
nausea 2 08JAN2021 10/1 1 No O NA R
(08JAN2021)N/N
GENRL Fatigue/
fatigue2 08JAN2021 10/1 1 No O NA R
(08JAN2021)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 33
FDA-CBER-2022-5812-0221024
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1009
10091334 RESP Rhinorrhoea/
runny nose 2 11JAN2021 12/1 1 No O NA R
(11JAN2021)N/N
C4591001
1009
10091342 BLOOD Lymphadenopathy/
swollen cervical lymph
nodes bilateral2 31JAN2021 28/3 1 No O NA R
(02FEB2021)N/N
C4591001
1009
10091361 INJ&P Ligament sprain/
sprained right thumb 1 02JAN2021 17/30 2 No O NA R
(31JAN2021)N/N
C4591001
1009
10091363 NERV Presyncope/
Vasovagal Reaction 1 09FEB2021 55/1 1 No O NA R
(09FEB2021)N/N
C4591001
1009
10091366 GENRL Injection site pain/
Mild Injection Site Pain 2 26FEB2021 1/2 1 Yes NA R
(27FEB2021)N/N
C4591001
1009
10091370 NERV Headache/
headache 1 06JAN2021 20/1 3 No O NA/TC R
(06JAN2021)N/N
C4591001
1009
10091379 INJ&P Fall/
GROUND LEVEL FALL2 26FEB2021 44/1 2 No O NA R
(26FEB2021)N/N
C4591001
1009
10091380 INJ&P Clavicle fracture/
Right Clavicle Fracture 1 18JAN2021 21/C 2 No O NA/TC N N/N
INJ&P Procedural pain/
pain after wisdom teeth
removal2 11FEB2021 24/5 1 No O NA/TC R
(15FEB2021)N/N
C4591001
1009
10091382 MUSC Arthralgia/
RIGHT KNEE PAIN 1 10JAN2021 7/16 2 No O NA R
(25JAN2021)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 34
FDA-CBER-2022-5812-0221025
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1009
10091399 INJ&P Foot fracture/
Left Fifth Metatarsal
Fracture2 23FEB2021 26/C 2 No O NA/TC RG N/N
C4591001
1009
10091403 RESP Rhinorrhoea/
runny nose 1 10JAN2021 3/4 1 Yes NA R
(13JAN2021)N/N
C4591001
1009
10091406 MUSC Joint swelling/
Swilling in bilateral knees1 25JAN2021 18/C 1 No O NA/TC N N/N
C4591001
1009
10091410 GENRL Fatigue/
FATIGUE 2 01FEB2021 1/3 2 Yes NA R
(03FEB2021)N/N
Injection site pain/
INJECTION SITE PAIN2 01FEB2021 1/3 2 Yes NA R
(03FEB2021)N/N
C4591001
1013
10131824 GENRL Peripheral swelling/
SWELLING LEFT ARM 1 05DEC2020 5/2 1 Yes NA R
(06DEC2020)N/N
C4591001
1013
10131839 INJ&P Concussion/
CONCUSSION 2 01MAR2021 69/C 2 No O NA RG N/N
C4591001
1016
10161316# GENRL Chills/
chills 3 26FEB2021 2/1 2 Yes NA R
(26FEB2021)N/N
MUSC Myalgia/
muscle pain3 26FEB2021 2/1 2 Yes NA/TC R
(26FEB2021)N/N
C4591001
1016
10161344 BLOOD Lymphadenopathy/
enlarged lymph nodes, right
anterior cervical nodes2 25NOV2020 15/43 1 No O NA R
(06JAN2021)N/N
INFEC Infectious mononucleosis/
infectious mononuclesosis2 25NOV2020 15/43 1 No O NA R
(06JAN2021)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 35
FDA-CBER-2022-5812-0221026
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1039
10391246# GENRL Fatigue/
fatigue 3 27FEB2021 2/3 2 Yes NA R
(01MAR2021)N/N
Pain/
generalized achiness3 27FEB2021 2/4 2 Yes NA R
(02MAR2021)N/N
Pyrexia/
fever3 27FEB2021 2/2 1 Yes NA R
(28FEB2021)N/N
NERV Headache/
headache3 27FEB2021 2/3 1 Yes NA R
(01MAR2021)N/N
C4591001
1039
10391250 PSYCH Tic/
exacerbation of tic disorder2 09JAN2021 13/C 1 No O NA RG N/N
C4591001
1039
10391314 NEOPL Fibroadenoma of breast/
Exacerbation of
fibroadenoma of ri ght breas t2 06FEB2021 10/C 1 No O NA RG N/N
C4591001
1039
10391326 PSYCH Depression/
Depression Exacerbation 1 26JAN2021 16/5 3 No O NA/TC/TCN R
(30JAN2021)Y/N
C4591001
1039
10391337 SKIN Urticaria/
urticaria, both hands 2 04FEB2021 2/3 1 Yes NA R
(06FEB2021)N/N
C4591001
1044
10441275 MUSC Myalgia/
myalgia 2 04JAN2021 7/1 1 Yes NA/TC R
(04JAN2021)N/N
C4591001
1044
10441292 GENRL Oedema peripheral/
Edema Toes (Bilateral) 1 17DEC2020 1/3 1 No O NA/TC R
(19DEC2020)N/N
C4591001
1044
10441304 SKIN Rash/
rash 2 25FEB2021 38/3 1 No O NA/TC R
(27FEB2021)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 36
FDA-CBER-2022-5812-0221027
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1044
10441335 SKIN Acne/
Worsening of acne 2 27FEB2021 30/C 1 No O NA/TC RG N/N
C4591001
1044
10441337 INJ&P Humerus fracture/
Broken humerus (right arm)1 10JAN2021 3/C 2 No O NA/TC RG N/N
C4591001
1044
10441338 NEOPL Skin papilloma/
Wart on second toe (left) 2 01FEB2021 4/7 1 No O NA/TC R
(07FEB2021)N/N
C4591001
1044
10441351 INJ&P Muscle strain/
Left hip flexor strain 2 11FEB2021 11/17 2 No O NA/TC R
(27FEB2021)N/N
C4591001
1044
10441361 INJ&P Concussion/
Concussion 1 23JAN2021 13/22 1 No O NA R
(13FEB2021)N/N
C4591001
1044
10441373 SKIN Urticaria/
hives forehead 1 12JAN2021 1/1 1 Yes NA R
(12JAN2021)N/N
PSYCH Anxiety/
Worsenin g of Anxiet y2 05MAR2021 30/C 2 No O NA/TC RG N/N
C4591001
1057
10571451 INFEC Vulvovaginal mycotic
infection/
VAGINAL YEAST
INFECTION1 13JAN2021 2/C 2 No O NA/TC N N/N
C4591001
1066
10661422 SKIN Rash/
rash on torso 1 24DEC2020 3/C 1 No O NA N N/N
C4591001
1077
10771278 GASTR Diarrhoea/
DIARRHEA 2 23DEC2020 1/2 2 Yes NA R
(24DEC2020)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 37
FDA-CBER-2022-5812-0221028
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Vomiting/
VOMITING2 23DEC2020 1/1 1 Yes NA R
(23DEC2020)N/N
GENRL Fatigue/
FATIGUE2 23DEC2020 1/2 2 Yes NA R
(24DEC2020)N/N
Injection site pain/
RIGHT ARM INJECTION
SITE PAIN2 23DEC2020 1/2 1 Yes NA R
(24DEC2020)N/N
Injection site swelling/
INJECTION SITE
SWELLING2 23DEC2020 1/2 2 Yes NA R
(24DEC2020)N/N
Pyrexia/
FEVER2 23DEC2020 1/2 3 Yes NA/TC R
(24DEC2020)N/N
PSYCH Disorientation/
DISORIENTATION2 23DEC2020 1/1 2 Yes NA R
(23DEC2020)N/N
C4591001
1077
10771279 GASTR Oral mucosal blistering/
ORAL/BUCCAL
BLISTERS2 07JAN2021 4/4 2 Yes NA R
(10JAN2021)N/N
C4591001
1084
10841556 INFEC Ear infection/
L Ear infection 2 28JAN2021 11/9 2 No O NA/TC R
(05FEB2021)N/N
C4591001
1084
10841558 INJ&P Ligament sprain/
left sprained ankle 2 27JAN2021 10/2 2 No O NA/TC R
(28JAN2021)N/N
C4591001
1091
10911422 INFEC Ear infection/
left ear infection 1 23DEC2020 10/8 1 No O NA/TC R
(30DEC2020)N/N
Otitis externa/
outer ear infection left ea r1 23DEC2020 10/8 1 No O NA/TC R
(30DEC2020)N/N
Otitis media/
middle ear infection left ea r1 23DEC2020 10/8 1 No O NA/TC R
(30DEC2020)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 38
FDA-CBER-2022-5812-0221029
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1091
10911433 SKIN Rash/
intermittent rash on wrist 1 19DEC2020 3/C 1 No O NA N N/N
C4591001
1123
11231442 PSYCH Depression/
Depression 1 23DEC2020 15/C 2 No O NA/TC N N/N
C4591001
1123
11231448 GASTR Diarrhoea/
Diarrhea 1 16DEC2020 6/3 1 Yes NA R
(18DEC2020)N/N
C4591001
1123
11231472 INFEC Tinea capitis/
Tinea capitis 1 01JAN2021 12/43 1 No O NA/TC R
(12FEB2021)N/N
SKIN Acne/
worsenin g of acne vul garis1 07JAN2021 18/C 1 No O NA/TC N N/N
C4591001
1123
11231507 PSYCH Depression/
Worsening of Depression 2 19JAN2021 2/5 2 No O NA/TC R
(23JAN2021)Y/N
C4591001
1123
11231520 INFEC Conjunctivitis/
Bilateral conjunctivitis 1 12JAN2021 14/6 1 No O NA/TC R
(17JAN2021)N/N
C4591001
1123
11231523 EYE Retinal haemorrhage/
INTRA RETINAL
HEMORRHAGE OD2 16FEB2021 22/C 2 No O NA RG N/N
C4591001
1124
11241251 GENRL Pyrexia/
Fever (102.2 degrees F) 2 09JAN2021 2/1 3 Yes NA/TC R
(09JAN2021)N/N
C4591001
1125
11251248 GENRL Fatigue/
Fatigue 2 05JAN2021 7/4 1 Yes NA/TC R
(08JAN2021)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 39
FDA-CBER-2022-5812-0221030
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1126
11261246 MUSC Pain in extremity/
Right leg pain 2 31DEC2020 9/C 1 No O NA N N/N
GASTR Aphthous ulcer/
Canker sore under ton gue2 12JAN2021 21/4 1 No O NA R
(15JAN2021)N/N
GENRL Nodule/
Red bump on right index
finger at cuticle2 13JAN2021 22/C 1 No O NA N N/N
C4591001
1126
11261254 IMMUN Food allergy/
Allergic reaction, nuts 1 09DEC2020 7/1 2 No O NA/TC R
(09DEC2020)N/N
C4591001
1126
11261262# GENRL Injection site pain/
Left upper arm injection site
pain3 10FEB2021 1/3 1 Yes NA R
(12FEB2021)N/N
C4591001
1126
11261263 BLOOD Lymphadenopathy/
LEFT AXILLA LYMPH
NODE SWELLING1 10DEC2020 7/4 1 Yes NA R
(13DEC2020)N/N
INJ&P Fall/
Mechanical Fall1 20DEC2020 17/1 2 No O NA R
(20DEC2020)N/N
Radius fracture/
RIGHT DISTAL RADIUS
TORUS FRACTURE1 20DEC2020 17/32 2 No O NA/TC R
(20JAN2021)N/N
C4591001
1126
11261268 SKIN Urticaria/
Facial Urticaria, worsening1 18DEC2020 5/14 1 No O NA R
(31DEC2020)N/N
MUSC Osteochondrosis/
Juvenile Osteochondrosis o f
bilateral fifth metatarsals1 28DEC2020 15/C 2 No O NA/TC/TCN RG N/N
C4591001
1126
11261275# GENRL Injection site pain/
Left upper arm injection site
pain3 08FEB2021 1/3 1 Yes NA/TC R
(10FEB2021)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 40
FDA-CBER-2022-5812-0221031
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GENRL Chills/
Chills3 09FEB2021 2/1 2 Yes NA/TC R
(09FEB2021)N/N
NERV Headache/
Headache3 09FEB2021 2/1 2 Yes NA/TC R
(09FEB2021)N/N
C4591001
1126
11261276# GENRL Injection site pain/
Left upper arm injection site
pain3 08FEB2021 1/3 2 Yes NA/TC R
(10FEB2021)N/N
GENRL Pyrexia/
Feve r3 09FEB2021 2/1 1 Yes NA/TC R
(09FEB2021)N/N
NERV Headache/
Headache3 09FEB2021 2/1 2 Yes NA/TC R
(09FEB2021)N/N
C4591001
1126
11261290 SKIN Pityriasis rosea/
Worsening Pityriasis Rosea1 23DEC2020 7/28 2 No O NA/TC R
(19JAN2021)N/N
C4591001
1126
11261296 INJ&P Accident/
Dirt bike nontraffic accident2 24JAN2021 17/1 2 No O NA/TC/TCN R
(24JAN2021)N/N
Contusion/
Left elbow contusion2 24JAN2021 17/8 1 No O NA/TCN R
(31JAN2021)N/N
Lip injury/
Lower lip laceration2 24JAN2021 17/13 1 No O NA/TC/TCN R
(05FEB2021)N/N
Tooth fracture/
Three teeth fractures2 24JAN2021 17/1 2 No O NA/TC/TCN R
(24JAN2021)N/N
C4591001
1126
11261301 GASTR Nausea/
Nausea 1 24DEC2020 3/2 2 Yes NA R
(25DEC2020)N/N
C4591001
1126
11261305# GENRL Injection site pain/
Left Upper Arm Injection
Site Pain3 24FEB2021 1/2 2 Yes NA R
(25FEB2021)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 41
FDA-CBER-2022-5812-0221032
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1126
11261307 NERV Migraine/
Migraine headache,
worsenin g1 24JAN2021 21/C 2 No O NA/TC RG N/N
C4591001
1126
11261309 GASTR Lip swelling/
Swollen lips 2 26JAN2021 2/2 1 Yes NA R
(27JAN2021)N/N
Mouth swelling/
Swollen mouth2 26JAN2021 2/2 1 Yes NA R
(27JAN2021)N/N
C4591001
1126
11261312 NERV Headache/
Headache 1 17JAN2021 13/5 2 No O NA R
(21JAN2021)N/N
C4591001
1126
11261314 SKIN Rash/
Skin rash L side of neck to
L scapula2 01FEB2021 4/3 1 Yes NA/TC R
(03FEB2021)N/N
C4591001
1131
11311280 NERV Presyncope/
vasovagal reaction
secondar y to vaccine1 17DEC2020 1/1 2 Yes NA R
(17DEC2020)N/N
C4591001
1131
11311283 INFEC Pilonidal cyst/
pilonidal cyst 1 29DEC2020 8/52 2 No O NA/TC R
(18FEB2021)N/N
C4591001
1131
11311287 RESP Rhinorrhoea/
rhinorrhea 1 17JAN2021 20/18 1 No O NA R
(03FEB2021)N/N
BLOOD Lymphadenopathy/
enlarge lymph nods-
neck(bilateral)2 27JAN2021 10/8 1 Yes NA R
(03FEB2021)N/N
C4591001
1131
11311301 MUSC Arthralgia/
sacroiliac joint pain 1 15JAN2021 5/C 2 No O NA N N/N
INJ&P Accident/
skiin g acciden t2 18FEB2021 14/C 2 No O NA/TC/TCN RG N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 42
FDA-CBER-2022-5812-0221033
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
INJ&P Clavicle fracture/
broken collar bone2 19FEB2021 15/C 1 No O NA/TC RG N/N
Clavicle fracture/
right clavicle fracture2 19FEB2021 15/C 2 No O NA/TC/TCN RG N/N
C4591001
1139
11391225 INJ&P Concussion/
concussion 2 01FEB2021 5/9 2 No O NA/TC R
(09FEB2021)N/N
C4591001
1139
11391246 MUSC Arthralgia/
Bilateral knee pain 1 11JAN2021 4/C 2 No O NA/TC RG N/N
C4591001
1139
11391248 INJ&P Muscle strain/
Muscle Strain 2 10MAR2021 41/C 1 No O NA RG N/N
C4591001
1140
11401343 NERV Migraine/
complex migraine 1 23DEC2020 3/1 3 Yes NA/TC/TCN R
(23DEC2020)N/N
C4591001
1140
11401353 MUSC Neck pain/
neck pain 2 03FEB2021 23/3 2 No O NA/TC R
(05FEB2021)N/N
C4591001
1140
11401357 GENRL Chills/
Mild Chills 2 11JAN2021 1/2 1 Yes NA R
(12JAN2021)N/Y
Fatigue/
Mild Fati gue2 11JAN2021 1/2 1 Yes NA R
(12JAN2021)N/Y
Injection site pain/
mild in jection site pain2 11JAN2021 1/2 1 Yes NA R
(12JAN2021)N/Y
C4591001
1142
11421352 INJ&P Patella fracture/
Fracture of left patella 2 31JAN2021 28/C 3 No O NA RG N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 43
FDA-CBER-2022-5812-0221034
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1142
11421385 BLOOD Lymphadenopathy/
left supraclavicular lymph
node swellin g1 07JAN2021 8/C 1 Yes NA RG N/N
C4591001
1142
11421394 NERV Paraesthesia/
transient feeling of pins and
needles to torso1 18JAN2021 8/C 1 No O NA RG N/N
C4591001
1147
11471262 PSYCH Generalised anxiety
disorder/
Generalized anxiety
disorder (worsenin g)2 25JAN2021 22/C 1 No O NA/TC N N/N
C4591001
1147
11471263 MUSC Limb mass/
Arm mass 1 2020 1/C 1 No O NA/TC N N/N
C4591001
1147
11471270# INV Body temperature
increased/
Increased bod y temperature3 25FEB2021 2/2 1 Yes NA R
(26FEB2021)N/N
MUSC Myalgia/
Myalgia3 25FEB2021 2/2 1 Yes NA R
(26FEB2021)N/N
NERV Headache/
Headache3 25FEB2021 2/2 1 Yes NA R
(26FEB2021)N/N
C4591001
1147
11471281 INFEC Appendicitis/
Acute appendicitis 2 22JAN2021 19/2 4 No O NA/TC/TCN R
(23JAN2021)Y/N
Focal peritonitis/
localized peritonitis,
without perforation or
gangrene2 22JAN2021 19/2 4 No O NA/TC/TCN R
(23JAN2021)Y/N
C4591001
1147
11471292 SKIN Acne/
Acne vulgaris (new
diagnosis)2 25JAN2021 17/C 1 No O NA/TC N N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 44
FDA-CBER-2022-5812-0221035
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1147
11471310 RESP Nasal congestion/
Nasal congestion 1 02JAN2021 13/8 1 No O NA/TC R
(09JAN2021)N/N
EAR Ear pain/
Left ear pain2 JAN2021 1/C 1 No O NA/TC RG N/N
C4591001
1147
11471322 EAR Ear pain/
Right ear pain 1 25JAN2021 21/7 1 No O NA/TC R
(31JAN2021)N/N
INFEC Conjunctivitis/
Acute con junctivitis, lef t2 25FEB2021 30/C 1 No O NA/TC RG N/N
C4591001
1147
11471323 SKIN Dermatitis contact/
Allergic reaction to surgical
dressin gs.2 09FEB2021 14/C 2 No O NA/TC RG N/N
C4591001
1147
11471327 GENRL Pyrexia/
Fever (104.7) 1 06JAN2021 2/3 4 Yes P/TC R
(08JAN2021)N/N
C4591001
1147
11471331 INJ&P Hand fracture/
