1 Moderna Clinical Study Report 16.2.7 Adverse Event Listing May 2021 11505 Pages

ModernaTX, Inc.
mRNA-1273
Clinical Study Report mRNA-1273-P301
16.2.7 Adverse Event Listings (Each Participant)

Listing 16.2.7.7 Unsolicited Severe TEAE Safety Set
Listing 16.2.7.8 Unsolicited Treatment-Related Severe TEAE Safety Set
Listing 16.2.7.10 Serious Treatment-Related Adverse Events Safety Set
Listing 16.2.7.11 Unsolicited Adverse Events Leading to Discontinuation from Study

Vaccine Safety Set
Listing 16.2.7.12 Unsolicited Adverse Events Leading to Discontinuation from Participation

in the Study Safety Set
Listing 16.2.7.13 Unsolicited Medically-Attended Adverse Events Safety Set
Listing 16.2.7.14 Unsolicited Adverse Events Leading to Death Safety Set
Listing 16.2.7.18 Unsolicited Adverse Events - Vasculitis Safety Set
Listing 16.2.7.20 Unsolicited Adverse Events - Arthritis Safety Set
Listing 16.2.7.21 Unsolicited Adverse Events - Angioedema Safety Set
Listing 16.2.7.22 Unsolicited Adverse Events - Peripheral Neuropathy Safety Set
Listing 16.2.7.23 Unsolicited Adverse Events - Demyelinating Disease of Central Nervous

System Safety Set
Listing 16.2.7.24 Unsolicited Adverse Events - Convulsions Safety Set
Listing 16.2.7.25 Solicited Local Adverse Reactions Persisting Beyond 7 Days After Any
Injection Safety Set
Listing 16.2.7.27 Unsolicited Adverse Events in Participants Who Died Safety Set
Listing 16.2.7.28 Unsolicited Adverse Events - Anaphylaxis Safety Set
Listing 16.2.7.30 Unsolicited Adverse Events - Autoimmune Disorder Safety Set
Listing 16.2.7.31 Local Adverse Reaction with Onset Date after Day 7 of Any Injection
Safety Set
Listing 16.2.7.32 Systemic Adverse Reaction with Onset Date after Day 7 of Any Injection
Safety Set
Listing 16.2.7.33 Unsolicited Adverse Events - Central Nervous System Vascular Disorders
Safety Set
FDA-CBER-2022-908-0001963
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ModernaTX, Inc. mRNA-1273
Clinical Study Report mRNA-1273-P301
Listing 16.2.7.34 Unsolicited Adverse Events - Dermal Filler Reaction Post Vaccination
Safety Set
Listing 16.2.7.35 Unsolicited Adverse Events - Bell's Palsy Safety Set
Listing 16.2.12 Death Listing Safety Set
FDA-CBER-2022-908-0001964
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ModernaTX, Inc. Page 1 of 674
mRNA-1273-P301 BLA (Data Extraction Date: 04MAY2021)
Listing 16.2.7.7
Unsolicited Severe TEAE
Safety Set
Treatment Group: Placebo
Start Date and Time TEAE/ Action Taken

System Organ Class/ (Relative Day)/ MAAE/ Relation- with IP/
Preferred Term/ End Date and Time Solicited Sev. SAE/ ship to Other Action
Verbatim (Relative Day) AR [1] Criteria [2] IP/SP [3] Taken Outcome
Subject ID: US3002046; Age (years): 60; Sex: F; Race: WHITE; Height (cm): 167.0; Weight (kg): 88.1; BMI (kg/m2): 31.6; Baseline
SARS-CoV-2 Status: Negative; Baseline RT-PCR: Negative; Baseline Elecsys SARS-CoV-2 Nucleocapsid bAb: Negative; Dose 1
Date/Time: 29JUL2020:14:40:00; Follow-up Days after 1st Dose: 101; Dose 2 Date/Time: ; Follow-up Days after 2nd Dose: NA
Injury, poisoning and 2020-08-12 Yes/ 3 Yes/3 NR/ DRUG RECOVERED/

procedural complications/ (15)/ Yes/ (2020-08-12/ NR WITHDRAWN/ RESOLVED
Hip fracture/ 2020-08-14 No ) CONCOMITANT
LEFT HIP FRACTURE (17) PROCEDURE
Subject ID: US3002273; Age (years): 38; Sex: F; Race: ASIAN; Height (cm): 155.0; Weight (kg): 139.1; BMI (kg/m2): 57.9; Baseline
Date/Time: 09SEP2020:15:12:00; Follow-up Days after 1st Dose: 199; Dose 2 Date/Time:
09OCT2020:09:47:00; Follow-up Days after 2nd Dose: 169
Reproductive system and 2020-11-26 Yes/ 3 No NR/ NOT RECOVERED/
breast disorders/ (49)/ Yes/ NR APPLICABLE/ RESOLVED
Menorrhagia/ 2021-02-08 No CONCOMITANT
MENORRHAGIA (123) MEDICATION,
CONCOMITANT
PROCEDURE
Note: Footnotes are listed on the last page.

Program Path: \\wilbtia\wilbtia01\Moderna MODMRNA1273P301_U\BLA\TLF\l16020707.sas 30JUN2021 09:54
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Listing 16.2.7.7
Safety Set

Date/Time: 13AUG2020:16:27:00; Follow-up Days after 1st Dose: 226; Dose 2 Date/Time:
10SEP2020:11:11:00; Follow-up Days after 2nd Dose: 198
Nervous system disorders/ 2020-12-11 Yes/ 3 Yes/3 NR/ NOT RECOVERED/
Cerebrovascular accident/ (93)/ Yes/ (2020-12-11/ NR APPLICABLE/ RESOLVED
STROKE 2020-12-11 No 2020-12-13) CONCOMITANT
(93) MEDICATION
Subject ID: US3012195; Age (years): 52; Sex: M; Race: WHITE; Height (cm): 190.5; Weight (kg): 110.7; BMI (kg/m2): 30.5; Baseline
Respiratory, thoracic 2020-10-08 Yes/ 3 No NR/ NOT RECOVERED/
and mediastinal (22)/ Yes/ NR APPLICABLE/ RESOLVED
disorders/ 2020-10-11 No NONE
Cough/ (25)
COUGH

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Listing 16.2.7.7
Safety Set

Injury, poisoning and 2020-11-09 Yes/ 3 No NR/ NOT NOT RECOVERED/
procedural complications/ (41)/ Yes/ NR APPLICABLE/ NOT RESOLVED
Rib fracture/ Ongoing No CONCOMITANT
COMPOUND FRACTURE, T4 MEDICATION
AND T3 RIBS, SECONDARY
TO GUNSHOT WOUND
Skin and subcutaneous 2020-11-09 Yes/ 3 No NR/ NOT RECOVERED/

tissue disorders/ (41)/ Yes/ NR APPLICABLE/ RESOLVED
Subcutaneous emphysema/ 2020-11-15 No CONCOMITANT
SUBCUTANEOUS EMPHYSEMA (47) MEDICATION
DUE TO GUNSHOT WOUND

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Listing 16.2.7.7
Safety Set

Date/Time: 29JUL2020:09:41:00; Follow-up Days after 1st Dose: 241; Dose 2 Date/Time:
Infections and 2020-10-22 Yes/ 3 No NR/ NOT RECOVERED/
infestations/ (51)/ Yes/ NR APPLICABLE/ RESOLVED
Suspected COVID-19/ 2020-11-09 No CONCOMITANT
POSSIBLE COVID INFECTION (69) MEDICATION
Nervous system disorders/ 2020-09-23 Yes/ 3 No NR/ NOT RECOVERED/
Carpal tunnel syndrome/ (14)/ Yes/ NR APPLICABLE/ RESOLVED
CARPAL TUNNEL SURGERY 2020-09-23 No CONCOMITANT
LEFT HAND (14) PROCEDURE

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Listing 16.2.7.7
Safety Set

Gastrointestinal 2020-10-16 Yes/ 3 No NR/ NOT RECOVERED/
disorders/ (23)/ Yes/ NR APPLICABLE/ RESOLVED
Gastrointestinal 2020-10-16 No CONCOMITANT
haemorrhage/ (23) MEDICATION,
GASTROINTESTINAL CONCOMITANT
HEMORRHAGE PROCEDURE
disorders/ 2021-02-11 No CONCOMITANT
Rhinalgia/ (142) MEDICATION
RIGHT NOSTRIL PAIN

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Listing 16.2.7.7
Safety Set

Neoplasms benign, 2021-01-14 Yes/ 3 Yes/3 NR/ NOT RECOVERED/
malignant and (113)/ Yes/ (2021-01-14/ NR APPLICABLE/ RESOLVED
unspecified (incl cysts 2021-01-14 No 2021-01-25) CONCOMITANT
and polyps)/ (113) PROCEDURE
Non-small cell lung
cancer/
NON- SMALL CELL
CARCINOMA OF THE LUNG
COVID-19/ 2020-12-01 No CONCOMITANT
COVID-19 (85) MEDICATION

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Listing 16.2.7.7
Safety Set

Subject ID: US3032112; Age (years): 30; Sex: F; Race: WHITE; Height (cm): ; Weight (kg): ; BMI (kg/m2): ; Baseline SARS-CoV-2
Status: Negative; Baseline RT-PCR: Negative; Baseline Elecsys SARS-CoV-2 Nucleocapsid bAb: Negative; Dose 1 Date/Time:
05AUG2020:20:44:00; Follow-up Days after 1st Dose: 234; Dose 2 Date/Time: 03SEP2020:09:07:00; Follow-up
Days after 2nd Dose: 205
Congenital, familial and 2020-08-11 Yes/ 3 Yes/5 NR/ NOT NOT RECOVERED/
genetic disorders/ (7)/ Yes/ NR APPLICABLE/ NOT RESOLVED
Talipes/ Ongoing No NONE
BILATERAL TALIPES
EQUINOVIRUS OF FETUS
Infections and 2020-11-30 Yes/ 3 Yes/3 NR/ NOT RECOVERED/
infestations/ (84)/ Yes/ (2020-12-03/ NR APPLICABLE/ RESOLVED
COVID-19/ 2020-12-09 No 2020-12-07) CONCOMITANT
COVID 19 (93) MEDICATION

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Listing 16.2.7.7
Safety Set

Metabolism and nutrition 2020-12-03 Yes/ 3 Yes/3 NR/ NOT RECOVERED/
disorders/ (87)/ Yes/ (2020-12-03/ NR APPLICABLE/ RESOLVED
Type 2 diabetes mellitus/ 2021-02-10 No 2020-12-07) CONCOMITANT
DIABETES MELLITUS TYPE 2 (156) MEDICATION
Neoplasms benign, 2020-12-29 Yes/ 3 Yes/6 NR/ NOT RECOVERING/
malignant and (103)/ Yes/ NR APPLICABLE/ RESOLVING
unspecified (incl cysts Ongoing No CONCOMITANT
and polyps)/ PROCEDURE
Endometrial cancer/
ENDOMETRIAL CANCER

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Listing 16.2.7.7
Safety Set

Cardiac disorders/ 2020-12-07 Yes/ 3 Yes/3 NR/ NOT RECOVERED/
Atrioventricular block (77)/ Yes/ (2020-12-07/ NR APPLICABLE/ RESOLVED
second degree/ 2021-01-08 No 2020-12-12) CONCOMITANT
SECOND DEGREE MOBITZ II (109) MEDICATION,
AV BLOCK, INTERMITTENT CONCOMITANT
PROCEDURE
Arachnoid cyst/ (49)/ Yes/ (2020-11-03/ NR APPLICABLE/ RESOLVED
GROWING/WORSENING OF 2020-11-03 No 2020-11-06) CONCOMITANT
ARACHNOID CYST ON LUMBAR (51) MEDICATION,
SPINE CONCOMITANT
PROCEDURE

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Listing 16.2.7.7
Safety Set

General disorders and 2020-09-16 Yes/ 3 No NR/ NOT RECOVERED/
administration site (26)/ No/ NA APPLICABLE/ RESOLVED
conditions/ 2020-09-29 Yes NONE
Pain/ (39)
SEVERE BODY ACHES
Musculoskeletal and 2020-09-16 Yes/ 3 No NR/ NOT RECOVERED/

connective tissue (26)/ No/ NA APPLICABLE/ RESOLVED
disorders/ 2020-09-29 Yes NONE
Myalgia/ (39)
SEVERE MUSCLE ACHES

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Listing 16.2.7.7
Safety Set

Subject ID: US3052044; Age (years): 64; Sex: M; Race: NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER; Height (cm): 175.3; Weight
(kg): 97.3; BMI (kg/m2): 31.7; Baseline SARS-CoV-2 Status: Negative; Baseline RT-PCR: Negative; Baseline Elecsys SARS-CoV-2
Nucleocapsid bAb: Negative; Dose 1 Date/Time: 31JUL2020:11:59:00; Follow-up Days after 1st Dose:
239; Dose 2 Date/Time: 26AUG2020:11:42:00; Follow-up Days after 2nd Dose: 213
Respiratory, thoracic 2020-12-06 Yes/ 3 Yes/2/3 NR/ DOSE NOT RECOVERED/
and mediastinal (103)/ Yes/ (2020-12-06/ NR CHANGED/ RESOLVED
disorders/ 2020-12-10 No 2020-12-10) CONCOMITANT
Chronic obstructive (107) MEDICATION
pulmonary disease/
COPD EXACERBATION
Injury, poisoning and 2020-08-29 Yes/ 3 No NA/ NOT RECOVERED/
procedural complications/ (18)/ Yes/ NA APPLICABLE/ RESOLVED
Joint dislocation/ 2020-08-30 No CONCOMITANT
DISLOCATED RIGHT (19) MEDICATION
SHOULDER INJURY

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Listing 16.2.7.7
Safety Set

malignant and (36)/ Yes/ NR APPLICABLE/ RESOLVED
unspecified (incl cysts 2021-04-14 No CONCOMITANT
and polyps)/ (210) MEDICATION,
Thyroid cancer/ CONCOMITANT
THYROID CANCER PROCEDURE
Nervous system disorders/ 2020-09-24 14:08 Yes/ 3 Yes/3 NR/ NOT RECOVERED/
Syncope/ (2)/ Yes/ (2020-09-24/ NR APPLICABLE/ RESOLVED
SYNCOPE 2020-09-25 10:18 No 2020-09-26) NONE
(2)

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Listing 16.2.7.7
Safety Set

Nervous system disorders/ 2020-08-28 18:13 Yes/ 3 No R/ DOSE NOT RECOVERED/
Headache/ (1)/ No/ R CHANGED/ RESOLVED
HEADACHE 2020-09-02 21:48 Yes NONE
(6)
COVID-19/ 2020-12-18 No 2020-12-18)/4 CONCOMITANT

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Listing 16.2.7.7
Safety Set

Blood and lymphatic 2020-12-09 Yes/ 3 Yes/3 NA/ NOT RECOVERED/
system disorders/ (76)/ Yes/ (2020-12-09/ NA APPLICABLE/ RESOLVED
Thrombocytosis/ 2020-12-18 No 2020-12-18) NONE
THROMBOCYTOSIS (85)
Infections and 2020-12-09 Yes/ 3 Yes/2/3 NA/ NOT RECOVERED/

infestations/ (76)/ Yes/ (2020-12-09/ NA APPLICABLE/ RESOLVED
COVID-19 pneumonia/ 2020-12-18 No 2020-12-18) CONCOMITANT
BILATERAL PNEUMONIA DUE (85) MEDICATION
TO COVID-19

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Listing 16.2.7.7
Safety Set

Respiratory, thoracic 2020-12-09 Yes/ 3 Yes/2/3 NA/ NOT RECOVERED/
and mediastinal (76)/ Yes/ (2020-12-09/ NA APPLICABLE/ RESOLVED
Acute respiratory (85) MEDICATION
failure/
ACUTE RESPIRATORY
FAILURE WITH HYPOXIA
Subject ID: US3052374; Age (years): 54; Sex: F; Race: BLACK OR AFRICAN AMERICAN; Height (cm): 165.0; Weight (kg): 72.7;
BMI (kg/m2): 26.7; Baseline SARS-CoV-2 Status: Negative; Baseline RT-PCR: Negative; Baseline Elecsys SARS-CoV-2 Nucleocapsid
bAb: Negative; Dose 1 Date/Time: 04SEP2020:09:52:00; Follow-up Days after 1st Dose: 204; Dose 2
Date/Time: 07OCT2020:09:50:00; Follow-up Days after 2nd Dose: 171
General disorders and 2020-10-07 17:00 Yes/ 3 No R/ DOSE NOT RECOVERED/
administration site (1)/ No/ NR CHANGED/ RESOLVED
conditions/ 2020-10-22 23:59 Yes NONE
Fatigue/ (16)
FATIGUE

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Listing 16.2.7.7
Safety Set

Musculoskeletal and 2020-10-07 17:00 Yes/ 3 No R/ DOSE NOT RECOVERED/
connective tissue (1)/ No/ NR CHANGED/ RESOLVED
disorders/ 2020-10-22 23:59 Yes NONE
Arthralgia/ (16)
JOINT ACHES IN SEVERAL
JOINTS

Myalgia/ (16)
MUSCLE ACHES ALL OVER

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Listing 16.2.7.7
Safety Set

Musculoskeletal and 2020-09-15 Yes/ 3 Yes/3 NR/ DOSE NOT RECOVERED/
connective tissue (8)/ Yes/ (2021-02-18/ NR CHANGED/ RESOLVED
Intervertebral disc (164) PROCEDURE
protrusion/
HERNEATED DISKS
Injury, poisoning and 2020-08-22 Yes/ 3 No NR/ DOSE NOT RECOVERED/
procedural complications/ (6)/ Yes/ NR CHANGED/ RESOLVED
Ligament sprain/ 2020-09-09 No CONCOMITANT
BACK SPRAIN (24) MEDICATION

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Listing 16.2.7.7
Safety Set

Neoplasms benign, 2020-08-21 Yes/ 3 No NR/ DOSE NOT RECOVERED/
malignant and (4)/ Yes/ NR CHANGED/ RESOLVED
Malignant melanoma/
MELANOMA ON RIGHT CALF
Investigations/ 2020-08-31 15:52 Yes/ 3 No NR/ DOSE NOT RECOVERED/
Blood pressure increased/ (1)/ No/ NR CHANGED/ RESOLVED
ELEVATED BLOOD PRESSURE 2020-09-03 10:44 No CONCOMITANT
[POST-DOSE] (3) MEDICATION

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Listing 16.2.7.7
Safety Set

Vascular disorders/ 2020-09-01 13:55 Yes/ 3 No NR/ DOSE NOT NOT RECOVERED/
Hypertension/ (1)/ No/ NR CHANGED/ NOT RESOLVED
WORSENING OF Ongoing No NONE
HYPERTENSION (POST-DOSE)
Subject ID: US3092021; Age (years): 65; Sex: M; Race: BLACK OR AFRICAN AMERICAN; Height (cm): 187.9; Weight (kg): 132.3;
bAb: Negative; Dose 1 Date/Time: 05AUG2020:13:23:00; Follow-up Days after 1st Dose: 234; Dose
2 Date/Time: 02SEP2020:15:13:00; Follow-up Days after 2nd Dose: 206
Respiratory, thoracic 2020-11-15 Yes/ 3 Yes/3 NR/ NOT RECOVERED/
and mediastinal (75)/ Yes/ (2020-11-15/ NR APPLICABLE/ RESOLVED
disorders/ 2020-11-17 No 2020-11-17) NONE
Chronic obstructive (77)
pulmonary disease/
COPD EXACEBRATION

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Listing 16.2.7.7
Safety Set

pulmonary disease/
COPD EXACERBATION
Infections and 2021-01-12 Yes/ 3 No NR/ NOT RECOVERING/
infestations/ (127)/ Yes/ NR APPLICABLE/ RESOLVING
Sinusitis/ Ongoing No CONCOMITANT
SINUS INFECTION MEDICATION

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Listing 16.2.7.7
Safety Set

Nerve compression/ (61)/ Yes/ (2020-10-26/ NR APPLICABLE/ RESOLVED WITH
PINCHED NERVE SECONDARY 2020-10-28 No 2020-10-30) CONCOMITANT SEQUELAE:
TO SURGICAL COMPLICATION (63) MEDICATION, DIMINISHED
CONCOMITANT BILATERAL GRIP
PROCEDURE STRENGTH
Infections and 2020-08-27 Yes/ 3 No NR/ DOSE NOT RECOVERED/
infestations/ (18)/ Yes/ NR CHANGED/ RESOLVED
Viral infection/ 2020-08-29 No NONE
VIRAL ILLNESS (20)

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Listing 16.2.7.7
Safety Set

Injury, poisoning and 2020-08-24 Yes/ 3 No NR/ NOT RECOVERED/
procedural complications/ (15)/ Yes/ NR APPLICABLE/ RESOLVED
Procedural pain/ 2020-09-21 No CONCOMITANT
PAIN SECONDARY TO SPINAL (43) MEDICATION
FUSION
Cardiac disorders/ 2020-12-30 Yes/ 3 No NR/ DOSE NOT RECOVERED/
Atrial fibrillation/ (111)/ Yes/ NR CHANGED/ RESOLVED
WORSENING SYMPTOMS OF 2021-02-23 No CONCOMITANT
ATRIAL FIBRILLATION (166) PROCEDURE

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Listing 16.2.7.7
Safety Set

Infections and 2020-09-01 Yes/ 3 Yes/3 NR/ DOSE RECOVERED/
infestations/ (20)/ Yes/ (2020-09-02/ NR DELAYED/ RESOLVED
Pharyngitis 2020-09-14 No 2020-09-03) CONCOMITANT
streptococcal/ (33) MEDICATION
STREP-PHARYNGITIS
Injury, poisoning and 2020-09-19 Yes/ 3 No NR/ DOSE NOT RECOVERING/
procedural complications/ (10)/ Yes/ NR CHANGED/ RESOLVING
Muscle rupture/ Ongoing No CONCOMITANT
RIGHT UPPER ARM MUSCLE MEDICATION
TEAR

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Listing 16.2.7.7
Safety Set

Procedural haemorrhage/ 2020-10-06 No CONCOMITANT
BLEEDING FROM SURGICAL (22) MEDICATION
SITE
Hand fracture/ 2020-11-29 No CONCOMITANT
RIGHT 5TH METACARPAL (76) PROCEDURE
FRACTURE

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Listing 16.2.7.7
Safety Set

Cellulitis/ 2020-12-06 No CONCOMITANT
CELLULITIS LOWER LEFT (77) MEDICATION
EXTREMITY
Gastrointestinal 2020-10-05 Yes/ 3 No NR/ DOSE NOT RECOVERED/
disorders/ (13)/ No/ NR CHANGED/ RESOLVED
Diarrhoea/ 2020-10-07 No NONE
DIARRHEA (15)

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Listing 16.2.7.7
Safety Set

bAb: Negative; Dose 1 Date/Time: 28JUL2020:13:04:00; Follow-up Days after 1st Dose: 242; Dose 2
Date/Time: 25AUG2020:12:03:00; Follow-up Days after 2nd Dose: 214
Musculoskeletal and 2020-09-14 Yes/ 3 No NR/ DOSE NOT RECOVERED/
connective tissue (21)/ Yes/ NR CHANGED/ RESOLVED
Back pain/ (26) MEDICATION
BACK PAIN
26AUG2020:16:35:00; Follow-up Days after 2nd Dose: 213
Diverticulitis/ 2021-01-13 No 2021-01-13) NONE
DIVERTICULITIS (141)

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Listing 16.2.7.7
Safety Set

Nervous system disorders/ 2020-10-02 Yes/ 3 No NR/ DOSE NOT RECOVERED/
Headache/ (38)/ No/ NR CHANGED/ RESOLVED
HEADACHES 2020-10-04 Yes CONCOMITANT
(40) MEDICATION
Date/Time: 09OCT2020:09:46:00; Follow-up Days after 1st Dose: 169; Dose 2 Date/Time:
10NOV2020:11:50:00; Follow-up Days after 2nd Dose: 137
Musculoskeletal and 2020-12-28 Yes/ 3 Yes/3 NR/ NOT RECOVERED/
connective tissue (49)/ Yes/ (2021-03-14/ NR APPLICABLE/ RESOLVED WITH
disorders/ 2021-03-14 No 2021-03-19) CONCOMITANT SEQUELAE:
Spinal osteoarthritis/ (125) MEDICATION, PAIN
EXACERBATION OF CONCOMITANT
DEGENERATIVE JOINT PROCEDURE
DISEASE LUMBAR SPINE

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Listing 16.2.7.7
Safety Set

Subject ID: US3142007; Age (years): 60; Sex: F; Race: MULTIPLE: White, American Indian or Alaska Native; Height (cm): 175.3;
Weight (kg): 77.4; BMI (kg/m2): 25.2; Baseline SARS-CoV-2 Status: Negative; Baseline RT-PCR: Negative; Baseline Elecsys
SARS-CoV-2 Nucleocapsid bAb: Negative; Dose 1 Date/Time: 30JUL2020:12:50:00; Follow-up Days after 1st
Dose: 240; Dose 2 Date/Time: 28AUG2020:09:03:00; Follow-up Days after 2nd Dose: 211
infestations/ (24)/ No/ NR CHANGED/ RESOLVED
Tooth abscess/ 2020-08-24 No CONCOMITANT
TOOTH ABSCESS (26) MEDICATION,
CONCOMITANT
PROCEDURE
COVID-19 INFECTION (71) MEDICATION

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Listing 16.2.7.7
Safety Set

Investigations/ 2020-07-28 18:44 Yes/ 3 No R/ DOSE NOT RECOVERED/
Blood pressure increased/ (1)/ Yes/ NR CHANGED/ RESOLVED
ELEVATED BLOOD PRESSURE 2020-07-29 15:00 No NONE
(1)
Injury, poisoning and 2020-11-03 Yes/ 3 Yes/3 NR/ NOT RECOVERED/
procedural complications/ (54)/ Yes/ (2020-11-03/ NR APPLICABLE/ RESOLVED
Sternal fracture/ 2021-03-12 No 2020-11-05) NONE
NON-DISPLACED CLOSED (183)
FRACTURE LOWER STERNUM

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Listing 16.2.7.7
Safety Set

and mediastinal (11)/ Yes/ NR APPLICABLE/ RESOLVED WITH
disorders/ 2020-10-16 No CONCOMITANT SEQUELAE:
Pulmonary embolism/ (36) MEDICATION CONDITION IS
BILATERAL PULMONARY STABLE AND
EMBOLISM ONGOING BUT
PATIENT MUST
TAKE XARELTO
FOR PE
PROPHYLAXIS.

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Listing 16.2.7.7
Safety Set

Pulmonary infarction/ (36) MEDICATION XARELTO FOR
BILATERAL PULMONARY PROPHYLAXSIS
INFARCTS
SARS-CoV-2 Status: Positive; Baseline RT-PCR: Negative; Baseline Elecsys SARS-CoV-2 Nucleocapsid bAb: Positive; Dose 1
Metabolism and nutrition 2020-09-26 00:00 Yes/ 3 No NR/ DOSE NOT RECOVERED/
disorders/ (1)/ Yes/ NR CHANGED/ RESOLVED
Dehydration/ 2020-09-29 00:00 No CONCOMITANT
DEHYDRATION (4) MEDICATION

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Listing 16.2.7.7
Safety Set

SARS-CoV-2 Nucleocapsid bAb: Negative; Dose 1 Date/Time: 09SEP2020:11:40:00; Follow-up Days after 1st
Dose: 106; Dose 2 Date/Time: 08OCT2020:09:03:00; Follow-up Days after 2nd Dose: 77
Musculoskeletal and 2020-11-05 Yes/ 3 No NR/ DOSE NOT NOT RECOVERED/
connective tissue (29)/ Yes/ NR CHANGED/ NOT RESOLVED
disorders/ Ongoing No CONCOMITANT
Undifferentiated MEDICATION
connective tissue
disease/
UNDIFFERENTIATED
CONNECTIVE TISSUE
DISEASE

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Listing 16.2.7.7
Safety Set

Subject ID: US3152523; Age (years): 71; Sex: M; Race: ASIAN; Height (cm): 165.0; Weight (kg): 69.6; BMI (kg/m2): 25.6; Baseline
SYMPTOMATIC COVID-19 (86) MEDICATION
Dizziness/ (79)/ Yes/ NR APPLICABLE/ RESOLVED
LIGHTHEADEDNESS 2020-11-11 No CONCOMITANT
(80) MEDICATION

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Listing 16.2.7.7
Safety Set

connective tissue (5)/ Yes/ NR APPLICABLE/ RESOLVED
disorders/ 2021-02-08 Yes CONCOMITANT
Arthralgia/ (165) MEDICATION
WORSENING OF LEFT HIP
PAIN

Osteoarthritis/ (165) PROCEDURE
OSTEOARTHRITIS OF LEFT
HIP

FDA-CBER-2022-908-0001998
36
Listing 16.2.7.7
Safety Set

Procedural pain/ Ongoing No CONCOMITANT
PAIN FROM LEFT HIP MEDICATION
REPLACEMENT
Foreign body/ 2020-11-04 No CONCOMITANT
WOODEN FOREIGN BODY LEFT (65) MEDICATION,
SOLE CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0001999
37
Listing 16.2.7.7
Safety Set

Tonsillitis/ 2021-02-25 No CONCOMITANT
WORSENING OF RECURRENT (136) PROCEDURE
TONSILLITIS

Sleep apnoea syndrome/ (136) PROCEDURE
WORSENING OF OBSTRUCTIVE
SLEEP APNEA

FDA-CBER-2022-908-0002000
38
Listing 16.2.7.7
Safety Set

Metabolism and nutrition 2020-12-08 Yes/ 3 No NR/ NOT RECOVERED/
Hypomagnesaemia/ 2020-12-10 No CONCOMITANT
HYPOMAGNESEMIA (94) MEDICATION

Type 2 diabetes mellitus/ 2020-12-10 No CONCOMITANT
WORSENING OF DIABETES (94) MEDICATION
TYPE 2

FDA-CBER-2022-908-0002001
39
Listing 16.2.7.7
Safety Set

Vitamin B1 deficiency/ 2020-12-10 No CONCOMITANT
THIAMINE DEFICIENCY (94) MEDICATION
Vascular disorders/ 2020-12-08 Yes/ 3 No NR/ NOT RECOVERED/

Hypertension/ (92)/ Yes/ NR APPLICABLE/ RESOLVED
WORSENING OF 2020-12-10 No CONCOMITANT
HYPERTENSION (94) MEDICATION

FDA-CBER-2022-908-0002002
40
Listing 16.2.7.7
Safety Set

Paroxysmal arrhythmia/ (92)/ Yes/ (2020-12-08/ NR APPLICABLE/ RESOLVED
CARDIAC ARRHYTHMIA 2020-12-11 No 2020-12-12) CONCOMITANT
PAROXYSMAL (95) MEDICATION,
CONCOMITANT
PROCEDURE
Date/Time: 11AUG2020:12:05:00; Follow-up Days after 1st Dose: 228; Dose 2 Date/Time: ; Follow-up Days after 2nd Dose: NA
Renal and urinary 2020-08-29 Yes/ 3 No NR/ NOT NOT RECOVERED/

disorders/ (19)/ Yes/ NR APPLICABLE/ NOT RESOLVED
Nephrolithiasis/ Ongoing No CONCOMITANT
RIGHT KIDNEY MEDICATION,
NEPHROLITHIASIS CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002003
41
Listing 16.2.7.7
Safety Set

Renal and urinary 2020-08-29 Yes/ 3 No NR/ NOT RECOVERED/

Renal colic/ 2020-08-30 No NONE
ACUTE RENAL COLIC (20)

Pyelonephritis/ 2020-09-26 No CONCOMITANT
UPDATE FOR ORIGINAL SAE. (47) MEDICATION,
SECOND HOSPITALIZATION CONCOMITANT
DUE TO UNRESOLVED RIGHT PROCEDURE
KIDNEY PYELONEPHRITIS

FDA-CBER-2022-908-0002004
42
Listing 16.2.7.7
Safety Set

Cardiac disorders/ 2020-09-07 Yes/ 3 Yes/3 NR/ DOSE NOT RECOVERED/

Acute left ventricular (21)/ Yes/ (2020-09-07/ NR CHANGED/ RESOLVED
failure/ 2020-09-15 No 2020-09-15) CONCOMITANT
ACUTE EXACERBATION OF (29) MEDICATION
SYSTOLIC HEART FAILURE

Atrial fibrillation/ (21)/ Yes/ (2020-09-07/ NR CHANGED/ RESOLVED
ATRIAL FIBRILATION WITH 2020-09-15 No 2020-09-15) CONCOMITANT
RAPID VENTRICULAR RATE (29) MEDICATION

FDA-CBER-2022-908-0002005
43
Listing 16.2.7.7
Safety Set

General disorders and 2020-09-07 Yes/ 3 Yes/3 NR/ DRUG RECOVERED/

administration site (21)/ Yes/ (2020-09-07/ NR WITHDRAWN/ RESOLVED
conditions/ 2020-09-15 No 2020-09-15) NONE
Non-cardiac chest pain/ (29)
NON CARDIAC CHEST PAIN
Rib fracture/ 2021-03-01 No 2021-01-27) CONCOMITANT
RIGHT RIB CAGE MULTIPLE (167) MEDICATION,
FRACTURES CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002006
44
Listing 16.2.7.7
Safety Set

Cardiac failure (24)/ Yes/ (2020-09-12/ NR APPLICABLE/ RESOLVED
congestive/ 2020-09-16 No 2020-09-16) CONCOMITANT
ACUTE EXACERBATION OF (28) MEDICATION,
CONGESTION HEART FAILURE CONCOMITANT
PROCEDURE

CHRONIC CONGESTIVE HEART
FAILURE

FDA-CBER-2022-908-0002007
45
Listing 16.2.7.7
Safety Set

disorders/ 2020-11-12 No ) CONCOMITANT
Chronic obstructive (50) MEDICATION,
pulmonary disease/ CONCOMITANT
WORSENING OF CHRONIC PROCEDURE
OBSTRUCTIVE PULMONARY
DISEASE

FDA-CBER-2022-908-0002008
46
Listing 16.2.7.7
Safety Set


FDA-CBER-2022-908-0002009
47
Listing 16.2.7.7
Safety Set

and mediastinal (79)/ No/ NR APPLICABLE/ RESOLVED
Epistaxis/ (79)
EPISTAXIS (SECONDARY TO
NASAL SURGERY)

FDA-CBER-2022-908-0002010
48
Listing 16.2.7.7
Safety Set

Rotator cuff syndrome/ (29) MEDICATION,
LEFT ROTATOR CUFF TEAR CONCOMITANT
PROCEDURE
Cardiac disorders/ 2020-10-06 Yes/ 3 No NR/ NOT RECOVERED/

Bradycardia/ (29)/ Yes/ NR APPLICABLE/ RESOLVED
BRADYCARDIA 2020-10-06 No NONE
(29)

FDA-CBER-2022-908-0002011
49
Listing 16.2.7.7
Safety Set

Syncope/ (47)/ Yes/ NR APPLICABLE/ RESOLVED
SYNCOPE 2020-10-24 No NONE
(47)
connective tissue (131)/ Yes/ (2021-01-18/ NR APPLICABLE/ RESOLVED
WORSENING OF LEFT KNEE
OSTEOARTHRITIS

FDA-CBER-2022-908-0002012
50
Listing 16.2.7.7
Safety Set

Gastroenteritis/ 2020-11-10 No NONE
GASTROENTERITIS (60)

FDA-CBER-2022-908-0002013
51
Listing 16.2.7.7
Safety Set

Neoplasms benign, 2021-01-26 Yes/ 3 No NR/ NOT NOT RECOVERED/
malignant and (123)/ Yes/ NR APPLICABLE/ NOT RESOLVED
and polyps)/ MEDICATION
Hepatic cancer/
LIVER CANCER
Subject ID: US3192734; Age (years): 58; Sex: F; Race: BLACK OR AFRICAN AMERICAN; Height (cm): ; Weight (kg): ; BMI (kg/m2):
; Baseline SARS-CoV-2 Status: Negative; Baseline RT-PCR: Negative; Baseline Elecsys SARS-CoV-2 Nucleocapsid bAb: Negative;
Dose 1 Date/Time: 04OCT2020:14:09:00; Follow-up Days after 1st Dose: 174; Dose 2 Date/Time:
Hypoxia/ (24) MEDICATION
HYPOXIA DUE TO RLL
PNEUMONIA

FDA-CBER-2022-908-0002014
52
Listing 16.2.7.7
Safety Set

Infections and 2020-11-21 Yes/ 3 Yes/3 NR/ DOSE NOT RECOVERED/
infestations/ (20)/ Yes/ (2020-11-18/ NR CHANGED/ RESOLVED
Coccidioidomycosis/ 2020-12-02 No 2020-11-25) CONCOMITANT
VALLEY FEVER (31) MEDICATION

FDA-CBER-2022-908-0002015
53
Listing 16.2.7.7
Safety Set

bAb: Negative; Dose 1 Date/Time: 09AUG2020:09:40:00; Follow-up Days after 1st Dose: 230; Dose 2
Date/Time: 18SEP2020:14:32:00; Follow-up Days after 2nd Dose: 190
Renal and urinary 2021-01-15 Yes/ 3 Yes/3 NR/ NOT RECOVERED/
Acute kidney injury/ 2021-01-26 No 2021-02-09) CONCOMITANT
ACUTE RENAL FAILURE (131) PROCEDURE
UNSPECIFIED

Acute respiratory (135) MEDICATION,
failure/ CONCOMITANT
ACUTE HYPOXIC PROCEDURE
RESPIRATORY FAILURE

FDA-CBER-2022-908-0002016
54
Listing 16.2.7.7
Safety Set

Pneumonia/ 2021-02-05 No 2021-02-09) CONCOMITANT
PNEUMONIA (141) MEDICATION

Ileus paralytic/ 2021-02-09 No NONE
ADYNAMIC ILEUS (145)

FDA-CBER-2022-908-0002017
55
Listing 16.2.7.7
Safety Set

Gastrointestinal 2021-01-15 Yes/ 3 Yes/3 NR/ NOT RECOVERED/
Pancreatitis/ 2021-02-09 No 2021-02-09) CONCOMITANT
PANCREATITIS (145) MEDICATION,
CONCOMITANT
PROCEDURE

Sepsis/ 2021-02-09 No 2021-02-09) CONCOMITANT
SEPSIS (145) MEDICATION

FDA-CBER-2022-908-0002018
56
Listing 16.2.7.7
Safety Set

Diabetic ketoacidosis/ 2021-02-09 No 2021-02-09) CONCOMITANT
DIABETIC KETOACIDOSIS (145) MEDICATION
Reproductive system and 2020-12-01 Yes/ 3 Yes/3 NR/ NOT RECOVERED/
breast disorders/ (68)/ Yes/ (2020-12-17/ NR APPLICABLE/ RESOLVED
Benign prostatic 2020-12-18 No 2020-12-18) CONCOMITANT
hyperplasia/ (85) MEDICATION,
WORSENING OF ENLARGED CONCOMITANT
PROSTATE (BENIGN PROCEDURE
PROSTATIC HYPERPLASIA)

FDA-CBER-2022-908-0002019
57
Listing 16.2.7.7
Safety Set

Skin laceration/ 2021-01-14 No CONCOMITANT
LACERATIONS TO BOTH (112) MEDICATION
HANDS
COVID 19 (PNEUMONIA) (109) MEDICATION

FDA-CBER-2022-908-0002020
58
Listing 16.2.7.7
Safety Set

Vascular disorders/ 2020-08-06 15:33 Yes/ 3 No R/ DOSE NOT RECOVERED/

Hypertension/ (1)/ Yes/ NR CHANGED/ RESOLVED
HYPERTENSION 2020-08-07 16:03 No NONE
(2)
Vascular disorders/ 2020-08-07 12:51 Yes/ 3 No R/ DOSE NOT RECOVERING/

Hypertension/ (1)/ Yes/ NR CHANGED/ RESOLVING
HYPERTENSION - Ongoing No NONE
EXACERBATION

FDA-CBER-2022-908-0002021
59
Listing 16.2.7.7
Safety Set

Cardiac disorders/ 2020-09-03 Yes/ 3 Yes/3 NR/ DOSE RECOVERED/
Atrial fibrillation/ (27)/ Yes/ (2020-09-03/ NR DELAYED/ RESOLVED
NEW ONSET-ATRIAL 2020-09-05 No 2020-09-05)/6 CONCOMITANT
FIBRILLATION (29) MEDICATION
Psychiatric disorders/ 2020-10-02 Yes/ 3 Yes/3 NR/ NOT NOT RECOVERED/
Alcoholism/ (15)/ Yes/ (2020-10-10/ NR APPLICABLE/ NOT RESOLVED
CHRONIC ALCOHOLIC Ongoing No 2020-10-30)/6 CONCOMITANT
RELAPSE PROCEDURE

FDA-CBER-2022-908-0002022
60
Listing 16.2.7.7
Safety Set

Encephalopathy/ (15)/ Yes/ (2020-10-02/ NR APPLICABLE/ RESOLVED
ENCEPHALOPATHY 2020-10-03 No 2020-10-03) CONCOMITANT
(16) MEDICATION
Neoplasms benign, 2020-10-01 Yes/ 3 No NR/ NOT RECOVERED/
Thyroid cancer recurrent/
THYROID CANCER RELAPSE

FDA-CBER-2022-908-0002023
61
Listing 16.2.7.7
Safety Set

administration site (15)/ Yes/ NR APPLICABLE/ RESOLVED WITH
conditions/ 2020-11-10 No CONCOMITANT SEQUELAE:
Gait disturbance/ (27) PROCEDURE NO BILATERAL
GAIT DYSFUNCTION AND FEET CONTROL,
ADL'S AND SELF-CARE RIGHT SIDE OF
DEFICITS BODY
PARALYSIS.

FDA-CBER-2022-908-0002024
62
Listing 16.2.7.7
Safety Set

Aphasia/ (15)/ Yes/ NR APPLICABLE/ RESOLVED WITH
MILD EXPRESSIVE AND 2020-11-10 No CONCOMITANT SEQUELAE:
RECEPTIVE APHASIA. (27) PROCEDURE RESIDUAL
EFFECTS FROM
CVA

Hypertension/ (15)/ Yes/ NR APPLICABLE/ RESOLVED WITH
HYPERTENSION 2020-11-10 No CONCOMITANT SEQUELAE:
(27) MEDICATION ALTHOUGH NOW
TREATED WITH
MEDICATION
WILL CONTINUE
WITH DIAGNOSIS

FDA-CBER-2022-908-0002025
63
Listing 16.2.7.7
Safety Set

disorders/ (15)/ Yes/ NR APPLICABLE/ RESOLVED WITH
Dyslipidaemia/ 2020-11-15 No CONCOMITANT SEQUELAE:
DYSLIPIDEMIA (32) MEDICATION THIS HAS BEEN
TREATED WITH
MEDICATION
HOWEVER WILL
NEVER RESOLVE
WITHOUT
MEDICATION.

FDA-CBER-2022-908-0002026
64
Listing 16.2.7.7
Safety Set

Nervous system disorders/ 2021-01-12 Yes/ 3 No NR/ DOSE NOT RECOVERING/
Neuralgia/ (90)/ Yes/ NA CHANGED/ RESOLVING
NERVE PAIN SECONDARY TO Ongoing No CONCOMITANT
STROKE MEDICATION
Nervous system disorders/ 2020-09-29 Yes/ 3 No R/ DOSE NOT RECOVERED/
HEADACHE - WORSENING OF 2020-10-05 Yes CONCOMITANT
ONGOING CONDITION. (10) MEDICATION

FDA-CBER-2022-908-0002027
65
Listing 16.2.7.7
Safety Set

COVID-19 POSITIVE (97) MEDICATION

FDA-CBER-2022-908-0002028
66
Listing 16.2.7.7
Safety Set

complete/ 2021-01-19 No 2021-01-19) CONCOMITANT
COMPLETE HEART BLOCKAGE (128) PROCEDURE

SYNCOPE 2021-01-19 No 2021-01-19) CONCOMITANT
(128) MEDICATION

FDA-CBER-2022-908-0002029
67
Listing 16.2.7.7
Safety Set

General disorders and 2020-10-01 Yes/ 3 No R/ DOSE NOT RECOVERED/
administration site (7)/ No/ R CHANGED/ RESOLVED
Injection site (10)
induration/
SWELLING/HARDNESS AT
INJECTION SITE
Subject ID: US3232137; Age (years): 21; Sex: F; Race: OTHER: MIDDLE EASTERN; Height (cm): 154.0; Weight (kg): 60.1; BMI
(kg/m2): 25.3; Baseline SARS-CoV-2 Status: Negative; Baseline RT-PCR: Negative; Baseline Elecsys SARS-CoV-2 Nucleocapsid
COVID-19/ 2021-02-09 No NONE
COVID POSITIVE (134)

FDA-CBER-2022-908-0002030
68
Listing 16.2.7.7
Safety Set

Ankle fracture/ 2021-03-31 No 2020-11-05) CONCOMITANT
TRIMALLEOLAR ANKLE (202) MEDICATION,
FRACTURE, RIGHT CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002031
69
Listing 16.2.7.7
Safety Set

CELLULITIS, LOWER LEFT (23) MEDICATION
LEG
Vascular disorders/ 2020-09-19 Yes/ 3 No NR/ DOSE NOT RECOVERED/

Phlebitis/ (9)/ Yes/ NR CHANGED/ RESOLVED
PHIEBITIS 2020-10-03 No CONCOMITANT
(23) MEDICATION

FDA-CBER-2022-908-0002032
70
Listing 16.2.7.7
Safety Set

Squamous cell carcinoma/ CONCOMITANT
SQUAMOUS CELL CARCINOMA, PROCEDURE
LOWER LEG, LEFT

FDA-CBER-2022-908-0002033
71
Listing 16.2.7.7
Safety Set

Foot fracture/ 2021-03-01 No CONCOMITANT
BROKEN RIGHT FOOT (160) PROCEDURE
Diverticulitis/ 2020-10-02 No CONCOMITANT
DIVERTICULITIS (36) MEDICATION

FDA-CBER-2022-908-0002034
72
Listing 16.2.7.7
Safety Set

Infections and 2020-09-15 Yes/ 3 No NR/ DRUG RECOVERED/

infestations/ (16)/ Yes/ NR WITHDRAWN/ RESOLVED
Pneumonia/ 2020-10-22 No CONCOMITANT
COMMUNITY ACQUIRED (53) MEDICATION
PNEUMONIA
Respiratory, thoracic 2020-10-05 Yes/ 3 No NR/ DOSE RECOVERED/

and mediastinal (36)/ Yes/ NR DELAYED/ RESOLVED
Asthma/ (53) MEDICATION
ASTHMA EXACERBATION

FDA-CBER-2022-908-0002035
73
Listing 16.2.7.7
Safety Set

Facial bones fracture/ 2020-11-30 No CONCOMITANT
BROKEN NOSE (64) PROCEDURE

Skin laceration/ 2020-11-30 No 2020-11-22) CONCOMITANT
HEAD LACERATION (64) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002036
74
Listing 16.2.7.7
Safety Set

DENTAL ABSCESS (19) MEDICATION
General disorders and 2020-11-23 Yes/ 3 No NR/ DOSE NOT RECOVERED/
administration site (43)/ Yes/ NR CHANGED/ RESOLVED
conditions/ 2020-11-23 No NONE
Chest discomfort/ (43)
CHEST PRESSURE

FDA-CBER-2022-908-0002037
75
Listing 16.2.7.7
Safety Set

Upper respiratory tract 2020-10-25 No NONE
infection/ (27)
UPPER RESPIRATORY
INFECTION


FDA-CBER-2022-908-0002038
76
Listing 16.2.7.7
Safety Set

Date/Time: 24SEP2020:16:06:00; Follow-up Days after 1st Dose: 184; Dose 2 Date/Time: ; Follow-up Days after 2nd Dose: NA
Hepatobiliary disorders/ 2020-10-23 Yes/ 3 Yes/3 NR/ DRUG RECOVERED/

Cholecystitis acute/ (30)/ Yes/ (2020-10-23/ NR WITHDRAWN/ RESOLVED
ACUTE CHOLECYSTITIS 2020-11-04 No 2020-11-04) CONCOMITANT
(42) MEDICATION,
CONCOMITANT
PROCEDURE
Infections and 2020-10-23 Yes/ 3 Yes/2/3 NR/ DRUG RECOVERED/

infestations/ (30)/ Yes/ (2020-10-23/ NR WITHDRAWN/ RESOLVED
Septic shock/ 2020-11-04 No 2020-11-04) NONE
SEPTIC SHOCK (42)

FDA-CBER-2022-908-0002039
77
Listing 16.2.7.7
Safety Set

Appendicitis/ 2020-11-06 No 2020-11-07) CONCOMITANT
APPENDICITIS (8) PROCEDURE
SYMPTOMATIC RT-PCR (116) MEDICATION
CONFORMED COVID19
INFECTION

FDA-CBER-2022-908-0002040
78
Listing 16.2.7.7
Safety Set


Psychiatric disorders/ 2020-11-19 Yes/ 3 No NR/ NOT RECOVERED/
Anxiety/ (73)/ Yes/ NR APPLICABLE/ RESOLVED
ANXIETY 2021-02-11 No CONCOMITANT
(157) MEDICATION

FDA-CBER-2022-908-0002041
79
Listing 16.2.7.7
Safety Set

administration site (74)/ Yes/ NR APPLICABLE/ RESOLVED
conditions/ 2021-02-11 Yes CONCOMITANT
Pain/ (157) MEDICATION
PAIN, GENERALIZED
Vascular disorders/ 2020-12-02 Yes/ 3 No NR/ NOT RECOVERING/

Hypertension/ (86)/ Yes/ NR APPLICABLE/ RESOLVING
HYPERTENSION Ongoing No CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0002042
80
Listing 16.2.7.7
Safety Set

Epistaxis/ (107) MEDICATION,
RIGHT-SIDED EPISTAXIS CONCOMITANT
PROCEDURE
Nervous system disorders/ 2021-01-10 Yes/ 3 No NR/ NOT RECOVERING/

Paraesthesia/ (125)/ Yes/ NR APPLICABLE/ RESOLVING
LEFT LOWER LEG Ongoing No CONCOMITANT
PARESTHESIA MEDICATION

FDA-CBER-2022-908-0002043
81
Listing 16.2.7.7
Safety Set

Nervous system disorders/ 2021-01-10 Yes/ 3 No NR/ NOT NOT RECOVERED/
Paraesthesia/ (125)/ Yes/ NR APPLICABLE/ NOT RESOLVED
PARESTHESIA OF SKIN, Ongoing No CONCOMITANT
RIGHT HAND, THIRD, MEDICATION
FOURTH, FIFTH FINGER
Vascular disorders/ 2020-11-04 Yes/ 3 No NR/ NOT NOT RECOVERED/
Thrombophlebitis (64)/ Yes/ NR APPLICABLE/ NOT RESOLVED
superficial/ Ongoing No CONCOMITANT
SUPERFICIAL MEDICATION
THROMBOPHLEBITIS, RIGHT
LEG

FDA-CBER-2022-908-0002044
82
Listing 16.2.7.7
Safety Set

Musculoskeletal chest (119) MEDICATION
pain/
WORSENING INTERMITTENT
CHEST WALL PAIN NON
CARDIAC

FDA-CBER-2022-908-0002045
83
Listing 16.2.7.7
Safety Set

Lactic acidosis/ 2021-01-07 No CONCOMITANT
LACTIC ACIDOSIS (126) MEDICATION,
CONCOMITANT
PROCEDURE
Anosmia/ (102)/ Yes/ NR APPLICABLE/ RESOLVED
LOSS OF SMELL 2020-12-31 No NONE
(119)

FDA-CBER-2022-908-0002046
84
Listing 16.2.7.7
Safety Set

Headache/ (102)/ Yes/ NR APPLICABLE/ RESOLVED
HEADACHE 2020-12-31 Yes CONCOMITANT
(119) MEDICATION

Nasal congestion/ (119) MEDICATION
NASAL CONGESTION

FDA-CBER-2022-908-0002047
85
Listing 16.2.7.7
Safety Set

Oropharyngeal pain/ (119) MEDICATION
SORE THROAT

Rhinorrhoea/ (119)
RHINORRHEA

FDA-CBER-2022-908-0002048
86
Listing 16.2.7.7
Safety Set

Shift work disorder/ (50)/ Yes/ NR APPLICABLE/ RESOLVING
WORSENING OF SHIFT WORK Ongoing No CONCOMITANT
SLEEP DISORDER MEDICATION
Gastrointestinal 2020-12-01 Yes/ 3 No NR/ DOSE NOT RECOVERING/
disorders/ (78)/ Yes/ NR CHANGED/ RESOLVING
Gastric ulcer/ Ongoing No CONCOMITANT
STOMACH ULCER MEDICATION

FDA-CBER-2022-908-0002049
87
Listing 16.2.7.7
Safety Set

(75) MEDICATION

Fatigue/ (73)
FATIGUE

FDA-CBER-2022-908-0002050
88
Listing 16.2.7.7
Safety Set

HYPOXIA

FDA-CBER-2022-908-0002051
89
Listing 16.2.7.7
Safety Set

Vascular disorders/ 2021-02-01 Yes/ 3 No NR/ DOSE NOT RECOVERING/
Varicose vein/ (130)/ Yes/ NR CHANGED/ RESOLVING
VARICOSE VEINES Ongoing No CONCOMITANT
WORSENING PROCEDURE

FDA-CBER-2022-908-0002052
90
Listing 16.2.7.7
Safety Set

Infections and 2021-02-16 Yes/ 3 No NR/ DOSE RECOVERED/
infestations/ (147)/ Yes/ NR DELAYED/ RESOLVED
LEFT NARE CELLULITIS (161) MEDICATION

Staphylococcal infection/ 2021-03-02 No CONCOMITANT
METHICILLIN RESISTANT (161) MEDICATION
STAPHYLOCOCCUS AUREUS,
LEFT NARE

FDA-CBER-2022-908-0002053
91
Listing 16.2.7.7
Safety Set

Endocrine disorders/ 2020-09-04 Yes/ 3 No NR/ DOSE NOT RECOVERING/
Hypothyroidism/ (13)/ Yes/ NR CHANGED/ RESOLVING
WORSENING OF Ongoing No CONCOMITANT
HYPOTHYROIDISM MEDICATION
COVID-19/ 2020-11-09 No NONE
COVID 19 (46)

FDA-CBER-2022-908-0002054
92
Listing 16.2.7.7
Safety Set

COVID-19/ 2021-01-13 No NONE
COVID-19 (112)
Gastrointestinal / Yes/ 3 No NR/ DOSE NOT NOT RECOVERED/
disorders/ Ongoing Yes/ NR CHANGED/ NOT RESOLVED
Abdominal pain/ No NONE
ABDOMINAL PAIN, LEFT,
RIGHT

FDA-CBER-2022-908-0002055
93
Listing 16.2.7.7
Safety Set

Myalgia/ (13) MEDICATION
MUSCLE ACHES, MULTIPLE
SITES

FDA-CBER-2022-908-0002056
94
Listing 16.2.7.7
Safety Set

Ligament injury/ Ongoing No NONE
C6-C7 LIGAMENTOUS INJURY

Limb injury/ Ongoing No CONCOMITANT
BLUNT INJURY TO RLE PROCEDURE

FDA-CBER-2022-908-0002057
95
Listing 16.2.7.7
Safety Set

Road traffic accident/ 2020-11-25 No 2020-12-04) CONCOMITANT
MOTOR VEHICLE ACCIDENT (79) MEDICATION
Reproductive system and 2020-11-25 Yes/ 3 No NR/ DOSE NOT RECOVERED/

breast disorders/ (79)/ Yes/ NR CHANGED/ RESOLVED
Prostatomegaly/ 2021-01-01 No NONE
SEVER PROSTATOMEGALY (116)

FDA-CBER-2022-908-0002058
96
Listing 16.2.7.7
Safety Set

Haematoma/ (79)/ Yes/ NR CHANGED/ RESOLVED
RIGHT CALF HEMATOMA 2021-01-04 No CONCOMITANT
(119) PROCEDURE

Skin laceration/ 2021-01-07 No NONE
PUNCTATE LACERATION (122)
ANTERIOR SCALP

FDA-CBER-2022-908-0002059
97
Listing 16.2.7.7
Safety Set

Respiratory, thoracic 2020-11-25 Yes/ 3 No NR/ DOSE NOT RECOVERED/
and mediastinal (79)/ Yes/ NR CHANGED/ RESOLVED
Pleural effusion/ (123)
LEFT PLEURAL EFFUSION

Gastrointestinal 2021-01-11 No 2021-01-11) CONCOMITANT
INTERNAL GI HEMORRHAGE - CONCOMITANT
MOTOR VEHICAL ACCIDENT PROCEDURE

FDA-CBER-2022-908-0002060
98
Listing 16.2.7.7
Safety Set

Fatigue/ (66)
FATIGUE

Fatigue/ (98)
FATIGUE

FDA-CBER-2022-908-0002061
99
Listing 16.2.7.7
Safety Set

Myalgia/ (98)
MUSCLE ACHES

Abdominal hernia/ 2020-12-29 No 2021-01-04) CONCOMITANT
ABDOMINAL HERNIA (104) PROCEDURE

FDA-CBER-2022-908-0002062
100
Listing 16.2.7.7
Safety Set

Vomiting/ 2020-12-27 Yes NONE
VOMITING (97)

Nausea/ 2020-12-30 Yes NONE
NAUSEA (100)

FDA-CBER-2022-908-0002063
101
Listing 16.2.7.7
Safety Set

Injury, poisoning and 2020-08-27 Yes/ 3 Yes/3 NR/ DOSE NOT RECOVERED/
procedural complications/ (3)/ Yes/ (2020-08-30/ NR CHANGED/ RESOLVED
Cartilage injury/ 2020-12-31 No 2020-09-04) CONCOMITANT
LEFT HIP LABRUM TEAR (129) MEDICATION
Hypertension/ (8)/ No/ NR APPLICABLE/ RESOLVED
EXACERBATION OF 2020-10-28 No NONE
HYPERTENSION (9)

FDA-CBER-2022-908-0002064
102
Listing 16.2.7.7
Safety Set

Respiratory, thoracic 2020-09-26 Yes/ 3 Yes/3 NR/ DRUG RECOVERED/

and mediastinal (32)/ Yes/ (2020-09-26/ NR WITHDRAWN/ RESOLVED
failure/
ACUTE RESPIRATORY
FAILURE

FDA-CBER-2022-908-0002065
103
Listing 16.2.7.7
Safety Set

bAb: Negative; Dose 1 Date/Time: 12OCT2020:10:27:00; Follow-up Days after 1st Dose: 166; Dose 2
Date/Time: 11NOV2020:11:27:00; Follow-up Days after 2nd Dose: 136

FDA-CBER-2022-908-0002066
104
Listing 16.2.7.7
Safety Set

Investigations/ 2021-01-08 Yes/ 3 No NR/ NOT RECOVERED/
Blood pressure diastolic (122)/ Yes/ NR APPLICABLE/ RESOLVED
increased/ 2021-02-08 No NONE
ELEVATED DIASTOLIC BLOOD (153)
PRESSURE
Tachycardia/ (15)/ No/ NR CHANGED/ RESOLVED
TACHYCARDIA 2020-09-29 No NONE
(15)

FDA-CBER-2022-908-0002067
105
Listing 16.2.7.7
Safety Set

infestations/ (145)/ Yes/ (2021-02-19/ NR APPLICABLE/ RESOLVED WITH
Pneumonia/ 2021-02-24 No 2021-02-22) CONCOMITANT SEQUELAE:
PNEUMONIA (157) MEDICATION RESIDUAL
EXERCISE
INTOLERANCE
AND NECK
STIFFNESS

FDA-CBER-2022-908-0002068
106
Listing 16.2.7.7
Safety Set

Meningitis aseptic/ 2021-03-06 No 2021-02-22) CONCOMITANT SEQUELAE:
ASEPTIC MENINGITIS (167) MEDICATION ONGOING
EXERCISE
INTOLERANCE
AND NECK
STIFFNESS
Chills/ (34) MEDICATION
CHILLS

FDA-CBER-2022-908-0002069
107
Listing 16.2.7.7
Safety Set

Pyrexia/ (34) MEDICATION
FEVER

Fatigue/ (40) MEDICATION
FATIGUE

FDA-CBER-2022-908-0002070
108
Listing 16.2.7.7
Safety Set

Investigations/ 2020-10-16 Yes/ 3 No NR/ NOT NOT RECOVERED/
Blood pressure systolic (29)/ No/ NR APPLICABLE/ NOT RESOLVED
increased/ Ongoing No NONE
ELEVATED SYSTOLIC BLOOD
PRESSURE

Angina pectoris/ (89)/ Yes/ (2020-12-16/ NR APPLICABLE/ RESOLVED
CHEST PAIN (CARDIAC 2020-12-18 No 2020-12-18) CONCOMITANT
RELATED) (92) MEDICATION

FDA-CBER-2022-908-0002071
109
Listing 16.2.7.7
Safety Set

Diabetes mellitus 2020-12-18 No 2020-12-18) CONCOMITANT
inadequate control/ (92) MEDICATION
UNCONTROLLED DIABETES
MELLITUS II

Hyponatraemia/ 2020-12-18 No NONE
HYPONATREMIA (92)

FDA-CBER-2022-908-0002072
110
Listing 16.2.7.7
Safety Set

Vascular disorders/ 2020-12-16 Yes/ 3 Yes/3 NR/ NOT RECOVERED/
Hypertension/ (90)/ Yes/ (2020-12-16/ NR APPLICABLE/ RESOLVED
UNCONTROLLED 2020-12-18 No 2020-12-18) CONCOMITANT

Angina pectoris/ (146)/ Yes/ (2021-02-11/ NR APPLICABLE/ RESOLVED
ANGINA 2021-02-13 No 2021-02-13) CONCOMITANT
(149) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002073
111
Listing 16.2.7.7
Safety Set

Blood pressure systolic (29)/ No/ NR APPLICABLE/ RESOLVED
ELEVATED SYSTOLIC BLOOD (29)
PRESSURE
Fatigue/ (35)
FATIGUE

FDA-CBER-2022-908-0002074
112
Listing 16.2.7.7
Safety Set

Rhabdomyolysis/ (118) MEDICATION
RHABDOMYOLISIS
Cardiac disorders/ 2020-09-17 10:47 Yes/ 3 No NR/ DOSE NOT RECOVERED/
Bradycardia/ (1)/ No/ NR CHANGED/ RESOLVED
BRADYCARDIA 2020-09-17 21:00 No NONE
(1)

FDA-CBER-2022-908-0002075
113
Listing 16.2.7.7
Safety Set


Investigations/ 2020-10-28 Yes/ 3 No NR/ DOSE NOT RECOVERED/

Blood pressure diastolic (70)/ No/ NR CHANGED/ RESOLVED
PRESSURE

FDA-CBER-2022-908-0002076
114
Listing 16.2.7.7
Safety Set


Blood pressure systolic (70)/ No/ NR CHANGED/ RESOLVED
PRESSURE
Infections and 2020-09-04 Yes/ 3 Yes/3 NR/ DRUG RECOVERED/

infestations/ (15)/ Yes/ (2020-09-03/ NR WITHDRAWN/ RESOLVED WITH
Osteomyelitis/ 2020-10-16 No 2020-09-09) CONCOMITANT SEQUELAE:
LEFT GREAT TOE (57) MEDICATION, RECOVERED WITH
OSTEOMYELITIS CONCOMITANT SEQUALAE LEFT
PROCEDURE GREAT TOE
AMPUTATION

FDA-CBER-2022-908-0002077
115
Listing 16.2.7.7
Safety Set

Transient ischaemic (126)/ Yes/ NR APPLICABLE/ RESOLVED
attack/ 2021-02-17 No CONCOMITANT
TRANSIENT ISCHEMIC (150) MEDICATION
ATTACK
Migraine with aura/ (102)/ Yes/ NR APPLICABLE/ RESOLVED
OCULAR MIGRAINE 2021-01-01 No CONCOMITANT
EXACERBATION (103) MEDICATION

FDA-CBER-2022-908-0002078
116
Listing 16.2.7.7
Safety Set

Blood pressure systolic (29)/ No/ NR APPLICABLE/ NOT RESOLVED
PRESSURE

Blood pressure diastolic (29)/ No/ NR APPLICABLE/ RESOLVED
PRESSURE

FDA-CBER-2022-908-0002079
117
Listing 16.2.7.7
Safety Set

Blood pressure systolic (41)/ Yes/ NR APPLICABLE/ RESOLVED
ELEVATED DIASTOLIC AND (48)
SYSTOLIC BLOOD PRESSURE
Hepatobiliary disorders/ 2020-11-27 Yes/ 3 Yes/3 NR/ NOT RECOVERED/

Cholecystitis/ (66)/ Yes/ (2020-11-28/ NR APPLICABLE/ RESOLVED
CHOLECYSTITIS 2020-11-28 No 2020-11-29) CONCOMITANT
(67) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002080
118
Listing 16.2.7.7
Safety Set

Rhinovirus infection/ 2021-02-16 No CONCOMITANT
UPPER RESPIRATORY (147) MEDICATION
INFECTION
(RHINOVIRUS/ENTEROVIRUS)
PRESSURE

FDA-CBER-2022-908-0002081
119
Listing 16.2.7.7
Safety Set

Ligament sprain/ 2021-02-20 No NONE
LEFT WRIST SPRAIN (149)
Psychiatric disorders/ 2021-02-02 Yes/ 3 Yes/3 NR/ NOT RECOVERED/
Mania/ (128)/ Yes/ (2021-02-02/ NR APPLICABLE/ RESOLVED
MANIC EPISODE 2021-02-15 No 2021-02-15) CONCOMITANT
(141) MEDICATION

FDA-CBER-2022-908-0002082
120
Listing 16.2.7.7
Safety Set

Endocrine disorders/ 2020-10-15 Yes/ 3 No NR/ NOT NOT RECOVERED/
Thyroid mass/ (18)/ Yes/ NR APPLICABLE/ NOT RESOLVED
HYPERFUNCTIONING THYROID Ongoing No NONE
NODULE
increased/ 2020-10-27 11:17 No NONE
PRESSURE

FDA-CBER-2022-908-0002083
121
Listing 16.2.7.7
Safety Set

Osteonecrosis/ (126)
IDIOPATHIC AVASCULAR
NECROSIS RIGHT HIP

Osteoarthritis/ (128) MEDICATION,
WORSENING OSTEOARTHRITIS CONCOMITANT
RIGHT HIP PROCEDURE

FDA-CBER-2022-908-0002084
122
Listing 16.2.7.7
Safety Set

Upper respiratory tract 2020-12-06 No CONCOMITANT
infection/ (60) MEDICATION
UPPER RESPIRATORY
INFECTION
Vascular disorders/ 2021-01-12 10:41 Yes/ 3 No NR/ NOT RECOVERED/
EXACERBATION OF 2021-02-09 14:03 No CONCOMITANT

FDA-CBER-2022-908-0002085
123
Listing 16.2.7.7
Safety Set

INCREASED DIASTOLIC (129)
BLOOD PRESSURE

INCREASED SYSTOLIC BLOOD (129)
PRESSURE

FDA-CBER-2022-908-0002086
124
Listing 16.2.7.7
Safety Set


EXACERBATION OF 2020-11-03 No CONCOMITANT
SYMPTOMATIC COVID 19 (26) MEDICATION

FDA-CBER-2022-908-0002087
125
Listing 16.2.7.7
Safety Set

PRESSURE
Vascular disorders/ 2020-09-11 12:47 Yes/ 3 No NR/ DOSE NOT RECOVERED/
EXACERBATION OF 2020-10-09 08:12 No CONCOMITANT

FDA-CBER-2022-908-0002088
126
Listing 16.2.7.7
Safety Set

Small intestinal 2020-11-10 No 2020-11-10) CONCOMITANT
obstruction/ (29) MEDICATION
SMALL BOWEL OBSTRUCTION
Vascular disorders/ 2020-09-25 Yes/ 3 No NR/ DOSE NOT UNKNOWN
Hypertension/ (43)/ Yes/ NR CHANGED/
MEDICATION

FDA-CBER-2022-908-0002089
127
Listing 16.2.7.7
Safety Set

2 Date/Time: ; Follow-up Days after 2nd Dose: NA
Hypertension/ (53)/ No/ NR APPLICABLE/ NOT RESOLVED
HYPERTENSION Ongoing No NONE
Nervous system disorders/ 2020-09-14 Yes/ 3 Yes/6 NR/ DOSE RECOVERED/

Syncope/ (29)/ No/ R DELAYED/ RESOLVED
CONVULSIVE SYNCOPE 2020-09-14 No CONCOMITANT
(29) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002090
128
Listing 16.2.7.7
Safety Set

Fatigue/ (16)
FATIGUE
Meniscus injury/ 2020-10-14 No CONCOMITANT
LEFT KNEE MENISCAL TEAR (52) PROCEDURE

FDA-CBER-2022-908-0002091
129
Listing 16.2.7.7
Safety Set

Uterine haemorrhage/ 2020-11-18 No CONCOMITANT
UTERINE BLEEDING (56) MEDICATION,
CONCOMITANT
PROCEDURE
POST SURGICAL (120) MEDICATION
AUGMENTATION BREAST
PAIN, BILATERALLY

FDA-CBER-2022-908-0002092
130
Listing 16.2.7.7
Safety Set

Abdominal pain upper/ 2020-10-12 No CONCOMITANT
ABDOMINAL PAIN, LEFT (25) MEDICATION
UPPER QUADRANT
WORSENING HYPERTENSION Ongoing No NONE

FDA-CBER-2022-908-0002093
131
Listing 16.2.7.7
Safety Set

COVID-19/ 2020-10-02 No NONE
COVID-19 (36)
Sciatica/ (18)/ Yes/ NR CHANGED/ RESOLVED
SCIATICA- WORSENING 2021-01-04 No CONCOMITANT
(152) MEDICATION

FDA-CBER-2022-908-0002094
132
Listing 16.2.7.7
Safety Set

Investigations/ 2020-10-21 Yes/ 3 No NR/ DOSE NOT RECOVERING/
Blood pressure systolic (30)/ No/ NR CHANGED/ RESOLVING
GRADE 3 ELEVATED
Blood pressure increased/ (93)/ Yes/ NR APPLICABLE/ NOT RESOLVED
ELEVATED BLOOD PRESSURE Ongoing No NONE

FDA-CBER-2022-908-0002095
133
Listing 16.2.7.7
Safety Set

MEDICATION
Gastrointestinal 2020-09-13 Yes/ 3 Yes/3 NR/ DOSE NOT RECOVERED/
disorders/ (10)/ Yes/ (2020-09-13/ NR CHANGED/ RESOLVED
Colitis/ 2020-09-25 No 2020-09-15) CONCOMITANT
ACUTE FOCAL COLITIS (22) MEDICATION

FDA-CBER-2022-908-0002096
134
Listing 16.2.7.7
Safety Set

malignant and (52)/ Yes/ NR APPLICABLE/ RESOLVED WITH
unspecified (incl cysts 2021-01-13 No CONCOMITANT SEQUELAE:
and polyps)/ (106) PROCEDURE PATIENT
Intraductal REPORTS SHE
proliferative breast WILL BE
lesion/ STARTING
DUCTAL CARCINOMA IN SITU HORMONE
RIGHT BREAST BLOCKER
MEDICATION
THIS THURSDAY
(04MAR2021) AS
RECOMMENDED BY
ONCOLOGIST FOR
PREVENTION OF
DUCTAL
CARCINOMA
RECURRENCE.

FDA-CBER-2022-908-0002097
135
Listing 16.2.7.7
Safety Set

Psychiatric disorders/ 2020-10-14 Yes/ 3 No NR/ DRUG NOT RECOVERED/

Depression suicidal/ (31)/ Yes/ NR WITHDRAWN/ NOT RESOLVED
DEPRESSION WITH SUICIDAL Ongoing No NONE
IDEATION
Systolic hypertension/ (1)/ No/ NR CHANGED/ RESOLVED
ELEVATED SYSTOLIC 2020-09-08 10:08 No NONE
HYPERTENSION (28)

FDA-CBER-2022-908-0002098
136
Listing 16.2.7.7
Safety Set

Blood pressure systolic (1)/ Yes/ NR CHANGED/ RESOLVED
GRADE 3 INCREASED (26)
Hypertension/ (117)/ No/ NR DELAYED/ NOT RESOLVED
HYPERTENSION MEDICATION

FDA-CBER-2022-908-0002099
137
Listing 16.2.7.7
Safety Set

Hypertension/ (1)/ No/ NR CHANGED/ RESOLVED
HYPERTENSION (SYSTOLIC) 2020-10-15 09:00 No NONE
WORSENING (56)
Vascular disorders/ 2020-10-22 09:28 Yes/ 3 No NR/ DOSE NOT
Hypertension/ (28)/ No/ NR CHANGED/
Investigations/ 2020-09-29 18:56 Yes/ 3 No NR/ DOSE NOT RECOVERING/
Blood pressure increased/ (1)/ No/ NR CHANGED/ RESOLVING

FDA-CBER-2022-908-0002100
138
Listing 16.2.7.7
Safety Set

infestations/ (9)/ No/ NR APPLICABLE/ RESOLVED
Urinary tract infection/ 2020-11-15 No CONCOMITANT
URINARY TRACT INFECTION (13) MEDICATION
WORSENING OF 2021-01-13 12:57 No NONE
HYPERTENSION (63)

FDA-CBER-2022-908-0002101
139
Listing 16.2.7.7
Safety Set

Migraine/ (29)/ Yes/ NR CHANGED/ RESOLVED
MIGRAINE/HEADACHE 2020-09-19 Yes CONCOMITANT
(46) MEDICATION

FDA-CBER-2022-908-0002102
140
Listing 16.2.7.7
Safety Set

Injury, poisoning and 2020-08-25 Yes/ 3 Yes/3 NR/ DOSE RECOVERED/
procedural complications/ (22)/ Yes/ (2020-08-25/ NR DELAYED/ RESOLVED
Hip fracture/ 2020-08-26 No 2020-08-31) CONCOMITANT
FRACTURED LEFT HIP (23) MEDICATION,
CONCOMITANT
PROCEDURE
COVID 19 PNEUMONIA (106) MEDICATION

FDA-CBER-2022-908-0002103
141
Listing 16.2.7.7
Safety Set

Dizziness/ (127)/ Yes/ (2021-01-19/ NR APPLICABLE/ RESOLVED
DIZZINESS 2021-01-22 No 2021-01-22) CONCOMITANT
(130) PROCEDURE
APPENDICITIS (15) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002104
142
Listing 16.2.7.7
Safety Set

Breast cancer/
MALIGNANT RIGHT BREAST
TUMOR
(12) MEDICATION

FDA-CBER-2022-908-0002105
143
Listing 16.2.7.7
Safety Set

Acute myocardial (99)/ Yes/ (2020-12-21/ NR APPLICABLE/ RESOLVED
infarction/ 2020-12-23 No 2020-12-23) CONCOMITANT
ACUTE MYOCARDIAL (101) PROCEDURE
INFARCTION
Fatigue/ (21)
FATIGUE

FDA-CBER-2022-908-0002106
144
Listing 16.2.7.7
Safety Set

General disorders and 2020-12-25 Yes/ 3 Yes/3 NR/ NOT RECOVERED/
administration site (79)/ Yes/ (2020-12-25/ NR APPLICABLE/ RESOLVED
conditions/ 2020-12-28 Yes 2020-12-28) CONCOMITANT
FEVER
FORIEGN BODY, RIGHT (19) MEDICATION
INDEX FINGER

FDA-CBER-2022-908-0002107
145
Listing 16.2.7.7
Safety Set

COVID-19/ 2020-11-26 No 2020-11-26) CONCOMITANT SEQUELAE:
SARS COVID-19 (86) MEDICATION WHILE SUBJECT
WAS DISCHARGED
26NOV2020 HE
WAS SENT HOME
WITH
SUPPLEMENTAL
OXYGEN OF 1
LITER TO USE
AS NEEDED.

FDA-CBER-2022-908-0002108
146
Listing 16.2.7.7
Safety Set

SEVERE HEADACHE 2020-08-16 Yes CONCOMITANT
(9) MEDICATION
Injury, poisoning and 2020-08-26 Yes/ 3 Yes/3 NR/ DOSE RECOVERED/

procedural complications/ (19)/ Yes/ (2020-08-26/ NR DELAYED/ RESOLVED
Post procedural 2020-09-01 No 2020-09-01) CONCOMITANT
POST OPERATIVE BLEEDING CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002109
147
Listing 16.2.7.7
Safety Set

ATRIAL FIBRILLATION 2020-09-01 No 2020-09-01) CONCOMITANT
(17) MEDICATION
Pulmonary embolism/ (57) MEDICATION
PULMONARY EMBOLISM

FDA-CBER-2022-908-0002110
148
Listing 16.2.7.7
Safety Set

Respiratory, thoracic 2020-11-09 Yes/ 3 Yes/3 NR/ DOSE NOT RECOVERED/
and mediastinal (20)/ Yes/ (2020-11-09/ NR CHANGED/ RESOLVED WITH
Emphysema/ (22) MEDICATION SUBJECT WAS
WORSENING OF EMPHYSEMA SENT HOME ON 2
LITERS OF
CONTINUOUS
OXYGEN

FDA-CBER-2022-908-0002111
149
Listing 16.2.7.7
Safety Set


Chest pain/ (37)
CHEST PAIN (ETIOLOGY -
UNDETERMINED)

FDA-CBER-2022-908-0002112
150
Listing 16.2.7.7
Safety Set

MEDICATION
Femoral hernia/ 2020-08-28 No CONCOMITANT
FEMORAL HERNIA (16) PROCEDURE

FDA-CBER-2022-908-0002113
151
Listing 16.2.7.7
Safety Set

WORSENING OSTEOARTHRITIS
Headache/ (22)/ Yes/ NR CHANGED/ RESOLVED
(29) MEDICATION

FDA-CBER-2022-908-0002114
152
Listing 16.2.7.7
Safety Set

Musculoskeletal and 2020-08-20 Yes/ 3 Yes/3 R/ DRUG RECOVERING/

connective tissue (16)/ Yes/ (2020-08-20/ NR WITHDRAWN/ RESOLVING
disorders/ Ongoing No 2020-08-21) CONCOMITANT
Polymyalgia rheumatica/ MEDICATION
POSSIBLE POLYMYALGIA
RHEUMATICA
DIZZINESS 2020-11-30 No CONCOMITANT
(84) PROCEDURE

FDA-CBER-2022-908-0002115
153
Listing 16.2.7.7
Safety Set

(29) MEDICATION
Seizure/ (12)/ Yes/ NR APPLICABLE/ RESOLVED
SEIZURE 2020-10-09 No CONCOMITANT
(12) PROCEDURE

FDA-CBER-2022-908-0002116
154
Listing 16.2.7.7
Safety Set

Hypertensive urgency/ (10)/ Yes/ (2020-09-25/ NR APPLICABLE/ RESOLVED
HYPERTENSIVE URGENCY 2020-09-30 No 2020-09-30) CONCOMITANT
(15) MEDICATION

Cervical spinal stenosis/ (17)
CERVICAL STENOSIS

FDA-CBER-2022-908-0002117
155
Listing 16.2.7.7
Safety Set

Spinal stenosis/ (47) MEDICATION,
SPINAL STENOSIS CONCOMITANT
PROCEDURE
Subject ID: US3432215; Age (years): 60; Sex: M; Race: MULTIPLE: Black or African American, American Indian or Alaska Native;
Height (cm): 166.6; Weight (kg): 78.5; BMI (kg/m2): 28.3; Baseline SARS-CoV-2 Status: Negative; Baseline RT-PCR: Negative;
Baseline Elecsys SARS-CoV-2 Nucleocapsid bAb: Negative; Dose 1 Date/Time: 20AUG2020:14:52:00;
Follow-up Days after 1st Dose: 219; Dose 2 Date/Time: 15SEP2020:09:57:00; Follow-up Days after 2nd Dose: 193
Gastrointestinal 2021-01-19 Yes/ 3 No NR/ NOT RECOVERING/
disorders/ (127)/ Yes/ NR APPLICABLE/ RESOLVING
Abdominal pain upper/ Ongoing No CONCOMITANT
STOMACH PAIN MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002118
156
Listing 16.2.7.7
Safety Set

SARS-CoV-2 Status: ; Baseline RT-PCR: ; Baseline Elecsys SARS-CoV-2 Nucleocapsid bAb: ; Dose 1 Date/Time: 02SEP2020:12:37:00;

Blood pressure systolic (28)/ No/ NA CHANGED/ RESOLVED
PRESSURE 182 MM/HG
PRESSURE

FDA-CBER-2022-908-0002119
157
Listing 16.2.7.7
Safety Set

Subject ID: US3432517; Age (years): 55; Sex: M; Race: OTHER: LATINO; Height (cm): 175.0; Weight (kg): 59.5; BMI (kg/m2):
19.4; Baseline SARS-CoV-2 Status: Negative; Baseline RT-PCR: Negative; Baseline Elecsys SARS-CoV-2 Nucleocapsid bAb:
Negative; Dose 1 Date/Time: 17SEP2020:11:03:00; Follow-up Days after 1st Dose: 191; Dose 2
Nephrolithiasis/ 2021-02-03 No 2021-02-03) CONCOMITANT
KIDNEY STONES (112) MEDICATION,
CONCOMITANT
PROCEDURE
Subject ID: US3432585; Age (years): 30; Sex: F; Race: OTHER: MIXED; Height (cm): 167.0; Weight (kg): 56.1; BMI (kg/m2): 20.1;
Baseline SARS-CoV-2 Status: Negative; Baseline RT-PCR: Negative; Baseline Elecsys SARS-CoV-2 Nucleocapsid bAb: Negative;
Costochondritis/ (33) MEDICATION
COSTOCHONDRITIS

FDA-CBER-2022-908-0002120
158
Listing 16.2.7.7
Safety Set

WORSENING OF 2020-09-08 No NONE
HYPERTENSION (27)
WORSENING OF RIGHT HIP CONCOMITANT
OSTEOARTHRITIS PROCEDURE

FDA-CBER-2022-908-0002121
159
Listing 16.2.7.7
Safety Set

Metabolism and nutrition Yes/ 3 Yes/3 NR/ NOT RECOVERED/
disorders/ Yes/ NA APPLICABLE/ RESOLVED
Diabetic ketoacidosis/ No NONE
DIABETIC KETOACIDOSIS
Cardiac disorders/ 2020-10-09 14:44 Yes/ 3 No NR/ DOSE NOT NOT RECOVERED/
Tachycardia/ (26)/ No/ NR CHANGED/ NOT RESOLVED
TACHYCARDIA Ongoing No NONE

FDA-CBER-2022-908-0002122
160
Listing 16.2.7.7
Safety Set

WORSENING ELEVATED BLOOD 2020-10-09 15:49 No NONE
PRESSURE (26)

FDA-CBER-2022-908-0002123
161
Listing 16.2.7.7
Safety Set

Arthralgia/ (9)
ARTHRYALGIA IN BOTH LEGS
(POST-DOSE)

FDA-CBER-2022-908-0002124
162
Listing 16.2.7.7
Safety Set

Bronchitis/ 2021-01-24 No CONCOMITANT
BRONCHITIS (131) MEDICATION

FDA-CBER-2022-908-0002125
163
Listing 16.2.7.7
Safety Set

Sciatica/ (126)/ Yes/ NR APPLICABLE/ RESOLVING
SCIATICA RADIATING TO Ongoing No CONCOMITANT
RIGHT LEG EXACERBATION MEDICATION
COVID-19 (106) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002126
164
Listing 16.2.7.7
Safety Set

Nephrolithiasis/ 2020-10-03 No CONCOMITANT
KIDNEY STONE LEFT SIDE (17) MEDICATION
Date/Time: ; Follow-up Days after 2nd Dose: NA
Gout/ 2020-09-30 No 2020-09-30) CONCOMITANT
GOUT EXACERBATION IN (36) MEDICATION
RIGHT KNEE

FDA-CBER-2022-908-0002127
165
Listing 16.2.7.7
Safety Set

Chronic kidney disease/ 2020-09-30 No 2020-09-30) CONCOMITANT
CHRONIC KIDNEY DISEASE
STAGE III
Blood and lymphatic 2020-10-21 Yes/ 3 Yes/3 NR/ NOT RECOVERED/

system disorders/ (57)/ Yes/ (2020-10-22/ NR APPLICABLE/ RESOLVED
Anaemia/ 2020-10-26 No 2020-10-26) CONCOMITANT
EXACERBATION OF ANEMIA (62) MEDICATION

FDA-CBER-2022-908-0002128
166
Listing 16.2.7.7
Safety Set

bAb: Negative; Dose 1 Date/Time: 02SEP2020:15:14:00; Follow-up Days after 1st Dose: 206; Dose
Abdominal discomfort/ 2020-09-29 No CONCOMITANT
GI DISTRESS (28) MEDICATION
Metabolism and nutrition 2020-09-25 Yes/ 3 No NR/ DOSE NOT RECOVERED/

Hypokalaemia/ 2020-09-25 No CONCOMITANT
HYPOKALEMIA (24) MEDICATION

FDA-CBER-2022-908-0002129
167
Listing 16.2.7.7
Safety Set

Nervous system disorders/ 2020-10-08 12:56 Yes/ 3 No NR/ DOSE NOT RECOVERED/
Presyncope/ (1)/ Yes/ R CHANGED/ RESOLVED
VASOVAGAL SYNDROME 2020-10-08 14:30 No NONE
(1)
Subject ID: US3482286; Age (years): 52; Sex: M; Race: MULTIPLE: Black or African American, Asian; Height (cm): 180.3; Weight
Nucleocapsid bAb: Negative; Dose 1 Date/Time: 13OCT2020:10:40:00; Follow-up Days after 1st Dose:
165; Dose 2 Date/Time: 12NOV2020:08:59:00; Follow-up Days after 2nd Dose: 135

FDA-CBER-2022-908-0002130
168
Listing 16.2.7.7
Safety Set

COVID 19 (73) MEDICATION,
CONCOMITANT
PROCEDURE

Nausea/ 2021-02-03 Yes 2021-02-03) NONE
INTRACTABLE NAUSEA (80)

FDA-CBER-2022-908-0002131
169
Listing 16.2.7.7
Safety Set

SUPERIMPOSED ON CHRONIC
KIDNEY DISEASE
Metabolism and nutrition 2021-02-01 Yes/ 3 No NR/ DOSE RECOVERING/

disorders/ (78)/ Yes/ NR DELAYED/ RESOLVING
Type 2 diabetes mellitus/ Ongoing No CONCOMITANT
DIABETES TYPE II, NEW MEDICATION
ONSET

FDA-CBER-2022-908-0002132
170
Listing 16.2.7.7
Safety Set

Fatigue/ (22)
FATIGUE

Pain/ (22)
BODY ACHES

FDA-CBER-2022-908-0002133
171
Listing 16.2.7.7
Safety Set

Cerebrovascular accident/ (29)/ Yes/ (2020-10-30/ NR APPLICABLE/ RESOLVED WITH
CEREBROVASCULAR ACCIDENT 2020-11-11 No 2020-11-11)/4 CONCOMITANT SEQUELAE:
(41) MEDICATION RIGHT LOWER
EXTREMITY
WEAKNESS
Subject ID: US3492085; Age (years): 29; Sex: F; Race: NOT REPORTED; Height (cm): 161.5; Weight (kg): 73.8; BMI (kg/m2): 28.3;
Dose 1 Date/Time: 08SEP2020:11:11:00; Follow-up Days after 1st Dose: 200; Dose 2
Pharyngitis 2020-10-25 No CONCOMITANT
STREP THROAT

FDA-CBER-2022-908-0002134
172
Listing 16.2.7.7
Safety Set

Pelvi-ureteric 2021-03-25 No CONCOMITANT
obstruction/ (170) MEDICATION,
URETEROPELVIC JUNCTION CONCOMITANT
OBSTRUCTION PROCEDURE
2 Date/Time: 09OCT2020:12:32:00; Follow-up Days after 2nd Dose: 169
and mediastinal (19)/ No/ NR CHANGED/ RESOLVED
Oropharyngeal pain/ (22)
SORE THROAT

FDA-CBER-2022-908-0002135
173
Listing 16.2.7.7
Safety Set

Muscle strain/ 2020-10-05 No CONCOMITANT
PULLED GROIN MUSCLE (22) MEDICATION
Musculoskeletal and 2020-09-17 12:00 Yes/ 3 No NR/ DOSE NOT RECOVERED/
disorders/ 2020-09-18 22:00 No CONCOMITANT
Foot deformity/ (2) MEDICATION
PAIN FROM BUNION TO
RIGHT FOOT

FDA-CBER-2022-908-0002136
174
Listing 16.2.7.7
Safety Set

Appendicitis perforated/ 2021-01-11 No 2021-01-11) CONCOMITANT
APPENDICITIS/PERFORATED (89) MEDICATION,
APPENDIX, S/P CONCOMITANT
APPENDECTOMY PROCEDURE
Tendonitis/ (44) MEDICATION
SHOULDER TENDONITIS

FDA-CBER-2022-908-0002137
175
Listing 16.2.7.7
Safety Set

Psychiatric disorders/ 2020-11-03 Yes/ 3 No NR/ DOSE NOT RECOVERED/
Insomnia/ (19)/ No/ NR CHANGED/ RESOLVED
INSOMNIA 2020-11-30 No CONCOMITANT
(46) MEDICATION
SORE THROAT

FDA-CBER-2022-908-0002138
176
Listing 16.2.7.7
Safety Set

Nervous system disorders/ 2020-09-16 Yes/ 3 Yes/3 NR/ DOSE NOT RECOVERED/
Migraine/ (20)/ Yes/ (2020-09-22/ NR CHANGED/ RESOLVED
MIGRAINE EXACERBATION 2020-09-23 Yes 2020-09-23) CONCOMITANT
(27) MEDICATION
Subject ID: US3502216; Age (years): 39; Sex: M; Race: AMERICAN INDIAN OR ALASKA NATIVE; Height (cm): 174.4; Weight (kg):
79.0; BMI (kg/m2): 26.0; Baseline SARS-CoV-2 Status: Negative; Baseline RT-PCR: Negative; Baseline Elecsys SARS-CoV-2
Nucleocapsid bAb: Negative; Dose 1 Date/Time: 23OCT2020:09:19:00; Follow-up Days after 1st Dose: 155; Dose
2 Date/Time: 20NOV2020:08:36:00; Follow-up Days after 2nd Dose: 127
Immune system disorders/ 2020-11-02 Yes/ 3 No NR/ DOSE NOT RECOVERED/
Anaphylactic reaction/ (11)/ Yes/ NR CHANGED/ RESOLVED
ANAPHYLAXIS 2020-11-02 No CONCOMITANT
(11) MEDICATION

FDA-CBER-2022-908-0002139
177
Listing 16.2.7.7
Safety Set

Injection site (10)
lymphadenopathy/
IPSILATERAL INJECTION
SITE AXILLARY
LYMPHADENOPATHY

FDA-CBER-2022-908-0002140
178
Listing 16.2.7.7
Safety Set

General disorders and 2020-10-11 Yes/ 3 No R/ NOT RECOVERED/
administration site (32)/ No/ NR APPLICABLE/ RESOLVED
Chills/ (32)
CHILLS
Nervous system disorders/ 2020-10-15 Yes/ 3 No R/ NOT RECOVERED/

Headache/ (36)/ No/ NR APPLICABLE/ RESOLVED
(36) MEDICATION

FDA-CBER-2022-908-0002141
179
Listing 16.2.7.7
Safety Set

Chills/ (73)
CHILLS

FATIGUE

FDA-CBER-2022-908-0002142
180
Listing 16.2.7.7
Safety Set

Musculoskeletal and 2020-10-15 Yes/ 3 No R/ NOT RECOVERED/
connective tissue (36)/ No/ NR APPLICABLE/ RESOLVED
GENERALIZED MUSCLE ACHES
Tendonitis/ (84)
LEFT POSTERIOR ANKLE
TENDONITIS

FDA-CBER-2022-908-0002143
181
Listing 16.2.7.7
Safety Set

Tendon rupture/ 2020-12-02 No CONCOMITANT
LEFT POSTERIOR ANKLE (84) PROCEDURE
TENDON TEAR
Muscle spasms/ (49) MEDICATION
EXERCISE WORSENED BACK
MUSCLE SPASMS

FDA-CBER-2022-908-0002144
182
Listing 16.2.7.7
Safety Set

conditions/ 2020-09-22 07:00 Yes CONCOMITANT
Injection site pain/ (11) MEDICATION
INJECTION SITE PAIN
Asthma/ (116)
WORSENING BRONCHOGENIC
ASTHMA

FDA-CBER-2022-908-0002145
183
Listing 16.2.7.7
Safety Set


Fatigue/ (132)
INTERMITTENT FATIGUE
Nervous system disorders/ 2020-08-31 Yes/ 3 No R/ DRUG RECOVERED/

Headache/ (3)/ No/ R WITHDRAWN/ RESOLVED
WORSENING HEADACHE 2020-09-20 Yes CONCOMITANT
(23) MEDICATION

FDA-CBER-2022-908-0002146
184
Listing 16.2.7.7
Safety Set

Basal cell carcinoma/ CONCOMITANT
BASAL CELL CARCINOMA ON PROCEDURE
SCALP

FDA-CBER-2022-908-0002147
185
Listing 16.2.7.7
Safety Set

Infections and 2020-12-13 Yes/ 3 No NR/ DOSE NOT UNKNOWN
infestations/ (66)/ No/ NR CHANGED/
Viral upper respiratory Ongoing No NONE
tract infection/
VIRAL UPPER RESPIRATORY
INFECTION CAUSATIVE
ORGANISM UNKNOWN
Animal bite/ 2020-12-06 No NONE
DOG SCRATCHES/ BITE (89)

FDA-CBER-2022-908-0002148
186
Listing 16.2.7.7
Safety Set

FACIAL WOUNDS REQUIRING (113) MEDICATION,
3 TOTAL STITCHES CONCOMITANT
PROCEDURE
NECK STRAIN DUE TO FALL (76) MEDICATION

FDA-CBER-2022-908-0002149
187
Listing 16.2.7.7
Safety Set

and polyps)/ MEDICATION,
Papillary thyroid cancer/ CONCOMITANT
PAPILLARY THYROID CANCER PROCEDURE
Subject ID: US3522446; Age (years): 62; Sex: M; Race: UNKNOWN; Height (cm): 172.7; Weight (kg): 90.5; BMI (kg/m2): 30.3;
Dose 1 Date/Time: 28AUG2020:14:50:00; Follow-up Days after 1st Dose: 211; Dose 2 Date/Time:
Fatigue/ (11)
SEVERE FATIGUE

FDA-CBER-2022-908-0002150
188
Listing 16.2.7.7
Safety Set

Subject ID: US3522536; Age (years): 65; Sex: F; Race: OTHER: "INDIA SUB-CONTINENT" PER PT; Height (cm): 167.6; Weight (kg):
Nucleocapsid bAb: Negative; Dose 1 Date/Time: 02SEP2020:15:35:00; Follow-up Days after 1st Dose: 206; Dose
BACK STRAIN (36) MEDICATION
PAIN POST SURGERY FOR (90) MEDICATION
MUCOSAL GUM GRAFTING FOR
GUM RECESSION AND BONE
LOSS

FDA-CBER-2022-908-0002151
189
Listing 16.2.7.7
Safety Set

WORSENING OF MIGRANE 2020-11-04 Yes NONE
CONDITION GREATER IN (27)
SEVERITY THAN BASELINE
Gastroenteritis 2020-12-01 No CONCOMITANT
bacterial/ (50) MEDICATION
BACTERIAL
GASTROENTERITIS

FDA-CBER-2022-908-0002152
190
Listing 16.2.7.7
Safety Set

POST SURGICAL PAIN (57) MEDICATION
(REPAIR OF FRACTRUED
FEMUR)

FDA-CBER-2022-908-0002153
191
Listing 16.2.7.7
Safety Set

Penile cancer/
CANCEROUS TUMOR-PENIS
Cardiac disorders/ 2020-09-08 Yes/ 3 No NR/ DOSE NOT RECOVERING/

Ventricular fibrillation/ (13)/ Yes/ NR CHANGED/ RESOLVING
VENTRICULAR Ongoing No CONCOMITANT
FIBRILLATION- MEDICATION
INTERMEDIATE

FDA-CBER-2022-908-0002154
192
Listing 16.2.7.7
Safety Set


Nausea/ 2020-10-09 Yes CONCOMITANT
NAUSEA (44) MEDICATION

(141)

FDA-CBER-2022-908-0002155
193
Listing 16.2.7.7
Safety Set

Syncope/ (29)/ No/ R CHANGED/ RESOLVED
(29)

FDA-CBER-2022-908-0002156
194
Listing 16.2.7.7
Safety Set

infection/ (62)
UPPER RESPIRATORY
ILLNESS, UNKNOWN
ORGANISM
BACK PAIN

FDA-CBER-2022-908-0002157
195
Listing 16.2.7.7
Safety Set

EPIGASTRIC PAIN (17) MEDICATION
BACK PAIN, LOWER

FDA-CBER-2022-908-0002158
196
Listing 16.2.7.7
Safety Set

Psychiatric disorders/ 2020-09-19 Yes/ 3 Yes/3 NR/ DRUG RECOVERED/
Anxiety/ (16)/ Yes/ (2020-09-19/ NR WITHDRAWN/ RESOLVED
ANXIETY EXACERBATION 2020-09-23 No 2020-09-23) CONCOMITANT
(20) MEDICATION
Psychiatric disorders/ 2020-09-19 Yes/ 3 Yes/3 NR/ DOSE NOT RECOVERED/

Depression/ (16)/ Yes/ (2020-09-19/ NR CHANGED/ RESOLVED
DEPRESSION EXACERBATION 2020-09-23 No 2020-09-23) CONCOMITANT
(20) MEDICATION

FDA-CBER-2022-908-0002159
197
Listing 16.2.7.7
Safety Set

POLYARTHRALGIAS
Eye disorders/ 2020-09-08 Yes/ 3 Yes/6 NR/ DRUG RECOVERED/
Retinal detachment/ (18)/ Yes/ NR WITHDRAWN/ RESOLVED
RETINAL DETACHMENT OF 2020-09-12 No CONCOMITANT
LEFT EYE (22) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002160
198
Listing 16.2.7.7
Safety Set

Eye disorders/ 2020-10-01 Yes/ 3 Yes/6 NR/ NOT RECOVERED/
Retinal tear/ (41)/ Yes/ NR APPLICABLE/ RESOLVED
HORSESHOE TEAR OF RIGHT 2020-10-06 No CONCOMITANT
EYE (46) PROCEDURE
KIDNEY STONE (85) MEDICATION
EXACERBATION

FDA-CBER-2022-908-0002161
199
Listing 16.2.7.7
Safety Set

Vascular disorders/ 2020-09-01 14:07 Yes/ 3 No NR/ DRUG NOT RECOVERED/

Hypertension/ (1)/ Yes/ NR WITHDRAWN/ NOT RESOLVED
WORSENING HYPERTENSION Ongoing No CONCOMITANT
MEDICATION
procedural complications/ (8)/ No/ NR CHANGED/ RESOLVED
Joint injury/ 2020-09-28 No CONCOMITANT
RIGHT KNEE INJURY (19) MEDICATION

FDA-CBER-2022-908-0002162
200
Listing 16.2.7.7
Safety Set

Injury, poisoning and 2021-01-15 Yes/ 3 No NR/ NOT RECOVERING/
procedural complications/ (99)/ Yes/ NR APPLICABLE/ RESOLVING
Ankle fracture/ Ongoing No CONCOMITANT
BROKEN RIGHT ANKLE MEDICATION
conditions/ 2020-12-05 No CONCOMITANT
Oedema peripheral/ (59) MEDICATION
LEFT LEG EDEMA

FDA-CBER-2022-908-0002163
201
Listing 16.2.7.7
Safety Set

Oesophageal stenosis/ 2020-11-18 No NONE
ESOPHAGEAL STRICTURE (42)
WORSENING HYPERTENSION 2020-10-15 No NONE
(29)

FDA-CBER-2022-908-0002164
202
Listing 16.2.7.7
Safety Set

bAb: Negative; Dose 1 Date/Time: 08OCT2020:12:17:00; Follow-up Days after 1st Dose: 170; Dose
NON-CARDIAC CHEST PAIN
disorders/ (81)/ No/ NR CHANGED/ RESOLVING
Constipation/ Ongoing No NONE
SEVERE CONSTIPATION

FDA-CBER-2022-908-0002165
203
Listing 16.2.7.7
Safety Set

ASTHMA ATTACK
Cerebrovascular accident/ (100)/ No/ (2021-01-03/ NR APPLICABLE/ RESOLVED
CVA 2021-01-13 No 2021-01-13) CONCOMITANT
(113) MEDICATION

FDA-CBER-2022-908-0002166
204
Listing 16.2.7.7
Safety Set

Colitis/ 2021-01-14 No 2020-12-24)/6 CONCOMITANT
ACUTE COLITIS (112) MEDICATION

FDA-CBER-2022-908-0002167
205
Listing 16.2.7.7
Safety Set

Blood and lymphatic 2020-11-08 Yes/ 3 Yes/3 NR/ NOT NOT RECOVERED/
system disorders/ (41)/ No/ (2020-11-09/ NR APPLICABLE/ NOT RESOLVED
Anaemia macrocytic/ Ongoing No 2020-11-13) CONCOMITANT
MACROCYTIC ANEMIA PROCEDURE

Fall/ 2020-11-08 No 2020-11-13) CONCOMITANT
FALL (41) MEDICATION

FDA-CBER-2022-908-0002168
206
Listing 16.2.7.7
Safety Set

Uterine leiomyoma/
MULTIPLE FIBROIDS
COVID-19 POSITIVE (95) MEDICATION

FDA-CBER-2022-908-0002169
207
Listing 16.2.7.7
Safety Set

Ear and labyrinth 2020-09-11 Yes/ 3 No NR/ DOSE NOT RECOVERED/
Vertigo/ 2020-09-13 No NONE
VERTIGO (27)
SYSTOLIC HYPERTENSION 2020-10-19 No NONE
(34)

FDA-CBER-2022-908-0002170
208
Listing 16.2.7.7
Safety Set

Subject ID: US3582033; Age (years): 76; Sex: M; Race: MULTIPLE: White, American Indian or Alaska Native; Height (cm): 171.2;
SARS-CoV-2 Nucleocapsid bAb: Negative; Dose 1 Date/Time: 24AUG2020:13:06:00; Follow-up Days after 1st
Dose: 215; Dose 2 Date/Time: 18SEP2020:09:06:00; Follow-up Days after 2nd Dose: 190
HIGH BLOOD PRESSURE 2020-09-04 07:31 No NONE
(11)
Subject ID: US3582082; Age (years): 49; Sex: F; Race: OTHER: LATINA; Height (cm): 155.7; Weight (kg): 86.1; BMI (kg/m2):
General disorders and 2020-09-29 12:00 Yes/ 3 No R/ NOT RECOVERED/
administration site (1)/ No/ R APPLICABLE/ RESOLVED
Fatigue/ (11)
FATIGUE

FDA-CBER-2022-908-0002171
209
Listing 16.2.7.7
Safety Set

SYSTOLIC HYPERTENSION 2020-10-08 No NONE
(35)

VERTIGO (11)

FDA-CBER-2022-908-0002172
210
Listing 16.2.7.7
Safety Set

Subject ID: US3582180; Age (years): 37; Sex: M; Race: MULTIPLE: Black or African American, Asian; Height (cm): 177.8; Weight
LOW BACK PAIN
EXACERBATION
White coat hypertension/ (1)/ No/ NR CHANGED/ RESOLVED
WORSENING OF WHITE COAT 2020-11-08 12:00 No NONE
HYPERTENSION (20)

FDA-CBER-2022-908-0002173
211
Listing 16.2.7.7
Safety Set

White coat hypertension/ (28)/ No/ NR CHANGED/ RESOLVED
WORSENING OF WHITE COAT 2021-01-07 16:00 No NONE
HYPERTENSION (81)
Endometrial hyperplasia/ 2021-03-16 No 2021-03-17) CONCOMITANT
ATYPICAL COMPLEX (183) MEDICATION,
HYPERPLASIA CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002174
212
Listing 16.2.7.7
Safety Set

Subject ID: US3602051; Age (years): 52; Sex: M; Race: OTHER: HISPANIC; Height (cm): 175.3; Weight (kg): 69.1; BMI (kg/m2):
Musculoskeletal chest (18)
pain/
RIB PAIN

FDA-CBER-2022-908-0002175
213
Listing 16.2.7.7
Safety Set

Infections and 2020-11-29 19:00 Yes/ 3 Yes/3 NR/ NOT RECOVERED/
COVID-19/ 2021-02-11 No 2020-12-20)/4 CONCOMITANT SEQUELAE:
SYMPTOMATIC COVID - 19 (116) MEDICATION, RECOVERING
CONCOMITANT WITH SEQUELAE
PROCEDURE WITH RESTING
TACHYCARDIA
AND EXERTIONAL
DYSPNEA AND
REQUIRING
NASAL OXYGEN
SUPPLEMENTATIO
N

FDA-CBER-2022-908-0002176
214
Listing 16.2.7.7
Safety Set

Skin cancer/
BACK SKIN CANCER
bAb: Negative; Dose 1 Date/Time: 11AUG2020:15:44:00; Follow-up Days after 1st Dose: 95; Dose 2 Date/Time:
; Follow-up Days after 2nd Dose: NA
Psychiatric disorders/ 2020-08-29 Yes/ 3 No NR/ DRUG RECOVERED/
Anxiety/ (19)/ Yes/ NR WITHDRAWN/ RESOLVED
(25) MEDICATION

FDA-CBER-2022-908-0002177
215
Listing 16.2.7.7
Safety Set

Hepatobiliary disorders/ 2020-11-29 Yes/ 3 No NR/ NOT NOT RECOVERED/
Hepatic cyst/ (63)/ Yes/ NR APPLICABLE/ NOT RESOLVED
LIVER CYST Ongoing No NONE
Transient global amnesia/ (75)/ Yes/ NR APPLICABLE/ RESOLVED
TGA PRESUMED (TRANSIENT 2021-01-02 No NONE
GLOBAL AMNESIA) (76)

Transient ischaemic (75)/ Yes/ NR APPLICABLE/ RESOLVED
attack/ 2021-01-02 No NONE
BRAIN TIA PRESUMED (76)

FDA-CBER-2022-908-0002178
216
Listing 16.2.7.7
Safety Set

Injury, poisoning and 2020-10-30 Yes/ 3 No NR/ DOSE NOT NOT RECOVERED/
procedural complications/ (30)/ Yes/ NR CHANGED/ NOT RESOLVED
Foot fracture/ Ongoing No CONCOMITANT
RIGHT CALCANEUS FRACTURE MEDICATION
Angina pectoris/ (35)/ Yes/ NR APPLICABLE/ RESOLVED
WORSENING ANGINA 2020-12-28 No CONCOMITANT
(41) MEDICATION

FDA-CBER-2022-908-0002179
217
Listing 16.2.7.7
Safety Set

Date/Time: 21OCT2020:10:52:00; Follow-up Days after 1st Dose: 157; Dose 2 Date/Time: ; Follow-up Days after 2nd Dose: NA
Musculoskeletal and 2020-10-27 Yes/ 3 No NR/ NOT RECOVERING/

connective tissue (7)/ Yes/ NR APPLICABLE/ RESOLVING
disorders/ Ongoing Yes CONCOMITANT
Arthralgia/ MEDICATION
SEVERE RIGHT ANKLE PAIN
Infections and 2020-11-06 Yes/ 3 No NR/ DOSE NOT NOT RECOVERED/

infestations/ (17)/ Yes/ NR CHANGED/ NOT RESOLVED
Cellulitis/ Ongoing No CONCOMITANT
RIGHT ANKLE CELLULITIS MEDICATION

FDA-CBER-2022-908-0002180
218
Listing 16.2.7.7
Safety Set

Vascular disorders/ 2020-11-06 Yes/ 3 Yes/3 NR/ DOSE NOT RECOVERED/

Hypotension/ (17)/ Yes/ (2020-11-06/ NR CHANGED/ RESOLVED
HYPOTENSION (1ST 2020-11-13 No 2020-11-26) CONCOMITANT
EPISODE) (24) MEDICATION

Encephalopathy/ (22)/ Yes/ NR APPLICABLE/ RESOLVED
DIFFUSE ENCEPHALOPATHY 2020-11-25 No NONE
(36)

FDA-CBER-2022-908-0002181
219
Listing 16.2.7.7
Safety Set


Dysphagia/ 2020-11-22 No NONE
DIFFICULTY SWALLOWING (33)
Vascular disorders/ 2020-11-21 Yes/ 3 Yes/3 NR/ DOSE NOT RECOVERED/

Hypotension/ (32)/ Yes/ (2020-11-06/ NR CHANGED/ RESOLVED
HYPOTENSION (2ND 2020-11-23 No 2020-11-26) CONCOMITANT
EPISODE) (34) MEDICATION

FDA-CBER-2022-908-0002182
220
Listing 16.2.7.7
Safety Set

Eye disorders/ 2020-09-22 Yes/ 3 No NR/ NOT RECOVERING/
Blepharitis/ (5)/ Yes/ NR APPLICABLE/ RESOLVING
BLEPHARITIS (RIGHT EYE) Ongoing No CONCOMITANT
MEDICATION,
CONCOMITANT
PROCEDURE
(28)

FDA-CBER-2022-908-0002183
221
Listing 16.2.7.7
Safety Set

(178)
Genital herpes/ 2020-11-09 No NONE
GENITAL HERPES (28)

FDA-CBER-2022-908-0002184
222
Listing 16.2.7.7
Safety Set

(9) MEDICATION
Muscle spasms/ (26)
CRAMPING

FDA-CBER-2022-908-0002185
223
Listing 16.2.7.7
Safety Set

Road traffic accident/ 2020-09-25 No NONE
MOTOR VEHICLE ACCIDENT (30)

CLOSED FRACTURE OF (138) MEDICATION,
MULTIPLE RIBS CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002186
224
Listing 16.2.7.7
Safety Set

Scapula fracture/ 2021-01-11 No CONCOMITANT
CLOSED FRACTURE OF BODY (138) MEDICATION,
OF RIGHT SCAPULA CONCOMITANT
PROCEDURE
LEFT HIP PROCEDURE

FDA-CBER-2022-908-0002187
225
Listing 16.2.7.7
Safety Set

Gastritis/ 2020-09-06 No NONE
GASTRITIS (7)
FALL (ACCIDENTAL) (60) PROCEDURE

FDA-CBER-2022-908-0002188
226
Listing 16.2.7.7
Safety Set

HIP FRACTURE S/P FALL (63) MEDICATION,
CONCOMITANT
PROCEDURE
COVID19 (103) MEDICATION

FDA-CBER-2022-908-0002189
227
Listing 16.2.7.7
Safety Set

Eye disorders/ 2020-09-23 Yes/ 3 No NR/ DOSE NOT RECOVERED/
Blindness/ (21)/ Yes/ NR CHANGED/ RESOLVED
50% VISION LOSS RIGHT 2020-10-01 No NONE
EYE DUE TO FLOATER (29)
Urticaria/ 2020-12-23 No CONCOMITANT
GENERALIZED HIVES (77) MEDICATION
(URTICARIA)

FDA-CBER-2022-908-0002190
228
Listing 16.2.7.7
Safety Set

ASTHMA EXACERBATION
RELATED TO COVID19
INFECTION

FDA-CBER-2022-908-0002191
229
Listing 16.2.7.7
Safety Set

Immune system disorders/ 2020-10-16 Yes/ 3 No NR/ NOT RECOVERED/
Drug hypersensitivity/ (7)/ Yes/ NR APPLICABLE/ RESOLVED
ALLERGIC REACTION TO 2020-10-16 No CONCOMITANT
AUGMENTIN (7) MEDICATION,
CONCOMITANT
PROCEDURE
Benign prostatic 2021-01-12 No CONCOMITANT
hyperplasia/ (121) PROCEDURE
BENIGN PROSTATIC
HYPERPLASIA

FDA-CBER-2022-908-0002192
230
Listing 16.2.7.7
Safety Set

WORSENING HYPERTENSION 2020-09-25 12:01 No NONE
(ELEVATED BLOOD PRESSURE (30)
AT DAY 29)

Trigeminal neuralgia/ (75)/ Yes/ NR APPLICABLE/ RESOLVED
TRIGEMINAL NEURALGIA 2020-12-08 No CONCOMITANT
(POST DENTAL (75) MEDICATION
APPOINTMENT)

FDA-CBER-2022-908-0002193
231
Listing 16.2.7.7
Safety Set

WORSENING HYPERTENSION 2021-01-13 12:54 No NONE
(ELEVATED BLOOD (111)
PRESSURE)
BMI (kg/m2): 36.4; Baseline SARS-CoV-2 Status: Positive; Baseline RT-PCR: Negative; Baseline Elecsys SARS-CoV-2 Nucleocapsid
bAb: Positive; Dose 1 Date/Time: 21SEP2020:12:44:00; Follow-up Days after 1st Dose: 187; Dose
Respiratory rate (36)/ No/ NR APPLICABLE/ NOT RESOLVED
ELEVATED RESPIRATION
(ASYMPTOMATIC)

FDA-CBER-2022-908-0002194
232
Listing 16.2.7.7
Safety Set

Appendicitis/ 2020-09-09 No 2020-09-10)/6 CONCOMITANT
ACUTE APPENDICITIS (9) MEDICATION,
CONCOMITANT
PROCEDURE

Abdominal pain/ 2020-09-10 No 2020-09-10) CONCOMITANT
ABDOMINAL PAIN (10) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002195
233
Listing 16.2.7.7
Safety Set

Subject ID: US3662124; Age (years): 37; Sex: M; Race: OTHER: PERUVIAN; Height (cm): 168.0; Weight (kg): 70.9; BMI (kg/m2):
Procedural complication/ 2020-11-12 No CONCOMITANT
PERFORATION OF ROOT (24) MEDICATION
CANAL SPACE DUE TO
ENDODONTIC TREATMENT
Ear and labyrinth 2020-12-28 Yes/ 3 No NR/ NOT NOT RECOVERED/
Vertigo/ Ongoing No CONCOMITANT
VERTIGO MEDICATION

FDA-CBER-2022-908-0002196
234
Listing 16.2.7.7
Safety Set

Asthenia/ (69)
GENERALIZED WEAKNESS
Negative; Dose 1 Date/Time: 05OCT2020:14:33:00; Follow-up Days after 1st Dose: 173; Dose 2
infestations/ (22)/ Yes/ NR APPLICABLE/ RESOLVED WITH
COVID-19/ 2020-12-14 No CONCOMITANT SEQUELAE:
SYMPTOMATIC COVID-19 (43) MEDICATION, AE ADDED OF
CONCOMITANT MULTISYSTEM
PROCEDURE INFLAMMATORY
SYNDROME

FDA-CBER-2022-908-0002197
235
Listing 16.2.7.7
Safety Set

Subject ID: US3662181; Age (years): 61; Sex: M; Race: MULTIPLE: White, Black or African American; Height (cm): 171.5; Weight
Schizoaffective disorder/ (5)/ Yes/ (2020-10-26/ NR CHANGED/ RESOLVED
SCHIZOAFFECTIVE 2020-10-30 No 2020-10-30) NONE
DISORDERS, WORSENING (9)
Investigations/ 2020-09-21 Yes/ 3 No NR/ DRUG RECOVERED/

Blood pressure diastolic (34)/ No/ NR WITHDRAWN/ RESOLVED
increased/ 2020-10-17 No CONCOMITANT
ELEVATED DIASTOLIC BLOOD (60) MEDICATION
PRESSURE

FDA-CBER-2022-908-0002198
236
Listing 16.2.7.7
Safety Set

Subject ID: US3672199; Age (years): 71; Sex: M; Race: WHITE; Height (cm): ; Weight (kg): ; BMI (kg/m2): ; Baseline SARS-CoV-2
Post procedural 2020-10-08 No 2020-10-08) NONE
haematoma/ (21)
HEMATOMA R GROIN
FOLLOWING ANGIOPLASTY
Vascular disorders/ 2021-01-20 00:00 Yes/ 3 No NR/ NOT RECOVERING/
Hypertension/ (119)/ No/ NR APPLICABLE/ RESOLVING
HYPERTENSION

FDA-CBER-2022-908-0002199
237
Listing 16.2.7.7
Safety Set

Dizziness/ (14)/ Yes/ NR CHANGED/ RESOLVED
DIZZINESS 2020-10-01 No NONE
(15)

Asthenia/ (18)

FDA-CBER-2022-908-0002200
238
Listing 16.2.7.7
Safety Set

LIGHTHEADEDNESS 2020-10-04 No NONE
(18)
Gastric ulcer 2020-12-16 No 2020-12-16) CONCOMITANT
BLEEDING GASTRIC ULCER CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002201
239
Listing 16.2.7.7
Safety Set

HYPERTENSION 2021-03-17 No NONE
(171)
WORSENING OF BACK PAIN

FDA-CBER-2022-908-0002202
240
Listing 16.2.7.7
Safety Set

(29)
Bacterial vaginosis/ 2020-10-03 No NONE
BACTERIAL VAGINOSIS (29)

FDA-CBER-2022-908-0002203
241
Listing 16.2.7.7
Safety Set

(56)
Ear and labyrinth 2021-01-12 Yes/ 3 No NR/ NOT RECOVERED/
disorders/ (100)/ No/ NR APPLICABLE/ RESOLVED
Eustachian tube 2021-01-13 No NONE
dysfunction/ (101)
EUSTACHIAN TUBE
DYSFUNCTION, RIGHT EAR.

FDA-CBER-2022-908-0002204
242
Listing 16.2.7.7
Safety Set

Vascular disorders/ 2020-10-08 Yes/ 3 No R/ DOSE NOT RECOVERED/
Diastolic hypertension/ (29)/ No/ R CHANGED/ RESOLVED
DIASTOLIC HYPERTENSION 2020-10-16 No NONE
(37)
Hypotension/ (92)/ No/ NR APPLICABLE/ RESOLVED
HYPOTENSION 2021-01-28 No NONE
(113)

FDA-CBER-2022-908-0002205
243
Listing 16.2.7.7
Safety Set

Subject ID: US3692117; Age (years): 47; Sex: F; Race: OTHER: HISPANIC; Height (cm): 154.4; Weight (kg): 74.3; BMI (kg/m2):
Fungal infection/ 2020-10-11 No CONCOMITANT
YEAST INFECTION (26) MEDICATION
Dose 1 Date/Time: 18SEP2020:12:46:00; Follow-up Days after 1st Dose: 180; Dose 2 Date/Time:
(36)

FDA-CBER-2022-908-0002206
244
Listing 16.2.7.7
Safety Set

Cardiac disorders/ 2020-10-23 14:58 Yes/ 3 No NR/ NOT RECOVERED/
Bradycardia/ (1)/ No/ NR APPLICABLE/ RESOLVED
(28)
Gastrointestinal 2020-11-04 Yes/ 3 No NR/ NOT NOT RECOVERED/

Gastrooesophageal reflux Ongoing No CONCOMITANT
disease/ MEDICATION
GASTROESOPHAGEAL REFLUX
DISEASE

FDA-CBER-2022-908-0002207
245
Listing 16.2.7.7
Safety Set

Psychiatric disorders/ 2020-11-02 Yes/ 3 No NR/ DOSE NOT NOT RECOVERED/
Anxiety/ (18)/ Yes/ NR CHANGED/ NOT RESOLVED
ANXIETY Ongoing No CONCOMITANT
MEDICATION

Depression/ (18)/ Yes/ NR CHANGED/ NOT RESOLVED
DEPRESSION Ongoing No CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0002208
246
Listing 16.2.7.7
Safety Set

(29)
Drug hypersensitivity/ (19)/ Yes/ NR CHANGED/ RESOLVED
MACROBID ALLERGIC 2020-11-09 No CONCOMITANT
REACTION (19) MEDICATION

FDA-CBER-2022-908-0002209
247
Listing 16.2.7.7
Safety Set

Food allergy/ (48)/ No/ NR CHANGED/ RESOLVED
ALLERGIC REACTION TO 2020-12-08 No CONCOMITANT
FOOD (NEW ALLERGIES) (48) MEDICATION
Subject ID: US3702051; Age (years): 43; Sex: F; Race: UNKNOWN; Height (cm): 168.7; Weight (kg): 123.2; BMI (kg/m2): 43.3;
RGHT KNEE PAIN (POST (51) MEDICATION
ARTHROSCOPIC SURGERY ON
10/22/2020)

FDA-CBER-2022-908-0002210
248
Listing 16.2.7.7
Safety Set

Joint swelling/ (51) MEDICATION
RIGHT KNEE SWELLING

RASH/HIVES (EXACERBATION (99) MEDICATION
OF BASELINE CONDITION
SEASONAL ALLERGIES)

FDA-CBER-2022-908-0002211
249
Listing 16.2.7.7
Safety Set

Neoplasms benign, 2020-10-01 Yes/ 3 Yes/2/3 NR/ NOT RECOVERED/
unspecified (incl cysts 2020-11-13 No 2020-11-14)/6 CONCOMITANT
Prostate cancer/ CONCOMITANT
PROGRESSION PROSTATE PROCEDURE
CANCER

FDA-CBER-2022-908-0002212
250
Listing 16.2.7.7
Safety Set

and polyps)/ (178) MEDICATION, INCREASED
Prostate cancer CONCOMITANT PAIN, OSSEOUS
metastatic/ PROCEDURE METASTASES,
METASTATIC CASTRATE MULTIPLE BONY
SENSITIVE PROSTRATE LYTIC LESIONS,
CANCER WITH METASTASES T9 AND T12 FOR
PAIN
MANAGEMENT

FDA-CBER-2022-908-0002213
251
Listing 16.2.7.7
Safety Set

POSITIVE COVID 19 (125) MEDICATION,
CONCOMITANT
PROCEDURE

WORSENING OF COVID-19 (119) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002214
252
Listing 16.2.7.7
Safety Set

COVID-19 PNEUMONIA (119) MEDICATION
Musculoskeletal and 2020-08-15 Yes/ 3 No R/ DOSE NOT RECOVERED/
Arthralgia/ (11)
JOINT ACHES BILATERAL
LEGS

FDA-CBER-2022-908-0002215
253
Listing 16.2.7.7
Safety Set

JOINT ACHES, LEFT HIP
conditions/ 2020-10-21 No 2020-10-21) CONCOMITANT
Incarcerated hernia/ (35) MEDICATION,
ACUTE INCARCERATED LEFT CONCOMITANT
HERNIA LOWER QUADRANT PROCEDURE

FDA-CBER-2022-908-0002216
254
Listing 16.2.7.7
Safety Set

Urinary retention/ 2020-10-26 No 2020-10-21) CONCOMITANT
ACUTE URINARY RETENTION (40) MEDICATION,
CONCOMITANT
PROCEDURE

PULMONARY EMBOLISM

FDA-CBER-2022-908-0002217
255
Listing 16.2.7.7
Safety Set

Urinary tract infection/ 2020-11-10 No 2020-10-28) CONCOMITANT
URINARY TRACT INFECTION (55) MEDICATION,
CONCOMITANT
PROCEDURE
Hypertension/ (1)/ Yes/ R CHANGED/ RESOLVED
(49)

FDA-CBER-2022-908-0002218
256
Listing 16.2.7.7
Safety Set

Vascular disorders/ 2021-01-15 Yes/ 3 Yes/3 NR/ NOT RECOVERING/
Deep vein thrombosis/ (109)/ Yes/ (2021-01-29/ NR APPLICABLE/ RESOLVING
DEEP VEIN THROMBOSIS - Ongoing No 2021-01-31) CONCOMITANT
RIGHT LEG MEDICATION
Subject ID: US3732304; Age (years): 55; Sex: F; Race: MULTIPLE: White, Black or African American; Height (cm): 167.0; Weight
Nucleocapsid bAb: Negative; Dose 1 Date/Time: 09SEP2020:16:07:00; Follow-up Days after 1st Dose:
199; Dose 2 Date/Time: 07OCT2020:14:26:00; Follow-up Days after 2nd Dose: 171
and mediastinal (19)/ Yes/ (2020-10-29/ NR APPLICABLE/ RESOLVED WITH
Pulmonary embolism/ (191) MEDICATION SHORTNESS OF
BILATERAL PULMONARY BREATH OR
EMBOLISM EXERTION WHEN
BENDING DOWN

FDA-CBER-2022-908-0002219
257
Listing 16.2.7.7
Safety Set

Presyncope/ (1)/ No/ NR CHANGED/ RESOLVED
VASOVAGAL EPISODE 2020-10-15 No NONE
(1)
HYPTERTENSION 2020-11-16 No NONE
(56)
Aortic aneurysm/ (17)/ Yes/ NR APPLICABLE/ NOT RESOLVED
THORACIC ANEURYSM Ongoing No NONE

FDA-CBER-2022-908-0002220
258
Listing 16.2.7.7
Safety Set

Abdominal pain/ 2020-10-02 No CONCOMITANT
ABDOMINAL PAIN (11) MEDICATION
Dose 1 Date/Time: 31AUG2020:15:48:00; Follow-up Days after 1st Dose: 208; Dose 2

FDA-CBER-2022-908-0002221
259
Listing 16.2.7.7
Safety Set

Sinusitis/ 2020-12-11 No CONCOMITANT
SINUSITIS (77) MEDICATION

FDA-CBER-2022-908-0002222
260
Listing 16.2.7.7
Safety Set

Cardiac disorders/ 2020-11-26 Yes/ 3 No NR/ NOT NOT RECOVERED/
Cardiac failure (49)/ Yes/ NR APPLICABLE/ NOT RESOLVED
congestive/ Ongoing No NONE
DIASTOLIC CONGESTIVE
HEART FAILURE

failure/
ACUTE HYPOXEMIC
RESPIRATORY FAILURE

FDA-CBER-2022-908-0002223
261
Listing 16.2.7.7
Safety Set

(124)
Major depression/ (6)/ Yes/ (2020-09-16/ NR CHANGED/ RESOLVED
MAJOR DEPRESSIVE 2020-09-17 No 2020-09-17) NONE
DISORDER WITHOUT (7)
PSYCHOTIC FEATURES

FDA-CBER-2022-908-0002224
262
Listing 16.2.7.7
Safety Set

Subject ID: US3742364; Age (years): 64; Sex: M; Race: NOT REPORTED; Height (cm): 165.1; Weight (kg): 74.8; BMI (kg/m2): 27.4;
SYNCOPE 2021-01-11 No 2021-01-11) NONE
(89)

FDA-CBER-2022-908-0002225
263
Listing 16.2.7.7
Safety Set

Diverticulitis/ 2020-11-09 No 2020-11-09) CONCOMITANT SEQUELAE:
DIVERTICULITIS (28) MEDICATION, AS OF 08 DEC
CONCOMITANT 2020,
PROCEDURE PARTICIPANT
STILL WITH
TEMPORARY
COLOSTOMY.
WILL GO BACK
FOR REVERSAL.

FDA-CBER-2022-908-0002226
264
Listing 16.2.7.7
Safety Set

Subject ID: US3742395; Age (years): 61; Sex: M; Race: OTHER: MULATO; Height (cm): 185.4; Weight (kg): 97.5; BMI (kg/m2):
Vascular disorders/ 2020-09-25 Yes/ 3 No NR/ DRUG RECOVERED/
Deep vein thrombosis/ (9)/ Yes/ NR WITHDRAWN/ RESOLVED WITH
DEEP VEIN THROMBOSIS 2021-02-15 No CONCOMITANT SEQUELAE:
(152) MEDICATION HAD FOLLOW-UP
VISIT IN
FEBRUARY, DR.
TOLD HIM THIS
IS A CHRONIC
CONDITION AND
HE WOULD BE
TAKING ELIQUIS
FOR LIFE.

FDA-CBER-2022-908-0002227
265
Listing 16.2.7.7
Safety Set

NEW LOSS OF SMELL 2020-12-22 No NONE
(91)

(91) MEDICATION

FDA-CBER-2022-908-0002228
266
Listing 16.2.7.7
Safety Set

Clear cell renal cell
carcinoma/
CLEAR CELL RENAL
CARCINOMA

FDA-CBER-2022-908-0002229
267
Listing 16.2.7.7
Safety Set

Post-traumatic pain/ Ongoing No NONE
BACK PAIN RELATED TO CAR
ACCIDENT

Lumbar vertebral 2020-09-16 No CONCOMITANT
fracture/ (1) MEDICATION,
CLOSED FRACTURE OF 2ND CONCOMITANT
AND 3RD LUMBAR PROCEDURE

FDA-CBER-2022-908-0002230
268
Listing 16.2.7.7
Safety Set

Injury, poisoning and 2020-09-16 14:00 Yes/ 3 No NR/ NOT RECOVERED/
Road traffic accident/ 2020-09-16 14:05 No CONCOMITANT
MOTOR VEHICLE ACCIDENT (1) MEDICATION,
CONCOMITANT
PROCEDURE
(11) MEDICATION

FDA-CBER-2022-908-0002231
269
Listing 16.2.7.7
Safety Set

Dyspnoea/ (98) MEDICATION
DIFFICULTY BREATHING
Tibia fracture/ 2020-09-03 No CONCOMITANT
FRACTURED TIBIA (25) MEDICATION

FDA-CBER-2022-908-0002232
270
Listing 16.2.7.7
Safety Set

General disorders and 2020-09-04 Yes/ 3 Yes/3 NR/ DRUG NOT RECOVERED/
administration site (24)/ Yes/ (2020-09-05/ NR WITHDRAWN/ NOT RESOLVED
conditions/ Ongoing No 2020-09-14) CONCOMITANT
Incarcerated hernia/ MEDICATION,
ACUTE INCARCERATED CONCOMITANT
VENTRAL HERNIA PROCEDURE
Renal and urinary 2020-09-05 Yes/ 3 No NR/ DOSE RECOVERED/

disorders/ (25)/ Yes/ NR DELAYED/ RESOLVED
Acute kidney injury/ 2020-09-14 No NONE
ACUTE KIDNEY INJURY (34)

FDA-CBER-2022-908-0002233
271
Listing 16.2.7.7
Safety Set

Appendiceal abscess/ 2020-12-07 No CONCOMITANT
APPENDICEAL ABSCESS (69) PROCEDURE

Appendicitis/ 2020-12-07 No ) CONCOMITANT
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002234
272
Listing 16.2.7.7
Safety Set

Neoplasms benign, / Yes/ 3 No NR/ NOT RECOVERED/
malignant and 2021-04-08 Yes/ NR APPLICABLE/ RESOLVED
unspecified (incl cysts (234) No CONCOMITANT
Basal cell carcinoma/
FOREHEAD BASAL CELL
CARCINOMA

FDA-CBER-2022-908-0002235
273
Listing 16.2.7.7
Safety Set

Subject ID: US3782050; Age (years): 30; Sex: M; Race: MULTIPLE: White, Asian; Height (cm): 188.0; Weight (kg): 94.7; BMI
COVID-19/ 2020-12-23 No NONE
SYMPTOMATIC COVID-19 (94)

FDA-CBER-2022-908-0002236
274
Listing 16.2.7.7
Safety Set

Skin and subcutaneous 2020-08-28 Yes/ 3 No NR/ DRUG NOT RECOVERED/

tissue disorders/ (5)/ Yes/ NR WITHDRAWN/ NOT RESOLVED
Angioedema/ Ongoing No CONCOMITANT
ANGIODEMA MEDICATION

FDA-CBER-2022-908-0002237
275
Listing 16.2.7.7
Safety Set

MEDICATION
Atrial fibrillation/ (84)/ Yes/ NR APPLICABLE/ NOT RESOLVED
ATRIAL FIBRILLATION Ongoing No CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0002238
276
Listing 16.2.7.7
Safety Set

SYMPTOMATIC COVID 19 (49) MEDICATION SEE AE 5,6,7.
PARTICIPANT
STATES THAT
SHE STILL HAS
RASH, POSSIBLE
PERIPHERAL
NEUROPATHY,
AND OCCASIONAL
CARDIAC
PALPITATIONS;
09DEC2020 SEE
AE 8,9

FDA-CBER-2022-908-0002239
277
Listing 16.2.7.7
Safety Set

Hypertension/ (1)/ Yes/ NR CHANGED/ NOT RESOLVED

FDA-CBER-2022-908-0002240
278
Listing 16.2.7.7
Safety Set

Squamous cell carcinoma
of skin/
SQUAMOUS CELL
CARCINOMA-SCALP

FDA-CBER-2022-908-0002241
279
Listing 16.2.7.7
Safety Set

Sciatica/ (102)/ Yes/ NR APPLICABLE/ RESOLVED
RIGHT SIDED SCIATICA 2020-12-30 No NONE
(111)
RIGHT UPPER QUAD PAIN PROCEDURE

FDA-CBER-2022-908-0002242
280
Listing 16.2.7.7
Safety Set

Infections and 2020-11-13 Yes/ 3 No NR/ NOT UNKNOWN
infestations/ (51)/ Yes/ NR APPLICABLE/
COVID-19/ Ongoing No CONCOMITANT
SYMPTOMATIC COVID-19 MEDICATION
Phrenic nerve injury/ Ongoing No CONCOMITANT
PHRENIC NERVE DAMAGE MEDICATION

FDA-CBER-2022-908-0002243
281
Listing 16.2.7.7
Safety Set

Cardiac failure/ (7)/ Yes/ (2020-09-09/ NR APPLICABLE/ RESOLVED WITH
HEART FAILURE 2020-09-12 No 2020-09-12) CONCOMITANT SEQUELAE:
(10) MEDICATION CONTINUING ON
OXYGEN
WORSENING OF ASTHMA

FDA-CBER-2022-908-0002244
282
Listing 16.2.7.7
Safety Set

Asthma/ (16)
WORSENING OF ASTHMA

and mediastinal (22)/ No/ NR APPLICABLE/ RESOLVED
WORSENING OF ASTHMA

FDA-CBER-2022-908-0002245
283
Listing 16.2.7.7
Safety Set

tissue disorders/ (23)/ No/ NR APPLICABLE/ RESOLVED WITH
Urticaria/ 2020-10-10 No CONCOMITANT SEQUELAE:
URTICARIAL RASH, (31) MEDICATION CORTISONE AND
GENERALIZED BENEDRYL
Infections and 2020-09-03 08:00 Yes/ 3 Yes/3 NR/ DOSE RECOVERED/
Urinary tract infection/ 2020-09-06 No 2020-09-06) CONCOMITANT

FDA-CBER-2022-908-0002246
284
Listing 16.2.7.7
Safety Set

Myocardial infarction/ (106)/ Yes/ (2020-12-28/ NR APPLICABLE/ RESOLVED
MYOCARDIAL INFARCTION 2021-01-09 No 2021-01-09) CONCOMITANT
(118) MEDICATION,
CONCOMITANT
PROCEDURE
WORSENING OF HEADACHE 2020-09-26 Yes CONCOMITANT
(10) MEDICATION

FDA-CBER-2022-908-0002247
285
Listing 16.2.7.7
Safety Set

breast disorders/ (21)/ No/ NR CHANGED/ RESOLVED WITH
Dysmenorrhoea/ 2020-09-17 No CONCOMITANT SEQUELAE:
EXTREME MENSTRUAL (22) MEDICATION PATIENT TOOK
CRAMPING PAMPRIN
MULTI-SYMPTOM
Hypertensive emergency/ (4)/ Yes/ (2020-08-31/ NR APPLICABLE/ RESOLVED
HYPERTENSIVE EMERGENCY 2020-09-02 No 2020-09-02) CONCOMITANT
(6) MEDICATION

FDA-CBER-2022-908-0002248
286
Listing 16.2.7.7
Safety Set


ST ELEVATION MYOCARDIAL (46) MEDICATION,
INFARCTION (UNSPECIFIED CONCOMITANT
ARTERY) PROCEDURE
Neoplasms benign, / Yes/ 3 Yes/6 NR/ NOT RECOVERED/
malignant and 2021-01-18 Yes/ NR APPLICABLE/ RESOLVED
unspecified (incl cysts (162) No CONCOMITANT
Endometrial cancer/
ENDOMETRIOID CARCINOMA

FDA-CBER-2022-908-0002249
287
Listing 16.2.7.7
Safety Set

pulmonary disease/
COPD EXACERBATION
BACK PAIN

FDA-CBER-2022-908-0002250
288
Listing 16.2.7.7
Safety Set

Hypertension/ (30)/ Yes/ NR WITHDRAWN/ RESOLVED
HYPERTENSION 2020-10-15 No CONCOMITANT
(46) MEDICATION
Subject ID: US3862099; Age (years): 51; Sex: M; Race: NOT REPORTED; Height (cm): 186.7; Weight (kg): 115.5; BMI (kg/m2):
Negative; Dose 1 Date/Time: 31AUG2020:16:23:00; Follow-up Days after 1st Dose: 208; Dose 2
Flank pain/ (196) MEDICATION,
LEFT FLANK PAIN CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002251
289
Listing 16.2.7.7
Safety Set

WORSENING OF BRONCHITIS (33) MEDICATION
Confusional state/ (47)/ Yes/ NR APPLICABLE/ RESOLVED
CONFUSION 2020-10-19 No NONE
(48)

FDA-CBER-2022-908-0002252
290
Listing 16.2.7.7
Safety Set

Pyelonephritis/ 2020-10-23 No 2020-10-23) CONCOMITANT
PYELONEPHRITIS (52) MEDICATION
pain/
LOCALIZE MUSCULOSKELETAL
DISCOMFORT CHEST

FDA-CBER-2022-908-0002253
291
Listing 16.2.7.7
Safety Set

Gout/ 2021-01-09 No CONCOMITANT
GOUT FLARE UP RIGHT KNEE (128) MEDICATION
Musculoskeletal and 2020-09-14 Yes/ 3 No NR/ NOT NOT RECOVERED/
connective tissue (7)/ No/ NR APPLICABLE/ NOT RESOLVED
disorders/ Ongoing No NONE
Intervertebral disc
degeneration/
EXACERBATION DDD / BACK
PAIN

FDA-CBER-2022-908-0002254
292
Listing 16.2.7.7
Safety Set

Aortic stenosis/ (65)/ Yes/ NR CHANGED/ RESOLVED
AORTIC STENOSIS 2021-03-02 No CONCOMITANT
(176) PROCEDURE


FDA-CBER-2022-908-0002255
293
Listing 16.2.7.7
Safety Set

Ear and labyrinth 2020-08-31 Yes/ 3 No NR/ DRUG RECOVERED/

disorders/ (21)/ Yes/ NR WITHDRAWN/ RESOLVED
VERTIGO (21)
Gastrointestinal 2020-08-31 Yes/ 3 No NR/ DRUG RECOVERED/

Retching/ 2020-08-31 No NONE
DRY HEAVES (21)
Investigations/ 2020-12-28 Yes/ 3 Yes/3 NR/ NOT RECOVERING/
Transaminases increased/ (105)/ Yes/ (2021-01-13/ NR APPLICABLE/ RESOLVING
TRANSAMINITIS Ongoing No 2021-01-17) NONE

FDA-CBER-2022-908-0002256
294
Listing 16.2.7.7
Safety Set

Flank pain/ (123) MEDICATION
FLANK PAIN (LEFT SIDE
SPREAD TO RIGHT SIDE AND
AROUND TO RIGHT UPPER
QUADRANT POSTERIOR)

Pyelonephritis/ 2021-01-22 No 2021-01-17) CONCOMITANT

FDA-CBER-2022-908-0002257
295
Listing 16.2.7.7
Safety Set


ACUTE BRONCHITIS (46) MEDICATION
SARS-CoV-2 Status: ; Baseline RT-PCR: ; Baseline Elecsys SARS-CoV-2 Nucleocapsid bAb: Negative; Dose 1 Date/Time:
Metabolism and nutrition 2020-12-31 Yes/ 3 No NR/ DOSE NOT RECOVERING/
Vitamin D deficiency/ Ongoing No NONE
VITAMIN D DEFICIENCY

FDA-CBER-2022-908-0002258
296
Listing 16.2.7.7
Safety Set

Infections and 2020-09-03 Yes/ 3 No NR/ DOSE NOT RECOVERING/
infestations/ (14)/ Yes/ NR CHANGED/ RESOLVING
Gingivitis/ Ongoing No CONCOMITANT
WORESNING OF GINGIVITIS MEDICATION
LACERATION LEFT HAND 5TH (102) MEDICATION,
DIGIT CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002259
297
Listing 16.2.7.7
Safety Set

Arthritis/ (28) MEDICATION,
WORSENING OF LEFT CONCOMITANT
SHOULDER ULNOHUMERAL PROCEDURE
ARTHRITIS
BROKEN BONE IN RIGHT (72) MEDICATION
FOOT

FDA-CBER-2022-908-0002260
298
Listing 16.2.7.7
Safety Set

SPRAINED RIGHT ANKLE (72) MEDICATION
Gingivitis/ 2020-10-14 No CONCOMITANT
GUM INFECTION (45) MEDICATION

FDA-CBER-2022-908-0002261
299
Listing 16.2.7.7
Safety Set

RIGHT FIFTH METATARSAL (100) MEDICATION,
SHAFT FRACTURE CONCOMITANT
PROCEDURE
RIGHT KNEE TORN MENISCUS (93) MEDICATION

FDA-CBER-2022-908-0002262
300
Listing 16.2.7.7
Safety Set

Subject ID: US3882034; Age (years): 34; Sex: M; Race: MULTIPLE: White, Other: MIXED; Height (cm): 172.7; Weight (kg): 92.7;
bAb: Negative; Dose 1 Date/Time: 05OCT2020:14:15:00; Follow-up Days after 1st Dose: 79; Dose 2 Date/Time:
Musculoskeletal and 2020-10-30 Yes/ 3 No NR/ DOSE NOT RECOVERING/
connective tissue (26)/ Yes/ NR CHANGED/ RESOLVING
Back pain/ MEDICATION
WORSENING LOW BACK PAIN
GENERALIZED MYALGIA

FDA-CBER-2022-908-0002263
301
Listing 16.2.7.7
Safety Set

GENERALIZED ARTHRALGIA

Fatigue/ (15)
FATIGUE

FDA-CBER-2022-908-0002264
302
Listing 16.2.7.7
Safety Set

COVID-19 pneumonia/ 2021-01-03 No CONCOMITANT SEQUELAE:
COVID - 19 PNEUMONIA (91) MEDICATION DYSPNEA ON
EXERTION.