Fracture of mi ddle phalanx
of left index fin ger2 24FEB2021 28/C 1 No O NA RG N/N
C4591001
1150
11501127 GENRL Fatigue/
Fatigue 2 12NOV2020 2/1 1 Yes NA R
(12NOV2020)N/N
C4591001
1150
11501129 INJ&P Concussion/
Concussion 2 11JAN2021 63/60 2 No O NA R
(11MAR2021)N/N
C4591001
1150
11501130 GASTR Nausea/
Nausea 2 09NOV2020 1/3 2 Yes NA R
(11NOV2020)N/N
NERV Dizziness/
Dizziness2 09NOV2020 1/3 1 Yes NA R
(11NOV2020)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 45
FDA-CBER-2022-5812-0221036
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1150
11501131# GENRL Fatigue/
Fatigue 3 23FEB2021 1/3 2 Yes NA R
(25FEB2021)N/N
Injection site pain/
Pain at in jection site3 23FEB2021 1/3 2 Yes NA R
(25FEB2021)N/N
Pain/
Generalized Bod y Aches3 23FEB2021 1/3 2 Yes NA R
(25FEB2021)N/N
NERV Headache/
Headache3 23FEB2021 1/3 2 Yes NA R
(25FEB2021)N/N
C4591001
1150
11501132 GASTR Diarrhoea/
Diarrhea 2 09NOV2020 1/2 2 Yes NA R
(10NOV2020)N/N
C4591001
1150
11501182# GENRL Injection site pain/
Injection Site Pain 3 25FEB2021 1/2 1 Yes NA R
(26FEB2021)N/N
C4591001
1150
11501193 PSYCH Attention deficit
hyperactivity disorder/
ADHD1 DEC2020 1/C 1 No O NA RG N/N
C4591001
1150
11501287 GENRL Injection site pain/
Injection Site Pain 1 08JAN2021 2/1 1 Yes NA/TC R
(08JAN2021)N/N
C4591001
1152
11521615 SKIN Rash/
generalized rash upper body1 03DEC2020 1/8 1 No O NA R
(10DEC2020)N/N
C4591001
1152
11521640 INFEC Ear infection/
right ear infection, NFI 1 20DEC2020 14/7 2 No O NA/TC R
(26DEC2020)N/N
C4591001
1152
11521641 EYE Eyelid rash/
rash right eyelid 1 07DEC2020 1/2 1 Yes NA R
(08DEC2020)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 46
FDA-CBER-2022-5812-0221037
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
SKIN Rash/
rash bilateral extremities1 08DEC2020 2/1 1 Yes NA R
(08DEC2020)N/N
C4591001
1152
11521654 PSYCH Depression/
Worsened Depression 1 26DEC2020 18/C 2 No O NA/TC N N/N
C4591001
1152
11521683 BLOOD Lymphadenopathy/
Swollen Lymph Node (Left
Clavicle)1 26DEC2020 12/C 1 No O NA N N/N
C4591001
1152
11521704 BLOOD Lymphadenopathy/
swollen lymph node left
axilla1 26DEC2020 6/10 2 Yes NA R
(04JAN2021)N/N
C4591001
1152
11521706 GENRL Fatigue/
Fatigue 1 21DEC2020 1/7 3 Yes NA/TC R
(27DEC2020)N/N
NERV Headache/
HEADACHE1 26DEC2020 6/2 3 Yes NA/TC R
(27DEC2020)N/N
C4591001
1152
11521740 INJ&P Tooth fracture/
Chipped baby tooth 2 17FEB2021 22/1 1 No O NA R
(17FEB2021)N/N
C4591001
1152
11521749 GASTR Abdominal pain/
ABDOMINAL CRAMPS 1 09JAN2021 2/1 1 Yes NA R
(09JAN2021)N/N
C4591001
1152
11521756 GASTR Diarrhoea/
Diarrhea 2 06FEB2021 6/3 1 No O NA R
(08FEB2021)N/N
C4591001
1156
11561310 INFEC Body tinea/
TINEA CORPORIS 1 08DEC2020 8/18 1 No O NA R
(25DEC2020)N/N
C4591001
1223
12231267 GENRL Fatigue/
fatigue 2 27JAN2021 1/3 2 Yes NA R
(29JAN2021)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 47
FDA-CBER-2022-5812-0221038
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Pyrexia/
fever1 27JAN2021 21/3 1 Yes NA/TC R
(29JAN2021)N/N
MUSC Myalgia/
generalized muscle aches2 27JAN2021 1/3 1 Yes NA R
(29JAN2021)N/N
C4591001
1223
12231271 GENRL Injection site pain/
injection site pain 1 29JAN2021 22/4 1 Yes NA R
(01FEB2021)N/N
C4591001
1223
12231281 GENRL Pyrexia/
fever 2 03FEB2021 2/2 1 Yes NA R
(04FEB2021)N/N
MUSC Myalgia/
muscle ache generalize d2 03FEB2021 2/3 1 Yes NA R
(05FEB2021)N/N
NERV Headache/
headache2 03FEB2021 2/3 1 Yes NA/TC R
(05FEB2021)N/N
C4591001
1223
12231286 NERV Headache/
headache 2 05FEB2021 3/3 1 Yes NA/TC R
(07FEB2021)N/N
C4591001
1270
12701205 INFEC Subcutaneous abscess/
Subcutaneous Tissue
Abcess Ri ght Earlobe1 19DEC2020 5/17 1 No O NA/TCN R
(04JAN2021)N/N
C4591001
1270
12701222 PSYCH Suicidal ideation/
SUICIDAL IDEATION 2 16FEB2021 40/C 3 No O NA/TCN N Y/N
C4591001
1270
12701233 GASTR Rectal prolapse/
Rectal Prolapse 2 22FEB2021 28/C 1 No O NA/TC RG N/N
C4591001
1270
12701236 PSYCH Anxiety/
Anxiety 1 11JAN2021 6/C 1 No O NA RG N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 48
FDA-CBER-2022-5812-0221039
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1270
12701237 MUSC Musculoskeletal chest pain/
Rib pain on right side 1 10FEB2021 35/29 1 No O NA R
(10MAR2021)N/N
16-25 C4591001
1001
10011125 NERV Dizziness/
dizziness* 04AUG2020 1/1 1 Yes NA R
(04AUG2020)N/N
NERV Migraine/
migraine headache1 05AUG2020 2/5 3 Yes NA R
(09AUG2020)N/N
MUSC Myalgia/
diffuse m yalgias1 06AUG2020 3/2 3 Yes NA R
(07AUG2020)N/N
PSYCH Disorientation/
disorientation1 08AUG2020 5/2 1 No O NA R
(09AUG2020)N/N
C4591001
1003
10031111 MUSC Psoriatic arthropathy/
psoriatic arthritis 2 26SEP2020 38/C 2 Yes NA/TC N Y/N
C4591001
1005
10051024 METAB Decreased appetite/
DECREASED APPETITE2 01SEP2020 2/1 2 Yes NA R
(01SEP2020)N/N
C4591001
1005
10051071# GENRL Chills/
CHILLS 4 11FEB2021 2/2 2 Yes NA R
(12FEB2021)N/N
Fatigue/
FATIGUE4 11FEB2021 2/2 2 Yes NA R
(12FEB2021)N/N
MUSC Myalgia/
GENERALIZED
MYALGIA4 11FEB2021 2/2 2 Yes NA R
(12FEB2021)N/N
NERV Headache/
HEADACHE4 11FEB2021 2/2 2 Yes NA R
(12FEB2021)N/N
C4591001
1005
10051411 GASTR Abdominal pain/
ABDOMINAL PAIN 2 29JAN2021 2/4 3 No O NA/TC R
(01FEB2021)Y/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 49
FDA-CBER-2022-5812-0221040
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1005
10051442 GENRL Fatigue/
FATIGUE 2 14JAN2021 2/3 2 Yes NA R
(16JAN2021)N/N
Injection site pain/
INJECTION SITE PAIN2 14JAN2021 2/4 1 Yes NA R
(17JAN2021)N/N
Injection site swelling/
INJECTION SITE
SWELLING (1 INCH)2 14JAN2021 2/4 1 Yes NA R
(17JAN2021)N/N
MUSC Arthralgia/
GENERALIZED
ARTHRALGIA2 14JAN2021 2/3 1 Yes NA R
(16JAN2021)N/N
Myalgia/
GENERALIZED
MYALGIA2 14JAN2021 2/3 2 Yes NA R
(16JAN2021)N/N
NERV Headache/
WORSENING OF
HEADACHE2 14JAN2021 2/3 2 Yes NA/TC R
(16JAN2021)N/N
C4591001
1006
10061031 INFEC Oral fungal infection/
ORAL YEAST
INFECTION1 16AUG2020 4/11 2 No O NA/TC R
(26AUG2020)N/N
C4591001
1006
10061194 INFEC Otitis externa/
Otitis Externa Left 2 15JAN2021 24/13 3 No O NA/TC/TCN R
(27JAN2021)N/N
C4591001
1006
10061194# INJ&P Mouth injury/
Oral laceration 2 15FEB2021 55/10 1 No O NA/TC/TCN R
(24FEB2021)N/N
C4591001
1006
10061202 NERV Headache/
Headache 2 22DEC2020 1/2 1 Yes NA R
(23DEC2020)N/N
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Page 50
FDA-CBER-2022-5812-0221041
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1006
10061204 GENRL Injection site bruising/
1 MM BRUISING AT
INJECTION SITE LEFT
DELTOID2 22DEC2020 1/25 1 Yes NA R
(15JAN2021)N/Y
C4591001
1006
10061205 INJ&P Foot fracture/
Left Great Toe Fracture 2 29JAN2021 37/C 2 No O NA/TC RG N/N
C4591001
1006
10061208 GENRL Pain/
Body Aches 2 24DEC2020 2/1 1 Yes NA/TC R
(24DEC2020)N/N
NERV Headache/
Headache2 24DEC2020 2/1 1 Yes NA/TC R
(24DEC2020)N/N
RESP Oropharyngeal pain/
Sore Throa t2 24DEC2020 2/1 1 Yes NA/TC R
(24DEC2020)N/N
C4591001
1006
10061215 INJ&P Ligament sprain/
Knee sprain Right 1 10DEC2020 7/3 1 No O NA/TC R
(12DEC2020)N/N
MUSC Arthralgia/
right shoulder pain2 23JAN2021 2/C 3 No O NA/TC/TCN RG N/N
C4591001
1006
10061216# GENRL Chills/
Chills 3 13FEB2021 2/1 1 Yes NA R
(13FEB2021)N/N
C4591001
1006
10061240 GENRL Injection site pain/
Injection site pain 2 05JAN2021 1/1 1 Yes NA/TC R
(05JAN2021)N/N
Pyrexia/
Feve r2 05JAN2021 1/1 1 Yes NA/TC R
(05JAN2021)N/N
C4591001
1006
10061246# GENRL Chills/
Chills 3 18FEB2021 2/3 2 Yes NA/TC R
(20FEB2021)N/N
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Page 51
FDA-CBER-2022-5812-0221042
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
NERV Headache/
Headache3 18FEB2021 2/3 2 Yes NA/TC R
(20FEB2021)N/N
C4591001
1007
10071154# GENRL Injection site pain/
Injection Site Arm Soreness3 14JAN2021 1/2 1 Yes NA R
(15JAN2021)N/N
GENRL Chills/
chills4 02FEB2021 1/2 2 Yes NA R
(03FEB2021)N/N
Pyrexia/
fever4 02FEB2021 1/2 2 Yes NA/TC R
(03FEB2021)N/N
C4591001
1007
10071463# EYE Lacrimation increased/
Watery Eyes 3 03MAR2021 3/3 1 No O NA R
(05MAR2021)N/N
C4591001
1007
10071464 GASTR Nausea/
nausea 1 19NOV2020 2/2 1 Yes NA R
(20NOV2020)N/N
C4591001
1007
10071470# GENRL Injection site pain/
Injection site pain 3 24FEB2021 2/1 1 Yes NA R
(24FEB2021)N/N
NERV Headache/
Headache3 24FEB2021 2/1 1 Yes NA R
(24FEB2021)N/N
C4591001
1007
10071493# GENRL Injection site pain/
Injection site pain 2 22FEB2021 63/3 1 Yes NA R
(24FEB2021)N/N
GENRL Fatigue/
Fatigue3 23FEB2021 2/8 1 No O NA R
(02MAR2021)N/N
NERV Headache/
Headache3 23FEB2021 2/2 1 Yes NA R
(24FEB2021)N/N
C4591001
1007
10071502 GENRL Injection site discomfort/
Weighted feeling in
injection site ar m1 03DEC2020 1/3 1 Yes NA R
(05DEC2020)N/N
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Page 52
FDA-CBER-2022-5812-0221043
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
INFEC Cellulitis/
Right axillar y cellulitis2 01JAN2021 11/8 2 No O NA/TC R
(08JAN2021)N/N
Folliculitis/
Right axillar y folliculitis2 01JAN2021 11/8 2 No O NA R
(08JAN2021)N/N
C4591001
1007
10071510# GENRL Injection site pain/
Injection Site Pain 3 22FEB2021 1/2 1 Yes NA/TC/TCN R
(23FEB2021)N/N
C4591001
1007
10071538# GENRL Fatigue/
Fatigue 3 19FEB2021 2/1 1 Yes NA R
(19FEB2021)N/N
C4591001
1007
10071548# NERV Presyncope/
Vasovagal response with
venipuncture2 11MAR2021 72/1 2 No O NA R
(11MAR2021)N/N
C4591001
1007
10071553 GENRL Injection site pain/
injection site pain 1 10DEC2020 1/3 1 Yes NA R
(12DEC2020)N/Y
NERV Dizziness/
Lightheaded*10DEC2020 1/1 1 No O NA R
(10DEC2020)N/N
C4591001
1007
10071553# GENRL Chills/
Chills 3 18FEB2021 2/2 1 Yes NA R
(19FEB2021)N/N
Injection site pain/
Injection site pain3 18FEB2021 2/3 1 Yes NA R
(20FEB2021)N/N
Pain/
Body aches3 18FEB2021 2/2 1 Yes NA R
(19FEB2021)N/N
NERV Headache/
Headache3 18FEB2021 2/2 2 Yes NA/TC R
(19FEB2021)N/N
C4591001
1008
10081776# GENRL Pain/
body aches 3 27FEB2021 2/3 2 Yes NA/TC R
(01MAR2021)N/N
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Page 53
FDA-CBER-2022-5812-0221044
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Pyrexia/
Feve r3 27FEB2021 2/3 2 Yes NA/TC R
(01MAR2021)N/N
NERV Headache/
Headache3 27FEB2021 2/C 2 Yes NA/TC RG N/N
C4591001
1009
10091261 INJ&P Skin laceration/
left index finger laceration2 10FEB2021 71/C 2 No O NA/TC/TCN RG N/N
C4591001
1009
10091278 EAR Ear pain/
ear ache 2 21JAN2021 31/8 1 No O NA R
(28JAN2021)N/N
C4591001
1009
10091285 GENRL Injection site pain/
pain at injection site 2 22DEC2020 1/2 1 Yes NA R
(23DEC2020)N/N
INFEC Impetigo/
impeti go on face2 12JAN2021 22/9 1 No O NA/TC R
(20JAN2021)N/N
C4591001
1009
10091286# GENRL Chills/
chills 3 06JAN2021 2/4 1 Yes NA R
(09JAN2021)N/N
Pain/
body aches3 06JAN2021 2/4 1 Yes NA R
(09JAN2021)N/N
NERV Headache/
Headache3 06JAN2021 2/4 1 Yes NA R
(09JAN2021)N/N
C4591001
1013
10131005 MUSC Arthropathy/
CYST, WRIST, LEFT 2 SEP2020 14/ 1 No O NA/TCN R N/N
C4591001
1013
10131059 GENRL Fatigue/
FATIGUE 2 26AUG2020 2/1 3 Yes NA R
(26AUG2020)N/N
MUSC Myalgia/
MUSCLE PAIN2 26AUG2020 2/1 2 Yes NA R
(26AUG2020)N/N
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Page 54
FDA-CBER-2022-5812-0221045
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1015
10151006# GENRL Chills/
Chills 3 29JAN2021 2/2 1 Yes NA R
(30JAN2021)N/N
Fatigue/
Fatigue3 29JAN2021 2/2 1 Yes NA R
(30JAN2021)N/N
Injection site pain/
Injection site pain3 29JAN2021 2/2 1 Yes NA R
(30JAN2021)N/N
INV Body temperature
increased/
Increased body temperature
99F3 29JAN2021 2/2 1 Yes NA R
(30JAN2021)N/N
NERV Headache/
Headache3 29JAN2021 2/2 1 Yes NA R
(30JAN2021)N/N
GENRL Fatigue/
Fatigue4 17FEB2021 2/2 1 Yes NA R
(18FEB2021)N/N
Injection site pain/
Injection site pain4 17FEB2021 2/3 1 Yes NA R
(19FEB2021)N/N
MUSC Myalgia/
Myalgias4 17FEB2021 2/2 1 Yes NA R
(18FEB2021)N/N
C4591001
1015
10151029# GENRL Injection site pain/
Injection site pain 3 22DEC2020 1/2 1 Yes NA R
(23DEC2020)N/Y
GENRL Injection site pain/
Injection site pain4 11JAN2021 1/2 1 Yes NA R
(12JAN2021)N/Y
C4591001
1015
10151035 BLOOD Lymphadenopathy/
Swollen lymph node - left
armpit axillar y2 04SEP2020 1/5 1 Yes NA R
(08SEP2020)N/N
C4591001
1016
10161003# GASTR Nausea/
nausea 3 03FEB2021 1/3 1 Yes NA R
(05FEB2021)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 55
FDA-CBER-2022-5812-0221046
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GENRL Chills/
chills3 03FEB2021 1/3 1 Yes NA R
(05FEB2021)N/N
Pain/
generalized bod y aches3 03FEB2021 1/3 2 Yes NA/TC R
(05FEB2021)N/N
Pyrexia/
subjective feve r3 03FEB2021 1/3 1 Yes NA/TC R
(05FEB2021)N/N
C4591001
1016
10161028 SKIN Dermatitis contact/
Contact dermatitis 1 08AUG2020 6/8 2 No O NA/TC R
(15AUG2020)N/N
C4591001
1016
10161349 SKIN Rash erythematous/
rash, top ten toes(red rash)1 09NOV2020 4/C 1 No O NA N N/N
C4591001
1018
10181133 SURG Wisdom teeth removal/
Wisdom tooth extraction 1 20AUG2020 9/1 1 No O NA/TC R
(20AUG2020)N/N
C4591001
1039
10391243# GENRL Injection site pain/
Injection Arm Soreness 3 26JAN2021 1/1 1 Yes NA R
(26JAN2021)N/N
GENRL Fatigue/
Fatigue4 24FEB2021 2/1 1 Yes NA R
(24FEB2021)N/N
C4591001
1039
10391254# GENRL Injection site pain/
injection site pain 3 27JAN2021 1/2 1 Yes NA R
(28JAN2021)N/N
C4591001
1044
10441234 RESP Reflux laryngitis/
Laryngopharyngeal Reflux2 DEC2020 1/C 1 No O NA/TC RG N/N
C4591001
1044
10441237# GENRL Injection site pain/
injection site pain 3 25FEB2021 1/3 1 Yes NA R
(27FEB2021)N/N
NERV Headache/
headache3 25FEB2021 1/4 1 Yes NA/TC R
(28FEB2021)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 56
FDA-CBER-2022-5812-0221047
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1044
10441240 GASTR Nausea/
nausea 1 09DEC2020 17/1 1 No O NA/TC R
(09DEC2020)N/N
C4591001
1044
10441242 NERV Dizziness/
dizziness 1 24NOV2020 1/1 1 Yes NA R
(24NOV2020)N/N
C4591001
1044
10441242# SKIN Eczema/
Worsening of eczema (face)2 26FEB2021 74/3 1 No O NA/TC R
(28FEB2021)N/N
C4591001
1044
10441244 GENRL Injection site pain/
injection site pain 1 24NOV2020 1/4 1 Yes NA R
(27NOV2020)N/N
C4591001
1044