FDA-CBER-2022-908-0002265
303
Listing 16.2.7.7
Safety Set


MEDICATION
HYPERTENSION- GRADE 3 (1)

FDA-CBER-2022-908-0002266
304
Listing 16.2.7.7
Safety Set

Cardiac disorders/ 2020-09-24 Yes/ 3 No NR/ DOSE RECOVERED/

Cardiac failure (30)/ Yes/ NR DELAYED/ RESOLVED
congestive/ 2020-10-23 No NONE
WORSENING OF CONGESTIVE (59)
HEART FAILURE
Vascular disorders/ 2020-09-24 Yes/ 3 No NR/ DOSE RECOVERED/

Hypertension/ (30)/ Yes/ NR DELAYED/ RESOLVED
HYPERTENSION (59)

FDA-CBER-2022-908-0002267
305
Listing 16.2.7.7
Safety Set

Hypertension/ (1)/ No/ R CHANGED/ RESOLVED
HYPERTENSION (GRADE 3) 2020-09-25 11:54 No NONE
(1)
Gastrointestinal / Yes/ 3 No NR/ DOSE NOT RECOVERED/

disorders/ 2021-04-07 Yes/ NR CHANGED/ RESOLVED
Abdominal hernia/ (223) No CONCOMITANT

FDA-CBER-2022-908-0002268
306
Listing 16.2.7.7
Safety Set

GRADE 3 HYPERTENSION 2021-01-08 12:41 No NONE
(102)
HYPERTENSION (WORSENING 2020-09-24 No CONCOMITANT
OF) (25) MEDICATION

FDA-CBER-2022-908-0002269
307
Listing 16.2.7.7
Safety Set

HYPERTENSION (WORSENING Ongoing No NONE
OF)
Blood pressure systolic (1)/ No/ R CHANGED/ RESOLVED
PRESSURE GRADE 3

FDA-CBER-2022-908-0002270
308
Listing 16.2.7.7
Safety Set

PRESSURE GRADE 3
HYPERTENSION (WORSENING 2020-09-01 13:11 No NONE
OF) (1)

FDA-CBER-2022-908-0002271
309
Listing 16.2.7.7
Safety Set

HYPERTENSION (28)

(28)

FDA-CBER-2022-908-0002272
310
Listing 16.2.7.7
Safety Set

HYPERTENSION 2021-03-01 13:01 No CONCOMITANT
(181) MEDICATION
(1)

FDA-CBER-2022-908-0002273
311
Listing 16.2.7.7
Safety Set

HYPERTENSION (1)

FDA-CBER-2022-908-0002274
312
Listing 16.2.7.7
Safety Set

Vascular disorders/ 2020-10-01 13:42 Yes/ 3 No R/ NOT RECOVERED/
WORSENING 2020-10-01 13:52 No NONE
HYPERTENSION-GRADE 3 (1)

HYPERTENSION, WORSENING 2020-11-18 No NONE
(49)

FDA-CBER-2022-908-0002275
313
Listing 16.2.7.7
Safety Set

(1)

(1)

FDA-CBER-2022-908-0002276
314
Listing 16.2.7.7
Safety Set

Atrial fibrillation/ (76)/ Yes/ (2020-12-18/ NR APPLICABLE/ RESOLVED
PAROXYSMAL ATRIAL 2020-12-25 No 2020-12-28) CONCOMITANT
Subject ID: US3912124; Age (years): 55; Sex: F; Race: AMERICAN INDIAN OR ALASKA NATIVE; Height (cm): 160.0; Weight (kg):
Vascular disorders/ 2020-10-07 Yes/ 3 No NR/ DOSE RECOVERED/
Hypertension/ (30)/ No/ NR DELAYED/ RESOLVED
HYPERTENSION GRADE 3 2020-10-07 No NONE
(30)

FDA-CBER-2022-908-0002277
315
Listing 16.2.7.7
Safety Set

Subject ID: US3912163; Age (years): 43; Sex: M; Race: OTHER: ARABIC; Height (cm): 181.6; Weight (kg): 120.0; BMI (kg/m2):
HYPERTENSION (28)
Cardiac disorders/ 2021-02-01 Yes/ 3 Yes/2/3 NR/ NOT RECOVERED/

NSTEMI-NON ST-ELEVATION (113) MEDICATION,
MYOCARDIAL INFARCTION CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002278
316
Listing 16.2.7.7
Safety Set

MEDICATION

FDA-CBER-2022-908-0002279
317
Listing 16.2.7.7
Safety Set

Schizophrenia/ (51)/ Yes/ (2020-12-01/ NR APPLICABLE/ RESOLVED
WORSENING OF 2020-12-04 No 2020-12-04) NONE
SCHIZOPHRENIA PSYCHOTIC (54)
DISORDER

Confusional state/ (7)/ Yes/ (2020-09-07/ NR WITHDRAWN/ RESOLVED
CONFUSION 2020-09-09 No 2020-09-09) CONCOMITANT
(9) PROCEDURE

FDA-CBER-2022-908-0002280
318
Listing 16.2.7.7
Safety Set

disorders/ (30)/ Yes/ (2020-10-20/ NR APPLICABLE/ RESOLVED WITH
Hiatus hernia/ 2020-10-22 No 2020-10-22) CONCOMITANT SEQUELAE:
HIATAL HERNIA (32) MEDICATION, THE PATIENT IS
CONCOMITANT ON MEDICATION
PROCEDURE FOR CONTINUOUS
GERD AND THE
HIATAL HERNIA
IS STILL
ONGOING. THE
PATIENT HAD NO
SURGERY FOR IT

FDA-CBER-2022-908-0002281
319
Listing 16.2.7.7
Safety Set

COVID-19/ 2020-12-06 No NONE
CONFIRMED COVID 19 (70)

WORSENING LEFT KNEE CONCOMITANT

FDA-CBER-2022-908-0002282
320
Listing 16.2.7.7
Safety Set

PNEUMONIA DUE TO COVID (63) MEDICATION,
19 POSITIVE CONCOMITANT
PROCEDURE

Renal impairment/ 2020-11-20 No 2020-12-09) NONE
DECREASE IN KIDNEY (44)
FUNCTION IN RELATION TO
COVID-19

FDA-CBER-2022-908-0002283
321
Listing 16.2.7.7
Safety Set

Coronary artery disease/ (131)/ Yes/ (2021-03-05/ NR APPLICABLE/ RESOLVED WITH
WORSENING CORONARY 2021-03-11 No 2021-03-11) CONCOMITANT SEQUELAE:
ARTERY DISEASE (155) MEDICATION, CORONARY
CONCOMITANT ARTERY DISEASE
PROCEDURE
Cardiac disorders/ 2020-12-29 Yes/ 3 Yes/2/3 NR/ NOT NOT RECOVERED/

Atrial fibrillation/ (105)/ Yes/ (2020-12-29/ NR APPLICABLE/ NOT RESOLVED
ATRIAL FIBRILLATION Ongoing No 2021-01-21) NONE

FDA-CBER-2022-908-0002284
322
Listing 16.2.7.7
Safety Set

system disorders/ (113)/ Yes/ (2020-12-29/ NR APPLICABLE/ NOT RESOLVED
Blood loss anaemia/ Ongoing No 2021-01-21) CONCOMITANT
ANEMIA SECONDARY TO GI PROCEDURE
BLEED
Gastrointestinal 2021-01-06 Yes/ 3 Yes/2/3 NR/ NOT NOT RECOVERED/

disorders/ (113)/ Yes/ (2020-12-29/ NR APPLICABLE/ NOT RESOLVED
Gastrointestinal Ongoing No 2021-01-21) NONE
haemorrhage/
GI BLEED OF UNKNOWN
CAUSE

FDA-CBER-2022-908-0002285
323
Listing 16.2.7.7
Safety Set

Infections and 2021-01-08 Yes/ 3 Yes/3 NR/ NOT NOT RECOVERED/

infestations/ (115)/ Yes/ (2020-12-29/ NR APPLICABLE/ NOT RESOLVED
COVID-19 pneumonia/ Ongoing No 2021-01-21) CONCOMITANT
PNEUMONIA SECONDARY TO MEDICATION,
COVID-19 CONCOMITANT
PROCEDURE
Cervical spinal stenosis/ (29) PROCEDURE
C5-C6 SEVERE LEFT CANAL
STENOSIS

FDA-CBER-2022-908-0002286
324
Listing 16.2.7.7
Safety Set

Neoplasms benign, 2020-10-28 Yes/ 3 Yes/6 NR/ NOT NOT RECOVERED/
Lung adenocarcinoma/
RIGHT LUNG
ADENOCARCINOMA
DIARRHEA INTERMITTENT (62)

FDA-CBER-2022-908-0002287
325
Listing 16.2.7.7
Safety Set

17OCT2020:10:11:00; Follow-up Days after 1st Dose: 161; Dose 2 Date/Time: 18NOV2020:14:12:00; Follow-up

failure/
ACUTE RESPIRATORY
FAILURE

FDA-CBER-2022-908-0002288
326
Listing 16.2.7.7
Safety Set

malignant and (20)/ No/ NR APPLICABLE/ NOT RESOLVED
Prostate cancer/
PROSTATE CANCER

FDA-CBER-2022-908-0002289
327
Listing 16.2.7.7
Safety Set

bAb: Positive; Dose 1 Date/Time: 29AUG2020:09:46:00; Follow-up Days after 1st Dose: 210; Dose 2
Pregnancy, puerperium 2020-12-10 Yes/ 3 Yes/6 NR/ NOT RECOVERED/
and perinatal conditions/ (78)/ Yes/ NR APPLICABLE/ RESOLVED
Abortion spontaneous/ 2020-12-17 No NONE
SPONTANEOUS ABORTION (85)
HYPERTENSION [WORSENING 2020-10-01 15:19 No NONE
OF BASELINE ELEVATED (1)
GRADE 3]

FDA-CBER-2022-908-0002290
328
Listing 16.2.7.7
Safety Set


Gastritis/ 2020-09-30 No 2020-09-30) CONCOMITANT
GASTRITIS W/ INTRACTABLE (29) PROCEDURE
VOMITING


FDA-CBER-2022-908-0002291
329
Listing 16.2.7.7
Safety Set


Pericarditis/ (60)/ Yes/ (2020-10-31/ NR APPLICABLE/ RESOLVED
PERICARDITIS 2020-11-03 No 2020-11-03) CONCOMITANT
(63) MEDICATION
ELEVATED GRADE 3 BP 2020-09-04 No NONE
(2)

FDA-CBER-2022-908-0002292
330
Listing 16.2.7.7
Safety Set

(127)
bAb: Positive; Dose 1 Date/Time: 15SEP2020:16:53:00; Follow-up Days after 1st Dose: 193; Dose 2
ELEVATED GRADE 3 BLOOD 2020-10-20 No NONE
PRESSURE (36)

FDA-CBER-2022-908-0002293
331
Listing 16.2.7.7
Safety Set

Blood pressure increased/ (112)/ No/ NR APPLICABLE/ RESOLVED
ELEVATED BLOOD PRESSURE 2021-02-11 No NONE
(119)
Investigations/ 2021-02-12 Yes/ 3 No NR/ DOSE RECOVERED/
Blood pressure increased/ (117)/ No/ NR DELAYED/ RESOLVED
(117)

FDA-CBER-2022-908-0002294
332
Listing 16.2.7.7
Safety Set

Blood pressure increased/ (36)/ No/ NR WITHDRAWN/ RESOLVED
WORSENING OF BASELINE 2020-10-23 No NONE
ELEVATED GRADE 3 BLOOD (36)
PRESSURE
Spinal osteoarthritis/ (134) PROCEDURE
WORSENING OF LUMBAR
SPONDYLOSIS

FDA-CBER-2022-908-0002295
333
Listing 16.2.7.7
Safety Set

BMI (kg/m2): 29.8; Baseline SARS-CoV-2 Status: Positive; Baseline RT-PCR: Positive; Baseline Elecsys SARS-CoV-2 Nucleocapsid
bAb: Positive; Dose 1 Date/Time: 05OCT2020:15:31:00; Follow-up Days after 1st Dose: 173; Dose 2
ELEVATED GRADE 3 (58)
Septic shock/ 2020-12-04 No 2020-11-20) CONCOMITANT
SEPTIC SHOCK (67) MEDICATION

FDA-CBER-2022-908-0002296
334
Listing 16.2.7.7
Safety Set

Tooth socket haemorrhage/ 2021-01-18 No 2021-01-18) CONCOMITANT
HEMORRHAGE FROM WISDOM (116) MEDICATION,
TOOTH EXTRACTION #32 CONCOMITANT
PROCEDURE
Coronary artery disease/ (15)/ Yes/ (2020-09-25/ NR CHANGED/ RESOLVED
CORONARY ARTERY DISEASE 2020-09-26 No 2020-09-26)/6 CONCOMITANT
(31) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002297
335
Listing 16.2.7.7
Safety Set

Musculoskeletal and 2020-11-30 Yes/ 3 Yes/3 NR/ NOT NOT RECOVERED/
connective tissue (62)/ Yes/ (2020-12-03/ NR APPLICABLE/ NOT RESOLVED
disorders/ Ongoing No 2020-12-07)/4 NONE
Muscular weakness/
DIFFUSE MUSCLE WEAKNESS
Viral upper respiratory 2020-12-16 No CONCOMITANT
tract infection/ (80) MEDICATION
VIRAL UPPER RESPIRATORY
INFECTION

FDA-CBER-2022-908-0002298
336
Listing 16.2.7.7
Safety Set

ACUTE EXACERBATION OF
ASTHMA
Viral diarrhoea/ 2021-02-14 No NONE
DIARRHEA (2ND NON-COVID (124)
VIRAL SYNDROME)

FDA-CBER-2022-908-0002299
337
Listing 16.2.7.7
Safety Set

Gastrointestinal 2020-12-26 00:00 Yes/ 3 Yes/3 NR/ NOT RECOVERED/

Gastritis/ 2020-12-31 No 2020-12-31) CONCOMITANT
ACUTE GASTRITIS WITHOUT (113) MEDICATION,
BLEEDING CONCOMITANT
PROCEDURE
Hypoglycaemia/ 2021-02-05 No 2021-02-08) CONCOMITANT
HYPOGLYCEMIA (92) MEDICATION

FDA-CBER-2022-908-0002300
338
Listing 16.2.7.7
Safety Set

COVID-19/ 2020-12-12 No NONE
COVID 19 (53)
WORSENING HYPERTENSION 2021-01-21 No CONCOMITANT
(87) MEDICATION

FDA-CBER-2022-908-0002301
339
Listing 16.2.7.7
Safety Set

Fatigue/ (34)
FATIGUE
HEADACHES 2020-10-30 Yes NONE
(19)

FDA-CBER-2022-908-0002302
340
Listing 16.2.7.7
Safety Set
Treatment Group: mRNA-1273

Uterine leiomyoma/
UTERINE FIBROID
Blood and lymphatic 2020-08-25 21:00 Yes/ 3 No R/ NOT RECOVERED/
system disorders/ (1)/ Yes/ NR APPLICABLE/ RESOLVED
Lymph node pain/ 2020-08-25 No CONCOMITANT
UNDERARM GLAND (1) MEDICATION
TENDERNESS, LEFT

FDA-CBER-2022-908-0002303
341
Listing 16.2.7.7
Safety Set

PAIN AT INJECTION SITE,
LEFT ARM

Injection site pain/ (21)
LEFT ARM

FDA-CBER-2022-908-0002304
342
Listing 16.2.7.7
Safety Set

Bradycardia/ (124)/ Yes/ NR APPLICABLE/ RESOLVED WITH
BRADYCARDIA 2021-03-16 No CONCOMITANT SEQUELAE:
(195) PROCEDURE NEED FOR
PACEMAKER
Crohn's disease/ 2021-04-27 No 2020-11-07) CONCOMITANT SEQUELAE:
CROHN'S DISEASE (232) MEDICATION ONGOING
SYMPTOMS

FDA-CBER-2022-908-0002305
343
Listing 16.2.7.7
Safety Set

COLITIS (23) MEDICATION

congestive/ 2020-10-12 No 2020-10-12) NONE
EXACERBATION OF (35)
DIASTOLIC CHF

FDA-CBER-2022-908-0002306
344
Listing 16.2.7.7
Safety Set

Clostridium difficile 2020-10-25 No 2020-10-12) CONCOMITANT
CLOSTRIDIUM DIFFICILE

FDA-CBER-2022-908-0002307
345
Listing 16.2.7.7
Safety Set

Intraductal
proliferative breast
lesion/
DUCTAL CARCINOMA INSITUU
LEFT BREAST

FDA-CBER-2022-908-0002308
346
Listing 16.2.7.7
Safety Set

General disorders and 2020-07-29 12:08 Yes/ 3 No NR/ DOSE NOT RECOVERED/
Fatigue/ (8)
FATIGUE

connective tissue (3)/ No/ R CHANGED/ RESOLVED
Myalgia/ (9)

FDA-CBER-2022-908-0002309
347
Listing 16.2.7.7
Safety Set

Gastrointestinal / Yes/ 3 No NR/ NOT NOT RECOVERED/
disorders/ Ongoing Yes/ NR APPLICABLE/ NOT RESOLVED
Barrett's oesophagus/ No NONE
BARRETTS ESOPHGEUS

Oesophageal carcinoma/ CONCOMITANT
ESOPHAGEAL CANCER PROCEDURE

FDA-CBER-2022-908-0002310
348
Listing 16.2.7.7
Safety Set

(10) MEDICATION

Fatigue/ (15)
FATIGUE

FDA-CBER-2022-908-0002311
349
Listing 16.2.7.7
Safety Set

Investigations/ 2020-08-17 Yes/ 3 No NR/ DOSE NOT NOT RECOVERED/
Hepatic enzyme increased/ (18)/ Yes/ NR CHANGED/ NOT RESOLVED
ELEVATED LIVER ENZYMES Ongoing No NONE
Gastritis/ Ongoing No CONCOMITANT
ACUTE GASTRITIS MEDICATION
STOMACH CRAMPS MEDICATION

FDA-CBER-2022-908-0002312
350
Listing 16.2.7.7
Safety Set

Abortion spontaneous/ 2021-02-02 No CONCOMITANT
SPONTANEOUS ABORTION OF (132) MEDICATION
PREGNANCY
Nucleocapsid bAb: Negative; Dose 1 Date/Time: 07AUG2020:12:47:00; Follow-up Days after 1st Dose:
232; Dose 2 Date/Time: 04SEP2020:12:56:00; Follow-up Days after 2nd Dose: 204
and mediastinal (2)/ No/ NA CHANGED/ RESOLVED
Rhinorrhoea/ (9) MEDICATION
SEVERE RHINORRHEA

FDA-CBER-2022-908-0002313
351
Listing 16.2.7.7
Safety Set

and mediastinal (2)/ No/ NA CHANGED/ RESOLVED
Nasal congestion/ (10)
SEVERE NASAL CONGESTION
disorders/ (20)/ Yes/ NA APPLICABLE/ RESOLVED
SEVERE NAUSEA (23)

FDA-CBER-2022-908-0002314
352
Listing 16.2.7.7
Safety Set

Headache/ (20)/ Yes/ NA APPLICABLE/ RESOLVED
SEVERE HEADACHE 2020-10-10 Yes NONE
(24)
General disorders and 2020-08-05 Yes/ 3 Yes/3 NR/ DOSE NOT RECOVERED/
administration site (7)/ Yes/ (2020-08-05/ NR CHANGED/ RESOLVED
Chest pain/ (8) MEDICATION
CHEST PAIN NOS

FDA-CBER-2022-908-0002315
353
Listing 16.2.7.7
Safety Set

administration site (31)/ Yes/ R APPLICABLE/ RESOLVED
conditions/ 2020-09-20 00:00 No CONCOMITANT
Adverse drug reaction/ (33) MEDICATION
ADVERSE EFFECT OF DRUG

PAIN AFTER INJECTIONS

FDA-CBER-2022-908-0002316
354
Listing 16.2.7.7
Safety Set

Procedural nausea/ 2020-10-30 No CONCOMITANT
POST OP NAUSEA RECURRENT (57) MEDICATION

POST OPERATIVE PAIN, (100) MEDICATION
GENERALIZED

FDA-CBER-2022-908-0002317
355
Listing 16.2.7.7
Safety Set

General disorders and 2020-10-13 Yes/ 3 No NR/ NOT RECOVERING/
administration site (21)/ Yes/ NR APPLICABLE/ RESOLVING
conditions/ Ongoing Yes CONCOMITANT
Pain/ MEDICATION
GENERALIZED PAIN

Alcohol poisoning/ 2020-10-28 No CONCOMITANT
ACUTE ALCOHOL (36) MEDICATION,
INTOXICATION CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002318
356
Listing 16.2.7.7
Safety Set

connective tissue (36)/ Yes/ NR APPLICABLE/ NOT RESOLVED
disorders/ Ongoing Yes NONE
Arthralgia/
JOINT PAIN, GENERALIZED
Renal and urinary 2020-10-28 Yes/ 3 No NR/ NOT RECOVERING/

Urinary retention/ Ongoing No CONCOMITANT
URINARY RETENTION MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002319
357
Listing 16.2.7.7
Safety Set

Hepatobiliary disorders/ 2020-08-15 Yes/ 3 No NR/ DOSE NOT RECOVERED/
Cholelithiasis/ (4)/ Yes/ NR CHANGED/ RESOLVED
GALLSTONES 2020-08-25 No CONCOMITANT
(14) MEDICATION,
CONCOMITANT
PROCEDURE
CHOLECYSTITIS 2020-10-19 No 2020-10-05)/6 CONCOMITANT
(29) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002320
358
Listing 16.2.7.7
Safety Set

Cardiac failure (58)/ Yes/ NR APPLICABLE/ NOT RESOLVED
congestive/ Ongoing No CONCOMITANT
NEW ONSET CONGESTIVE MEDICATION,
HEART FAILURE CONCOMITANT
PROCEDURE
infestations/ (112)/ Yes/ NA APPLICABLE/ RESOLVED
Suspected COVID-19/ 2021-01-07 No NONE
COVID-19 LIKE ILLNESS (116)

FDA-CBER-2022-908-0002321
359
Listing 16.2.7.7
Safety Set

Atrial fibrillation/ (22)/ Yes/ (2020-08-20/ NR DELAYED/ RESOLVED
ATRIAL FIBRILLATION WITH 2020-08-23 No 2020-08-23) NONE
RVR (25)
Gastrointestinal 2020-08-20 Yes/ 3 Yes/3 NR/ DOSE RECOVERED/

disorders/ (22)/ Yes/ (2020-08-20/ NR DELAYED/ RESOLVED
Nausea/ 2020-08-23 Yes 2020-08-23) CONCOMITANT

FDA-CBER-2022-908-0002322
360
Listing 16.2.7.7
Safety Set

Vascular disorders/ 2020-08-20 Yes/ 3 Yes/3 NR/ DOSE RECOVERED/
Hypertensive urgency/ (22)/ Yes/ (2020-08-20/ NR DELAYED/ RESOLVED
HYPERTENSIVE URGENCY 2020-08-23 No 2020-08-23) CONCOMITANT
(25) MEDICATION
Bile duct stone/ (107)/ Yes/ (2021-01-13/ NR APPLICABLE/ RESOLVED
CHOLEDOCHOLITHIASIS 2021-01-17 No 2021-01-18) CONCOMITANT
(111) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002323
361
Listing 16.2.7.7
Safety Set

Pancreatitis/ 2021-01-17 No NONE
POST ECRP PANCREATITIS (111)
Musculoskeletal and / Yes/ 3 No NR/ NOT NOT RECOVERED/
connective tissue Ongoing Yes/ NR APPLICABLE/ NOT RESOLVED
disorders/ Yes CONCOMITANT
RIGHT KNEE PAIN

FDA-CBER-2022-908-0002324
362
Listing 16.2.7.7
Safety Set

Infections and 2021-01-18 Yes/ 3 No NR/ DOSE NOT UNKNOWN
infestations/ (141)/ Yes/ NR CHANGED/
Pyelonephritis/ Ongoing No CONCOMITANT
PYELONEPHRITIS MEDICATION
Muscle rupture/ 2021-01-18 No CONCOMITANT
TORN LEFT BICEP (139) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002325
363
Listing 16.2.7.7
Safety Set

Blood and lymphatic 2020-11-22 Yes/ 3 No NR/ NOT RECOVERED/

Leukocytosis/ 2020-12-01 No CONCOMITANT
UTI LEUKOCYTOSIS (118) MEDICATION

Concussion/ 2021-01-10 No NONE
CONCUSSION (158)

FDA-CBER-2022-908-0002326
364
Listing 16.2.7.7
Safety Set

infestations/ (3)/ Yes/ R CHANGED/ RESOLVED
LEFT ARM (8) MEDICATION
ERYTHEMA-NON-URTICARIAL-
DIFFIUSE ERYTHEMATOUS
PLAQUE WITH LINEAR
EXTENSION MED AND
DISTAL/POSSIBLE
CELLULITIS

FDA-CBER-2022-908-0002327
365
Listing 16.2.7.7
Safety Set

Tooth fracture/ 2020-12-18 No CONCOMITANT
CRACKED TOOTH (88) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002328
366
Listing 16.2.7.7
Safety Set

Neoplasms benign, 2020-08-12 Yes/ 3 Yes/6 NR/ DRUG NOT RECOVERED/

malignant and (17)/ Yes/ NR WITHDRAWN/ NOT RESOLVED
Metastases to lung/
METASTASES TO LUNGS
[RECURRENCE OF THROAT
CANCE]

FDA-CBER-2022-908-0002329
367
Listing 16.2.7.7
Safety Set


Throat cancer/
RECURRENCE OF THROAT
CANCER [WITH METASTASES
TO LUNGS]

FDA-CBER-2022-908-0002330
368
Listing 16.2.7.7
Safety Set

Chills/ (49) MEDICATION
CHILLS

FATIGUE

FDA-CBER-2022-908-0002331
369
Listing 16.2.7.7
Safety Set

BODY ACHES

(49) MEDICATION

FDA-CBER-2022-908-0002332
370
Listing 16.2.7.7
Safety Set

Migraine/ (24)/ No/ NR CHANGED/ RESOLVED
COMPLICATED MIGRAINE 2020-08-23 Yes CONCOMITANT
(27) MEDICATION
Conjunctivitis viral/ 2021-03-16 No CONCOMITANT
VIRAL CONJUNCTIVITIS (204) MEDICATION
(BILATERAL)

FDA-CBER-2022-908-0002333
371
Listing 16.2.7.7
Safety Set

Movement disorder/ (1)/ No/ R CHANGED/ RESOLVED
DIFFICULTY RAISING LEFT 2020-08-01 23:59 No NONE
ARM (4)

Spondylitis/
WORSENING SPINAL
ARTHRITIS

FDA-CBER-2022-908-0002334
372
Listing 16.2.7.7
Safety Set

Appendicitis perforated/ 2020-11-27 No 2020-11-27) CONCOMITANT
APPENDICITIS PERFORATED (71) PROCEDURE

Peritonitis/ 2020-11-27 No 2020-11-27) CONCOMITANT
LOCALIZED PERITONITIS (71) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002335
373
Listing 16.2.7.7
Safety Set

Acute kidney injury/ 2020-11-24 No 2020-11-24) CONCOMITANT SEQUELAE:
ACUTE ON CHRONIC END (56) MEDICATION, EDEMA WITH
STAGE RENAL DISEASE CONCOMITANT ONGOING
PROCEDURE DIALYSIS

FDA-CBER-2022-908-0002336
374
Listing 16.2.7.7
Safety Set

Cardiac failure acute/ (84)/ Yes/ (2020-12-24/ NR APPLICABLE/ RESOLVED WITH
ACUTE ON CHRONIC 2021-01-03 No 2021-01-03) CONCOMITANT SEQUELAE:
COMBINED SYSTOLIC AND (96) MEDICATION, THE PATIENT
DIASTOLIC HEART FAILURE CONCOMITANT CONTINUES TO
PROCEDURE HAVE
CONGESTIVE
HEART FAILURE
BUT HAD
REACHED A
STABLE STATE
AND WAS
DISCHARGED
FROM HOSPITAL
ON 1/3/2021

FDA-CBER-2022-908-0002337
375
Listing 16.2.7.7
Safety Set

Cartilage injury/ 2021-01-21 No CONCOMITANT
LEFT HIP LABRAL TEAR (70) PROCEDURE
FALL (40) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002338
376
Listing 16.2.7.7
Safety Set

RIGHT HIP FRACTURE (41) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002339
377
Listing 16.2.7.7
Safety Set

Invasive ductal breast
carcinoma/
INVASIVE DUCTAL BREAST
CARCINOMA STAGE 1C GRADE
3

FDA-CBER-2022-908-0002340
378
Listing 16.2.7.7
Safety Set

Anxiety/ (125)/ Yes/ NR CHANGED/ RESOLVED
ANXIETY ATTACK 2021-01-17 No NONE
(125)

Fatigue/ (20)
FATIGUE

FDA-CBER-2022-908-0002341
379
Listing 16.2.7.7
Safety Set

Duodenal ulcer/ 2021-03-01 No 2020-10-23) CONCOMITANT
DUODENAL ULCER (153) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002342
380
Listing 16.2.7.7
Safety Set

Neoplasms benign, 2020-12-01 Yes/ 3 No NR/ DOSE NOT RECOVERING/
malignant and (82)/ Yes/ NR CHANGED/ RESOLVING
Breast cancer/ CONCOMITANT
BREAST CANCER (LEFT PROCEDURE
BREAST)
Renal and urinary 2020-10-07 Yes/ 3 No NR/ DOSE NOT RECOVERED/
LEFT KIDNEY STONE 4MM (18) MEDICATION

FDA-CBER-2022-908-0002343
381
Listing 16.2.7.7
Safety Set

Cardiac disorders/ 2020-09-09 Yes/ 3 No NR/ DOSE NOT NOT RECOVERED/
Coronary artery disease/ (17)/ Yes/ NR CHANGED/ NOT RESOLVED
CORONARY ARTERY DISEASE Ongoing No CONCOMITANT
MEDICATION,
CONCOMITANT
PROCEDURE
Nervous system disorders/ 2020-07-30 Yes/ 3 Yes/3 NR/ DOSE NOT RECOVERED/
Cerebrovascular accident/ (4)/ Yes/ (2020-07-30/ NR CHANGED/ RESOLVED
MILD CEREBROVASCULAR 2020-07-31 No 2020-07-31) CONCOMITANT
ACCIDENT (5) MEDICATION

FDA-CBER-2022-908-0002344
382
Listing 16.2.7.7
Safety Set

SYNCOPE AND COLLAPSE 2020-11-17 No 2020-11-17) NONE
(PRIMARY) (63)

Acute kidney injury/ 2020-11-17 No 2020-11-17) NONE

FDA-CBER-2022-908-0002345
383
Listing 16.2.7.7
Safety Set

Acute kidney injury/ 2020-12-10 No 2020-12-11) NONE

Syncope/ (80)/ No/ (2020-12-04/ NR APPLICABLE/ RESOLVED
(87) MEDICATION

FDA-CBER-2022-908-0002346
384
Listing 16.2.7.7
Safety Set

Salpingitis/ 2020-11-26 No 2020-11-12) CONCOMITANT
BILATERAL ACUTE (64) MEDICATION
SALPINGITIS
Iron deficiency anaemia/ 2021-04-06 No CONCOMITANT
IRON DEFICIENCY ANEMIA (226) MEDICATION

FDA-CBER-2022-908-0002347
385
Listing 16.2.7.7
Safety Set

Ankle fracture/ 2021-02-12 No CONCOMITANT
BROKEN RIGHT ANKLE (156) MEDICATION

FDA-CBER-2022-908-0002348
386
Listing 16.2.7.7
Safety Set

Neoplasms benign, 2020-12-23 Yes/ 3 No NR/ NOT RECOVERING/
Colon cancer/
COLON CANCER

FDA-CBER-2022-908-0002349
387
Listing 16.2.7.7
Safety Set

connective tissue (21)/ No/ NR CHANGED/ RESOLVING
Temporomandibular joint MEDICATION
syndrome/
WORSENING
TEMPOROMANDIBULAR JOINT
DYSFUNCTION

FDA-CBER-2022-908-0002350
388
Listing 16.2.7.7
Safety Set

Incarcerated incisional 2021-01-12 No 2021-01-15) CONCOMITANT
hernia/ (132) MEDICATION,
WORSENING OF CONCOMITANT
INCARCERATED RECURRENT PROCEDURE
INCISIONAL VENTRAL
HERNIA

FDA-CBER-2022-908-0002351
389
Listing 16.2.7.7
Safety Set

Bursitis/ (53) MEDICATION,
RIGHT OLECRANON BURSITIS CONCOMITANT
(RIGHT ELBOW INFECTION) PROCEDURE
Reproductive system and 2020-08-27 Yes/ 3 Yes/3 NR/ DOSE RECOVERED/
breast disorders/ (25)/ Yes/ (2020-08-27/ NR DELAYED/ RESOLVED
Uterine haemorrhage/ 2020-08-28 No 2020-08-28) CONCOMITANT
ABNORMAL UTERINE (26) MEDICATION,
BLEEDING CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002352
390
Listing 16.2.7.7
Safety Set

Reproductive system and 2020-09-22 Yes/ 3 Yes/3 NR/ DOSE RECOVERED/
breast disorders/ (51)/ Yes/ (2020-09-22/ NR DELAYED/ RESOLVED
Uterine haemorrhage/ 2020-09-22 No 2020-09-23) CONCOMITANT
ABNORMAL UTERINE (51) PROCEDURE
BLEEDING
Acute coronary syndrome/ (50)/ Yes/ (2020-10-23/ NR APPLICABLE/ RESOLVED
ACUTE CORONARY SYNDROME 2020-10-20 No 2020-10-29) CONCOMITANT
(NON ST ELEVATED (50) MEDICATION,
MYOCARDIAL INFARCTION) CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002353
391
Listing 16.2.7.7
Safety Set

Injection site (9)
lymphadenopathy/
LEFT AXILLARY
LYMPHADENOPATHY
IPSILATERAL TO INJECTION
SITE

FDA-CBER-2022-908-0002354
392
Listing 16.2.7.7
Safety Set

Tachycardia/ (35)/ Yes/ NR APPLICABLE/ RESOLVED
(50)

DYSPNEA

FDA-CBER-2022-908-0002355
393
Listing 16.2.7.7
Safety Set

Investigations/ 2020-12-13 Yes/ 3 Yes/3 NR/ NOT NOT RECOVERED/
Hepatic enzyme increased/ (101)/ Yes/ (2020-12-13/ NR APPLICABLE/ NOT RESOLVED
ELEVATED LIVER ENZYMES Ongoing No 2020-12-21) NONE
Injection site erythema/ (19) MEDICATION
INJECTION SITE/ARM
REDNESS NON-URTICARIAL

FDA-CBER-2022-908-0002356
394
Listing 16.2.7.7
Safety Set

Reproductive system and 2020-09-04 Yes/ 3 No NR/ DRUG NOT RECOVERED/

breast disorders/ (26)/ Yes/ NR WITHDRAWN/ NOT RESOLVED
Breast mass/ Ongoing No CONCOMITANT
MASS ON RIGHT BREAST PROCEDURE
POSSITIVE FOR CANCER
KIDNEY STONE (43) MEDICATION

FDA-CBER-2022-908-0002357
395
Listing 16.2.7.7
Safety Set

pulmonary disease/
COPD EXACERBATION
Ventricular tachycardia/ (40)/ Yes/ NR CHANGED/ NOT RESOLVED
VENTRICULAR TACHYCARIA Ongoing No CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0002358
396
Listing 16.2.7.7
Safety Set

Neoplasms benign, 2020-12-22 Yes/ 3 No NR/ DOSE NOT NOT RECOVERED/
malignant and (93)/ No/ NR CHANGED/ NOT RESOLVED
carcinoma/
BREAST CARCINOMA
(INVASIVE DUCTAL
CARCINOMA - LEFT BREAST)

FDA-CBER-2022-908-0002359
397
Listing 16.2.7.7
Safety Set

Infections and 2020-09-23 00:00 Yes/ 3 No NR/ DOSE NOT RECOVERED/
Pneumonia/ 2020-10-20 23:59 No CONCOMITANT
PNEUMONIA (29) MEDICATION,
CONCOMITANT
PROCEDURE
Neoplasms benign, 2020-12-04 Yes/ 3 Yes/3 NR/ DOSE NOT RECOVERED/

malignant and (74)/ Yes/ (2020-12-04/ NR CHANGED/ RESOLVED
Thymoma malignant/
INVASIVE THYMOMA

FDA-CBER-2022-908-0002360
398
Listing 16.2.7.7
Safety Set

Neoplasms benign, 2021-01-14 Yes/ 3 Yes/3 NR/ DOSE NOT RECOVERED/
malignant and (115)/ Yes/ (2021-01-14/ NR CHANGED/ RESOLVED
Thymoma malignant/ CONCOMITANT
INVASIVE THYMOMA PROCEDURE
SMALL BOWEL OBSTRUCTION CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002361
399
Listing 16.2.7.7
Safety Set

Immune system disorders/ 2020-08-31 Yes/ 3 No R/ DOSE NOT RECOVERED/
Type IV hypersensitivity (8)/ Yes/ R CHANGED/ RESOLVED
reaction/ 2020-09-04 No CONCOMITANT
DELAYED (12) MEDICATION
TYPE-HYPERSENSITIVITY
infestations/ (11)/ Yes/ R CHANGED/ RESOLVED
SINUS INFECTION (21) MEDICATION

FDA-CBER-2022-908-0002362
400
Listing 16.2.7.7
Safety Set

Bronchitis/ 2020-10-27 No 2020-10-21) CONCOMITANT
Osteonecrosis/ MEDICATION
WORSENING OF BILATERAL
FEMORAL HEAD NECROSIS

FDA-CBER-2022-908-0002363
401
Listing 16.2.7.7
Safety Set

CEREBROVASCULAR ACCIDENT 2021-01-09 No 2021-01-12) CONCOMITANT
(118) MEDICATION
PNEUMONIA, LEFT LOWER (97) MEDICATION
LOBE

FDA-CBER-2022-908-0002364
402
Listing 16.2.7.7
Safety Set

Coronary artery disease/ (21)/ Yes/ NR CHANGED/ RESOLVING
CORONARY ARTERY DISEASE Ongoing No NONE
Appendicitis/ 2020-12-17 No CONCOMITANT
APPENDICITIS (72) PROCEDURE

FDA-CBER-2022-908-0002365
403
Listing 16.2.7.7
Safety Set

Subject ID: US3242321; Age (years): 35; Sex: F; Race: MULTIPLE: White, Asian; Height (cm): 167.6; Weight (kg): 62.7; BMI
Gastrointestinal 2020-10-13 10:00 Yes/ 3 No NR/ DOSE NOT RECOVERED/
Umbilical hernia/ 2020-10-17 No CONCOMITANT
UMBILICAL HERNIA (6) MEDICATION,
CONCOMITANT
PROCEDURE
Psychiatric disorders/ 2020-09-29 Yes/ 3 Yes/2/3 NR/ DRUG RECOVERED/
Schizoaffective disorder/ (7)/ Yes/ (2020-09-29/ NR WITHDRAWN/ RESOLVED
WORSENING OF 2020-10-03 No 2020-10-03) CONCOMITANT
SCHIZOAFFECTIVE DISORDER (11) MEDICATION

FDA-CBER-2022-908-0002366
404
Listing 16.2.7.7
Safety Set

Investigations/ Yes/ 3 Yes/3 NR/ NOT RECOVERED/
Heart rate irregular/ Yes/ (2021-04-05/ NR APPLICABLE/ RESOLVED
IRREGULAR HEART BEAT No 2021-04-13) NONE
Investigations/ ----- 00:00/ Yes/ 3 Yes/3 NR/ NOT RECOVERED/

Heart rate irregular/ Yes/ NR APPLICABLE/ RESOLVED
IRREGULAR HEART BEAT No NONE

FDA-CBER-2022-908-0002367
405
Listing 16.2.7.7
Safety Set

Pleural effusion/ (20) MEDICATION
SMALL BILATERAL PLEURAL
EFFUSIONS

FDA-CBER-2022-908-0002368
406
Listing 16.2.7.7
Safety Set

Respiratory failure/ (20) MEDICATION
HYPOXEMIA RESPIRATORY
FAILURE ON ADMISSION,
RESOLVED

FDA-CBER-2022-908-0002369
407
Listing 16.2.7.7
Safety Set

Pneumonia mycoplasmal/ 2020-10-20 No 2020-10-10) CONCOMITANT
BILATERAL MULTIFOCAL (30) MEDICATION
PNEUMONIA RIGHT GREATER
THAN LEFT DUE TO
MYCOPLASMA PNEUMONIA
Gastrointestinal 2020-09-30 00:00 Yes/ 3 Yes/3 NR/ DOSE NOT RECOVERED/


FDA-CBER-2022-908-0002370
408
Listing 16.2.7.7
Safety Set

malignant and (162)/ Yes/ (2021-02-05/ NR APPLICABLE/ NOT RESOLVED
unspecified (incl cysts Ongoing No 2021-02-11) CONCOMITANT
Metastatic neoplasm/
SEQUELAE FROM METASTATIC
MALIGNANCY OF UNKNOWN
ORIGIN
Hypothyroidism/ (28)/ Yes/ NR CHANGED/ RESOLVING

FDA-CBER-2022-908-0002371
409
Listing 16.2.7.7
Safety Set

Neck pain/ MEDICATION
NECK PAIN IN POSTERIOR
NECK
Foot deformity/ (151) MEDICATION,
BUNION, LEFT FOOT, CONCOMITANT
WORSENING PROCEDURE

FDA-CBER-2022-908-0002372
410
Listing 16.2.7.7
Safety Set

Immune system disorders/ 2020-08-23 Yes/ 3 No NR/ DOSE NOT RECOVERING/
Seasonal allergy/ (12)/ Yes/ NR CHANGED/ RESOLVING
SEASONAL ALLERGIES Ongoing No CONCOMITANT
MEDICATION
Abdominal pain lower/ 2020-10-15 No CONCOMITANT
LEFT LOWER QUADRANT PAIN (36) MEDICATION

FDA-CBER-2022-908-0002373
411
Listing 16.2.7.7
Safety Set

Flank pain/ (36) MEDICATION,
LEFT FLANK PAIN CONCOMITANT
PROCEDURE
Rectal haemorrhage/ 2020-10-19 No NONE
RECTAL BLEEDING (66)

FDA-CBER-2022-908-0002374
412
Listing 16.2.7.7
Safety Set

HEADACHE 2020-10-01 Yes NONE
(16)

Gastrointestinal 2020-11-07 No 2020-11-07) CONCOMITANT
procedural complication/ (53) MEDICATION
RECTAL PROLAPSE REPAIR
COMPLICATION DUE TO
CONSTIPATION

FDA-CBER-2022-908-0002375
413
Listing 16.2.7.7
Safety Set

PAIN AT INJECTION SITE

FDA-CBER-2022-908-0002376
414
Listing 16.2.7.7
Safety Set

SUSPECTED COVID-19 (124)
NASAL CONGESTION

FDA-CBER-2022-908-0002377
415
Listing 16.2.7.7
Safety Set

Rhinorrhoea/ (29)
RUNNY NOSE

DIARRHEA (29)

FDA-CBER-2022-908-0002378
416
Listing 16.2.7.7
Safety Set

Subject ID: US3272369; Age (years): 22; Sex: F; Race: MULTIPLE: White, Black or African American, American Indian or Alaska
Native; Height (cm): 166.5; Weight (kg): 103.2; BMI (kg/m2): 37.2; Baseline SARS-CoV-2 Status: Negative; Baseline RT-PCR:
Negative; Baseline Elecsys SARS-CoV-2 Nucleocapsid bAb: Negative; Dose 1 Date/Time: 04SEP2020:11:19:00; Follow-up Days after
1st Dose: 204; Dose 2 Date/Time: 02OCT2020:09:10:00; Follow-up Days after 2nd Dose: 176
SUSPECTED COVID-19 (90)
Migraine/ (119)/ Yes/ NR APPLICABLE/ NOT RESOLVED
MIGRAINES POST FALL Ongoing Yes CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0002379
417
Listing 16.2.7.7
Safety Set

Pleural effusion/ (26)
BILATERAL PLEURAL
EFFUSIONS

FDA-CBER-2022-908-0002380
418
Listing 16.2.7.7
Safety Set

CHOLELITHIASIS 2020-08-27 No CONCOMITANT
(20) MEDICATION,
CONCOMITANT
PROCEDURE
Hypertensive emergency/ (29)/ Yes/ NR CHANGED/ RESOLVED
HYPERTENSIVE EMERGENCY 2020-12-09 No CONCOMITANT
(98) MEDICATION

FDA-CBER-2022-908-0002381
419
Listing 16.2.7.7
Safety Set

Fall/ 2020-11-14 No NONE
FALL (71)

Subdural haematoma/ 2021-01-26 No 2020-11-17) CONCOMITANT
SUBDURAL HEMATOMA (144) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002382
420
Listing 16.2.7.7
Safety Set

Nasal septum deviation/ (38) PROCEDURE
DEVIATED SEPTUM
Neoplasms benign, 2020-11-01 Yes/ 3 Yes/6 NR/ DOSE NOT NOT RECOVERED/
malignant and (46)/ Yes/ NR CHANGED/ NOT RESOLVED
Prostate cancer/
PROSTATE CANCER

FDA-CBER-2022-908-0002383
421
Listing 16.2.7.7
Safety Set

Spondylolisthesis/ MEDICATION
SPONDYLOLISTHESIS
Large intestine 2020-10-06 No 2020-10-16) CONCOMITANT
perforation/ (15) PROCEDURE
PERFORATED COLON

FDA-CBER-2022-908-0002384
422
Listing 16.2.7.7
Safety Set

PULMONARY EMBOLISM

RIGHT LUNG PULMONARY
EMBOLI

FDA-CBER-2022-908-0002385
423
Listing 16.2.7.7
Safety Set

Atrial fibrillation/ (34)/ Yes/ NR APPLICABLE/ RESOLVED
ATRIAL FIBRILLATION 2020-10-25 No CONCOMITANT
(34) PROCEDURE
Abscess limb/ 2021-01-25 No 2021-01-15) CONCOMITANT
RIGHT GLUTE ABSCESS (126) MEDICATION

FDA-CBER-2022-908-0002386
424
Listing 16.2.7.7
Safety Set

FALL (41)

FDA-CBER-2022-908-0002387
425
Listing 16.2.7.7
Safety Set

Femur fracture/ 2020-12-22 No 2020-11-19) CONCOMITANT
R BROKEN FEMUR (90) PROCEDURE
Invasive lobular breast
carcinoma/
INVASIVE LOBULAR BREAST
CARCINOMA

FDA-CBER-2022-908-0002388
426
Listing 16.2.7.7
Safety Set

ELEVATED BLOOD (28)
(SYSTOLIC) PRESSURE
Stress cardiomyopathy/ (102)/ Yes/ (2020-12-18/ NR APPLICABLE/ RESOLVED
TAKOTSUBO CARDIOMYOPATHY 2021-02-25 No 2020-12-19) CONCOMITANT
(171) MEDICATION

FDA-CBER-2022-908-0002389
427
Listing 16.2.7.7
Safety Set

Injection site macule/ (42)
REDNESS (MACULAR
NON-URTICARIAL) AT
INJECTION SITE (LEFT
ARM)

FDA-CBER-2022-908-0002390
428
Listing 16.2.7.7
Safety Set

SYSTOLIC BLOOD PRESSURE (1)
INCREASE
Humerus fracture/ 2020-11-30 No CONCOMITANT
LEFT HUMERUS FRACTURE (110) PROCEDURE

FDA-CBER-2022-908-0002391
429
Listing 16.2.7.7
Safety Set

Blood pressure increased/ (29)/ No/ NR APPLICABLE/ RESOLVED
(144)
EXACERBATION OF 2020-09-11 12:17 No NONE
HYPERTENSION (ELEVATED (28)
SYSTOLIC BLOOD PRESSURE)

FDA-CBER-2022-908-0002392
430
Listing 16.2.7.7
Safety Set

Systolic hypertension/ (29)/ No/ NR APPLICABLE/ RESOLVED
EXACERBATION OF 2021-03-02 No NONE
HYPERTENSION (ELEVATED (173)
SYSTOLIC BLOOD PRESSURE)
MACULAR NON-UTICARIAL
REDNESS AT INJECTION
SITE

FDA-CBER-2022-908-0002393
431
Listing 16.2.7.7
Safety Set

SITE
(MACULAR/NON-UTICARIAL)

FDA-CBER-2022-908-0002394
432
Listing 16.2.7.7
Safety Set

UPPER RESPIRATORY
INFECTION
PRESSURE

FDA-CBER-2022-908-0002395
433
Listing 16.2.7.7
Safety Set


PRESSURE

FDA-CBER-2022-908-0002396
434
Listing 16.2.7.7
Safety Set

PRESSURE
Large intestine polyp/ 2020-12-29 No CONCOMITANT
COLON POLYPS (100) PROCEDURE

FDA-CBER-2022-908-0002397
435
Listing 16.2.7.7
Safety Set

INTESTINAL INFECTION

Deep vein thrombosis/ (97)/ Yes/ NR APPLICABLE/ RESOLVED
LEFT LOWER EXTREMITY 2021-04-01 No CONCOMITANT
DEEP VEIN THROMBOSIS (186) MEDICATION

FDA-CBER-2022-908-0002398
436
Listing 16.2.7.7
Safety Set

decreased/ 2020-10-06 No NONE
DECREASED SYSTOLIC BLOOD (16)
PRESSURE
Blood pressure diastolic (28)/ No/ NR CHANGED/ RESOLVED
PRESSURE

FDA-CBER-2022-908-0002399
437
Listing 16.2.7.7
Safety Set

infection/ (89)
UPPER RESPIRATORY
INFECTION
Depression/ (77)/ Yes/ (2021-03-02/ NR APPLICABLE/ RESOLVED
EXACERBATION OF 2021-03-31 No 2021-03-05) CONCOMITANT
DEPRESSION (183) MEDICATION

FDA-CBER-2022-908-0002400
438
Listing 16.2.7.7
Safety Set

DIARRHEA (35)
03SEP2020:16:33:00; Follow-up Days after 1st Dose: 205; Dose 2 Date/Time: 01OCT2020:16:00:00; Follow-up
PRESSURE

FDA-CBER-2022-908-0002401
439
Listing 16.2.7.7
Safety Set

Tooth infection/ 2020-11-09 No CONCOMITANT
LOWER RIGHT BACK TOOTH (61) MEDICATION,
INFECTION CONCOMITANT
PROCEDURE
Blood pressure systolic (1)/ No/ NR CHANGED/ NOT RESOLVED
PRESSURE

FDA-CBER-2022-908-0002402
440
Listing 16.2.7.7
Safety Set

Fatigue/ (15)
FATIGUE

Abdominal abscess/ 2020-11-14 No CONCOMITANT
ABSCESS AND CELLULITIS (38) MEDICATION,
OF ABDOMEN CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002403
441
Listing 16.2.7.7
Safety Set



MYALGIA

FDA-CBER-2022-908-0002404
442
Listing 16.2.7.7
Safety Set

Wrist fracture/ 2020-12-10 No CONCOMITANT
RIGHT SCAPHOID FRACTURE (64) MEDICATION,
CONCOMITANT
PROCEDURE
Eyelid infection/ 2020-12-25 No CONCOMITANT
EYE LID INFECTION (TOP (78) MEDICATION
LEFT EYE LID AND BOTTOM
RIGHT EYE LID)

FDA-CBER-2022-908-0002405
443
Listing 16.2.7.7
Safety Set

ALLERGIC REACTION 2021-01-02 No CONCOMITANT
(CLINDAMYCIN) (86) MEDICATION
General disorders and 2020-10-17 Yes/ 3 Yes/6 R/ NOT RECOVERED/
Swelling face/ (8) MEDICATION
FACIAL SWELLING

FDA-CBER-2022-908-0002406
444
Listing 16.2.7.7
Safety Set

Post procedural 2021-01-14 No 2021-01-14)/6 CONCOMITANT
haemorrhage/ (78) PROCEDURE
POST-OP VAGINAL
HEMORRHAGE
and polyps)/ (57) PROCEDURE URINARY
Prostate cancer/ INCONTINENCE
PROSTATE ADENOCARCINOMA AND ERECTILE
DYSFUNCTION

FDA-CBER-2022-908-0002407
445
Listing 16.2.7.7
Safety Set

Injection site rash/ (8)
LEFT UPPER ARM INJECTION
SITE REACTION
(ERYTHEMATOUS,
NON-PRURITIC RASH)

FDA-CBER-2022-908-0002408
446
Listing 16.2.7.7
Safety Set

Injury, poisoning and 2020-09-25 11:00 Yes/ 3 No NR/ DOSE NOT NOT RECOVERED/
procedural complications/ (17)/ No/ NR CHANGED/ NOT RESOLVED
Tibia fracture/ Ongoing No CONCOMITANT
LEFT DISTAL TIBIA MEDICATION
FRACTURE
Vascular disorders/ 2020-10-06 Yes/ 3 No NR/ DOSE NOT
HYPERTENSION

FDA-CBER-2022-908-0002409
447
Listing 16.2.7.7
Safety Set

Small intestinal 2020-10-22 No NONE
obstruction/ (36)
Investigations/ 2020-11-11 Yes/ 3 Yes/3 NR/ NOT RECOVERED/
Hepatic enzyme increased/ (44)/ Yes/ (2020-11-11/ NR APPLICABLE/ RESOLVED
ELEVATED LIVER 2020-11-13 No 2020-11-13) NONE
TRANSAMINASE LEVEL (46)

FDA-CBER-2022-908-0002410
448
Listing 16.2.7.7
Safety Set

Skin and subcutaneous 2020-11-11 Yes/ 3 Yes/3 NR/ NOT RECOVERED/
tissue disorders/ (44)/ Yes/ (2020-11-11/ NR APPLICABLE/ RESOLVED
Rash/ 2020-12-15 No 2020-11-13) CONCOMITANT
GENERALIZED RASH SKIN (78) MEDICATION
ERUPTION
(103)

FDA-CBER-2022-908-0002411
449
Listing 16.2.7.7
Safety Set

Eye disorders/ 2020-11-06 Yes/ 3 No NR/ NOT RECOVERED/
Retinal detachment/ (60)/ Yes/ NR APPLICABLE/ RESOLVED
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002412
450
Listing 16.2.7.7
Safety Set

HEADACHE ASSOCIATED WITH 2020-10-08 No CONCOMITANT
HYPERTENSIVE EPISODE (31) MEDICATION
connective tissue (1)/ Yes/ R CHANGED/ RESOLVED
Neck pain/ (3) MEDICATION
WORSENING OF CHRONIC
NECK PAIN

FDA-CBER-2022-908-0002413
451
Listing 16.2.7.7
Safety Set

Headache/ (1)/ Yes/ R CHANGED/ RESOLVED
HEADACHE 2020-09-21 08:00 Yes CONCOMITANT
(3) MEDICATION
PNEUMONIA RIGHT LOWER (115) MEDICATION
LOBE

FDA-CBER-2022-908-0002414
452
Listing 16.2.7.7
Safety Set

ASTHMA EXACERBATION
Subject ID: US3362285; Age (years): 66; Sex: M; Race: BLACK OR AFRICAN AMERICAN; Height (cm): ; Weight (kg): ; BMI (kg/m2):
SYNCOPAL EPISODE 2021-01-05 No NONE
(76)

FDA-CBER-2022-908-0002415
453
Listing 16.2.7.7
Safety Set

Subject ID: US3362285; Age (years): 66; Sex: M; Race: BLACK OR AFRICAN AMERICAN; Height (cm): ; Weight (kg): ; BMI (kg/m2):
Atrioventricular block/ (76)/ Yes/ NR APPLICABLE/ RESOLVED
HEART BLOCK 2021-02-25 No CONCOMITANT
(127) PROCEDURE
(3)

FDA-CBER-2022-908-0002416
454
Listing 16.2.7.7
Safety Set

Skin and subcutaneous 2020-10-13 08:00 Yes/ 3 No R/ DOSE NOT RECOVERING/
tissue disorders/ (1)/ Yes/ NR CHANGED/ RESOLVING
Urticaria/ Ongoing No CONCOMITANT
GENERALIZED RASH, MEDICATION
URTICARIAL
Fatigue/ (9)
FATIGUE

FDA-CBER-2022-908-0002417
455
Listing 16.2.7.7
Safety Set

Myalgia/ (9)
MUSCLE ACHES
Myalgia/ (11)
MUSCLE ACHES

FDA-CBER-2022-908-0002418
456
Listing 16.2.7.7
Safety Set

Small intestinal 2020-12-30 No 2020-12-30)/6 CONCOMITANT
obstruction/ (100) MEDICATION
(27) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002419
457
Listing 16.2.7.7
Safety Set


Hepatitis A/ 2020-09-25 No 2020-09-25) CONCOMITANT
HEPATITIS A (24) MEDICATION
Fatigue/ (9)
FATIGUE

FDA-CBER-2022-908-0002420
458
Listing 16.2.7.7
Safety Set

Tendon injury/ 2020-09-22 No CONCOMITANT
WRIST TENDON LACERATION, (14) PROCEDURE
RIGHT
Pleurisy/ (10) MEDICATION
PLEURISY

FDA-CBER-2022-908-0002421
459
Listing 16.2.7.7
Safety Set

(9) MEDICATION

Dehydration/ 2020-10-12 No CONCOMITANT

FDA-CBER-2022-908-0002422
460
Listing 16.2.7.7
Safety Set

Nervous system disorders/ 2020-10-12 Yes/ 3 No NR/ DOSE RECOVERED/

Syncope/ (29)/ Yes/ NR DELAYED/ RESOLVED
(29)
WORSENING SPINAL CONCOMITANT
STENOSIS PROCEDURE

FDA-CBER-2022-908-0002423
461
Listing 16.2.7.7
Safety Set

KIDNEY STONE (14) MEDICATION,
CONCOMITANT
PROCEDURE
SPINAL STENOSIS CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002424
462
Listing 16.2.7.7
Safety Set

Gastrooesophageal reflux 2020-10-24 No 2020-10-24) CONCOMITANT
disease/ (53) MEDICATION
GERD
Furuncle/ 2020-12-11 No CONCOMITANT
INFECTED L THIGH (100) MEDICATION
FURUNCLE

FDA-CBER-2022-908-0002425
463
Listing 16.2.7.7
Safety Set

Subject ID: US3432081; Age (years): 28; Sex: F; Race: OTHER: LATINO; Height (cm): 161.0; Weight (kg): 55.9; BMI (kg/m2):
CONCOMITANT
PROCEDURE
EPIGASTRIC PAIN (23) MEDICATION

FDA-CBER-2022-908-0002426
464
Listing 16.2.7.7
Safety Set

malignant and (49)/ Yes/ (2020-11-23/ NR APPLICABLE/ NOT RESOLVED
unspecified (incl cysts Ongoing No 2020-12-23) CONCOMITANT
Meningioma/ CONCOMITANT
PROGRESSION OF PROCEDURE
MENINGIOMA

FDA-CBER-2022-908-0002427
465
Listing 16.2.7.7
Safety Set

Injury, poisoning and 2020-11-23 Yes/ 3 Yes/3 NR/ NOT RECOVERING/
procedural complications/ (75)/ Yes/ (2020-11-23/ NR APPLICABLE/ RESOLVING
Procedural haemorrhage/ Ongoing No 2020-12-23) CONCOMITANT
INTRA-OPERATIVE MEDICATION
MEDICATION INDUCED
HYPERTENSIVE
INTRAPARENCHYMAL
HEMORRHAGE

Mental status changes/ (109)/ Yes/ (2020-12-30/ NR APPLICABLE/ RESOLVED
ALTERED MENTAL STATUS 2021-01-04 No 2021-01-04) CONCOMITANT
(117) PROCEDURE

FDA-CBER-2022-908-0002428
466
Listing 16.2.7.7
Safety Set

Investigations/ 2020-09-14 Yes/ 3 No R/ DOSE NOT RECOVERED/
ELEVATED SYSTOLIC B/P (2)
Intentional self-injury/ (30)/ Yes/ (2020-10-24/ NR APPLICABLE/ RESOLVED
SELF- INJURIOUS BEHAVIOR 2020-10-30 No 2020-10-30)/6 NONE
(43)

FDA-CBER-2022-908-0002429
467
Listing 16.2.7.7
Safety Set

Gastroenteritis/ 2020-11-22 No CONCOMITANT
GASTROENTERITIS (61) MEDICATION
Blood pressure systolic (1)/ No/ NR CHANGED/ RESOLVING
ELEVATED SYSTOLIC B/P
191 MMHG MAX

FDA-CBER-2022-908-0002430
468
Listing 16.2.7.7
Safety Set

Blood pressure diastolic (1)/ No/ NR CHANGED/ RESOLVING
ELEVATED DIASTOLIC BLOOD
PRESSURE 168 MM/HG
PRESSURE 162

FDA-CBER-2022-908-0002431
469
Listing 16.2.7.7
Safety Set

Burns second degree/ 2020-11-18 No CONCOMITANT
SECOND DEGREE BURNS (34) MEDICATION
(FACE, R EAR, R HAND)
Investigations/ 2020-10-27 07:13 Yes/ 3 No NR/ DOSE NOT NOT RECOVERED/
Blood pressure diastolic (28)/ No/ NR CHANGED/ NOT RESOLVED
ELEVATED DIASTOLIC BP

FDA-CBER-2022-908-0002432
470
Listing 16.2.7.7
Safety Set

Blood pressure systolic (28)/ No/ NR CHANGED/ NOT RESOLVED
PRESSURE
Weight (kg): 67.0; BMI (kg/m2): 27.5; Baseline SARS-CoV-2 Status: ; Baseline RT-PCR: ; Baseline Elecsys SARS-CoV-2 Nucleocapsid
Inguinal hernia/ 2020-11-24 No 2020-11-24) CONCOMITANT
HERNIA S/P LEFT INGUINAL (7) MEDICATION,
HERNIA REPAIR CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002433
471
Listing 16.2.7.7
Safety Set

WORSENING OF HTN 2020-10-05 11:00 No NONE
(26)
PULMONARY EMBOLISM

FDA-CBER-2022-908-0002434
472
Listing 16.2.7.7
Safety Set

Deep vein thrombosis/ (44)/ Yes/ (2020-11-03/ NR APPLICABLE/ RESOLVED
DEEP VEIN THROMBOSIS 2020-11-04 No 2020-11-04) CONCOMITANT
(LEFT LEG) (45) MEDICATION

Dyspnoea/ (53) PROCEDURE
SHORTNESS OF BREATH

FDA-CBER-2022-908-0002435
473
Listing 16.2.7.7
Safety Set

WORSENING OF LEFT KNEE CONCOMITANT
Spinal osteoarthritis/ (100) MEDICATION,
CERVICAL SPONDYLOSIS CONCOMITANT
WITH RADICULOPATHY PROCEDURE

FDA-CBER-2022-908-0002436
474
Listing 16.2.7.7
Safety Set

Infections and 2020-09-02 21:00 Yes/ 3 Yes/3 NR/ DOSE NOT RECOVERED/
Peritonitis/ 2020-09-03 10:51 No 2020-09-04) CONCOMITANT
LOCALIZED PERITONITIS (2) PROCEDURE
Infections and 2020-09-02 21:00 Yes/ 3 Yes/3 NR/ DOSE NOT RECOVERED/
Appendicitis/ 2020-09-04 10:51 No 2020-09-04) CONCOMITANT
ACUTE APPENDICITIS (3) PROCEDURE

FDA-CBER-2022-908-0002437
475
Listing 16.2.7.7
Safety Set


NECK PAIN

Rib fracture/ 2020-11-12 No CONCOMITANT
FRACTURED RIB (59) MEDICATION

FDA-CBER-2022-908-0002438
476
Listing 16.2.7.7
Safety Set


pain/
CHEST WALL PAIN
(MUSCULOSKELETAL)

Musculoskeletal pain/ (59) MEDICATION
PAIN SHOULDER

FDA-CBER-2022-908-0002439
477
Listing 16.2.7.7
Safety Set


Concussion/ 2020-11-28 No CONCOMITANT
CONCUSSION (75) MEDICATION
Investigations/ 2020-11-09 09:17 Yes/ 3 No NR/ DOSE RECOVERED/
Blood pressure increased/ (25)/ Yes/ NR DELAYED/ RESOLVED
(33)

FDA-CBER-2022-908-0002440
478
Listing 16.2.7.7
Safety Set

RIGHT WRIST SPRAIN (19)
Muscle strain/ Ongoing No CONCOMITANT
STRAINED BACK MUSCLE MEDICATION

FDA-CBER-2022-908-0002441
479
Listing 16.2.7.7
Safety Set

CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002442
480
Listing 16.2.7.7
Safety Set

infection/ (82)
UPPER RESPIRATORY
INFECTION
Infections and 2021-01-04 Yes/ 3 No NA/ DOSE NOT RECOVERED/
Atypical pneumonia/ 2021-01-19 No NONE
WALKING PNEUMONIA (112)

FDA-CBER-2022-908-0002443
481
Listing 16.2.7.7
Safety Set

Nausea/ Ongoing Yes CONCOMITANT
OCCASIONAL NAUSEA MEDICATION
Stab wound/ 2020-11-09 No NONE
STAB INJURY, RIGHT (12)
FOREARM

FDA-CBER-2022-908-0002444
482
Listing 16.2.7.7
Safety Set

Colitis/ 2020-11-19 No CONCOMITANT

Campylobacter 2020-11-19 No CONCOMITANT
gastroenteritis/ (70) MEDICATION
CAMPYLOBACTER ENTERITIS

FDA-CBER-2022-908-0002445
483
Listing 16.2.7.7
Safety Set

Skin and subcutaneous 2020-08-25 Yes/ 3 No R/ DRUG RECOVERED/

tissue disorders/ (9)/ Yes/ NR WITHDRAWN/ RESOLVED
Rash macular/ 2020-09-04 No CONCOMITANT
NON-URTICARIAL MACULAR (19) MEDICATION
RASH WITH BLANCHING
ERYTHEMA ON LEFT DELTOID

FDA-CBER-2022-908-0002446
484
Listing 16.2.7.7
Safety Set

disorders/ 2020-10-05 08:00 Yes CONCOMITANT
PAST DAY 7 OF REACTO
PERIOD
LEFT SIDED SCIATICA 2020-10-15 No CONCOMITANT
FLARE-UP (30) MEDICATION

FDA-CBER-2022-908-0002447
485
Listing 16.2.7.7
Safety Set

conditions/ 2020-09-18 11:15 No NONE
NON-URTICARIAL, MACULAR,
REDNESS ON LEFT DELTOID
AT THE INJECTION SITE

FDA-CBER-2022-908-0002448
486
Listing 16.2.7.7
Safety Set

Herpes zoster/ 2020-10-28 No CONCOMITANT
NEUROPATHIC (51) MEDICATION
PAIN/SHINGLES OF T6 AND
T7 DERMATOME REGION

FDA-CBER-2022-908-0002449
487
Listing 16.2.7.7
Safety Set

Atrial flutter/ (21)/ Yes/ (2020-11-05/ NR DELAYED/ RESOLVED WITH
PAROXYSMAL ATRIAL 2021-01-14 No 2020-11-07) CONCOMITANT SEQUELAE:
FLUTTER (91) MEDICATION, NEW BASELINE A
CONCOMITANT FIB WITH
PROCEDURE PAROXYSMAL A
FLUTTER -
CONTROLLED ON
AMIODARONE.

FDA-CBER-2022-908-0002450
488
Listing 16.2.7.7
Safety Set

connective tissue (58)/ No/ NR CHANGED/ NOT RESOLVED
RIGHT KNEE PAIN
Dyspnoea/ (23)
SHORTNESS OF BREATH

FDA-CBER-2022-908-0002451
489
Listing 16.2.7.7
Safety Set

Gout/ 2020-11-13 No NONE
GOUT (50)

HEAD LACERATION DUE TO (63) MEDICATION,
FALL CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002452
490
Listing 16.2.7.7
Safety Set

infection/ (35)
UPPER RESPIRATORY
INFECTION OF UNKNOWN
ETIOLOGY- FEVER, NASAL
CONGESTION, GENERALIZED
MUSCLE AND BODY ACHES,
FATIGUE

FDA-CBER-2022-908-0002453
491
Listing 16.2.7.7
Safety Set

ASTHMA EXACERBATION
Haematoma/ (33)/ Yes/ (2020-11-10/ NR APPLICABLE/ RESOLVED
HEMATOMA OF THE R LEG 2020-11-13 No 2020-11-17) CONCOMITANT
(43) PROCEDURE

FDA-CBER-2022-908-0002454
492
Listing 16.2.7.7
Safety Set

Cough/ (45)
COUGH

Proctitis chlamydial/ 2020-10-23 No CONCOMITANT
CHLAMYDIA PROSTATITIS (18) MEDICATION

FDA-CBER-2022-908-0002455
493
Listing 16.2.7.7
Safety Set

Seasonal allergy/ (29)/ No/ NR CHANGED/ RESOLVED
EXACERBATION OF SEASONAL 2020-10-21 No CONCOMITANT
ALLERGIES - NASAL (43) MEDICATION
CONGESTION, RUNNY NOSE
Dyspnoea/ (24)
SHORTNESS OF BREATH

FDA-CBER-2022-908-0002456
494
Listing 16.2.7.7
Safety Set

Peripheral vascular (14)/ Yes/ NR CHANGED/ RESOLVED
disorder/ 2020-10-23 No CONCOMITANT
WORSENING PERIPHERAL (39) PROCEDURE
VASCULAR DISEASE WITH
ACUTE BLOCKAGE
Ovarian cyst/ 2020-11-18 No CONCOMITANT
OVARIAN CYST-LIKELY (34) MEDICATION
BENIGN

FDA-CBER-2022-908-0002457
495
Listing 16.2.7.7
Safety Set

Blood and lymphatic 2020-09-28 Yes/ 3 No R/ DOSE NOT RECOVERED/
system disorders/ (4)/ Yes/ R CHANGED/ RESOLVED
Lymphadenopathy/ 2020-10-02 No NONE
LEFT AXILLARY (8)
LYMPHADENOPATHY -
IPSILATERAL

FDA-CBER-2022-908-0002458
496
Listing 16.2.7.7
Safety Set

SCALP

FDA-CBER-2022-908-0002459
497
Listing 16.2.7.7
Safety Set

Injection site (11)
induration/
INJECTION SITE
INDURATION

Injection site swelling/ (11)
INJECTION SITE SWELLING

FDA-CBER-2022-908-0002460
498
Listing 16.2.7.7
Safety Set

Malaise/ (14) MEDICATION
MALAISE
SWELLING AT INJECTION
SITE

FDA-CBER-2022-908-0002461
499
Listing 16.2.7.7
Safety Set

Injection site erythema/ (17)
ERYTHEMA AT INJECTION
SITE
Dizziness/ (2)/ No/ R CHANGED/ RESOLVED
DIZZINESS 2020-09-12 07:30 No NONE
(2)

FDA-CBER-2022-908-0002462
500
Listing 16.2.7.7
Safety Set

COVID LIKE ILLNESS (109) MEDICATION
Eye disorders/ 2020-09-28 Yes/ 3 No NR/ NOT NOT RECOVERED/
Glaucoma/ (5)/ Yes/ NR APPLICABLE/ NOT RESOLVED
GLAUCOMA OF LEFT EYE Ongoing No CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0002463
501
Listing 16.2.7.7
Safety Set

Musculoskeletal and 2020-09-25 22:00 Yes/ 3 No R/ NOT RECOVERED/
connective tissue (1)/ No/ R APPLICABLE/ RESOLVED
disorders/ 2020-10-09 08:30 No NONE
Pain in extremity/ (14)
RIGHT LEG MUSCLE ACHES
Nervous system disorders/ 2020-09-25 22:16 Yes/ 3 No NR/ NOT RECOVERED/

INTERMITTENT HEADACHE 2020-10-03 21:10 Yes CONCOMITANT
(9) MEDICATION

FDA-CBER-2022-908-0002464
502
Listing 16.2.7.7
Safety Set

Atrial fibrillation/ (26)/ Yes/ (2020-10-27/ NR APPLICABLE/ RESOLVED WITH
ATRIAL FIBRILLATION 2020-11-06 No 2020-10-30) CONCOMITANT SEQUELAE:
(36) MEDICATION, SUBJECT NOW
CONCOMITANT HAS ONGOING
PROCEDURE ATRIAL
FIBRILLATION,
NO LONGER A
SERIOUS
ADVERSE EVENT.