10441246 INFEC Otitis media/
otitis media (Left ear) 1 02JAN2021 6/6 1 No O NA/TC R
(07JAN2021)N/N
C4591001
1054
10541012 GASTR Diarrhoea/
diarrhea - 1 episode 2 17SEP2020 7/1 1 Yes NA R
(17SEP2020)N/N
C4591001
1057
10571373# GENRL Injection site pain/
INJECTION SITE PAIN
ON LEFT ARM3 26JAN2021 1/3 2 Yes NA R
(28JAN2021)N/N
C4591001
1066
10661396# GENRL Injection site pain/
pain at injection site 3 22DEC2020 1/3 1 Yes NA R
(24DEC2020)N/N
GENRL Fatigue/
fatigue3 23DEC2020 2/2 1 Yes NA R
(24DEC2020)N/N
MUSC Myalgia/
muscle pain3 23DEC2020 2/2 1 Yes NA R
(24DEC2020)N/N
NERV Headache/
headache3 23DEC2020 2/2 1 Yes NA R
(24DEC2020)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 57
FDA-CBER-2022-5812-0221048
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1071
10711039 GENRL Fatigue/
FATIGUE 2 09SEP2020 6/13 2 Yes NA R
(21SEP2020)N/N
NERV Headache/
HEADACHE2 09SEP2020 6/13 1 Yes NA R
(21SEP2020)N/N
C4591001
1081
10811012# GENRL Injection site pain/
pain at site of injection (left
deltoid)3 01MAR2021 1/2 1 Yes NA R
(02MAR2021)N/N
GASTR Diarrhoea/
diarrhea (one episode)3 02MAR2021 2/1 1 Yes NA R
(02MAR2021)N/N
GENRL Chills/
chills3 02MAR2021 2/1 1 Yes NA R
(02MAR2021)N/N
Pyrexia/
fever (101.9)3 02MAR2021 2/2 1 Yes NA/TC R
(03MAR2021)N/N
C4591001
1083
10831001 INJ&P Fall/
Fall 2 26AUG2020 6/1 2 No O NA R
(26AUG2020)N/N
Fibula fracture/
Fibula fracture2 26AUG2020 6/C 2 No O NA/TC RG N/N
C4591001
1083
10831084 INJ&P Meniscus injury/
Torn Meniscus-Right 1 17AUG2020 7/C 1 No O NA/TC/TCN RG N/N
C4591001
1087
10871064 INFEC Tooth infection/
Wisdom Teeth Infection -
Right lower quadran t2 15JAN2021 136/15 2 No O NA/TC R
(29JAN2021)N/N
C4591001
1087
10871078 RESP Rhinitis allergic/
Worsening of Allergic
Rhinitis2 02FEB2021 156/C 1 No O NA/TC N N/N
C4591001
1087
10871078# EYE Blepharitis/
Blepharitis - Right Eye 2 19FEB2021 173/C 1 No O NA/TC N N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 58
FDA-CBER-2022-5812-0221049
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1089
10891015 INFEC Tonsillitis/
Tonsillitis 2 14SEP2020 28/1 2 No O NA/TCN R
(14SEP2020)N/N
PSYCH Depression/
worsenin g depression2 02NOV2020 77/30 2 No O NA/TC R
(01DEC2020)N/N
C4591001
1090
10901038 RESP Oropharyngeal pain/
sore throat 1 20AUG2020 17/4 2 No O NA R
(23AUG2020)N/N
C4591001
1090
10901044# GENRL Fatigue/
Fatigue 3 17FEB2021 2/2 2 Yes NA R
(18FEB2021)N/N
Injection site pain/
Injection site pain-ri ght arm3 17FEB2021 2/2 2 Yes NA R
(18FEB2021)N/N
C4591001
1090
10901201# GENRL Chills/
Chills 3 03MAR2021 1/3 2 Yes NA R
(05MAR2021)N/N
MUSC Myalgia/
Myalgia3 03MAR2021 1/3 2 Yes NA/TC R
(05MAR2021)N/N
C4591001
1091
10911067# GENRL Injection site pain/
injection pain 3 12JAN2021 1/1 1 Yes NA R
(12JAN2021)N/Y
GENRL Chills/
chills4 03FEB2021 2/1 1 Yes NA R
(03FEB2021)N/N
Fatigue/
fatigue4 03FEB2021 2/1 1 Yes NA R
(03FEB2021)N/N
MUSC Arthralgia/
generalized arthral gia4 03FEB2021 2/1 2 Yes NA R
(03FEB2021)N/N
Myalgia/
Myalgia4 03FEB2021 2/1 1 Yes NA R
(03FEB2021)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 59
FDA-CBER-2022-5812-0221050
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1091
10911088 GASTR Crohn's disease/
Crohn's Disease 2 NOV2020 62/C 2 No O NA/TC RG N/N
C4591001
1091
10911095# MUSC Myalgia/
myalgia 4 03FEB2021 2/2 1 Yes NA R
(04FEB2021)N/N
C4591001
1091
10911392 GENRL Oedema peripheral/
left foot edema 1 01DEC2020 2/37 2 No O NA/TC R
(06JAN2021)N/N
MUSC Arthralgia/
right knee joint pain2 24DEC2020 3/14 2 No O NA/TC R
(06JAN2021)N/N
C4591001
1091
10911398 RESP Asthma/
asthma attack 1 14DEC2020 12/1 1 No O NA R
(14DEC2020)N/N
C4591001
1092
10921223 GENRL Injection site pain/
Injection Site pain 1 12OCT2020 1/2 1 Yes NA R
(13OCT2020)N/N
NERV Headache/
Headache1 13OCT2020 2/1 2 Yes NA R
(13OCT2020)N/N
C4591001
1095
10951055 REPRO Cervical dysplasia/
ASCUS of cervix 1 10AUG2020 7/18 1 No O NA/TC R
(27AUG2020)N/N
C4591001
1095
10951106 MUSC Arthralgia/
polyarthralgia 2 03SEP2020 7/2 1 No O NA R
(04SEP2020)N/N
C4591001
1095
10951308 PSYCH Depression/
worsening of depression 2 DEC2020 1/C 1 No O NA/TC N N/N
C4591001
1095
10951310 PSYCH Attention deficit
hyperactivity disorder/ 2 25JAN2021 42/C 1 No O NA/TC N N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 60
FDA-CBER-2022-5812-0221051
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
ADHD diagnosed by
Psychiatris t
C4591001
1095
10951317 GENRL Fatigue/
Fatigue 2 15DEC2020 1/1 1 Yes NA R
(15DEC2020)N/Y
C4591001
1095
10951319 INJ&P Joint dislocation/
L Patellar Dislocation 2 02JAN2021 6/C 1 No O NA/TC RG N/N
C4591001
1096
10961031 INJ&P Exposure during pregnancy/
EXPOSURE DURING
PREGNANCY1 14AUG2020 1/40 No O P R
(22SEP2020)N/N
RESP Oropharyngeal pain/
Sore throa t1 05OCT2020 53/3 1 No O NA R
(07OCT2020)N/N
INFEC Urinary tract infection/
urinar y tract infection1 22JAN2021 162/C 1 No O NA/TC N N/N
C4591001
1107
11071010 INFEC Vulvovaginal mycotic
infection/
YEAST INFECTION
VAGINAL1 11AUG2020 13/7 1 No O NA/TC R
(17AUG2020)N/N
C4591001
1107
11071010# GENRL Pain/
BODYACHES 3 18FEB2021 1/2 1 Yes NA R
(19FEB2021)N/N
Pyrexia/
FEVER3 18FEB2021 1/2 1 Yes NA/TC R
(19FEB2021)N/N
NERV Dizziness/
DIZZINESS3 18FEB2021 1/1 1 Yes NA R
(18FEB2021)N/Y
Headache/
HEADACHE3 18FEB2021 1/2 1 Yes NA R
(19FEB2021)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 61
FDA-CBER-2022-5812-0221052
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1109
11091030 GENRL Injection site erythema/
Injection Site Redness 1 30JUL2020 1/2 1 Yes NA R
(31JUL2020)N/N
C4591001
1109
11091242# GENRL Fatigue/
FATIGUE 4 14FEB2021 2/C 1 Yes NA N N/N
NERV Headache/
HEADACHE4 14FEB2021 2/2 1 Yes NA R
(15FEB2021)N/N
C4591001
1110
11101057# GENRL Injection site pain/
Pain at the site of injection.3 29DEC2020 1/2 1 Yes NA R
(30DEC2020)N/N
C4591001
1110
11101379 GENRL Fatigue/
Fatigue 1 14NOV2020 2/1 2 Yes NA R
(14NOV2020)N/N
MUSC Arthralgia/
Joint Pain (Generalized)1 14NOV2020 2/1 1 Yes NA R
(14NOV2020)N/N
C4591001
1112
11121078 INFEC Pharyngitis streptococcal/
Strep Throat 1 24AUG2020 20/12 1 No O NA/TC R
(04SEP2020)N/N
C4591001
1112
11121125 INFEC Tinea infection/
Ringworm 1 19AUG2020 3/31 2 No O NA/TC R
(18SEP2020)N/N
C4591001
1112
11121125# MUSC Myalgia/
Muscle Aches 3 26JAN2021 1/3 2 Yes NA/TC R
(28JAN2021)N/N
C4591001
1114
11141008# GENRL Chills/
CHILLS 3 30JAN2021 1/2 1 Yes NA R
(31JAN2021)N/N
Injection site pain/
ARM PAIN AT
INJECTION SITE3 30JAN2021 1/2 1 Yes NA R
(31JAN2021)N/N
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16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1114
11141009# GENRL Fatigue/
FATIGUE 3 01FEB2021 1/3 1 Yes NA R
(03FEB2021)N/N
Injection site pain/
Injection site pain3 01FEB2021 1/3 1 Yes NA R
(03FEB2021)N/N
C4591001
1120
11201250 SKIN Rash/
Rash torso and legs 1 27AUG2020 7/16 1 No O NA/TC R
(11SEP2020)N/N
NERV Burning sensation/
Burning sensation in palm
of left han d2 16SEP2020 6/1 2 No O NA R
(16SEP2020)N/N
C4591001
1125
11251243 GENRL Injection site pain/
Grade 3 Pain at Injection
site1 09DEC2020 2/1 3 Yes P R
(09DEC2020)N/N
NERV Headache/
Grade 3 Headache1 09DEC2020 2/1 3 Yes P/TC R
(09DEC2020)N/N
C4591001
1126
11261205 METAB Decreased appetite/
Decreased appetite 1 23NOV2020 13/C 1 No O NA RG N/N
PSYCH Depressed mood/
Depressed moo d1 23NOV2020 13/C 1 No O NA RG N/N
C4591001
1126
11261206# GENRL Injection site pain/
Pain, injection site 3 04FEB2021 2/2 1 Yes NA R
(05FEB2021)N/N
C4591001
1126
11261207# GENRL Injection site pain/
Pain Injection Site 3 19FEB2021 1/3 1 Yes NA R
(21FEB2021)N/N
C4591001
1126
11261210# GENRL Injection site pain/
Left upper arm injection site
pain3 24FEB2021 1/2 1 Yes NA R
(25FEB2021)N/N
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Page 63
FDA-CBER-2022-5812-0221054
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1126
11261211# GENRL Chills/
Chills 3 08FEB2021 1/2 1 Yes NA R
(09FEB2021)N/N
Injection site pain/
Injection site pain3 08FEB2021 1/2 2 Yes NA R
(09FEB2021)N/N
NERV Headache/
Headache3 08FEB2021 1/2 1 Yes NA R
(09FEB2021)N/N
C4591001
1126
11261214# GENRL Chills/
Chills 3 09FEB2021 1/2 1 Yes NA/TC R
(10FEB2021)N/N
Injection site pain/
Injection site pain3 09FEB2021 1/2 1 Yes NA/TC R
(10FEB2021)N/N
Malaise/
Malaise3 09FEB2021 1/2 1 Yes NA/TC R
(10FEB2021)N/N
C4591001
1126
11261215# GENRL Injection site pain/
Left arm injection site pain3 05FEB2021 1/3 1 Yes NA R
(07FEB2021)N/N
C4591001
1126
11261220# GENRL Injection site pain/
Left upper arm injection site
pain3 17FEB2021 1/4 2 Yes NA/TC R
(20FEB2021)N/N
NERV Headache/
Headache3 17FEB2021 1/2 1 Yes NA/TC R
(18FEB2021)N/N
GENRL Chills/
Chills3 18FEB2021 2/1 2 Yes NA R
(18FEB2021)N/N
Pyrexia/
Feve r3 18FEB2021 2/1 1 Yes NA/TC R
(18FEB2021)N/N
C4591001
1126
11261223# GENRL Injection site pain/
Injection site pain 3 12FEB2021 2/1 1 Yes NA R
(12FEB2021)N/N
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Page 64
FDA-CBER-2022-5812-0221055
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1126
11261224# GENRL Malaise/
Malaise 3 12FEB2021 2/2 2 Yes NA R
(13FEB2021)N/N
C4591001
1126
11261228# GENRL Injection site pain/
Injection Site Pain 3 12FEB2021 1/3 1 Yes NA R
(14FEB2021)N/N
NERV Headache/
Headache3 12FEB2021 1/3 2 Yes NA/TC R
(14FEB2021)N/N
C4591001
1126
11261236# GENRL Fatigue/
Fatigue 3 05FEB2021 1/4 2 Yes NA R
(08FEB2021)N/N
Injection site pain/
Pain, in jection site3 05FEB2021 1/3 2 Yes NA R
(07FEB2021)N/N
C4591001
1126
11261237# GENRL Injection site pain/
Injection Site Pain 3 11FEB2021 2/3 1 Yes NA R
(13FEB2021)N/N
C4591001
1126
11261238# GENRL Injection site pain/
Injection site pain 3 10FEB2021 1/3 1 Yes NA R
(12FEB2021)N/N
C4591001
1126
11261244# BLOOD Lymphadenopathy/
Lymph node swelling left
armpi t3 24FEB2021 1/2 1 Yes NA R
(25FEB2021)N/N
GENRL Injection site pain/
Left upper arm injection site
pain3 24FEB2021 1/3 1 Yes NA R
(26FEB2021)N/N
GENRL Chills/
Chills3 25FEB2021 2/1 2 Yes NA R
(25FEB2021)N/N
Pyrexia/
Feve r3 25FEB2021 2/1 1 Yes NA R
(25FEB2021)N/N
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Page 65
FDA-CBER-2022-5812-0221056
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1126
11261247# GENRL Injection site pain/
Left upper arm injection site
pain3 11FEB2021 1/3 2 Yes NA/TC R
(13FEB2021)N/N
GENRL Fatigue/
Fatigue3 12FEB2021 2/1 1 Yes NA R
(12FEB2021)N/N
C4591001
1126
11261248# GENRL Injection site pain/
Left upper arm injection site
pain3 11FEB2021 1/3 1 Yes NA/TC R
(13FEB2021)N/N
MUSC Myalgia/
Muscle aches, generalize d3 12FEB2021 2/2 2 Yes NA/TC R
(13FEB2021)N/N
GENRL Pyrexia/
Feve r3 13FEB2021 3/1 2 Yes NA/TC R
(13FEB2021)N/N
C4591001
1126
11261259# GASTR Irritable bowel syndrome/
Worsening irritable bowel
syndrome2 14FEB2021 55/C 2 No O NA/TC/TCN N N/N
C4591001
1126
11261260# GENRL Chills/
Chills 3 12FEB2021 2/1 2 Yes NA R
(12FEB2021)N/N
Fatigue/
Fatigue3 12FEB2021 2/2 2 Yes NA R
(13FEB2021)N/N
MUSC Myalgia/
Muscle aches, generalize d3 12FEB2021 2/2 1 Yes NA/TC R
(13FEB2021)N/N
INFEC Vulvitis/
Vulvitis3 16FEB2021 6/7 2 No O NA/TC R
(22FEB2021)N/N
RENAL Dysuria/
Dysuria3 17FEB2021 7/6 2 No O NA R
(22FEB2021)N/N
C4591001
1126
11261261# GENRL Injection site pain/
Left upper arm injection site
pain3 10FEB2021 1/2 2 Yes NA R
(11FEB2021)N/N
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Page 66
FDA-CBER-2022-5812-0221057
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1128
11281057 INFEC Tonsillitis/
tonsillitis 2 19SEP2020 25/C 1 No O NA N N/N
C4591001
1128
11281098 SKIN Macule/
Erythematous, Macule
upper anterior thi gh2 13SEP2020 10/27 2 No O NA/TC R
(09OCT2020)N/N
MUSC Musculoskeletal chest pain/
chest wall pain2 08OCT2020 35/5 1 No O NA R
(12OCT2020)N/N
C4591001
1128
11281098# GENRL Chills/
Chills 3 22JAN2021 1/2 1 Yes NA R
(23JAN2021)N/N
Injection site pain/
Injection Site Soreness, Left
Arm3 22JAN2021 1/3 1 Yes NA R
(24JAN2021)N/N
C4591001
1129
11291097 INFEC Urinary tract infection/
urinary tract infection 2 19DEC2020 110/3 2 No O NA/TC R
(21DEC2020)N/N
C4591001
1129
11291256# EYE Eye pain/
eye pain 3 16FEB2021 1/2 1 Yes NA R
(17FEB2021)N/N
GENRL Chills/
chills3 16FEB2021 1/2 1 Yes NA R
(17FEB2021)N/N
NERV Headache/
headache3 16FEB2021 1/3 1 Yes NA/TC R
(18FEB2021)N/N
MUSC Back pain/
back pain muscula r3 17FEB2021 2/1 1 Yes NA R
(17FEB2021)N/N
GENRL Chills/
Chills4 10MAR2021 2/2 1 Yes NA R
(11MAR2021)N/N
C4591001
1129
11291260# IMMUN Anaphylactoid reaction/
Anaphylactoid Reaction 3 27JAN2021 3/1 4 Yes P/TC R
(27JAN2021)Y/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 67
FDA-CBER-2022-5812-0221058
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1129
11291262 GASTR Lip swelling/
lip swelling 1 23NOV2020 1/12 1 No O NA/TC R
(04DEC2020)N/N
GASTR Aphthous ulcer/
worsening canker sore
episode of lips1 27NOV2020 5/8 2 Yes NA/TC R
(04DEC2020)N/N
C4591001
1129
11291263# GENRL Injection site pain/
left deltoid injection site
soreness3 27JAN2021 1/2 1 Yes NA R
(28JAN2021)N/N
C4591001
1131
11311279 GENRL Fatigue/
fatigue 2 12JAN2021 2/4 1 Yes NA R
(15JAN2021)N/N
Injection site pain/
injection site pain2 12JAN2021 2/3 1 Yes NA R
(14JAN2021)N/N
C4591001
1139
11391089 MUSC Musculoskeletal discomfort /
Left Shoulder discomfort 1 26AUG2020 15/12 1 Yes NA R
(06SEP2020)N/N
C4591001
1139
11391138 INFEC Sinusitis/
sinusitis 2 08JAN2021 23/18 2 No O NA/TC R
(25JAN2021)N/N
C4591001
1140
11401321# GENRL Injection site pain/
Pain at injection site 3 17FEB2021 1/2 1 Yes NA R
(18FEB2021)N/N
C4591001
1141
11411006 MUSC Back pain/
Back Pain 1 31JUL2020 1/10 3 Yes NA/TC R
(09AUG2020)N/N
INFEC Gingivitis/
Gum Infection2 01DEC2020 103/72 1 No O NA/TC R
(10FEB2021)N/N
C4591001
1141
11411010 PSYCH Anxiety/
Anxiousness 2 14SEP2020 14/93 2 No O NA/TCN R
(15DEC2020)N/N
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Page 68
FDA-CBER-2022-5812-0221059
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Depressed mood/
Low Moo d2 14SEP2020 14/93 2 No O NA/TCN R
(15DEC2020)N/N
C4591001
1141