FDA-CBER-2022-908-0002465
503
Listing 16.2.7.7
Safety Set

ATRIAL FIBRILLATION 2020-12-09 No CONCOMITANT
(69) MEDICATION,
CONCOMITANT
PROCEDURE
INTERMITTENT ABDOMINAL (127) MEDICATION
PAIN

FDA-CBER-2022-908-0002466
504
Listing 16.2.7.7
Safety Set

Skin and subcutaneous 2020-10-01 Yes/ 3 No NR/ DOSE NOT RECOVERED/
tissue disorders/ (15)/ No/ NR CHANGED/ RESOLVED
Erythema/ 2020-10-03 Yes NONE
BILATERAL CHEST ERYTHEMA (17)
PATCHES; NON-URTICARIAL;
bAb: Negative; Dose 1 Date/Time: 30SEP2020:13:44:00; Follow-up Days after 1st Dose: 23; Dose 2 Date/Time:
Skin and subcutaneous 2020-10-18 Yes/ 3 No NR/ DOSE NOT RECOVERING/
Hidradenitis/ Ongoing No CONCOMITANT
WORSENING OF MEDICATION,
HIDRADENITIS SUPPURITIVA CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002467
505
Listing 16.2.7.7
Safety Set

(20) MEDICATION
Nephrolithiasis/ 2020-10-07 No NONE
FLANK PAIN-PASSING (36)
KIDNEY STONE

FDA-CBER-2022-908-0002468
506
Listing 16.2.7.7
Safety Set

LUMBAR BACK PAIN
Vulval disorder/ 2021-02-22 No CONCOMITANT
VULVULAR (168) PROCEDURE
LESION-MALIGNANT

FDA-CBER-2022-908-0002469
507
Listing 16.2.7.7
Safety Set

RIGHT LOWER WISDOM TOOTH (101) MEDICATION,
PAIN/INFECTION CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002470
508
Listing 16.2.7.7
Safety Set

unspecified (incl cysts 2020-11-05 No NONE
and polyps)/ (57)
Malignant melanoma in
situ/
MELANOMA IN SITU (LEFT
SHOULDER)

FDA-CBER-2022-908-0002471
509
Listing 16.2.7.7
Safety Set

tissue disorders/ (43)/ Yes/ NR CHANGED/ RESOLVED
Actinic keratosis/ 2020-11-13 No CONCOMITANT
ACTINIC KERATOSIS (LEFT (65) PROCEDURE
CHEEK)

Fatigue/ (84)
FATIGUE

FDA-CBER-2022-908-0002472
510
Listing 16.2.7.7
Safety Set

FEVER OF 101.5

Vertigo/ 2020-12-16 No CONCOMITANT
VERTIGO (93) MEDICATION

FDA-CBER-2022-908-0002473
511
Listing 16.2.7.7
Safety Set

(3) MEDICATION
Spinal pain/ MEDICATION
INTERMITTENT MID-BACK
PAIN (THORACIC SPINE)

FDA-CBER-2022-908-0002474
512
Listing 16.2.7.7
Safety Set

MEDICATION
administration site (32)/ Yes/ NA APPLICABLE/ RESOLVED
Chest discomfort/ (32) MEDICATION,
CHEST PRESSURE - CONCOMITANT
MODERATE PROCEDURE

FDA-CBER-2022-908-0002475
513
Listing 16.2.7.7
Safety Set

Abdominal pain/ 2020-11-02 No NONE
ABDOMINAL PAIN (41)
Migraine/ (1)/ No/ R CHANGED/ RESOLVED
SEVERE MIGRAINE 2020-10-04 Yes CONCOMITANT
(3) MEDICATION

FDA-CBER-2022-908-0002476
514
Listing 16.2.7.7
Safety Set

Injury, poisoning and 2020-12-11 Yes/ 3 Yes/3 NR/ NOT RECOVERING/
procedural complications/ (75)/ Yes/ (2021-03-24/ NR APPLICABLE/ RESOLVING
Joint injury/ Ongoing No 2021-03-24)/4 CONCOMITANT
RIGHT KNEE INJURY MEDICATION,
CONCOMITANT
PROCEDURE
Migraine/ (64)/ Yes/ NR APPLICABLE/ RESOLVED
EXACERBATION OF MIGRAINE 2021-03-15 Yes CONCOMITANT
HEADACHES (167) MEDICATION

FDA-CBER-2022-908-0002477
515
Listing 16.2.7.7
Safety Set

SEVERE RIGHT-SIDED 2020-12-21 Yes CONCOMITANT
HEADACHE (81) MEDICATION
General disorders and 2020-09-23 Yes/ 3 No R/ DRUG RECOVERED/

administration site (13)/ Yes/ NR WITHDRAWN/ RESOLVED
RIGHT DELTOID MACULAR,
NON-URTICARIAL REDNESS
AT INJECTION SITE 120MM
BY 86MM OBLONG

FDA-CBER-2022-908-0002478
516
Listing 16.2.7.7
Safety Set

Nervous system disorders/ 2020-10-23 Yes/ 3 No NR/ DOSE NOT NOT RECOVERED/
Lumbar radiculopathy/ (43)/ Yes/ NR CHANGED/ NOT RESOLVED
LUMBAR RADICULOPATHY Ongoing No CONCOMITANT
MEDICATION
Respiratory, thoracic 2020-10-26 Yes/ 3 No NR/ DOSE NOT NOT RECOVERED/
and mediastinal (6)/ Yes/ NR CHANGED/ NOT RESOLVED
Bronchiectasis/ MEDICATION
NEW DIAGNOSIS OF
BRONCHIECTASIS

FDA-CBER-2022-908-0002479
517
Listing 16.2.7.7
Safety Set

OF R HIP PROCEDURE
Syncope/ (1)/ No/ NR CHANGED/ RESOLVED
WORSENING OF OCCASIIONAL 2020-09-26 11:00 No CONCOMITANT
SYNCOPE OCCURRING WITH (2) MEDICATION
MEDICAL EVENTS

FDA-CBER-2022-908-0002480
518
Listing 16.2.7.7
Safety Set

Injection site urticaria/ (26)
URTICARIAL INJECTION
SITE ERYTHEMA.
OPTICAL MIGRAINE 2020-09-24 No NONE
(2)

FDA-CBER-2022-908-0002481
519
Listing 16.2.7.7
Safety Set

Cardiomyopathy/ (27)/ Yes/ NR APPLICABLE/ RESOLVED
CATECHOLAMINE 2020-11-13 No CONCOMITANT
CARDIOMYOPATHY (52) MEDICATION,
CONCOMITANT
PROCEDURE
Head injury/ 2020-10-15 No CONCOMITANT
HEAD INJURY (22) MEDICATION

FDA-CBER-2022-908-0002482
520
Listing 16.2.7.7
Safety Set

FOREHEAD LACERATION (22) PROCEDURE

OSTEOARTHRITIS LEFT HIP PROCEDURE

FDA-CBER-2022-908-0002483
521
Listing 16.2.7.7
Safety Set

unspecified (incl cysts 2020-11-23 No 2020-11-23)/6 CONCOMITANT
Clear cell renal cell CONCOMITANT
carcinoma/ PROCEDURE
KIDNEY CANCER, RIGHT
KIDNEY CLEAR CELL RENAL
CELL CARCINOMA, WHO/ISUP
GRADE 3

FDA-CBER-2022-908-0002484
522
Listing 16.2.7.7
Safety Set

Facial paralysis/ (82)/ Yes/ NR APPLICABLE/ RESOLVING
BELL'S PALSY - COMPLETE Ongoing No CONCOMITANT
PERIPHERAL FACIAL NERVE MEDICATION,
PARALYSIS ON LEFT SIDE. CONCOMITANT
PROCEDURE
Osteoarthritis/ MEDICATION
OSTEOARTHRITIS IN KNEES

FDA-CBER-2022-908-0002485
523
Listing 16.2.7.7
Safety Set

Fatigue/ (23)
FATIGUE
Vascular disorders/ 2020-09-10 17:02 Yes/ 3 No NR/ DOSE NOT RECOVERING/
MEDICATION

FDA-CBER-2022-908-0002486
524
Listing 16.2.7.7
Safety Set

Plasma cell myeloma/
WORSENING MULTIPLE
MYELOMA

FDA-CBER-2022-908-0002487
525
Listing 16.2.7.7
Safety Set

BILATERAL ELBOW AND
RIGHT KNEE ARTHRALGIAS

GENERALIZED MYALGIAS

FDA-CBER-2022-908-0002488
526
Listing 16.2.7.7
Safety Set

(17)

Subarachnoid haemorrhage/ (17)/ Yes/ (2020-11-13/ NR APPLICABLE/ RESOLVED
SUBARACHNOID HEMORRHAGE 2020-12-11 No 2020-11-15) CONCOMITANT
(45) MEDICATION

FDA-CBER-2022-908-0002489
527
Listing 16.2.7.7
Safety Set

Nervous system disorders/ 2020-11-07 Yes/ 3 Yes/3 NR/ DRUG RECOVERED/
Seizure/ (30)/ Yes/ (2020-11-07/ NR WITHDRAWN/ RESOLVED
EXACERBATION OF SEIZURE 2020-11-09 No 2020-11-08) CONCOMITANT
DISORDER (32) MEDICATION
(36)

FDA-CBER-2022-908-0002490
528
Listing 16.2.7.7
Safety Set

General disorders and 2020-08-24 Yes/ 3 Yes/3 NR/ DOSE NOT RECOVERED/
administration site (12)/ Yes/ (2020-08-29/ NR CHANGED/ RESOLVED
NON-CARDIAC CHEST PAIN,
NON-SPECIFIED
Rotator cuff syndrome/ (208) PROCEDURE
LEFT ROTATOR CUFF TEAR

FDA-CBER-2022-908-0002491
529
Listing 16.2.7.7
Safety Set

Cervical radiculopathy/ (36)/ Yes/ NR APPLICABLE/ RESOLVED
CERVICAL RADICULOPATHY 2020-11-06 No CONCOMITANT
(52) MEDICATION

LEFT KNEE MENISCUS TEAR (72) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002492
530
Listing 16.2.7.7
Safety Set

Renal and urinary 2020-12-19 Yes/ 3 No NA/ NOT RECOVERED/

Urinary incontinence/ 2020-12-24 No CONCOMITANT
URINARY INCONTINENCE (121) PROCEDURE

Urinary retention/ 2021-02-09 No NONE
URINARY RETENTION (168)

FDA-CBER-2022-908-0002493
531
Listing 16.2.7.7
Safety Set


FRACTURED LEFT ANKLE (73) MEDICATION

Hepatic enzyme increased/ (9)/ Yes/ NR WITHDRAWN/ RESOLVED
ELEVATED LIVER ENZYMES 2020-12-17 No NONE
(101)

FDA-CBER-2022-908-0002494
532
Listing 16.2.7.7
Safety Set

(99) MEDICATION
WORSENING BACK PAIN

FDA-CBER-2022-908-0002495
533
Listing 16.2.7.7
Safety Set

Hypertension/ (26)/ No/ NR CHANGED/ RESOLVING
MEDICATION
SEVERE SCIATIC PAIN 2021-01-12 No CONCOMITANT
(114) MEDICATION

FDA-CBER-2022-908-0002496
534
Listing 16.2.7.7
Safety Set

Skin and subcutaneous 2020-10-22 Yes/ 3 No R/ DOSE NOT RECOVERED/
Pruritus/ 2020-10-24 No CONCOMITANT
SEVERE ITCHING (16) MEDICATION

Rash/ 2020-10-24 No CONCOMITANT
RASH ON TRUNK/BACK - (16) MEDICATION
NONURTICARIAL

FDA-CBER-2022-908-0002497
535
Listing 16.2.7.7
Safety Set

(29)
Systolic hypertension/ (1)/ Yes/ NR CHANGED/ RESOLVED
SYSTOLIC HYPERTENSION 2020-08-28 14:15 No NONE
(7)

FDA-CBER-2022-908-0002498
536
Listing 16.2.7.7
Safety Set

(40)
BACK SPASMS

FDA-CBER-2022-908-0002499
537
Listing 16.2.7.7
Safety Set

Fatigue/ (9)
FATIGUE
Injection site (29) MEDICATION
lymphadenopathy/
LEFT (INJECTION SIDE)
AXILLARY LYMPHADENOPATHY

FDA-CBER-2022-908-0002500
538
Listing 16.2.7.7
Safety Set

SYSTOLIC HYPERTENSION 2020-09-09 19:00 No NONE
(1)
PRESSURE

FDA-CBER-2022-908-0002501
539
Listing 16.2.7.7
Safety Set

(27)
Injury, poisoning and 2020-08-25 Yes/ 3 Yes/3 NR/ DOSE NOT RECOVERED/
procedural complications/ (6)/ Yes/ (2020-08-25/ NR CHANGED/ RESOLVED
Femoral neck fracture/ 2020-10-05 No 2020-08-28) CONCOMITANT
RIGHT SUBCAPITAL FEMORAL (47) MEDICATION,
NECK FRACTURE, DISPLACED CONCOMITANT
GARDEN III PROCEDURE

FDA-CBER-2022-908-0002502
540
Listing 16.2.7.7
Safety Set

Vertigo/ Ongoing No NONE
VERTIGO
NSTEMI (NON-ST SEGMENT (99) MEDICATION,
ELEVATION MYOCARDIAL CONCOMITANT
INFARCTION) PROCEDURE

FDA-CBER-2022-908-0002503
541
Listing 16.2.7.7
Safety Set

Ligament injury/ 2021-01-15 No CONCOMITANT
LIGAMENT TEAR (LEFT (128) MEDICATION
KNEE)

FDA-CBER-2022-908-0002504
542
Listing 16.2.7.7
Safety Set

administration site (8)/ Yes/ R CHANGED/ RESOLVED
Injection site macule/ (12) MEDICATION
NON-URTICARIAL
RETICULATE MACULAR
SITE, RIGHT ARM

FDA-CBER-2022-908-0002505
543
Listing 16.2.7.7
Safety Set

SITE, NON-URTICARIAL
RIGHT LEG EDEMA

FDA-CBER-2022-908-0002506
544
Listing 16.2.7.7
Safety Set

Fibula fracture/ Ongoing No CONCOMITANT
LEFT FIBULA FRACTURE MEDICATION
Sepsis/ 2021-01-21 No CONCOMITANT

FDA-CBER-2022-908-0002507
545
Listing 16.2.7.7
Safety Set

Diabetes mellitus 2020-11-04 No NONE
inadequate control/ (50)
UNCONTROLLED DIABETES
bAb: Negative; Dose 1 Date/Time: 22SEP2020:15:07:00; Follow-up Days after 1st Dose: 17; Dose 2 Date/Time:
Psychiatric disorders/ 2020-09-28 Yes/ 3 No NR/ DOSE NOT RECOVERING/
Depression/ (7)/ No/ NR CHANGED/ RESOLVING
WORSENING DEPRESSION Ongoing No NONE
Blood pressure increased/ (1)/ No/ NR CHANGED/ NOT RESOLVED

FDA-CBER-2022-908-0002508
546
Listing 16.2.7.7
Safety Set

LEFT ARM
(NON-URTICARIAL)
INJECTION SITE RED PATCH
Investigations/ 2020-10-05 11:00 Yes/ 3 No R/ DOSE NOT NOT RECOVERED/

FDA-CBER-2022-908-0002509
547
Listing 16.2.7.7
Safety Set

Psychiatric disorders/ 2020-11-23 Yes/ 3 No R/ NOT RECOVERING/
Grief reaction/ (55)/ Yes/ R APPLICABLE/ RESOLVING
DEPRESSION/GRIEF Ongoing No CONCOMITANT
MEDICATION
Hypertension/ (1)/ No/ NA CHANGED/ RESOLVED
(29)

FDA-CBER-2022-908-0002510
548
Listing 16.2.7.7
Safety Set

(29)
POST-DOSE ELEVATED BLOOD Ongoing No NONE
PRESSURE

FDA-CBER-2022-908-0002511
549
Listing 16.2.7.7
Safety Set

procedural complications/ (7)/ No/ NR CHANGED/ RESOLVING
Foot fracture/ Ongoing No NONE
BROKEN TOE

BACK PAIN (WORSENING)

FDA-CBER-2022-908-0002512
550
Listing 16.2.7.7
Safety Set

HIP PAIN (RIGHT)
Subject ID: US3632101; Age (years): 24; Sex: M; Race: OTHER: PUERTO RICAN; Height (cm): 175.3; Weight (kg): 76.5; BMI (kg/m2):
Gastrointestinal 2020-10-22 Yes/ 3 No R/ NOT RECOVERED/
Dyspepsia/ 2020-10-23 No CONCOMITANT
CHEST TIGHTNESS (DUE TO (4) MEDICATION
INDIGESTION)

FDA-CBER-2022-908-0002513
551
Listing 16.2.7.7
Safety Set

MEDICATION
Cardiac disorders/ 2021-01-01 Yes/ 3 No NR/ NOT RECOVERING/
Palpitations/ (89)/ Yes/ NR APPLICABLE/ RESOLVING
WORSENING PALPITATIONS Ongoing No CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0002514
552
Listing 16.2.7.7
Safety Set

unspecified (incl cysts Ongoing No NONE
and polyps)/
Prostate cancer/
PROSTATE CANCER
DIAGNOSIS

FDA-CBER-2022-908-0002515
553
Listing 16.2.7.7
Safety Set

Injection site urticaria/ (11) MEDICATION
INJECTION SITE
URTICARIAL RASH FROM
VACCINE #1
Nervous system disorders/ 2020-11-04 19:24 Yes/ 3 No R/ NOT RECOVERED/
(11) MEDICATION

FDA-CBER-2022-908-0002516
554
Listing 16.2.7.7
Safety Set

Negative; Baseline Elecsys SARS-CoV-2 Nucleocapsid bAb: Negative; Dose 1 Date/Time: 13OCT2020:15:07:00; Follow-up Days after
1st Dose: 165; Dose 2 Date/Time: 10NOV2020:16:27:00; Follow-up Days after 2nd Dose: 137
WORSENING MIGRAINES 2020-10-30 08:00 Yes CONCOMITANT
(17) MEDICATION
Nervous system disorders/ 2020-11-30 Yes/ 3 Yes/3 R/ NOT RECOVERED/

CRYPTOGENIC STROKE 2020-12-15 No 2020-12-08)/6 CONCOMITANT
(OFFICIAL DIAGNOSIS ON (82) MEDICATION,
12/4, SYMPTOMS BEGINNING CONCOMITANT
ON 11/30) PROCEDURE

FDA-CBER-2022-908-0002517
555
Listing 16.2.7.7
Safety Set

Breast cancer female/ CONCOMITANT
MALIG NEOPLM OF PROCEDURE
UPPER-OUTER QUADRANT OF
RIGHT FEMALE BRAEST

FDA-CBER-2022-908-0002518
556
Listing 16.2.7.7
Safety Set

General disorders and 2020-10-20 12:06 Yes/ 3 No NR/ NOT RECOVERED/
Fatigue/ (14)
FATIGUE
Subject ID: US3662121; Age (years): 39; Sex: F; Race: OTHER: MAYA; Height (cm): 141.3; Weight (kg): 57.9; BMI (kg/m2): 29.0;
LACERATED LEFT THUMB (18) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002519
557
Listing 16.2.7.7
Safety Set

Subject ID: US3662121; Age (years): 39; Sex: F; Race: OTHER: MAYA; Height (cm): 141.3; Weight (kg): 57.9; BMI (kg/m2): 29.0;
Limb injury/ 2020-10-11 No NONE
PAIN IN CUT FINGER (21)
ELEVATED BLOOD PRESSURE Ongoing No CONCOMITANT
(WORSENING) MEDICATION

FDA-CBER-2022-908-0002520
558
Listing 16.2.7.7
Safety Set


SITE (L)
ERYTHEMA AT SITE OF
INJECTION (LEFT ARM)

FDA-CBER-2022-908-0002521
559
Listing 16.2.7.7
Safety Set

RECURRENT SMALL BOWEL CONCOMITANT
OBSTRUCTION PROCEDURE
Vascular disorders/ / Yes/ 3 No NR/ DOSE NOT RECOVERED/
Arterial occlusive 2021-03-03 Yes/ NR CHANGED/ RESOLVED
disease/ (183) No CONCOMITANT
BLOCKED ARTERY PROCEDURE

FDA-CBER-2022-908-0002522
560
Listing 16.2.7.7
Safety Set


COLITIS (49) MEDICATION

Pancreatitis/ 2020-10-13 No CONCOMITANT
PANCREATITIS (49) MEDICATION

FDA-CBER-2022-908-0002523
561
Listing 16.2.7.7
Safety Set


Superficial injury of 2020-12-01 No 2020-12-02) CONCOMITANT
eye/ (98) MEDICATION,
SCRATCHED CORNEA - L EYE CONCOMITANT
PROCEDURE
Scleritis/ (7)/ Yes/ NR CHANGED/ RESOLVED
EYE REDNESS (SCLERITIS) 2020-09-07 No CONCOMITANT
(10) MEDICATION

FDA-CBER-2022-908-0002524
562
Listing 16.2.7.7
Safety Set

(26)
(28)

FDA-CBER-2022-908-0002525
563
Listing 16.2.7.7
Safety Set

Conjunctivitis/ 2020-11-03 No CONCOMITANT
PINK EYE BILATERAL (56) MEDICATION
Ear infection/ 2020-09-21 No CONCOMITANT
EAR INFECTION (12) MEDICATION
Vascular disorders/ 2020-11-04 Yes/ 3 No NR/ DOSE NOT NOT RECOVERED/

FDA-CBER-2022-908-0002526
564
Listing 16.2.7.7
Safety Set

(2)
system disorders/ (11)/ No/ NR APPLICABLE/ RESOLVED
Anaemia/ 2021-02-26 No CONCOMITANT
ANEMIA (130) MEDICATION

FDA-CBER-2022-908-0002527
565
Listing 16.2.7.7
Safety Set

THROAT PAIN FROM (19) MEDICATION
INTUBATION

Cough/ (19) MEDICATION
COUGH FROM INTUBATION

FDA-CBER-2022-908-0002528
566
Listing 16.2.7.7
Safety Set

General disorders and 2020-11-19 Yes/ 3 No NR/ NOT NOT RECOVERED/
administration site (23)/ Yes/ NA APPLICABLE/ NOT RESOLVED
conditions/ Ongoing Yes CONCOMITANT
Pain/ MEDICATION
WORSENING OF PAIN FROM
RUPTURED L5

FDA-CBER-2022-908-0002529
567
Listing 16.2.7.7
Safety Set

Subject ID: US3692177; Age (years): 39; Sex: M; Race: MULTIPLE: White, Other: HISPANIC; Height (cm): 174.9; Weight (kg):
Rotator cuff syndrome/ MEDICATION
BILATERAL SHOULDER CUFF
TENDONITIS
Metabolism and nutrition 2020-12-07 Yes/ 3 No NR/ NOT NOT RECOVERED/
disorders/ (25)/ No/ NR APPLICABLE/ NOT RESOLVED
Glucose tolerance Ongoing No CONCOMITANT
impaired/ MEDICATION
PRE-DIABETIC

FDA-CBER-2022-908-0002530
568
Listing 16.2.7.7
Safety Set

COUGH

FDA-CBER-2022-908-0002531
569
Listing 16.2.7.7
Safety Set

Respiratory, thoracic 2020-11-20 12:22 Yes/ 3 No R/ NOT RECOVERED/
Tachypnoea/ (64)
TACHYPNEA
Dose 1 Date/Time: 04SEP2020:14:21:00; Follow-up Days after 1st Dose: 175; Dose 2 Date/Time: ; Follow-up Days
after 2nd Dose: NA
Gastrointestinal 2020-09-04 Yes/ 3 No R/ DOSE NOT RECOVERED/
NAUSEA (8)

FDA-CBER-2022-908-0002532
570
Listing 16.2.7.7
Safety Set

after 2nd Dose: NA
Fatigue/ (8)
FATIGUE
SITE

FDA-CBER-2022-908-0002533
571
Listing 16.2.7.7
Safety Set

Injection site swelling/ (15) MEDICATION
SITE
MEDICATION

FDA-CBER-2022-908-0002534
572
Listing 16.2.7.7
Safety Set

PAIN IN THE INJECTION
SITE
General disorders and 2020-09-10 17:00 Yes/ 3 No NR/ DOSE NOT RECOVERED/
PAIN AT INJECTION SITE
GRADE 3

FDA-CBER-2022-908-0002535
573
Listing 16.2.7.7
Safety Set

FATIGUE

GENERALIZED JOINT ACHES

FDA-CBER-2022-908-0002536
574
Listing 16.2.7.7
Safety Set


(9) MEDICATION

FDA-CBER-2022-908-0002537
575
Listing 16.2.7.7
Safety Set

(9) MEDICATION
Labile hypertension/ (29)/ No/ NR CHANGED/ NOT RESOLVED
LABILE HYPERTENSION Ongoing No NONE

FDA-CBER-2022-908-0002538
576
Listing 16.2.7.7
Safety Set

Supraventricular (100)/ Yes/ (2020-12-24/ NR APPLICABLE/ RESOLVED
tachycardia/ 2020-12-25 No 2020-12-25) CONCOMITANT
SUPRAVENTRICULAR (101) MEDICATION
TACHYCARDIA
Rectal cancer/ CONCOMITANT
RECTAL CARCINOMA PROCEDURE

FDA-CBER-2022-908-0002539
577
Listing 16.2.7.7
Safety Set

(215)
Nervous system disorders/ 2020-11-21 Yes/ 3 No NR/ NOT UNKNOWN
Headache/ (51)/ No/ NR APPLICABLE/
HEADACHE, TEMPORAL Ongoing Yes NONE

FDA-CBER-2022-908-0002540
578
Listing 16.2.7.7
Safety Set

Pyrexia/ (28)
FEVER (103 F)
EXACERBATION OF Ongoing No CONCOMITANT

FDA-CBER-2022-908-0002541
579
Listing 16.2.7.7
Safety Set

(31)
EXACERBATION (28)

FDA-CBER-2022-908-0002542
580
Listing 16.2.7.7
Safety Set

KNEE PAIN
Pelvic pain/ 2021-01-11 No 2021-01-11) CONCOMITANT
LEFT SIDE PELVIC PAIN (109) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002543
581
Listing 16.2.7.7
Safety Set

Fatigue/ (13)
FATIGUE
Nucleocapsid bAb: Negative; Dose 1 Date/Time: 31AUG2020:13:00:00; Follow-up Days after 1st Dose: 208; Dose
Limb injury/ 2020-10-15 No CONCOMITANT
TRAUMATIC INJURY L FOOT (18) MEDICATION

FDA-CBER-2022-908-0002544
582
Listing 16.2.7.7
Safety Set

TRAUMATIC INJURY LEFT (18) MEDICATION
HAND
Chills/ (1)
RIGORS

FDA-CBER-2022-908-0002545
583
Listing 16.2.7.7
Safety Set

UTI (29) MEDICATION


FDA-CBER-2022-908-0002546
584
Listing 16.2.7.7
Safety Set


Vomiting/ 2020-11-09 Yes CONCOMITANT
VOMITING (36) MEDICATION

FDA-CBER-2022-908-0002547
585
Listing 16.2.7.7
Safety Set

Ventricular (108)/ Yes/ NR APPLICABLE/ RESOLVED
extrasystoles/ 2021-02-15 No NONE
EXACERBATION OF (131)
PREMATURE VENTRICULAR
CONTRACTIONS
HYPERTENSION (8)

FDA-CBER-2022-908-0002548
586
Listing 16.2.7.7
Safety Set

Fatigue/ (9)
FATIGUE
Gastrointestinal 2020-09-10 16:00 Yes/ 3 No R/ DOSE NOT RECOVERED/

disorders/ (2)/ No/ R CHANGED/ RESOLVED
Nausea/ 2020-09-17 16:00 Yes NONE
NAUSEA (9)

FDA-CBER-2022-908-0002549
587
Listing 16.2.7.7
Safety Set

Chills/ (9)
CHILLS
Fatigue/ (14)
FATIGUE

FDA-CBER-2022-908-0002550
588
Listing 16.2.7.7
Safety Set

NONURTICARIAL ERYTHEMA
AT INJECTION SITE
Myalgia/ (12)
MUSCLE ACHES UPPER AND
LOWER EXTREMITIES

FDA-CBER-2022-908-0002551
589
Listing 16.2.7.7
Safety Set

Fatigue/ (19)
FATIGUE
Facial paralysis/ (32)/ Yes/ (2020-11-06/ NR APPLICABLE/ RESOLVED
BELL'S PALSY 2020-12-29 No 2020-11-07) CONCOMITANT
(85) MEDICATION

FDA-CBER-2022-908-0002552
590
Listing 16.2.7.7
Safety Set

Fatigue/ (57)
FATIGUE

Rhinorrhoea/ (57)
RUNNY NOSE

FDA-CBER-2022-908-0002553
591
Listing 16.2.7.7
Safety Set

(58) MEDICATION

NASAL CONGESSTION

FDA-CBER-2022-908-0002554
592
Listing 16.2.7.7
Safety Set

Facial paralysis/ (87)/ Yes/ NR APPLICABLE/ RESOLVED
BELL'S PALSY 2021-01-31 No CONCOMITANT
(118) MEDICATION
(11)

FDA-CBER-2022-908-0002555
593
Listing 16.2.7.7
Safety Set

(42) MEDICATION

Fatigue/ (43)
FATIGUE

FDA-CBER-2022-908-0002556
594
Listing 16.2.7.7
Safety Set

Gastrointestinal 2020-11-09 Yes/ 3 Yes/2/3 NR/ NOT RECOVERED/
Diarrhoea/ 2020-11-15 No 2020-11-15) NONE
DIARRHEA (47)

Faeces discoloured/ 2020-11-11 No NONE
BLACK STOOL (43)

FDA-CBER-2022-908-0002557
595
Listing 16.2.7.7
Safety Set

Renal and urinary 2020-11-10 Yes/ 3 Yes/2/3 NR/ NOT RECOVERED/
ACUTE KIDNEY INJURY (43) MEDICATION

LEFT UPPER LOBE (50) MEDICATION
PNEUMONIA

FDA-CBER-2022-908-0002558
596
Listing 16.2.7.7
Safety Set

Infections and 2020-11-10 Yes/ 3 Yes/2/3 NR/ NOT RECOVERED/
Infections and 2020-12-24 Yes/ 3 Yes/3 NR/ NOT NOT RECOVERED/

infestations/ (86)/ Yes/ (2020-12-24/ NR APPLICABLE/ NOT RESOLVED
Urinary tract infection/ Ongoing No 2020-12-25) CONCOMITANT
URINARY TRACT INFECTION MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002559
597
Listing 16.2.7.7
Safety Set

Muscular weakness/ (79)
BILATERAL LOWER
EXTREMITY WEAKNESS
Fatigue/ (9)
FATIGUE

FDA-CBER-2022-908-0002560
598
Listing 16.2.7.7
Safety Set

JOINTS

WHOLE BODY MYALGIA

FDA-CBER-2022-908-0002561
599
Listing 16.2.7.7
Safety Set

R ARM CELLULITIS (41) MEDICATION
STREP PHARYNGITIS

FDA-CBER-2022-908-0002562
600
Listing 16.2.7.7
Safety Set

(1)
Hypersensitivity/ (64)/ Yes/ NR APPLICABLE/ RESOLVED
ALLERGIC REATION 2020-12-01 No CONCOMITANT
(65) MEDICATION

FDA-CBER-2022-908-0002563
601
Listing 16.2.7.7
Safety Set

Angina unstable/ (118)/ Yes/ (2020-12-26/ NR APPLICABLE/ RESOLVED
UNSTABLE ANGINA 2021-01-04 No 2020-12-28) CONCOMITANT
(130) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002564
602
Listing 16.2.7.7
Safety Set

Neoplasms benign, 2020-08-28 Yes/ 3 Yes/6 NR/ DOSE NOT NOT RECOVERED/
Prostate cancer/ CONCOMITANT
PROSTATE CANCER PROCEDURE

Plasma cell myeloma/
MULTIPLE MYELOMA

FDA-CBER-2022-908-0002565
603
Listing 16.2.7.7
Safety Set

LEFT SPRAINED THUMB (75) PROCEDURE
Skin and subcutaneous 2020-09-09 09:00 Yes/ 3 No R/ NOT RECOVERED/
Dermatitis/ 2020-09-17 09:00 No NONE
DERMATITIS ON LEFT ARM (9)

FDA-CBER-2022-908-0002566
604
Listing 16.2.7.7
Safety Set

Obesity/ 2020-12-26 No 2020-12-26) CONCOMITANT
WORSENING OBESITY (110) PROCEDURE
(57) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002567
605
Listing 16.2.7.7
Safety Set

Neoplasms benign, 2020-10-02 11:00 Yes/ 3 Yes/6 R/ NOT RECOVERED/
malignant and (30)/ Yes/ R APPLICABLE/ RESOLVED WITH
unspecified (incl cysts 2020-12-22 No NONE SEQUELAE:
and polyps)/ (112) PER MD, THE
B-cell small lymphocytic PATIENT HAS
lymphoma/ STABLE DISEASE
SMALL LYMPHOCYTIC AT THIS TIME
LYMPHOMA AND IS BEING
WATCHED FOR
PROGRESSION.
THE PATIENT
DOES NOT
CURRENTLY MEET
CRITERIA TO
START FIRST
LINE
TREATMENT.

FDA-CBER-2022-908-0002568
606
Listing 16.2.7.7
Safety Set

SEVERE KNEE PAIN
Musculoskeletal and 2020-08-12 Yes/ 3 No R/ DOSE NOT NOT RECOVERED/
Temporomandibular joint
syndrome/
TMJ

FDA-CBER-2022-908-0002569
607
Listing 16.2.7.7
Safety Set

Injection site (68)
lymphadenopathy/
UNDER ARM GLAND SWELLING
ON SIDE OF INJECTION

FDA-CBER-2022-908-0002570
608
Listing 16.2.7.7
Safety Set

ABDOMINAL PAIN (49) MEDICATION,
CONCOMITANT
PROCEDURE
, FEELING LIGHTHEADED 2020-10-08 No NONE
(8)

FDA-CBER-2022-908-0002571
609
Listing 16.2.7.7
Safety Set

Cardiac flutter/ (7)/ Yes/ NR CHANGED/ RESOLVED
FLUTTERING IN CHEST - 2020-10-08 09:32 No NONE
WORSENING ARRYTHMIA (7)
Dose 1 Date/Time: 23OCT2020:08:51:00; Follow-up Days after 1st Dose: 155; Dose 2
administration site (34)/ No/ NR APPLICABLE/ RESOLVED WITH
conditions/ 2021-01-03 No CONCOMITANT SEQUELAE:
Swelling face/ (47) MEDICATION PREDNISONE
SWELLING IN FACE

FDA-CBER-2022-908-0002572
610
Listing 16.2.7.7
Safety Set

Toxic shock syndrome/ 2020-08-25 No 2020-08-25) CONCOMITANT
SUSPECTED TOXIC SHOCK (24) MEDICATION
SYNDROME
SYNCOPAL EPISODE 2020-09-23 No 2020-09-23) CONCOMITANT
(15) MEDICATION

FDA-CBER-2022-908-0002573
611
Listing 16.2.7.7
Safety Set

Respiratory, thoracic 2020-12-19 Yes/ 3 Yes/2/3 NR/ NOT RECOVERED/
Acute respiratory (77)
failure/
ACUTE HYPOXEMIA
RESPIRATORY FAILURE
(WORSENING)

FDA-CBER-2022-908-0002574
612
Listing 16.2.7.7
Safety Set

Pneumothorax/ (77) MEDICATION,
WORSENING LEFT CONCOMITANT
PNEUMOTHORAX PROCEDURE
Subject ID: US3842042; Age (years): 51; Sex: F; Race: OTHER: COSTARICAN; Height (cm): 151.0; Weight (kg): 105.1; BMI (kg/m2):
LEFT HIP PAIN

FDA-CBER-2022-908-0002575
613
Listing 16.2.7.7
Safety Set

Ear and labyrinth 2020-09-29 23:59 Yes/ 3 No R/ NOT RECOVERED/
VERTIGO (2)

FDA-CBER-2022-908-0002576
614
Listing 16.2.7.7
Safety Set

Hepatobiliary disorders/ 2021-01-04 Yes/ 3 No NR/ NOT RECOVERED/
Cholecystitis/ (89)/ Yes/ NR APPLICABLE/ RESOLVED
CHOLECYSTITIS 2021-01-11 No CONCOMITANT
(96) PROCEDURE
Renal and urinary 2020-11-23 Yes/ 3 Yes/3 NR/ DOSE RECOVERED/

disorders/ (33)/ Yes/ (2020-11-23/ NR DELAYED/ RESOLVED
Nephrolithiasis/ 2020-11-29 No 2020-11-29) NONE
KIDNEY STONES (39)

FDA-CBER-2022-908-0002577
615
Listing 16.2.7.7
Safety Set

Retinal detachment/ (25)/ Yes/ NR CHANGED/ RESOLVED
LEFT EYE RETINAL 2020-09-11 No CONCOMITANT
DETACHMENT (32) PROCEDURE

FDA-CBER-2022-908-0002578
616
Listing 16.2.7.7
Safety Set


(112) MEDICATION

FDA-CBER-2022-908-0002579
617
Listing 16.2.7.7
Safety Set

PAROXYSMAL ATRIAL 2020-10-22 18:00 No CONCOMITANT
FIBRILLATION (23) PROCEDURE
Injection site (5)
hypoaesthesia/
INJECTION SITE NUMBNESS

FDA-CBER-2022-908-0002580
618
Listing 16.2.7.7
Safety Set

RIGHT RIB FRACTURES (119) MEDICATION
(#9-#11)

ACUTE RESPIRATORY PROCEDURE
FAILURE

FDA-CBER-2022-908-0002581
619
Listing 16.2.7.7
Safety Set

PNEUMONIA (BILATERAL) (132) MEDICATION,
CONCOMITANT
PROCEDURE

Septic shock/ 2021-01-06 No CONCOMITANT
SEPTIC SHOCK OF UNKNOWN (132) MEDICATION
ETIOLOGY

FDA-CBER-2022-908-0002582
620
Listing 16.2.7.7
Safety Set

Blood and lymphatic 2020-12-25 Yes/ 3 No NR/ DOSE NOT RECOVERED/
system disorders/ (120)/ Yes/ NR CHANGED/ RESOLVED
Leukocytosis/ 2021-01-25 No NONE
LEUKOCYTOSIS (151)
Coronary artery (121)/ Yes/ (2020-12-30/ NR APPLICABLE/ RESOLVED
occlusion/ 2021-01-02 No 2021-01-02) CONCOMITANT
LEFT ANTERIOR DESCENDING (124) MEDICATION,
ARTERY HEART BLOCKAGE CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002583
621
Listing 16.2.7.7
Safety Set

Arthralgia/ (42) MEDICATION,
RIGHT KNEE PAIN CONCOMITANT
PROCEDURE
Infections and 2020-08-04 00:00 Yes/ 3 No NR/ DOSE RECOVERED/
infestations/ (1)/ No/ NR DELAYED/ RESOLVED
Gingivitis/ 2020-12-16 00:00 No CONCOMITANT
ONGOING WORSENING (135) MEDICATION
GINGIVITIS

FDA-CBER-2022-908-0002584
622
Listing 16.2.7.7
Safety Set

Diarrhoea/ 2020-09-14 No 2020-08-22) CONCOMITANT
DIARRHEA UNSPECIFIED (39) MEDICATION
TYPE

Enteritis/ 2020-09-14 No NONE
ILEITIS (39)

FDA-CBER-2022-908-0002585
623
Listing 16.2.7.7
Safety Set

Subject ID: US3872118; Age (years): 36; Sex: F; Race: MULTIPLE: White, Black or African American, Asian; Height (cm): 157.5;
CHOLEYSTITIS 2020-11-15 No 2020-11-16) CONCOMITANT
(69) MEDICATION,
CONCOMITANT
PROCEDURE

Cholelithiasis/ (69)/ Yes/ NR APPLICABLE/ RESOLVED
CHOLELITHIASIS (69) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002586
624
Listing 16.2.7.7
Safety Set

RECURRENCE OF PAROXYSMAL 2020-12-22 No CONCOMITANT
ATRIAL FIB (106) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002587
625
Listing 16.2.7.7
Safety Set

connective tissue (14)/ No/ NA CHANGED/ RESOLVED
LEFT UPPER ARM PAIN
RIGHT HIP ABDUCTOR
TENDONITIS

FDA-CBER-2022-908-0002588
626
Listing 16.2.7.7
Safety Set

Food allergy/ (21)/ No/ NR APPLICABLE/ RESOLVED
WALNUT ALLERGIC REACTION 2020-10-13 No CONCOMITANT
(21) MEDICATION
NASAL FRACTURE (14) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002589
627
Listing 16.2.7.7
Safety Set

Animal bite/ 2021-02-17 No NONE
DOG BITE ON LEFT HAND (140)

FDA-CBER-2022-908-0002590
628
Listing 16.2.7.7
Safety Set

(kg/m2): 37.8; Baseline SARS-CoV-2 Status: Positive; Baseline RT-PCR: Positive; Baseline Elecsys SARS-CoV-2 Nucleocapsid
CHEST DISCOMFORT ( NON
CARDIAC )
Fatigue/ (13)
FATIGUE

FDA-CBER-2022-908-0002591
629
Listing 16.2.7.7
Safety Set

Fatigue/ (10)
FATIGUE

(10)

FDA-CBER-2022-908-0002592
630
Listing 16.2.7.7
Safety Set

FATIGUE

Clavicle fracture/ Ongoing No CONCOMITANT
LEFT CLAVICULAR FRACTURE MEDICATION

FDA-CBER-2022-908-0002593
631
Listing 16.2.7.7
Safety Set

FALL FROM GROUND LEVEL (84)

Haematoma/ (84)/ Yes/ NR APPLICABLE/ RESOLVED WITH
RIGHT LEG HEMATOMA 2020-12-21 No CONCOMITANT SEQUELAE:
(85) PROCEDURE POST-DEBRIDEME
NT WOUND R LEG

FDA-CBER-2022-908-0002594
632
Listing 16.2.7.7
Safety Set

Subarachnoid haemorrhage/ (84)/ Yes/ (2020-12-20/ NR APPLICABLE/ RESOLVED WITH
SUBARACHNOID HEMORRHAGE 2020-12-22 No 2020-12-22) CONCOMITANT SEQUELAE:
(86) MEDICATION BLOOD IN
SUBARACHNOID
SPACE.
FALL FROM ON ICE GROUND (102)

FDA-CBER-2022-908-0002595
633
Listing 16.2.7.7
Safety Set

procedural complications/ (102)/ Yes/ (2021-01-07/ NR APPLICABLE/ RESOLVED WITH
Craniocerebral injury/ 2021-01-08 No 2021-01-08) NONE SEQUELAE:
TRAUMATIC BRAIN INJURY (103) HEADACHE

Subdural haematoma/ 2021-01-08 No NONE
FRONTAL SUBDURAL (103)
HEMATOMA

FDA-CBER-2022-908-0002596
634
Listing 16.2.7.7
Safety Set

Facial bones fracture/ 2021-02-25 No NONE
FRACTURE LEFT AND RIGHT (151)
MAXILLARY SINUS

FRACTURE ORBITS (151) MEDICATION
BILATERAL NON-DISPLACED

FDA-CBER-2022-908-0002597
635
Listing 16.2.7.7
Safety Set

Facial bones fracture/ 2021-02-25 No NONE
FRACTURE ZYGOMATIC (151)
ARCHES BILATERAL
NON-DISPLACED
(140) MEDICATION

FDA-CBER-2022-908-0002598
636
Listing 16.2.7.7
Safety Set

Cholelithiasis/ (147)/ Yes/ (2021-02-22/ NR APPLICABLE/ RESOLVED
CHOLELITHIASIS 2021-03-01 No 2021-02-25) CONCOMITANT
(154) MEDICATION,
CONCOMITANT
PROCEDURE
HYPERTENSION (1)

FDA-CBER-2022-908-0002599
637
Listing 16.2.7.7
Safety Set

OBSTRUCTING (42) PROCEDURE
NEPHROLITHIASIS
Musculoskeletal and 2020-11-03 Yes/ 3 Yes/3 NR/ NOT NOT RECOVERED/

connective tissue (41)/ Yes/ (2020-11-03/ NR APPLICABLE/ NOT RESOLVED
disorders/ Ongoing No ) CONCOMITANT
Flank pain/ MEDICATION,
FLANK PAIN (LEFT) CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002600
638
Listing 16.2.7.7
Safety Set

Renal and urinary 2020-11-03 Yes/ 3 Yes/3 NR/ NOT NOT RECOVERED/
Acute kidney injury/ Ongoing No 2020-11-22) CONCOMITANT
ACUTE RENAL FAILURE MEDICATION

Bacterial pyelonephritis/ 2020-11-17 No CONCOMITANT
KLEBSIELLA COMPLICATED (55) MEDICATION
PYELONEPHRITIS

FDA-CBER-2022-908-0002601
639
Listing 16.2.7.7
Safety Set

General disorders and 2020-11-08 Yes/ 3 Yes/3 NR/ NOT NOT RECOVERED/
administration site (46)/ Yes/ (2020-11-03/ NR APPLICABLE/ NOT RESOLVED
Generalised oedema/ PROCEDURE
ANASARCA

Duodenal ulcer 2020-11-08 No 2020-11-22) CONCOMITANT SEQUELAE:
perforation/ (46) PROCEDURE ANEMIA
PERFORATED DUODENAL
ULCER

FDA-CBER-2022-908-0002602
640
Listing 16.2.7.7
Safety Set

system disorders/ (53)/ Yes/ (2020-11-03/ NR APPLICABLE/ NOT RESOLVED
Anaemia/ Ongoing No 2020-11-22) CONCOMITANT
ANEMIA MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002603
641
Listing 16.2.7.7
Safety Set

Respiratory, thoracic 2020-11-18 Yes/ 3 No NR/ NOT NOT RECOVERED/
and mediastinal (56)/ Yes/ NR APPLICABLE/ NOT RESOLVED
Pleural effusion/
BIBASAL INFILTRATES,
PLEURAL EFFUSIONS,
WORSENING

Malnutrition/ Ongoing No CONCOMITANT
MALNUTRITION MEDICATION

FDA-CBER-2022-908-0002604
642
Listing 16.2.7.7
Safety Set

Vascular disorders/ 2020-08-29 12:14 Yes/ 3 No NR/ DOSE NOT UNKNOWN
malignant and (16)/ No/ NR APPLICABLE/ RESOLVED
situ/
MALIGNANT MELANOMA IN
SITU (R UPPER BACK)

FDA-CBER-2022-908-0002605
643
Listing 16.2.7.7
Safety Set

HYPERTENSION (28)
HYPERTENSION GRADE 3 2020-08-31 21:00 No NONE
(1)

FDA-CBER-2022-908-0002606
644
Listing 16.2.7.7
Safety Set

(1)

HYPERTENSION (2)

FDA-CBER-2022-908-0002607
645
Listing 16.2.7.7
Safety Set


HYPERTENSION, WORSENING 2020-11-04 No NONE
(62)

FDA-CBER-2022-908-0002608
646
Listing 16.2.7.7
Safety Set

connective tissue (2)/ Yes/ NR APPLICABLE/ RESOLVED WITH
Muscle spasms/ (61) MEDICATION SUBJECT
MUSCLE SPASMS-BILATERAL REPORTS EVENT
UPPER EXTREMITIES NO LONGER
SEVERE BUT
DOES NOTICE
INTERMITTENT
SPASMS WITHOUT
THE
INTENSITY/SEVE
RITY.

FDA-CBER-2022-908-0002609
647
Listing 16.2.7.7
Safety Set

HYPERTENSION- GRADE 3 2020-10-15 No NONE
(10)
HYPERTENSION GRADE 3 (1)
Cardiac disorders/ 2020-09-18 14:19 Yes/ 3 No NR/ DOSE NOT NOT RECOVERED/
Bradycardia/ (1)/ No/ NR CHANGED/ NOT RESOLVED
WORSENING OF BRADYCARDIA Ongoing No NONE

FDA-CBER-2022-908-0002610
648
Listing 16.2.7.7
Safety Set

(1)
Cardiac disorders/ 2020-10-21 12:33 Yes/ 3 No NR/ DOSE NOT RECOVERING/
Bradycardia/ (1)/ No/ NR CHANGED/ RESOLVING
WORSENING OF BRADYCARDIA Ongoing No NONE
(3)

FDA-CBER-2022-908-0002611
649
Listing 16.2.7.7
Safety Set

HYPERTENSION (29)

HYPERTENSION

FDA-CBER-2022-908-0002612
650
Listing 16.2.7.7
Safety Set

Hypertension/ (29)/ Yes/ NR APPLICABLE/ NOT RESOLVED
HYPERTENSION, Ongoing No NONE
UN-CONTROLLED
Coronary artery (70)/ Yes/ NR APPLICABLE/ RESOLVED
occlusion/ 2020-12-03 No CONCOMITANT
CORONARY ARTERY BLOCKAGE (70) PROCEDURE

FDA-CBER-2022-908-0002613
651
Listing 16.2.7.7
Safety Set

Cardiac disorders/ 2021-02-03 Yes/ 3 No NR/ NOT UNKNOWN
Left ventricular (154)/ Yes/ NR APPLICABLE/
hypertrophy/ Ongoing No NONE
CHRONIC LEFT VENTRICULAR
HYPERTROPHY

SEPTIC SHOCK (158) MEDICATION

FDA-CBER-2022-908-0002614
652
Listing 16.2.7.7
Safety Set

Vascular disorders/ 2021-02-10 Yes/ 3 Yes/3 NR/ NOT UNKNOWN
Polyarteritis nodosa/ (161)/ Yes/ (2021-02-03/ NR APPLICABLE/
POLYARTERITIS NODOSA Ongoing No 2021-03-23) CONCOMITANT
MEDICATION
Drug withdrawal syndrome/ (176) MEDICATION
SUBOXONE WITHDRAWAL

FDA-CBER-2022-908-0002615
653
Listing 16.2.7.7
Safety Set

Fatigue/ (63)
FATIGUE
Gastrointestinal 2020-11-06 Yes/ 3 Yes/3 NR/ NOT NOT RECOVERED/
Gastritis/ Ongoing No 2020-11-12) CONCOMITANT
GASTRITIS MEDICATION

FDA-CBER-2022-908-0002616
654
Listing 16.2.7.7
Safety Set

Gastrointestinal 2020-11-06 Yes/ 3 Yes/3 NR/ NOT NOT RECOVERED/
Nausea/ Ongoing Yes 2020-11-12) CONCOMITANT
INTERMITTENT NAUSEA MEDICATION
Lumbar radiculopathy/ (90)/ Yes/ NR APPLICABLE/ RESOLVED
WORSENING OF LUMBAR 2021-01-29 No CONCOMITANT
RADICULOPATHY (107) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002617
655
Listing 16.2.7.7
Safety Set

Depression/ (78)/ Yes/ (2021-01-08/ NR APPLICABLE/ RESOLVED WITH
WORSENING DEPRESSION 2021-02-02 No 2021-01-13) CONCOMITANT SEQUELAE:
(103) MEDICATION RETURNED TO
PATIENT'S
BASELINE
Limb injury/ Ongoing No CONCOMITANT
TEAR IN RIGHT SHOULDER MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002618
656
Listing 16.2.7.7
Safety Set

Non-cardiac chest pain/ (117) MEDICATION
NON-CARDIAC CHEST PAIN
(GENERAL PAIN AND
DISCOMFORT)

FDA-CBER-2022-908-0002619
657
Listing 16.2.7.7
Safety Set

Subject ID: US3932215; Age (years): 66; Sex: M; Race: MULTIPLE: White, Native Hawaiian or other Pacific Islander; Height
(cm): 182.0; Weight (kg): 64.7; BMI (kg/m2): 19.5; Baseline SARS-CoV-2 Status: Negative; Baseline RT-PCR: Negative; Baseline
Elecsys SARS-CoV-2 Nucleocapsid bAb: Negative; Dose 1 Date/Time: 30SEP2020:13:47:00; Follow-up Days
after 1st Dose: 178; Dose 2 Date/Time: 29OCT2020:10:30:00; Follow-up Days after 2nd Dose: 149
COLITIS (145) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002620
658
Listing 16.2.7.7
Safety Set

connective tissue (27)/ Yes/ NR CHANGED/ RESOLVED WITH
Spinal pain/ (67) MEDICATION, REDUCED PAIN
WORSENING NECK/CERVICAL CONCOMITANT IN CERVICAL
SPINE PAIN PROCEDURE AND NECK.
BACK TO BASE
LINE
Hypoglycaemia/ 2021-02-03 No 2021-02-02) CONCOMITANT

FDA-CBER-2022-908-0002621
659
Listing 16.2.7.7
Safety Set

TRAUMA CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002622
660
Listing 16.2.7.7
Safety Set

disorders/ (75)/ No/ (2020-12-12/ NR APPLICABLE/ RESOLVED
MELLITUS II

Perineal abscess/ 2020-12-31 No CONCOMITANT
PERINEAL ABSCESS (RIGHT (94) MEDICATION,
THIGH) CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002623
661
Listing 16.2.7.7
Safety Set

Spondylolisthesis/ (80) MEDICATION,
DEGENERATIVE PROCEDURE
SPONDYLOLITHESIS
Investigations/ 2020-10-02 16:16 Yes/ 3 No R/ NOT RECOVERED/
DIASTOLIC BLOOD PRESSURE

FDA-CBER-2022-908-0002624
662
Listing 16.2.7.7
Safety Set

Giardiasis/ 2021-03-12 No 2021-03-08) CONCOMITANT
DIARRHEA FROM GIARDIA (151) MEDICATION
GRADE 3 BLOOD PRESSURE 2020-09-08 No NONE
INCREASE (1)

FDA-CBER-2022-908-0002625
663
Listing 16.2.7.7
Safety Set

Investigations/ 2020-10-08 Yes/ 3 No NR/ DOSE RECOVERED/
Blood pressure systolic (31)/ No/ NR DELAYED/ RESOLVED
PRESSURE
HIP FRACTURE (22) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002626
664
Listing 16.2.7.7
Safety Set

PRESSURE
(29)

FDA-CBER-2022-908-0002627
665
Listing 16.2.7.7
Safety Set

Hypertension/ (29)/ No/ NR WITHDRAWN/ RESOLVED
(55)
Cellulitis/ 2021-03-08 No 2021-02-23) CONCOMITANT
CELLULITIS - RIGHT UPPER (162) MEDICATION
ARM

FDA-CBER-2022-908-0002628
666
Listing 16.2.7.7
Safety Set

Lower limb fracture/ 2020-12-04 No CONCOMITANT
SPIRAL FRACTURE OF TIBIA (61) MEDICATION,
& FIBULA, RIGHT LEG CONCOMITANT
PROCEDURE
Hypertensive urgency/ (100)/ Yes/ (2021-01-09/ NR APPLICABLE/ RESOLVED
HYPERTENSIVE URGENCY 2021-01-10 No 2021-01-10) NONE
(102)

FDA-CBER-2022-908-0002629
667
Listing 16.2.7.7
Safety Set

Subject ID: US3972104; Age (years): 55; Sex: M; Race: MULTIPLE: Black or African American, Other: CAJUN; Height (cm): 173.0;
Vomiting/ 2021-03-29 Yes 2021-03-29) NONE
INTRACTABLE VOMITING (180)

Depression/ (190)/ Yes/ (2021-04-08/ NR CHANGED/ RESOLVED
DEPESSION 2021-04-13 No 2021-04-13) NONE
(195)

FDA-CBER-2022-908-0002630
668
Listing 16.2.7.7
Safety Set

Subject ID: US3972104; Age (years): 55; Sex: M; Race: MULTIPLE: Black or African American, Other: CAJUN; Height (cm): 173.0;
Substance-induced mood (190)/ Yes/ (2021-04-08/ NR APPLICABLE/ RESOLVED
disorder/ 2021-04-13 No 2021-04-13) NONE
SUBSTANCE INDUCED MOOD (195)
DISORDER, ALCOHOL USE
DISORDER
SEVERE-WITHDRAWAL,HYPERG
LYCEMIA SLEEPLESSNES

FDA-CBER-2022-908-0002631
669
Listing 16.2.7.7
Safety Set

SHORTNESS OF BREATH
POSSIBLE FLUID IN THE
LUNGS

FDA-CBER-2022-908-0002632
670
Listing 16.2.7.7
Safety Set

disorders/ 2020-12-30 No 2020-12-30)/4 CONCOMITANT SEQUELAE:
Osteoarthritis/ (92) MEDICATION POST OPERATIVE
WORSENING R KNEE OSTEO PAIN AND NEED
ARTHRITIS FOR ADJUSTMENT
TO THE
REPLACEMENT
--NEED FOR
PHYSICAL
THERAPY

FDA-CBER-2022-908-0002633
671
Listing 16.2.7.7
Safety Set

Diabetic foot infection/ 2021-03-18 No 2021-01-30) CONCOMITANT
DIABETIC FOOT INFECTION (161) MEDICATION,
LEFT FOOT CONCOMITANT
PROCEDURE
Nervous system disorders/ 2021-02-03 00:00 Yes/ 3 Yes/3 NR/ NOT RECOVERING/
Hemiparesis/ (128)/ Yes/ (2021-02-03/ NR APPLICABLE/ RESOLVING
RIGHT SIDED HEMIPARESIS Ongoing No 2021-02-12) CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0002634
672
Listing 16.2.7.7
Safety Set

ATRIAL FIBRILLATION WITH 2020-10-20 No 2020-10-22) CONCOMITANT
RAPID VENTRICULAR RATE, (8) MEDICATION
NEW ONSET

FDA-CBER-2022-908-0002635
673
Listing 16.2.7.7
Safety Set

Diarrhoea/ 2020-10-09 No CONCOMITANT
DIARRHEA (18) MEDICATION


FDA-CBER-2022-908-0002636
674
Listing 16.2.7.7
Safety Set

Decreased appetite/ 2020-10-07 No NONE
ANOREXIA (16)

Fatigue/ (18)
FATIGUE

FDA-CBER-2022-908-0002637
675
Listing 16.2.7.7
Safety Set
TEAE = Treatment-Emergent Adverse Event; MAAE = Medically-Attended Adverse Event; AR = Adverse Reaction; SAE = Serious Adverse
Event; IP = Investigational Product; SP = Study Procedure.
Relative day is defined as days from the most recent injection date.
MedDRA version 23.0.
[1] Sev. = Severity, 1 = Grade 1/Mild, 2 = Grade 2/Moderate, 3 = Grade 3/Severe, 4 = Grade 4, 5 = Grade 5.
[2] 1 = Death, 2 = Life threatening, 3 = Requires inpatient or prolongation of existing Hospitalization (Hospital Admission
Date/ Hospital Discharge Date), 4 = Persistent or significant disability or incapacity, 5 = Congenital anomaly or birth
defect, 6 = Other medically important event.
[3] R = Related, NR = Not Related, NA = Not Applicable.
FDA-CBER-2022-908-0002638
676
Listing 16.2.7.8
Unsolicited Treatment-Related Severe TEAE
Safety Set

HEADACHE 2020-09-02 21:48 Yes NONE
(6)
Fatigue/ (16)
FATIGUE

FDA-CBER-2022-908-0002639
677
Listing 16.2.7.8
Safety Set

Arthralgia/ (16)
JOINTS

Myalgia/ (16)

FDA-CBER-2022-908-0002640
678
Listing 16.2.7.8
Safety Set

(1)

(2)

FDA-CBER-2022-908-0002641
679
Listing 16.2.7.8
Safety Set

Vascular disorders/ 2020-08-07 12:51 Yes/ 3 No R/ DOSE NOT RECOVERING/

HYPERTENSION - Ongoing No NONE
EXACERBATION
HEADACHE - WORSENING OF 2020-10-05 Yes CONCOMITANT
ONGOING CONDITION. (10) MEDICATION

FDA-CBER-2022-908-0002642
680
Listing 16.2.7.8
Safety Set

Injection site (10)
induration/
SWELLING/HARDNESS AT
INJECTION SITE
Fatigue/ (16)
FATIGUE

FDA-CBER-2022-908-0002643
681
Listing 16.2.7.8
Safety Set

MIGRAINE/HEADACHE 2020-09-19 Yes CONCOMITANT
(46) MEDICATION
(12) MEDICATION

FDA-CBER-2022-908-0002644
682
Listing 16.2.7.8
Safety Set

Fatigue/ (21)
FATIGUE
SEVERE HEADACHE 2020-08-16 Yes CONCOMITANT
(9) MEDICATION

FDA-CBER-2022-908-0002645
683
Listing 16.2.7.8
Safety Set


RHEUMATICA
Arthralgia/ (9)
ARTHRYALGIA IN BOTH LEGS
(POST-DOSE)

FDA-CBER-2022-908-0002646
684
Listing 16.2.7.8
Safety Set

Injection site (10)
lymphadenopathy/
IPSILATERAL INJECTION
SITE AXILLARY
LYMPHADENOPATHY

FDA-CBER-2022-908-0002647
685
Listing 16.2.7.8
Safety Set

Chills/ (32)
CHILLS

(36) MEDICATION

FDA-CBER-2022-908-0002648
686
Listing 16.2.7.8
Safety Set

Chills/ (73)
CHILLS

FATIGUE

FDA-CBER-2022-908-0002649
687
Listing 16.2.7.8
Safety Set

INJECTION SITE PAIN

FDA-CBER-2022-908-0002650
688
Listing 16.2.7.8
Safety Set


Fatigue/ (132)

(23) MEDICATION

FDA-CBER-2022-908-0002651
689
Listing 16.2.7.8
Safety Set

BACK PAIN
Fatigue/ (11)
FATIGUE

FDA-CBER-2022-908-0002652
690
Listing 16.2.7.8
Safety Set

(15)

Asthenia/ (18)

FDA-CBER-2022-908-0002653
691
Listing 16.2.7.8
Safety Set

(18)
Diastolic hypertension/ (29)/ No/ R CHANGED/ RESOLVED
DIASTOLIC HYPERTENSION 2020-10-16 No NONE
(37)

FDA-CBER-2022-908-0002654
692
Listing 16.2.7.8
Safety Set

Arthralgia/ (11)
JOINT ACHES BILATERAL
LEGS
JOINT ACHES, LEFT HIP

FDA-CBER-2022-908-0002655
693
Listing 16.2.7.8
Safety Set

Hypertension/ (1)/ Yes/ R CHANGED/ RESOLVED
(49)
(11) MEDICATION

FDA-CBER-2022-908-0002656
694
Listing 16.2.7.8
Safety Set

WORSENING OF HEADACHE 2020-09-26 Yes CONCOMITANT
(10) MEDICATION
GENERALIZED MYALGIA

FDA-CBER-2022-908-0002657
695
Listing 16.2.7.8
Safety Set


Fatigue/ (15)
FATIGUE

FDA-CBER-2022-908-0002658
696
Listing 16.2.7.8
Safety Set

HYPERTENSION- GRADE 3 (1)
HYPERTENSION (GRADE 3) 2020-09-25 11:54 No NONE
(1)

FDA-CBER-2022-908-0002659
697
Listing 16.2.7.8
Safety Set

HYPERTENSION (WORSENING 2020-09-01 13:11 No NONE
OF) (1)
WORSENING 2020-10-01 13:52 No NONE
HYPERTENSION-GRADE 3 (1)

FDA-CBER-2022-908-0002660
698
Listing 16.2.7.8
Safety Set

(1)

(1)

FDA-CBER-2022-908-0002661
699
Listing 16.2.7.8
Safety Set

HYPERTENSION [WORSENING 2020-10-01 15:19 No NONE
OF BASELINE ELEVATED (1)
GRADE 3]

FDA-CBER-2022-908-0002662
700
Listing 16.2.7.8
Safety Set

Blood and lymphatic 2020-08-25 21:00 Yes/ 3 No R/ NOT RECOVERED/
Lymph node pain/ 2020-08-25 No CONCOMITANT
UNDERARM GLAND (1) MEDICATION
TENDERNESS, LEFT

LEFT ARM

FDA-CBER-2022-908-0002663
701
Listing 16.2.7.8
Safety Set


LEFT ARM
Myalgia/ (9)

FDA-CBER-2022-908-0002664
702
Listing 16.2.7.8
Safety Set

Fatigue/ (15)
FATIGUE
Adverse drug reaction/ (33) MEDICATION
ADVERSE EFFECT OF DRUG

FDA-CBER-2022-908-0002665
703
Listing 16.2.7.8
Safety Set

PAIN AFTER INJECTIONS
Movement disorder/ (1)/ No/ R CHANGED/ RESOLVED
DIFFICULTY RAISING LEFT 2020-08-01 23:59 No NONE
ARM (4)

FDA-CBER-2022-908-0002666
704
Listing 16.2.7.8
Safety Set


Fatigue/ (20)
FATIGUE

FDA-CBER-2022-908-0002667
705
Listing 16.2.7.8
Safety Set

Injection site (9)
lymphadenopathy/
LEFT AXILLARY
LYMPHADENOPATHY
SITE

FDA-CBER-2022-908-0002668
706
Listing 16.2.7.8
Safety Set

INJECTION SITE/ARM
REDNESS NON-URTICARIAL
Immune system disorders/ 2020-08-31 Yes/ 3 No R/ DOSE NOT RECOVERED/
Type IV hypersensitivity (8)/ Yes/ R CHANGED/ RESOLVED
reaction/ 2020-09-04 No CONCOMITANT
DELAYED (12) MEDICATION
TYPE-HYPERSENSITIVITY

FDA-CBER-2022-908-0002669
707
Listing 16.2.7.8
Safety Set

REDNESS (MACULAR
NON-URTICARIAL) AT
INJECTION SITE (LEFT
ARM)

FDA-CBER-2022-908-0002670
708
Listing 16.2.7.8
Safety Set

MACULAR NON-UTICARIAL
SITE

FDA-CBER-2022-908-0002671
709
Listing 16.2.7.8
Safety Set

SITE
(MACULAR/NON-UTICARIAL)
Fatigue/ (15)
FATIGUE

FDA-CBER-2022-908-0002672
710
Listing 16.2.7.8
Safety Set



MYALGIA

FDA-CBER-2022-908-0002673
711
Listing 16.2.7.8
Safety Set

FACIAL SWELLING

FDA-CBER-2022-908-0002674
712
Listing 16.2.7.8
Safety Set

Injection site rash/ (8)
LEFT UPPER ARM INJECTION
SITE REACTION
(ERYTHEMATOUS,
NON-PRURITIC RASH)

FDA-CBER-2022-908-0002675
713
Listing 16.2.7.8
Safety Set

NECK PAIN

Headache/ (1)/ Yes/ R CHANGED/ RESOLVED
(3) MEDICATION

FDA-CBER-2022-908-0002676
714
Listing 16.2.7.8
Safety Set

(3)
Skin and subcutaneous 2020-10-13 08:00 Yes/ 3 No R/ DOSE NOT RECOVERING/
GENERALIZED RASH, MEDICATION
URTICARIAL

FDA-CBER-2022-908-0002677
715
Listing 16.2.7.8
Safety Set

Fatigue/ (9)
FATIGUE

Myalgia/ (9)
MUSCLE ACHES

FDA-CBER-2022-908-0002678
716
Listing 16.2.7.8
Safety Set

Myalgia/ (11)
MUSCLE ACHES
Fatigue/ (9)
FATIGUE

FDA-CBER-2022-908-0002679
717
Listing 16.2.7.8
Safety Set

(9) MEDICATION
Investigations/ 2020-09-14 Yes/ 3 No R/ DOSE NOT RECOVERED/
ELEVATED SYSTOLIC B/P (2)

FDA-CBER-2022-908-0002680
718
Listing 16.2.7.8
Safety Set


RASH WITH BLANCHING

FDA-CBER-2022-908-0002681
719
Listing 16.2.7.8
Safety Set

PAST DAY 7 OF REACTO
PERIOD

FDA-CBER-2022-908-0002682
720
Listing 16.2.7.8
Safety Set

conditions/ 2020-09-18 11:15 No NONE
NON-URTICARIAL, MACULAR,
REDNESS ON LEFT DELTOID
AT THE INJECTION SITE

FDA-CBER-2022-908-0002683
721
Listing 16.2.7.8
Safety Set

system disorders/ (4)/ Yes/ R CHANGED/ RESOLVED
LEFT AXILLARY (8)
LYMPHADENOPATHY -
IPSILATERAL

FDA-CBER-2022-908-0002684
722
Listing 16.2.7.8
Safety Set

Injection site (11)
induration/
INJECTION SITE
INDURATION

INJECTION SITE SWELLING

FDA-CBER-2022-908-0002685
723
Listing 16.2.7.8
Safety Set

Malaise/ (14) MEDICATION
MALAISE
SITE

FDA-CBER-2022-908-0002686
724
Listing 16.2.7.8
Safety Set

SITE
Dizziness/ (2)/ No/ R CHANGED/ RESOLVED
DIZZINESS 2020-09-12 07:30 No NONE
(2)

FDA-CBER-2022-908-0002687
725
Listing 16.2.7.8
Safety Set

Musculoskeletal and 2020-09-25 22:00 Yes/ 3 No R/ NOT RECOVERED/
RIGHT LEG MUSCLE ACHES
Fatigue/ (84)
FATIGUE

FDA-CBER-2022-908-0002688
726
Listing 16.2.7.8
Safety Set

FEVER OF 101.5
(3) MEDICATION

FDA-CBER-2022-908-0002689
727
Listing 16.2.7.8
Safety Set

Migraine/ (1)/ No/ R CHANGED/ RESOLVED
SEVERE MIGRAINE 2020-10-04 Yes CONCOMITANT
(3) MEDICATION

BY 86MM OBLONG

FDA-CBER-2022-908-0002690
728
Listing 16.2.7.8
Safety Set

Syncope/ (1)/ No/ NR CHANGED/ RESOLVED
WORSENING OF OCCASIIONAL 2020-09-26 11:00 No CONCOMITANT
SYNCOPE OCCURRING WITH (2) MEDICATION
MEDICAL EVENTS
SITE ERYTHEMA.

FDA-CBER-2022-908-0002691
729
Listing 16.2.7.8
Safety Set

OPTICAL MIGRAINE 2020-09-24 No NONE
(2)
Fatigue/ (23)
FATIGUE

FDA-CBER-2022-908-0002692
730
Listing 16.2.7.8
Safety Set

BILATERAL ELBOW AND
RIGHT KNEE ARTHRALGIAS


FDA-CBER-2022-908-0002693
731
Listing 16.2.7.8
Safety Set

SEVERE ITCHING (16) MEDICATION

RASH ON TRUNK/BACK - (16) MEDICATION
NONURTICARIAL

FDA-CBER-2022-908-0002694
732
Listing 16.2.7.8
Safety Set

BACK SPASMS

Fatigue/ (9)
FATIGUE

FDA-CBER-2022-908-0002695
733
Listing 16.2.7.8
Safety Set

Injection site (29) MEDICATION
lymphadenopathy/
LEFT (INJECTION SIDE)
AXILLARY LYMPHADENOPATHY

FDA-CBER-2022-908-0002696
734
Listing 16.2.7.8
Safety Set

Injection site macule/ (12) MEDICATION
NON-URTICARIAL
RETICULATE MACULAR
SITE, RIGHT ARM

FDA-CBER-2022-908-0002697
735
Listing 16.2.7.8
Safety Set

SITE, NON-URTICARIAL

FDA-CBER-2022-908-0002698
736
Listing 16.2.7.8
Safety Set

LEFT ARM
(NON-URTICARIAL)
INJECTION SITE RED PATCH
Investigations/ 2020-10-05 11:00 Yes/ 3 No R/ DOSE NOT NOT RECOVERED/

FDA-CBER-2022-908-0002699
737
Listing 16.2.7.8
Safety Set

Psychiatric disorders/ 2020-11-23 Yes/ 3 No R/ NOT RECOVERING/
Grief reaction/ (55)/ Yes/ R APPLICABLE/ RESOLVING
DEPRESSION/GRIEF Ongoing No CONCOMITANT
MEDICATION
Hypertension/ (1)/ No/ NA CHANGED/ RESOLVED
(29)

FDA-CBER-2022-908-0002700
738
Listing 16.2.7.8
Safety Set

(29)
Dyspepsia/ 2020-10-23 No CONCOMITANT
CHEST TIGHTNESS (DUE TO (4) MEDICATION
INDIGESTION)

FDA-CBER-2022-908-0002701
739
Listing 16.2.7.8
Safety Set

Injection site urticaria/ (11) MEDICATION
INJECTION SITE
URTICARIAL RASH FROM
VACCINE #1
Nervous system disorders/ 2020-11-04 19:24 Yes/ 3 No R/ NOT RECOVERED/
(11) MEDICATION

FDA-CBER-2022-908-0002702
740
Listing 16.2.7.8
Safety Set

Negative; Baseline Elecsys SARS-CoV-2 Nucleocapsid bAb: Negative; Dose 1 Date/Time: 13OCT2020:15:07:00; Follow-up Days after
1st Dose: 165; Dose 2 Date/Time: 10NOV2020:16:27:00; Follow-up Days after 2nd Dose: 137
WORSENING MIGRAINES 2020-10-30 08:00 Yes CONCOMITANT
(17) MEDICATION

ON 11/30) PROCEDURE

FDA-CBER-2022-908-0002703
741
Listing 16.2.7.8
Safety Set


SITE (L)
ERYTHEMA AT SITE OF
INJECTION (LEFT ARM)

FDA-CBER-2022-908-0002704
742
Listing 16.2.7.8
Safety Set

Respiratory, thoracic 2020-11-20 12:22 Yes/ 3 No R/ NOT RECOVERED/
Tachypnoea/ (64)
TACHYPNEA
after 2nd Dose: NA
NAUSEA (8)

FDA-CBER-2022-908-0002705
743
Listing 16.2.7.8
Safety Set

after 2nd Dose: NA
Fatigue/ (8)
FATIGUE
SITE

FDA-CBER-2022-908-0002706
744
Listing 16.2.7.8
Safety Set

SITE
PAIN IN THE INJECTION
SITE

FDA-CBER-2022-908-0002707
745
Listing 16.2.7.8
Safety Set

Fatigue/ (13)
FATIGUE
Chills/ (1)
RIGORS

FDA-CBER-2022-908-0002708
746
Listing 16.2.7.8
Safety Set

Fatigue/ (9)
FATIGUE
Gastrointestinal 2020-09-10 16:00 Yes/ 3 No R/ DOSE NOT RECOVERED/

disorders/ (2)/ No/ R CHANGED/ RESOLVED
Nausea/ 2020-09-17 16:00 Yes NONE
NAUSEA (9)

FDA-CBER-2022-908-0002709
747
Listing 16.2.7.8
Safety Set

Chills/ (9)
CHILLS
Fatigue/ (14)
FATIGUE

FDA-CBER-2022-908-0002710
748
Listing 16.2.7.8
Safety Set

NONURTICARIAL ERYTHEMA
AT INJECTION SITE
Myalgia/ (12)
MUSCLE ACHES UPPER AND
LOWER EXTREMITIES

FDA-CBER-2022-908-0002711
749
Listing 16.2.7.8
Safety Set

Fatigue/ (19)
FATIGUE
(11)

FDA-CBER-2022-908-0002712
750
Listing 16.2.7.8
Safety Set

Fatigue/ (9)
FATIGUE

JOINTS

FDA-CBER-2022-908-0002713
751
Listing 16.2.7.8
Safety Set

WHOLE BODY MYALGIA
Skin and subcutaneous 2020-09-09 09:00 Yes/ 3 No R/ NOT RECOVERED/
Dermatitis/ 2020-09-17 09:00 No NONE
DERMATITIS ON LEFT ARM (9)

FDA-CBER-2022-908-0002714
752
Listing 16.2.7.8
Safety Set

WATCHED FOR
PROGRESSION.
THE PATIENT
DOES NOT
CURRENTLY MEET
CRITERIA TO
START FIRST
LINE
TREATMENT.

FDA-CBER-2022-908-0002715
753
Listing 16.2.7.8
Safety Set

Temporomandibular joint
syndrome/
TMJ
Ear and labyrinth 2020-09-29 23:59 Yes/ 3 No R/ NOT RECOVERED/
VERTIGO (2)

FDA-CBER-2022-908-0002716
754
Listing 16.2.7.8
Safety Set

connective tissue (14)/ No/ NA CHANGED/ RESOLVED
LEFT UPPER ARM PAIN
Fatigue/ (13)
FATIGUE

FDA-CBER-2022-908-0002717
755
Listing 16.2.7.8
Safety Set

Fatigue/ (10)
FATIGUE

(10)

FDA-CBER-2022-908-0002718
756
Listing 16.2.7.8
Safety Set

FATIGUE
HYPERTENSION (1)

FDA-CBER-2022-908-0002719
757
Listing 16.2.7.8
Safety Set

(1)

FDA-CBER-2022-908-0002720
758
Listing 16.2.7.8
Safety Set

connective tissue (2)/ Yes/ NR APPLICABLE/ RESOLVED WITH
Muscle spasms/ (61) MEDICATION SUBJECT
MUSCLE SPASMS-BILATERAL REPORTS EVENT
UPPER EXTREMITIES NO LONGER
SEVERE BUT
DOES NOTICE
INTERMITTENT
SPASMS WITHOUT
THE
INTENSITY/SEVE
RITY.

FDA-CBER-2022-908-0002721
759
Listing 16.2.7.8
Safety Set

HYPERTENSION GRADE 3 (1)
(1)

FDA-CBER-2022-908-0002722
760
Listing 16.2.7.8
Safety Set

(3)
Investigations/ 2020-10-02 16:16 Yes/ 3 No R/ NOT RECOVERED/
DIASTOLIC BLOOD PRESSURE

FDA-CBER-2022-908-0002723
761
Listing 16.2.7.8
Safety Set

GRADE 3 BLOOD PRESSURE 2020-09-08 No NONE
INCREASE (1)

FDA-CBER-2022-908-0002724
762
Listing 16.2.7.8
Safety Set
FDA-CBER-2022-908-0002725
763
Listing 16.2.7.10
Serious Treatment-Related Adverse Events
Safety Set

Subject ID: US3432023; Age (years): 83; Sex: M; Race: WHITE; Risk Factors for Severe COVID-19[4]: SC; Height (cm): 171.1;
Dose: 234; Dose 2 Date/Time: ; Follow-up Days after 2nd Dose: NA
RHEUMATICA
Subject ID: US3552232; Age (years): 70; Sex: M; Race: WHITE; Risk Factors for Severe COVID-19[4]: D; Height (cm): 174.0;
Cardiac disorders/ 2020-09-26 Yes/ 4 Yes/3 R/ DOSE NOT RECOVERED/
Acute myocardial (29)/ Yes/ (2020-09-26/ NR CHANGED/ RESOLVED
NON-ST ELEVATED (29) MEDICATION
MYOCARDIAL INFARCTION

FDA-CBER-2022-908-0002726
764
Listing 16.2.7.10
Safety Set

Metabolism and nutrition 2020-09-26 Yes/ 4 Yes/3 R/ DOSE NOT RECOVERED/
Hypomagnesaemia/ 2020-10-08 No 2020-10-08) CONCOMITANT
HYPOMAGNESIA (41) MEDICATION
Renal and urinary 2020-09-26 Yes/ 4 Yes/3 R/ DOSE NOT RECOVERED/

ACUTE KIDNEY INJURY (41) MEDICATION

FDA-CBER-2022-908-0002727
765
Listing 16.2.7.10
Safety Set

Cardiac disorders/ 2020-09-26 Yes/ 4 Yes/3 R/ DOSE NOT RECOVERED/
Atrial fibrillation/ (29)/ Yes/ (2020-09-26/ NR CHANGED/ RESOLVED WITH
PAROXYSMAL ATRIAL 2020-10-30 No 2020-10-08) CONCOMITANT SEQUELAE:
FIBRILLATION (63) MEDICATION SUBJECT IS
CURRENTLY IN
SINUS RHYTHM,
BUT COULD
INTERMITTENTLY
GO IN AND OUT
OF ATRIAL
FIBRILLATION.
ON MEDICATION
AND FOLLOWING
UP WITH PCP TO
CONTROL AND
MONITOR.

FDA-CBER-2022-908-0002728
766
Listing 16.2.7.10
Safety Set

Respiratory, thoracic 2020-09-26 Yes/ 4 Yes/3 R/ DOSE NOT RECOVERED/
Organising pneumonia/ (83) MEDICATION
CRYPTOGENIC ORGANIZING
PNEUMONIA
Respiratory, thoracic 2020-09-28 Yes/ 4 Yes/3 R/ DRUG RECOVERED/

RESPIRATORY FAILURE

FDA-CBER-2022-908-0002729
767
Listing 16.2.7.10
Safety Set

Subject ID: US3602030; Age (years): 41; Sex: F; Race: UNKNOWN; Risk Factors for Severe COVID-19[4]:; Height (cm): 160.0;
General disorders and 2020-09-17 Yes/ 2 Yes/6 R/ DOSE NOT RECOVERED/
Swelling face/ (17) PROCEDURE
SWELLING TO THE RIGHT
SIDE OF THE FACE
Nervous system disorders/ 2020-09-17 Yes/ 2 Yes/6 R/ DOSE NOT RECOVERED/

Paraesthesia/ (7)/ Yes/ NR CHANGED/ RESOLVED
TINGLING ON RIGHT SIDE 2020-09-28 No NONE
OF FACE (18)

FDA-CBER-2022-908-0002730
768
Listing 16.2.7.10
Safety Set

Injury, poisoning and 2020-09-17 Yes/ 2 Yes/6 R/ DOSE NOT RECOVERED/
Immunisation anxiety 2020-10-07 No NONE
related reaction/ (27)
ANXIETY RELATED TO THE
VACCINE
General disorders and 2020-10-06 Yes/ 2 Yes/4 R/ DOSE RECOVERED/

administration site (26)/ Yes/ R DELAYED/ RESOLVED
Feeling hot/ (36) PROCEDURE
LEFT SIDED CHEST WALL
WARMTH

FDA-CBER-2022-908-0002731
769
Listing 16.2.7.10
Safety Set

Nervous system disorders/ 2020-10-06 Yes/ 2 Yes/4/6 R/ DOSE RECOVERED/
Paraesthesia/ (26)/ Yes/ R DELAYED/ RESOLVED
LEFT SIDED TINGLING 2020-10-16 No CONCOMITANT
(36) PROCEDURE
Subject ID: US3602051; Age (years): 52; Sex: M; Race: OTHER: HISPANIC; Risk Factors for Severe COVID-19[4]: CL; Height (cm):
175.3; Weight (kg): 69.1; BMI (kg/m2): 22.5; Baseline SARS-CoV-2 Status: Negative; Baseline RT-PCR: Negative; Baseline Elecsys
Injury, poisoning and 2020-10-29 Yes/ 4 Yes/6 R/ NOT RECOVERED/
INCREASED BLEEDING INTRA (16) PROCEDURE
OPERATIVE TIME

FDA-CBER-2022-908-0002732
770
Listing 16.2.7.10
Safety Set

Subject ID: US3212326; Age (years): 46; Sex: F; Race: ASIAN; Risk Factors for Severe COVID-19[4]:; Height (cm): 154.9; Weight
Nervous system disorders/ 2020-09-25 17:00 Yes/ 2 Yes/6 R/ NOT RECOVERED/
Autonomic nervous system (1)/ Yes/ NR APPLICABLE/ RESOLVED WITH
imbalance/ 2021-03-01 15:00 No CONCOMITANT SEQUELAE:
AUTONOMIC DYSFUNCTION (158) MEDICATION PALPITATIONS
Subject ID: US3322329; Age (years): 51; Sex: F; Race: WHITE; Risk Factors for Severe COVID-19[4]:; Height (cm): 185.4; Weight
FACIAL SWELLING

FDA-CBER-2022-908-0002733
771
Listing 16.2.7.10
Safety Set

Cardiac disorders/ 2020-11-16 Yes/ 4 Yes/3 R/ NOT RECOVERED/
Pericardial effusion/ (68)/ Yes/ (2020-11-26/ NR APPLICABLE/ RESOLVED
PERICARDIAL EFFUSION 2021-02-22 No 2020-12-01)/6 CONCOMITANT
(166) MEDICATION,
CONCOMITANT
PROCEDURE
Cardiac disorders/ 2020-11-16 Yes/ 2 Yes/3 R/ NOT RECOVERED/

Pericarditis/ (68)/ Yes/ (2020-11-26/ NR APPLICABLE/ RESOLVED
PERICARDITIS 2021-02-22 No 2020-12-01)/6 CONCOMITANT
(166) MEDICATION

FDA-CBER-2022-908-0002734
772
Listing 16.2.7.10
Safety Set

Respiratory, thoracic 2020-11-17 Yes/ 4 Yes/3 R/ NOT RECOVERED/
Pleural effusion/ (166) PROCEDURE
PLEURAL EFFUSIONS
(BILATERAL)
General disorders and 2020-09-30 10:00 Yes/ 2 Yes/6 R/ NOT RECOVERED/
CHEEK SWELLING,
BILATERAL

FDA-CBER-2022-908-0002735
773
Listing 16.2.7.10
Safety Set

Gastrointestinal 2020-09-15 12:00 Yes/ 4 Yes/3 R/ NOT RECOVERED/
Nausea/ 2020-09-21 Yes 2020-09-18) CONCOMITANT
Gastrointestinal 2020-09-15 12:00 Yes/ 4 Yes/3 R/ NOT RECOVERED/

Vomiting/ 2020-09-21 Yes 2020-09-18) CONCOMITANT
INTRACTABLE VOMITING (8) MEDICATION

FDA-CBER-2022-908-0002736
774
Listing 16.2.7.10
Safety Set

Subject ID: US3552191; Age (years): 66; Sex: F; Race: WHITE; Risk Factors for Severe COVID-19[4]: D; Height (cm): 165.1;
Endocrine disorders/ 2020-09-30 Yes/ 4 Yes/3 R/ NOT RECOVERED/
Basedow's disease/ (8)/ Yes/ (2020-10-09/ NR APPLICABLE/ RESOLVED WITH
GRAVES' DISEASE 2021-02-01 No 2020-10-10)/4 CONCOMITANT SEQUELAE:
(132) MEDICATION, PER NOTES FROM
CONCOMITANT PHYSICIAN'S PE
PROCEDURE TODAY AT
CLINIC,
SUBJECT HAS
REACHED NEW
BASELINE, HAS
ONGOING
FATIGUE AND
NEEDS
MEDICATIONS
(SEE CON MEDS)

FDA-CBER-2022-908-0002737
775
Listing 16.2.7.10
Safety Set

183; Dose 2 Date/Time: ; Follow-up Days after 2nd Dose: NA
ON 11/30) PROCEDURE
Skin and subcutaneous 2020-09-23 Yes/ 2 Yes/6 R/ NOT RECOVERED/
tissue disorders/ (2)/ No/ NR APPLICABLE/ RESOLVED
Angioedema/ 2020-09-25 No CONCOMITANT
ANGIOEDEMA [LIPS] (4) MEDICATION

FDA-CBER-2022-908-0002738
776
Listing 16.2.7.10
Safety Set

Subject ID: US3742169; Age (years): 57; Sex: M; Race: ASIAN; Risk Factors for Severe COVID-19[4]: CL; Height (cm): 167.1;
Musculoskeletal and 2020-08-31 23:00 Yes/ 2 Yes/6 R/ DRUG RECOVERING/
connective tissue (1)/ Yes/ NR WITHDRAWN/ RESOLVING
Rheumatoid arthritis/ MEDICATION
RHEUMATOID ARTHRITIS
Subject ID: US3812085; Age (years): 31; Sex: M; Race: ASIAN; Risk Factors for Severe COVID-19[4]:; Height (cm): 188.0; Weight
Skin and subcutaneous 2020-09-10 Yes/ 1 Yes/6 R/ NOT NOT RECOVERED/
tissue disorders/ (9)/ Yes/ NR APPLICABLE/ NOT RESOLVED
Alopecia areata/ Ongoing No CONCOMITANT
ALOPECIA AREATA MEDICATION

FDA-CBER-2022-908-0002739
777
Listing 16.2.7.10
Safety Set

Nervous system disorders/ 2020-12-08 Yes/ 2 Yes/6 R/ NOT NOT RECOVERED/
Multiple sclerosis/ (72)/ Yes/ NR APPLICABLE/ NOT RESOLVED
MULTIPLE SCLEROSIS Ongoing No CONCOMITANT
MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002740
778
Listing 16.2.7.10
Safety Set

Subject ID: US3822043; Age (years): 75; Sex: F; Race: WHITE; Risk Factors for Severe COVID-19[4]: CL; Height (cm): 153.7;
WATCHED FOR
PROGRESSION.
THE PATIENT
DOES NOT
CURRENTLY MEET
CRITERIA TO
START FIRST
LINE
TREATMENT.

FDA-CBER-2022-908-0002741
779
Listing 16.2.7.10
Safety Set
[4] CL = Chronic Lung Disease, SC = Significant Cardiac Disease, SO = Severe Obesity, D = Diabetes, L = Liver Disease, H
= Human Immunodeficiency Virus Infection.
FDA-CBER-2022-908-0002742
780
Listing 16.2.7.11
Unsolicited Adverse Events Leading to Discontinuation from Study Vaccine
Safety Set

infestations/ (53)/ No/ NR WITHDRAWN/ RESOLVED
COVID-19/ 2020-10-22 No NONE
COVID-19 (87)


FDA-CBER-2022-908-0002743
781
Listing 16.2.7.11
Safety Set



COVID-19/ 2020-09-24 No NONE
COVID-19 (46)

FDA-CBER-2022-908-0002744
782
Listing 16.2.7.11
Safety Set


infestations/ (23)/ Yes/ NA WITHDRAWN/ RESOLVED
SARS-CoV-2 Status: Positive; Baseline RT-PCR: Positive; Baseline Elecsys SARS-CoV-2 Nucleocapsid bAb: Positive; Dose 1
Infections and 2020-08-18 08:00 No/ 1 No NA/ DRUG RECOVERED/

COVID-19/ 2020-08-18 08:01 No NONE
SARSCOV-2 INFECTION (1)

FDA-CBER-2022-908-0002745
783
Listing 16.2.7.11
Safety Set

Gastrointestinal 2020-09-12 Yes/ 4 Yes/3 NR/ DRUG RECOVERED/

disorders/ (24)/ Yes/ (2020-09-12/ NR WITHDRAWN/ RESOLVED
Duodenal ulcer 2020-09-17 No 2020-09-17) CONCOMITANT
ACUTE DUODENAL ULCER CONCOMITANT
WITH HEMORRHAGE PROCEDURE
SARS-CoV-2 Status: Positive; Baseline RT-PCR: Positive; Baseline Elecsys SARS-CoV-2 Nucleocapsid bAb: Negative; Dose 1
Infections and 2020-08-22 08:00 No/ 1 No NR/ DRUG RECOVERED/

COVID-19/ 2020-08-22 08:01 No NONE
SARS-COV-2 INFECTION (1)

FDA-CBER-2022-908-0002746
784
Listing 16.2.7.11
Safety Set


COVID-19/ 2020-10-06 No NONE
COVID-19 (54)
Ear and labyrinth 2020-09-21 Yes/ 1 No NR/ DRUG RECOVERING/

disorders/ (32)/ Yes/ NA WITHDRAWN/ RESOLVING
VERTIGO MEDICATION

FDA-CBER-2022-908-0002747
785
Listing 16.2.7.11
Safety Set



COVID-19/ 2020-09-26 No NONE
COVID 19 DIAGNOSIS (44)

FDA-CBER-2022-908-0002748
786
Listing 16.2.7.11
Safety Set


COVID-19/ 2020-09-17 No NONE

infestations/ (17)/ Yes/ NR WITHDRAWN/ RESOLVED WITH
SYMPTOMATIC COVID-19 (30) MEDICATION COUGH

FDA-CBER-2022-908-0002749
787
Listing 16.2.7.11
Safety Set

Infections and 2020-08-20 19:00 Yes/ 1 No NR/ DRUG RECOVERED/

COVID-19/ 2020-09-03 06:30 No NONE

Pyelonephritis acute/ 2020-09-26 No 2020-09-04) CONCOMITANT
ACUTE PYELONEPHRITIS (47) MEDICATION,
(RIGHT KIDNEY) CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002750
788
Listing 16.2.7.11
Safety Set



COVID 19 SYMPTOMATIC (18) MEDICATION

FDA-CBER-2022-908-0002751
789
Listing 16.2.7.11
Safety Set


Cardiac disorders/ 2020-10-18 Yes/ 2 No NR/ DRUG NOT RECOVERED/

Tachycardia/ (15)/ No/ NR WITHDRAWN/ NOT RESOLVED
WORSENING OF TACHYCARDIA Ongoing No NONE

FDA-CBER-2022-908-0002752
790
Listing 16.2.7.11
Safety Set



COVID-19/ 2020-11-30 No NONE

FDA-CBER-2022-908-0002753
791
Listing 16.2.7.11
Safety Set


COVID-19/ 2020-10-05 No NONE
SARS COVID-19 (36)

FDA-CBER-2022-908-0002754
792
Listing 16.2.7.11
Safety Set


COMMUNITY ACQUIRED (53) MEDICATION
PNEUMONIA

FDA-CBER-2022-908-0002755
793
Listing 16.2.7.11
Safety Set

Hepatobiliary disorders/ 2020-10-23 Yes/ 3 Yes/3 NR/ DRUG RECOVERED/

Cholecystitis acute/ (30)/ Yes/ (2020-10-23/ NR WITHDRAWN/ RESOLVED
ACUTE CHOLECYSTITIS 2020-11-04 No 2020-11-04) CONCOMITANT
(42) MEDICATION,
CONCOMITANT
PROCEDURE
Hepatobiliary disorders/ 2020-10-23 Yes/ 2 No NR/ DRUG RECOVERED/

Cholelithiasis/ (30)/ Yes/ NR WITHDRAWN/ RESOLVED
CHOLELITHIASIS 2020-11-04 No NONE
(42)

FDA-CBER-2022-908-0002756
794
Listing 16.2.7.11
Safety Set


Cholecystitis infective/ 2020-11-04 No NONE
ACUTE GANRENOUS (42)
CHOLECYSTITIS

Escherichia bacteraemia/ 2020-11-04 No NONE
ESCHERICHIA COLI (42)
BACTERMIA

FDA-CBER-2022-908-0002757
795
Listing 16.2.7.11
Safety Set


Septic shock/ 2020-11-04 No 2020-11-04) NONE
SEPTIC SHOCK (42)

Urinary tract infection 2020-11-04 No NONE
enterococcal/ (42)
ENTEROCOCCUS FAECALIS
URINARY TRACT INFECTION

FDA-CBER-2022-908-0002758
796
Listing 16.2.7.11
Safety Set

Injury, poisoning and 2020-10-23 Yes/ 2 No NR/ DRUG RECOVERED/

procedural complications/ (30)/ Yes/ NR WITHDRAWN/ RESOLVED
Post procedural bile 2020-11-04 No NONE
leak/ (42)
BILIARY LEAK STATUS POST
STENT PLACEMENT


FDA-CBER-2022-908-0002759
797
Listing 16.2.7.11
Safety Set


COVID-19 (35) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002760
798
Listing 16.2.7.11
Safety Set


failure/
ACUTE RESPIRATORY
FAILURE

FDA-CBER-2022-908-0002761
799
Listing 16.2.7.11
Safety Set




FDA-CBER-2022-908-0002762
800
Listing 16.2.7.11
Safety Set


infestations/ (15)/ Yes/ (2020-09-03/ NR WITHDRAWN/ RESOLVED WITH
Osteomyelitis/ 2020-10-16 No 2020-09-09) CONCOMITANT SEQUELAE:
LEFT GREAT TOE (57) MEDICATION, RECOVERED WITH
OSTEOMYELITIS CONCOMITANT SEQUALAE LEFT
PROCEDURE GREAT TOE
AMPUTATION


FDA-CBER-2022-908-0002763
801
Listing 16.2.7.11
Safety Set


SYMPTOMATIC COVID -19 (35) MEDICATION

FDA-CBER-2022-908-0002764
802
Listing 16.2.7.11
Safety Set


Subject ID: US3332060; Age (years): 43; Sex: F; Race: OTHER: PAKISTANI, BRAZILIAN; Height (cm): 170.9; Weight (kg): 53.1;
Nervous system disorders/ 2020-08-25 11:00 Yes/ 2 No R/ DRUG RECOVERED/
Migraine/ (1)/ No/ NR WITHDRAWN/ RESOLVED
WORSENING OF MIGRIANES 2020-08-27 11:00 Yes CONCOMITANT
(3) MEDICATION

FDA-CBER-2022-908-0002765
803
Listing 16.2.7.11
Safety Set


Colon cancer stage III/
STAGE III COLON CANCER

FDA-CBER-2022-908-0002766
804
Listing 16.2.7.11
Safety Set

Respiratory, thoracic 2020-09-18 Yes/ 2 No R/ DRUG RECOVERED/

and mediastinal (8)/ Yes/ R WITHDRAWN/ RESOLVED
Pleurisy/ (39) MEDICATION
IDIOPATHIC PLEURISY WITH
RECURRENCE

IDEATION

FDA-CBER-2022-908-0002767
805
Listing 16.2.7.11
Safety Set



FDA-CBER-2022-908-0002768
806
Listing 16.2.7.11
Safety Set

Dose 1 Date/Time: 12OCT2020:12:37:00; Follow-up Days after 1st Dose: 166; Dose 2 Date/Time: ; Follow-up Days
after 2nd Dose: NA
Musculoskeletal and 2020-10-26 Yes/ 2 No NR/ DRUG NOT RECOVERED/
connective tissue (15)/ Yes/ NR WITHDRAWN/ NOT RESOLVED
Synovitis/ MEDICATION
NEW ONSET OF SYMMETRICAL
SYNOVITIS OF HANDS AND
FEET

FDA-CBER-2022-908-0002769
807
Listing 16.2.7.11
Safety Set




FDA-CBER-2022-908-0002770
808
Listing 16.2.7.11
Safety Set


COVID-19/ 2020-08-31 10:14 No NONE
COVID-19 (13)

COVID-19/ 2020-09-14 No NONE
COVID 19 (33)

FDA-CBER-2022-908-0002771
809
Listing 16.2.7.11
Safety Set

Pregnancy, puerperium 2020-09-25 Yes/ 1 No NR/ DRUG NOT RECOVERED/

and perinatal conditions/ (33)/ Yes/ NR WITHDRAWN/ NOT RESOLVED
Pregnancy/ Ongoing No NONE
PREGNANCY

COVID-19/ 2020-08-26 No
COVID-19 [POSITIVE TEST] (13)

FDA-CBER-2022-908-0002772
810
Listing 16.2.7.11
Safety Set

Vascular disorders/ 2020-09-14 Yes/ 2 No R/ DRUG RECOVERING/

Hypertension/ (24)/ No/ NR WITHDRAWN/ RESOLVING
MEDICATION

RHEUMATICA

FDA-CBER-2022-908-0002773
811
Listing 16.2.7.11
Safety Set

General disorders and 2020-10-01 Yes/ 5 Yes/1/3 NR/ DRUG FATAL

administration site (37)/ Yes/ (2020-10-01/ NR WITHDRAWN/
Systemic inflammatory (38)
response syndrome/
SEVERE SYSTEMIC
INFLAMMATORY SYNDROME IN
THE SETTING OF CLL

FDA-CBER-2022-908-0002774
812
Listing 16.2.7.11
Safety Set



FDA-CBER-2022-908-0002775
813
Listing 16.2.7.11
Safety Set

COVID 19, CONFIRMED (26) MEDICATION

FDA-CBER-2022-908-0002776
814
Listing 16.2.7.11
Safety Set

Subject ID: US3492242; Age (years): 29; Sex: M; Race: MULTIPLE: White, Black or African American, Native Hawaiian or other
Pacific Islander; Height (cm): 180.0; Weight (kg): 223.0; BMI (kg/m2): 68.8; Baseline SARS-CoV-2 Status: Negative; Baseline
RT-PCR: Negative; Baseline Elecsys SARS-CoV-2 Nucleocapsid bAb: Negative; Dose 1 Date/Time:
23SEP2020:10:46:00; Follow-up Days after 1st Dose: 185; Dose 2 Date/Time: ; Follow-up Days after 2nd Dose: NA
Infections and 2020-11-10 Yes/ 1 No NR/ DRUG NOT RECOVERED/

infestations/ (29)/ Yes/ NR WITHDRAWN/ NOT RESOLVED
COVID-19 MEDICATION

FDA-CBER-2022-908-0002777
815
Listing 16.2.7.11
Safety Set


(23) MEDICATION

tissue disorders/ (3)/ No/ NR WITHDRAWN/ RESOLVED
INTERMITTENT HIVES (FACE (132) MEDICATION
AND NECK)

FDA-CBER-2022-908-0002778
816
Listing 16.2.7.11
Safety Set


Asymptomatic COVID-19/ 2020-09-12 No NONE
ASYMPTOMATIC COVID-19 (11)
INFECTION


FDA-CBER-2022-908-0002779
817
Listing 16.2.7.11
Safety Set


INFECTION
Injury, poisoning and 2020-08-16 Yes/ 2 No R/ DRUG RECOVERED/

Ulnar nerve injury/ 2020-10-15 No CONCOMITANT
ULNAR NERVE IRRITATION (64) MEDICATION

FDA-CBER-2022-908-0002780
818
Listing 16.2.7.11
Safety Set

Cardiac disorders/ 2020-09-07 Yes/ 4 Yes/3 NR/ DRUG RECOVERED/

Acute myocardial (12)/ Yes/ (2020-09-07/ NR WITHDRAWN/ RESOLVED WITH
infarction/ 2020-10-06 No 2020-10-06) CONCOMITANT SEQUELAE:
ACUTE MYOCARDIAL (41) MEDICATION, VENTRICULAR
INFARTION CONCOMITANT FIBRILLATION-I
PROCEDURE NTERMEDIATE,
ANXIETY,
WHEEZING

FDA-CBER-2022-908-0002781
819
Listing 16.2.7.11
Safety Set

Musculoskeletal and 2020-09-25 Yes/ 2 No NR/ DRUG NOT RECOVERED/

connective tissue (24)/ Yes/ NR WITHDRAWN/ NOT RESOLVED
Back pain/ (77) MEDICATION,
WORSENING BACK PAIN CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002782
820
Listing 16.2.7.11
Safety Set

Musculoskeletal and 2020-09-03 Yes/ 2 No NR/ DRUG RECOVERED/

connective tissue (7)/ Yes/ NR WITHDRAWN/ RESOLVED
POLYARTHRALGIAS
Anxiety/ (16)/ Yes/ (2020-09-19/ NR WITHDRAWN/ RESOLVED
ANXIETY EXACERBATION 2020-09-23 No 2020-09-23) CONCOMITANT
(20) MEDICATION

FDA-CBER-2022-908-0002783
821
Listing 16.2.7.11
Safety Set

Cardiac disorders/ 2020-09-12 Yes/ 2 No R/ DRUG RECOVERED/

Atrial fibrillation/ (25)/ Yes/ R WITHDRAWN/ RESOLVED
WORSENED ATRIAL 2020-10-16 No NONE
FIBRILLATION (59)

Depression/ (15)/ No/ NR WITHDRAWN/ RESOLVED
WORSENING DEPRESSION 2020-10-12 No CONCOMITANT
(54) MEDICATION

FDA-CBER-2022-908-0002784
822
Listing 16.2.7.11
Safety Set

Eye disorders/ 2020-09-08 Yes/ 3 Yes/6 NR/ DRUG RECOVERED/
Retinal detachment/ (18)/ Yes/ NR WITHDRAWN/ RESOLVED
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002785
823
Listing 16.2.7.11
Safety Set

Respiratory, thoracic 2020-09-28 Yes/ 4 Yes/3 R/ DRUG RECOVERED/

RESPIRATORY FAILURE
Vascular disorders/ 2020-09-01 14:07 Yes/ 3 No NR/ DRUG NOT RECOVERED/

Hypertension/ (1)/ Yes/ NR WITHDRAWN/ NOT RESOLVED
MEDICATION

FDA-CBER-2022-908-0002786
824
Listing 16.2.7.11
Safety Set


Depression/ (11)/ Yes/ (2020-09-16/ NR WITHDRAWN/ RESOLVED
WORSENING DEPRESSION 2020-10-01 No 2020-09-21) CONCOMITANT
(28) MEDICATION

Atrial fibrillation/ (16)/ Yes/ NR WITHDRAWN/ RESOLVED
WORSENING ATRIAL 2020-10-16 No CONCOMITANT
FIBRILLATION ARRHYTHMIA (31) MEDICATION

FDA-CBER-2022-908-0002787
825
Listing 16.2.7.11
Safety Set


infestations/ (1)/ No/ NA WITHDRAWN/ RESOLVED
Asymptomatic COVID-19/ 2020-08-28 23:59 No NONE
POSITIVE

FDA-CBER-2022-908-0002788
826
Listing 16.2.7.11
Safety Set


procedural complications/ (7)/ No/ NR WITHDRAWN/ RESOLVED
Immunisation anxiety 2020-09-30 No NONE
related reaction/ (29)
ANXIETY DUE THE SIDE
EFFECTS OF THE FIRST IP


FDA-CBER-2022-908-0002789
827
Listing 16.2.7.11
Safety Set

bAb: Negative; Dose 1 Date/Time: 11AUG2020:15:44:00; Follow-up Days after 1st Dose: 95; Dose 2 Date/Time:
Anxiety/ (19)/ Yes/ NR WITHDRAWN/ RESOLVED
(25) MEDICATION
Nervous system disorders/ 2020-10-03 Yes/ 2 No R/ DRUG RECOVERING/

Paraesthesia/ (15)/ Yes/ NR WITHDRAWN/ RESOLVING
DECREASE IN SENSATION Ongoing No CONCOMITANT
AND PARESTHESIA MEDICATION

FDA-CBER-2022-908-0002790
828
Listing 16.2.7.11
Safety Set


COVID-19 (SARS-COV-2 (36) MEDICATION
CONFIRMED 10/27/2020)


FDA-CBER-2022-908-0002791
829
Listing 16.2.7.11
Safety Set

Skin and subcutaneous 2020-08-18 12:15 Yes/ 2 No R/ DRUG RECOVERED/

Rash pruritic/ 2020-08-26 No CONCOMITANT
PRUITIC RASH LOWER (10) MEDICATION
EXTREMITIES

increased/ 2020-10-17 No CONCOMITANT
ELEVATED DIASTOLIC BLOOD (60) MEDICATION
PRESSURE

FDA-CBER-2022-908-0002792
830
Listing 16.2.7.11
Safety Set


Ischaemic stroke/ (11)/ Yes/ (2020-09-10/ NR WITHDRAWN/ RESOLVED WITH
ISCHEMIC STROKE (FRONTAL 2020-09-11 No 2020-09-11) CONCOMITANT SEQUELAE:
LOBE) (12) MEDICATION AE OF SPEECH
DEFICIT

Speech disorder/ (11)/ Yes/ (2020-09-10/ NR WITHDRAWN/ RESOLVED
SPEECH DEFICIT 2021-01-26 No 2020-09-11)/4 CONCOMITANT
(149) PROCEDURE

FDA-CBER-2022-908-0002793
831
Listing 16.2.7.11
Safety Set


infection/ (36)
UPPER RESPIRATORY
INFECTION (URI)

FDA-CBER-2022-908-0002794
832
Listing 16.2.7.11
Safety Set


Ventricular (5)/ Yes/ NR WITHDRAWN/ RESOLVED
PREMATURE VENTRICULAR (22)
CONTRACTIONS

FDA-CBER-2022-908-0002795
833
Listing 16.2.7.11
Safety Set

after 2nd Dose: NA
Infections and 2020-09-01 23:00 Yes/ 2 No R/ DRUG RECOVERED/
Varicella zoster virus 2020-10-03 No NONE
infection/ (33)
EXACERBATION OF
VARICELLA ZOSTER
Infections and 2020-09-14 Yes/ 2 No NR/ DRUG UNKNOWN

infestations/ (19)/ Yes/ NR WITHDRAWN/
SYMPTOMATIC COVID-19 MEDICATION

FDA-CBER-2022-908-0002796
834
Listing 16.2.7.11
Safety Set


COVID-19/ 2020-09-29 No NONE
COVID-19 (26)

FDA-CBER-2022-908-0002797
835
Listing 16.2.7.11
Safety Set

Subject ID: US3742395; Age (years): 61; Sex: M; Race: OTHER: MULATO; Height (cm): 185.4; Weight (kg): 97.5; BMI (kg/m2):
Deep vein thrombosis/ (9)/ Yes/ NR WITHDRAWN/ RESOLVED WITH
DEEP VEIN THROMBOSIS 2021-02-15 No CONCOMITANT SEQUELAE:
(152) MEDICATION HAD FOLLOW-UP
VISIT IN
FEBRUARY, DR.
TOLD HIM THIS
IS A CHRONIC
CONDITION AND
HE WOULD BE
TAKING ELIQUIS
FOR LIFE.

FDA-CBER-2022-908-0002798
836
Listing 16.2.7.11
Safety Set

Subject ID: US3742477; Age (years): 49; Sex: F; Race: NOT REPORTED; Height (cm): 156.2; Weight (kg): 105.1; BMI (kg/m2):


FDA-CBER-2022-908-0002799
837
Listing 16.2.7.11
Safety Set

Skin and subcutaneous 2020-08-28 Yes/ 3 No NR/ DRUG NOT RECOVERED/

Angioedema/ Ongoing No CONCOMITANT
ANGIODEMA MEDICATION

FDA-CBER-2022-908-0002800
838
Listing 16.2.7.11
Safety Set

COVID-19/ 2020-09-26 No NONE
COVID-19 (44)
COVID-19/ 2020-08-28 No NONE

FDA-CBER-2022-908-0002801
839
Listing 16.2.7.11
Safety Set


COVID-19/ 2021-01-11 No NONE
COVID-19 INFECTION (140)
Eye disorders/ 2020-08-09 Yes/ 1 No R/ DRUG RECOVERED/

Eye swelling/ (6)/ Yes/ NR WITHDRAWN/ RESOLVED
SWELLING UNDER EYE, 2020-09-21 No CONCOMITANT
BILATERAL (49) MEDICATION

FDA-CBER-2022-908-0002802
840
Listing 16.2.7.11
Safety Set


Heart rate irregular/ (21)/ Yes/ NR WITHDRAWN/ RESOLVED
IRREGULAR HEART BEAT 2020-09-10 No NONE
(21)

FDA-CBER-2022-908-0002803
841
Listing 16.2.7.11
Safety Set

Hypertension/ (30)/ Yes/ NR WITHDRAWN/ RESOLVED
(46) MEDICATION


FDA-CBER-2022-908-0002804
842
Listing 16.2.7.11
Safety Set

Ear and labyrinth 2020-08-31 Yes/ 3 No NR/ DRUG RECOVERED/

VERTIGO (21)
Gastrointestinal 2020-08-31 Yes/ 3 No NR/ DRUG RECOVERED/

Retching/ 2020-08-31 No NONE
DRY HEAVES (21)

FDA-CBER-2022-908-0002805
843
Listing 16.2.7.11
Safety Set


URTICARIAL RASH ON (10) MEDICATION
BUTTOCKS AND BILATERAL
AXILLA


FDA-CBER-2022-908-0002806
844
Listing 16.2.7.11
Safety Set

PULMONARY EMBOLISM, LLL

Confusional state/ (7)/ Yes/ (2020-09-07/ NR WITHDRAWN/ RESOLVED
CONFUSION 2020-09-09 No 2020-09-09) CONCOMITANT
(9) PROCEDURE

FDA-CBER-2022-908-0002807
845
Listing 16.2.7.11
Safety Set

Nervous system disorders/ 2020-09-09 Yes/ 2 No NR/ DRUG RECOVERED/

Amnesia/ (16)/ No/ NR WITHDRAWN/ RESOLVED
INTERMITTENT MEMORY LOSS 2020-09-11 No NONE
(18)

Cardiac failure (20)/ Yes/ (2020-10-05/ NR WITHDRAWN/ RESOLVED
congestive/ 2020-10-11 No 2020-10-11)/6 CONCOMITANT
WORSENING OF CONGESTIVE (26) MEDICATION,
HEART FAILURE CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002808
846
Listing 16.2.7.11
Safety Set


disorders/ 2020-11-05 No 2020-10-11)/6 NONE
pulmonary disease/
EXACERBATED COPD CAUSED
BY WORSENING CONGESTIVE
HEART FAILURE

FDA-CBER-2022-908-0002809
847
Listing 16.2.7.11
Safety Set

SARS-CoV-2 Nucleocapsid bAb: Negative; Dose 1 Date/Time: 13OCT2020:12:05:00; Follow-up Days after 1st
COVID-19/ 2020-12-09 No NONE
COVID-19 (58)
Headache/ (24)/ No/ NR WITHDRAWN/ RESOLVED
(43) MEDICATION

FDA-CBER-2022-908-0002810
848
Listing 16.2.7.11
Safety Set

Respiratory, thoracic 2020-09-25 Yes/ 1 No NR/ DRUG RECOVERED/
and mediastinal (24)/ No/ NR WITHDRAWN/ RESOLVED
SORE THROAT


FDA-CBER-2022-908-0002811
849
Listing 16.2.7.11
Safety Set


Femur fracture/ 2020-11-22 No 2020-10-22) CONCOMITANT
LEFT FEMUR FRACTURE (42) PROCEDURE

Joint injury/ 2020-11-22 No NONE
RIGHT KNEE INJURY (42)

FDA-CBER-2022-908-0002812
850
Listing 16.2.7.11
Safety Set


Blood pressure increased/ (36)/ No/ NR WITHDRAWN/ RESOLVED
WORSENING OF BASELINE 2020-10-23 No NONE
ELEVATED GRADE 3 BLOOD (36)
PRESSURE

FDA-CBER-2022-908-0002813
851
Listing 16.2.7.11
Safety Set


Vascular disorders/ 2020-09-14 Yes/ 2 No NR/ DRUG NOT RECOVERED/

Orthostatic hypotension/ (48)/ Yes/ NR WITHDRAWN/ NOT RESOLVED
ORTHOSTATIC HYOTENSION Ongoing No NONE

FDA-CBER-2022-908-0002814
852
Listing 16.2.7.11
Safety Set


PNUEMONIA (24) PROCEDURE

Overdose/ 2020-08-19 No 2020-08-19) NONE
OVERDOSE OF KLONOPIN (24)

FDA-CBER-2022-908-0002815
853
Listing 16.2.7.11
Safety Set


Respiratory failure/ (24) PROCEDURE
LUNG FAILURE
Cardiac failure (19)/ Yes/ (2020-09-10/ NR WITHDRAWN/ RESOLVED
congestive/ 2020-09-14 No 2020-09-14) NONE
CONGESTIVE HEART FAILURE (26)

FDA-CBER-2022-908-0002816
854
Listing 16.2.7.11
Safety Set

Drug abuse/ (22)/ Yes/ (2020-09-10/ NR WITHDRAWN/ RESOLVED
COCAINE ABUSE 2020-09-10 No 2020-09-14) NONE
(22)

COVID-19/ 2020-09-08 No NONE
COVID-19 INFECTION (19)

FDA-CBER-2022-908-0002817
855
Listing 16.2.7.11
Safety Set

Respiratory, thoracic 2020-08-27 Yes/ 1 No NR/ DRUG NOT RECOVERED/

and mediastinal (30)/ Yes/ NR WITHDRAWN/ NOT RESOLVED
Dyspnoea/
EXACERBATION OF CHRONIC
DYSPNEA

FDA-CBER-2022-908-0002818
856
Listing 16.2.7.11
Safety Set


MULTIPLE PULMONARY
EMBOLI
Investigations/ 2020-08-31 Yes/ 1 No NR/ DRUG NOT RECOVERED/

Hepatic enzyme increased/ (18)/ Yes/ NR WITHDRAWN/ NOT RESOLVED

FDA-CBER-2022-908-0002819
857
Listing 16.2.7.11
Safety Set


Pancreatitis acute/ 2020-09-30 No 2020-09-30) CONCOMITANT
ACUTE PANCREATITIS (44) PROCEDURE
Gastrointestinal 2020-08-12 Yes/ 2 No NR/ DRUG NOT RECOVERED/

disorders/ (7)/ Yes/ NR WITHDRAWN/ NOT RESOLVED
Abdominal pain lower/ Ongoing No CONCOMITANT
INTERMITTENT RIGHT LOWER MEDICATION
QUADRANT PAIN

FDA-CBER-2022-908-0002820
858
Listing 16.2.7.11
Safety Set


Metastases to lung/
METASTASES TO LUNGS
[RECURRENCE OF THROAT
CANCE]

FDA-CBER-2022-908-0002821
859
Listing 16.2.7.11
Safety Set


Throat cancer/
RECURRENCE OF THROAT
CANCER [WITH METASTASES
TO LUNGS]

FDA-CBER-2022-908-0002822
860
Listing 16.2.7.11
Safety Set


Urticaria/ 2020-08-11 No NONE
HYPERSENSITIVITY RASH - (16)
BILATERAL ELBOWS
(MACULAR - URTICARIAL)
Blood and lymphatic 2020-08-22 Yes/ 2 No R/ DRUG RECOVERED/

system disorders/ (4)/ No/ NR WITHDRAWN/ RESOLVED
Lymphadenopathy/ 2020-09-07 No CONCOMITANT
LEFT ARMPIT SWELLING (20) MEDICATION

FDA-CBER-2022-908-0002823
861
Listing 16.2.7.11
Safety Set


Skin and subcutaneous 2020-08-22 23:00 Yes/ 1 No R/ DRUG RECOVERED/

tissue disorders/ (2)/ No/ R WITHDRAWN/ RESOLVED
Urticaria/ 2020-08-25 05:00 No CONCOMITANT
SKIN RASH (CONSISTENT (4) MEDICATION
WITH HIVES) (ARMS, LEGS,
CHEST, AND BACK)

FDA-CBER-2022-908-0002824
862
Listing 16.2.7.11
Safety Set


Psoriasis/ 2020-11-17 No CONCOMITANT
PSORIASIS FLARE (83) MEDICATION
COVID-LIKE ILLNESS (66) MEDICATION

FDA-CBER-2022-908-0002825
863
Listing 16.2.7.11
Safety Set

Reproductive system and 2020-09-04 Yes/ 3 No NR/ DRUG NOT RECOVERED/

breast disorders/ (26)/ Yes/ NR WITHDRAWN/ NOT RESOLVED
MASS ON RIGHT BREAST PROCEDURE
POSSITIVE FOR CANCER

FDA-CBER-2022-908-0002826
864
Listing 16.2.7.11
Safety Set

Musculoskeletal and 2020-08-25 Yes/ 1 No R/ DRUG RECOVERING/

WORSENING UPPER
EXTREMITIES ARTHRALGIA

SAR-COV-2 (21) MEDICATION

FDA-CBER-2022-908-0002827
865
Listing 16.2.7.11
Safety Set



FDA-CBER-2022-908-0002828
866
Listing 16.2.7.11
Safety Set


COVID-19/ 2020-08-29 No NONE
SYMPTOMATIC COVID 19 (8)

Headache/ (1)/ No/ NR WITHDRAWN/ RESOLVED
OCCIPITAL HEADACHE 2020-09-30 Yes CONCOMITANT
(42) MEDICATION

FDA-CBER-2022-908-0002829
867
Listing 16.2.7.11
Safety Set


Ageusia/ (9)/ Yes/ NR WITHDRAWN/ RESOLVED
NEW LOSS OF TASTE 2020-09-15 No NONE
(34)

FDA-CBER-2022-908-0002830
868
Listing 16.2.7.11
Safety Set

Anosmia/ (9)/ Yes/ NR WITHDRAWN/ RESOLVED
(34)

Cervical radiculopathy/ (18)/ Yes/ NR WITHDRAWN/ RESOLVED
EXACERBATION OF LEFT 2020-10-09 No CONCOMITANT
CERVICAL RADICULOPATHY (51) MEDICATION

FDA-CBER-2022-908-0002831
869
Listing 16.2.7.11
Safety Set

Coronary artery disease/ (35)/ Yes/ (2020-10-15/ NR WITHDRAWN/ RESOLVED
EXACERBATION OF CORONARY 2020-10-16 No 2020-10-16) CONCOMITANT
ARTERY DISEASE (36) MEDICATION,
CONCOMITANT
PROCEDURE

COVID-19/ 2020-10-09 08:00 No CONCOMITANT

FDA-CBER-2022-908-0002832
870
Listing 16.2.7.11
Safety Set

Injury, poisoning and 2020-10-13 Yes/ 1 No NR/ DRUG RECOVERING/

procedural complications/ (34)/ Yes/ R WITHDRAWN/ RESOLVING
Head injury/ Ongoing No NONE
HEAD TRAUMA
Vascular disorders/ 2020-10-21 Yes/ 2 No NR/ DRUG NOT RECOVERED/

Hypertension/ (26)/ No/ NR WITHDRAWN/ NOT RESOLVED
(UNSPECIFIED)

FDA-CBER-2022-908-0002833
871
Listing 16.2.7.11
Safety Set

Gastrointestinal 2020-08-03 16:20 Yes/ 2 No R/ DRUG RECOVERED/

Swollen tongue/ 2020-08-03 18:20 No NONE
TONGUE SWELLING - POST (1)
INJECTION ALLERGIC
REACTION
Dose 1 Date/Time: 13AUG2020:10:11:00; Follow-up Days after 1st Dose: 226; Dose 2 Date/Time: ; Follow-up Days
after 2nd Dose: NA

FDA-CBER-2022-908-0002834
872
Listing 16.2.7.11
Safety Set

Musculoskeletal and 2020-09-08 Yes/ 2 No NR/ DRUG RECOVERED/

connective tissue (16)/ Yes/ NR WITHDRAWN/ RESOLVED
WORSENING OF LEFT HIP CONCOMITANT
PAIN/ARTHRITIS PROCEDURE

FDA-CBER-2022-908-0002835
873
Listing 16.2.7.11
Safety Set

Musculoskeletal and 2020-09-09 Yes/ 4 Yes/3 NR/ DRUG RECOVERED/

connective tissue (17)/ Yes/ (2020-09-29/ NR WITHDRAWN/ RESOLVED
Fracture nonunion/ (43) MEDICATION,
WORSENING OF ANTERIOR CONCOMITANT
LEFT PELVIC RING PROCEDURE
NON-UNION

FDA-CBER-2022-908-0002836
874
Listing 16.2.7.11
Safety Set


Gastric cancer/ CONCOMITANT
GASTRIC CANCER PROCEDURE

Hepatitis A/ 2020-09-25 No 2020-09-25) CONCOMITANT
HEPATITIS A (24) MEDICATION

FDA-CBER-2022-908-0002837
875
Listing 16.2.7.11
Safety Set

08AUG2020:14:23:00; Follow-up Days after 1st Dose: 231; Dose 2 Date/Time: ; Follow-up Days after 2nd Dose: NA

Herpes simplex/ 2020-08-25 No CONCOMITANT
HERPES SIMPLEX (18) MEDICATION
Lung abscess/ 2021-01-20 No 2020-09-01) CONCOMITANT
ABSCESS OF LUNG (170) MEDICATION

FDA-CBER-2022-908-0002838
876
Listing 16.2.7.11
Safety Set

PNEUMONIA (170) MEDICATION,
CONCOMITANT
PROCEDURE


FDA-CBER-2022-908-0002839
877
Listing 16.2.7.11
Safety Set


(ASYMPTOMATIC)

FDA-CBER-2022-908-0002840
878
Listing 16.2.7.11
Safety Set


RASH WITH BLANCHING

FDA-CBER-2022-908-0002841
879
Listing 16.2.7.11
Safety Set

Cardiac disorders/ 2020-10-28 Yes/ 4 Yes/2/3 NR/ DRUG RECOVERED/
Myocardial infarction/ (13)/ Yes/ (2020-10-29/ NR WITHDRAWN/ RESOLVED WITH
MYOCARDIAL INFARCTION 2020-10-31 No 2020-10-31)/4 CONCOMITANT SEQUELAE:
(16) MEDICATION, SHORTNESS OF
CONCOMITANT BREATH &
PROCEDURE IMPAIRED
CARDIAC
FUNCTION (CHF)

FDA-CBER-2022-908-0002842
880
Listing 16.2.7.11
Safety Set



FDA-CBER-2022-908-0002843
881
Listing 16.2.7.11
Safety Set


BY 86MM OBLONG

FDA-CBER-2022-908-0002844
882
Listing 16.2.7.11
Safety Set


Seizure/ (30)/ Yes/ (2020-11-07/ NR WITHDRAWN/ RESOLVED
EXACERBATION OF SEIZURE 2020-11-09 No 2020-11-08) CONCOMITANT

FDA-CBER-2022-908-0002845
883
Listing 16.2.7.11
Safety Set


SHINGLES (39) MEDICATION

Hepatic enzyme increased/ (9)/ Yes/ NR WITHDRAWN/ RESOLVED
ELEVATED LIVER ENZYMES 2020-12-17 No NONE
(101)

FDA-CBER-2022-908-0002846
884
Listing 16.2.7.11
Safety Set


administration site (8)/ No/ R WITHDRAWN/ RESOLVED
SITE RASH TO LEFT ARM

FDA-CBER-2022-908-0002847
885
Listing 16.2.7.11
Safety Set

Colorectal cancer/
COLORECTAL CANCER
Subject ID: US3562230; Age (years): 45; Sex: M; Race: OTHER: MEXICAN AMERICAN; Height (cm): 176.5; Weight (kg): 171.4; BMI
bAb: Negative; Dose 1 Date/Time: 15OCT2020:13:51:00; Follow-up Days after 1st Dose: 37; Dose 2 Date/Time:
Liver abscess/ 2020-11-17 No 2020-11-17) CONCOMITANT
LIVER ABCESS (34) MEDICATION

FDA-CBER-2022-908-0002848
886
Listing 16.2.7.11
Safety Set


Neuropathy peripheral/ (1)/ No/ NR WITHDRAWN/ RESOLVED
PERIPHERAL NEUROPATHY 2020-11-04 No CONCOMITANT
(45) MEDICATION

COVID-19/ 2020-11-06 No NONE
COVID-19 (43)

FDA-CBER-2022-908-0002849
887
Listing 16.2.7.11
Safety Set


SITE (L)

FDA-CBER-2022-908-0002850
888
Listing 16.2.7.11
Safety Set


administration site (9)/ No/ NR WITHDRAWN/ RESOLVED
SITE (L)

FDA-CBER-2022-908-0002851
889
Listing 16.2.7.11
Safety Set


Induration/ (16)
RIGHT ARM INDURATION

RIGHT ARM ERYTHEMA (45)
(URTICARIAL)

FDA-CBER-2022-908-0002852
890
Listing 16.2.7.11
Safety Set


administration site (8)/ No/ NR WITHDRAWN/ RESOLVED
SITE

GENERALIZED PRURITIS (84) MEDICATION

FDA-CBER-2022-908-0002853
891
Listing 16.2.7.11
Safety Set


Angioedema/ 2020-09-19 No NONE
ANGIOEDEMA (23)
Skin and subcutaneous 2020-09-21 Yes/ 2 No R/ DRUG NOT RECOVERED/

WORSENING OF URITICARIA MEDICATION

FDA-CBER-2022-908-0002854
892
Listing 16.2.7.11
Safety Set


Product issues/ 2020-09-29 Yes/ 2 No NR/ DRUG RECOVERED/

Device dislocation/ (20)/ Yes/ NR WITHDRAWN/ RESOLVED
DISPLACED LEFT BREAST 2020-10-05 No CONCOMITANT
SILICONE IMPLANT (26) PROCEDURE

FDA-CBER-2022-908-0002855
893
Listing 16.2.7.11
Safety Set

Musculoskeletal and 2020-08-31 23:00 Yes/ 2 Yes/6 R/ DRUG RECOVERING/

Rheumatoid arthritis/ MEDICATION
RHEUMATOID ARTHRITIS

FDA-CBER-2022-908-0002856
894
Listing 16.2.7.11
Safety Set

General disorders and 2020-09-03 00:00 No/ 2 No R/ DRUG RECOVERED/

INJECTION SITE REDNESS,
LEFT ARM NON-URTICARIAL
Skin and subcutaneous 2020-11-09 Yes/ 2 No NR/ DRUG RECOVERED/

Psoriasis/ 2020-12-05 No CONCOMITANT
EXACERBATION PSORIASIS (44) MEDICATION

FDA-CBER-2022-908-0002857
895
Listing 16.2.7.11
Safety Set

Subject ID: US3842060; Age (years): 57; Sex: M; Race: OTHER: CUBAN; Height (cm): 174.5; Weight (kg): 88.3; BMI (kg/m2): 29.0;
A-SYMPTOMATIC COVID-19 (9)

Rash pruritic/ 2020-10-02 No NONE
RASH [ERYTHEMATOUS AND (22)
PRURITIC] OF VACCINATED
ARM

FDA-CBER-2022-908-0002858
896
Listing 16.2.7.11
Safety Set

Blood and lymphatic 2020-09-16 Yes/ 1 No R/ DRUG RECOVERED/

system disorders/ (6)/ No/ NR WITHDRAWN/ RESOLVED
IPSILATERAL AXILLARY (15)
LYMPHADENOPATHY

Viral infection/ 2020-11-11 No CONCOMITANT
VIRAL LIKE ILLNESS (27) MEDICATION

FDA-CBER-2022-908-0002859
897
Listing 16.2.7.11
Safety Set

COVID-19 (ASYMPTOMATIC) (45)

COVID-19/ 2020-12-03 No NONE
COVID-19 (42)

FDA-CBER-2022-908-0002860
898
Listing 16.2.7.11
Safety Set


HIVES (19) MEDICATION
Bipolar disorder/ (110)/ Yes/ NR WITHDRAWN/ NOT RESOLVED
BIPOLAR DISORDER Ongoing No CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0002861
899
Listing 16.2.7.11
Safety Set

Substance abuse/ (10)/ Yes/ NR WITHDRAWN/ NOT RESOLVED
POLYSUBSTANCE ABUSE Ongoing No NONE

FDA-CBER-2022-908-0002862
900
Listing 16.2.7.11
Safety Set

TRAUMA CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002863
901
Listing 16.2.7.11
Safety Set

HIP FRACTURE (22) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002864
902
Listing 16.2.7.11
Safety Set

PRESSURE
(55)

FDA-CBER-2022-908-0002865
903
Listing 16.2.7.11
Safety Set


Idiopathic intracranial (4)/ No/ NR WITHDRAWN/ RESOLVED
hypertension/ 2020-10-01 No CONCOMITANT
WORSENING PSEUDOTUMOR (21) MEDICATION
CEREBRI

FDA-CBER-2022-908-0002866
904
Listing 16.2.7.11
Safety Set

General disorders and 2020-09-21 15:00 Yes/ 1 No R/ DRUG RECOVERED/
LEFT DELTOID INJECTION
SITE SWELLING

FDA-CBER-2022-908-0002867
905
Listing 16.2.7.11
Safety Set
FDA-CBER-2022-908-0002868
906
Listing 16.2.7.12
Unsolicited Adverse Events Leading to Discontinuation from Participation in the Study
Safety Set


Infections and 2020-11-09 Yes/ 5 Yes/1 NR/ NOT FATAL

FDA-CBER-2022-908-0002869
907
Listing 16.2.7.12
Safety Set



VERTIGO MEDICATION

FDA-CBER-2022-908-0002870
908
Listing 16.2.7.12
Safety Set

Nucleocapsid bAb: Negative; Dose 1 Date/Time: 21SEP2020:12:39:00; Follow-up Days after 1st Dose: 13; Dose 2
Gastrointestinal 2020-10-02 Yes/ 5 Yes/1/3 NR/ NOT FATAL
disorders/ (12)/ Yes/ (2020-10-02/ NR APPLICABLE/
Gastric perforation/ 2020-10-03 No 2020-10-03)/4/ CONCOMITANT
INTRA-ABDOMINAL (13) 6 PROCEDURE
PERFORATION
Hepatic cancer/
LIVER CANCER

FDA-CBER-2022-908-0002871
909
Listing 16.2.7.12
Safety Set

Neoplasms benign, 2021-01-26 Yes/ 5 Yes/1/3 NR/ NOT FATAL
malignant and (123)/ Yes/ NR APPLICABLE/
and polyps)/ (145) MEDICATION
Pancreatic carcinoma
stage IV/
STAGE 4 PANCREATIC
CANCER


FDA-CBER-2022-908-0002872
910
Listing 16.2.7.12
Safety Set

Nervous system disorders/ 2020-11-05 Yes/ 5 Yes/1/4 NR/ NOT FATAL
Amyotrophic lateral (49)/ Yes/ NR APPLICABLE/
sclerosis/ 2020-12-12 No NONE
COMPLICATION OF (86)
AMYOTROPHIC LATERAL
SCLEROSIS
Cardiac disorders/ 2020-10-01 Yes/ 5 Yes/1 NR/ NOT FATAL
Myocardial infarction/ (29)/ Yes/ NR APPLICABLE/
MYOCARDIAL INFARCTION 2020-10-01 No CONCOMITANT
(29) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002873
911
Listing 16.2.7.12
Safety Set

MYOCARDIAL INFARCTION 2021-01-04 No NONE
(103)
FATAL MYOCARDIAL 2020-11-16 No NONE
INFARCTION (47)

FDA-CBER-2022-908-0002874
912
Listing 16.2.7.12
Safety Set

Dose 1 Date/Time: 14SEP2020:09:51:00; Follow-up Days after 1st Dose: 7; Dose 2 Date/Time: ; Follow-up Days after 2nd Dose: NA

Cardio-respiratory (7)/ Yes/ NR APPLICABLE/
arrest/ 2020-09-20 No CONCOMITANT
CARDIOPULMONARY ARREST (7) MEDICATION,
CONCOMITANT
PROCEDURE

IDEATION

FDA-CBER-2022-908-0002875
913
Listing 16.2.7.12
Safety Set

General disorders and 2021-01-25 Yes/ 5 Yes/1 NR/ NOT FATAL
administration site (120)/ Yes/ NR APPLICABLE/
Death/ (120)
DEATH-UNKNOWN CAUSE
Skin and subcutaneous 2020-09-12 Yes/ 2 No NR/ DOSE NOT NOT RECOVERED/
tissue disorders/ (24)/ Yes/ NR CHANGED/ NOT RESOLVED
Dermatitis allergic/ Ongoing No CONCOMITANT
ALLERGIC RASH - UNKNOWN MEDICATION
ETIOLOGY

FDA-CBER-2022-908-0002876
914
Listing 16.2.7.12
Safety Set

General disorders and 2020-10-01 Yes/ 5 Yes/1/3 NR/ DRUG FATAL

administration site (37)/ Yes/ (2020-10-01/ NR WITHDRAWN/
Systemic inflammatory (38)
response syndrome/
SEVERE SYSTEMIC
INFLAMMATORY SYNDROME IN
THE SETTING OF CLL
Infections and 2021-01-03 Yes/ 5 Yes/1/3 NR/ NOT FATAL
infestations/ (103)/ Yes/ (2021-01-23/ NR APPLICABLE/

FDA-CBER-2022-908-0002877
915
Listing 16.2.7.12
Safety Set

Psychiatric disorders/ 2020-12-13 Yes/ 5 Yes/1 NR/ NOT FATAL
Completed suicide/ (87)/ No/ NR APPLICABLE/
COMMITTED SUICIDE 2020-12-13 No NONE
(87)

FDA-CBER-2022-908-0002878
916
Listing 16.2.7.12
Safety Set

Myocardial infarction/ (86)/ No/ NR APPLICABLE/
(86)
administration site (64)/ No/ NR APPLICABLE/
Death/ (64)
DEATH (UNKNOWN CAUSE)

FDA-CBER-2022-908-0002879
917
Listing 16.2.7.12
Safety Set

Nervous system disorders/ 2021-01-06 Yes/ 5 Yes/1 NR/ NOT FATAL
Seizure/ (97)/ Yes/ NR APPLICABLE/
SEIZURE 2021-01-06 No NONE
(97)
Infections and 2020-12-24 Yes/ 5 Yes/1/3 NR/ NOT FATAL
SARS-COV-2 INFECTION (109) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002880
918
Listing 16.2.7.12
Safety Set

Respiratory, thoracic 2020-08-27 Yes/ 1 No NR/ DRUG NOT RECOVERED/

and mediastinal (30)/ Yes/ NR WITHDRAWN/ NOT RESOLVED
Dyspnoea/
EXACERBATION OF CHRONIC
DYSPNEA

MULTIPLE PULMONARY
EMBOLI

FDA-CBER-2022-908-0002881
919
Listing 16.2.7.12
Safety Set

Investigations/ 2020-08-31 Yes/ 1 No NR/ DRUG NOT RECOVERED/

Hepatic enzyme increased/ (18)/ Yes/ NR WITHDRAWN/ NOT RESOLVED

Pancreatitis acute/ 2020-09-30 No 2020-09-30) CONCOMITANT
ACUTE PANCREATITIS (44) PROCEDURE

FDA-CBER-2022-908-0002882
920
Listing 16.2.7.12
Safety Set

Cardiac disorders/ 2020-12-19 Yes/ 5 Yes/1/3 NR/ NOT FATAL
Cardiac failure (110)/ Yes/ (2020-12-19/ NR APPLICABLE/
END STAGE CONGESTIVE (145) MEDICATION
HEART FAILURE

Gastric cancer/ CONCOMITANT
GASTRIC CANCER PROCEDURE

FDA-CBER-2022-908-0002883
921
Listing 16.2.7.12
Safety Set

Cardiac arrest/ (89)/ No/ NR APPLICABLE/
CARDIAC ARREST 2021-01-03 No NONE
(89)
Myocardial infarction/ (58)/ No/ NR APPLICABLE/
PROVISIONAL DIAGNOSIS 2020-11-27 No NONE
ONLY - SUDDEN FATAL (58)
EVENT, LIKELY MYOCARDIAL
INFARCTION

FDA-CBER-2022-908-0002884
922
Listing 16.2.7.12
Safety Set

Cardiac disorders/ 2020-09-01 Yes/ 5 Yes/1 NR/ DOSE NOT FATAL

Cardio-respiratory (21)/ Yes/ NR CHANGED/
arrest/ 2020-09-01 No NONE
CARDIOPULMONARY ARREST (21)
Colorectal cancer/
COLORECTAL CANCER

FDA-CBER-2022-908-0002885
923
Listing 16.2.7.12
Safety Set

malignant and (102)/ Yes/ (2021-01-16/ NR APPLICABLE/
Hepatocellular carcinoma/
WORSENING METASTATIC
HEPATOCELLULAR CARCINOMA

Induration/ (16)
RIGHT ARM INDURATION

FDA-CBER-2022-908-0002886
924
Listing 16.2.7.12
Safety Set


RIGHT ARM ERYTHEMA (45)
(URTICARIAL)
after 2nd Dose: NA
Infections and 2021-01-01 Yes/ 5 Yes/1/2/3 NR/ NOT FATAL
COVID-19/ 2021-02-25 No ) CONCOMITANT
COVID-19 INFECTION (175) MEDICATION,
(ONSET 1/1/2021, CONCOMITANT
DIAGNOSIS 1/5/2021) PROCEDURE

FDA-CBER-2022-908-0002887
925
Listing 16.2.7.12
Safety Set

Nucleocapsid bAb: Negative; Dose 1 Date/Time: 20AUG2020:10:46:00; Follow-up Days after 1st Dose: 74; Dose 2
(45)
Respiratory, thoracic 2021-01-11 Yes/ 5 Yes/1 NR/ NOT FATAL
and mediastinal (77)/ Yes/ NR APPLICABLE/
Pulmonary mass/ (108)
RIGHT LOWER LOBE
PULMONARY NODULE
CONCERNING FOR PRIMARY
LUNG MALIGNANCY

FDA-CBER-2022-908-0002888
926
Listing 16.2.7.12
Safety Set

Cardiac disorders/ 2021-03-09 Yes/ 5 Yes/1/2/3 NR/ NOT FATAL
Cardio-respiratory (155)/ Yes/ (2021-03-09/ NR APPLICABLE/
arrest/ 2021-03-09 No 2021-03-09) CONCOMITANT
CARDIOPULMONARY ARREST (155) MEDICATION,
CONCOMITANT
PROCEDURE
Psychiatric disorders/ 2020-09-16 Yes/ 5 Yes/1 NR/ NOT FATAL

Completed suicide/ (21)/ Yes/ NR APPLICABLE/
SUICIDE 2020-09-16 No NONE
(21)

FDA-CBER-2022-908-0002889
927
Listing 16.2.7.12
Safety Set

General disorders and 2020-12-17 Yes/ 5 Yes/1/3 NR/ NOT FATAL
Death/ (70)
DEATH (DETAILS UNKNOWN)
Gastrointestinal 2020-11-08 Yes/ 5 Yes/1 NR/ NOT FATAL
disorders/ (46)/ Yes/ NR APPLICABLE/
GI BLEED

FDA-CBER-2022-908-0002890
928
Listing 16.2.7.12
Safety Set

General disorders and 2020-11-20 Yes/ 5 Yes/1/3 NR/ NOT FATAL
administration site (58)/ Yes/ (2020-11-03/ NR APPLICABLE/
Multiple organ (60) MEDICATION,
dysfunction syndrome/ CONCOMITANT
MULTISYSTEM ORGAN PROCEDURE
FAILURE

FDA-CBER-2022-908-0002891
929
Listing 16.2.7.12
Safety Set

Respiratory, thoracic 2020-11-20 Yes/ 5 Yes/1/3 NR/ NOT FATAL
and mediastinal (58)/ Yes/ (2020-11-03/ NR APPLICABLE/
Acute respiratory (60) PROCEDURE
failure/
ACUTE HYPOXIC
RESPIRATORY FAILURE
Death/ (138)
DEATH OF UNKNOWN ORIGIN

FDA-CBER-2022-908-0002892
930
Listing 16.2.7.12
Safety Set

Death/ (54)
DEATH- PENDING AUTOPSY
Substance abuse/ (10)/ Yes/ NR WITHDRAWN/ NOT RESOLVED
POLYSUBSTANCE ABUSE Ongoing No NONE

FDA-CBER-2022-908-0002893
931
Listing 16.2.7.12
Safety Set

Injury, poisoning and 2020-10-15 Yes/ 5 Yes/1 NR/ DOSE NOT FATAL
procedural complications/ (37)/ No/ NR CHANGED/
Head injury/ 2020-10-15 No NONE
HEAD TRAUMA (37)
Death/ (110)
UNDETERMINED CAUSE
PENDING AUTOPSY

FDA-CBER-2022-908-0002894
932
Listing 16.2.7.12
Safety Set

Cardiac disorders/ 2020-12-03 Yes/ 5 Yes/1 NR/ DOSE NOT FATAL
Coronary artery disease/ (71)/ No/ NR CHANGED/
DEATH SUSPECTED DUE TO 2020-12-03 No NONE
CORONARY ARTERY DISEASE (71)
Metabolism and nutrition 2020-12-03 Yes/ 5 Yes/1 NR/ NOT FATAL

disorders/ (71)/ No/ NR APPLICABLE/
Diabetic complication/ 2020-12-03 No NONE
DEATH PROBABLY TO (71)
COMPLICATIONS OF
DIABETES MELLITUS

FDA-CBER-2022-908-0002895
933
Listing 16.2.7.12
Safety Set
FDA-CBER-2022-908-0002896
934
Listing 16.2.7.13
Unsolicited Medically-Attended Adverse Events
Safety Set



Cervical spinal stenosis/ MEDICATION,
CERVICAL STENOSIS CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002897
935
Listing 16.2.7.13
Safety Set


Hyperlipidaemia/ Ongoing No CONCOMITANT
HYPERLIPIDEMIA MEDICATION

SUSPECTED COVID-19 (18) MEDICATION

FDA-CBER-2022-908-0002898
936
Listing 16.2.7.13
Safety Set


Pneumonia/ 2020-09-12 No 2020-09-12) NONE
PNEUMONIA (47)

SYMPTOMATIC COVID19 (91) MEDICATION

FDA-CBER-2022-908-0002899
937
Listing 16.2.7.13
Safety Set

Nervous system disorders/ 2020-11-11 Yes/ 2 No NA/ NOT RECOVERED/

Headache/ (78)/ Yes/ NA APPLICABLE/ RESOLVED
(79) MEDICATION


FDA-CBER-2022-908-0002900
938
Listing 16.2.7.13
Safety Set



COVID-19/ 2021-01-05 No NONE
COVID-19 (131)