11411016# GENRL Injection site pain/
injection site pain 3 01FEB2021 1/4 1 Yes NA R
(04FEB2021)N/N
GASTR Nausea/
Nausea4 22FEB2021 1/2 1 Yes NA R
(23FEB2021)N/N
INV Body temperature
increased/
Elevated Body Temperature
T. Max 100.1 F4 22FEB2021 1/2 1 Yes NA R
(23FEB2021)N/N
MUSC Myalgia/
Diffuse Myalgia in
vaccinated ar m4 22FEB2021 1/2 1 Yes NA/TC R
(23FEB2021)N/N
C4591001
1141
11411021 GENRL Injection site pain/
muscle soreness injection
area2 25AUG2020 1/2 1 Yes NA R
(26AUG2020)N/N
C4591001
1141
11411029 MUSC Arthralgia/
Arthralgias 2 17SEP2020 23/12 2 Yes NA/TC/TCN R
(28SEP2020)N/N
PSYCH Anxiety/
Anxiet y Flare up2 18SEP2020 24/C 1 Yes NA/TC/TCN N N/N
C4591001
1141
11411032# GENRL Fatigue/
Fatigue 3 07JAN2021 1/4 2 Yes NA R
(10JAN2021)N/N
Injection site pain/
Injection site pain left
deltoi d3 07JAN2021 1/4 2 Yes NA R
(10JAN2021)N/N
C4591001
1141
11411053 PSYCH Anxiety/
Worsening Anxiety 2 02DEC2020 99/62 2 No O NA/TC/TCN R
(01FEB2021)N/N
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Page 69
FDA-CBER-2022-5812-0221060
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Depression/
Worsenin g depression2 02DEC2020 99/62 2 No O NA/TC/TCN R
(01FEB2021)N/N
C4591001
1141
11411056 GENRL Injection site
hyperaesthesia/
Hyperethesia left deltoid
region on in jection site2 02SEP2020 1/1 1 Yes NA R
(02SEP2020)N/Y
C4591001
1141
11411067 MUSC Plantar fasciitis/
worsening of plantar
fasciitis left foo t2 14SEP2020 13/C 2 No O NA/TC RG N/N
C4591001
1141
11411067# GENRL Fatigue/
fatigue 3 21DEC2020 1/3 1 Yes NA R
(23DEC2020)N/N
Injection site pain/
injection site pain3 21DEC2020 1/6 1 Yes NA R
(26DEC2020)N/N
GENRL Fatigue/
Fatigue4 13JAN2021 1/4 2 Yes NA R
(16JAN2021)N/N
NERV Headache/
Headache (worse than
typical)4 13JAN2021 1/2 2 Yes NA/TC R
(14JAN2021)N/N
GASTR Nausea/
Nausea4 14JAN2021 2/2 1 Yes NA R
(15JAN2021)N/N
GENRL Pyrexia/
Feve r4 14JAN2021 2/2 1 Yes NA/TC R
(15JAN2021)N/N
MUSC Myalgia/
Generalized M yalgia4 14JAN2021 2/2 2 Yes NA R
(15JAN2021)N/N
GENRL Injection site pain/
Arm Pain (in jection)4 16JAN2021 4/2 1 Yes NA R
(17JAN2021)N/N
C4591001
1141
11411070# GENRL Chills/
chills 3 23DEC2020 1/2 1 Yes NA R
(24DEC2020)N/N
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Page 70
FDA-CBER-2022-5812-0221061
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Fatigue/
fatigue3 23DEC2020 1/2 1 Yes NA R
(24DEC2020)N/N
Injection site pain/
injection site pain3 23DEC2020 1/2 2 Yes NA/TC R
(24DEC2020)N/N
GENRL Pyrexia/
Feve r4 15JAN2021 2/1 1 Yes NA/TC R
(15JAN2021)N/N
C4591001
1141
11411074# GASTR Abdominal discomfort/
Stomach discomfort 4 25FEB2021 2/1 2 Yes NA R
(25FEB2021)N/N
GENRL Chills/
chills4 25FEB2021 2/1 2 Yes NA R
(25FEB2021)N/N
Malaise/
Malaise4 25FEB2021 2/1 2 Yes NA R
(25FEB2021)N/N
Pyrexia/
Fever (101 F)4 25FEB2021 2/1 2 Yes NA/TC R
(25FEB2021)N/N
MUSC Myalgia/
myalgia4 25FEB2021 2/1 3 Yes NA/TC R
(25FEB2021)N/N
NERV Headache/
Headache4 25FEB2021 2/1 2 Yes NA/TC R
(25FEB2021)N/N
C4591001
1142
11421045# GENRL Injection site pain/
injection site pain 3 26FEB2021 1/2 2 Yes NA R
(27FEB2021)N/N
SKIN Ecchymosis/
ecchymosis at left
antecubital fossa3 27FEB2021 2/C 1 No O NA RG N/N
C4591001
1142
11421059# GENRL Injection site pain/
injection site pain 3 29DEC2020 1/2 2 Yes NA R
(30DEC2020)N/N
GENRL Fatigue/
fatigue4 22JAN2021 2/2 1 Yes NA R
(23JAN2021)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 71
FDA-CBER-2022-5812-0221062
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Injection site pain/
injection site pain4 22JAN2021 2/2 1 Yes NA R
(23JAN2021)N/N
Pain/
body aches4 22JAN2021 2/2 1 Yes NA R
(23JAN2021)N/N
C4591001
1142
11421078# GENRL Injection site pain/
injection site pain 3 07JAN2021 2/2 1 Yes NA R
(08JAN2021)N/N
C4591001
1147
11471258# GENRL Injection site pain/
Pain at injection site 3 26FEB2021 1/3 1 Yes NA R
(28FEB2021)N/N
C4591001
1147
11471259 EYE Eye pain/
Ocular pain, bilateral 2 05JAN2021 25/C 1 No O NA/TC N N/N
Ocular hyperaemia/
Ocular redness, bilateral2 05JAN2021 25/C 1 No O NA/TC N N/N
C4591001
1147
11471272 INJ&P Ligament sprain/
Sprained Ankle 2 14JAN2021 18/C 1 No O NA/TC N N/N
C4591001
1149
11491335† GENRL Injection site pain/
mild pain at site of injection
(right arm)1 27OCT2020 2/2 1 Yes NA/TC R
(28OCT2020)N/N
C4591001
1150
11501148# GENRL Injection site pain/
Pain at injection site 3 18FEB2021 1/3 1 Yes NA R
(20FEB2021)N/N
GENRL Fatigue/
Fatigue3 19FEB2021 2/2 1 Yes NA R
(20FEB2021)N/N
Pain/
Generalized Bod y Aches3 19FEB2021 2/2 1 Yes NA R
(20FEB2021)N/N
NERV Dizziness/
Dizziness3 19FEB2021 2/2 1 Yes NA R
(20FEB2021)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 72
FDA-CBER-2022-5812-0221063
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1150
11501149# GENRL Injection site pain/
Pain at injection site 3 16FEB2021 1/3 2 Yes NA R
(18FEB2021)N/N
GENRL Fatigue/
Fatigue3 17FEB2021 2/2 1 Yes NA R
(18FEB2021)N/N
Pain/
Generalized Bod y Aches3 17FEB2021 2/2 1 Yes NA R
(18FEB2021)N/N
NERV Headache/
Headache3 17FEB2021 2/2 1 Yes NA R
(18FEB2021)N/N
C4591001
1150
11501151# GENRL Injection site pain/
Pain at injection site 3 23FEB2021 1/3 2 Yes NA R
(25FEB2021)N/N
GENRL Fatigue/
Fatigue3 24FEB2021 2/1 1 Yes NA R
(24FEB2021)N/N
C4591001
1150
11501153# GENRL Injection site pain/
Pain at injection site 3 24FEB2021 1/3 1 Yes NA R
(26FEB2021)N/N
PSYCH Depression/
Worsening Depression- no
prior hospitalizations for
depression3 02MAR2021 7/C 4 No O NA RG Y/N
C4591001
1150
11501155# GENRL Injection site pain/
Pain at injection site 3 12FEB2021 2/1 1 Yes NA R
(12FEB2021)N/N
C4591001
1150
11501158# GENRL Injection site pain/
Pain at injection site 3 18FEB2021 1/3 2 Yes NA R
(20FEB2021)N/N
C4591001
1150
11501159# GENRL Injection site pain/
Pain at injection site 3 18FEB2021 1/3 2 Yes NA R
(20FEB2021)N/N
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16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1150
11501169# GENRL Injection site pain/
Injection Site Pain 3 18FEB2021 2/2 1 Yes NA R
(19FEB2021)N/N
C4591001
1150
11501170# GENRL Injection site pain/
Injection Site Pain 3 17FEB2021 2/3 1 Yes NA R
(19FEB2021)N/N
C4591001
1152
11521024# INJ&P Upper limb fracture/
broken right arm 2 15JAN2021 136/C 2 No O NA/TC/TCN N N/N
C4591001
1152
11521591# NERV Headache/
Headache 3 12MAR2021 2/1 2 Yes NA/TC R
(12MAR2021)N/N
C4591001
1152
11521643 ENDO Autoimmune thyroiditis/
Hashimoto's disease 2 12FEB2021 47/C 2 No O NA N N/N
C4591001
1156
11561300 GENRL Pyrexia/
FEVER 1 18NOV2020 2/2 3 Yes NA R
(19NOV2020)N/N
C4591001
1156
11561329 NERV Headache/
HEADACHE 2 07JAN2021 2/42 1 Yes NA/TC R
(17FEB2021)N/N
C4591001
1161
11611016 INJ&P Exposure during pregnancy/
Exposure during Pregnancy2 17JAN2021 60/C 1 No O NA UNK N/N
C4591001
1162
11621019 INFEC Sinusitis/
sinus infection 2 06OCT2020 42/C 1 No O NA/TC N N/N
C4591001
1162
11621583 NERV Headache/
headache 1 28OCT2020 1/2 1 Yes NA R
(29OCT2020)N/N
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16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1170
11701022 GENRL Pain/
Exercise Induced Body
Soreness1 06SEP2020 21/2 1 No O NA/TC R
(07SEP2020)N/N
NERV Headache/
Headache2 09SEP2020 2/2 1 Yes NA R
(10SEP2020)N/N
C4591001
1171
11711027 INJ&P Muscle strain/
Lower back strain 2 18SEP2020 15/11 2 No O NA/TC R
(28SEP2020)N/N
C4591001
1185
11851060# GENRL Fatigue/
Fatigue 4 17FEB2021 2/2 1 Yes NA R
(18FEB2021)N/N
NERV Somnolence/
Drowsiness4 17FEB2021 2/2 1 Yes NA R
(18FEB2021)N/N
C4591001
1194
11941045# GENRL Injection site pain/
Pain at injection site 3 18JAN2021 1/3 1 Yes NA R
(20JAN2021)N/N
C4591001
1194
11941047# GENRL Injection site pain/
Pain at injection site 3 26JAN2021 2/4 2 Yes NA R
(29JAN2021)N/N
GENRL Fatigue/
Fatigue4 15FEB2021 1/4 1 Yes NA R
(18FEB2021)N/N
Injection site pain/
Pain at in jection site4 15FEB2021 1/5 2 Yes NA R
(19FEB2021)N/N
C4591001
1194
11941067# GENRL Fatigue/
Fatigue 3 15JAN2021 1/6 3 Yes NA R
(20JAN2021)N/N
Injection site pain/
Pain at in jection site3 15JAN2021 1/6 2 Yes NA R
(20JAN2021)N/N
Injection site swelling/
Swellin g at in jection pain3 15JAN2021 1/2 1 Yes NA R
(16JAN2021)N/N
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16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
NERV Headache/
Headache3 16JAN2021 2/3 2 Yes NA R
(18JAN2021)N/N
GENRL Injection site pain/
Pain at in jection site4 05FEB2021 1/7 2 Yes NA R
(11FEB2021)N/N
C4591001
1194
11941086# GENRL Injection site pain/
Pain at injection site 3 28JAN2021 1/3 2 Yes NA R
(30JAN2021)N/N
NERV Headache/
Headache3 29JAN2021 2/2 2 Yes NA R
(30JAN2021)N/N
NERV Headache/
Headache4 19FEB2021 2/3 2 Yes NA R
(21FEB2021)N/N
C4591001
1194
11941092# GENRL Injection site pain/
Pain at the injection site 3 27JAN2021 2/3 2 Yes NA R
(29JAN2021)N/N
C4591001
1194
11941103# GENRL Injection site pain/
Pain at injection site 3 13JAN2021 2/4 1 Yes NA R
(16JAN2021)N/N
C4591001
1195
11951066# GENRL Chills/
Chills 3 20JAN2021 2/1 1 Yes NA R
(20JAN2021)N/N
C4591001
1195
11951100 GASTR Vomiting/
Emesis 1 18OCT2020 1/1 1 No O NA R
(18OCT2020)N/N
C4591001
1195
11951148 MUSC Spinal disorder/
cervical spine syndrome 1 02NOV2020 14/45 1 No O NA/TC R
(16DEC2020)N/N
C4591001
1195
11951148# GENRL Injection site pain/
pain injection site 3 09FEB2021 2/7 2 Yes NA R
(15FEB2021)N/N
GASTR Nausea/
Nausea3 24FEB2021 17/2 1 Yes NA/TC R
(25FEB2021)N/N
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Page 76
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16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1197
11971031 MUSC Tenosynovitis/
Tenosynovitis right forearm2 15JAN2021 71/C 2 No O NA/TC N N/N
C4591001
1197
11971031# NERV Headache/
headache 4 24FEB2021 1/2 1 Yes NA R
(25FEB2021)N/N
C4591001
1203
12031026 NERV Headache/
headache 1 07NOV2020 19/1 2 No O NA/TC R
(07NOV2020)N/N
GASTR Inguinal hernia/
inguinal hernia lef t1 09NOV2020 21/103 2 No O NA/TC/TCN R
(19FEB2021)Y/N
C4591001
1203
12031026# NERV Headache/
systemic vaccination
reaction headache3 01MAR2021 1/1 2 Yes NA/TC R
(01MAR2021)N/N
C4591001
1203
12031047# GENRL Injection site pain/
tenderness at injection site3 10FEB2021 1/2 1 Yes NA R
(11FEB2021)N/N
GENRL Malaise/
Malaise4 03MAR2021 1/3 2 Yes NA R
(05MAR2021)N/N
MUSC Arthralgia/
Arthral gia4 03MAR2021 1/3 2 Yes NA R
(05MAR2021)N/N
GENRL Pyrexia/
Feve r4 04MAR2021 2/2 1 Yes NA/TC R
(05MAR2021)N/N
C4591001
1213
12131003# GENRL Injection site pain/
PAIN AT INJECTION
SITE3 08JAN2021 1/2 2 Yes NA R
(09JAN2021)N/N
MUSC Myalgia/
MUSCLE PAIN3 08JAN2021 1/2 2 Yes NA R
(09JAN2021)N/N
GENRL Injection site pain/
PAIN AT INJECTION
SITE4 29JAN2021 1/2 2 Yes NA/TC R
(30JAN2021)N/N
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Page 77
FDA-CBER-2022-5812-0221068
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
NERV Headache/
HEADACHE4 29JAN2021 1/2 2 Yes NA/TC R
(30JAN2021)N/N
SKIN Hyperhidrosis/
SWEATING4 29JAN2021 1/2 2 Yes NA/TC R
(30JAN2021)N/N
C4591001
1213
12131018# GENRL Injection site pain/
PAIN AT INJECTION
SITE3 12JAN2021 1/2 2 Yes NA R
(13JAN2021)N/N
NERV Headache/
HEADACHE3 12JAN2021 1/2 2 Yes NA R
(13JAN2021)N/N
GENRL Injection site pain/
PAIN AT INJECTION
SITE4 01FEB2021 1/3 2 Yes NA R
(03FEB2021)N/N
NERV Headache/
HEADACHE4 01FEB2021 1/3 3 Yes NA R
(03FEB2021)N/N
C4591001
1214
12141012# GENRL Injection site pain/
Pain at injection site 3 02FEB2021 1/2 2 Yes NA R
(03FEB2021)N/N
GENRL Fatigue/
Fatigue3 03FEB2021 2/2 2 Yes NA R
(04FEB2021)N/N
NERV Headache/
Headache3 03FEB2021 2/2 2 Yes NA R
(04FEB2021)N/N
GENRL Injection site pain/
pain at in jection site4 24FEB2021 1/4 2 Yes NA R
(27FEB2021)N/N
GENRL Fatigue/
Fatigue4 25FEB2021 2/2 2 Yes NA R
(26FEB2021)N/N
NERV Headache/
Headache4 25FEB2021 2/2 2 Yes NA R
(26FEB2021)N/N
C4591001
1214
12141022# GENRL Injection site pain/
pain at injection site 3 01FEB2021 1/3 2 Yes NA R
(03FEB2021)N/N
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Page 78
FDA-CBER-2022-5812-0221069
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GENRL Injection site pain/
pain at in jection site4 22FEB2021 1/4 2 Yes NA R
(25FEB2021)N/N
GENRL Fatigue/
fatigue4 23FEB2021 2/2 2 Yes NA R
(24FEB2021)N/N
C4591001
1214
12141027# GENRL Injection site pain/
pain at injection site 3 01FEB2021 1/2 3 Yes NA R
(02FEB2021)N/N
GENRL Fatigue/
fatigue4 23FEB2021 1/2 2 Yes NA/TC R
(24FEB2021)N/N
MUSC Pain in extremity/
arm pain4 23FEB2021 1/2 2 Yes NA/TC R
(24FEB2021)N/N
C4591001
1214
12141053# MUSC Pain in extremity/
Arm Pain 3 07JAN2021 1/2 1 Yes NA R
(08JAN2021)N/N
MUSC Pain in extremity/
Arm Pain4 26JAN2021 1/2 1 Yes NA R
(27JAN2021)N/N
GENRL Fatigue/
Fatigue4 27JAN2021 2/2 1 Yes NA R
(28JAN2021)N/N
C4591001
1217
12171032# GENRL Injection site pain/
Injection pain (Arm pain) 3 07JAN2021 1/3 1 Yes NA R
(09JAN2021)N/N
GENRL Fatigue/
Lassitude4 28JAN2021 1/2 1 Yes NA R
(29JAN2021)N/N
Injection site pain/
Injection pain(arm pain)4 28JAN2021 1/2 1 Yes NA R
(29JAN2021)N/N
C4591001
1217
12171041# GENRL Injection site pain/
arm pain (injection pain) 3 20JAN2021 1/3 1 Yes NA R
(22JAN2021)N/N
GENRL Pyrexia/
38 C Feve r4 12FEB2021 1/2 1 Yes NA R
(13FEB2021)N/N
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Page 79
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16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1223
12231005# GENRL Injection site pain/
injection site pain 3 11FEB2021 1/3 1 Yes NA R
(13FEB2021)N/N
C4591001
1223
12231008# GENRL Fatigue/
fatigue 4 15JAN2021 2/1 1 Yes NA R
(15JAN2021)N/N
MUSC Back pain/
back pain4 15JAN2021 2/1 1 Yes NA R
(15JAN2021)N/N
C4591001
1223
12231025# GENRL Injection site pain/
injection site pain 3 17FEB2021 1/2 1 Yes NA R
(18FEB2021)N/N
C4591001
1223
12231036# GENRL Fatigue/
fatigue 3 22FEB2021 1/2 1 Yes NA R
(23FEB2021)N/N
C4591001
1223
12231057 GENRL Fatigue/
Fatigue 2 22SEP2020 1/2 1 Yes NA/TC R
(23SEP2020)N/N
Pyrexia/
Feve r2 22SEP2020 1/2 1 Yes NA/TC R
(23SEP2020)N/N
MUSC Myalgia/
Myalgia2 22SEP2020 1/2 1 Yes NA/TC R
(23SEP2020)N/N
NERV Headache/
Headache2 22SEP2020 1/2 1 Yes NA/TC R
(23SEP2020)N/N
C4591001
1223
12231073 GASTR Nausea/
nausea 2 04OCT2020 13/2 2 No O NA R
(05OCT2020)N/N
NERV Dizziness/
Dizziness2 04OCT2020 13/2 2 No O NA R
(05OCT2020)N/N
C4591001
1223
12231073# GENRL Chills/
chills 3 10FEB2021 1/2 1 Yes NA R
(11FEB2021)N/N
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Page 80
FDA-CBER-2022-5812-0221071
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
NERV Headache/
headache3 10FEB2021 1/2 1 Yes NA R
(11FEB2021)N/N
C4591001
1224
12241168 GENRL Pyrexia/
Fever - 101.0F 2 18DEC2020 9/1 1 Yes NA/TC R
(18DEC2020)N/N
SKIN Rash/
Rash - bilateral upper arms2 18DEC2020 9/1 1 Yes NA/TC R
(18DEC2020)N/N
C4591001
1226
12261049 GENRL Pyrexia/
fever (38 C) 2 04SEP2020 1/2 1 Yes NA R
(05SEP2020)N/N
NERV Headache/
Headache2 04SEP2020 1/2 1 Yes NA R
(05SEP2020)N/N
C4591001
1226
12261082 GASTR Nausea/
nausea 1 19AUG2020 9/1 1 No O NA/TC R
(19AUG2020)N/N
MUSC Torticollis/
torticollis1 24AUG2020 14/1 1 No O NA/TC R
(24AUG2020)N/N
C4591001
1226
12261100# GENRL Fatigue/
Fatigue 3 22JAN2021 1/3 2 Yes NA/TC R
(24JAN2021)N/N
Injection site pain/
Pain at in jection site3 22JAN2021 1/3 2 Yes NA/TC R
(24JAN2021)N/N
GENRL Pyrexia/
Fever 39 C4 11FEB2021 2/3 2 Yes NA/TC R
(13FEB2021)N/N
C4591001
1226
12261124 MUSC Pain in extremity/
Pain in legs 1 19AUG2020 8/3 2 No O NA/TC R
(21AUG2020)N/N
C4591001
1226
12261126 MUSC Back pain/
acute low back pain 1 20AUG2020 9/C 2 No O NA/TC RG N/N
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Page 81
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16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1226
12261126# GENRL Fatigue/
tiredness 3 02FEB2021 2/3 2 Yes NA R
(04FEB2021)N/N
Injection site pain/
pain at the in jection site3 02FEB2021 2/3 2 Yes NA/TC R
(04FEB2021)N/N
MUSC Myalgia/
muscle pain3 02FEB2021 2/3 2 Yes NA/TC R
(04FEB2021)N/N
GENRL Injection site pain/
Pain at the in jection site4 22FEB2021 1/4 2 Yes NA/TC R
(25FEB2021)N/N
Injection site swelling/
Swellin g at the in jection site4 22FEB2021 1/4 2 Yes NA/TC R
(25FEB2021)N/N
GENRL Chills/
Chills4 23FEB2021 2/3 2 Yes NA/TC R
(25FEB2021)N/N
INV Body temperature
increased/
Increased body temperature
37.6 C4 23FEB2021 2/3 2 Yes NA/TC R
(25FEB2021)N/N
MUSC Arthralgia/
Joint pain4 23FEB2021 2/3 2 Yes NA/TC R
(25FEB2021)N/N
C4591001
1226
12261144 NERV Headache/
Headache 1 27AUG2020 16/1 1 No O NA R
(27AUG2020)N/N
NERV Headache/
Headache2 09SEP2020 2/3 1 Yes NA R
(11SEP2020)N/N
C4591001
1226
12261158# GENRL Chills/
Chills 3 01FEB2021 1/2 2 Yes NA/TC R
(02FEB2021)N/N
Injection site pain/
Pain at the in jection site3 01FEB2021 1/2 2 Yes NA/TC R
(02FEB2021)N/N
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16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
MUSC Myalgia/
Myalgia3 01FEB2021 1/2 2 Yes NA/TC R
(02FEB2021)N/N
NERV Headache/
Headache3 01FEB2021 1/2 2 Yes NA/TC R
(02FEB2021)N/N
GENRL Chills/
chills4 22FEB2021 1/2 1 Yes NA/TC R
(23FEB2021)N/N
Pain/
body pain4 22FEB2021 1/2 1 Yes NA/TC R
(23FEB2021)N/N
C4591001
1226
12261172# GENRL Chills/
chills 3 30JAN2021 1/2 1 Yes NA/TC R
(31JAN2021)N/N
NERV Headache/
headache3 30JAN2021 1/2 1 Yes NA/TC R
(31JAN2021)N/N
C4591001
1226
12261207# GENRL Pyrexia/
Fever 38 C 4 20FEB2021 1/3 1 Yes NA/TC R
(22FEB2021)N/N
C4591001
1226
12261230# GENRL Pain/
body pain 3 06FEB2021 2/4 1 Yes NA/TC R
(09FEB2021)N/N
C4591001
1226
12261238# GENRL Injection site pain/
pain at the injection site 4 21FEB2021 2/1 1 Yes NA R
(21FEB2021)N/N
C4591001
1226
12261251# GASTR Nausea/
Nausea 3 22JAN2021 1/2 1 Yes NA R
(23JAN2021)N/N
GENRL Injection site pain/
Pain at in jection site3 22JAN2021 1/2 1 Yes NA/TC R
(23JAN2021)N/N
GENRL Injection site pain/
pain at the in jection site4 10FEB2021 1/3 1 Yes NA/TC R
(12FEB2021)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
Page 83
FDA-CBER-2022-5812-0221074
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GASTR Nausea/
Nausea4 11FEB2021 2/2 1 Yes NA/TC R
(12FEB2021)N/N
C4591001
1230
12301057# MUSC Myalgia/
New onset of muscle pain.3 29JAN2021 2/4 3 Yes NA/TC R
(01FEB2021)N/N
GENRL Injection site pain/
Pain at in jection site.3 07FEB2021 11/14 2 Yes NA R
(20FEB2021)N/N
GENRL Peripheral swelling/
Swellin g left upper arm.4 17FEB2021 2/4 2 Yes NA R
(20FEB2021)N/N
MUSC Myalgia/
New onset of muscle pain.4 17FEB2021 2/4 2 Yes NA R
(20FEB2021)N/N
MUSC Arthralgia/
New onset of joint pain left
upper wris t4 19FEB2021 4/15 3 Yes NA/TC R
(05MAR2021)N/N
C4591001
1230
12301114# GENRL Chills/
Chills 3 18FEB2021 2/1 2 Yes NA R
(18FEB2021)N/N
MUSC Myalgia/
Muscle pain in upper arms
and le gs.3 18FEB2021 2/1 2 Yes NA R
(18FEB2021)N/N
C4591001
1231
12311141 INFEC Genital herpes/
exacerbated genital herpes2 27SEP2020 26/9 1 No O NA/TC/TCN R
(05OCT2020)N/N
C4591001
1231
12311164 GASTR Abdominal pain/
Abdominal pain 2 02SEP2020 1/2 3 No O NA/TC/TCN R
(03SEP2020)N/N
C4591001
1231
12311191 INFEC Cystitis/
Cystitis 1 09OCT2020 57/3 1 No O NA/TC R
(11OCT2020)N/N
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16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1231
12311199 INFEC Genital herpes simplex/
Genital herpes simplex type
22 16SEP2020 14/13 1 No O NA/TC R
(28SEP2020)N/N
C4591001
1231
12311229 CARD Tachycardia/
tachycardia 2 06OCT2020 33/39 2 No O NA R
(13NOV2020)N/N
C4591001
1231
12311281 INFEC Appendicitis/
acute appendicitis 2 18SEP2020 15/19 3 No O NA/TC/TCN R
(06OCT2020)Y/N
INV Electrocardiogram QT
prolonged/
QT interval prolon gation2 18SEP2020 15/1 1 No O NA R
(18SEP2020)N/N
C4591001
1231
12311306 GENRL Chest pain/
Self-limited oppressive
chest pain1 02SEP2020 19/1 1 No O NA R
(02SEP2020)N/N
C4591001
1231
12311387 INJ&P Exposure during pregnancy/
Drug Exposed Pregnancy 2 07NOV2020 65/C No O NA UNK N/N
INFEC Urinary tract infection/
Complicated Urinary Tract
Infection2 04JAN2021 123/15 3 No O NA/TC R
(18JAN2021)Y/N
C4591001
1231
12311388 NERV Headache/
headache 1 16AUG2020 2/8 1 No O NA R
(23AUG2020)N/N
MUSC Myalgia/
GENERALIZED
MYALGIA1 18AUG2020 4/7 1 Yes NA R
(24AUG2020)N/N
MUSC Arthralgia/
ARTHRALGIA1 21AUG2020 7/4 1 No O NA R
(24AUG2020)N/N
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16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
SURG Tooth extraction/
Programmed extraction of
the ri ght third mola r2 26SEP2020 24/1 1 No CND NA/TC/TCN R
(26SEP2020)N/N
C4591001
1231
12311436 GASTR Diarrhoea/
diarrhea 2 30SEP2020 28/2 1 No O NA/TCN R
(01OCT2020)N/N
C4591001
1232
12321213 INJ&P Exposure during pregnancy/
Exposure during pregnancy1 01OCT2020 23/C
No O P UNK N/N
C4591001
1241
12411010 GENRL Injection site erythema/
Injection site erythema 1 07AUG2020 1/1 1 Yes NA R
(07AUG2020)N/Y
C4591001
1241
12411011 MUSC Myalgia/
Myalgia 2 27AUG2020 2/3 1 Yes NA R
(29AUG2020)N/N
C4591001
1241
12411028# GENRL Injection site pain/
Injection site pain 3 25JAN2021 1/3 1 Yes NA R
(27JAN2021)N/N
GENRL Fatigue/
Fatigue4 15FEB2021 1/2 1 Yes NA R
(16FEB2021)N/N
Injection site pain/
Injection site pain4 15FEB2021 1/2 1 Yes NA R
(16FEB2021)N/N
GENRL Pyrexia/
Feve r4 16FEB2021 2/1 1 Yes NA R
(16FEB2021)N/N
C4591001
1241
12411034 SURG Sclerotherapy/
Sclerotherapy 2 23SEP2020 22/1 1 No O NA R
(23SEP2020)N/N
C4591001
1241
12411127# GENRL Injection site pain/
Injection site pain 3 01FEB2021 1/2 2 Yes NA/TC R
(02FEB2021)N/N
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16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Pyrexia/
Feve r3 01FEB2021 1/2 1 Yes NA/TC R
(02FEB2021)N/N
NERV Headache/
Headache3 01FEB2021 1/2 1 Yes NA/TC R
(02FEB2021)N/N
GENRL Injection site pain/
Injection site pain4 23FEB2021 2/4 1 Yes NA/TC R
(26FEB2021)N/N
Pyrexia/
Feve r4 23FEB2021 2/4 1 Yes NA/TC R
(26FEB2021)N/N
NERV Headache/
Headache4 23FEB2021 2/4 1 Yes NA/TC R
(26FEB2021)N/N
C4591001
1241
12411157# GENRL Injection site pain/
Injection site pain 3 26JAN2021 1/2 1 Yes NA R
(27JAN2021)N/N
C4591001
1241
12411171# MUSC Myalgia/
Myalgia 3 04FEB2021 1/3 2 Yes NA/TC R
(06FEB2021)N/N
C4591001
1241
12411178# GENRL Injection site pain/
Injection site pain 3 29JAN2021 2/2 1 Yes NA R
(30JAN2021)N/N
GENRL Fatigue/
Fatigue4 19FEB2021 2/3 1 Yes NA R
(21FEB2021)N/N
Injection site pain/
Injection site pain4 19FEB2021 2/3 1 Yes NA R
(21FEB2021)N/N
C4591001
1241
12411205# GENRL Injection site pain/
Injection site pain 4 19FEB2021 1/3 1 Yes NA R
(21FEB2021)N/N
C4591001
1241
12411220# GENRL Injection site pain/
Injection site pain 3 29JAN2021 2/3 1 Yes NA R
(31JAN2021)N/N
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16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Injection site swelling/
Injection site swellin g3 29JAN2021 2/3 1 Yes NA R
(31JAN2021)N/N
MUSC Myalgia/
Myalgia4 19FEB2021 2/2 1 Yes NA R
(20FEB2021)N/N
C4591001
1246
12461026 INFEC Sinusitis/
Sinusitis 2 27OCT2020 9/15 2 No O NA/TC R
(10NOV2020)N/N
C4591001
1246
12461028# MUSC Pain in extremity/
Painful Left arm 3 24FEB2021 1/3 1 Yes NA/TC R
(26FEB2021)N/N
C4591001
1246
12461070 INFEC Urinary tract infection/
Urine tract Infection-
pathogen unknown2 15NOV2020 23/4 2 No O NA/TC R
(18NOV2020)N/N
PSYCH Depression/
Worsenin g of depression2 25DEC2020 63/22 3 No O NA/TC/TCN R
(15JAN2021)Y/N
C4591001
1246
12461082# GENRL Injection site pain/
Painful Left Arm injection
area3 11FEB2021 1/2 1 Yes NA R
(12FEB2021)N/N
C4591001
1246
12461084# GENRL Injection site pain/
Painful left arm injection
site.3 12FEB2021 1/3 1 Yes NA/TC R
(14FEB2021)N/N
C4591001
1246
12461092# GENRL Injection site pain/
Painful left arm injection
site3 12FEB2021 1/3 1 Yes NA/TC R
(14FEB2021)N/N
C4591001
1246
12461094# GENRL Injection site pain/
Painful left arm at injection
side3 12FEB2021 1/4 2 Yes NA/TC R
(15FEB2021)N/N
C4591001
1247
12471121 INJ&P Flail chest/
Flail Chest 2 30OCT2020 10/C 3 No O NA/TC/TCN N Y/N
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16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Road traffic accident/
Motorc yle acciden t2 30OCT2020 10/1 2 No O NA R
(30OCT2020)N/N
C4591001
1247
12471185 GENRL Fatigue/
Fatigue 1 06OCT2020 1/9 1 Yes NA R
(14OCT2020)N/N
MUSC Myalgia/
Muscle pain1 06OCT2020 1/2 1 Yes NA R
(07OCT2020)N/N
NERV Headache/
Headache1 06OCT2020 1/5 1 Yes NA R
(10OCT2020)N/N
GENRL Chills/
Chills1 07OCT2020 2/2 2 Yes NA R
(08OCT2020)N/N
Injection site pain/
Injection site pain1 07OCT2020 2/2 2 Yes NA R
(08OCT2020)N/N
MUSC Myalgia/
Muscle Pain1 07OCT2020 2/2 2 Yes NA R
(08OCT2020)N/N
GENRL Injection site pain/
Injection pain1 08OCT2020 3/2 1 Yes NA R
(09OCT2020)N/N
GENRL Pyrexia/
Feve r2 27OCT2020 1/3 2 Yes NA R
(29OCT2020)N/N
C4591001
1247
12471197 GENRL Fatigue/
Fatigue 1 07OCT2020 2/7 2 Yes NA R
(13OCT2020)N/N
NERV Headache/
Headache1 07OCT2020 2/2 2 Yes NA R
(08OCT2020)N/N
C4591001
1247
12471199 GENRL Fatigue/
Fatigue 1 06OCT2020 1/1 2 Yes NA R
(06OCT2020)N/N
Injection site erythema/
Injection site redness1 06OCT2020 1/2 3 Yes NA R
(07OCT2020)N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
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16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Injection site pain/
Injection site pain1 06OCT2020 1/2 2 Yes NA R
(07OCT2020)N/N
Injection site swelling/
Injection site swellin g1 06OCT2020 1/1 3 Yes NA R
(06OCT2020)N/N
C4591001
1248
12481001 GENRL Chills/
Chills 2 18SEP2020 2/1 2 Yes NA/TC R
(18SEP2020)N/N
Pyrexia/
Feve r2 18SEP2020 2/1 2 Yes NA/TC R
(18SEP2020)N/N
C4591001
1248
12481004# GENRL Fatigue/
fatigue 3 14JAN2021 2/2 1 Yes NA R
(15JAN2021)N/N
Pain/
body aches3 14JAN2021 2/2 1 Yes NA R
(15JAN2021)N/N
Pyrexia/
mild feve r3 14JAN2021 2/2 1 Yes NA R
(15JAN2021)N/N
C4591001
1270
12701152# GENRL Chills/
Chills 3 03FEB2021 1/1 1 Yes NA R
(03FEB2021)N/N
Fatigue/
Fatigue3 03FEB2021 1/7 1 Yes NA R
(09FEB2021)N/N
Injection site pain/
Injection Site Pain3 03FEB2021 1/3 1 Yes NA R
(05FEB2021)N/N
GASTR Nausea/
Nausea3 06FEB2021 4/1 1 Yes NA R
(06FEB2021)N/N
GENRL Injection site pain/
Injetion Site Pain4 24FEB2021 1/2 1 Yes NA R
(25FEB2021)N/N
C4591001
1270
12701154 PSYCH Generalised anxiety
disorder/ 2 14JAN2021 39/C 1 No O NA/TCN N N/N
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FDA-CBER-2022-5812-0221081
16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Generalized Anxiety
Disorde r
MUSC Back pain/
Chronic Low back pain2 19JAN2021 44/C 1 No O NA/TCN N N/N
C4591001
1270
12701155# GENRL Chills/
Chills 3 06FEB2021 2/2 1 Yes NA R
(07FEB2021)N/N
Injection site pain/
Injection Site Pain3 06FEB2021 2/2 2 Yes NA R
(07FEB2021)N/N
MUSC Myalgia/
Muscle pain, generalize d3 06FEB2021 2/2 1 Yes NA R
(07FEB2021)N/N
C4591001
1270
12701164# MUSC Pain in extremity/
Right antecubital pain 2 02FEB2021 51/1 1 No O NA/TCN R
(02FEB2021)N/N
NERV Headache/
Headache3 03FEB2021 2/2 1 Yes NA R
(04FEB2021)N/N
C4591001
1270
12701175 GENRL Injection site pain/
Left Arm Injection Site Pain1 01DEC2020 1/7 2 Yes NA R
(07DEC2020)N/N
C4591001
1270
12701178 SKIN Seborrhoeic dermatitis/
Seborrheic Dermatitis of
Scalp2 10JAN2021 20/C 1 No O NA/TC N N/N
C4591001
1270
12701178# GENRL Injection site pain/
Injection Site Pain 3 03FEB2021 1/2 1 Yes NA/TC R
(04FEB2021)N/N
C4591001
1270
12701186 SKIN Rash/
Rash to trunk 2 21JAN2021 31/C 1 No O NA RG N/N
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
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16.2.7.4.1.1 Listing of Adverse Events – Subjects 12 Through 25 Years of Age (Reactogenicity Subset)
Age
Group
(Years) Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No.Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
C4591001
1270
12701190# GENRL Injection site pain/
Injection site pain 3 08FEB2021 1/3 1 Yes NA R
(10FEB2021)N/N
GENRL Fatigue/
Fatigue3 09FEB2021 2/2 1 Yes NA R
(10FEB2021)N/N
Abbreviations: C = continuing; Du r = duration; Imm = immediate. Refer to the AE legend page (Li sting 16.2.7.1) for additional definitions.
Note: MedDRA (v23.1) coding dictionary applied.