FDA-CBER-2022-908-0002901
939
Listing 16.2.7.13
Safety Set

Psychiatric disorders/ 2021-01-17 Yes/ 2 No NR/ NOT NOT RECOVERED/

Insomnia/ (143)/ Yes/ NR APPLICABLE/ NOT RESOLVED
WORSENING OF INSOMNIA Ongoing No CONCOMITANT
MEDICATION


FDA-CBER-2022-908-0002902
940
Listing 16.2.7.13
Safety Set


Hepatobiliary disorders/ 2020-10-04 Yes/ 2 No NR/ NOT NOT RECOVERED/

Hepatic steatosis/ (38)/ Yes/ NR APPLICABLE/ NOT RESOLVED
FATTY LIVER Ongoing No NONE

FDA-CBER-2022-908-0002903
941
Listing 16.2.7.13
Safety Set


Vitamin B12 deficiency/ Ongoing No NONE
VITAMIN B12 DEFICIENCY
Nervous system disorders/ 2020-11-27 Yes/ 2 No NA/ NOT NOT RECOVERED/

Tremor/ (72)/ Yes/ NR APPLICABLE/ NOT RESOLVED
TREMORS Ongoing No CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0002904
942
Listing 16.2.7.13
Safety Set



Livedo reticularis/ 2020-09-26 No NONE
LIVEDO RETICULARIS (26)

FDA-CBER-2022-908-0002905
943
Listing 16.2.7.13
Safety Set


Radius fracture/ 2021-01-05 No CONCOMITANT
LEFT DISTAL RADIUS (125) PROCEDURE
FRACTURE
Infections and 2020-11-01 08:00 Yes/ 2 No NR/ NOT RECOVERED/


FDA-CBER-2022-908-0002906
944
Listing 16.2.7.13
Safety Set


WORSENING OF LEFT
SHOULDER PAIN

ASYMPTOMATIC SARS-COV-2 (40)

FDA-CBER-2022-908-0002907
945
Listing 16.2.7.13
Safety Set


WORSENING OF DEPRESSION Ongoing No CONCOMITANT
MEDICATION
Infections and 2020-11-09 Yes/ 1 No NR/ NOT NOT RECOVERED/

infestations/ (57)/ Yes/ NA APPLICABLE/ NOT RESOLVED
Hordeolum/ Ongoing No CONCOMITANT
LEFT EYE HORDEOLUM MEDICATION

FDA-CBER-2022-908-0002908
946
Listing 16.2.7.13
Safety Set

Metabolism and nutrition 2020-09-15 09:00 Yes/ 1 No NR/ DOSE NOT NOT RECOVERED/
disorders/ (28)/ Yes/ NR CHANGED/ NOT RESOLVED
Obesity/ Ongoing No CONCOMITANT
WORSENING OF OBESITY MEDICATION

Depression/ (48)/ Yes/ NR APPLICABLE/ NOT RESOLVED
MEDICATION

FDA-CBER-2022-908-0002909
947
Listing 16.2.7.13
Safety Set


Migraine/ (84)/ Yes/ NA APPLICABLE/ RESOLVING
WORSENING OF MIGRAINES Ongoing Yes CONCOMITANT
MEDICATION


FDA-CBER-2022-908-0002910
948
Listing 16.2.7.13
Safety Set


Angioedema/ 2020-09-12 No CONCOMITANT
ACE INHIBITOR INDUCED (13) MEDICATION
ANGIOEDEMA

RIGHT FOOT FRACTURE (54) MEDICATION

FDA-CBER-2022-908-0002911
949
Listing 16.2.7.13
Safety Set


Dental caries/ 2020-11-16 No CONCOMITANT
DENTAL CARIES (50) MEDICATION,
CONCOMITANT
PROCEDURE

ACUTE LEFT EAR INFECTION (34) MEDICATION

FDA-CBER-2022-908-0002912
950
Listing 16.2.7.13
Safety Set


Cough/ (87)
COUGH

LEFT SHOULDER MUSCLE (29) MEDICATION
STRAIN

FDA-CBER-2022-908-0002913
951
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0002914
952
Listing 16.2.7.13
Safety Set


Costochondritis/ (109) MEDICATION
COSTOCHONDRITIS

NEPHROLITHIASIS (19) MEDICATION

FDA-CBER-2022-908-0002915
953
Listing 16.2.7.13
Safety Set


infestations/ (60)/ Yes/ NA APPLICABLE/ RESOLVED WITH
COVID-19/ 2020-12-19 No NONE SEQUELAE:
COVID-19 (75) ATRIAL
FIBRILLATION

Atrial fibrillation/ (62)/ Yes/ NR APPLICABLE/ NOT RESOLVED
MEDICATION

FDA-CBER-2022-908-0002916
954
Listing 16.2.7.13
Safety Set


Hydrocephalus/ (62)/ Yes/ (2020-12-07/ NA APPLICABLE/ RESOLVED
HYDROCEPHALUS 2020-12-15 No 2020-12-22) CONCOMITANT
(71) MEDICATION,
CONCOMITANT
PROCEDURE

disorders/ (72)/ Yes/ NA APPLICABLE/ NOT RESOLVED
Vitamin B12 deficiency/ Ongoing No CONCOMITANT
VITAMIN B-12 DEFICIENCY MEDICATION

FDA-CBER-2022-908-0002917
955
Listing 16.2.7.13
Safety Set

Renal and urinary 2020-12-16 Yes/ 2 No NR/ NOT RECOVERING/

Urinary retention/ Ongoing No CONCOMITANT
URINARY RETENTION MEDICATION

Menorrhagia/ 2021-02-08 No CONCOMITANT
MENORRHAGIA (123) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002918
956
Listing 16.2.7.13
Safety Set



Benign ovarian tumour/
RIGHT OVARIAN MASS
(BENIGN)

FDA-CBER-2022-908-0002919
957
Listing 16.2.7.13
Safety Set


infestations/ (27)/ Yes/ NA DELAYED/ RESOLVED

MEDICATION

FDA-CBER-2022-908-0002920
958
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION

TOOTH ABSCESS (43) PROCEDURE

FDA-CBER-2022-908-0002921
959
Listing 16.2.7.13
Safety Set


Uterine perforation/ 2021-03-12 No CONCOMITANT
IUD PERFORATION OF (179) PROCEDURE
UTERINE WALL


FDA-CBER-2022-908-0002922
960
Listing 16.2.7.13
Safety Set



Gastroenteritis/ 2020-09-27 No CONCOMITANT
GASTROENTERITIS (4) MEDICATION

FDA-CBER-2022-908-0002923
961
Listing 16.2.7.13
Safety Set


Ulna fracture/ 2020-12-12 No CONCOMITANT
FRACTURE RIGHT ULNA (66) PROCEDURE


FDA-CBER-2022-908-0002924
962
Listing 16.2.7.13
Safety Set


Contusion/ 2020-10-20 No CONCOMITANT
LEFT KNEE CONTUSION (12) MEDICATION

MEDICATION

FDA-CBER-2022-908-0002925
963
Listing 16.2.7.13
Safety Set


Cystitis/ 2020-10-30 No CONCOMITANT
CYSTITIS (URINARY TRACT (12) MEDICATION
INFECTION)

Meniscus injury/ Ongoing No CONCOMITANT
TORN MENISCUS, RIGHT ARM MEDICATION

FDA-CBER-2022-908-0002926
964
Listing 16.2.7.13
Safety Set


Seasonal allergy/ (17)/ Yes/ NR CHANGED/ RESOLVED
WORSENING OF SEASONAL 2020-08-17 No CONCOMITANT
ALLERGIES (22) MEDICATION

Wound/ 2020-10-27 No CONCOMITANT
PUNCTURE WOUND IN LEFT (65) MEDICATION
FOOT FROM NAIL

FDA-CBER-2022-908-0002927
965
Listing 16.2.7.13
Safety Set


Splinter/ 2021-02-25 No CONCOMITANT
L HAND SPLINTER (185) MEDICATION

Ligament sprain/ Ongoing No NONE
SPRAIN RIGHT THUMB

FDA-CBER-2022-908-0002928
966
Listing 16.2.7.13
Safety Set


of skin/
SQUAMOUS CELL CARCINOMA
(NOSE)

FDA-CBER-2022-908-0002929
967
Listing 16.2.7.13
Safety Set


Rhinitis/ 2020-12-03 No CONCOMITANT
CORYZA (101) MEDICATION

Squamous cell carcinoma/
SQUAMOUS CELL CANCER
RIGHT ELBOW

FDA-CBER-2022-908-0002930
968
Listing 16.2.7.13
Safety Set


Seasonal allergy/ (105)/ Yes/ NR APPLICABLE/ RESOLVED

COVID-19/ 2021-01-01 No NONE
COVID-19 (129)

FDA-CBER-2022-908-0002931
969
Listing 16.2.7.13
Safety Set


Cyst/ (217) MEDICATION,
CYST ON BACK CONCOMITANT
PROCEDURE

infestations/ (67)/ Yes/ NR APPLICABLE/ NOT RESOLVED
Candida infection/ Ongoing No CONCOMITANT
THRUSH MEDICATION

FDA-CBER-2022-908-0002932
970
Listing 16.2.7.13
Safety Set


Scratch/ 2020-09-25 No CONCOMITANT
RIGHT CALF SCRATCHED BY (57) MEDICATION
METAL CONSTRUCTION WIRE

MEDICATION

FDA-CBER-2022-908-0002933
971
Listing 16.2.7.13
Safety Set


MEDICATION

Attention deficit (170)/ Yes/ NR APPLICABLE/ NOT RESOLVED
hyperactivity disorder/ Ongoing No CONCOMITANT
WORSENING OF ADD MEDICATION

FDA-CBER-2022-908-0002934
972
Listing 16.2.7.13
Safety Set


Hypogonadism/ (104)/ Yes/ NR APPLICABLE/ NOT RESOLVED
LOW TESTERONE Ongoing No CONCOMITANT
(HYPOGONADISM) MEDICATION
Reproductive system and 2020-12-15 Yes/ 1 No NR/ NOT NOT RECOVERED/

breast disorders/ (104)/ Yes/ NR APPLICABLE/ NOT RESOLVED
Benign prostatic Ongoing No CONCOMITANT
hyperplasia/ MEDICATION
WORSENING OF BPH

FDA-CBER-2022-908-0002935
973
Listing 16.2.7.13
Safety Set


Erectile dysfunction/ Ongoing No CONCOMITANT
ERECTILE DYSFUNCTION MEDICATION

Toothache/ 2020-10-01 No NONE
TOOTH PAIN, LEFT UPPER (28)
MOLAR

FDA-CBER-2022-908-0002936
974
Listing 16.2.7.13
Safety Set


Toothache/ 2020-10-01 No CONCOMITANT
WORSENING OF TOOTH PAIN, (28) MEDICATION,
LEFT UPPER MOLAR CONCOMITANT
PROCEDURE

Root canal infection/ 2020-10-18 No CONCOMITANT
ORAL INFECTION, DUE TO (45) MEDICATION
PARTIAL ROOT CANAL

FDA-CBER-2022-908-0002937
975
Listing 16.2.7.13
Safety Set


TOOTH PAIN, LEFT UPPER (56) MEDICATION,
MOLAR, DUE TO ROOT CANAL CONCOMITANT
PROCEDURE

Cystocele/ 2020-10-22 No CONCOMITANT
WORSENING OF CYSTOCELE (77) PROCEDURE

FDA-CBER-2022-908-0002938
976
Listing 16.2.7.13
Safety Set


POST OP HYSTERECTOMY (77) MEDICATION
PAIN

Post-traumatic pain/ 2021-01-01 No CONCOMITANT
PAIN IN LEFT HIP DUE TO (120) MEDICATION
FALL

FDA-CBER-2022-908-0002939
977
Listing 16.2.7.13
Safety Set


Dysuria/ 2020-12-18 No CONCOMITANT
WORSENING OF DIFFICULTY (106) PROCEDURE
URINATING

Osteoarthritis/ (53) MEDICATION
OSTEOARTHRITIS RIGHT
KNEE

FDA-CBER-2022-908-0002940
978
Listing 16.2.7.13
Safety Set


Bursitis/ MEDICATION
BURSITIS, LEFT HEEL

Deafness unilateral/ Ongoing No NONE
SLIGHT HEARING LOSS IN
LEFT EAR

FDA-CBER-2022-908-0002941
979
Listing 16.2.7.13
Safety Set


Vitamin D deficiency/ Ongoing No CONCOMITANT
VITAMIN D DEFICIENCY MEDICATION
Skin and subcutaneous 2020-09-01 Yes/ 1 No NR/ NOT NOT RECOVERED/

Dermatitis/ Ongoing No CONCOMITANT
WORSENING OF DERMATITIS MEDICATION
(BACKS OF EARS, ABOVE
EYES, INSIDE OF ELBOWS,
TOP OF LEGS)

FDA-CBER-2022-908-0002942
980
Listing 16.2.7.13
Safety Set


Hypercholesterolaemia/ 2020-12-15 No CONCOMITANT
WORSENING OF (99) MEDICATION
HYPERCHOLESTEROLEMIA

administration site (32)/ Yes/ NR APPLICABLE/ NOT RESOLVED
conditions/ Ongoing No NONE
Cyst/
CYST IN LEFT KNEE

FDA-CBER-2022-908-0002943
981
Listing 16.2.7.13
Safety Set


Hypercholesterolaemia/ Ongoing No NONE
WORSENING OF

HYPERTENSION

FDA-CBER-2022-908-0002944
982
Listing 16.2.7.13
Safety Set



Gonorrhoea/ 2020-09-09 No CONCOMITANT
POSSIBLE GONORRHEA (30) MEDICATION
(NEGATIVE RESULT)

FDA-CBER-2022-908-0002945
983
Listing 16.2.7.13
Safety Set


STROKE 2020-12-11 No 2020-12-13) CONCOMITANT
(93) MEDICATION

DIVERTICULITIS FLARE (11) MEDICATION

FDA-CBER-2022-908-0002946
984
Listing 16.2.7.13
Safety Set


Tendonitis/ MEDICATION
TENDONITIS, LEFT ELBOW

COVID-19/ 2020-09-28 No NONE
COVID-19 (18)

FDA-CBER-2022-908-0002947
985
Listing 16.2.7.13
Safety Set


Uterine polyp/ 2020-12-10 No CONCOMITANT
UTERINE POLYP (91) MEDICATION,
CONCOMITANT
PROCEDURE

BODY ACHES

FDA-CBER-2022-908-0002948
986
Listing 16.2.7.13
Safety Set


MUSCLE ACHES

WORSENING OF RIGHT
SHOULDER PAIN

FDA-CBER-2022-908-0002949
987
Listing 16.2.7.13
Safety Set


RIGHT INDEX FINGER (8) PROCEDURE
LACERATION

Pain/ (114)
RADIATING PAIN FROM
RIGHT THIGH TO CHEST

FDA-CBER-2022-908-0002950
988
Listing 16.2.7.13
Safety Set


Vulvovaginal dryness/ Ongoing No CONCOMITANT
VAGINAL DRYNESS MEDICATION

DENTAL CARIES (86) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002951
989
Listing 16.2.7.13
Safety Set


MEDICATION

DIARRHEA (21)

FDA-CBER-2022-908-0002952
990
Listing 16.2.7.13
Safety Set


Ageusia/ (21)/ Yes/ NR APPLICABLE/ RESOLVED
NEW LOSS OF TASTE 2020-10-10 No NONE
(24)

(24)

FDA-CBER-2022-908-0002953
991
Listing 16.2.7.13
Safety Set


(24)

Dyspnoea/ (24)
SHORTNESS OF BREATH

FDA-CBER-2022-908-0002954
992
Listing 16.2.7.13
Safety Set


Cough/ (25)
COUGH

RIGHT ANKLE SPRAIN (111) MEDICATION

FDA-CBER-2022-908-0002955
993
Listing 16.2.7.13
Safety Set


Blood testosterone (24)/ Yes/ NR APPLICABLE/ NOT RESOLVED
decreased/ Ongoing No CONCOMITANT
LOW TESTOSTERONE MEDICATION

Rash papular/ 2020-09-20 No CONCOMITANT
PAPULAR RASH, FACE, (28) MEDICATION
NON-URTICARIAL

FDA-CBER-2022-908-0002956
994
Listing 16.2.7.13
Safety Set


NASAL CONGESTION

Tooth fracture/ Ongoing No CONCOMITANT
CRACKED CROWN UPPER LEFT MEDICATION
MOLAR SECOND FROM THE
BACK

FDA-CBER-2022-908-0002957
995
Listing 16.2.7.13
Safety Set


(85)

PAIN DUE TO CRACKED (107) MEDICATION
CROWN

FDA-CBER-2022-908-0002958
996
Listing 16.2.7.13
Safety Set



Pneumonia/ Ongoing No CONCOMITANT
PNEUMONIA MEDICATION

FDA-CBER-2022-908-0002959
997
Listing 16.2.7.13
Safety Set


(155)

SORE THROAT

FDA-CBER-2022-908-0002960
998
Listing 16.2.7.13
Safety Set


Ear pain/ 2020-12-20 No CONCOMITANT
LEFT EAR ACHE (88) MEDICATION


FDA-CBER-2022-908-0002961
999
Listing 16.2.7.13
Safety Set


Syphilis/ 2020-12-17 No CONCOMITANT
SYPHILIS (85) MEDICATION


FDA-CBER-2022-908-0002962
1000
Listing 16.2.7.13
Safety Set



ADHD MEDICATION

FDA-CBER-2022-908-0002963
1001
Listing 16.2.7.13
Safety Set


RASH - LEFT SIDE OF (34) MEDICATION
GLUTEUS, NON-URTICARIAL

FDA-CBER-2022-908-0002964
1002
Listing 16.2.7.13
Safety Set


and polyps)/ (69)
situ/
MELANOMA (IN SITU), LEFT
FOREARM

FDA-CBER-2022-908-0002965
1003
Listing 16.2.7.13
Safety Set


ANKLE SPRAIN RIGHT (55) MEDICATION

infection/ (125)
URI

FDA-CBER-2022-908-0002966
1004
Listing 16.2.7.13
Safety Set


Loose tooth/ 2020-09-16 No CONCOMITANT
LOOSE MOLAR (15) PROCEDURE
Injury, poisoning and 2020-11-08 Yes/ 4 Yes/2/3 NR/ NOT RECOVERED/

Gun shot wound/ 2021-03-01 No 2020-11-15) CONCOMITANT
GUNSHOT WOUND, RIGHT (153) MEDICATION
SHOULDER AND SPINE

FDA-CBER-2022-908-0002967
1005
Listing 16.2.7.13
Safety Set


Rib fracture/ Ongoing No CONCOMITANT
COMPOUND FRACTURE, T4 MEDICATION
AND T3 RIBS, SECONDARY
TO GUNSHOT WOUND

Anxiety/ (41)/ Yes/ NR APPLICABLE/ NOT RESOLVED
POST-TRAUMATIC ANXIETY Ongoing No CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0002968
1006
Listing 16.2.7.13
Safety Set


Pneumothorax/ (47) PROCEDURE
BILATERAL LUNG COLLAPSE

Subcutaneous emphysema/ 2020-11-15 No CONCOMITANT
SUBCUTANEOUS EMPHYSEMA (47) MEDICATION
DUE TO GUNSHOT WOUND

FDA-CBER-2022-908-0002969
1007
Listing 16.2.7.13
Safety Set


RASH, BACK AND BUTTOCKS (54) MEDICATION
NON UTICARIAL

Rhinitis/ 2020-12-05 No NONE
CORYZA (67)

FDA-CBER-2022-908-0002970
1008
Listing 16.2.7.13
Safety Set


NAUSEA (47)

NASAL CONGESTION

FDA-CBER-2022-908-0002971
1009
Listing 16.2.7.13
Safety Set


Rhinorrhoea/ (49)
RHINORRHEA

Cough/ (50)
COUGH

FDA-CBER-2022-908-0002972
1010
Listing 16.2.7.13
Safety Set

Respiratory, thoracic 2020-12-02 Yes/ 2 No NR/ DOSE NOT RECOVERING/

and mediastinal (62)/ Yes/ NR CHANGED/ RESOLVING
Cough/ MEDICATION
COUGH

DEHYDRATION, DUE TO (7) MEDICATION
HANGOVER

FDA-CBER-2022-908-0002973
1011
Listing 16.2.7.13
Safety Set


Arrhythmia/ (6)/ Yes/ NR CHANGED/ RESOLVED
WORSENING OF ARRHYTHMIA, 2020-09-22 No NONE
DUE TO HANGOVER (9)

Hangover/ (9) MEDICATION
HANGOVER

FDA-CBER-2022-908-0002974
1012
Listing 16.2.7.13
Safety Set

Nervous system disorders/ 2020-10-13 07:00 Yes/ 1 No NR/ NOT RECOVERED/

Paraesthesia/ (1)/ Yes/ NR APPLICABLE/ RESOLVED
TINGLING, RIGHT SIDE OF 2020-10-14 15:00 No NONE
NECK, SHOULDER (2)


FDA-CBER-2022-908-0002975
1013
Listing 16.2.7.13
Safety Set



WORSENING OF BACK PAIN,
LUMBAR

FDA-CBER-2022-908-0002976
1014
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-12-25 No NONE

Lung cyst/ PROCEDURE
CYST, LEFT LUNG

FDA-CBER-2022-908-0002977
1015
Listing 16.2.7.13
Safety Set


Reproductive system and 2020-10-20 Yes/ 1 No NR/ DOSE NOT NOT RECOVERED/
breast disorders/ (6)/ Yes/ NR CHANGED/ NOT RESOLVED

FDA-CBER-2022-908-0002978
1016
Listing 16.2.7.13
Safety Set



Osteopenia/ MEDICATION
OSTEOPENIA

FDA-CBER-2022-908-0002979
1017
Listing 16.2.7.13
Safety Set



Arthropod sting/ Ongoing No CONCOMITANT
YELLOW JACKET STING MEDICATION

FDA-CBER-2022-908-0002980
1018
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-10-11 No NONE
POSITIVE COVID -19 (17)

Pyrexia/ (90)
FEVER

FDA-CBER-2022-908-0002981
1019
Listing 16.2.7.13
Safety Set


SORE THROAT
bAb: Negative; Dose 1 Date/Time: 29JUL2020:10:17:00; Follow-up Days after 1st Dose: 241; Dose
2 Date/Time: 27AUG2020:09:17:00; Follow-up Days after 2nd Dose: 212
Gastrointestinal 2020-06-16 No/ 4 Yes/3 NR/ NOT RECOVERED/

disorders/ (-43)/ Yes/ (2020-10-21/ NR APPLICABLE/ RESOLVED
Inguinal hernia/ 2020-10-22 No 2020-10-22) CONCOMITANT
WORSENING OF INGUINAL (86) PROCEDURE
HERNIA

FDA-CBER-2022-908-0002982
1020
Listing 16.2.7.13
Safety Set


Breast pain/ 2020-10-22 No 2020-10-22) CONCOMITANT
WORSENING OF BILATERAL (86) PROCEDURE
LARGE PAINFUL BREAST

POSSIBLE COVID INFECTION (69) MEDICATION

FDA-CBER-2022-908-0002983
1021
Listing 16.2.7.13
Safety Set


Acute sinusitis/ 2020-11-09 No CONCOMITANT
ACUTE SINUSITIS (69) MEDICATION

Haematuria/ 2020-08-18 No CONCOMITANT
HEMATURIA (21) MEDICATION

FDA-CBER-2022-908-0002984
1022
Listing 16.2.7.13
Safety Set


Prostatitis/ 2020-08-18 No NONE
PROSTATITIS (21)
Metabolism and nutrition 2020-10-12 Yes/ 2 No NR/ DOSE NOT NOT RECOVERED/
Gout/ Ongoing No CONCOMITANT
GOUT MEDICATION

FDA-CBER-2022-908-0002985
1023
Listing 16.2.7.13
Safety Set

(22) MEDICATION

FDA-CBER-2022-908-0002986
1024
Listing 16.2.7.13
Safety Set


ELEVATED HYPERTENSION 2021-01-15 No CONCOMITANT
(128) MEDICATION

DENTAL INFECTION (128) MEDICATION

FDA-CBER-2022-908-0002987
1025
Listing 16.2.7.13
Safety Set


Carpal tunnel syndrome/ (14)/ Yes/ NR APPLICABLE/ RESOLVED
CARPAL TUNNEL SURGERY 2020-09-23 No CONCOMITANT
LEFT HAND (14) PROCEDURE

Subcutaneous abscess/ 2021-01-01 No CONCOMITANT
RIGHT FACIAL ABSCESS (121) MEDICATION

FDA-CBER-2022-908-0002988
1026
Listing 16.2.7.13
Safety Set



BODY ACHES

FDA-CBER-2022-908-0002989
1027
Listing 16.2.7.13
Safety Set


POSITIVE COVID 19 (102) MEDICATION
INFECTION

Restless legs syndrome/ (58)/ Yes/ NR APPLICABLE/ NOT RESOLVED
WORSENING OF RESTLESS Ongoing No CONCOMITANT
LEG SYNDROME MEDICATION

FDA-CBER-2022-908-0002990
1028
Listing 16.2.7.13
Safety Set


Back pain/ MEDICATION,
BACK PAIN CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0002991
1029
Listing 16.2.7.13
Safety Set


Spinal osteoarthritis/ MEDICATION,
SPONDYLOSIS CONCOMITANT
PROCEDURE

LEFT SIDE OF FACE 2020-10-16 No NONE
TINGLING (23)

FDA-CBER-2022-908-0002992
1030
Listing 16.2.7.13
Safety Set


GASTROINTESTINAL CONCOMITANT
HEMORRHAGE PROCEDURE

CHEST PAIN NON CARDIAC

FDA-CBER-2022-908-0002993
1031
Listing 16.2.7.13
Safety Set


Musculoskeletal pain/ (160)
PAIN TO BACK OF LEFT
SHOULDER

FDA-CBER-2022-908-0002994
1032
Listing 16.2.7.13
Safety Set


Joint swelling/
ENLARGEMENT OF DIP JOINT
4TH DIGIT LEFT HAND

FDA-CBER-2022-908-0002995
1033
Listing 16.2.7.13
Safety Set


Joint swelling/
ENLARGEMENT OF DIP JOINT
4TH DIGIT RIGHT HAND

Mastoiditis/ 2020-08-19 No CONCOMITANT
MASTOIDITIS RIGHT (14) MEDICATION

FDA-CBER-2022-908-0002996
1034
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-08-30 No NONE
COVID 19 INFECTION (24)

Attention deficit (37)/ Yes/ NR APPLICABLE/ RESOLVED WITH
hyperactivity disorder/ 2020-12-15 No CONCOMITANT SEQUELAE:
ATTENTION DEFICIT (99) MEDICATION SUBJECT IS
DISORDER STABLE ON
MEDICATION

FDA-CBER-2022-908-0002997
1035
Listing 16.2.7.13
Safety Set


POTENTIAL COVID-19 (178) MEDICATION
ILLNES

Dyspepsia/ 2020-10-25 No NONE
CHEST PAIN - HEARTBURN (41)

FDA-CBER-2022-908-0002998
1036
Listing 16.2.7.13
Safety Set


Hypoaesthesia/ (40)/ Yes/ NR APPLICABLE/ RESOLVED
LEFT ARM NUMBNESS 2020-10-25 No NONE
(41)

Dyspnoea/ (41)
SHORTNESS OF BREATH

FDA-CBER-2022-908-0002999
1037
Listing 16.2.7.13
Safety Set

Subject ID: US3022180; Age (years): 46; Sex: F; Race: OTHER: ASHKENAZI JEWISH; Height (cm): 162.0; Weight (kg): 78.1; BMI

Radius fracture/ Ongoing No NONE
LEFT BROKEN RADIAL NECK
Investigations/ 2020-10-19 Yes/ 1 No NR/ NOT UNKNOWN

Cardiac murmur/ (27)/ Yes/ NR APPLICABLE/
HEART MURMER Ongoing No NONE

FDA-CBER-2022-908-0003000
1038
Listing 16.2.7.13
Safety Set


Rhinalgia/ (142) MEDICATION
RIGHT NOSTRIL PAIN
Injury, poisoning and 2020-10-11 Yes/ 4 Yes/3 NR/ NOT NOT RECOVERED/
procedural complications/ (18)/ Yes/ (2020-10-11/ NR APPLICABLE/ NOT RESOLVED
Rib fracture/ Ongoing No 2020-10-14) CONCOMITANT
FRACTURE RIBS MEDICATION

FDA-CBER-2022-908-0003001
1039
Listing 16.2.7.13
Safety Set


(18) PROCEDURE

Dehydration/ 2020-10-14 No 2020-10-14) NONE
DEHYDRATION (21)

FDA-CBER-2022-908-0003002
1040
Listing 16.2.7.13
Safety Set


Diarrhoea/ 2020-11-13 No 2020-11-13) CONCOMITANT

Dehydration/ 2020-11-13 No 2020-11-13) NONE
DEHYDRATION (51)

FDA-CBER-2022-908-0003003
1041
Listing 16.2.7.13
Safety Set

Gastrointestinal 2020-12-16 Yes/ 1 No NR/ DOSE NOT NOT RECOVERED/

Colitis microscopic/ Ongoing No CONCOMITANT
LYMPHOCYTIS COLITIS MEDICATION

FDA-CBER-2022-908-0003004
1042
Listing 16.2.7.13
Safety Set


Non-small cell lung
cancer/
NON- SMALL CELL
CARCINOMA OF THE LUNG

FDA-CBER-2022-908-0003005
1043
Listing 16.2.7.13
Safety Set


Tendon rupture/ 2020-12-18 No CONCOMITANT
ANTERIOR TIBIAL TENDON (93) PROCEDURE
RUPTURE
Gastrointestinal / Yes/ 1 No NR/ NOT RECOVERED/

disorders/ 2021-02-10 Yes/ NR APPLICABLE/ RESOLVED
Haematochezia/ (175) No CONCOMITANT
HEMATOCHEZIA PROCEDURE

FDA-CBER-2022-908-0003006
1044
Listing 16.2.7.13
Safety Set



RIGHT ANTERIOR CERVICAL (61)
CHAIN LN

FDA-CBER-2022-908-0003007
1045
Listing 16.2.7.13
Safety Set



FDA-CBER-2022-908-0003008
1046
Listing 16.2.7.13
Safety Set

Blood and lymphatic 2020-12-22 Yes/ 1 No NR/ NOT NOT RECOVERED/

system disorders/ (97)/ Yes/ NR APPLICABLE/ NOT RESOLVED
Lymphadenopathy/ Ongoing No NONE
LEFT ANTERIOR CHAIN
LYMPH NODE, IPSILATERAL
TO LYMPH NODE ON
POSTERIOR CHAIN LYMPH
NODE

FDA-CBER-2022-908-0003009
1047
Listing 16.2.7.13
Safety Set


LEFT POSTERIOR-CHAIN
LYMPH NODE IPSILATERAL
TO LYMPH NODE IN
ANTERIOR CHAIN

Otitis media/ Ongoing No CONCOMITANT
LEFT OTITIS MEDIA MEDICATION

FDA-CBER-2022-908-0003010
1048
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003011
1049
Listing 16.2.7.13
Safety Set


Folliculitis/ 2021-01-14 No CONCOMITANT
SCALP FOLLICULITIS (113) MEDICATION
Blood and lymphatic 2020-10-20 Yes/ 1 No NR/ NOT UNKNOWN

system disorders/ (29)/ Yes/ NR APPLICABLE/
LEFT CERVICAL
LYMPHADENOPATHY

FDA-CBER-2022-908-0003012
1050
Listing 16.2.7.13
Safety Set


TENDINITIS RIGHT WRIST

Ovarian cyst/ 2021-01-08 No NONE
(L) OVARIAN CYST (113)

FDA-CBER-2022-908-0003013
1051
Listing 16.2.7.13
Safety Set

General disorders and 2020-09-24 Yes/ 1 No NR/ DOSE RECOVERED/

administration site (35)/ Yes/ NR DELAYED/ RESOLVED
Fatigue/ (37)
FATIGUE

Pain/ (37)
BODY ACHES

FDA-CBER-2022-908-0003014
1052
Listing 16.2.7.13
Safety Set


Headache/ (35)/ Yes/ NR DELAYED/ RESOLVED
(37) MEDICATION
Respiratory, thoracic 2020-09-24 Yes/ 2 No NR/ DOSE RECOVERED/

and mediastinal (35)/ Yes/ NR DELAYED/ RESOLVED
Cough/ (37)
COUGH

FDA-CBER-2022-908-0003015
1053
Listing 16.2.7.13
Safety Set


Herpes zoster/ Ongoing No CONCOMITANT
HERPES ZOSTER MEDICATION
Respiratory, thoracic 2020-09-25 16:00 Yes/ 1 No NR/ DOSE NOT RECOVERED/

Epistaxis/ (4)
NOSE BLEED

FDA-CBER-2022-908-0003016
1054
Listing 16.2.7.13
Safety Set



PAIN IN FINGERS AND
BILATERAL HANDS

FDA-CBER-2022-908-0003017
1055
Listing 16.2.7.13
Safety Set

Cardiac disorders/ 2020-10-28 Yes/ 1 No NR/ NOT UNKNOWN

Tachycardia/ (31)/ Yes/ NR APPLICABLE/
TACHYCARDIA ASSOCIATED Ongoing No NONE
WITH PSEUDOEPHEDRINE
bAb: Positive; Dose 1 Date/Time: 24AUG2020:10:17:00; Follow-up Days after 1st Dose: 215; Dose

WORSENING OF RIGHT KNEE CONCOMITANT
ARTHRITIS PROCEDURE

FDA-CBER-2022-908-0003018
1056
Listing 16.2.7.13
Safety Set


RIGHT SHOULDER PAIN

Arthropod bite/ 2020-09-10 No NONE
LEFT ANKLE BUG BITE (8)

FDA-CBER-2022-908-0003019
1057
Listing 16.2.7.13
Safety Set


LEFT GROIN STRAIN (37) MEDICATION

Stress fracture/ 2020-10-26 No NONE
LEFT FOOT STRESS (54)
FRACTURE

FDA-CBER-2022-908-0003020
1058
Listing 16.2.7.13
Safety Set


NEPHROLITHIASIS

CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003021
1059
Listing 16.2.7.13
Safety Set


Rhinorrhoea/ MEDICATION
RHINORRHEA

MEDICATION

FDA-CBER-2022-908-0003022
1060
Listing 16.2.7.13
Safety Set


COVID LIKE ILLNESS (71)


FDA-CBER-2022-908-0003023
1061
Listing 16.2.7.13
Safety Set



Myositis/ (104) MEDICATION
RIGHT SHOULDER MUSCLE
INFLAMMATION

FDA-CBER-2022-908-0003024
1062
Listing 16.2.7.13
Safety Set


COVID -19 (93) MEDICATION

STREP THROAT

FDA-CBER-2022-908-0003025
1063
Listing 16.2.7.13
Safety Set



COVID-19/ 2020-11-05 No NONE
COVID-19 (67)

FDA-CBER-2022-908-0003026
1064
Listing 16.2.7.13
Safety Set


MUSCLE SPASMS OF LOWER
BACK

SORE THROAT

FDA-CBER-2022-908-0003027
1065
Listing 16.2.7.13
Safety Set


DENTAL DECAY (182) MEDICATION


FDA-CBER-2022-908-0003028
1066
Listing 16.2.7.13
Safety Set


Constipation/ 2020-10-05 No CONCOMITANT
CONSTIPATION


FDA-CBER-2022-908-0003029
1067
Listing 16.2.7.13
Safety Set


(220) MEDICATION
Infections and 2020-11-05 Yes/ 1 No R/ NOT RECOVERED/

infestations/ (65)/ Yes/ R APPLICABLE/ RESOLVED
COVID-19/ 2020-12-22 No NONE
COVID 19 (112)

FDA-CBER-2022-908-0003030
1068
Listing 16.2.7.13
Safety Set


CELLULITIS OF RIGHT (38) MEDICATION
HALLUX

FDA-CBER-2022-908-0003031
1069
Listing 16.2.7.13
Safety Set


PARTIAL TEAR OF (190) PROCEDURE
TRIANGULAR
FIBROCARTILAGINOUS
COMPLEX

FDA-CBER-2022-908-0003032
1070
Listing 16.2.7.13
Safety Set


Ligament rupture/ 2021-03-11 No CONCOMITANT
TEAR OF THE SCAPHOLUNATE (190) PROCEDURE
LIGAMENT

Tension headache/ (4)/ Yes/ NR CHANGED/ RESOLVED
TENSION HEADACHE 2020-08-25 Yes CONCOMITANT
(21) MEDICATION

FDA-CBER-2022-908-0003033
1071
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003034
1072
Listing 16.2.7.13
Safety Set

Congenital, familial and 2020-08-11 Yes/ 3 Yes/5 NR/ NOT NOT RECOVERED/
genetic disorders/ (7)/ Yes/ NR APPLICABLE/ NOT RESOLVED
Talipes/ Ongoing No NONE
BILATERAL TALIPES
EQUINOVIRUS OF FETUS

COVID-19/ 2020-12-21 No NONE
COVID -19 (104)

FDA-CBER-2022-908-0003035
1073
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION


FDA-CBER-2022-908-0003036
1074
Listing 16.2.7.13
Safety Set

Injury, poisoning and 2021-01-12 00:00 Yes/ 2 No NR/ NOT RECOVERED/

Cartilage injury/ 2021-03-12 00:01 No CONCOMITANT
SUPERIOR GLENOID LABRUM (184) MEDICATION,
LESION OF LEFT SHOULDER CONCOMITANT
PROCEDURE


FDA-CBER-2022-908-0003037
1075
Listing 16.2.7.13
Safety Set


Body tinea/ Ongoing No CONCOMITANT
TINEA CORPORIS MEDICATION

MEDICATION

FDA-CBER-2022-908-0003038
1076
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-09-24 No NONE
COVID-19 (46)

GENERALIZED URTICARIA (46) MEDICATION

FDA-CBER-2022-908-0003039
1077
Listing 16.2.7.13
Safety Set


infestations/ (22)/ Yes/ NA CHANGED/ RESOLVED
infection/ (30)
UPPER RESPIRATORY
INFECTION


FDA-CBER-2022-908-0003040
1078
Listing 16.2.7.13
Safety Set


Hypogonadism/ (99)/ Yes/ NR APPLICABLE/ NOT RESOLVED
HYPOGONADISM Ongoing No CONCOMITANT
MEDICATION

Secondary hypertension/ (116)/ Yes/ NR APPLICABLE/ NOT RESOLVED
HYPERTENSION SECONDARY Ongoing No CONCOMITANT
TO HYPOGONADISM MEDICATION

FDA-CBER-2022-908-0003041
1079
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003042
1080
Listing 16.2.7.13
Safety Set


Metabolic encephalopathy/ (87)/ Yes/ NR APPLICABLE/ RESOLVED
METABOLIC ENCEPHALOPATHY 2020-12-05 No NONE
(89)

DIABETES MELLITUS TYPE 2 (156) MEDICATION

FDA-CBER-2022-908-0003043
1081
Listing 16.2.7.13
Safety Set


Hyperlipidaemia/ 2021-04-06 No CONCOMITANT
HYPERLIPIDEMIA (211) MEDICATION

(211) MEDICATION

FDA-CBER-2022-908-0003044
1082
Listing 16.2.7.13
Safety Set


TOOTH ABCESS (15) MEDICATION,
CONCOMITANT
PROCEDURE

Cholecystitis acute/ (115)/ Yes/ NR APPLICABLE/ RESOLVED
ACUTE CHOLECYSTITIS 2020-12-31 No CONCOMITANT
(115) PROCEDURE

FDA-CBER-2022-908-0003045
1083
Listing 16.2.7.13
Safety Set


CYSTITIS (19) MEDICATION
Infections and 2020-11-09 Yes/ 5 Yes/1 NR/ NOT FATAL


FDA-CBER-2022-908-0003046
1084
Listing 16.2.7.13
Safety Set


Infections and 2021-01-05 Yes/ 1 No NR/ DOSE RECOVERING/

infestations/ (113)/ Yes/ NR DELAYED/ RESOLVING
Tooth abscess/ Ongoing No CONCOMITANT
DENTAL ABSCESS MEDICATION

FDA-CBER-2022-908-0003047
1085
Listing 16.2.7.13
Safety Set

Skin and subcutaneous 2021-02-01 Yes/ 2 No NR/ DOSE RECOVERED/

tissue disorders/ (140)/ Yes/ NR DELAYED/ RESOLVED
URTICARIAL HIVES-FACE (149) MEDICATION
Skin and subcutaneous 2021-02-05 Yes/ 1 No NR/ NOT RECOVERING/

tissue disorders/ (144)/ Yes/ NR APPLICABLE/ RESOLVING
Alopecia/ Ongoing No CONCOMITANT
HAIR LOSS MEDICATION

FDA-CBER-2022-908-0003048
1086
Listing 16.2.7.13
Safety Set


Nephrolithiasis/ 2021-01-26 No NONE
RENAL CALCULI (134)

Muscle strain/ 2021-03-15 No NONE
MUSCLE SPRAIN OF THE (182)
CALF

FDA-CBER-2022-908-0003049
1087
Listing 16.2.7.13
Safety Set


SUSPECTED COVID-19 (73) MEDICATION
Reproductive system and 2020-12-28 Yes/ 1 No NR/ NOT RECOVERING/

breast disorders/ (105)/ Yes/ NR APPLICABLE/ RESOLVING
Dyspareunia/ Ongoing No CONCOMITANT
DYSPAREUNIA PROCEDURE

FDA-CBER-2022-908-0003050
1088
Listing 16.2.7.13
Safety Set


Endometriosis/ Ongoing No CONCOMITANT
WORSENING OF MEDICATION,
ENDOMETRIOSIS CONCOMITANT
PROCEDURE

Uterine polyp/ Ongoing No NONE
UTERINE POLYPS

FDA-CBER-2022-908-0003051
1089
Listing 16.2.7.13
Safety Set


Vaginal haemorrhage/ Ongoing No CONCOMITANT
ABNORMAL VAGINAL PROCEDURE
BLEEDING


FDA-CBER-2022-908-0003052
1090
Listing 16.2.7.13
Safety Set


Seasonal allergy/ (22)/ Yes/ NR CHANGED/ RESOLVED

Postmenopausal 2021-02-01 No CONCOMITANT
POSTMENOPAUSAL VAGINAL
BLEEDING

FDA-CBER-2022-908-0003053
1091
Listing 16.2.7.13
Safety Set


Cervical polyp/ 2020-12-23 No CONCOMITANT
CERVICAL POLYP (97) PROCEDURE

Endometrial cancer/
ENDOMETRIAL CANCER

FDA-CBER-2022-908-0003054
1092
Listing 16.2.7.13
Safety Set


RIGHT LOWER ABSCESS OF (33) MEDICATION,
TOOTH CONCOMITANT
PROCEDURE

WORSENING OF ASTHMA

FDA-CBER-2022-908-0003055
1093
Listing 16.2.7.13
Safety Set



Hypocalcaemia/ Ongoing No CONCOMITANT
HYPOCALCEMIA MEDICATION

FDA-CBER-2022-908-0003056
1094
Listing 16.2.7.13
Safety Set



Pneumonia viral/ 2020-12-17 No NONE
VIRAL PNEUMONIA (87)

FDA-CBER-2022-908-0003057
1095
Listing 16.2.7.13
Safety Set


(87) MEDICATION

second degree/ 2021-01-08 No 2020-12-12) CONCOMITANT
SECOND DEGREE MOBITZ II (109) MEDICATION,
AV BLOCK, INTERMITTENT CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003058
1096
Listing 16.2.7.13
Safety Set


Mitral valve (78)/ Yes/ NR APPLICABLE/ RESOLVED
incompetence/ 2021-01-08 No NONE
MITRAL REGURGITATION (109)


FDA-CBER-2022-908-0003059
1097
Listing 16.2.7.13
Safety Set


Hypercholesterolaemia/ Ongoing No CONCOMITANT
HYPERCHOLESTEROLEMIA MEDICATION

UPPER RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003060
1098
Listing 16.2.7.13
Safety Set


Depression/ (162)/ Yes/ NR APPLICABLE/ RESOLVED
WORSENING OF DEPRESSION 2021-03-02 No NONE
(167)
Immune system disorders/ 2020-10-20 Yes/ 2 No NR/ NOT RECOVERING/

Seasonal allergy/ (29)/ Yes/ NR APPLICABLE/ RESOLVING
WORSENING OF SEASONAL Ongoing No CONCOMITANT
ALLERGIES MEDICATION

FDA-CBER-2022-908-0003061
1099
Listing 16.2.7.13
Safety Set



Tinnitus/ 2021-04-13 No CONCOMITANT
WORSENING OF TINNITUS (208) MEDICATION

FDA-CBER-2022-908-0003062
1100
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003063
1101
Listing 16.2.7.13
Safety Set


PERIODONTAL ABSCESS (72) MEDICATION
BOTTOM RIGHT TOOTH

DENTAL DECAY (102) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003064
1102
Listing 16.2.7.13
Safety Set


Dermatitis contact/ 2020-09-30 No CONCOMITANT
CONTACT DERMATITIS RIGHT (42) MEDICATION
EAR AND CHEEK
Injury, poisoning and 2020-10-15 Yes/ 1 No NOT RECOVERED/

procedural complications/ (22)/ Yes/ APPLICABLE/ RESOLVED
SPRAINED LOWER BACK (25) MEDICATION
MUSCLES TRIMMING TREES

FDA-CBER-2022-908-0003065
1103
Listing 16.2.7.13
Safety Set



COVID-19/ 2020-10-31 No NONE
COVID-19 (37)

FDA-CBER-2022-908-0003066
1104
Listing 16.2.7.13
Safety Set



Dysphagia/ Ongoing No CONCOMITANT
DYSPHAGIA MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003067
1105
Listing 16.2.7.13
Safety Set


Medical device site (21) MEDICATION
inflammation/
INFLAMMATION AROUND BONE
SCREWS IN BACK


FDA-CBER-2022-908-0003068
1106
Listing 16.2.7.13
Safety Set


(33) MEDICATION

Anxiety/ (15)/ Yes/ NR CHANGED/ RESOLVING
MEDICATION

FDA-CBER-2022-908-0003069
1107
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-11-12 No NONE

Hordeolum/ 2020-09-15 No CONCOMITANT
BILATERAL HORDEOLUM (49) MEDICATION

FDA-CBER-2022-908-0003070
1108
Listing 16.2.7.13
Safety Set


Sinus tachycardia/ (16)/ Yes/ NR CHANGED/ RESOLVING
SINUS TACHYCARDIA Ongoing No CONCOMITANT
EXASEBATION MEDICATION
SARS-CoV-2 Nucleocapsid bAb: Negative; Dose 1 Date/Time: 29JUL2020:09:57:00; Follow-up Days after 1st
Dose: 241; Dose 2 Date/Time: 26AUG2020:09:21:00; Follow-up Days after 2nd Dose: 213

DENTAL INFECTION (21) MEDICATION

FDA-CBER-2022-908-0003071
1109
Listing 16.2.7.13
Safety Set


RIGHT KNEE MENISCAL TEAR (114) MEDICATION,
CONCOMITANT
PROCEDURE

Vulvovaginal candidiasis/ 2020-12-20 No CONCOMITANT
VULOVAGINAL CANDIDIASIS (117) MEDICATION

FDA-CBER-2022-908-0003072
1110
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-11-09 No NONE
COVID-19 (70)

COVID-19/ 2020-11-10 No NONE
COVID-19 (76)

FDA-CBER-2022-908-0003073
1111
Listing 16.2.7.13
Safety Set


STREPTOCCAL PHARYNGITIS
Metabolism and nutrition 2020-11-03 Yes/ 1 No NR/ NOT RECOVERING/

BILATERAL LONG FINDER MEDICATION
PIP JOINT GOUT

FDA-CBER-2022-908-0003074
1112
Listing 16.2.7.13
Safety Set


COUGH

Bacterial vaginosis/ Ongoing No CONCOMITANT
BACTERIAL VAGINOSIS MEDICATION

FDA-CBER-2022-908-0003075
1113
Listing 16.2.7.13
Safety Set

Subject ID: US3042047; Age (years): 44; Sex: M; Race: OTHER: LABANESE; Height (cm): 182.9; Weight (kg): 121.8; BMI (kg/m2):


Tachycardia/ (140)/ Yes/ NA APPLICABLE/ RESOLVED
(140)

FDA-CBER-2022-908-0003076
1114
Listing 16.2.7.13
Safety Set


Sinusitis bacterial/ 2020-09-30 No CONCOMITANT
BACTERIAL SINUSITIS (23) MEDICATION

tissue disorders/ (90)/ Yes/ NA APPLICABLE/ NOT RESOLVED
Acne/ Ongoing No CONCOMITANT
GENERALIZED ACNE MEDICATION

FDA-CBER-2022-908-0003077
1115
Listing 16.2.7.13
Safety Set


GENERALIZED ACNE MEDICATION


FDA-CBER-2022-908-0003078
1116
Listing 16.2.7.13
Safety Set


Coeliac disease/ Ongoing No NONE
CELIAC DISEASE

COVID-19/ 2020-11-07 No NONE
COVID-19 (68)

FDA-CBER-2022-908-0003079
1117
Listing 16.2.7.13
Safety Set


disorders/ (108)/ Yes/ NA APPLICABLE/ RESOLVING
Oesophageal spasm/ Ongoing No CONCOMITANT
ESOPHAGEAL SPASMS MEDICATION

MEDICATION

FDA-CBER-2022-908-0003080
1118
Listing 16.2.7.13
Safety Set


Anxiety/ (29)/ Yes/ NA APPLICABLE/ RESOLVED
WORSENING OF ANXIETY 2020-11-01 No CONCOMITANT
(60) MEDICATION


FDA-CBER-2022-908-0003081
1119
Listing 16.2.7.13
Safety Set


INTERMITTENT LOWER BACK
PAIN

COVID-19/ 2020-09-24 No NONE

FDA-CBER-2022-908-0003082
1120
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-12-09 No NONE
POSITIVE

COVID-19/ 2020-12-02 No NONE
COVID-19 ILLNESS (91)

FDA-CBER-2022-908-0003083
1121
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-11-12 No NONE
COVID-19 (71)

Gastrointestinal 2020-12-01 No NONE
inflammation/ (90)
NON-INFECTIOUS
GASTROENTERITIS

FDA-CBER-2022-908-0003084
1122
Listing 16.2.7.13
Safety Set


CHEST PAIN-NON-CARDIAC

LEFT LOWER LOBE (13) MEDICATION
PNEUMONIA

FDA-CBER-2022-908-0003085
1123
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION

COVID-19/ 2020-11-16 No NONE

FDA-CBER-2022-908-0003086
1124
Listing 16.2.7.13
Safety Set


VIRAL SYNDROME OF (45) MEDICATION
UNKNOWN ETIOLOGY

RIGHT GLUTEUS MEDIUM (139) MEDICATION,
MUSCLE TEAR CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003087
1125
Listing 16.2.7.13
Safety Set

Respiratory, thoracic 2020-11-19 Yes/ 1 No NR/ NOT RECOVERING/

and mediastinal (77)/ Yes/ NR APPLICABLE/ RESOLVING
Asthma/ MEDICATION
ASTHMA


FDA-CBER-2022-908-0003088
1126
Listing 16.2.7.13
Safety Set


Hypertension/ (24)/ Yes/ NA CHANGED/ NOT RESOLVED
MEDICATION

WORSENED ANXIETY 2021-02-07 No CONCOMITANT
(153) MEDICATION

FDA-CBER-2022-908-0003089
1127
Listing 16.2.7.13
Safety Set



infestations/ (109)/ Yes/ NA APPLICABLE/ RESOLVING
COVID-19/ Ongoing No NONE
COVID-19

FDA-CBER-2022-908-0003090
1128
Listing 16.2.7.13
Safety Set



RIGHT ELBOW CELLULITIS (88) MEDICATION

FDA-CBER-2022-908-0003091
1129
Listing 16.2.7.13
Safety Set


Foot fracture/ 2020-11-16 No NONE
BROKEN TOE-LEFT FOOT-3RD (68)
TOE IN

Migraine/ (29)/ Yes/ NA APPLICABLE/ RESOLVING
MIGRAINE EXACERBATION Ongoing Yes CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0003092
1130
Listing 16.2.7.13
Safety Set


disease/ MEDICATION
DISEASE


FDA-CBER-2022-908-0003093
1131
Listing 16.2.7.13
Safety Set


WORSENING LEFT SHOULD
PAIN

Tonsillitis/ Ongoing No CONCOMITANT
TONSILITIS MEDICATION

FDA-CBER-2022-908-0003094
1132
Listing 16.2.7.13
Safety Set



Upper respiratory tract Ongoing No CONCOMITANT
infection/ MEDICATION
UPPER RESPIRATORY
ILLNESS

FDA-CBER-2022-908-0003095
1133
Listing 16.2.7.13
Safety Set


Tachycardia/ (104)/ Yes/ NA APPLICABLE/ NOT RESOLVED
TACHYCARDIA Ongoing No CONCOMITANT
MEDICATION


FDA-CBER-2022-908-0003096
1134
Listing 16.2.7.13
Safety Set


VIRAL SYNDROME OF (120) MEDICATION
UNKNOWN ETIOLOGY

Pneumonia/ Ongoing No CONCOMITANT
PNEUMONIA MEDICATION

FDA-CBER-2022-908-0003097
1135
Listing 16.2.7.13
Safety Set


Social circumstances/ 2020-09-22 Yes/ 1 No NR/ NOT RECOVERING/

Menopause/ (12)/ Yes/ NR APPLICABLE/ RESOLVING
PREMENOPAUSE Ongoing No CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0003098
1136
Listing 16.2.7.13
Safety Set


Pneumothorax/ (95) PROCEDURE
RIGHT COLLAPSED LUNG

BACTERIAL SINUSITIS (59) MEDICATION

FDA-CBER-2022-908-0003099
1137
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-10-06 No NONE
COVID-19 (54)

ACUTE BACTERIAL (46) MEDICATION
SINUSITIS

FDA-CBER-2022-908-0003100
1138
Listing 16.2.7.13
Safety Set


SOFT TISSUE INJURY-LEFT (118) MEDICATION
SHOULDER

Arachnoid cyst/ (49)/ Yes/ (2020-11-03/ NR APPLICABLE/ RESOLVED
GROWING/WORSENING OF 2020-11-03 No 2020-11-06) CONCOMITANT
ARACHNOID CYST ON LUMBAR (51) MEDICATION,
SPINE CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003101
1139
Listing 16.2.7.13
Safety Set


Neuralgia/ (51)/ Yes/ NR APPLICABLE/ RESOLVING
BILATERAL LOWER LEG Ongoing No CONCOMITANT
NEURALGIA MEDICATION

connective tissue (120)/ Yes/ NA APPLICABLE/ NOT RESOLVED
Intervertebral disc MEDICATION
protrusion/
HERNIATED L4 DISC

FDA-CBER-2022-908-0003102
1140
Listing 16.2.7.13
Safety Set


(124) PROCEDURE


FDA-CBER-2022-908-0003103
1141
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-11-17 No NONE
COVID-19 (64)


FDA-CBER-2022-908-0003104
1142
Listing 16.2.7.13
Safety Set


Psychiatric disorders/ 2020-11-30 Yes/ 1 No NR/ NOT RECOVERING/

Depression/ (76)/ Yes/ NA APPLICABLE/ RESOLVING
WORSENING DEPRESSION Ongoing No CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0003105
1143
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003106
1144
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-11-08 No NONE
COVID-19 (54)

breast disorders/ (70)/ Yes/ NA APPLICABLE/ RESOLVING

FDA-CBER-2022-908-0003107
1145
Listing 16.2.7.13
Safety Set



COVID-19/ 2020-10-21 No NONE
COVID-19 (36)

FDA-CBER-2022-908-0003108
1146
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-10-21 No NONE
COVID-19 (36)
Psychiatric disorders/ 2021-01-15 Yes/ 1 No NR/ NOT UNKNOWN

Anxiety/ (122)/ Yes/ NA APPLICABLE/
WORSENING ANXIETY Ongoing No CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0003109
1147
Listing 16.2.7.13
Safety Set


Post-traumatic stress (122)/ Yes/ NA APPLICABLE/ RESOLVING
disorder/ Ongoing No CONCOMITANT
WORSENING POST-TRAUMATIC MEDICATION
STRESS DISORDER

FDA-CBER-2022-908-0003110
1148
Listing 16.2.7.13
Safety Set


Intervertebral disc (82)
protrusion/
3 RUPTURED DISCS IN
LUMBAR SPINE

Oral candidiasis/ 2020-10-02 No CONCOMITANT
ORAL CANDIDIASIS (44) MEDICATION

FDA-CBER-2022-908-0003111
1149
Listing 16.2.7.13
Safety Set



Anxiety/ (111)/ Yes/ NA APPLICABLE/ RESOLVED
WORSENING ANXIETY 2021-02-15 No CONCOMITANT
(151) MEDICATION

FDA-CBER-2022-908-0003112
1150
Listing 16.2.7.13
Safety Set



Type 2 diabetes mellitus/ Ongoing No NONE
DIABETES TYPE 2

FDA-CBER-2022-908-0003113
1151
Listing 16.2.7.13
Safety Set

BMI (kg/m2): 61.5; Baseline SARS-CoV-2 Status: ; Baseline RT-PCR: ; Baseline Elecsys SARS-CoV-2 Nucleocapsid bAb: Negative;

ACUTE BACTERIAL (32) MEDICATION
SINUSITIS

Cystitis/ 2020-09-07 No NONE
BLADDER INFECTION (18)

FDA-CBER-2022-908-0003114
1152
Listing 16.2.7.13
Safety Set


VERTIGO MEDICATION

STREP THROAT

FDA-CBER-2022-908-0003115
1153
Listing 16.2.7.13
Safety Set

Vascular disorders/ 2020-10-01 Yes/ 1 No NA/ NOT RECOVERING/

MEDICATION

COVID-19/ 2021-01-27 No NONE
COVID-19 (126)

FDA-CBER-2022-908-0003116
1154
Listing 16.2.7.13
Safety Set


STREPTOCOCCAL
PHYARNGITIS

MEDICATION

FDA-CBER-2022-908-0003117
1155
Listing 16.2.7.13
Safety Set

Infections and 2020-08-21 Yes/ 2 No NA/ NOT RECOVERED/

COVID-19/ 2020-09-02 No NONE
COVID-19 (35)


FDA-CBER-2022-908-0003118
1156
Listing 16.2.7.13
Safety Set


GOUT MEDICATION
Respiratory, thoracic 2020-12-06 Yes/ 3 Yes/2/3 NR/ DOSE NOT RECOVERED/

pulmonary disease/
COPD EXACERBATION

FDA-CBER-2022-908-0003119
1157
Listing 16.2.7.13
Safety Set


TOOTH INFECTION (24) MEDICATION
Ear and labyrinth 2020-09-12 Yes/ 2 No R/ DOSE NOT RECOVERED/

disorders/ (9)/ Yes/ R CHANGED/ RESOLVED
VERTIGO (14)

FDA-CBER-2022-908-0003120
1158
Listing 16.2.7.13
Safety Set

Nervous system disorders/ 2020-10-13 Yes/ 1 No NA/ NOT RECOVERED/

Syncope/ (41)/ Yes/ NA APPLICABLE/ RESOLVED
VASOVAGAL SYNCOPE 2020-10-13 No NONE
(41)
Subject ID: US3052141; Age (years): 29; Sex: F; Race: MULTIPLE: American Indian or Alaska Native, Native Hawaiian or other
Pacific Islander; Height (cm): 165.0; Weight (kg): 105.0; BMI (kg/m2): 38.6; Baseline SARS-CoV-2 Status: ; Baseline RT-PCR:
; Baseline Elecsys SARS-CoV-2 Nucleocapsid bAb: Negative; Dose 1 Date/Time: 07AUG2020:17:40:00;


FDA-CBER-2022-908-0003121
1159
Listing 16.2.7.13
Safety Set


Joint dislocation/ 2020-08-30 No CONCOMITANT
DISLOCATED RIGHT (19) MEDICATION
SHOULDER INJURY
Psychiatric disorders/ 2020-09-20 Yes/ 2 No NR/ NOT UNKNOWN

Attention deficit (39)/ Yes/ NR APPLICABLE/
ADHD MEDICATION

FDA-CBER-2022-908-0003122
1160
Listing 16.2.7.13
Safety Set

Reproductive system and 2021-02-03 Yes/ 2 No NR/ DOSE NOT RECOVERING/

breast disorders/ (115)/ Yes/ NR CHANGED/ RESOLVING
Ovarian cyst/ Ongoing No CONCOMITANT
BILATERAL OVARIAN CYST MEDICATION

FDA-CBER-2022-908-0003123
1161
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-12-21 No NONE SEQUELAE:
COVID-19 (88) PATIENT TESTED
POSITIVE FOR
COVID 19 ON
11-17-2020.
PATIENT WAS
SEEN AT WOMACK
ER WHERE SHE
TESTED
POSITIVE. WE
ARE FOLLOWING
UP WITH
PATIENT AND
SHE SEEMS TO
BE DOING WELL!
RESOLVED 21
DEC 2020

FDA-CBER-2022-908-0003124
1162
Listing 16.2.7.13
Safety Set


Lymphadenitis/ 2020-10-13 No CONCOMITANT
LEFT SIDED LYMPHADENITIS (27) MEDICATION
OF THE SALIVARY GLAND

Thyroid cancer/ CONCOMITANT
THYROID CANCER PROCEDURE

FDA-CBER-2022-908-0003125
1163
Listing 16.2.7.13
Safety Set


RIGHT EAR INFECTION (68) MEDICATION

Ear infection fungal/ 2020-11-27 No CONCOMITANT
RIGHT EAR FUNGAL (72) MEDICATION
INFECTION

FDA-CBER-2022-908-0003126
1164
Listing 16.2.7.13
Safety Set


Horner's syndrome/ (14)/ Yes/ NR APPLICABLE/ RESOLVED
HORNER'S SYNDROME 2020-10-09 No NONE
(26)
Nervous system disorders/ 2020-09-24 14:08 Yes/ 3 Yes/3 NR/ NOT RECOVERED/
SYNCOPE 2020-09-25 10:18 No 2020-09-26) NONE
(2)

FDA-CBER-2022-908-0003127
1165
Listing 16.2.7.13
Safety Set


Subject ID: US3052312; Age (years): 51; Sex: M; Race: AMERICAN INDIAN OR ALASKA NATIVE; Height (cm): ; Weight (kg): ; BMI
(kg/m2): ; Baseline SARS-CoV-2 Status: Negative; Baseline RT-PCR: Negative; Baseline Elecsys SARS-CoV-2 Nucleocapsid bAb:

Sinusitis/ 2020-11-26 No NONE
SINUS INFECTION (63)

FDA-CBER-2022-908-0003128
1166
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-12-18 No 2020-12-18)/4 CONCOMITANT
Blood and lymphatic 2020-12-09 Yes/ 3 Yes/3 NA/ NOT RECOVERED/

system disorders/ (76)/ Yes/ (2020-12-09/ NA APPLICABLE/ RESOLVED
Thrombocytosis/ 2020-12-18 No 2020-12-18) NONE
THROMBOCYTOSIS (85)

FDA-CBER-2022-908-0003129
1167
Listing 16.2.7.13
Safety Set

Infections and 2020-12-09 Yes/ 3 Yes/2/3 NA/ NOT RECOVERED/

infestations/ (76)/ Yes/ (2020-12-09/ NA APPLICABLE/ RESOLVED
BILATERAL PNEUMONIA DUE (85) MEDICATION
TO COVID-19

FDA-CBER-2022-908-0003130
1168
Listing 16.2.7.13
Safety Set

Respiratory, thoracic 2020-12-09 Yes/ 3 Yes/2/3 NA/ NOT RECOVERED/

failure/
ACUTE RESPIRATORY
FAILURE WITH HYPOXIA

Insomnia/ (35)/ Yes/ NR APPLICABLE/ RESOLVED
(138) MEDICATION

FDA-CBER-2022-908-0003131
1169
Listing 16.2.7.13
Safety Set


RIGHT LABRUM TEAR (32) MEDICATION,
CONCOMITANT
PROCEDURE

COVID-19/ 2020-11-13 No NONE
COVID- 19 (43)

FDA-CBER-2022-908-0003132
1170
Listing 16.2.7.13
Safety Set



UPPER RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003133
1171
Listing 16.2.7.13
Safety Set


COVID-19/ 2021-02-12 No NONE
COVID-19 (128)

RIGHT THIGH RASH (148) MEDICATION

FDA-CBER-2022-908-0003134
1172
Listing 16.2.7.13
Safety Set


Abdominal pain lower/ 2020-10-14 No NONE
LOWER ABDOMINAL PAIN (8)

Intervertebral disc (164) PROCEDURE
protrusion/
HERNEATED DISKS

FDA-CBER-2022-908-0003135
1173
Listing 16.2.7.13
Safety Set


VIRAL SYNDROME (28)


FDA-CBER-2022-908-0003136
1174
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003137
1175
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION

Animal bite/ 2020-09-05 No CONCOMITANT
DOG BITE, RIGHT HAND (37) MEDICATION

FDA-CBER-2022-908-0003138
1176
Listing 16.2.7.13
Safety Set


Nasopharyngitis/ 2020-11-14 No CONCOMITANT
COMMON COLD (61) MEDICATION

SARS COV 2 INFECTION (191) MEDICATION

FDA-CBER-2022-908-0003139
1177
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003140
1178
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003141
1179
Listing 16.2.7.13
Safety Set


DENTAL ABSCESS (106) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003142
1180
Listing 16.2.7.13
Safety Set


Tooth abscess/ 2020-12-20 No 2020-12-14) CONCOMITANT
WORSENING OF DENTAL (115) MEDICATION,
ABSCESS CONCOMITANT
PROCEDURE


FDA-CBER-2022-908-0003143
1181
Listing 16.2.7.13
Safety Set


Cellulitis/ 2020-12-14 No NONE
FACIAL CELLULITIS (109)


FDA-CBER-2022-908-0003144
1182
Listing 16.2.7.13
Safety Set


Trismus/ (109)
TRISMUS

infection/ (135)
UPPER RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003145
1183
Listing 16.2.7.13
Safety Set


ABSESS TOOTH (33) MEDICATION

Viral infection/ Ongoing No NONE
VIRAL SYNDORME

FDA-CBER-2022-908-0003146
1184
Listing 16.2.7.13
Safety Set


infection/ (98)
UPPER RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003147
1185
Listing 16.2.7.13
Safety Set


infection/ (140)
UPPER RESPIRATORY
INFECTION

VIRAL SYNDROME (151) MEDICATION

FDA-CBER-2022-908-0003148
1186
Listing 16.2.7.13
Safety Set


Musculoskeletal and 2020-08-04 22:00 Yes/ 1 No NR/ DOSE NOT RECOVERED/

BACK PAIN

FDA-CBER-2022-908-0003149
1187
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-10-01 No NONE
COVID-19 (32)

STREP THROAT

FDA-CBER-2022-908-0003150
1188
Listing 16.2.7.13
Safety Set


Fractured sacrum/ 2021-03-11 No NONE
FRACTURE OF THE SACRUM (192)

Pelvic fracture/ 2021-03-11 No 2021-01-08) CONCOMITANT
FRACTURE OF SUPERIOR RIM (192) MEDICATION,
RIGHT PUBIS CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003151
1189
Listing 16.2.7.13
Safety Set


Pelvic fracture/ 2021-03-11 No NONE
RIGHT INFERIOR PUBIS (192)
FRACTURE

GENERALIZED NAUSEA (119) MEDICATION

FDA-CBER-2022-908-0003152
1190
Listing 16.2.7.13
Safety Set


GENERALIZED PAIN

Splenic calcification/ Ongoing No NONE
CALCIFICATION OF THE
SPLEEN

FDA-CBER-2022-908-0003153
1191
Listing 16.2.7.13
Safety Set


Cardiac steatosis/ (120)/ Yes/ NR APPLICABLE/ NOT RESOLVED
FATTY INFILTRATION OF Ongoing No NONE
RIGHT VENTRICULAR WALL

Kyphosis/
KYPHOSIS

FDA-CBER-2022-908-0003154
1192
Listing 16.2.7.13
Safety Set


Scoliosis/
THORACIC DEXTROSCOLIOSIS

Spinal osteoarthritis/
MULTILEVEL SPONDYLOSIS

FDA-CBER-2022-908-0003155
1193
Listing 16.2.7.13
Safety Set


Atelectasis/
BIBASILAR DEPENDENT
ATELECTASIS

Arteriosclerosis/ (120)/ Yes/ NR APPLICABLE/ NOT RESOLVED
CALCIFICATION AT ORIGINS Ongoing No NONE
OF THE MESENTERIC AND
RENAL ARTERIES.