Note: * = Prevaccination AE, # = AE occurring on or after subjec t unblinding date, † = human immunodeficiency virus (HIV)-positive subject.
a. Relative day (Rel Day) = da te of AE - date of last vacci nation + 1. For an AE that occurred before the date of the firs t study vaccination, + 1 was not
added to compute relative day.
b. Duration (days) was calculated as the difference from th e start of the first reported ev ent to resolution of the last r eported event, inclusive.
c. Vaccine related (Vax Rel) : relationship to investigation al vaccine as assessed by the investigator.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (20:15) Source Dat a: adae Table Generation: 27MAR2021 (01:37)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unblinded/C4591001 BLA/adae l002 ped
090177e196ac9161\Final\Final On: 31-Mar-2021 13:06 (GMT)
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16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
16-55/
C4591001
1001
10011083 INFEC Urinary tract infection/
urinary tract infection 2 14SEP2020 27/7 1 No O NA R
(20SEP2020) N/N
16-55/
C4591001
1001
10011089 INJ&P Fall/
Fall from mountainbike 2 04SEP2020 18/C 2 No O NA/TCN N N/N
Ligament sprain/
Sprained shoulde r 2 04SEP2020 18/C 2 No O NA N N/N
16-55/
C4591001
1001
10011092 GENRL Chest discomfort/
intermittent chest discomfort 2 14SEP2020 27/15 1 No O NA R
(28SEP2020) N/N
INJ&P Ligament rupture/
right ACL rupture# 2 15JAN2021 150/33 2 No O NA/TC R
(16FEB2021) N/N
GENRL Feeling hot/
Feeling Warm# 4 10FEB2021 2/2 1 Yes NA/TC R
(11FEB2021) N/N
MUSC Myalgia/
Muscle aches# 4 10FEB2021 2/2 1 Yes NA/TC R
(11FEB2021) N/N
NERV Headache/
Headache# 4 10FEB2021 2/2 1 Yes NA/TC R
(11FEB2021) N/N
16-55/
C4591001
1001
10011106 MUSC Back pain/
Lower Back Pain 1 02AUG2020 3/2 2 Yes NA R
(03AUG2020) N/N
16-55/
C4591001
1001
10011113 NERV Migraine/
worsening migraine 1 07AUG2020 5/9 2 No O NA R
(15AUG2020) N/N
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16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
16-55/
C4591001
1001
10011125 NERV Dizziness/
dizziness*
04AUG2020 1/1 1 Yes NA R
(04AUG2020) N/N
NERV Migraine/
migraine headache 1 05AUG2020 2/5 3 Yes NA R
(09AUG2020) N/N
MUSC Myalgia/
diffuse m yalgias 1 06AUG2020 3/2 3 Yes NA R
(07AUG2020) N/N
PSYCH Disorientation/
disorientation 1 08AUG2020 5/2 1 No O NA R
(09AUG2020) N/N
16-55/
C4591001
1001
10011130 INJ&P Arthropod bite/
Insect bites, left ankle 1 07AUG2020 3/3 1 No O NA/TC R
(09AUG2020) N/N
16-55/
C4591001
1001
10011132 RESP Allergic respiratory disease/
Allergy upper respiratory 2 01SEP2020 7/3 1 No O NA R
(03SEP2020) N/N
16-55/
C4591001
1001
10011135 BLOOD Lymphadenopathy/
Left axilla lymphadenopathy# 3 15JAN2021 2/12 2 Yes NA R
(26JAN2021) N/N
GENRL Injection site pain/
Left arm pain at in jection site# 3 15JAN2021 2/33 2 Yes NA/TC R
(16FEB2021) N/N
16-55/
C4591001
1001
10011138 MUSC Arthralgia/
exacerbation of history of left
shoulder pain 2 15SEP2020 20/C 1 No O NA N N/N
16-55/
C4591001 MUSC Pain in extremity/
right arm pain 2 11SEP2020 16/3 1 No O NA R
(13SEP2020) N/N
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16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
1001
10011143
16-55/
C4591001
1001
10011145 GASTR Gastrooesophageal reflux disease/
exacerbation of gastroesophageal
reflux disease 2 03SEP2020 7/2 1 No O NA R
(04SEP2020) N/N
INV Body temperature increased/
elevated temperature 2 03SEP2020 7/1 1 Yes NA R
(03SEP2020) N/N
16-55/
C4591001
1001
10011149 GENRL Malaise/
Malaise 1 14AUG2020 8/5 1 No O NA R
(18AUG2020) N/N
NERV Sciatica/
Back pain, subjectively described as
sciatica 1 18AUG2020 12/C 1 No O NA/TC N N/N
INJ&P Muscle strain/
muscle strain 2 23SEP2020 27/3 1 No O NA R
(25SEP2020) N/N
16-55/
C4591001
1003
10031101 SKIN Dermatitis contact/
Poison Ivy on both legs, both arms,
and both wrists. 2 09SEP2020 23/15 2 No O NA/TC R
(23SEP2020) N/N
VASC Hypertension/
Hypertension 2 16SEP2020 30/C 1 No O NA/TC N N/N
16-55/
C4591001
1003
10031111 MUSC Psoriatic arthropathy/
psoriatic arthritis 2 26SEP2020 38/C 2 Yes NA/TC N Y/N
16-55/
C4591001 METAB Obesity/
obesity 2 03SEP2020 14/C 3 No O NA/TC/TCN RG N/N
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16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
1003
10031125
16-55/
C4591001
1003
10031147 VASC Hypertension/
worsening hypertension 2 SEP2020 7/C 1 No O NA/TC N N/N
REPRO Endometriosis/
endometriosis# 3 29JAN2021 19/C 2 No O NA/TC N N/N
16-55/
C4591001
1003
10031155 GENRL Fatigue/
Mild Fatigue 1 11AUG2020 6/2 1 No O NA R
(12AUG2020) N/N
16-55/
C4591001
1003
10031156 GENRL Pyrexia/
fever 102# 3 30JAN2021 2/2 2 Yes NA R
(31JAN2021) N/N
SKIN Rash/
rash on torso# 3 31JAN2021 3/3 2 Yes NA R
(02FEB2021) N/N
16-55/
C4591001
1003
10031160 INJ&P Contusion/
traumatic bruise left knee 1 10AUG2020 5/6 2 No O NA/TC R
(15AUG2020) N/N
Fall/
fall from bic ycle 1 10AUG2020 5/6 2 No O NA/TC R
(15AUG2020) N/N
PSYCH Anxiety/
Anxiety 2 NOV2020 67/C 2 No O NA/TC N N/N
16-55/
C4591001
1003
10031166 GASTR Diverticulum/
R/O worsening of diverticular
disease# 2 04FEB2021 161/21 2 No O NA R
(24FEB2021) N/N
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FDA-CBER-2022-5812-0221087
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
16-55/
C4591001
1003
10031186 INJ&P Exposure during pregnancy/
Exposure During partner Pregnancy 2 17SEP2020 15/C
No O NA UNK N/N
16-55/
C4591001
1003
10031197 CONG Congenital ureteropelvic junction
obstruction/
Congenital right ureteropelvic
junction obstruction 2 01DEC2020 90/58 3 No O NA/TC/TCN R
(27JAN2021) Y/N
16-55/
C4591001
1003
10031201 IMMUN Hypersensitivity/
Allergy Attack 2 20SEP2020 18/1 1 No O NA/TC R
(20SEP2020) N/N
INFEC Sinusitis/
Sinus Infection 2 22SEP2020 20/4 1 No O NA/TC R
(25SEP2020) N/N
16-55/
C4591001
1003
10031205 EYE Uveitis/
bilateral Uveitis 2 DEC2020 89/C 2 No O NA/TC N N/N
INV Biopsy breast normal/
Left breast lesion biops y benign 2 11JAN2021 130/1 1 No O NA R
(11JAN2021) N/N
16-55/
C4591001
1003
10031206 GASTR Colitis ulcerative/
ulcerative colitis 2 24OCT2020 51/16 3 No O NA R
(08NOV2020) N/N
16-55/
C4591001
1003
10031207 VASC Deep vein thrombosis/
bilateral lower extremity DVT 2 27DEC2020 115/48 3 No O NA/TC R
(12FEB2021) Y/N
CONG Protein S deficiency/
S protein deficienc y 2 28DEC2020 116/C 2 No O NA/TC N N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 97
FDA-CBER-2022-5812-0221088
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
RESP Pulmonary embolism/
pulmonary embolism 2 28DEC2020 116/15 3 No O NA/TC R
(11JAN2021) Y/N
16-55/
C4591001
1005
10051003 MUSC Back pain/
BACK PAIN 2 30SEP2020 32/9 2 No O NA/TC R
(08OCT2020) N/N
16-55/
C4591001
1005
10051024 METAB Decreased appetite/
DECREASED APPETITE 2 01SEP2020 2/1 2 Yes NA R
(01SEP2020) N/N
16-55/
C4591001
1005
10051026 EAR Vertigo positional/
INTERMITTENT POSITIONAL
VERTIGO 1 13AUG2020 3/5 1 Yes NA R
(17AUG2020) N/N
16-55/
C4591001
1005
10051028 MUSC Myalgia/
generalized myalgia# 3 23FEB2021 1/C 2 Yes NA/TC N N/N
16-55/
C4591001
1005
10051054 GENRL Non-cardiac chest pain/
INTERMITTENT NON CARDIAC
CHEST PAIN 2 09SEP2020 6/9 2 No O NA R
(17SEP2020) Y/N
16-55/
C4591001
1005
10051055 GENRL Fatigue/
FATIGUE 1 19AUG2020 7/2 1 Yes NA R
(20AUG2020) N/N
MUSC Myalgia/
MUSCLE PAIN 1 19AUG2020 7/2 1 Yes NA R
(20AUG2020) N/N
16-55/
C4591001 GENRL Chills/
CHILLS 2 03SEP2020 2/1 2 Yes NA R
(03SEP2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 98
FDA-CBER-2022-5812-0221089
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
1005
10051066
16-55/
C4591001
1005
10051071 GENRL Chills/
CHILLS# 4 11FEB2021 2/2 2 Yes NA R
(12FEB2021) N/N
Fatigue/
FATIGUE# 4 11FEB2021 2/2 2 Yes NA R
(12FEB2021) N/N
MUSC Myalgia/
GENERALIZED MYALGIA# 4 11FEB2021 2/2 2 Yes NA R
(12FEB2021) N/N
NERV Headache/
HEADACHE# 4 11FEB2021 2/2 2 Yes NA R
(12FEB2021) N/N
16-55/
C4591001
1005
10051075 GENRL Fatigue/
FATIGUE 2 06SEP2020 3/9 1 Yes NA R
(14SEP2020) N/N
16-55/
C4591001
1005
10051076 GENRL Chills/
CHILLS 2 09SEP2020 1/3 1 Yes NA R
(11SEP2020) N/N
Injection site pain/
INJECTION SITE PAIN 2 09SEP2020 1/3 1 Yes NA R
(11SEP2020) N/N
Malaise/
MALAISE 2 09SEP2020 1/3 1 Yes NA R
(11SEP2020) N/N
MUSC Myalgia/
MYALGIA 2 09SEP2020 1/2 2 Yes NA/TC R
(10SEP2020) N/N
GENRL Pyrexia/
FEVER 100.9 2 10SEP2020 2/1 1 Yes NA R
(10SEP2020) N/N
16-55/
C4591001 GENRL Injection site pain/
PAIN AT INJECTION SITE 1 17AUG2020 1/2 1 Yes NA R
(18AUG2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 99
FDA-CBER-2022-5812-0221090
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
1005
10051077
MUSC Myalgia/
MYALGIA 1 17AUG2020 1/2 1 Yes NA R
(18AUG2020) N/N
16-55/
C4591001
1005
10051081 GENRL Injection site pain/
SORENESS AT INJECTION SITE 1 19AUG2020 1/4 1 Yes NA R
(22AUG2020) N/Y
Injection site warmth/
CALOR AT INJECTION SITE 1 19AUG2020 1/1 1 Yes NA R
(19AUG2020) N/Y
GASTR Diarrhoea/
DIARRHEA 1 20AUG2020 2/2 1 Yes NA R
(21AUG2020) N/N
16-55/
C4591001
1005
10051082 GENRL Injection site pain/
PAIN AT INJECTION SITE 1 20AUG2020 2/2 1 Yes NA R
(21AUG2020) N/N
NERV Depressed level of consciousness/
CLOUDING OF CONCIOUSNESS 1 05SEP2020 18/8 1 No O NA R
(12SEP2020) N/N
16-55/
C4591001
1005
10051084 EYE Conjunctival oedema/
RIGHT EYE CONJUNCTIVA
SWELLING 2 09SEP2020 1/2 2 Yes NA R
(10SEP2020) N/N
Eye irritation/
RIGHT EYE IRRITATION 2 09SEP2020 1/2 2 Yes NA/TC R
(10SEP2020) N/N
Ocular hyperaemia/
RIGHT EYE ERYTHEMA 2 09SEP2020 1/2 2 Yes NA R
(10SEP2020) N/N
GENRL Fatigue/
FATIGUE# 4 13JAN2021 2/1 2 Yes NA R
(13JAN2021) N/N
Pyrexia/
FEVER (101.9F)# 4 13JAN2021 2/1 2 Yes NA/TC R
(13JAN2021) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 100
FDA-CBER-2022-5812-0221091
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
MUSC Myalgia/
GENERALIZED MYALGIA# 4 13JAN2021 2/1 2 Yes NA R
(13JAN2021) N/N
16-55/
C4591001
1005
10051093 NERV Dizziness/
DIZZINESS 2 21SEP2020 12/4 1 No O NA R
(24SEP2020) N/N
Dizziness/
LIGHT HEADED 2 21SEP2020 12/4 1 No O NA R
(24SEP2020) N/N
16-55/
C4591001
1005
10051094 GENRL Injection site pain/
PAIN AT INJECTION SITE# 3 18DEC2020 2/1 1 Yes NA R
(18DEC2020) N/N
16-55/
C4591001
1005
10051100 GENRL Injection site pain/
SORE INJECTION SITE ARM
RADIATING TO NECK 1 21AUG2020 2/2 1 Yes NA R
(22AUG2020) N/N
GENRL Chills/
CHILLS 2 09SEP2020 1/2 1 Yes NA R
(10SEP2020) N/N
Pyrexia/
FEVER 2 09SEP2020 1/2 1 Yes NA R
(10SEP2020) N/N
MUSC Myalgia/
MYALGIA 2 09SEP2020 1/2 1 Yes NA R
(10SEP2020) N/N
16-55/
C4591001
1005
10051105 GENRL Injection site pain/
PAIN AT INJECTION SITE# 3 22DEC2020 2/3 1 Yes NA R
(24DEC2020) N/N
16-55/
C4591001
1005
10051107 GENRL Malaise/
MALAISE 1 22AUG2020 2/1 1 Yes NA R
(22AUG2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 101
FDA-CBER-2022-5812-0221092
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
MUSC Myalgia/
GENERALIZED MYALGIA 1 22AUG2020 2/1 1 Yes NA R
(22AUG2020) N/N
16-55/
C4591001
1005
10051119 GENRL Injection site pain/
PAIN AT INJECTION SITE*
24AUG2020 1/4 1 Yes NA R
(27AUG2020) N/N
16-55/
C4591001
1005
10051123 MUSC Myalgia/
Muscle Aches 2 15SEP2020 2/2 1 Yes NA R
(16SEP2020) N/N
INFEC Urinary tract infection/
URINATRY TRACT INFECTION 2 14OCT2020 31/15 2 No O NA/TC R
(28OCT2020) N/N
16-55/
C4591001
1005
10051125 GENRL Injection site pain/
INJECTION SITE PAIN 1 25AUG2020 2/5 1 Yes NA R
(29AUG2020) N/N
GENRL Chills/
CHILLS 2 17SEP2020 2/1 1 Yes NA R
(17SEP2020) N/N
Fatigue/
FATIGUE 2 17SEP2020 2/1 1 Yes NA R
(17SEP2020) N/N
MUSC Myalgia/
GENERALIZED MYALGIA 2 17SEP2020 2/1 1 Yes NA R
(17SEP2020) N/N
16-55/
C4591001
1005
10051129 GENRL Injection site pain/
INJECTION SITE PAIN 1 24AUG2020 1/5 1 Yes NA R
(28AUG2020) N/N
GENRL Asthenia/
ASTHENIA 1 26AUG2020 3/1 1 Yes NA/TC R
(26AUG2020) N/N
16-55/
C4591001 MUSC Arthralgia/
LEFT SHOULDER PAIN 1 05SEP2020 13/18 2 No O NA/TC R
(22SEP2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 102
FDA-CBER-2022-5812-0221093
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
1005
10051134
16-55/
C4591001
1005
10051135 GENRL Injection site pain/
INJECTION SITE PAIN 1 24AUG2020 1/1 1 Yes NA R
(24AUG2020) N/N
16-55/
C4591001
1005
10051145 GENRL Injection site pain/
INJECTION SITE PAIN 1 26AUG2020 2/2 1 Yes NA R
(27AUG2020) N/N
GASTR Diarrhoea/
DIARRHEA 1 28AUG2020 4/1 1 Yes NA R
(28AUG2020) N/N
RESP Oropharyngeal pain/
SORE THROAT 1 28AUG2020 4/1 1 Yes NA R
(28AUG2020) N/N
GASTR Diarrhoea/
INTERMITTENT DIARRHEA 1 02SEP2020 9/13 1 Yes NA R
(14SEP2020) N/N
GENRL Injection site pain/
INJECTION SITE PAIN 2 14SEP2020 1/2 1 Yes NA R
(15SEP2020) N/N
MUSC Pain in extremity/
RIGHT LEG PAIN 2 14SEP2020 1/2 1 Yes NA R
(15SEP2020) N/N
RESP Oropharyngeal pain/
SORE THROAT 2 14SEP2020 1/1 1 Yes NA R
(14SEP2020) N/N
RESP Oropharyngeal pain/
SORE THROAT 2 19SEP2020 6/1 1 No O NA R
(19SEP2020) N/N
GASTR Diarrhoea/
DIARRHEA 2 20SEP2020 7/1 1 No O NA R
(20SEP2020) N/N
16-55/
C4591001
1005
10051146 GENRL Injection site pain/
INJECTION SITE PAIN 1 25AUG2020 1/2 1 Yes NA/TC R
(26AUG2020) N/Y
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 103
FDA-CBER-2022-5812-0221094
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
MUSC Myalgia/
GENERALIZED MYALGIA 1 26AUG2020 2/2 1 Yes NA R
(27AUG2020) N/N
GASTR Nausea/
NAUSEA 2 15SEP2020 2/2 2 Yes NA R
(16SEP2020) N/N
GENRL Asthenia/
WEAKNESS 2 15SEP2020 2/2 2 Yes NA R
(16SEP2020) N/N
Pyrexia/
FEVER 2 15SEP2020 2/2 1 Yes NA/TC R
(16SEP2020) N/N
MUSC Arthralgia/
GENERALIZED ARTHRALGIA 2 15SEP2020 2/2 2 Yes NA R
(16SEP2020) N/N
Myalgia/
GENERALIZED MYALGIA 2 15SEP2020 2/2 2 Yes NA R
(16SEP2020) N/N
GENRL Chills/
CHILLS 2 16SEP2020 3/1 2 Yes NA R
(16SEP2020) N/N
16-55/
C4591001
1005
10051150 NERV Nerve compression/
PINCHED NERVE IN NECK 2 15SEP2020 2/72 2 Yes NA/TC R
(25NOV2020) N/N
16-55/
C4591001
1005
10051151 GENRL Injection site pain/
INJECTION SITE PAIN 1 27AUG2020 2/3 1 Yes NA R
(29AUG2020) N/N
MUSC Myalgia/
GENERALIZED MYALGIA 1 27AUG2020 2/3 1 Yes NA R
(29AUG2020) N/N
16-55/
C4591001
1005
10051161 GENRL Chills/
CHILLS 2 17SEP2020 1/2 2 Yes NA R
(18SEP2020) N/N
GENRL Fatigue/
FATIGUE 2 18SEP2020 2/1 1 Yes NA R
(18SEP2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 104
FDA-CBER-2022-5812-0221095
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
MUSC Myalgia/
GENERALIZED MYALGIA 2 18SEP2020 2/1 1 Yes NA R
(18SEP2020) N/N
16-55/
C4591001
1005
10051165 GENRL Injection site pain/
INJECTION SITE PAIN 1 27AUG2020 2/1 1 Yes NA R
(27AUG2020) N/N
GASTR Diarrhoea/
DIARRHEA 1 14SEP2020 20/2 1 No O NA R
(15SEP2020) N/N
GENRL Chills/
CHILLS 2 18SEP2020 2/1 1 Yes NA R
(18SEP2020) N/N
Injection site pain/
INJECTION SITE PAIN 2 18SEP2020 2/1 1 Yes NA R
(18SEP2020) N/N
Pyrexia/
FEVER 100.5 2 18SEP2020 2/1 1 Yes NA R
(18SEP2020) N/N
16-55/
C4591001
1005
10051166 INFEC Helicobacter gastritis/
H Pylori gastroenteritis# 3 09JAN2021 19/11 1 No O NA/TC R
(19JAN2021) N/N
GENRL Chills/
CHILLS# 4 12JAN2021 1/2 2 Yes NA R
(13JAN2021) N/N
Pyrexia/
FEVER# 4 12JAN2021 1/2 1 Yes NA R
(13JAN2021) N/N
MUSC Myalgia/
GENERALIZED MYALGIA# 4 12JAN2021 1/2 2 Yes NA R
(13JAN2021) N/N
NERV Headache/
HEADACHE# 4 12JAN2021 1/3 2 Yes NA R
(14JAN2021) N/N
GENRL Chills/
CHILLS# 4 13JAN2021 2/2 1 Yes NA R
(14JAN2021) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 105
FDA-CBER-2022-5812-0221096
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Pyrexia/
FEVER 101.0# 4 13JAN2021 2/2 2 Yes NA R
(14JAN2021) N/N
MUSC Myalgia/
GENERALIZED MYALIGA# 4 13JAN2021 2/2 1 Yes NA R
(14JAN2021) N/N
16-55/
C4591001
1005
10051168 MUSC Costochondritis/
LEFT CHOSTOCHONDRITIS 1 16SEP2020 21/4 1 No O NA/TC R
(19SEP2020) N/N
16-55/
C4591001
1005
10051169 METAB Decreased appetite/
LACK OF APPETITE 1 27AUG2020 1/2 1 Yes NA R
(28AUG2020) N/N
MUSC Musculoskeletal stiffness/
LEFT SHOULDER STIFFNESS 1 27AUG2020 1/3 1 Yes NA R
(29AUG2020) N/N
Musculoskeletal stiffness/
STIFFNESS ON LEFT SIDE OF
NECK 1 27AUG2020 1/3 1 Yes NA R
(29AUG2020) N/N
NERV Dizziness/
LIGHT HEADED 1 27AUG2020 1/2 1 Yes NA R
(28AUG2020) N/N
Headache/
HEADACHE 1 27AUG2020 1/2 1 Yes NA/TC R
(28AUG2020) N/N
NERV Lethargy/
LETHARGY 1 29AUG2020 3/3 2 Yes NA R
(31AUG2020) N/N
16-55/
C4591001
1005
10051170 GENRL Injection site pain/
injection site pain# 4 05FEB2021 1/C 2 Yes NA N N/N
16-55/
C4591001 GASTR Dyspepsia/
HEARTBURN 2 16SEP2020 2/2 2 Yes NA R
(17SEP2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 106
FDA-CBER-2022-5812-0221097
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
1005
10051171
Nausea/
NAUSEA 2 16SEP2020 2/2 1 Yes NA R
(17SEP2020) N/N
NERV Migraine/
WORSENING OF MIGRINES 2 16SEP2020 2/2 2 Yes NA/TC R
(17SEP2020) N/N
16-55/
C4591001
1005
10051175 GENRL Chills/
CHILLS# 4 28JAN2021 1/2 2 Yes NA R
(29JAN2021) N/N
Pyrexia/
FEVER (102.6)# 4 28JAN2021 1/2 2 Yes NA R
(29JAN2021) N/N
MUSC Myalgia/
GENERALIZED MYALGIA# 4 28JAN2021 1/2 2 Yes NA R
(29JAN2021) N/N
16-55/
C4591001
1005
10051178 GENRL Injection site pain/
PAIN AT INJECTION SITE 1 29AUG2020 2/2 1 Yes NA R
(30AUG2020) N/N
IMMUN Allergy to arthropod sting/
BEE STING REACTION 1 11SEP2020 15/5 1 No O NA/TC R
(15SEP2020) N/N
GENRL Chills/
CHILLS 2 19SEP2020 2/1 1 Yes NA R
(19SEP2020) N/N
Fatigue/
FATIGUE 2 19SEP2020 2/2 1 Yes NA R
(20SEP2020) N/N
Injection site pain/
INJECTION SITE PAIN 2 19SEP2020 2/2 1 Yes NA R
(20SEP2020) N/N
Pyrexia/
FEVER 100.4 2 19SEP2020 2/1 1 Yes NA/TC R
(19SEP2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 107
FDA-CBER-2022-5812-0221098
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
MUSC Arthralgia/
GENERALIZED ARTHRALGIA 2 19SEP2020 2/2 2 Yes NA/TC R
(20SEP2020) N/N
Myalgia/
GENERALIZED MYALGIA 2 19SEP2020 2/2 2 Yes NA/TC R
(20SEP2020) N/N
GASTR Vomiting/
EMESIS 2 01OCT2020 14/1 2 No O NA R
(01OCT2020) N/N
16-55/
C4591001
1005
10051179 EYE Eye pain/
STINGING IN EYES 1 28AUG2020 1/1 1 Yes NA R
(28AUG2020) N/N
RESP Cough/
COUGH 1 28AUG2020 1/1 1 Yes NA R
(28AUG2020) N/Y
Throat irritation/
TICKLE IN THROAT 1 28AUG2020 1/1 1 Yes NA R
(28AUG2020) N/Y
Upper-airway cough syndrome/
POST NASAL DRIP 1 28AUG2020 1/1 1 Yes NA R
(28AUG2020) N/N
16-55/
C4591001
1005
10051181 GENRL Injection site pain/
INJECTION SITE PAIN 1 29AUG2020 2/2 1 Yes NA R
(30AUG2020) N/N
GENRL Injection site pain/
INJECTION SITE PAIN 2 19SEP2020 2/2 2 Yes NA R
(20SEP2020) N/N
16-55/
C4591001
1005
10051182 GENRL Fatigue/
EXTREME FATIGUE 1 29AUG2020 2/1 2 Yes NA R
(29AUG2020) N/N
16-55/
C4591001
1005
10051183 GENRL Injection site pain/
INJECTION SITE PAIN 1 31AUG2020 1/7 1 Yes NA R
(06SEP2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 108
FDA-CBER-2022-5812-0221099
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GENRL Pain/
BODY ACHES 1 01SEP2020 2/3 1 Yes NA/TC R
(03SEP2020) N/N
RESP Cough/
COUGH 1 01SEP2020 2/3 1 Yes NA/TC R
(03SEP2020) N/N
Nasal congestion/
NASAL CONGESTION 1 01SEP2020 2/3 1 Yes NA/TC R
(03SEP2020) N/N
GENRL Injection site pain/
INJECTION SITE PAIN 1 23SEP2020 24/6 1 Yes NA R
(28SEP2020) N/N
16-55/
C4591001
1005
10051187 NERV Headache/
HEADACHE 2 21SEP2020 1/2 2 Yes NA R
(22SEP2020) N/N
GENRL Fatigue/
FATIGUE 2 22SEP2020 2/2 2 Yes NA R
(23SEP2020) N/N
16-55/
C4591001
1005
10051188 GENRL Fatigue/
FATIGUE 1 01SEP2020 1/3 2 Yes NA R
(03SEP2020) N/N
Injection site pain/
INJECTION SITE PAIN 1 01SEP2020 1/8 1 Yes NA R
(08SEP2020) N/N
MUSC Myalgia/
MUSCLE ACHES 1 01SEP2020 1/3 1 Yes NA R
(03SEP2020) N/N
GENRL Fatigue/
FATIGUE 2 24SEP2020 1/3 2 Yes NA R
(26SEP2020) N/N
Injection site pain/
INJECTION SITE PAIN 2 24SEP2020 1/8 2 Yes NA R
(01OCT2020) N/N
MUSC Myalgia/
MUSCLE ACHES 2 24SEP2020 1/3 1 Yes NA/TC R
(26SEP2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 109
FDA-CBER-2022-5812-0221100
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
16-55/
C4591001
1005
10051189 GENRL Injection site pain/
injection site pain# 3 24FEB2021 1/2 1 Yes NA R
(25FEB2021) N/N
16-55/
C4591001
1005
10051192 GENRL Injection site pain/
INJECTION SITE PAIN 2 23SEP2020 1/3 2 Yes NA/TC R
(25SEP2020) N/N
GENRL Fatigue/
FATIGUE 2 24SEP2020 2/2 2 Yes NA R
(25SEP2020) N/N
Pain/
BODY ACHES 2 24SEP2020 2/2 2 Yes NA R
(25SEP2020) N/N
16-55/
C4591001
1005
10051198 GENRL Chills/
chills# 4 12MAR2021 1/2 2 Yes NA R
(13MAR2021)N/N
Pyrexia/
fever 102F# 4 12MAR2021 1/2 2 Yes NA/TC R
(13MAR2021)N/N
MUSC Myalgia/
generalized m yalgia# 4 12MAR2021 1/2 2 Yes NA/TC R
(13MAR2021)N/N
16-55/
C4591001
1005
10051199 GENRL Injection site pain/
INJECTION SITE PAIN 1 03SEP2020 1/3 2 Yes NA/TC R
(05SEP2020) N/N
GENRL Injection site pain/
PAIN AT INJECTION SITE 2 24SEP2020 1/3 2 Yes NA/TC R
(26SEP2020) N/N
GENRL Chills/
BODY CHILLS 2 25SEP2020 2/2 2 Yes NA R
(26SEP2020) N/N
16-55/
C4591001 GENRL Injection site pain/
INJECTION SITE PAIN 1 03SEP2020 1/3 1 Yes NA R
(05SEP2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 110
FDA-CBER-2022-5812-0221101
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
1005
10051200
16-55/
C4591001
1005
10051203 GENRL Injection site pain/
INJECTION SITE PAIN 1 03SEP2020 1/4 1 Yes NA R
(06SEP2020) N/N
GASTR Diarrhoea/
LOOSE STOOL 1 04SEP2020 2/3 1 Yes NA R
(06SEP2020) N/N
GENRL Chills/
CHILLS 1 04SEP2020 2/3 1 Yes NA R
(06SEP2020) N/N
Pyrexia/
FEVER 1 04SEP2020 2/3 1 Yes NA R
(06SEP2020) N/N
MUSC Myalgia/
GENERALIZED MYALGIA 1 04SEP2020 2/3 1 Yes NA/TC R
(06SEP2020) N/N
INFEC Gastroenteritis/
GASTROENTERITIS 1 19SEP2020 17/1 2 No O NA R
(19SEP2020) N/N
GENRL Fatigue/
FATIGUE 2 23SEP2020 2/4 1 Yes NA R
(26SEP2020) N/N
Pain/
BODY ACHES 2 23SEP2020 2/4 1 Yes NA R
(26SEP2020) N/N
16-55/
C4591001
1005
10051210 GENRL Fatigue/
FATIGUE 2 23SEP2020 2/2 1 Yes NA R
(24SEP2020) N/N
MUSC Myalgia/
MYALGIA 2 23SEP2020 2/2 1 Yes NA/TC R
(24SEP2020) N/N
NERV Headache/
HEADACHE 2 23SEP2020 2/2 1 Yes NA/TC R
(24SEP2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 111
FDA-CBER-2022-5812-0221102
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
16-55/
C4591001
1005
10051216 GASTR Diarrhoea/
DIARRHEA 2 27SEP2020 4/3 1 Yes NA/TC R
(29SEP2020) N/N
16-55/
C4591001
1005
10051217 GENRL Feeling hot/
overall body CALOR - no fever 1 04SEP2020 2/1 1 Yes NA R
(04SEP2020) N/N
Injection site pain/
PAIN AT INJECTION SITE 1 04SEP2020 2/3 2 Yes NA R
(06SEP2020) N/N
RESP Oropharyngeal pain/
SORE THROAT 1 05SEP2020 3/1 1 Yes NA R
(05SEP2020) N/N
16-55/
C4591001
1005
10051219 GENRL Injection site pain/
INJECTION SITE PAIN 1 04SEP2020 2/2 1 Yes NA R
(05SEP2020) N/N
RENAL Pollakiuria/
INCREASED FREQUENCY OF
URINATION 1 04SEP2020 2/4 1 Yes NA R
(07SEP2020) N/N
16-55/
C4591001
1005
10051220 GENRL Fatigue/
fatigue# 4 09FEB2021 2/1 2 Yes NA R
(09FEB2021) N/N
MUSC Myalgia/
generalized m yalgia# 4 09FEB2021 2/1 2 Yes NA R
(09FEB2021) N/N
16-55/
C4591001
1005
10051221 GENRL Chills/
chills# 4 17FEB2021 1/2 2 Yes NA R
(18FEB2021) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 112
FDA-CBER-2022-5812-0221103
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Pyrexia/
fever# 4 17FEB2021 1/2 2 Yes NA R
(18FEB2021) N/N
MUSC Myalgia/
generalized m yalgia# 4 17FEB2021 1/2 2 Yes NA R
(18FEB2021) N/N
NERV Headache/
headache# 4 17FEB2021 1/2 2 Yes NA R
(18FEB2021) N/N
16-55/
C4591001
1005
10051223 GENRL Injection site pain/
injection site pain 1 13OCT2020 2/4 2 Yes NA/TC R
(16OCT2020) N/N
16-55/
C4591001
1005
10051224 MUSC Myalgia/
GENERALIZED MYALGIAS# 4 29JAN2021 3/1 1 Yes NA R
(29JAN2021) N/N
NERV Headache/
HEADACHE# 4 29JAN2021 3/1 1 Yes NA R
(29JAN2021) N/N
16-55/
C4591001
1005
10051232 INFEC Ear infection/
LEFT EAR INFECTION 1 23OCT2020 12/6 2 No O NA/TC R
(28OCT2020) N/N
16-55/
C4591001
1005
10051236 GENRL Chills/
CHILLS 2 04NOV2020 2/1 1 Yes NA R
(04NOV2020) N/N
16-55/
C4591001
1005
10051241 GENRL Fatigue/
FATIGUE 1 14OCT2020 2/3 1 Yes NA R
(16OCT2020) N/N
Injection site pain/
PAIN AT INJECTION SITE 1 14OCT2020 2/5 1 Yes NA R
(18OCT2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 113
FDA-CBER-2022-5812-0221104
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
MUSC Myalgia/
MYALGIA 1 14OCT2020 2/3 1 Yes NA R
(16OCT2020) N/N
GENRL Fatigue/
FATIGUE 2 03NOV2020 1/3 2 Yes NA R
(05NOV2020) N/N
Injection site pain/
INJECTION SITE PAIN 2 03NOV2020 1/4 2 Yes NA/TC R
(06NOV2020) N/N
MUSC Myalgia/
MYALGIA 2 03NOV2020 1/3 2 Yes NA R
(05NOV2020) N/N
NERV Headache/
HEADACHE 2 03NOV2020 1/3 2 Yes NA R
(05NOV2020) N/N
GENRL Pyrexia/
FEVER 2 04NOV2020 2/2 1 Yes NA/TC R
(05NOV2020) N/N
MUSC Arthralgia/
GENERALIZED ARTHRALGIA 2 05NOV2020 3/8 1 Yes NA R
(12NOV2020) N/N
16-55/
C4591001
1005
10051244 NERV Migraine/
WORSENING OF MIGRAINES 2 07NOV2020 6/1 2 No O NA/TC R
(07NOV2020) N/N
16-55/
C4591001
1005
10051246 GENRL Injection site pain/
INJECTION SITE PAIN 2 02NOV2020 1/2 1 Yes NA R
(03NOV2020) N/N
16-55/
C4591001
1005
10051259 GENRL Injection site pain/
PAIN AT INJECTION SITE 1 15OCT2020 2/2 1 Yes NA/TC R
(16OCT2020) N/N
Malaise/
MALAISE 1 15OCT2020 2/2 1 Yes NA R
(16OCT2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 114
FDA-CBER-2022-5812-0221105
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
MUSC Arthralgia/
SHOULDER ACHING NOT
INJECTION ARM 1 15OCT2020 2/2 1 Yes NA R
(16OCT2020) N/N
Myalgia/
MYALGIA 1 15OCT2020 2/2 1 Yes NA R
(16OCT2020) N/N
16-55/
C4591001
1005
10051264 GENRL Chills/
CHILLS# 3 16DEC2020 1/2 2 Yes NA R
(17DEC2020) N/N
MUSC Myalgia/
GENERALIZED MYALGIA# 3 16DEC2020 1/4 2 Yes NA/TC R
(19DEC2020) N/N
16-55/
C4591001
1005
10051270 GENRL Fatigue/
FATIGUE 1 15OCT2020 1/1 2 Yes NA R
(15OCT2020) N/N
16-55/
C4591001
1005
10051283 GENRL Injection site pain/
INJECTION SITE ARM PAIN 1 17OCT2020 2/4 1 Yes NA R
(20OCT2020) N/N
16-55/
C4591001
1005
10051285 GENRL Injection site pain/
PAIN AT INJECTION SITE 1 16OCT2020 1/5 2 Yes NA R
(20OCT2020) N/Y
GENRL Injection site pain/
PAIN AT INJECTION SITE 2 05NOV2020 1/2 1 Yes NA R
(06NOV2020) N/Y
MUSC Myalgia/
GENERALIZED MYALGIA 2 06NOV2020 2/1 1 Yes NA/TC R
(06NOV2020) N/N
16-55/
C4591001 INFEC Tooth abscess/
RIGHT TOOTH ABSCESS 1 20OCT2020 5/17 2 No O NA/TC R
(05NOV2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 115
FDA-CBER-2022-5812-0221106
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
1005
10051288
16-55/
C4591001
1005
10051290 GENRL Injection site pain/
INJECTION SITE PAIN 2 05NOV2020 2/31 1 Yes NA R
(05DEC2020) N/N
16-55/
C4591001
1005
10051301 GENRL Injection site pain/
PAIN AT INJECTION SITE 1 20OCT2020 2/3 1 Yes NA R
(22OCT2020) N/N
16-55/
C4591001
1005
10051302 GENRL Injection site pain/
MILD ARM PAIN AT INJECTION
SITE 1 19OCT2020 1/2 1 Yes NA R
(20OCT2020) N/N
16-55/
C4591001
1005
10051318 GENRL Pain/
BODY ACHES 1 21OCT2020 2/3 1 Yes NA R
(23OCT2020) N/N
16-55/
C4591001
1005
10051332 GENRL Injection site pain/
PAIN AT INJECTION SITE 1 20OCT2020 1/4 1 Yes NA R
(23OCT2020) N/N
GENRL Chills/
CHILLS 2 11NOV2020 2/1 1 Yes NA R
(11NOV2020) N/N
Pyrexia/
FEVER (101.5) 2 11NOV2020 2/1 2 Yes NA R
(11NOV2020) N/N
MUSC Myalgia/
MYALGIA 2 11NOV2020 2/2 1 Yes NA R
(12NOV2020) N/N
NERV Headache/
HEADACHE 2 11NOV2020 2/2 1 Yes NA R
(12NOV2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 116
FDA-CBER-2022-5812-0221107
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
16-55/
C4591001
1005
10051335 GENRL Injection site pain/
TENDERNESS AT INJECTION
SITE 1 22OCT2020 2/2 1 Yes NA R
(23OCT2020) N/N
16-55/
C4591001
1005
10051340 GASTR Nausea/
NAUSEA 1 21OCT2020 1/2 1 Yes NA R
(22OCT2020) N/N
GENRL Injection site pain/
TENDERNESS AT INJECTION
SITE 1 21OCT2020 1/2 1 Yes NA R
(22OCT2020) N/N
GENRL Fatigue/
FATIGUE 1 22OCT2020 2/1 1 Yes NA R
(22OCT2020) N/N
16-55/
C4591001
1005
10051341 INFEC Groin abscess/
LEFT GROIN ABSCESS 1 12DEC2020 53/20 2 No O NA/TC R
(31DEC2020) N/N
16-55/
C4591001
1005
10051346 GENRL Injection site pain/
PAIN AT INJECTION SITE 1 21OCT2020 1/4 1 Yes NA R
(24OCT2020) N/N
16-55/
C4591001
1005
10051349 GENRL Fatigue/
FATIGUE 1 22OCT2020 1/2 1 Yes NA R
(23OCT2020) N/N
Injection site pain/
PAIN AT INJECTION SITE 1 22OCT2020 1/3 1 Yes NA R
(24OCT2020) N/Y
GENRL Fatigue/
FATIGUE# 4 09FEB2021 2/2 2 Yes NA R
(10FEB2021) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 117
FDA-CBER-2022-5812-0221108
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Pyrexia/
FEVER (102.0)# 4 09FEB2021 2/2 2 Yes NA R
(10FEB2021) N/N
MUSC Myalgia/
GENERALIZED MYALGIA# 4 09FEB2021 2/2 2 Yes NA R
(10FEB2021) N/N
NERV Headache/
HEADACHE# 4 09FEB2021 2/2 2 Yes NA R
(10FEB2021) N/N
16-55/
C4591001
1005
10051350 GENRL Injection site pain/
INJECTION SITE PAIN 1 22OCT2020 1/3 1 Yes NA R
(24OCT2020) N/N
16-55/
C4591001
1005
10051358 GENRL Injection site pain/
INJECTION SITE PAIN# 3 08FEB2021 1/C 1 Yes NA N N/N
MUSC Myalgia/
GENERALIZED MYALGIA# 3 08FEB2021 1/2 1 Yes NA R
(09FEB2021) N/N
16-55/
C4591001
1005
10051361 GENRL Chills/
CHILLS 2 12NOV2020 2/2 2 Yes NA R
(13NOV2020) N/N
Fatigue/
FATIGUE 2 12NOV2020 2/2 2 Yes NA R
(13NOV2020) N/N
NERV Headache/
HEADACHE 2 12NOV2020 2/2 2 Yes NA R
(13NOV2020) N/N
16-55/
C4591001
1005
10051363 GASTR Nausea/
NAUSEA 2 13NOV2020 1/2 1 Yes NA R
(14NOV2020) N/N
MUSC Myalgia/
MYALGIA 2 13NOV2020 1/2 1 Yes NA R
(14NOV2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 118
FDA-CBER-2022-5812-0221109
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
VASC Hot flush/
HOT FLASHES 2 13NOV2020 1/2 1 Yes NA R
(14NOV2020) N/N
MUSC Arthralgia/
GENERALIZED JOINT ACHES 2 01DEC2020 19/9 1 No O NA R
(09DEC2020) N/N
16-55/
C4591001
1005
10051365 GENRL Injection site pain/
BURNING SENSATION AT
INJECTION SITE 1 23OCT2020 1/2 1 Yes NA R
(24OCT2020) N/N
GENRL Injection site pain/
INJECTION SITE PAIN 2 11NOV2020 1/3 1 Yes NA R
(13NOV2020) N/N
16-55/
C4591001
1005
10051366 GENRL Fatigue/
FATIGUE 2 13NOV2020 1/2 1 Yes NA R
(14NOV2020) N/N
Malaise/
MALAISE 2 13NOV2020 1/2 1 Yes NA R
(14NOV2020) N/N
MUSC Myalgia/
MUSCLE ACHES 2 13NOV2020 1/2 1 Yes NA/TC R
(14NOV2020) N/N
NERV Headache/
HEADACHES 2 13NOV2020 1/2 1 Yes NA/TC R
(14NOV2020) N/N
16-55/
C4591001
1005
10051368 MUSC Back pain/
WORSENING OF LOWER BACK
PAIN 1 04NOV2020 13/22 2 No O NA/TC R
(25NOV2020) N/N
NERV Dizziness/
LIGHTHEADED 1 09NOV2020 18/2 2 No O NA R
(10NOV2020) N/N
16-55/
C4591001
1005
10051369 GENRL Injection site pain/
INJECTION SITE PAIN 1 26OCT2020 1/3 1 Yes NA R
(28OCT2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 119
FDA-CBER-2022-5812-0221110
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GENRL Injection site pain/
PAIN AT INJECTION SITE 2 18NOV2020 1/2 1 Yes NA R
(19NOV2020) N/N
16-55/
C4591001
1005
10051378 GENRL Injection site pain/
PAIN AT INJECTION SITE 1 28OCT2020 2/2 1 Yes NA R
(29OCT2020) N/N
NERV Dizziness/
LIGHT HEADED 1 28OCT2020 2/2 1 Yes NA R
(29OCT2020) N/N
NERV Headache/
HEADACHE 2 18NOV2020 2/2 1 Yes NA R
(19NOV2020) N/N
16-55/
C4591001
1005
10051380 GENRL Injection site pain/
INJECTION SITE PAIN# 4 06JAN2021 1/3 2 Yes NA R
(08JAN2021) N/N
NERV Headache/
HEADACHE# 4 06JAN2021 1/5 2 Yes NA R
(10JAN2021) N/N
16-55/
C4591001
1005
10051385 GENRL Injection site pain/
PAIN AT INJECTION SITE 1 28OCT2020 1/3 1 Yes NA R
(30OCT2020) N/N
GENRL Pyrexia/
FEVER 101.4 2 17NOV2020 2/2 2 Yes NA R
(18NOV2020) N/N
MUSC Myalgia/
MYALGIA 2 17NOV2020 2/2 2 Yes NA R
(18NOV2020) N/N
NERV Headache/
WORSENING OF HEADACHE 2 17NOV2020 2/2 2 Yes NA R
(18NOV2020) N/N
16-55/
C4591001
1005
10051386 GENRL Injection site pain/
PAIN AT INJECTION SITE 1 29OCT2020 2/3 1 Yes NA R
(31OCT2020) N/N
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Page 120
FDA-CBER-2022-5812-0221111
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GENRL Malaise/
MALIASE 2 18NOV2020 2/2 1 Yes NA R
(19NOV2020) N/N
NERV Headache/
HEADACHE 2 18NOV2020 2/2 1 Yes NA R
(19NOV2020) N/N
16-55/
C4591001
1005
10051390 GENRL Fatigue/
FATIGUE 1 31OCT2020 2/7 1 Yes NA R
(06NOV2020) N/N
MUSC Myalgia/
MYALGIA 1 31OCT2020 2/7 1 Yes NA R
(06NOV2020) N/N
NERV Headache/
HEADACHE 1 31OCT2020 2/7 1 Yes NA R
(06NOV2020) N/N
16-55/
C4591001
1005
10051393 GENRL Injection site pain/
INJECTION SITE PAIN 1 30OCT2020 1/4 1 Yes NA R
(02NOV2020) N/N
16-55/
C4591001
1005
10051396 GENRL Injection site pain/
INJECTION SITE PAIN 2 23NOV2020 1/34 1 Yes NA R
(26DEC2020) N/N
MUSC Myalgia/
MYALGIA 2 24NOV2020 2/1 2 Yes NA/TC R
(24NOV2020) N/N
16-55/
C4591001
1005
10051398 GENRL Pyrexia/
fever post injection# 3 18FEB2021 1/1 1 Yes NA R
(18FEB2021) N/N
GENRL Injection site pain/
injection site reaction - arm pain# 3 19FEB2021 2/1 1 Yes NA R
(19FEB2021) N/N
GENRL Pyrexia/
fever 101F# 4 12MAR2021 2/1 2 Yes NA/TC R
(12MAR2021)N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 121
FDA-CBER-2022-5812-0221112
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
NERV Headache/
headache# 4 12MAR2021 2/1 2 Yes NA/TC R
(12MAR2021)N/N
16-55/
C4591001
1005
10051400 GENRL Injection site swelling/
INJECTION SITE SWELLING 2 23NOV2020 1/2 1 Yes NA R
(24NOV2020) N/N
16-55/
C4591001
1005
10051411 GASTR Abdominal pain/
ABDOMINAL PAIN 2 29JAN2021 2/4 3 No O NA/TC R
(01FEB2021) Y/N
16-55/
C4591001
1005
10051442 GENRL Fatigue/
FATIGUE 2 14JAN2021 2/3 2 Yes NA R
(16JAN2021) N/N
Injection site pain/
INJECTION SITE PAIN 2 14JAN2021 2/4 1 Yes NA R
(17JAN2021) N/N
Injection site swelling/
INJECTION SITE SWELLING (1
INCH) 2 14JAN2021 2/4 1 Yes NA R
(17JAN2021) N/N
MUSC Arthralgia/
GENERALIZED ARTHRALGIA 2 14JAN2021 2/3 1 Yes NA R
(16JAN2021) N/N
Myalgia/
GENERALIZED MYALGIA 2 14JAN2021 2/3 2 Yes NA R
(16JAN2021) N/N
NERV Headache/
WORSENING OF HEADACHE 2 14JAN2021 2/3 2 Yes NA/TC R
(16JAN2021) N/N
16-55/
C4591001
1006
10061023 INJ&P Bone contusion/
RIGHT HIP BONE CONTUSION 1 28AUG2020 17/8 2 No O NA/TC R
(04SEP2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 122
FDA-CBER-2022-5812-0221113
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
GENRL Fatigue/
Fatigue# 4 05FEB2021 2/1 2 Yes NA R
(05FEB2021) N/N
16-55/
C4591001
1006
10061031 INFEC Oral fungal infection/
ORAL YEAST INFECTION 1 16AUG2020 4/11 2 No O NA/TC R
(26AUG2020) N/N
16-55/
C4591001
1006
10061032 GENRL Chills/
generalized chills 2 05SEP2020 2/2 1 Yes NA R
(06SEP2020) N/N
MUSC Myalgia/
generalized muscle aches 2 05SEP2020 2/2 1 Yes NA R
(06SEP2020) N/N
16-55/
C4591001
1006
10061040 INFEC Pharyngitis streptococcal/
Strep throat 2 08SEP2020 5/11 2 No O NA/TC R
(18SEP2020) N/N
INFEC Clostridium difficile infection/
Clostridium Difficile Infection 2 30SEP2020 27/152 2 No O NA/TC R
(28FEB2021) N/N
GENRL Injection site pain/
Injection Site Pain# 3 18DEC2020 1/3 1 Yes NA R
(20DEC2020) N/N
INJ&P Procedural pain/
Post Surgical Pain# 3 28DEC2020 11/16 3 No O NA/TC R
(12JAN2021) N/N
INJ&P Exposure during pregnancy/
Exposure Durin g Pregnancy# 4 08FEB2021 32/C
No O NA UNK N/N
16-55/
C4591001
1006
10061052 INJ&P Exposure during pregnancy/
Exposure During Partner Pregnancy 2 01JAN2021 116/C
No O NA UNK N/N
16-55/
C4591001 NERV Dizziness/
Lightheadedness 1 18AUG2020 1/9 2 Yes NA R
(26AUG2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 123
FDA-CBER-2022-5812-0221114
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
1006
10061053
16-55/
C4591001
1006
10061056 GASTR Nausea/
Intermittent Nausea# 4 26JAN2021 2/3 1 Yes NA R
(28JAN2021) N/N
MUSC Myalgia/
Generalized Muscle Aches# 4 26JAN2021 2/3 1 Yes NA R
(28JAN2021) N/N
16-55/
C4591001
1006
10061067 GENRL Injection site pain/
Injection site tenderness# 3 23FEB2021 1/2 1 Yes NA R
(24FEB2021) N/N
IMMUN Seasonal allergy/
Worsenin g of seasonal aller gies# 3 01MAR2021 7/C 2 No O NA/TC RG N/N
16-55/
C4591001
1006
10061070 NERV Migraine/
Migraines - Intermittent 1 31AUG2020 13/C 3 No O NA N N/N
16-55/
C4591001
1006
10061074 INJ&P Skin laceration/
Left Index Finger Laceration# 2 02MAR2021 174/C 3 No O NA/TC/TCN N N/N
16-55/
C4591001
1006
10061079 GENRL Chills/
CHILLS 2 16SEP2020 1/2 1 Yes NA R
(17SEP2020) N/N
Pyrexia/
FEVER 2 16SEP2020 1/2 2 Yes NA R
(17SEP2020) N/N
GENRL Pain/
BODY ACHES-GENERALIZED 2 17SEP2020 2/3 2 Yes NA R
(19SEP2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 124
FDA-CBER-2022-5812-0221115
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
16-55/
C4591001
1006
10061088 MUSC Myalgia/
Generalized Muscle Aches# 3 05FEB2021 1/2 3 Yes NA/TC R
(06FEB2021) N/N
NERV Headache/
Headache# 3 05FEB2021 1/2 3 Yes NA/TC R
(06FEB2021) N/N
16-55/
C4591001
1006
10061089 CARD Tachycardia/
Tachycardia 2 10SEP2020 1/2 2 Yes NA R
(11SEP2020) N/N
16-55/
C4591001
1006
10061090 MUSC Back pain/
BACK ACHE 2 11SEP2020 1/1 1 Yes NA R
(11SEP2020) N/N
16-55/
C4591001
1006
10061093 NERV Paraesthesia/
FACIAL TINGLING 1 24AUG2020 1/1 1 Yes NA R
(24AUG2020) N/N
SKIN Rash/
CHEST RASH (8 cm) 1 24AUG2020 1/1 1 Yes NA R
(24AUG2020) N/N
GENRL Injection site pain/
INJECTION SITE PAIN 2 19SEP2020 2/2 1 Yes NA R
(20SEP2020) N/N
Pain/
GENERALIZED ACHES 2 19SEP2020 2/2 1 Yes NA R
(20SEP2020) N/N
Pyrexia/
FEVER 2 19SEP2020 2/2 2 Yes NA/TC R
(20SEP2020) N/N
16-55/
C4591001
1006
10061094 GENRL Injection site pain/
INJECTION SITE PAIN 2 19SEP2020 2/2 1 Yes NA R
(20SEP2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 125
FDA-CBER-2022-5812-0221116
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
Pain/
GENERALIZED ACHES 2 19SEP2020 2/2 1 Yes NA R
(20SEP2020) N/N
Pyrexia/
FEVER 2 19SEP2020 2/2 2 Yes NA/TC R
(20SEP2020) N/N
INJ&P Exposure during pregnancy/
Exposure Durin g Pregnancy 2 15NOV2020 59/C
No O NA UNK N/N
16-55/
C4591001
1006
10061095 GASTR Vomiting/
Vomiting# 3 21JAN2021 2/1 2 Yes NA/TC R
(21JAN2021) N/N
16-55/
C4591001
1006
10061099 INFEC Urinary tract infection/
Urinary Tract Infection# 3 23FEB2021 8/8 1 No O NA/TC R
(02MAR2021)N/N
16-55/
C4591001
1006
10061112 GENRL Chills/
Chills 2 16SEP2020 1/2 2 Yes NA/TC R
(17SEP2020) N/N
MUSC Myalgia/
mUSCLE aCHES 2 16SEP2020 1/2 2 Yes NA/TC R
(17SEP2020) N/N
16-55/
C4591001
1006
10061134 SKIN Dermatitis/
DERMATITIS-FACIAL 2 01OCT2020 10/62 2 No O NA/TC R
(01DEC2020) N/N
16-55/
C4591001
1006
10061137 GASTR Nausea/
Nausea 1 02SEP2020 2/1 1 Yes NA R
(02SEP2020) N/N
GENRL Pain/
Body aches 1 02SEP2020 2/1 3 Yes NA/TC R
(02SEP2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 126
FDA-CBER-2022-5812-0221117
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
16-55/
C4591001
1006
10061144 NERV Headache/
Headache 1 22SEP2020 20/2 1 No O NA/TC R
(23SEP2020) N/N
16-55/
C4591001
1006
10061151 NERV Headache/
Headache 2 05NOV2020 23/1 2 No O NA/TC R
(05NOV2020) N/N
16-55/
C4591001
1006
10061153 PSYCH Attention deficit hyperactivity
disorder/
Attention Deficit Hyperactive
Disorder 2 02NOV2020 22/C 2 No O NA N N/N
16-55/
C4591001
1006
10061160 GASTR Diarrhoea/
DIARRHEA 1 27SEP2020 3/3 2 Yes NA/TC R
(29SEP2020) N/N
Vomiting/
VOMITING 1 27SEP2020 3/3 2 Yes NA/TC R
(29SEP2020) N/N
NERV Headache/
HEADACHE 1 27SEP2020 3/3 2 Yes NA R
(29SEP2020) N/N
16-55/
C4591001
1006
10061161 INJ&P Maternal exposure before
pregnancy/
Maternal Exposure before
Pregnancy 2 28DEC2020 73/C
No O NA UNK N/N
16-55/
C4591001
1006
10061163 SKIN Urticaria/
hives left forearm 2 15NOV2020 32/6 1 No O NA R
(20NOV2020) N/N
INFEC Urinary tract infection/
URINARY TRACT INFECTION 2 26JAN2021 104/4 2 No O NA/TC R
(29JAN2021) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 127
FDA-CBER-2022-5812-0221118
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
16-55/
C4591001
1006
10061165 GENRL Pain/
Generalized Body Aches 2 16OCT2020 2/2 2 Yes NA R
(17OCT2020) N/N
Pyrexia/
Fever 2 16OCT2020 2/2 2 Yes NA R
(17OCT2020) N/N
16-55/
C4591001
1006
10061166 GENRL Chills/
CHILLS 1 27SEP2020 3/2 2 Yes NA R
(28SEP2020) N/N
GENRL Pain/
Body Aches 2 16OCT2020 2/3 2 Yes NA R
(18OCT2020) N/N
16-55/
C4591001
1006
10061170 MUSC Arthralgia/
Bilateral Ankle Joint Pain 2 28OCT2020 1/5 2 Yes NA/TC R
(01NOV2020) N/N
Neck pain/
Pain at base of nec k 2 28OCT2020 1/5 2 Yes NA/TC R
(01NOV2020) N/N
16-55/
C4591001
1006
10061176 RESP Asthma/
Acute Asthma Exacerbation# 2 03FEB2021 77/8 3 No O NA/TC R
(10FEB2021) Y/N
16-55/
C4591001
1006
10061194 INFEC Otitis externa/
Otitis Externa Left 2 15JAN2021 24/13 3 No O NA/TC/TCN R
(27JAN2021) N/N
INJ&P Mouth injury/
Oral laceration# 2 15FEB2021 55/10 1 No O NA/TC/TCN R
(24FEB2021) N/N
16-55/
C4591001 NERV Headache/
Headache 2 22DEC2020 1/2 1 Yes NA R
(23DEC2020) N/N
090177e196ac917a\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 128
FDA-CBER-2022-5812-0221119
16.2.7.4.1.2 Listing of Adverse Events – Phase 2/3 Subjects 16-55 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)bToxicity
Grade Vax
RelcCause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
1006
10061202
16-55/
C4591001
1006
10061204 GENRL Injection site bruising/
1 MM BRUISING AT INJECTION
SITE LEFT DELTOID 2 22DEC2020 1/25 1 Yes NA R
(15JAN2021) N/Y
16-55/
C4591001
1006
10061205 INJ&P Foot fracture/
Left Great Toe Fracture 2 29JAN2021 37/C 2 No O NA/TC RG N/N
16-55/
C4591001
1006
10061208 GENRL Pain/
Body Aches 2 24DEC2020 2/1 1 Yes NA/TC R
(24DEC2020) N/N
NERV Headache/
Headache 2 24DEC2020 2/1 1 Yes NA/TC R
(24DEC2020) N/N
RESP Oropharyngeal pain/
Sore Throa t 2 24DEC2020 2/1 1 Yes NA/TC R
(24DEC2020) N/N
16-55/
C4591001
1006
…[truncated]