FDA-CBER-2022-908-0003156
1194
Listing 16.2.7.13
Safety Set


Vascular calcification/ (120)/ Yes/ NR APPLICABLE/ NOT RESOLVED
ATHEROSCLEROTIC VASCULAR Ongoing No NONE
CALCIFICATION

Acute respiratory MEDICATION
failure/
ACUTE RESPIRATORY
FAILURE

FDA-CBER-2022-908-0003157
1195
Listing 16.2.7.13
Safety Set


Cardiomegaly/ (124)/ Yes/ NR APPLICABLE/ NOT RESOLVED
CARDIOMEGALY WITHOUT Ongoing No NONE
ACUTE ABNORMALITY

Total lung capacity (124)/ Yes/ NR APPLICABLE/ NOT RESOLVED
decreased/ Ongoing No NONE
LOW LUNG VOLUME

FDA-CBER-2022-908-0003158
1196
Listing 16.2.7.13
Safety Set


Atelectasis/
BIBASILAR ATELECTASIS

HYPOXIA

FDA-CBER-2022-908-0003159
1197
Listing 16.2.7.13
Safety Set


Atrial enlargement/ (125)/ Yes/ NR APPLICABLE/ NOT RESOLVED
DILATED ATRIUM Ongoing No NONE

Left ventricular (125)/ Yes/ NR APPLICABLE/ NOT RESOLVED
hypertrophy/ Ongoing No NONE
CONCENTRIC LEFT
VENTRICULAR HYPERTROPHY

FDA-CBER-2022-908-0003160
1198
Listing 16.2.7.13
Safety Set


Mitral valve (125)/ Yes/ NR APPLICABLE/ NOT RESOLVED
incompetence/ Ongoing No NONE
MITRAL REGURGITATION

Tricuspid valve (125)/ Yes/ NR APPLICABLE/ NOT RESOLVED
incompetence/ Ongoing No NONE
TRICUSPID REGURGITATION

FDA-CBER-2022-908-0003161
1199
Listing 16.2.7.13
Safety Set


MEDICATION

Oedema peripheral/
BILATERAL LOWER
EXTREMITY EDEMA

FDA-CBER-2022-908-0003162
1200
Listing 16.2.7.13
Safety Set


infection/ (95)
UPPER RESPIRATORY
INFECTION

SORE THROAT

FDA-CBER-2022-908-0003163
1201
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-12-16 No NONE
COVID 19 (104)

Dry skin/ 2020-11-30 No NONE
DRY SKIN, SCALP (84)

FDA-CBER-2022-908-0003164
1202
Listing 16.2.7.13
Safety Set


Coronary artery disease/ (133)/ Yes/ NR APPLICABLE/ NOT RESOLVED
WORSENING CORONARY Ongoing No NONE
ARTERY DISEASE

UPPER RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003165
1203
Listing 16.2.7.13
Safety Set


LOWER BACK PAIN

VIRAL SYNDROME (69)

FDA-CBER-2022-908-0003166
1204
Listing 16.2.7.13
Safety Set


CELLULITIS, RIGHT ROOT (33) MEDICATION

TYPE 2 DIABETES MELLITUS MEDICATION

FDA-CBER-2022-908-0003167
1205
Listing 16.2.7.13
Safety Set


Osteopenia/ MEDICATION
OSTEOPENIA

BLADDER INFECTION (92) MEDICATION

FDA-CBER-2022-908-0003168
1206
Listing 16.2.7.13
Safety Set


NAUSEA, RECURRENT (93) MEDICATION

Post procedural 2020-12-04 No CONCOMITANT
constipation/ (93) MEDICATION
POST OP CONSTIPATION

FDA-CBER-2022-908-0003169
1207
Listing 16.2.7.13
Safety Set


RIGHT KNEE PROCEDURE

POSTOPERATIVE PAIN (121) MEDICATION

FDA-CBER-2022-908-0003170
1208
Listing 16.2.7.13
Safety Set


COVID19 (75) MEDICATION

UPPER RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003171
1209
Listing 16.2.7.13
Safety Set


Arthralgia/ (10)
JOINT ACHES, GENERALIZED

(18)

FDA-CBER-2022-908-0003172
1210
Listing 16.2.7.13
Safety Set


COUGH

NASAL CONGESTION

FDA-CBER-2022-908-0003173
1211
Listing 16.2.7.13
Safety Set


RUNNY NOSE

Fatigue/ (18)
FATIGUE

FDA-CBER-2022-908-0003174
1212
Listing 16.2.7.13
Safety Set


SORE THROAT


FDA-CBER-2022-908-0003175
1213
Listing 16.2.7.13
Safety Set


infection/ (139)
UPPER RESPIRATORY
INFECTION


FDA-CBER-2022-908-0003176
1214
Listing 16.2.7.13
Safety Set


conditions/ Ongoing No CONCOMITANT
Oedema peripheral/ MEDICATION
EDEMA BILATERAL LOWER
EXTREMITIES

FDA-CBER-2022-908-0003177
1215
Listing 16.2.7.13
Safety Set


Prolactin-producing
pituitary tumour/
PROLACTINOMA

COVID-19/ 2021-01-19 No NONE
COVID 19 (137)

FDA-CBER-2022-908-0003178
1216
Listing 16.2.7.13
Safety Set


Prostate cancer/
PROSTATE CANCER


FDA-CBER-2022-908-0003179
1217
Listing 16.2.7.13
Safety Set



POST OPERATIVE PAIN MEDICATION
GENERALIZED

FDA-CBER-2022-908-0003180
1218
Listing 16.2.7.13
Safety Set



Influenza/ 2020-10-25 No CONCOMITANT
INFLUENZA A (45) MEDICATION

FDA-CBER-2022-908-0003181
1219
Listing 16.2.7.13
Safety Set


infection/ (26)
UPPER RESPIRATORY
INFECTION


FDA-CBER-2022-908-0003182
1220
Listing 16.2.7.13
Safety Set


disease/ MEDICATION
DISORDER

SARS COV 2 INFECTION (126) MEDICATION

FDA-CBER-2022-908-0003183
1221
Listing 16.2.7.13
Safety Set


SORE THROAT

PUNCTURE WOUND LEFT HAND (24) MEDICATION

FDA-CBER-2022-908-0003184
1222
Listing 16.2.7.13
Safety Set


infection/ (45)
UPPER RESPIRATORY
INFECTION

MEDICATION

FDA-CBER-2022-908-0003185
1223
Listing 16.2.7.13
Safety Set


Nasal septum deviation/ (163) PROCEDURE
DEVIATED SEPTUM

RIGHT HIP OSTEOARTHRITIS

FDA-CBER-2022-908-0003186
1224
Listing 16.2.7.13
Safety Set


Respiratory tract 2020-10-21 No NONE
infection viral/ (40)
VIRAL RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003187
1225
Listing 16.2.7.13
Safety Set


BACK PAIN

UPPER RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003188
1226
Listing 16.2.7.13
Safety Set



UPPER RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003189
1227
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION

Erectile dysfunction/ 2021-03-11 No CONCOMITANT
ERECTILE DYSFUNCTION (181) MEDICATION

FDA-CBER-2022-908-0003190
1228
Listing 16.2.7.13
Safety Set



Viral infection/ Ongoing No NONE
VIRAL SYNDORME

FDA-CBER-2022-908-0003191
1229
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003192
1230
Listing 16.2.7.13
Safety Set


infection/ (106)
UPPER RESPIRATORY
INFECTION


FDA-CBER-2022-908-0003193
1231
Listing 16.2.7.13
Safety Set

Respiratory, thoracic 2021-01-13 Yes/ 1 No NR/ NOT UNKNOWN

and mediastinal (96)/ Yes/ NR APPLICABLE/
Asthma/ MEDICATION
ASTHMA
Infections and 2020-10-07 12:00 Yes/ 2 No NR/ NOT RECOVERED/

Respiratory tract 2020-10-23 10:00 No CONCOMITANT
infection viral/ (17) MEDICATION
VIRAL RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003194
1232
Listing 16.2.7.13
Safety Set


infection/ (68)
UPPER RESPIRATORY
INFECTION


FDA-CBER-2022-908-0003195
1233
Listing 16.2.7.13
Safety Set


WORSENING OF SINUSITIS (37) MEDICATION

Otitis media/ 2020-11-27 No CONCOMITANT
OTITIS MEDIA (79) MEDICATION

FDA-CBER-2022-908-0003196
1234
Listing 16.2.7.13
Safety Set


BACK PAIN


FDA-CBER-2022-908-0003197
1235
Listing 16.2.7.13
Safety Set


Restless legs syndrome/ (14)/ Yes/ NR APPLICABLE/ RESOLVED
RESTLESS LEG SYNDROME 2021-01-12 No NONE
(127)


FDA-CBER-2022-908-0003198
1236
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003199
1237
Listing 16.2.7.13
Safety Set



COUGH

FDA-CBER-2022-908-0003200
1238
Listing 16.2.7.13
Safety Set


NASAL CONGESTION

BACK SPRAIN (24) MEDICATION

FDA-CBER-2022-908-0003201
1239
Listing 16.2.7.13
Safety Set



COVID-19/ 2021-01-20 No NONE
COVID-19 (128)

FDA-CBER-2022-908-0003202
1240
Listing 16.2.7.13
Safety Set


Malignant melanoma/
MELANOMA ON RIGHT CALF

Colitis/ Ongoing No CONCOMITANT
DIARRHEA (COLITIS) MEDICATION

FDA-CBER-2022-908-0003203
1241
Listing 16.2.7.13
Safety Set


BRUISED BIG TOE ON RIGHT (85) MEDICATION
FOOT

ATTENTION DEFICIT MEDICATION
HYPERACTIVITY DISORDER

FDA-CBER-2022-908-0003204
1242
Listing 16.2.7.13
Safety Set


Depression/ (30)/ Yes/ NR CHANGED/ RESOLVING
MEDICATION

MEDICATION

FDA-CBER-2022-908-0003205
1243
Listing 16.2.7.13
Safety Set


INSOMNIA Ongoing No CONCOMITANT
MEDICATION

Hot flush/ (18)/ Yes/ NR CHANGED/ RESOLVED
HOT FLASHES 2020-09-27 No NONE
(35)

FDA-CBER-2022-908-0003206
1244
Listing 16.2.7.13
Safety Set


disorders/ (32)/ Yes/ NR DELAYED/ NOT RESOLVED
Abnormal loss of weight/ Ongoing No NONE
WEIGHT LOSS
(UNEXPLAINED)

Cough/ (28)
COUGH

FDA-CBER-2022-908-0003207
1245
Listing 16.2.7.13
Safety Set


BACK PAIN

OSTEOARTHRITIS [BOTH
KNEES]

FDA-CBER-2022-908-0003208
1246
Listing 16.2.7.13
Safety Set


Bronchitis bacterial/ Ongoing No CONCOMITANT
BACTERIAL BRONCHITIS MEDICATION

Hordeolum/ Ongoing No CONCOMITANT
STYE ON LEFT EYE LID MEDICATION

FDA-CBER-2022-908-0003209
1247
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003210
1248
Listing 16.2.7.13
Safety Set


Back pain/ (52)
WORSENING OF LOWER BACK
PAIN

Vitreous floaters/ (99)/ Yes/ NR APPLICABLE/ NOT RESOLVED
EYE FLOATERS (LEFT EYE) Ongoing No NONE

FDA-CBER-2022-908-0003211
1249
Listing 16.2.7.13
Safety Set


BASAL CELL-RIGHT
FOREARM/UPPER ARM

FDA-CBER-2022-908-0003212
1250
Listing 16.2.7.13
Safety Set


RIGHT WRIST PAIN

Pain in extremity/ (57) MEDICATION
RIGHT HAND PAIN

FDA-CBER-2022-908-0003213
1251
Listing 16.2.7.13
Safety Set


ACNE MEDICATION

HYPERTENSION DIAGNOSIS Ongoing No CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0003214
1252
Listing 16.2.7.13
Safety Set


carcinoma/
STAGE 1A, T1C, PN0, M0,
HER2 POSITIVE, ESTROGEN
NEGATIVE, INVASIVE
DUCTAL CARCINOMA OF THE
LEFT BREAST

FDA-CBER-2022-908-0003215
1253
Listing 16.2.7.13
Safety Set


Sinus congestion/ (113) MEDICATION
SINUS CONGESTION

Back injury/ 2020-10-13 No NONE
HURT BACK (14)

FDA-CBER-2022-908-0003216
1254
Listing 16.2.7.13
Safety Set


DIAGNOSIS OF MEDICATION

DIAGNOSIS OF Ongoing No CONCOMITANT

FDA-CBER-2022-908-0003217
1255
Listing 16.2.7.13
Safety Set


NASAL CONGETION

Rhinorrhoea/ (97)
RHINORRHEA

FDA-CBER-2022-908-0003218
1256
Listing 16.2.7.13
Safety Set


NAUSEA (92)

DIARRHEA (94)

FDA-CBER-2022-908-0003219
1257
Listing 16.2.7.13
Safety Set


NAUSEA (94)


FDA-CBER-2022-908-0003220
1258
Listing 16.2.7.13
Safety Set


Hordeolum/ 2020-09-09 00:00 No CONCOMITANT
WORSENING OF STYE (RIGHT (8) MEDICATION
EYE)

NAUSEA R/T KIDNEY STONES (47) MEDICATION

FDA-CBER-2022-908-0003221
1259
Listing 16.2.7.13
Safety Set


KIDNEY STONES (47) MEDICATION

PINK EYE (78) MEDICATION

FDA-CBER-2022-908-0003222
1260
Listing 16.2.7.13
Safety Set


Trigeminal neuralgia/ (108)/ Yes/ NR APPLICABLE/ NOT RESOLVED
TRIGEMINAL NEURALGIA OF Ongoing No CONCOMITANT
RIGHT SIDE OF FACE MEDICATION

DENTAL ABSCESS (43) MEDICATION

FDA-CBER-2022-908-0003223
1261
Listing 16.2.7.13
Safety Set


ACNE MEDICATION

COVID-19/ 2021-01-04 No NONE
COVID-19 (90)

FDA-CBER-2022-908-0003224
1262
Listing 16.2.7.13
Safety Set


Syncope/ (4)/ Yes/ NR CHANGED/ RESOLVED
PASSED OUT R/T VASOVAGAL 2020-09-07 No NONE
SYNCOPE (4)

[LEFT FOREARM]

FDA-CBER-2022-908-0003225
1263
Listing 16.2.7.13
Safety Set


DIAGNOSIS OF ANXIETY Ongoing No CONCOMITANT
(MILD) MEDICATION

DIAGNOSIS OF DEPRESSION Ongoing No CONCOMITANT
(MILD) MEDICATION

FDA-CBER-2022-908-0003226
1264
Listing 16.2.7.13
Safety Set


Hypothyroidism/ (11)/ Yes/ NR APPLICABLE/ NOT RESOLVED


FDA-CBER-2022-908-0003227
1265
Listing 16.2.7.13
Safety Set



NASAL CONGESTION

FDA-CBER-2022-908-0003228
1266
Listing 16.2.7.13
Safety Set


MILD HEADACHE 2020-11-16 Yes NONE
(34)

SORE THROAT

FDA-CBER-2022-908-0003229
1267
Listing 16.2.7.13
Safety Set


STREPTOCOCCAL
PHARYNGITIS

Periarthritis/ (46) MEDICATION
"FROZEN" SHOULDER

FDA-CBER-2022-908-0003230
1268
Listing 16.2.7.13
Safety Set



FDA-CBER-2022-908-0003231
1269
Listing 16.2.7.13
Safety Set

Subject ID: US3082268; Age (years): 53; Sex: M; Race: MULTIPLE: Asian, Other: FILIPINO; Height (cm): 173.4; Weight (kg):

Cough/ (37)
COUGH (MILD)

HEADACHE (MILD) 2020-12-03 Yes NONE
(38)

FDA-CBER-2022-908-0003232
1270
Listing 16.2.7.13
Safety Set

Subject ID: US3082268; Age (years): 53; Sex: M; Race: MULTIPLE: Asian, Other: FILIPINO; Height (cm): 173.4; Weight (kg):

NASAL CONGESTION (MILD)

Atrial fibrillation/ (12)/ Yes/ NR APPLICABLE/ RESOLVED WITH
NEW ONSET ATRIAL 2020-10-03 No NONE SEQUELAE:
FIBRILLATION (13) PATIENT DIED
FROM
COMPLICATIONS
OF FATAL SAE

FDA-CBER-2022-908-0003233
1271
Listing 16.2.7.13
Safety Set

Gastrointestinal 2020-10-02 Yes/ 5 Yes/1/3 NR/ NOT FATAL

disorders/ (12)/ Yes/ (2020-10-02/ NR APPLICABLE/
Gastric perforation/ 2020-10-03 No 2020-10-03)/4/ CONCOMITANT
INTRA-ABDOMINAL (13) 6 PROCEDURE
PERFORATION

Hyperglycaemia/ 2020-10-03 No NONE
HYPERGLYCEMIA (13)

FDA-CBER-2022-908-0003234
1272
Listing 16.2.7.13
Safety Set


MEDICATION


FDA-CBER-2022-908-0003235
1273
Listing 16.2.7.13
Safety Set


pulmonary disease/
COPD EXACEBRATION
Skin and subcutaneous 2021-01-28 00:00 Yes/ 1 No NR/ NOT RECOVERED/

Dermatitis contact/ 2021-02-02 12:00 No CONCOMITANT
BURNS (CONTACT (154) MEDICATION
DERMATITIS)

FDA-CBER-2022-908-0003236
1274
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003237
1275
Listing 16.2.7.13
Safety Set


ASTHMA EXACERBATION

FDA-CBER-2022-908-0003238
1276
Listing 16.2.7.13
Safety Set


pulmonary disease/
CHRONIC OBSTRUCTIVE
PULMONARY DISEASE
EXACERBATION

FDA-CBER-2022-908-0003239
1277
Listing 16.2.7.13
Safety Set

Respiratory, thoracic / Yes/ 1 No NR/ NOT NOT RECOVERED/

and mediastinal Ongoing Yes/ NR APPLICABLE/ NOT RESOLVED
disorders/ No CONCOMITANT
Chronic obstructive MEDICATION
pulmonary disease/
CHRONIC OBSTRUCTIVE
PULMONARY DISEASE (COPD)

FDA-CBER-2022-908-0003240
1278
Listing 16.2.7.13
Safety Set


pain/
MUSCULOSKELETAL CHEST
PAIN

FDA-CBER-2022-908-0003241
1279
Listing 16.2.7.13
Safety Set


Cough/ (8)
COUGH

pulmonary disease/
COPD EXACERBATION

FDA-CBER-2022-908-0003242
1280
Listing 16.2.7.13
Safety Set


Malignant melanoma/
RIGHT LEG MELANOMA & C2

FRACTURED TOOTH (LOWER (36) MEDICATION
WISDOM)

FDA-CBER-2022-908-0003243
1281
Listing 16.2.7.13
Safety Set


COVID-19 LIKE SYMPTOMS (48) MEDICATION

COVID-19/ 2020-11-27 No NONE
COVID-19 (81)

FDA-CBER-2022-908-0003244
1282
Listing 16.2.7.13
Safety Set

Vascular disorders/ 2020-09-21 Yes/ 1 No NA/ NOT RECOVERING/

Hypertension/ (14)/ Yes/ NA APPLICABLE/ RESOLVING
MEDICATION

COVID-19/ 2021-01-25 No NONE
COVID-19 (140)

FDA-CBER-2022-908-0003245
1283
Listing 16.2.7.13
Safety Set


LOW BACK PAIN/MUSCLE
SPASMS

SINUS INFECTION MEDICATION

FDA-CBER-2022-908-0003246
1284
Listing 16.2.7.13
Safety Set


Iron deficiency/ Ongoing No CONCOMITANT
IRON DEFICIENCY MEDICATION


FDA-CBER-2022-908-0003247
1285
Listing 16.2.7.13
Safety Set


MEDICATION

Hypertension/ (52)/ Yes/ NA APPLICABLE/ RESOLVED
(52) MEDICATION

FDA-CBER-2022-908-0003248
1286
Listing 16.2.7.13
Safety Set


UPPER GUM INFECTION ON (22) PROCEDURE
LEFT SIDE

Hypercholesterolaemia/ Ongoing No NONE

FDA-CBER-2022-908-0003249
1287
Listing 16.2.7.13
Safety Set



Intussusception/ 2020-12-22 No CONCOMITANT
INTUSSUSCEPTION OF (102) MEDICATION,
JEJUNUM CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003250
1288
Listing 16.2.7.13
Safety Set


NAUSEA SECONDARY TO (116) MEDICATION
INTUSSUSCEPTION OF
JEJUNUM


FDA-CBER-2022-908-0003251
1289
Listing 16.2.7.13
Safety Set


MEDICATION

Hypoaesthesia/ (42)/ Yes/ NR APPLICABLE/ RESOLVED
NUMBNESS ON LEFT HAND 2021-03-04 No CONCOMITANT
RING FINGER AND PINKY (177) MEDICATION
FINGER

FDA-CBER-2022-908-0003252
1290
Listing 16.2.7.13
Safety Set


TINGLING ON LEFT HAND 2021-03-04 No CONCOMITANT
RING FINGER AND PINKY (177) MEDICATION
FINGER


FDA-CBER-2022-908-0003253
1291
Listing 16.2.7.13
Safety Set


LEFT HAND ANTERIOR (62) MEDICATION
LACERATION

LEFT BREAST MASS PROCEDURE

FDA-CBER-2022-908-0003254
1292
Listing 16.2.7.13
Safety Set



PULLED RIGHT MUSCLE (27)
BREAST TISSUE

FDA-CBER-2022-908-0003255
1293
Listing 16.2.7.13
Safety Set


CONFIRMED COVID-19 (120) MEDICATION
POSITIVE

LEFT BROKEN ANKLE (81) MEDICATION

FDA-CBER-2022-908-0003256
1294
Listing 16.2.7.13
Safety Set


Migraine/ (87)/ Yes/ NR APPLICABLE/ RESOLVED
MIGRAINES 2021-01-23 Yes CONCOMITANT
(89) MEDICATION

Gingival recession/ 2020-11-10 No CONCOMITANT
WORSENING OF GUM (54) MEDICATION,
RECESSION CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003257
1295
Listing 16.2.7.13
Safety Set


WORSENING MILD MEDICATION
INTERMITTENT ACNE
Metabolism and nutrition 2020-12-17 Yes/ 1 No NA/ NOT RECOVERING/


FDA-CBER-2022-908-0003258
1296
Listing 16.2.7.13
Safety Set


COLD LIKE SYMPTOMS (45) MEDICATION


FDA-CBER-2022-908-0003259
1297
Listing 16.2.7.13
Safety Set

Infections and 2020-11-27 Yes/ 1 No NA/ NOT RECOVERED/



FDA-CBER-2022-908-0003260
1298
Listing 16.2.7.13
Safety Set


Toothache/ Ongoing No CONCOMITANT
BILATERAL TEETH (WISDOM) MEDICATION
PAIN

MEDICATION

FDA-CBER-2022-908-0003261
1299
Listing 16.2.7.13
Safety Set


COVID LIKE SYMPTOMS (118) MEDICATION

COVID-19 LIKE-ILLNESS (72)

FDA-CBER-2022-908-0003262
1300
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003263
1301
Listing 16.2.7.13
Safety Set


COLITIS (INTERMITTENT (156) MEDICATION
FLARE UPS)


FDA-CBER-2022-908-0003264
1302
Listing 16.2.7.13
Safety Set


Foot deformity/ (36) PROCEDURE
RIGHT FLAT FOOT


FDA-CBER-2022-908-0003265
1303
Listing 16.2.7.13
Safety Set


Gingival disorder/ Ongoing No CONCOMITANT
GUM DISEASE MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003266
1304
Listing 16.2.7.13
Safety Set


TOOTH PAIN RIGHT SIDE (114) MEDICATION,
CONCOMITANT
PROCEDURE

Gastroenteritis viral/ 2020-09-30 No NONE
VIRAL GASTROENTERITIS (36)

FDA-CBER-2022-908-0003267
1305
Listing 16.2.7.13
Safety Set


Allergic sinusitis/ (149) MEDICATION
SEASONAL
ALLERGIES/SINUSITIS

FDA-CBER-2022-908-0003268
1306
Listing 16.2.7.13
Safety Set


Post-traumatic pain/ Ongoing No CONCOMITANT
MULTIPLE TRAUMAS DUE TO MEDICATION
MOTOR VEHICLE ACCIDENT
(LEFT SHOULDER, LEFT
NECK AND LEFT ANKLE
PAIN)

FDA-CBER-2022-908-0003269
1307
Listing 16.2.7.13
Safety Set



Post-traumatic pain/ 2020-11-25 No 2020-11-25) CONCOMITANT
CHEST PAIN TRAUMATIC DUE (58) MEDICATION
TO MOTOR VEHICLE
ACCIDENT

FDA-CBER-2022-908-0003270
1308
Listing 16.2.7.13
Safety Set


Hypertonic bladder/ Ongoing No CONCOMITANT
WORSENING OVERACTIVE MEDICATION
BLADDER


FDA-CBER-2022-908-0003271
1309
Listing 16.2.7.13
Safety Set


NOSE

FDA-CBER-2022-908-0003272
1310
Listing 16.2.7.13
Safety Set


POST SURGICAL (MOHS) (31) MEDICATION
PAIN

KIDNEY STONES (114) PROCEDURE

FDA-CBER-2022-908-0003273
1311
Listing 16.2.7.13
Safety Set

Metabolism and nutrition 2020-12-21 Yes/ 1 No NR/ NOT UNKNOWN



FDA-CBER-2022-908-0003274
1312
Listing 16.2.7.13
Safety Set

Musculoskeletal and 2020-10-05 20:00 Yes/ 1 No NR/ NOT RECOVERED/

LEFT ARM PAIN

Glucose tolerance Ongoing No NONE
impaired/
PRE-DIABETES

FDA-CBER-2022-908-0003275
1313
Listing 16.2.7.13
Safety Set



ACTINIC KERATOSES (RASH- (46) MEDICATION
FACE)

FDA-CBER-2022-908-0003276
1314
Listing 16.2.7.13
Safety Set


ACTINIC KERATOSES (46) MEDICATION
(RASH-THIGHS)
Subject ID: US3102001; Age (years): 36; Sex: M; Race: OTHER: ARABIC; Height (cm): 172.7; Weight (kg): 58.4; BMI (kg/m2):
Negative; Dose 1 Date/Time: 27JUL2020:15:36:00; Follow-up Days after 1st Dose: 243; Dose 2
Immune system disorders/ 2020-10-01 Yes/ 2 No NR/ NOT NOT RECOVERED/

Seasonal allergy/ (42)/ Yes/ NR APPLICABLE/ NOT RESOLVED
SEASONAL ALLERGIES Ongoing No CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0003277
1315
Listing 16.2.7.13
Safety Set


Arrhythmia/ (56)/ Yes/ (2020-12-16/ NR APPLICABLE/ RESOLVED
ARRHYTHMIA (UNKNOWN 2020-12-23 No 2020-12-23) CONCOMITANT
TYPE, WORSENING) (121) MEDICATION,
CONCOMITANT
PROCEDURE

(109)

FDA-CBER-2022-908-0003278
1316
Listing 16.2.7.13
Safety Set


Throat irritation/ (109)
ITCHY THROAT


FDA-CBER-2022-908-0003279
1317
Listing 16.2.7.13
Safety Set


Eczema/ Ongoing No CONCOMITANT
WORSENING OF ECZEMA MEDICATION
BILATERAL HANDS

STREP THROAT

FDA-CBER-2022-908-0003280
1318
Listing 16.2.7.13
Safety Set


MEDICATION

SORE THROAT

FDA-CBER-2022-908-0003281
1319
Listing 16.2.7.13
Safety Set


TOOTH ABCESS (27) MEDICATION


FDA-CBER-2022-908-0003282
1320
Listing 16.2.7.13
Safety Set


COVID-19/ 2021-01-05 No NONE
COVID-19 (105)

Asthenia/ (53)
WEAKNESS

FDA-CBER-2022-908-0003283
1321
Listing 16.2.7.13
Safety Set


Fatigue/ (56)
FATIGUE

BODY ACHES - ALL JOINTS

FDA-CBER-2022-908-0003284
1322
Listing 16.2.7.13
Safety Set



DIARRHEA (54)

FDA-CBER-2022-908-0003285
1323
Listing 16.2.7.13
Safety Set


(53) MEDICATION

(53)

FDA-CBER-2022-908-0003286
1324
Listing 16.2.7.13
Safety Set


TINGLING IN BILATERAL 2020-11-14 No NONE
HANDS AND BILATERAL FEET (53)

VASOVAGAL SYNCOPE 2020-11-14 No NONE
(53)

FDA-CBER-2022-908-0003287
1325
Listing 16.2.7.13
Safety Set


DEHYDRATION SECONDARY TO (56) MEDICATION
DIARRHEA

Electrolyte imbalance/ 2020-11-17 No NONE
ELECTROLYTE ABNORMALITY (56)
SECONDARY TO DIARRHEA

FDA-CBER-2022-908-0003288
1326
Listing 16.2.7.13
Safety Set


Sinus bradycardia/ (53)/ Yes/ NR APPLICABLE/ RESOLVED
SINUS BRADYCARDIA 2020-11-18 No CONCOMITANT
(57) PROCEDURE

Hypotension/ (53)/ Yes/ NR APPLICABLE/ RESOLVED
LOW BLOOD PRESSURE 2020-11-18 No CONCOMITANT
(57) PROCEDURE

FDA-CBER-2022-908-0003289
1327
Listing 16.2.7.13
Safety Set


Sinus arrest/ (54)/ Yes/ NR APPLICABLE/ NOT RESOLVED
SINUS PAUSE Ongoing No NONE
Subject ID: US3102285; Age (years): 49; Sex: F; Race: NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER; Height (cm): 144.7; Weight

MEDICATION

FDA-CBER-2022-908-0003290
1328
Listing 16.2.7.13
Safety Set



SWOLLEN GLANDS

FDA-CBER-2022-908-0003291
1329
Listing 16.2.7.13
Safety Set


Aortic aneurysm/ (19)/ Yes/ NR APPLICABLE/ NOT RESOLVED
AORTIC ANEURYSM Ongoing No NONE

MEDICATION

Stress/ (4)/ Yes/ NR CHANGED/ NOT RESOLVED
STRESS Ongoing No NONE

FDA-CBER-2022-908-0003292
1330
Listing 16.2.7.13
Safety Set


Insomnia/ (19)/ Yes/ NR CHANGED/ RESOLVED
INSOMNIA (WORSENING) 2020-09-30 No CONCOMITANT
(27) MEDICATION

HEADACHE MILD 2020-12-25 Yes CONCOMITANT
(71) MEDICATION

FDA-CBER-2022-908-0003293
1331
Listing 16.2.7.13
Safety Set


BODY ACHES MILD

RUNNY NOSE

FDA-CBER-2022-908-0003294
1332
Listing 16.2.7.13
Safety Set


Asthma/ MEDICATION
ASTHMATIC BRONCHITIS

disease/ MEDICATION
ACID REFLUX

FDA-CBER-2022-908-0003295
1333
Listing 16.2.7.13
Safety Set


DIARRHEA (18)


FDA-CBER-2022-908-0003296
1334
Listing 16.2.7.13
Safety Set


Haematuria/ 2020-10-15 No NONE
MICRO HEMATURIA (35)

Folliculitis/ Ongoing No CONCOMITANT
FOLLICULITIS, ARMPIT MEDICATION

FDA-CBER-2022-908-0003297
1335
Listing 16.2.7.13
Safety Set


COVID-19/ 2021-01-04 No NONE
COVID-19 (83)


FDA-CBER-2022-908-0003298
1336
Listing 16.2.7.13
Safety Set


Nerve compression/ (61)/ Yes/ (2020-10-26/ NR APPLICABLE/ RESOLVED WITH
PINCHED NERVE SECONDARY 2020-10-28 No 2020-10-30) CONCOMITANT SEQUELAE:
TO SURGICAL COMPLICATION (63) MEDICATION, DIMINISHED
CONCOMITANT BILATERAL GRIP
PROCEDURE STRENGTH

Rhinitis/ 2020-10-30 No CONCOMITANT
RHINITIS DUE TO (65) MEDICATION
INFECTIVE

FDA-CBER-2022-908-0003299
1337
Listing 16.2.7.13
Safety Set


COVID-19 DIAGNOSIS (75) MEDICATION


FDA-CBER-2022-908-0003300
1338
Listing 16.2.7.13
Safety Set


VIRAL SYNDROME (17)

FDA-CBER-2022-908-0003301
1339
Listing 16.2.7.13
Safety Set


of skin/
LEFT FOREARM SQUAMOUS
CELL CARCINOMA

FDA-CBER-2022-908-0003302
1340
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003303
1341
Listing 16.2.7.13
Safety Set


BASAL CELL CARCINOMA
LEFT SHOULDER

FDA-CBER-2022-908-0003304
1342
Listing 16.2.7.13
Safety Set


Cyst/ (59) PROCEDURE
RIGHT INDEX FINGER CYST

UPPER ABDOMINAL PAIN (81) MEDICATION

FDA-CBER-2022-908-0003305
1343
Listing 16.2.7.13
Safety Set


Muscle strain/ Ongoing No CONCOMITANT
L TRAPEZIUS MUSCLE MEDICATION
STRAIN

Cholelithiasis/ (27)/ Yes/ NR APPLICABLE/ RESOLVED
(240) PROCEDURE

FDA-CBER-2022-908-0003306
1344
Listing 16.2.7.13
Safety Set


and polyps)/ (38)
Benign breast neoplasm/
BENIGN RIGHT BREAST
NODULE

FDA-CBER-2022-908-0003307
1345
Listing 16.2.7.13
Safety Set


Myalgia/ (10)
MUSCLE ACHE

Arthralgia/ (12)
GENERALIZED JOINT ACHES

FDA-CBER-2022-908-0003308
1346
Listing 16.2.7.13
Safety Set


Fatigue/ (14)
FATIGUE

Lymphadenopathy/ 2020-08-19 No CONCOMITANT
BILATERAL AXILLARY (13) MEDICATION
LYMPHADENOPATHY

FDA-CBER-2022-908-0003309
1347
Listing 16.2.7.13
Safety Set


(17) MEDICATION


FDA-CBER-2022-908-0003310
1348
Listing 16.2.7.13
Safety Set

Musculoskeletal and 2020-11-15 Yes/ 2 No NR/ NOT UNKNOWN

connective tissue (73)/ Yes/ NR APPLICABLE/
INTERMITTENT NECK PAIN
Nervous system disorders/ 2020-11-15 Yes/ 2 No NR/ NOT UNKNOWN

Paraesthesia/ (73)/ Yes/ NR APPLICABLE/
INTERMITTENT RIGHT UPPER Ongoing No CONCOMITANT
EXTREMITY TINGLING MEDICATION

FDA-CBER-2022-908-0003311
1349
Listing 16.2.7.13
Safety Set


WORSENING NON MIGRAINE 2020-11-29 Yes CONCOMITANT
HEADACHE (87) MEDICATION

CHOLECYSTITIS 2021-02-04 No 2021-02-05) CONCOMITANT
(154) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003312
1350
Listing 16.2.7.13
Safety Set

Gastrointestinal 2021-01-04 Yes/ 2 No NR/ NOT UNKNOWN

Abdominal discomfort/ Ongoing No CONCOMITANT
GI DISCOMFORT MEDICATION

UTI (128) MEDICATION

FDA-CBER-2022-908-0003313
1351
Listing 16.2.7.13
Safety Set


COVID-19/ 2021-01-07 No NONE
COVID-19 (121)

FRACTURED LEFT WRIST (108) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003314
1352
Listing 16.2.7.13
Safety Set


Ingrown hair/ 2020-10-06 No CONCOMITANT
LEFT UNDERARM INGROWN (33) MEDICATION
HAIR
Psychiatric disorders/ 2020-10-16 Yes/ 1 No NR/ DOSE NOT UNKNOWN

Attention deficit (43)/ Yes/ NR CHANGED/
hyperactivity disorder/ Ongoing No NONE
ATTENTION DEFICIT
HYPERACTIVITY DISORDER

FDA-CBER-2022-908-0003315
1353
Listing 16.2.7.13
Safety Set


VIRAL ILLNESS (66)

VIRAL ILLNESS (20)

FDA-CBER-2022-908-0003316
1354
Listing 16.2.7.13
Safety Set

Cardiac disorders/ 2020-09-16 Yes/ 4 Yes/2/3 NR/ NOT RECOVERED/

Coronary artery disease/ (9)/ Yes/ (2020-09-18/ NR APPLICABLE/ RESOLVED
SEVERE CORONARY ARTERY 2020-09-24 No 2020-09-24)/6 CONCOMITANT
DISEASE (17) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003317
1355
Listing 16.2.7.13
Safety Set


Pleural effusion/ (25) MEDICATION,
PLEURAL EFFUSION CONCOMITANT
PROCEDURE

PAIN SECONDARY TO SPINAL (43) MEDICATION
FUSION

FDA-CBER-2022-908-0003318
1356
Listing 16.2.7.13
Safety Set


Impaired healing/ (24) MEDICATION
POOR WOUND HEALING

URI

FDA-CBER-2022-908-0003319
1357
Listing 16.2.7.13
Safety Set



LEFT KNEE CONTUSION (37) MEDICATION

FDA-CBER-2022-908-0003320
1358
Listing 16.2.7.13
Safety Set


LEFT SHOULDER CONTUSION (42) MEDICATION

Atrial fibrillation/ (37)/ Yes/ (2020-10-17/ NR APPLICABLE/ RESOLVED
PAROXYSMAL ATRIAL 2020-10-20 No 2020-10-20) CONCOMITANT

FDA-CBER-2022-908-0003321
1359
Listing 16.2.7.13
Safety Set


Atrial fibrillation/ (111)/ Yes/ NR CHANGED/ RESOLVED
WORSENING SYMPTOMS OF 2021-02-23 No CONCOMITANT
ATRIAL FIBRILLATION (166) PROCEDURE
Endocrine disorders/ 2020-09-01 Yes/ 1 No NR/ DOSE NOT NOT RECOVERED/

Hypothyroidism/ (21)/ Yes/ NR CHANGED/ NOT RESOLVED

FDA-CBER-2022-908-0003322
1360
Listing 16.2.7.13
Safety Set


Endometrial cancer/ CONCOMITANT
ENDOMETRIAL CANCER PROCEDURE
Musculoskeletal and / Yes/ 2 No NR/ NOT NOT RECOVERED/

connective tissue Ongoing Yes/ NR APPLICABLE/ NOT RESOLVED
disorders/ Yes CONCOMITANT
LEFT ELBOW PAIN

FDA-CBER-2022-908-0003323
1361
Listing 16.2.7.13
Safety Set



MEDICATION

FDA-CBER-2022-908-0003324
1362
Listing 16.2.7.13
Safety Set



Photophobia/ (110)/ Yes/ NR APPLICABLE/ RESOLVED
SENSITIVITY TO LIGHT 2020-12-29 No NONE
(112)

FDA-CBER-2022-908-0003325
1363
Listing 16.2.7.13
Safety Set



Pharyngitis 2020-09-14 No 2020-09-03) CONCOMITANT
STREP-PHARYNGITIS

FDA-CBER-2022-908-0003326
1364
Listing 16.2.7.13
Safety Set


TOOTH DECAY (139) PROCEDURE

VIRAL SYNDROME (81)

FDA-CBER-2022-908-0003327
1365
Listing 16.2.7.13
Safety Set


Muscle rupture/ Ongoing No CONCOMITANT
RIGHT UPPER ARM MUSCLE MEDICATION
TEAR

Rotator cuff syndrome/ MEDICATION
WORSENING L SHOULDER
TORN ROTATOR CUFF PAIN

FDA-CBER-2022-908-0003328
1366
Listing 16.2.7.13
Safety Set

Musculoskeletal and 2020-11-01 Yes/ 2 No NR/ NOT UNKNOWN

connective tissue (48)/ Yes/ NR APPLICABLE/
WORSENING LEFT SHOULDER
CALCIFIC TENDONITITS

COVID-19/ 2020-09-26 No NONE

FDA-CBER-2022-908-0003329
1367
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-09-17 No NONE

VIRAL SYNDROME (84)

FDA-CBER-2022-908-0003330
1368
Listing 16.2.7.13
Safety Set


BLEEDING FROM SURGICAL (22) MEDICATION
SITE

EXACERBATION OF HTN Ongoing No CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0003331
1369
Listing 16.2.7.13
Safety Set


Skin wound/ 2021-01-08 No CONCOMITANT
RIGHT HAND WOUND (115) MEDICATION

Hand fracture/ 2020-11-29 No CONCOMITANT
RIGHT 5TH METACARPAL (76) PROCEDURE
FRACTURE

FDA-CBER-2022-908-0003332
1370
Listing 16.2.7.13
Safety Set


Burns second degree/ Ongoing No NONE
2ND DEGREE BURN R ARM

Bone contusion/ 2021-01-15 No CONCOMITANT
BRUISED RIBS (120) MEDICATION

FDA-CBER-2022-908-0003333
1371
Listing 16.2.7.13
Safety Set


Hypothyroidism/ (133)/ Yes/ NR CHANGED/ NOT RESOLVED

Atrial fibrillation/ (19)/ Yes/ NR CHANGED/ NOT RESOLVED
MEDICATION

FDA-CBER-2022-908-0003334
1372
Listing 16.2.7.13
Safety Set



Musculoskeletal pain/ (149)
RIGHT SHOULDER PAIN

FDA-CBER-2022-908-0003335
1373
Listing 16.2.7.13
Safety Set


VIRAL SYNDROME (114)

Food poisoning/ 2020-11-22 No CONCOMITANT
FOOD POISONING (63) MEDICATION

FDA-CBER-2022-908-0003336
1374
Listing 16.2.7.13
Safety Set


Contusion/ Ongoing No CONCOMITANT
BRUISED COCCYX MEDICATION

Thoracic vertebral 2020-11-02 No 2020-11-06) CONCOMITANT
fracture/ (43) MEDICATION,
T12 FRACTURE CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003337
1375
Listing 16.2.7.13
Safety Set


CELLULITIS LOWER LEFT (77) MEDICATION
EXTREMITY


FDA-CBER-2022-908-0003338
1376
Listing 16.2.7.13
Safety Set


HYPERTENSION DIAGNOSIS Ongoing No CONCOMITANT
MEDICATION

UNKNOWN CHEST PAIN

FDA-CBER-2022-908-0003339
1377
Listing 16.2.7.13
Safety Set


Sinus tachycardia/ (113)/ Yes/ NR CHANGED/ NOT RESOLVED
SINUS TACHYCARDIA Ongoing No NONE


FDA-CBER-2022-908-0003340
1378
Listing 16.2.7.13
Safety Set



Candida infection/ Ongoing No CONCOMITANT
THRUSH MEDICATION

FDA-CBER-2022-908-0003341
1379
Listing 16.2.7.13
Safety Set


COVID-19/ 2021-01-29 No NONE
SYMPTOMATIC COVID -19 (156)


FDA-CBER-2022-908-0003342
1380
Listing 16.2.7.13
Safety Set


Insomnia/ (73)/ Yes/ NR APPLICABLE/ RESOLVED
(140) MEDICATION

COVID-19/ 2021-01-08 No NONE
COVID-19 (86)

FDA-CBER-2022-908-0003343
1381
Listing 16.2.7.13
Safety Set



VIRAL SYNDROME (44)

FDA-CBER-2022-908-0003344
1382
Listing 16.2.7.13
Safety Set



CHEST PAIN - GENERAL
PAIN AND DISCOMFORT.

FDA-CBER-2022-908-0003345
1383
Listing 16.2.7.13
Safety Set


COVID 19 - SYMPTOMATIC (97) MEDICATION


FDA-CBER-2022-908-0003346
1384
Listing 16.2.7.13
Safety Set


Ligament sprain/ Ongoing No NONE
(L) HAND SPRAIN

COVID POSITIVE MEDICATION

FDA-CBER-2022-908-0003347
1385
Listing 16.2.7.13
Safety Set


COVID-19 SYMPTOMATIC (74) MEDICATION


FDA-CBER-2022-908-0003348
1386
Listing 16.2.7.13
Safety Set



BACK PAIN

FDA-CBER-2022-908-0003349
1387
Listing 16.2.7.13
Safety Set


MEDICATION

Dyspnoea/ MEDICATION
SHORTNESS OF BREATH
(POTENTIALLY ASTHMA)

FDA-CBER-2022-908-0003350
1388
Listing 16.2.7.13
Safety Set


Diverticulitis/ 2021-01-13 No 2021-01-13) NONE
DIVERTICULITIS (141)

Mitral valve thickening/ (108)/ Yes/ NR CHANGED/ RESOLVED
MITRAL VALVE THICKENING 2020-12-15 No NONE
(MILD) (113)

FDA-CBER-2022-908-0003351
1389
Listing 16.2.7.13
Safety Set


Ventricular (108)/ Yes/ NR CHANGED/ RESOLVED
PREMATURE VENTRICULAR (113)
CONTRACTIONS

WORSENING OF DIARRHEA (23) MEDICATION

FDA-CBER-2022-908-0003352
1390
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003353
1391
Listing 16.2.7.13
Safety Set

Vascular disorders/ 2020-09-09 Yes/ 2 No NR/ DOSE NOT UNKNOWN

Hypertension/ (9)/ Yes/ NR CHANGED/
MEDICATION

Heart rate increased/ (21)/ Yes/ NR CHANGED/ RESOLVED
INCREASED HEART RATE 2020-08-27 No NONE
(21)

FDA-CBER-2022-908-0003354
1392
Listing 16.2.7.13
Safety Set

Diabetes mellitus/ Ongoing No CONCOMITANT
WORSENING DIABETES MEDICATION

Candida infection/ 2020-09-22 No CONCOMITANT
THRUSH (13) MEDICATION

FDA-CBER-2022-908-0003355
1393
Listing 16.2.7.13
Safety Set



Blood cholesterol (57)/ Yes/ NR CHANGED/ RESOLVING
increased/ Ongoing No CONCOMITANT
WORSENING HIGH MEDICATION
CHOLESTEROL

FDA-CBER-2022-908-0003356
1394
Listing 16.2.7.13
Safety Set


Anxiety/ (8)/ Yes/ NR CHANGED/ RESOLVING
MEDICATION

Major depression/ (8)/ Yes/ NR CHANGED/ RESOLVING
WORSENING MAJOR Ongoing No CONCOMITANT
DEPRESSIVE DISORDER MEDICATION

FDA-CBER-2022-908-0003357
1395
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-12-03 No NONE

Hiatus hernia/ Ongoing No CONCOMITANT
HIATAL HERNIA MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003358
1396
Listing 16.2.7.13
Safety Set

Ear and labyrinth 2020-09-02 22:00 Yes/ 2 No NR/ DOSE NOT RECOVERED/
Tympanic membrane 2020-09-17 10:00 No CONCOMITANT
perforation/ (16) MEDICATION
RIGHT EAR DRUM
PERFORATION

COVID (85) MEDICATION

FDA-CBER-2022-908-0003359
1397
Listing 16.2.7.13
Safety Set



GINGIVITIS (30) MEDICATION

FDA-CBER-2022-908-0003360
1398
Listing 16.2.7.13
Safety Set



COVID-19/ 2020-12-24 No NONE

FDA-CBER-2022-908-0003361
1399
Listing 16.2.7.13
Safety Set


COVID POSITIVE (94) MEDICATION


FDA-CBER-2022-908-0003362
1400
Listing 16.2.7.13
Safety Set



Spinal osteoarthritis/ (125) MEDICATION, PAIN
EXACERBATION OF CONCOMITANT
DEGENERATIVE JOINT PROCEDURE
DISEASE LUMBAR SPINE

FDA-CBER-2022-908-0003363
1401
Listing 16.2.7.13
Safety Set


Seizure/ (63)/ Yes/ NR DELAYED/ RESOLVED
SEIZURE 2021-02-22 No CONCOMITANT
(109) MEDICATION
Metabolism and nutrition 2020-11-19 08:00 Yes/ 2 No NR/ DOSE NOT RECOVERING/

FDA-CBER-2022-908-0003364
1402
Listing 16.2.7.13
Safety Set

Eye disorders/ 2021-01-01 Yes/ 2 No NR/ DOSE NOT RECOVERING/

Dry eye/ (43)/ Yes/ NR CHANGED/ RESOLVING
DRY EYES Ongoing No CONCOMITANT
MEDICATION

EDEMA BILATEEAL HANDS
AND FEET

FDA-CBER-2022-908-0003365
1403
Listing 16.2.7.13
Safety Set


Basedow's disease/ (29)/ Yes/ NR CHANGED/ RESOLVING
HYPERTHYROID GRAVES Ongoing No NONE
DISEASE

COVID-19/ 2020-11-17 No NONE
COVID-19 (50)

FDA-CBER-2022-908-0003366
1404
Listing 16.2.7.13
Safety Set


Goitre/ (49)/ Yes/ NR CHANGED/ NOT RESOLVED
ENLARGED THYROID Ongoing No NONE

COVID-19/ 2020-12-28 No NONE
POSITIVE COVID-19 (124)
DIAGNOSIS

FDA-CBER-2022-908-0003367
1405
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-12-12 No NONE
COVID-19 (103)

MEDICATION

FDA-CBER-2022-908-0003368
1406
Listing 16.2.7.13
Safety Set


COVID-19/ 2021-01-04 No NONE
COVID-19 (126)


FDA-CBER-2022-908-0003369
1407
Listing 16.2.7.13
Safety Set

Injury, poisoning and 2020-09-10 Yes/ 2 No R/ DOSE NOT RECOVERED/

procedural complications/ (8)/ Yes/ R CHANGED/ RESOLVED
RIGHT BROKEN WRIST (99) MEDICATION,
CONCOMITANT
PROCEDURE

STROKE 2020-11-23 No 2020-11-24) NONE
(76)

FDA-CBER-2022-908-0003370
1408
Listing 16.2.7.13
Safety Set


BILATERAL KNEE PAIN
TYPE II DIABETES MEDICATION

FDA-CBER-2022-908-0003371
1409
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003372
1410
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-12-17 No NONE
COVID-19 (86)

Lipase increased/ (4)/ Yes/ NR CHANGED/ RESOLVED
ELEVATED LIPASE 2020-08-11 No NONE
(16)

FDA-CBER-2022-908-0003373
1411
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003374
1412
Listing 16.2.7.13
Safety Set


Tendon rupture/ Ongoing No NONE
RIGHT HAND TORN TENDONS

(1)

FDA-CBER-2022-908-0003375
1413
Listing 16.2.7.13
Safety Set


Glycosylated haemoglobin (81)/ Yes/ NR CHANGED/ RESOLVED WITH
increased/ 2020-11-30 No NONE SEQUELAE:
ELEVATED HEMOGLOBIN A1C (98) DIAGNOSIS OF
LEVELS TYPE !!
DIABETES
Dyslipidaemia/ Ongoing No NONE
DYSLIPIDEMIA

FDA-CBER-2022-908-0003376
1414
Listing 16.2.7.13
Safety Set

Type 2 diabetes mellitus/ Ongoing No NONE
TYPE II DIABETES

infestations/ (17)/ Yes/ NR WITHDRAWN/ RESOLVED WITH
SYMPTOMATIC COVID-19 (30) MEDICATION COUGH

FDA-CBER-2022-908-0003377
1415
Listing 16.2.7.13
Safety Set


ALLERGIC REACTION POISON (8) MEDICATION
IVY

Trigger finger/ (100) MEDICATION
TRIGGER FINGER LEFT

FDA-CBER-2022-908-0003378
1416
Listing 16.2.7.13
Safety Set


Blood pressure increased/ (29)/ Yes/ NR CHANGED/ NOT RESOLVED
ELEVATED BLOOD PRESSURE Ongoing No CONCOMITANT
MEDICATION
Blood and lymphatic 2020-10-01 Yes/ 2 No NR/ DOSE NOT NOT RECOVERED/
system disorders/ (37)/ Yes/ NR CHANGED/ NOT RESOLVED
Iron deficiency anaemia/ Ongoing No CONCOMITANT
IRON DEFICIENCY ANEMIA MEDICATION

FDA-CBER-2022-908-0003379
1417
Listing 16.2.7.13
Safety Set


Papilloma viral 2020-12-29 No CONCOMITANT
infection/ (126) PROCEDURE
HPV INFECTION

UPPER RESPIRATORY TRACT
INFECTION

FDA-CBER-2022-908-0003380
1418
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION

Dacryostenosis acquired/ (15)/ Yes/ NR CHANGED/ RESOLVED
RIGHT EYE TEAR DUCT 2020-09-24 No CONCOMITANT
OBSTRUCTION (57) PROCEDURE

FDA-CBER-2022-908-0003381
1419
Listing 16.2.7.13
Safety Set


Dacryostenosis acquired/ (15)/ Yes/ NR CHANGED/ RESOLVED
L EYE TEAR DUCT 2020-09-28 No CONCOMITANT
OBSTRUCTION (61) PROCEDURE


FDA-CBER-2022-908-0003382
1420
Listing 16.2.7.13
Safety Set


RIGHT LEG CRAMPS

RIGHT KNEE TENDONITIS

FDA-CBER-2022-908-0003383
1421
Listing 16.2.7.13
Safety Set


Vascular disorders/ 2020-09-02 Yes/ 2 No R/ DOSE NOT NOT RECOVERED/

MEDICATION

FDA-CBER-2022-908-0003384
1422
Listing 16.2.7.13
Safety Set


Osteoarthritis/
OSTEOARTHRITIS BILATERAL
HANDS

FDA-CBER-2022-908-0003385
1423
Listing 16.2.7.13
Safety Set


Osteoarthritis/
OSTEOARTHRITIS- RIGHT
WRIST


FDA-CBER-2022-908-0003386
1424
Listing 16.2.7.13
Safety Set


TENDONITIS 4TH DIGIT
LEFT HAND

SYMPTOMATIC CONFIRMED (104) MEDICATION
COVID-19

FDA-CBER-2022-908-0003387
1425
Listing 16.2.7.13
Safety Set


Arthritis/ MEDICATION
LEFT KNEE ARTHRITIS-
WORSENING


FDA-CBER-2022-908-0003388
1426
Listing 16.2.7.13
Safety Set


COVID-19/ 2021-01-25 No NONE


FDA-CBER-2022-908-0003389
1427
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-12-29 No NONE

Blood pressure increased/ (33)/ Yes/ NR CHANGED/ NOT RESOLVED
INTERMITTENT ELEVATED Ongoing No CONCOMITANT
BLOOD PRESSURE MEDICATION

FDA-CBER-2022-908-0003390
1428
Listing 16.2.7.13
Safety Set

RIGHT SHOULDER POST MEDICATION
OPERATIVE PAIN

SITUATIONAL ECZEMA MEDICATION

FDA-CBER-2022-908-0003391
1429
Listing 16.2.7.13
Safety Set


Rib fracture/ 2021-01-28 No CONCOMITANT
DISPLACED ANTERIOR THIRD (140) MEDICATION
RIB FRACTURE

STERNAL PAIN

FDA-CBER-2022-908-0003392
1430
Listing 16.2.7.13
Safety Set


Sternal fracture/ 2021-03-12 No 2020-11-05) NONE
NON-DISPLACED CLOSED (183)
FRACTURE LOWER STERNUM

ABDOMINAL PAIN (25)

FDA-CBER-2022-908-0003393
1431
Listing 16.2.7.13
Safety Set


NAUSEA (26)


FDA-CBER-2022-908-0003394
1432
Listing 16.2.7.13
Safety Set


Hordeolum/ 2020-11-02 No CONCOMITANT
STYE RIGHT EYE (55) MEDICATION

disease/ MEDICATION
DISORDER

FDA-CBER-2022-908-0003395
1433
Listing 16.2.7.13
Safety Set


STREPTOCOCCAL
PHARYNGITIS

FDA-CBER-2022-908-0003396
1434
Listing 16.2.7.13
Safety Set


GENERALIZED JOINT PAIN,
INTERMITTENT


FDA-CBER-2022-908-0003397
1435
Listing 16.2.7.13
Safety Set


Tachycardia/ (126)/ Yes/ NR APPLICABLE/ RESOLVED
(158)

DECAYED TOOTH #4 (154) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003398
1436
Listing 16.2.7.13
Safety Set


Pelvic pain/ 2020-12-04 No NONE
PELVIC PAIN (82)

Generalised anxiety (27)/ Yes/ NR CHANGED/ NOT RESOLVED
GENERALIZED ANXIETY MEDICATION
DISORDER

FDA-CBER-2022-908-0003399
1437
Listing 16.2.7.13
Safety Set


Blood thyroid (1)/ Yes/ NA CHANGED/ RESOLVED
stimulating hormone 2020-12-16 No NONE
increased/ (94)
ELEVATED TSH

Arthropod bite/ 2020-08-18 No NONE
TICK BITE, LEFT GROIN (5)
AREA

FDA-CBER-2022-908-0003400
1438
Listing 16.2.7.13
Safety Set


Pulmonary embolism/ (36) MEDICATION CONDITION IS
BILATERAL PULMONARY STABLE AND
EMBOLISM ONGOING BUT
PATIENT MUST
TAKE XARELTO
FOR PE
PROPHYLAXIS.

FDA-CBER-2022-908-0003401
1439
Listing 16.2.7.13
Safety Set


Pulmonary infarction/ (36) MEDICATION XARELTO FOR
BILATERAL PULMONARY PROPHYLAXSIS
INFARCTS

MEDICATION

FDA-CBER-2022-908-0003402
1440
Listing 16.2.7.13
Safety Set


ABCESS, TOOTH (20) MEDICATION,
CONCOMITANT
PROCEDURE

NON URTICARIAL RASH TO (21) MEDICATION
TRUNK

FDA-CBER-2022-908-0003403
1441
Listing 16.2.7.13
Safety Set



Dysphagia/ 2020-11-02 No CONCOMITANT
DYSPHAGIA (46) PROCEDURE

FDA-CBER-2022-908-0003404
1442
Listing 16.2.7.13
Safety Set


INSOMNIA Ongoing No CONCOMITANT
MEDICATION

MEDICATION

FDA-CBER-2022-908-0003405
1443
Listing 16.2.7.13
Safety Set


MEDICATION

Bipolar disorder/ (15)/ Yes/ NR CHANGED/ RESOLVED
WORSENING OF BIPOLAR 2020-09-07 No CONCOMITANT

FDA-CBER-2022-908-0003406
1444
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-10-26 No NONE
CONFIRMED COVID-19 (42)
INFECTION

Stress fracture/ 2020-11-17 No NONE
STRESS FRACTURE RIGHT (64)
FOOT

FDA-CBER-2022-908-0003407
1445
Listing 16.2.7.13
Safety Set


SPRAINED LEFT ANKLE (132) MEDICATION
Eye disorders/ 2020-09-22 Yes/ 1 No NR/ DOSE NOT NOT RECOVERED/

Vitreous detachment/ (8)/ Yes/ NR CHANGED/ NOT RESOLVED
RIGHT POSTERIOR VITREOUS Ongoing No NONE
DETACHMENT

FDA-CBER-2022-908-0003408
1446
Listing 16.2.7.13
Safety Set


DENTAL PAIN (129) MEDICATION


FDA-CBER-2022-908-0003409
1447
Listing 16.2.7.13
Safety Set

Psychiatric disorders/ 2020-09-02 Yes/ 2 No NA/ DOSE NOT NOT RECOVERED/

Bipolar disorder/ (16)/ Yes/ NR CHANGED/ NOT RESOLVED
BIPOLAR DISORDER Ongoing No CONCOMITANT
MEDICATION

Anxiety/ (16)/ Yes/ NR CHANGED/ RESOLVED
WORSENING OF ANXIETY 2020-10-19 No CONCOMITANT
(63) MEDICATION

FDA-CBER-2022-908-0003410
1448
Listing 16.2.7.13
Safety Set



INFECTION

FDA-CBER-2022-908-0003411
1449
Listing 16.2.7.13
Safety Set


Cerumen impaction/ 2020-10-06 No CONCOMITANT
LEFT EAR CERUMEN (20) PROCEDURE
IMPACTION


FDA-CBER-2022-908-0003412
1450
Listing 16.2.7.13
Safety Set


Sciatica/ (3)/ Yes/ NA CHANGED/ RESOLVED
SCIATICA LEFT-SIDED 2020-08-26 No CONCOMITANT

MEDICATION

FDA-CBER-2022-908-0003413
1451
Listing 16.2.7.13
Safety Set


LEFT LEG (BENIGN)

RIGHT CHEST CONTUSION (30) MEDICATION

FDA-CBER-2022-908-0003414
1452
Listing 16.2.7.13
Safety Set


WORSENING OF RIGHT
SHOULDER OSTEOARTHRITIS

FDA-CBER-2022-908-0003415
1453
Listing 16.2.7.13
Safety Set


and polyps)/ (50)
Benign neoplasm of skin/
LEFT KNEE SKIN LESION,
BENIGN

FDA-CBER-2022-908-0003416
1454
Listing 16.2.7.13
Safety Set


CONTACT DERMATITIS - (50) MEDICATION
POISON IVY

WORSENING OF MIGRAINES 2020-09-02 Yes CONCOMITANT
(9) MEDICATION

FDA-CBER-2022-908-0003417
1455
Listing 16.2.7.13
Safety Set

Metabolism and nutrition 2020-09-26 00:00 Yes/ 3 No NR/ DOSE NOT RECOVERED/
Dehydration/ 2020-09-29 00:00 No CONCOMITANT

(84) PROCEDURE

FDA-CBER-2022-908-0003418
1456
Listing 16.2.7.13
Safety Set



Urinary tract infection/ Ongoing No CONCOMITANT
URINARY TRACT INFECTION MEDICATION

FDA-CBER-2022-908-0003419
1457
Listing 16.2.7.13
Safety Set


VAGINAL CANDIDIASIS (58) MEDICATION


FDA-CBER-2022-908-0003420
1458
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003421
1459
Listing 16.2.7.13
Safety Set


Rash erythematous/ 2020-11-10 No CONCOMITANT
WORSENING ERYTHEMATOUS (70) MEDICATION
RAISED PRURITIC RASH ON
EXTENSOR SURFACES OF
UPPER EXTREMITIES
BILATERAL

FDA-CBER-2022-908-0003422
1460
Listing 16.2.7.13
Safety Set


Spinal osteoarthritis/
WORSENING LUMBAR
SPONDYLSIS
Subject ID: US3152401; Age (years): 35; Sex: M; Race: MULTIPLE: Asian, American Indian or Alaska Native; Height (cm): 177.7;
Psychiatric disorders/ 2020-09-10 00:00 Yes/ 1 No NR/ DOSE NOT NOT RECOVERED/
Attention deficit (1)/ Yes/ NR CHANGED/ NOT RESOLVED
ATTENTION DEFICIT MEDICATION
DISORDER

FDA-CBER-2022-908-0003423
1461
Listing 16.2.7.13
Safety Set


Atrial tachycardia/ (17)/ Yes/ NR CHANGED/ NOT RESOLVED
ATRIAL TACHYCARDIA Ongoing No CONCOMITANT
MEDICATION

Fatigue/ (59)
FATIGUE

FDA-CBER-2022-908-0003424
1462
Listing 16.2.7.13
Safety Set


FALL (25)

Eyelid ptosis/ (25)/ Yes/ NR CHANGED/ RESOLVED
LEFT EYELID DROOP 2020-10-25 No NONE
(47)

FDA-CBER-2022-908-0003425
1463
Listing 16.2.7.13
Safety Set


BACK PAIN

FDA-CBER-2022-908-0003426
1464
Listing 16.2.7.13
Safety Set


Undifferentiated MEDICATION
connective tissue
disease/
UNDIFFERENTIATED
CONNECTIVE TISSUE
DISEASE

FDA-CBER-2022-908-0003427
1465
Listing 16.2.7.13
Safety Set


Osteoporosis/
WORSENING OSTEOPOROSIS

TONSILLITIS (53) MEDICATION

FDA-CBER-2022-908-0003428
1466
Listing 16.2.7.13
Safety Set


Chills/ (11)
CHILLS

BODY ACHES, GENERALIZED
MYALGIA

FDA-CBER-2022-908-0003429
1467
Listing 16.2.7.13
Safety Set


Blood cholesterol (64)/ Yes/ NR CHANGED/ NOT RESOLVED
WORSENING OF ELEVATED MEDICATION
CHOLESTEROL

Blood potassium (15)/ Yes/ NR CHANGED/ RESOLVING
decreased/ Ongoing No CONCOMITANT
LOW POTASSIUM MEDICATION

FDA-CBER-2022-908-0003430
1468
Listing 16.2.7.13
Safety Set


COVID-19/ 2021-01-04 No NONE


FDA-CBER-2022-908-0003431
1469
Listing 16.2.7.13
Safety Set



FDA-CBER-2022-908-0003432
1470
Listing 16.2.7.13
Safety Set

Infections and 2020-11-14 Yes/ 2 No R/ DOSE NOT RECOVERED/

Herpes simplex/ 2020-11-22 No CONCOMITANT
HSV TYPE 1 OUTBREAK ON (11) MEDICATION
LIPS


FDA-CBER-2022-908-0003433
1471
Listing 16.2.7.13
Safety Set


Muscle spasms/
WORSENING BACK MUSCLE
SPASMS

FDA-CBER-2022-908-0003434
1472
Listing 16.2.7.13
Safety Set


INFECTION TOOTH #13 (30) MEDICATION,
CONCOMITANT
PROCEDURE

Toothache/ Ongoing No NONE
DENTAL PAIN

FDA-CBER-2022-908-0003435
1473
Listing 16.2.7.13
Safety Set


Osteoporosis/
OSTEOPOROSIS

Epicondylitis/ Ongoing No NONE
RIGHT LATERAL
EPICONDYLITIS

FDA-CBER-2022-908-0003436
1474
Listing 16.2.7.13
Safety Set

Hand fracture/ Ongoing No CONCOMITANT
FRACTURED 5TH PHALANGES, MEDICATION
RIGHT HAND

INFLUENZA (29) MEDICATION

FDA-CBER-2022-908-0003437
1475
Listing 16.2.7.13
Safety Set


STREP PHARYNGITIS


FDA-CBER-2022-908-0003438
1476
Listing 16.2.7.13
Safety Set


(14) MEDICATION
Vascular disorders/ 2020-10-15 10:37 No/ 2 No NR/ DOSE NOT RECOVERED/


FDA-CBER-2022-908-0003439
1477
Listing 16.2.7.13
Safety Set


(53) MEDICATION

OTITIS MEDIA - RIGHT EAR (14) MEDICATION

FDA-CBER-2022-908-0003440
1478
Listing 16.2.7.13
Safety Set


WORSENING RESTLESS LEG Ongoing No CONCOMITANT
SYNDROME MEDICATION
General disorders and 2021-01-04 Yes/ 2 No NR/ DOSE NOT NOT RECOVERED/
administration site (53)/ Yes/ NR CHANGED/ NOT RESOLVED
Non-cardiac chest pain/
INTERMITTENT CHEST
TIGHTNESS (NON-CARDIAC)

FDA-CBER-2022-908-0003441
1479
Listing 16.2.7.13
Safety Set


PINK EYE (63) MEDICATION


FDA-CBER-2022-908-0003442
1480
Listing 16.2.7.13
Safety Set



Liver function test (71)/ Yes/ NR APPLICABLE/ NOT RESOLVED
abnormal/ Ongoing No NONE
ABNORMAL LIVER FUNCTION
STUDIES

FDA-CBER-2022-908-0003443
1481
Listing 16.2.7.13
Safety Set



FALL IN PARKING LOT (79)

FDA-CBER-2022-908-0003444
1482
Listing 16.2.7.13
Safety Set


LIGHTHEADEDNESS 2020-11-11 No CONCOMITANT
(80) MEDICATION

Hyponatraemia/ 2020-11-12 No CONCOMITANT
HYPONATREMIA (81) MEDICATION

FDA-CBER-2022-908-0003445
1483
Listing 16.2.7.13
Safety Set


ACUTE RENAL FAILURE (81) MEDICATION

(88)

FDA-CBER-2022-908-0003446
1484
Listing 16.2.7.13
Safety Set


Gastritis/ Ongoing No CONCOMITANT
WORSENING OF GASTRITIS MEDICATION


FDA-CBER-2022-908-0003447
1485
Listing 16.2.7.13
Safety Set


ATYPICAL MIGRAINE 2020-08-13 Yes NONE
(17)

WORSENED ANXIETY Ongoing No CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0003448
1486
Listing 16.2.7.13
Safety Set


Cataract/ (84)/ Yes/ NR APPLICABLE/ RESOLVED
CATARACT OF RIGHT EYE 2021-01-14 No CONCOMITANT
(143) PROCEDURE
Musculoskeletal and 2020-11-23 Yes/ 1 No NA/ NOT NOT RECOVERED/

connective tissue (91)/ Yes/ NA APPLICABLE/ NOT RESOLVED
HAND

FDA-CBER-2022-908-0003449
1487
Listing 16.2.7.13
Safety Set


Dry eye/ (149)/ Yes/ NR APPLICABLE/ RESOLVED
RIGHT DRY EYE 2021-01-26 No CONCOMITANT
(155) MEDICATION

UPPER RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003450
1488
Listing 16.2.7.13
Safety Set


ANTERIOR CERVICAL (49)
LYMPHADENOPATHY,
BILATERAL

BILATERAL FRONTAL (113) MEDICATION
SINUSITIS

FDA-CBER-2022-908-0003451
1489
Listing 16.2.7.13
Safety Set


ACUTE DIARRHEA (17) MEDICATION
Psoriasis/ Ongoing No CONCOMITANT
PSORIASIS MEDICATION

FDA-CBER-2022-908-0003452
1490
Listing 16.2.7.13
Safety Set


Musculoskeletal chest (16)
pain/
MUSCUOSKELETAL CHEST
TIGHTNESS

INTERMITTENT DIARRHEA (218)

FDA-CBER-2022-908-0003453
1491
Listing 16.2.7.13
Safety Set


Skin infection/ 2020-12-26 No CONCOMITANT
INFECTED ABRASIONS LEFT (123) MEDICATION
CALF

DENTAL CARIES (TOOTH #5) (100) PROCEDURE

FDA-CBER-2022-908-0003454
1492
Listing 16.2.7.13
Safety Set


conditions/ Ongoing No CONCOMITANT
Oedema peripheral/ MEDICATION
BILATERAL LOWER
EXTREMITY EDEMA

Stasis dermatitis/ Ongoing No CONCOMITANT
STASIS DERMATITIS LEFT MEDICATION
CALF

FDA-CBER-2022-908-0003455
1493
Listing 16.2.7.13
Safety Set


CELLULITIS LEFT LOWER (165) MEDICATION
EXTREMITY

FDA-CBER-2022-908-0003456
1494
Listing 16.2.7.13
Safety Set


ANTERIOR UPPER CHEST

FDA-CBER-2022-908-0003457
1495
Listing 16.2.7.13
Safety Set


WORSENING OF
OSTEOARTHRITIS LEFT KNEE

DENTAL CARRIES (RIGHT (100) PROCEDURE
MAXILLARY MOLAR)

FDA-CBER-2022-908-0003458
1496
Listing 16.2.7.13
Safety Set


VIRAL INFECTION (95)
UNSPECIFIED

PRESSURE

FDA-CBER-2022-908-0003459
1497
Listing 16.2.7.13
Safety Set


VIRAL INFECTION, (96) MEDICATION
UNSPECIFIED

VIRAL INFECTION, (104)
UNSPECIFIED

FDA-CBER-2022-908-0003460
1498
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003461
1499
Listing 16.2.7.13
Safety Set



Bronchospasm/ MEDICATION
EXERCISED-INDUCED
BRONCOSPASM

FDA-CBER-2022-908-0003462
1500
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION

ACUTE VIRAL INFECTION, (97) MEDICATION
UNSPECIFIED

FDA-CBER-2022-908-0003463
1501
Listing 16.2.7.13
Safety Set



WORSENING OF LEFT HIP
PAIN

FDA-CBER-2022-908-0003464
1502
Listing 16.2.7.13
Safety Set


Osteonecrosis/ (165) PROCEDURE
DEVELOPING AVASCULAR
NECROSIS OF LEFT HIP

FDA-CBER-2022-908-0003465
1503
Listing 16.2.7.13
Safety Set


HIP

PAIN FROM LEFT HIP MEDICATION
REPLACEMENT

FDA-CBER-2022-908-0003466
1504
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION

OCCIPITAL HEADACHE 2020-12-14 Yes NONE
(106)

FDA-CBER-2022-908-0003467
1505
Listing 16.2.7.13
Safety Set



Hypoglycaemia/ 2020-08-10 No CONCOMITANT

FDA-CBER-2022-908-0003468
1506
Listing 16.2.7.13
Safety Set


ACUTE BACK PAIN (DUE TO (41) MEDICATION
FALL)

COVID-19/ 2021-01-12 No NONE

FDA-CBER-2022-908-0003469
1507
Listing 16.2.7.13
Safety Set


WORSENING OF SYSTOLIC (142)
BLOOD PRESSURE

ECZEMA RIGHT FOREARM MEDICATION

FDA-CBER-2022-908-0003470
1508
Listing 16.2.7.13
Safety Set


UNSPECIFIED

COVID-19/ 2020-12-24 No NONE

FDA-CBER-2022-908-0003471
1509
Listing 16.2.7.13
Safety Set


disorders/ Ongoing Yes NONE
Arthralgia/
RIGHT KNEE PAIN


FDA-CBER-2022-908-0003472
1510
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003473
1511
Listing 16.2.7.13
Safety Set


Myalgia/ (57)

Blood pressure systolic (56)/ Yes/ NR CHANGED/ RESOLVED
ELEVATION OF SYSTOLIC (57)
BLOOD PRESSURE

FDA-CBER-2022-908-0003474
1512
Listing 16.2.7.13
Safety Set


Blood pressure diastolic (56)/ Yes/ NR CHANGED/ RESOLVED
ELEVATION OF DIASTOLIC (58)
BLOOD PRESSURE

WOODEN FOREIGN BODY LEFT (65) MEDICATION,
SOLE CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003475
1513
Listing 16.2.7.13
Safety Set


PAIN DUE TO REMOVAL OF (89) MEDICATION
WOODEN FOREIGN BODY LEFT
SOLE

Hepatic enzyme increased/ (81)/ Yes/ NR APPLICABLE/ RESOLVED
ELEVATION OF LIVER 2020-12-20 No NONE
ENZYMES (111)

FDA-CBER-2022-908-0003476
1514
Listing 16.2.7.13
Safety Set


Angina pectoris/ (43)/ Yes/ NR CHANGED/ RESOLVED
ANGINA 2021-02-14 No NONE
(165)

UNSPECIFIED

FDA-CBER-2022-908-0003477
1515
Listing 16.2.7.13
Safety Set


Dizziness/ (140)/ Yes/ NR APPLICABLE/ NOT RESOLVED
INTERMITTENT MEDICATION
LIGHTHEADEDNESS

Viral infection/ Ongoing No CONCOMITANT
VIRAL INFECTION, MEDICATION
UNSPECIFIED

FDA-CBER-2022-908-0003478
1516
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION

VIRAL INFECTION (146) MEDICATION
UNSPECIFIED

FDA-CBER-2022-908-0003479
1517
Listing 16.2.7.13
Safety Set


BILATERAL CERVICAL (111)
ANTERIOR LYMPHADENOPATHY

UNSPECIFIED

FDA-CBER-2022-908-0003480
1518
Listing 16.2.7.13
Safety Set


RIGHT CONJUNCTIVITIS (38) MEDICATION

(68) MEDICATION

FDA-CBER-2022-908-0003481
1519
Listing 16.2.7.13
Safety Set


UNSPECIFIED

conditions/ Ongoing Yes NONE
Fatigue/

FDA-CBER-2022-908-0003482
1520
Listing 16.2.7.13
Safety Set


UNSPECIFIED

Dry eye/ (142)/ Yes/ NR APPLICABLE/ NOT RESOLVED
BILATERAL DRY EYE Ongoing No CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0003483
1521
Listing 16.2.7.13
Safety Set


Pharyngitis/ 2021-01-24 No CONCOMITANT
PHARYNGITIS (133) MEDICATION

Dermatitis/ 2020-11-24 No CONCOMITANT
ACUTE DERMATITIS (77) MEDICATION

FDA-CBER-2022-908-0003484
1522
Listing 16.2.7.13
Safety Set


UNSPECIFIED


FDA-CBER-2022-908-0003485
1523
Listing 16.2.7.13
Safety Set


infection/ (20)
UPPER RESPIRATORY
INFECTION

UNSPECIFIED

FDA-CBER-2022-908-0003486
1524
Listing 16.2.7.13
Safety Set


Depression/ (30)/ Yes/ NR CHANGED/ RESOLVED
DEPRESSION (ACUTE) 2021-01-29 No CONCOMITANT
(169) MEDICATION

Haematuria/ 2020-09-19 No NONE
ACUTE HEMATURIA (5)

FDA-CBER-2022-908-0003487
1525
Listing 16.2.7.13
Safety Set

Renal and urinary 2020-09-28 Yes/ 1 No NR/ DOSE NOT NOT RECOVERED/
Nephrolithiasis/ Ongoing No NONE
RENAL CALCULI

Eye inflammation/ (116)/ Yes/ NR APPLICABLE/ RESOLVED
POST-OPERATIVE 2021-01-21 No CONCOMITANT
INFLAMMATION BILATERAL (129) MEDICATION
EYES

FDA-CBER-2022-908-0003488
1526
Listing 16.2.7.13
Safety Set


RHINOVIRUS INFECTION (98) MEDICATION

FDA-CBER-2022-908-0003489
1527
Listing 16.2.7.13
Safety Set


POST PROCEDURAL PAIN (84) MEDICATION
(LIPOSUCTION UPPER AND
LOWER ABDOMEN, LOWER
BACK; BUTTOCK
AUGMENTATION WITH FAT
GRAFTING)

FDA-CBER-2022-908-0003490
1528
Listing 16.2.7.13
Safety Set


UNSPECIFIED

WORSENING OF ANXIETY Ongoing No CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0003491
1529
Listing 16.2.7.13
Safety Set


MEDICATION


FDA-CBER-2022-908-0003492
1530
Listing 16.2.7.13
Safety Set


NAUSEA (12)

Vaccination complication/ 2020-10-22 No CONCOMITANT
FEBRILE REACTION TO (38) MEDICATION
SHINGRIX VACCINE

FDA-CBER-2022-908-0003493
1531
Listing 16.2.7.13
Safety Set


Haematospermia/ 2021-03-01 No CONCOMITANT
HEMATOSPERMIA (168) MEDICATION,
CONCOMITANT
PROCEDURE

UNSPECIFIED

FDA-CBER-2022-908-0003494
1532
Listing 16.2.7.13
Safety Set


LUMBAR STRAIN (60) MEDICATION


FDA-CBER-2022-908-0003495
1533
Listing 16.2.7.13
Safety Set


procedural complications/ (81)/ Yes/ R APPLICABLE/ RESOLVED
Procedural vomiting/ 2020-12-04 No NONE
VOMITING DURING (81)
VENIPUNCTURE

Gout/ 2020-09-29 No CONCOMITANT
WORSENING OF GOUT (GOUT (41) MEDICATION
ATTACK) RIGHT ANKLE

FDA-CBER-2022-908-0003496
1534
Listing 16.2.7.13
Safety Set


LUMBAR STRAIN (58)

COVID-19/ 2020-09-03 06:30 No NONE

FDA-CBER-2022-908-0003497
1535
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003498
1536
Listing 16.2.7.13
Safety Set


BILATERAL FRONTAL (70) MEDICATION
SINUSITIS

MEDICATION

FDA-CBER-2022-908-0003499
1537
Listing 16.2.7.13
Safety Set


Otitis externa/ 2020-10-28 No CONCOMITANT
LEFT OTITIS EXTERNA (42) MEDICATION

ACUTE VIRAL INFECTION, (60)
UNSPECIFIED

FDA-CBER-2022-908-0003500
1538
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003501
1539
Listing 16.2.7.13
Safety Set


infection/ (87)
UPPER RESPIRATORY
INFECTION


FDA-CBER-2022-908-0003502
1540
Listing 16.2.7.13
Safety Set


WORSENING OF
OSTEOARTHRITIS LEFT KNEE

FDA-CBER-2022-908-0003503
1541
Listing 16.2.7.13
Safety Set


WORSENING OF
OSTEOARTHRITIS OF RIGHT
KNEE

Adjustment disorder with (16)/ Yes/ NR APPLICABLE/ NOT RESOLVED
depressed mood/ Ongoing No CONCOMITANT
SITUATIONAL DEPRESSION MEDICATION

FDA-CBER-2022-908-0003504
1542
Listing 16.2.7.13
Safety Set


ACUTE VIRAL INFECTION, (55)
UNSPECIFIED


FDA-CBER-2022-908-0003505
1543
Listing 16.2.7.13
Safety Set


RIGHT HAND TENDINITIS

COVID-19/ 2021-01-01 No NONE

FDA-CBER-2022-908-0003506
1544
Listing 16.2.7.13
Safety Set

Renal and urinary 2020-09-14 Yes/ 1 No NR/ DOSE NOT NOT RECOVERED/
LEFT KIDNEY STONE MEDICATION

UNSPECIFIED

FDA-CBER-2022-908-0003507
1545
Listing 16.2.7.13
Safety Set


WORSENING OF RECURRENT (136) PROCEDURE
TONSILLITIS

Sleep apnoea syndrome/ (136) PROCEDURE
WORSENING OF OBSTRUCTIVE
SLEEP APNEA

FDA-CBER-2022-908-0003508
1546
Listing 16.2.7.13
Safety Set


Nasal septum deviation/
DEVIATED NASAL SEPTUM
Presyncope/ (28)/ Yes/ R CHANGED/ RESOLVED
VASOVAGAL EPISODE D/T 2020-10-21 13:09 No NONE
BLOOD DRAW (28)

FDA-CBER-2022-908-0003509
1547
Listing 16.2.7.13
Safety Set


UNSPECIFIED

Otitis media/ 2020-12-08 No NONE
OTITIS MEDIA, RIGHT EAR (47)

FDA-CBER-2022-908-0003510
1548
Listing 16.2.7.13
Safety Set



UNSPECIFIED

FDA-CBER-2022-908-0003511
1549
Listing 16.2.7.13
Safety Set



Bipolar disorder/ (22)/ Yes/ NR CHANGED/ NOT RESOLVED
WORSENING OF BIPOLAR Ongoing No CONCOMITANT
DEPRESSION MEDICATION

FDA-CBER-2022-908-0003512
1550
Listing 16.2.7.13
Safety Set


UNSPECIFIED

UNSPECIFIED

FDA-CBER-2022-908-0003513
1551
Listing 16.2.7.13
Safety Set


UNSPECIFIED


FDA-CBER-2022-908-0003514
1552
Listing 16.2.7.13
Safety Set

Infections and 2020-10-19 17:00 No/ 1 No NR/ DOSE NOT RECOVERED/

BILATERAL OTITIS EXTERNA (36) MEDICATION


FDA-CBER-2022-908-0003515
1553
Listing 16.2.7.13
Safety Set


Asymptomatic bacteriuria/ 2021-02-11 No CONCOMITANT
ASYMPTOMATIC BACTERIURIA (86) MEDICATION

ABDOMINAL WALL STRAIN (14)

FDA-CBER-2022-908-0003516
1554
Listing 16.2.7.13
Safety Set


Ear pain/ 2020-12-19 No NONE
(R) EARACHE (31)


FDA-CBER-2022-908-0003517
1555
Listing 16.2.7.13
Safety Set



LEFT LOWER LEG
INTERMITTENT CRAMPS

FDA-CBER-2022-908-0003518
1556
Listing 16.2.7.13
Safety Set


Constipation/ 2021-01-02 No NONE
CONSTIPATION (44)

HYPERTENSION

FDA-CBER-2022-908-0003519
1557
Listing 16.2.7.13
Safety Set


Paroxysmal arrhythmia/ (89)/ Yes/ NR APPLICABLE/ RESOLVED
CARDIAC ARRHYTHMIA 2020-12-05 No NONE
PAROXYSMAL (89)


FDA-CBER-2022-908-0003520
1558
Listing 16.2.7.13
Safety Set


Type 2 diabetes mellitus/ 2020-12-10 No CONCOMITANT
TYPE 2

Vitamin B1 deficiency/ 2020-12-10 No CONCOMITANT
THIAMINE DEFICIENCY (94) MEDICATION

FDA-CBER-2022-908-0003521
1559
Listing 16.2.7.13
Safety Set



Paroxysmal arrhythmia/ (92)/ Yes/ (2020-12-08/ NR APPLICABLE/ RESOLVED
CARDIAC ARRHYTHMIA 2020-12-11 No 2020-12-12) CONCOMITANT
PAROXYSMAL (95) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003522
1560
Listing 16.2.7.13
Safety Set


RIGHT KIDNEY MEDICATION,
NEPHROLITHIASIS CONCOMITANT
PROCEDURE

Renal colic/ 2020-08-30 No NONE
ACUTE RENAL COLIC (20)

FDA-CBER-2022-908-0003523
1561
Listing 16.2.7.13
Safety Set

Infections and 2020-09-01 Yes/ 4 Yes/2/3 NR/ NOT RECOVERED/

SEPTIC SHOCK (24) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003524
1562
Listing 16.2.7.13
Safety Set

Metabolism and nutrition 2020-09-01 Yes/ 4 Yes/2/3 NR/ NOT RECOVERED/

Metabolic acidosis/ 2020-09-03 No 2020-09-04) CONCOMITANT
PROFOUND METABOLIC (24) MEDICATION,
ACIDOSIS CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003525
1563
Listing 16.2.7.13
Safety Set


ACUTE HYPOXEMIC PROCEDURE
RESPIRATOY FAILURE

FDA-CBER-2022-908-0003526
1564
Listing 16.2.7.13
Safety Set


Pyelonephritis acute/ 2020-09-26 No 2020-09-04) CONCOMITANT
ACUTE PYELONEPHRITIS (47) MEDICATION,
(RIGHT KIDNEY) CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003527
1565
Listing 16.2.7.13
Safety Set


UPDATE FOR ORIGINAL SAE. (47) MEDICATION,
SECOND HOSPITALIZATION CONCOMITANT
DUE TO UNRESOLVED RIGHT PROCEDURE
KIDNEY PYELONEPHRITIS


FDA-CBER-2022-908-0003528
1566
Listing 16.2.7.13
Safety Set


Spinal stenosis/ MEDICATION
WORSENING SPINAL
STENOSIS

FDA-CBER-2022-908-0003529
1567
Listing 16.2.7.13
Safety Set


Fibula fracture/ 2021-02-10 No CONCOMITANT
DISPLACED FRACTURE OF (183) MEDICATION,
LATERAL MALLEOLUS OF CONCOMITANT
RIGHT FIBULA PROCEDURE

WORSENING INCREASED 2020-10-07 No NONE
BLOOD PRESSURE (29)

FDA-CBER-2022-908-0003530
1568
Listing 16.2.7.13
Safety Set


Chills/ (10)
INTERMITTENT CHILLS

INTERMITTENT HEADACHE 2020-08-25 Yes CONCOMITANT
(14) MEDICATION

FDA-CBER-2022-908-0003531
1569
Listing 16.2.7.13
Safety Set


COVID-19/ 2021-01-26 No NONE


FDA-CBER-2022-908-0003532
1570
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003533
1571
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003534
1572
Listing 16.2.7.13
Safety Set


RIGHT SHOULDER PAIN

disorders/ (12)/ Yes/ R APPLICABLE/ RESOLVED

FDA-CBER-2022-908-0003535
1573
Listing 16.2.7.13
Safety Set


International normalised (21)/ Yes/ NR CHANGED/ RESOLVED
ratio increased/ 2020-09-11 No CONCOMITANT
SUPRATHERAPEUTIC (25) MEDICATION
INTERNATIONAL NORMALIZED
RATIO (INCREASED)

Acute left ventricular (21)/ Yes/ (2020-09-07/ NR CHANGED/ RESOLVED
failure/ 2020-09-15 No 2020-09-15) CONCOMITANT
SYSTOLIC HEART FAILURE

FDA-CBER-2022-908-0003536
1574
Listing 16.2.7.13
Safety Set


ATRIAL FIBRILATION WITH 2020-09-15 No 2020-09-15) CONCOMITANT
RAPID VENTRICULAR RATE (29) MEDICATION


FDA-CBER-2022-908-0003537
1575
Listing 16.2.7.13
Safety Set


LEFT SIDE EYEBROW (122) PROCEDURE
LACERATION

Foreign body in ear/ 2021-02-05 No CONCOMITANT
BUG IN LEFT EAR (144) MEDICATION

FDA-CBER-2022-908-0003538
1576
Listing 16.2.7.13
Safety Set


connective tissue (10)/ Yes/ R APPLICABLE/ RESOLVED
RIB CAGE ARTHRALGIA
(LEFT SIDED)

FDA-CBER-2022-908-0003539
1577
Listing 16.2.7.13
Safety Set


Traumatic haemothorax/ 2021-01-27 No 2021-01-27) CONCOMITANT
HEMOPNEUMOTHORAX - (134) PROCEDURE
SECONDARY TO RIB CAGE
MULTIPLE FRACTURES.

FDA-CBER-2022-908-0003540
1578
Listing 16.2.7.13
Safety Set


RIGHT RIB CAGE MULTIPLE (167) MEDICATION,
FRACTURES CONCOMITANT
PROCEDURE

Skin abrasion/ 2021-03-03 No NONE
MULTIPLE SKIN ABRASIONS (169)

FDA-CBER-2022-908-0003541
1579
Listing 16.2.7.13
Safety Set


Cardiomegaly/ (24)/ Yes/ NR CHANGED/ NOT RESOLVED
CARDIOMEGALY Ongoing No NONE

Ascites/ 2020-09-15 No CONCOMITANT
UPPER ABDOMINAL ASCITES (27) MEDICATION

FDA-CBER-2022-908-0003542
1580
Listing 16.2.7.13
Safety Set


ACUTE EXACERBATION OF (28) MEDICATION,
CONGESTION HEART FAILURE CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003543
1581
Listing 16.2.7.13
Safety Set


Intervertebral disc MEDICATION
degeneration/
DEGENERATIVE L4-5
POSTERIOR DISC BULGE

FDA-CBER-2022-908-0003544
1582
Listing 16.2.7.13
Safety Set


CHRONIC CONGESTIVE HEART
FAILURE

SPRAIN LEFT ANKLE (150) MEDICATION
CALCANEUS

FDA-CBER-2022-908-0003545
1583
Listing 16.2.7.13
Safety Set


UNDERNEATH RIGHT BREAST (27) MEDICATION
FOLLICULITIS

UPPER RIGHT LEG PAIN

FDA-CBER-2022-908-0003546
1584
Listing 16.2.7.13
Safety Set


LEFT THIGH MUSCLE SPASM

BILATERAL LEGS EDEMA

FDA-CBER-2022-908-0003547
1585
Listing 16.2.7.13
Safety Set


Dyslipidaemia/ 2021-02-23 No CONCOMITANT
DYSLIPIDEMIA (184) MEDICATION

WORSENING OF DIZZINESS 2020-09-29 No CONCOMITANT
(9) MEDICATION

FDA-CBER-2022-908-0003548
1586
Listing 16.2.7.13
Safety Set


INTERMITTENT NAUSEA (11)

LEFT DELTOID IMJECTION
SITE PAIN

FDA-CBER-2022-908-0003549
1587
Listing 16.2.7.13
Safety Set


LEFT DELTOID INJECTION
SITE TENDERNESS


FDA-CBER-2022-908-0003550
1588
Listing 16.2.7.13
Safety Set


WORSENING OF BASELINE 2020-11-08 No CONCOMITANT

FDA-CBER-2022-908-0003551
1589
Listing 16.2.7.13
Safety Set


pulmonary disease/
CHRONIC OBSTRUCTIVE
PULMONARY DISEASE ACUTE
EXACERBATION

FDA-CBER-2022-908-0003552
1590
Listing 16.2.7.13
Safety Set


disorders/ 2020-11-12 No ) CONCOMITANT
Chronic obstructive (50) MEDICATION,
pulmonary disease/ CONCOMITANT
WORSENING OF CHRONIC PROCEDURE
DISEASE

FDA-CBER-2022-908-0003553
1591
Listing 16.2.7.13
Safety Set


ACUTE FLARE OF CHRONIC
BACK PAIN

FDA-CBER-2022-908-0003554
1592
Listing 16.2.7.13
Safety Set


CHRONIC LOWER BACK PAIN
Pregnancy, puerperium 2020-10-06 Yes/ 2 No NR/ NOT RECOVERED/

Abortion spontaneous/ 2020-10-13 No NONE
MISCARRIAGE - SECONDARY (49)
TO ECTOPIC PREGNANCY

FDA-CBER-2022-908-0003555
1593
Listing 16.2.7.13
Safety Set


Ectopic pregnancy/ 2020-10-13 No NONE
ECTOPIC PREGNANCY ENDED (49)
IN MISCARRIAGE

Neck pain/ (30)
NECK PAIN

FDA-CBER-2022-908-0003556
1594
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION


FDA-CBER-2022-908-0003557
1595
Listing 16.2.7.13
Safety Set


LOWER BACK PAIN

FDA-CBER-2022-908-0003558
1596
Listing 16.2.7.13
Safety Set

Respiratory, thoracic 2020-11-17 07:00 Yes/ 2 No NR/ NOT RECOVERED/

pulmonary disease/
BASELINE COPD

FDA-CBER-2022-908-0003559
1597
Listing 16.2.7.13
Safety Set

Musculoskeletal and 2020-11-17 08:00 Yes/ 2 No NR/ NOT RECOVERED/

LEFT KNEE CHRONIC PAIN

Irritable bowel syndrome/ 2020-11-29 No NONE
IBS EXACERBATION (14)

FDA-CBER-2022-908-0003560
1598
Listing 16.2.7.13
Safety Set


UNCONTROLLED 2020-11-26 No CONCOMITANT

UNCONTROLLED BLOOD 2020-12-14 13:55 No NONE
PRESSURE - HYPERTENSION (55)

FDA-CBER-2022-908-0003561
1599
Listing 16.2.7.13
Safety Set


Hypercholesterolaemia/ 2021-02-15 No CONCOMITANT
NEWLY DIAGNOSED (92) MEDICATION

NEWLY DIAGNOSED WITH 2021-02-15 No CONCOMITANT

FDA-CBER-2022-908-0003562
1600
Listing 16.2.7.13
Safety Set


SARS-COV-2 INFECTION (109) MEDICATION

Skin candida/ 2021-03-25 No CONCOMITANT
BILATERAL ARMPIT (128) MEDICATION
CANDIDIASIS

FDA-CBER-2022-908-0003563
1601
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION - (URI)


FDA-CBER-2022-908-0003564
1602
Listing 16.2.7.13
Safety Set


FRACTURED PRE MOLAR X2 (91) MEDICATION
LEFT UPPER SIDE

COVID 19 SYMPTOMATIC (18) MEDICATION

FDA-CBER-2022-908-0003565
1603
Listing 16.2.7.13
Safety Set


FOLIICULITIS NECK (43) MEDICATION
HAIRLINE

Skin infection/ 2020-12-14 No CONCOMITANT
SKIN INFECTION UPPER (26) MEDICATION
EXTREMITIES

FDA-CBER-2022-908-0003566
1604
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003567
1605
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003568
1606
Listing 16.2.7.13
Safety Set


Nervous system disorders/ 2020-08-13 Yes/ 2 No NR/ DOSE NOT RECOVERING/

Facial paralysis/ (17)/ Yes/ NR CHANGED/ RESOLVING
BELL'S PALSY 2020-08-25 No CONCOMITANT
(29) MEDICATION

FDA-CBER-2022-908-0003569
1607
Listing 16.2.7.13
Safety Set


ABSCESSED TOOTH (186) MEDICATION,
CONCOMITANT
PROCEDURE

Eye pain/ (26)/ Yes/ NR CHANGED/ RESOLVED
LEFT EYE PAIN 2020-08-24 No NONE
(27)

FDA-CBER-2022-908-0003570
1608
Listing 16.2.7.13
Safety Set



Blood iron decreased/ (16)/ Yes/ NR CHANGED/ RESOLVING
LOW IRON Ongoing No CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0003571
1609
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003572
1610
Listing 16.2.7.13
Safety Set


SHINGLES RIGHT TRUNK (75) MEDICATION


FDA-CBER-2022-908-0003573
1611
Listing 16.2.7.13
Safety Set


Thrombophlebitis (160)/ Yes/ NR CHANGED/ RESOLVED
superficial/ 2021-02-17 No CONCOMITANT
SUPERFICIAL (169) MEDICATION
THROMBOPHLEBITIS
Eye disorders/ 2020-08-19 Yes/ 2 No NR/ DOSE NOT NOT RECOVERED/

Macular oedema/ (14)/ Yes/ NR CHANGED/ NOT RESOLVED
WORSENING OF MACULAR Ongoing No CONCOMITANT
EDEMA-RIGHT EYE MEDICATION

FDA-CBER-2022-908-0003574
1612
Listing 16.2.7.13
Safety Set


Anaemia/ Ongoing No CONCOMITANT
ANEMIA MEDICATION

Chest discomfort/ (81)
CHEST TIGHTNESS-UNKNOWN
ETIOLOGY

FDA-CBER-2022-908-0003575
1613
Listing 16.2.7.13
Safety Set


(81)

Epistaxis/ (82) MEDICATION
SEVERE EPISTAXIS
SECONDARY TO NASAL
SURGICAL COMPLICATION

FDA-CBER-2022-908-0003576
1614
Listing 16.2.7.13
Safety Set


HYPOXIA SECONDARY TO
CHRONIC OBSTRUCTIVE
PULMONARY DISEASE AND
ASTHMA

FDA-CBER-2022-908-0003577
1615
Listing 16.2.7.13
Safety Set



COVID-19/ 2021-03-02 No NONE
COVID-19 (181)

FDA-CBER-2022-908-0003578
1616
Listing 16.2.7.13
Safety Set


Attention deficit (22)/ Yes/ NR CHANGED/ NOT RESOLVED
WORSENING OF ADHD MEDICATION

CELLULITIS LEFT HAND (18) MEDICATION

FDA-CBER-2022-908-0003579
1617
Listing 16.2.7.13
Safety Set

Rosacea/ Ongoing No CONCOMITANT
ROSACEA MEDICATION

Rotator cuff syndrome/ (29) MEDICATION,
LEFT ROTATOR CUFF TEAR CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003580
1618
Listing 16.2.7.13
Safety Set


Atelectasis/
INFRAHILAR ATELECTASIS

Bradycardia/ (29)/ Yes/ NR APPLICABLE/ RESOLVED
(29)

FDA-CBER-2022-908-0003581
1619
Listing 16.2.7.13
Safety Set


Non-cardiac chest pain/ (32) MEDICATION,
CHEST PAIN (NON-CARDIAC) CONCOMITANT
PROCEDURE

Asthenia/ (47)

FDA-CBER-2022-908-0003582
1620
Listing 16.2.7.13
Safety Set


(47)

Dehydration/ 2020-10-26 No 2020-10-26) CONCOMITANT

FDA-CBER-2022-908-0003583
1621
Listing 16.2.7.13
Safety Set


Animal bite/ 2020-08-23 No CONCOMITANT
CAT BITE RIGHT WRIST (17) MEDICATION

OSTEOARTHRITIS

FDA-CBER-2022-908-0003584
1622
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003585
1623
Listing 16.2.7.13
Safety Set


Rotator cuff syndrome/ (163) MEDICATION
SORE ROTATOR CUFF

Cough/ (117)
COUGH

FDA-CBER-2022-908-0003586
1624
Listing 16.2.7.13
Safety Set



Gastroenteritis viral/ 2020-08-13 No CONCOMITANT
VIRAL GASTROENTERITIS (3) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003587
1625
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003588
1626
Listing 16.2.7.13
Safety Set


FACIAL RASH (UNKNOWN) (68) MEDICATION


FDA-CBER-2022-908-0003589
1627
Listing 16.2.7.13
Safety Set


RASH (BILATERAL UPPER (124) MEDICATION
EXTREMITIES/LOWER
BACK/TRUNK)


FDA-CBER-2022-908-0003590
1628
Listing 16.2.7.13
Safety Set

Benign prostatic Ongoing No CONCOMITANT
hyperplasia/ MEDICATION
BENIGN PROSTATIC
HYPERPLASIA


FDA-CBER-2022-908-0003591
1629
Listing 16.2.7.13
Safety Set



Sinusitis fungal/ 2020-11-03 No CONCOMITANT
WORSENING OF FUNGAL (67) MEDICATION
SINUSITIS

FDA-CBER-2022-908-0003592
1630
Listing 16.2.7.13
Safety Set



Atrial fibrillation/ (10)/ Yes/ NR CHANGED/ RESOLVING
ATRIAL FIBRILATION Ongoing No CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0003593
1631
Listing 16.2.7.13
Safety Set


Small intestinal 2020-09-20 No NONE
obstruction/ (21)

Pharyngitis Ongoing No CONCOMITANT
streptococcal/ MEDICATION
STREP THROAT

FDA-CBER-2022-908-0003594
1632
Listing 16.2.7.13
Safety Set


SINUSITIS MEDICATION

Peripheral swelling/ (172)
RIGHT LEG SWELLING

FDA-CBER-2022-908-0003595
1633
Listing 16.2.7.13
Safety Set


Blister/ 2021-02-20 No NONE
BENIGN BLISTERY LESIONS (172)
ON LEGS

Urinary tract infection/ 2020-12-25 No NONE
URINARY TRACT INFECTION (115)

FDA-CBER-2022-908-0003596
1634
Listing 16.2.7.13
Safety Set


CELLULITIS ON RIGHT LEG (172)


FDA-CBER-2022-908-0003597
1635
Listing 16.2.7.13
Safety Set


Psychiatric disorders/ 2021-01-12 Yes/ 1 No NA/ DOSE NOT RECOVERING/

MEDICATION

FDA-CBER-2022-908-0003598
1636
Listing 16.2.7.13
Safety Set


Syncope/ (139)/ Yes/ NR APPLICABLE/ NOT RESOLVED
FAINTING EPISODE Ongoing No CONCOMITANT
PROCEDURE

COVID-19/ 2020-12-22 No NONE
COVID-19 (110)

FDA-CBER-2022-908-0003599
1637
Listing 16.2.7.13
Safety Set


COVID-LIKE ILLNESS (91)

MEDICATION

FDA-CBER-2022-908-0003600
1638
Listing 16.2.7.13
Safety Set



LEG AND ARM CELLULITIS (65) MEDICATION
BILATERALLY

FDA-CBER-2022-908-0003601
1639
Listing 16.2.7.13
Safety Set


SECONDARY ALLERGIC (65)
REACTION TO LEG AND ARM
CELLULITIS BILATERALLY

FDA-CBER-2022-908-0003602
1640
Listing 16.2.7.13
Safety Set


MOLAR ABSCESS (95) MEDICATION,
CONCOMITANT
PROCEDURE

COVID-19/ 2020-12-18 No NONE

FDA-CBER-2022-908-0003603
1641
Listing 16.2.7.13
Safety Set



Seasonal allergy/ (23)/ Yes/ NR APPLICABLE/ RESOLVED

FDA-CBER-2022-908-0003604
1642
Listing 16.2.7.13
Safety Set

SARS-CoV-2 Status: ; Baseline RT-PCR: Negative; Baseline Elecsys SARS-CoV-2 Nucleocapsid bAb: ; Dose 1 Date/Time:

Conjunctivitis/ Ongoing No CONCOMITANT
BACTERIAL CONJUNCTIVITIS MEDICATION

ATRIAL FIBRILLATION 2020-11-08 No NONE
(60)

FDA-CBER-2022-908-0003605
1643
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-12-09 No NONE


FDA-CBER-2022-908-0003606
1644
Listing 16.2.7.13
Safety Set


RIGHT CALF BURNING PAIN


FDA-CBER-2022-908-0003607
1645
Listing 16.2.7.13
Safety Set



(110)

FDA-CBER-2022-908-0003608
1646
Listing 16.2.7.13
Safety Set


Depression/ (46)/ Yes/ NR APPLICABLE/ RESOLVING
MEDICATION

Anxiety/ (71)/ Yes/ NR APPLICABLE/ RESOLVING
MEDICATION

FDA-CBER-2022-908-0003609
1647
Listing 16.2.7.13
Safety Set


Attention deficit (71)/ Yes/ NR APPLICABLE/ RESOLVING
ATTENTION-DEFICIT/HYPERA MEDICATION
CTIVITY DISORDER


FDA-CBER-2022-908-0003610
1648
Listing 16.2.7.13
Safety Set


Deep vein thrombosis/ (140)/ Yes/ NR APPLICABLE/ RESOLVING
DEEP VEIN THROMBOSIS Ongoing No CONCOMITANT
LEFT LEG MEDICATION

RIGHT EYE CATARACT 2021-02-11 No CONCOMITANT
(153) MEDICATION

FDA-CBER-2022-908-0003611
1649
Listing 16.2.7.13
Safety Set


LEFT EYE CATARACT 2021-02-25 No CONCOMITANT
(167) MEDICATION

Suspected COVID-19/ Ongoing No NONE
COVID-LIKE SYMPTOMS

FDA-CBER-2022-908-0003612
1650
Listing 16.2.7.13
Safety Set


Oral herpes/ 2020-09-11 No CONCOMITANT
RECURRENT HERPES SIMPLEX (28) MEDICATION
VIRUS ORAL

Peptic ulcer/ Ongoing No CONCOMITANT
PEPTIC ULCER MEDICATION

FDA-CBER-2022-908-0003613
1651
Listing 16.2.7.13
Safety Set


Renal cyst/ Ongoing No CONCOMITANT
RENAL CYST MEDICATION


FDA-CBER-2022-908-0003614
1652
Listing 16.2.7.13
Safety Set


NAUSEA/VOMITING (60) MEDICATION

Fatigue/ (54)
FATIGUE

FDA-CBER-2022-908-0003615
1653
Listing 16.2.7.13
Safety Set


FEVER

Clostridium difficile 2020-11-10 No 2020-11-10) CONCOMITANT
colitis/ (60) MEDICATION
C-DIFF - COLITIIS

FDA-CBER-2022-908-0003616
1654
Listing 16.2.7.13
Safety Set



Mental status changes/ (53)/ Yes/ NR APPLICABLE/ RESOLVED
ALTERED MENTAL STATUS 2020-11-05 No NONE
(55)

FDA-CBER-2022-908-0003617
1655
Listing 16.2.7.13
Safety Set


Hyponatraemia/ 2020-11-08 No NONE
HYPONATREMIA (58)

Dyspnoea/ (58)
SHORTNESS OF BREATH

FDA-CBER-2022-908-0003618
1656
Listing 16.2.7.13
Safety Set


(58)

ABDOMINAL PAIN (60)

FDA-CBER-2022-908-0003619
1657
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003620
1658
Listing 16.2.7.13
Safety Set



Acute kidney injury/ 2020-11-10 No NONE
ACUTE RENAL FAILURE (60)

FDA-CBER-2022-908-0003621
1659
Listing 16.2.7.13
Safety Set


Irritable bowel syndrome/ Ongoing No NONE
IRRITABLE BOWEL SYNDROME

(58)

FDA-CBER-2022-908-0003622
1660
Listing 16.2.7.13
Safety Set


Bladder spasm/ 2020-11-09 No CONCOMITANT
BLADDER SPASMS (59) MEDICATION

Tricuspid valve (59)/ Yes/ NR APPLICABLE/ RESOLVED
incompetence/ 2020-11-10 No CONCOMITANT
SEVERE TRICUSPID VALVE (60) MEDICATION
REGURGITATION

FDA-CBER-2022-908-0003623
1661
Listing 16.2.7.13
Safety Set


Oedema/ (60) MEDICATION
EDEMA

(60) MEDICATION

FDA-CBER-2022-908-0003624
1662
Listing 16.2.7.13
Safety Set


(60) MEDICATION


FDA-CBER-2022-908-0003625
1663
Listing 16.2.7.13
Safety Set


Asthenia/ (79)

Hyponatraemia/ 2020-11-29 No CONCOMITANT
MILD HYPONATREMIA (79) MEDICATION

FDA-CBER-2022-908-0003626
1664
Listing 16.2.7.13
Safety Set


LOOSE STOOLS (79)

RASH AND ITCHING FROM 2021-01-09 No NONE
NORVASC (120)

FDA-CBER-2022-908-0003627
1665
Listing 16.2.7.13
Safety Set



FDA-CBER-2022-908-0003628
1666
Listing 16.2.7.13
Safety Set


Vaccination site (24) MEDICATION
lymphadenopathy/
LYMPHADENOPATHY (LEFT
SIDE NECK/PREAURICULAR)
SIDE OF VACCINATION SITE

FDA-CBER-2022-908-0003629
1667
Listing 16.2.7.13
Safety Set



FINGER LACERATION 2.8CM (15)
SUTURED

FDA-CBER-2022-908-0003630
1668
Listing 16.2.7.13
Safety Set


HYPERTENSION (52)

Food poisoning/ 2020-12-05 No CONCOMITANT
FOOD POISONING (79) MEDICATION

FDA-CBER-2022-908-0003631
1669
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003632
1670
Listing 16.2.7.13
Safety Set


Musculoskeletal pain/ MEDICATION
RIGHT SHOULDER PAIN

Mallet finger/ Ongoing No CONCOMITANT
RIGHT HAND MALLET FINGER MEDICATION

FDA-CBER-2022-908-0003633
1671
Listing 16.2.7.13
Safety Set


Pneumonia/ 2020-12-13 No NONE
PNEUMONIA (84)

Hot flush/ (3)/ Yes/ NR APPLICABLE/ RESOLVED
HOT FLASHES 2020-09-03 No NONE
(15)

FDA-CBER-2022-908-0003634
1672
Listing 16.2.7.13
Safety Set


Blood cholesterol (75)/ Yes/ NR CHANGED/ RESOLVING
HIGH CHOLESTEROL MEDICATION


FDA-CBER-2022-908-0003635
1673
Listing 16.2.7.13
Safety Set



RECURRENT URINARY TRACT (127) MEDICATION
INFECTION

FDA-CBER-2022-908-0003636
1674
Listing 16.2.7.13
Safety Set



MEDICATION

FDA-CBER-2022-908-0003637
1675
Listing 16.2.7.13
Safety Set


Dermatitis allergic/ 2020-09-18 No CONCOMITANT
OTIS EXTERNA DERMATITIS, (29) MEDICATION
ALLERGIC

COVID-19 LIKE SYMPTOMS (50) MEDICATION

FDA-CBER-2022-908-0003638
1676
Listing 16.2.7.13
Safety Set



COVID-LIKE ILNESS (57) MEDICATION

FDA-CBER-2022-908-0003639
1677
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003640
1678
Listing 16.2.7.13
Safety Set


Proctalgia/ 2020-11-11 No CONCOMITANT
ANORECTAL PAIN (51) MEDICATION

Gastrointestinal pain/ 2020-11-11 No CONCOMITANT
COLON SPASM (51) MEDICATION

FDA-CBER-2022-908-0003641
1679
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003642
1680
Listing 16.2.7.13
Safety Set


Restless legs syndrome/ (85)/ Yes/ NR APPLICABLE/ RESOLVING
RESTLESS LEG SYNDROME Ongoing No CONCOMITANT
MEDICATION

Generalised anxiety (20)/ Yes/ NR APPLICABLE/ RESOLVING
GENERALIZED ANXIETY MEDICATION
DISORDER

FDA-CBER-2022-908-0003643
1681
Listing 16.2.7.13
Safety Set


Vascular disorders/ 2021-02-05 13:00 Yes/ 1 No NR/ NOT NOT RECOVERED/

MEDICATION

FDA-CBER-2022-908-0003644
1682
Listing 16.2.7.13
Safety Set


Congenital, familial and 2020-09-08 Yes/ 1 No NR/ DOSE NOT RECOVERING/

genetic disorders/ (14)/ Yes/ NR CHANGED/ RESOLVING
Hydrocele/ Ongoing No CONCOMITANT
RIGHT TESTICULAR MEDICATION
HYDROCELE

FDA-CBER-2022-908-0003645
1683
Listing 16.2.7.13
Safety Set


Folliculitis/ Ongoing No CONCOMITANT
FOLLICULITIS MEDICATION
Ear and labyrinth 2021-01-19 Yes/ 2 No NR/ NOT RECOVERING/

Meniere's disease/ Ongoing No CONCOMITANT
WORSENING OF MENIERES MEDICATION
DISEASE

FDA-CBER-2022-908-0003646
1684
Listing 16.2.7.13
Safety Set

Eye disorders/ 2020-12-11 Yes/ 1 No NR/ DOSE NOT RECOVERING/

Conjunctival haemorrhage/ (85)/ Yes/ NR CHANGED/ RESOLVING
SUBCONJUNCTIVAL Ongoing No NONE
HEMORRHAGE

Hand fracture/ Ongoing No CONCOMITANT
FINGER FRACTURE PROCEDURE

FDA-CBER-2022-908-0003647
1685
Listing 16.2.7.13
Safety Set


MEDICATION


FDA-CBER-2022-908-0003648
1686
Listing 16.2.7.13
Safety Set


Mastoiditis/ 2020-09-16 No CONCOMITANT
MASTOIDITIS (20) MEDICATION

COVID-19 pneumonia/ 2020-12-22 No CONCOMITANT
COVID-19 PNEUMONIA (89) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003649
1687
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-12-12 No NONE


FDA-CBER-2022-908-0003650
1688
Listing 16.2.7.13
Safety Set


Hepatic cancer/
LIVER CANCER

FDA-CBER-2022-908-0003651
1689
Listing 16.2.7.13
Safety Set


malignant and (123)/ Yes/ NR APPLICABLE/
Pancreatic carcinoma
stage IV/
STAGE 4 PANCREATIC
CANCER

FDA-CBER-2022-908-0003652
1690
Listing 16.2.7.13
Safety Set



Pericardial effusion/ (12)/ Yes/ (2020-09-14/ NR CHANGED/ RESOLVED
PERICARDITIS EFFUSION 2020-09-15 No 2020-09-15) NONE
(16)

FDA-CBER-2022-908-0003653
1691
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003654
1692
Listing 16.2.7.13
Safety Set


COVID-19/ 2021-01-20 No NONE


FDA-CBER-2022-908-0003655
1693
Listing 16.2.7.13
Safety Set


Blood urine present/ (76)/ Yes/ NR CHANGED/ RESOLVED
BLOOD IN URINE 2020-12-16 No CONCOMITANT
(80) MEDICATION


FDA-CBER-2022-908-0003656
1694
Listing 16.2.7.13
Safety Set



Road traffic accident/ 2020-10-28 No CONCOMITANT
BICYCLE ACCIDENT (29) MEDICATION

FDA-CBER-2022-908-0003657
1695
Listing 16.2.7.13
Safety Set


Skin abrasion/ 2020-10-28 No NONE
ABRASIONS ON ARMS AND (29)
KNEES

Haematoma/ (17)/ Yes/ NR CHANGED/ RESOLVED
L HIP HEMATOMA 2020-10-28 No NONE
(29)

FDA-CBER-2022-908-0003658
1696
Listing 16.2.7.13
Safety Set



COVID LIKE ILLNESS (15) MEDICATION

FDA-CBER-2022-908-0003659
1697
Listing 16.2.7.13
Safety Set


MEDICATION


FDA-CBER-2022-908-0003660
1698
Listing 16.2.7.13
Safety Set


HUMAN RHINOVIRUS (COLD (106) MEDICATION
SYMPTOMS)


FDA-CBER-2022-908-0003661
1699
Listing 16.2.7.13
Safety Set


Fatigue/ (31)
FATIGUE

BODY ACHES

FDA-CBER-2022-908-0003662
1700
Listing 16.2.7.13
Safety Set


(17) MEDICATION

Chills/ (10)
CHILLS

FDA-CBER-2022-908-0003663
1701
Listing 16.2.7.13
Safety Set


disorders/ 2020-11-22 No 2020-11-25)/6 NONE
Pulmonary fibrosis/ (21)
PULMONARY FIBROSIS

RLL PNEUMONIA (24) MEDICATION

FDA-CBER-2022-908-0003664
1702
Listing 16.2.7.13
Safety Set


HYPOXIA DUE TO RLL
PNEUMONIA

Coccidioidomycosis/ 2020-12-02 No 2020-11-25) CONCOMITANT
VALLEY FEVER (31) MEDICATION

FDA-CBER-2022-908-0003665
1703
Listing 16.2.7.13
Safety Set


Headache/ (11)/ Yes/ NR APPLICABLE/ RESOLVING
WORSENING HEADACHES Ongoing Yes CONCOMITANT
MEDICATION

MEDICATION

FDA-CBER-2022-908-0003666
1704
Listing 16.2.7.13
Safety Set

Vascular disorders/ 2020-11-04 Yes/ 1 No NA/ DOSE NOT RECOVERING/

MEDICATION


FDA-CBER-2022-908-0003667
1705
Listing 16.2.7.13
Safety Set



Vulvovaginal mycotic 2021-01-22 No CONCOMITANT
VAGINAL YEAST INFECTION

FDA-CBER-2022-908-0003668
1706
Listing 16.2.7.13
Safety Set



Hot flush/ (59)/ Yes/ NR APPLICABLE/ RESOLVING
HOT FLASHES Ongoing No CONCOMITANT
MEDICATION

FDA-CBER-2022-908-0003669
1707
Listing 16.2.7.13
Safety Set



FALL FROM ONE LEVEL TO (4)
ANOTHER

FDA-CBER-2022-908-0003670
1708
Listing 16.2.7.13
Safety Set


Contusion/ 2020-11-12 No NONE
CHEST CONTUSSION (25)


FDA-CBER-2022-908-0003671
1709
Listing 16.2.7.13
Safety Set



Oral herpes/ 2021-02-24 No CONCOMITANT
COLD SORES (104) MEDICATION

FDA-CBER-2022-908-0003672
1710
Listing 16.2.7.13
Safety Set


Bartholin's cyst/ 2021-01-22 No CONCOMITANT
BARTHOLIN'S CYST (67) MEDICATION,
CONCOMITANT
PROCEDURE

MEDICATION

FDA-CBER-2022-908-0003673
1711
Listing 16.2.7.13
Safety Set



UPPER RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003674
1712
Listing 16.2.7.13
Safety Set


STREP THROAT

UPPER RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003675
1713
Listing 16.2.7.13
Safety Set


Enterovirus infection/ 2020-12-08 No NONE
RESPIRATORY ENTEROVIRUS (20)

Rhinovirus infection/ 2020-12-08 No NONE
RESPIRATORY RHINOVIRUS (20)

FDA-CBER-2022-908-0003676
1714
Listing 16.2.7.13
Safety Set


COVID-LIKE SYMPTOMS (20)

MEDICATION

FDA-CBER-2022-908-0003677
1715
Listing 16.2.7.13
Safety Set


(15) MEDICATION

SORE THROAT

FDA-CBER-2022-908-0003678
1716
Listing 16.2.7.13
Safety Set


LOW BACK PAIN

MEDICATION

FDA-CBER-2022-908-0003679
1717
Listing 16.2.7.13
Safety Set



infection/ (33)
URI- PATHOGEN UNKNOWN

FDA-CBER-2022-908-0003680
1718
Listing 16.2.7.13
Safety Set


Vascular disorders/ 2021-01-16 Yes/ 2 No NR/ DOSE UNKNOWN

Hypertension/ (129)/ Yes/ NR DELAYED/

FDA-CBER-2022-908-0003681
1719
Listing 16.2.7.13
Safety Set


infection/ (131)

STREP THROAT

FDA-CBER-2022-908-0003682
1720
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003683
1721
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION

Rhinitis allergic/ (36)
ALLERGIC RHINITIS

FDA-CBER-2022-908-0003684
1722
Listing 16.2.7.13
Safety Set



COVID - 19 (72) MEDICATION

FDA-CBER-2022-908-0003685
1723
Listing 16.2.7.13
Safety Set



MEDICATION

FDA-CBER-2022-908-0003686
1724
Listing 16.2.7.13
Safety Set


URI- PATHOGEN RHINOVIRUS (72)

MEDICATION

FDA-CBER-2022-908-0003687
1725
Listing 16.2.7.13
Safety Set


(14)

SORE THROAT

FDA-CBER-2022-908-0003688
1726
Listing 16.2.7.13
Safety Set



Gastric ulcer/ Ongoing No CONCOMITANT
GASTRIC ULCER WITHOUT MEDICATION
HEMORRHAGE OR
PERFORATION

FDA-CBER-2022-908-0003689
1727
Listing 16.2.7.13
Safety Set


Hypertriglyceridaemia/ Ongoing No CONCOMITANT
HYPERTRIGLYCERIDEMIA MEDICATION

TYPE 2 DIABETES MELLITUS MEDICATION

FDA-CBER-2022-908-0003690
1728
Listing 16.2.7.13
Safety Set


Suicidal ideation/ (120)/ Yes/ NR APPLICABLE/ RESOLVED
SUICIDAL IDEATIONS 2021-01-22 No NONE
(127)

UNSPECIFIED

FDA-CBER-2022-908-0003691
1729
Listing 16.2.7.13
Safety Set


Constipation/ 2021-01-29 No CONCOMITANT
CONSTIPATION (134) MEDICATION

ACUTE HYPOXIC PROCEDURE
RESPIRATORY FAILURE

FDA-CBER-2022-908-0003692
1730
Listing 16.2.7.13
Safety Set



Gastritis/ 2021-02-09 No CONCOMITANT
UNSPECIFIED GASTRITIS (145) MEDICATION
WITHOUT BLEEDING

FDA-CBER-2022-908-0003693
1731
Listing 16.2.7.13
Safety Set


Ileus paralytic/ 2021-02-09 No NONE
ADYNAMIC ILEUS (145)

Pancreatitis/ 2021-02-09 No 2021-02-09) CONCOMITANT
PANCREATITIS (145) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003694
1732
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003695
1733
Listing 16.2.7.13
Safety Set


Electrolyte imbalance/ 2021-02-09 No CONCOMITANT
INTERMITTENT ELECTROLYTE (145) MEDICATION
IMBALANCES

Alcohol withdrawal (120)/ Yes/ NR APPLICABLE/ RESOLVED
syndrome/ 2021-02-09 No CONCOMITANT
ALCOHOL WITHDRAWAL (145) MEDICATION

FDA-CBER-2022-908-0003696
1734
Listing 16.2.7.13
Safety Set


MEDICATION

Ascites/ 2021-02-04 No CONCOMITANT
LOCULATED ASCITES (140) PROCEDURE

FDA-CBER-2022-908-0003697
1735
Listing 16.2.7.13
Safety Set


Dysphonia/ (191)
DYSPHONIA
Respiratory, thoracic 2021-02-06 Yes/ 2 No NR/ NOT RECOVERING/

and mediastinal (142)/ Yes/ NR APPLICABLE/ RESOLVING
Dyspnoea/ MEDICATION
DYSPNEA

FDA-CBER-2022-908-0003698
1736
Listing 16.2.7.13
Safety Set


NERVE PAIN IN NECK-
WORSENING

URI

FDA-CBER-2022-908-0003699
1737
Listing 16.2.7.13
Safety Set


Diverticulitis/ 2020-11-30 No NONE
DIVERTICULITIS (82)

Amenorrhoea/ 2020-10-22 No CONCOMITANT
AMENORRHEA (31) MEDICATION

FDA-CBER-2022-908-0003700
1738
Listing 16.2.7.13
Safety Set



COUGH

FDA-CBER-2022-908-0003701
1739
Listing 16.2.7.13
Safety Set


Foot deformity/ (91) PROCEDURE
WORSENING OF RIGHT
BUNION

FDA-CBER-2022-908-0003702
1740
Listing 16.2.7.13
Safety Set


Plantar fasciitis/ MEDICATION
BILATERAL PLANTAR
FASCIITIS

Rhinorrhoea/ (56)
RHINORRHEA

FDA-CBER-2022-908-0003703
1741
Listing 16.2.7.13
Safety Set



FATIGUE

FDA-CBER-2022-908-0003704
1742
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003705
1743
Listing 16.2.7.13
Safety Set


RIGHT SCIATICA PAIN 2021-02-04 No CONCOMITANT
(135) MEDICATION

HYPOTENSION 2021-02-04 No CONCOMITANT
(135) MEDICATION

FDA-CBER-2022-908-0003706
1744
Listing 16.2.7.13
Safety Set


Oropharyngeal pain/ MEDICATION
SORE THROAT

(16)

FDA-CBER-2022-908-0003707
1745
Listing 16.2.7.13
Safety Set




FDA-CBER-2022-908-0003708
1746
Listing 16.2.7.13
Safety Set


Chills/ (18)
CHILLS

FDA-CBER-2022-908-0003709
1747
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION OF UNKNOWN
ETIOLOGY

FDA-CBER-2022-908-0003710
1748
Listing 16.2.7.13
Safety Set


infection/ (49)

infection/ (65)

FDA-CBER-2022-908-0003711
1749
Listing 16.2.7.13
Safety Set


infection/ (82)

infection/ (103)

FDA-CBER-2022-908-0003712
1750
Listing 16.2.7.13
Safety Set


DENTAL INFECTION (40) MEDICATION,
CONCOMITANT
PROCEDURE

infection/ (99)
URI

FDA-CBER-2022-908-0003713
1751
Listing 16.2.7.13
Safety Set


Breast cancer/ CONCOMITANT
NONMETASTATIC BREAST PROCEDURE
CANCER

SPRAINED RIGHT KNEE (21) MEDICATION

FDA-CBER-2022-908-0003714
1752
Listing 16.2.7.13
Safety Set

Social circumstances/ 2020-12-01 Yes/ 1 No NR/ NOT RECOVERED/

Postmenopause/ (82)/ Yes/ NR APPLICABLE/ RESOLVED
POSTMENOPAUSAL 2020-12-01 No NONE
(82)

LACERATION TO LEFT SHIN (34) MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003715
1753
Listing 16.2.7.13
Safety Set



RASH- GENERALIZED, (61) MEDICATION
NONURTICARIAL

FDA-CBER-2022-908-0003716
1754
Listing 16.2.7.13
Safety Set


LACERATION LEFT 4TH (36)
DIGIT


FDA-CBER-2022-908-0003717
1755
Listing 16.2.7.13
Safety Set


Chronic obstructive MEDICATION
pulmonary disease/
DISEASE

FDA-CBER-2022-908-0003718
1756
Listing 16.2.7.13
Safety Set


Bipolar disorder/ (87)/ Yes/ NR APPLICABLE/ NOT RESOLVED
WORSENING OF BIPOLAR Ongoing No CONCOMITANT
DISORDER MEDICATION

infection/ (120)
URI- PATHOGEN UNKNOWN;
PROBABLY VIRAL

FDA-CBER-2022-908-0003719
1757
Listing 16.2.7.13
Safety Set


infection/ (24)
UPPER RESPIRATORY
INFECTION UNKNOWN CAUSE

WORSENING DIARRHEA (25) MEDICATION

FDA-CBER-2022-908-0003720
1758
Listing 16.2.7.13
Safety Set



LACERATION TO LEFT HAND (31) MEDICATION,
INDEX FINGER CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003721
1759
Listing 16.2.7.13
Safety Set


MEDICATION

RIGHT ANKLE SPRAIN (120)

FDA-CBER-2022-908-0003722
1760
Listing 16.2.7.13
Safety Set



Bone contusion/ 2020-11-18 No NONE
BRUISED RIBS (63)

FDA-CBER-2022-908-0003723
1761
Listing 16.2.7.13
Safety Set


Hiatus hernia/ Ongoing No CONCOMITANT
HIATAL HERNIA MEDICATION

PUNCTURE INJURY TO LEFT (89) MEDICATION
FOREFINGER

FDA-CBER-2022-908-0003724
1762
Listing 16.2.7.13
Safety Set



VERTIGO MEDICATION

FDA-CBER-2022-908-0003725
1763
Listing 16.2.7.13
Safety Set


Upper respiratory tract (96) MEDICATION
congestion/
UPPER RESPIRATORY
CONGESTION- UNKNOWN
CAUSE

FDA-CBER-2022-908-0003726
1764
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION - PATHOGEN
UNKNOWN

FDA-CBER-2022-908-0003727
1765
Listing 16.2.7.13
Safety Set


infection/ (45)
UPPER RESPIRATORY
INFECTION

SHORTNESS OF BREATH

FDA-CBER-2022-908-0003728
1766
Listing 16.2.7.13
Safety Set



URI

FDA-CBER-2022-908-0003729
1767
Listing 16.2.7.13
Safety Set


infection/ (121)

FDA-CBER-2022-908-0003730
1768
Listing 16.2.7.13
Safety Set


Benign prostatic 2020-12-18 No 2020-12-18) CONCOMITANT
hyperplasia/ (85) MEDICATION,
WORSENING OF ENLARGED CONCOMITANT
PROSTATE (BENIGN PROCEDURE
PROSTATIC HYPERPLASIA)

FDA-CBER-2022-908-0003731
1769
Listing 16.2.7.13
Safety Set


STREP THROAT

LACERATIONS TO BOTH (112) MEDICATION
HANDS

FDA-CBER-2022-908-0003732
1770
Listing 16.2.7.13
Safety Set


SYNCOPE (HYPOTENSIVE 2021-01-14 No NONE
EPISODE) (112)


FDA-CBER-2022-908-0003733
1771
Listing 16.2.7.13
Safety Set


INFECTED TOOTH (40) MEDICATION


FDA-CBER-2022-908-0003734
1772
Listing 16.2.7.13
Safety Set


Fungal skin infection/ 2020-10-01 No CONCOMITANT
FUNGAL INFECTION- SKIN- (38) MEDICATION
RIGHT LEG


FDA-CBER-2022-908-0003735
1773
Listing 16.2.7.13
Safety Set


Pyrexia/ (29)
FEVER

disease/ MEDICATION
ACID REFLUX

FDA-CBER-2022-908-0003736
1774
Listing 16.2.7.13
Safety Set



UPPER RESPIRATORY
INFECTION - UNKNOWN
PATHOGEN

FDA-CBER-2022-908-0003737
1775
Listing 16.2.7.13
Safety Set


RESTLESS LEG SYNDROME Ongoing No NONE


FDA-CBER-2022-908-0003738
1776
Listing 16.2.7.13
Safety Set


FEVER UNKNOWN CAUSE

FDA-CBER-2022-908-0003739
1777
Listing 16.2.7.13
Safety Set


infection/ (57)
UPPER RESPIRATORY
INFECTION (URI)-
PATHOGEN UNKNOWN

MEDICATION

FDA-CBER-2022-908-0003740
1778
Listing 16.2.7.13
Safety Set



COVID-19/ 2020-12-12 No NONE
COVID-19 (68)

FDA-CBER-2022-908-0003741
1779
Listing 16.2.7.13
Safety Set


Viral upper respiratory 2020-10-23 No NONE
tract infection/ (25)
URI- PROBABLY VIRAL

STREP THROAT

FDA-CBER-2022-908-0003742
1780
Listing 16.2.7.13
Safety Set


WORSENING BODY ACHES-
GENERAL, ARMS, LEGS

Wheezing/ (66) MEDICATION
WHEEZING

FDA-CBER-2022-908-0003743
1781
Listing 16.2.7.13
Safety Set

Reproductive system and 2020-12-01 Yes/ 1 No NR/ NOT UNKNOWN

breast disorders/ (63)/ Yes/ NR APPLICABLE/
Breast mass/ Ongoing No NONE
BILATERAL BREAST LUMPS
Endocrine disorders/ 2020-12-15 Yes/ 1 No NR/ NOT RECOVERED/

Hypothyroidism/ (76)/ Yes/ NR APPLICABLE/ RESOLVED
HYPOTHYROIDISM 2021-02-16 No CONCOMITANT
(139) MEDICATION

FDA-CBER-2022-908-0003744
1782
Listing 16.2.7.13
Safety Set

Endocrine disorders/ 2020-11-03 Yes/ 1 No NR/ NOT RECOVERED/

Hyperthyroidism/ (34)/ Yes/ NR APPLICABLE/ RESOLVED
HYPERTHYROIDISM (64) MEDICATION

OSTEOARTHRITIS BOTH
KNEES

FDA-CBER-2022-908-0003745
1783
Listing 16.2.7.13
Safety Set


MEDICATION


FDA-CBER-2022-908-0003746
1784
Listing 16.2.7.13
Safety Set

Infections and 2020-12-01 Yes/ Yes/3 NOT RECOVERED/

infestations/ (93)/ Yes/ (2020-12-07/ APPLICABLE/ RESOLVED

COVID 19 (PNEUMONIA) (109) MEDICATION

FDA-CBER-2022-908-0003747
1785
Listing 16.2.7.13
Safety Set


Liver function test (99)/ Yes/ NA CHANGED/ RESOLVED
ELEVATED LFTS (218)
WORSENING OF ERECTILE MEDICATION
DYSFUNCTION

FDA-CBER-2022-908-0003748
1786
Listing 16.2.7.13
Safety Set


Arthropod sting/ 2020-11-11 No CONCOMITANT
BEE STING OF RIGHT (73) MEDICATION
MIDDLE FINGER

infection/ (136)
UPPER RESPIRATORY
ILLNESS

FDA-CBER-2022-908-0003749
1787
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION

BILATERAL PYELONEPHRITIS (137) MEDICATION

FDA-CBER-2022-908-0003750
1788
Listing 16.2.7.13
Safety Set

Blood and lymphatic 2020-09-09 Yes/ 1 No NR/ DOSE NOT RECOVERING/

system disorders/ (27)/ Yes/ NR CHANGED/ RESOLVING
Iron deficiency anaemia/ Ongoing No CONCOMITANT
IRON DEFICIENCY ANEMIA MEDICATION

Lymphoedema/ (29)/ Yes/ NR CHANGED/ RESOLVED
WORSENING LYMPHEDEMA, 2020-09-15 No NONE
LEFT LOWER LEG (33)

FDA-CBER-2022-908-0003751
1789
Listing 16.2.7.13
Safety Set


ACUTE ASTHMA
EXACERBATION

(58) MEDICATION

FDA-CBER-2022-908-0003752
1790
Listing 16.2.7.13
Safety Set


Fatigue/ (64)
FATIGUE

Myalgia/ (64)
MYALGIA

FDA-CBER-2022-908-0003753
1791
Listing 16.2.7.13
Safety Set

BROKEN 5TH METATARSAL PROCEDURE
LEFT
disorders/ (78)/ Yes/ NA CHANGED/ NOT RESOLVED
WORSENING OF DIABETES MEDICATION
MELLITUS II

FDA-CBER-2022-908-0003754
1792
Listing 16.2.7.13
Safety Set



FDA-CBER-2022-908-0003755
1793
Listing 16.2.7.13
Safety Set


LOWER BACK PAIN


FDA-CBER-2022-908-0003756
1794
Listing 16.2.7.13
Safety Set


POST OPERATIVE PAIN (32) MEDICATION

FDA-CBER-2022-908-0003757
1795
Listing 16.2.7.13
Safety Set


Osteoarthritis/
OSTEOARTHRITIS OF RIGHT
KNEE

FDA-CBER-2022-908-0003758
1796
Listing 16.2.7.13
Safety Set


Conjunctivitis bacterial/ 2020-09-22 No CONCOMITANT
BACTERIAL (21) MEDICATION
CONJUNCTIVITIS, RIGHT
EYE


FDA-CBER-2022-908-0003759
1797
Listing 16.2.7.13
Safety Set



HUMAN (150)
ENTEROVIRUS/RHINOVIRUS

FDA-CBER-2022-908-0003760
1798
Listing 16.2.7.13
Safety Set



pain/
MUSCULAR CHEST WALL PAIN

FDA-CBER-2022-908-0003761
1799
Listing 16.2.7.13
Safety Set


Myalgia/ (52)
MYALGIA

(52)

FDA-CBER-2022-908-0003762
1800
Listing 16.2.7.13
Safety Set


Dyspnoea/ (51)
DYSPNEA

Cough/ (56)
COUGH

FDA-CBER-2022-908-0003763
1801
Listing 16.2.7.13
Safety Set


Bursitis/ (33) MEDICATION,
WORSENING BURSITIS OF CONCOMITANT
RIGHT HIP PROCEDURE

FDA-CBER-2022-908-0003764
1802
Listing 16.2.7.13
Safety Set


DEGENERATIVE JOINT
DISEASE

FDA-CBER-2022-908-0003765
1803
Listing 16.2.7.13
Safety Set


LACERATION OF LEFT INDEX (52) MEDICATION,
FINGER CONCOMITANT
PROCEDURE

Cellulitis/ Ongoing No CONCOMITANT
CELLULITIS OF RIGHT BIG MEDICATION
TOE

FDA-CBER-2022-908-0003766
1804
Listing 16.2.7.13
Safety Set


OTITIS EXTERNA (36) MEDICATION

UPPER RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003767
1805
Listing 16.2.7.13
Safety Set


COVID-19/ 2020-11-30 No NONE

COVID 19 (104) MEDICATION JOINT PAIN

FDA-CBER-2022-908-0003768
1806
Listing 16.2.7.13
Safety Set


RIGHT HIP PAIN

LUMBAGO

FDA-CBER-2022-908-0003769
1807
Listing 16.2.7.13
Safety Set


RIGHT KNEE PAIN

WORSENING OF RIGHT HIP
PAIN

FDA-CBER-2022-908-0003770
1808
Listing 16.2.7.13
Safety Set


MUSCLE SPASM OF RIGHT
LOWER BACK AND RIGHT HIP

FDA-CBER-2022-908-0003771
1809
Listing 16.2.7.13
Safety Set


Intervertebral disc
protrusion/
BULGING DISK (L1 & L2)

FDA-CBER-2022-908-0003772
1810
Listing 16.2.7.13
Safety Set


breast disorders/ (136)/ Yes/ NA CHANGED/ RESOLVED
Benign prostatic 2021-03-08 No CONCOMITANT
hyperplasia/ (182) MEDICATION
WORSENING OF BENIGN
PROSTATIC HYPERPLASIA

Prostatic specific (147)/ Yes/ NA CHANGED/ NOT RESOLVED
antigen increased/ Ongoing No NONE
ELEVATED PSA

FDA-CBER-2022-908-0003773
1811
Listing 16.2.7.13
Safety Set



Tendon rupture/ Ongoing No NONE
RIGHT 5TH DIGIT TENDON
RUPTURE

FDA-CBER-2022-908-0003774
1812
Listing 16.2.7.13
Safety Set


BACK PAIN DUE TO MOTOR MEDICATION
VEHICLE ACCIDENT

CERVICAL PAIN DUE TO MEDICATION
MOTOR VEHICLE ACCIDENT

FDA-CBER-2022-908-0003775
1813
Listing 16.2.7.13
Safety Set


procedural complications/ (46)/ Yes/ NA CHANGED/ RESOLVED

FRACTURED LEFT FOOT MEDICATION,
CONCOMITANT
PROCEDURE

FDA-CBER-2022-908-0003776
1814
Listing 16.2.7.13
Safety Set


infestations/ (86)/ Yes/ NA CHANGED/ NOT RESOLVED
Postoperative wound Ongoing No CONCOMITANT
POSTOPERATIVE WOUND
INFECTION, LEFT FOOT

FDA-CBER-2022-908-0003777
1815
Listing 16.2.7.13
Safety Set


UPPER RESPIRATORY
INFECTION


FDA-CBER-2022-908-0003778
1816
Listing 16.2.7.13
Safety Set


POISON IVY DERMATITIS (77) MEDICATION

Skin candida/ Ongoing No CONCOMITANT
CUTANEOUS CANDIDIASIS OF MEDICATION
TORSO

FDA-CBER-2022-908-0003779
1817
Listing 16.2.7.13
Safety Set


tissue disorders/ (118)/ Yes/ NA CHANGED/ RESOLVING
ECZEMA LOWER MIDSTERNUM MEDICATION

COVID-19 (122) MEDICATION ANOSMIA

FDA-CBER-2022-908-0003780
1818
Listing 16.2.7.13
Safety Set

Subject ID: US3212143; Age (years): 48; Sex: M; Race: OTHER: LATIN AMERICAN; Height (cm): 177.8; Weight (kg): 108.5; BMI
Nervous system disorders/ 2020-08-12 12:38 No/ 2 No NR/ DOSE NOT RECOVERED/
Syncope/ (1)/ Yes/ NR CHANGED/ RESOLVED
VASOVAGAL SYNCOPE 2020-08-12 12:39 No NONE
(1)

WORSENING OF RIGHT KNEE
OSTEOARTHRITIS PAIN

FDA-CBER-2022-908-0003781
1819
Listing 16.2.7.13
Safety Set



Joint injury/ 2020-09-03 No NONE
RIGHT WRIST INJURY (23)

FDA-CBER-2022-908-0003782
1820
Listing 16.2.7.13
Safety Set


Limb injury/ 2020-09-03 No NONE
RIGHT 4TH DIGIT INURY (23)

procedural complications/ (23)/ Yes/ NR CHANGED/ RESOLVED WITH
Limb injury/ 2020-09-03 No NONE SEQUELAE:
RIGHT THIGH INJURY (23) RIGHT THIGH
BRUISE

FDA-CBER-2022-908-0003783
1821
Listing 16.2.7.13
Safety Set



UPPER RESPIRATORY (74) MEDICATION
INFECTION DUE TO
RHINOVIRUS/ENTEROVIRUS

FDA-CBER-2022-908-0003784
1822
Listing 16.2.7.13
Safety Set


(104) MEDICATION


FDA-CBER-2022-908-0003785
1823
Listing 16.2.7.13
Safety Set


(160) MEDICATION

Foot fracture/ 2020-11-11 No NONE
5TH METATARSAL FX, LEFT (64)
LOWER EXTREMITY

FDA-CBER-2022-908-0003786
1824
Listing 16.2.7.13
Safety Set



UPPER RESPIRATORY
INFECTION

FDA-CBER-2022-908-0003787
1825
Listing 16.2.7.13
Safety Set

Nervous system disorders/ 2020-08-13 11:58 No/ 2 No NR/ NOT RECOVERED/

VASOVAGAL SYNCOPE 2020-08-13 11:59 No NONE
(1)

tissue disorders/ (146)/ Yes/ NA CHANGED/ RESOLVING
Dermatitis contact/ Ongoing No CONCOMITANT
AXILLARY CONTACT MEDICATION
DERMATITIS, BILATERAL

FDA-CBER-2022-908-0003788
1826
Listing 16.2.7.13
Safety Set


Spinal osteoarthritis/ MEDICATION
WORSENING OF
OSTEOARTHRITIS OF LUMBAR
SPINE


FDA-CBER-2022-908-0003789
1827
Listing 16.2.7.13
Safety Set


Upper limb fracture/ Ongoing No CONCOMITANT
LEFT SHOULDER FRACTURE MEDICATION


FDA-CBER-2022-908-0003790
1828
Listing 16.2.7.13
Safety Set


POST-TRAUMATIC RIGHT HIP (34) MEDICATION
PAIN

Fractured coccyx/ Ongoing No CONCOMITANT
FRACTURED COCCYX MEDICATION

FDA-CBER-2022-908-0003791
1829
Listing 16.2.7.13
Safety Set

Musculoskeletal and 2020-09-14 Yes/ 2 No NR/ DOSE RECOVERED/

connective tissue (32)/ Yes/ NR DELAYED/ RESOLVED
WORSENING OF LOWER BACK
PAIN


FDA-CBER-2022-908-0003792
1830
Listing 16.2.7.13
Safety Set


VAGINAL CANDIDIASIS (85) MEDICATION


FDA-CBER-2022-908-0003793
1831
Listing 16.2.7.13
Safety Set


AUTOIMMUNE RASH (214) MEDICATION
SECONDARY TO COVID 19

STREP PHARYNGITIS

FDA-CBER-2022-908-0003794
1832
Listing 16.2.7.13
Safety Set


Rash pruritic/ 2020-11-14 No CONCOMITANT
PURITIC RASH OF (47) MEDICATION
BILATERAL HANDS, ARMS
AND LEGS

SORE THROAT

FDA-CBER-2022-908-0003795
1833
Listing 16.2.7.13
Safety Set


FATIGUE

MYALGIA

FDA-CBER-2022-908-0003796
1834
Listing 16.2.7.13
Safety Set


(20) MEDICATION

Cough/ (20)
COUGH

FDA-CBER-2022-908-0003797
1835
Listing 16.2.7.13
Safety Set


NASAL CONGESTION

INFLUENZA A (85) MEDICATION

FDA-CBER-2022-908-0003798
1836
Listing 16.2.7.13
Safety Set


CONTACT DERMATITIS - (31) MEDICATION
RIGHT JAWLINE

infection/ (118)
UPPER RESPIRATORY
ILLNESS

FDA-CBER-2022-908-0003799
1837
Listing 16.2.7.13
Safety Set



FDA-CBER-2022-908-0003800
1838
Listing 16.2.7.13
Safety Set


infection/ (112)
UPPER RESPIRATORY
INFECTION


FDA-CBER-2022-908-0003801
1839
Listing 16.2.7.13
Safety Set


Periarthritis/ MEDICATION,
RIGHT SHOULDER ADHESIVE CONCOMITANT
CAPSULITIS PROCEDURE

FDA-CBER-2022-908-0003802
1840
Listing 16.2.7.13
Safety Set


ACUTE UPPER RESPIRATORY (37) MEDICATION
INFECTION DUE TO
RHINOVIRUS/ENTEROVIRUS


FDA-CBER-2022-908-0003803
1841
Listing 16.2.7.13
Safety Set


HUMAN (117) MEDICATION
ENTEROVIRUS/RHINOVIRUS


FDA-CBER-2022-908-0003804
1842
Listing 16.2.7.13
Safety Set


TOOTH DECAY (49) MEDICATION,
CONCOMITANT
PROCEDURE


FDA-CBER-2022-908-0003805
1843
Listing 16.2.7.13
Safety Set


NEPHROLITHIASIS (29) MEDICATION

LEFT CERVICAL
LYMPHADENOPATHY-ACUTE
SITE

FDA-CBER-2022-908-0003806
1844
Listing 16.2.7.13
Safety Set


disease/ MEDICATION
DISEASE


FDA-CBER-2022-908-0003807
1845
Listing 16.2.7.13
Safety Set



Conjunctivitis allergic/ (23)/ Yes/ NR CHANGED/ RESOLVED
ACUTE CONJUNCTIVITIS - 2020-09-14 No NONE
ALLERGIC (26)

FDA-CBER-2022-908-0003808
1846
Listing 16.2.7.13
Safety Set

Nervous system disorders/ 2020-11-10 Yes/ 1 No NR/ DOSE NOT NOT RECOVERED/
Ageusia/ (56)/ Yes/ NR CHANGED/ NOT RESOLVED
LOSS OF TASTE Ongoing No NONE
In

1 Moderna Clinical Study Report 16.2.7 Adverse Event Listing May 2021 11505 Pages

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1 Moderna Clinical Study Report 16.2.7 Adverse Event Listing May 2021 11505 Pages

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16.2.7 Adverse Event Listings (Each Participant)

Listing 16.2.7.8 Unsolicited Treatment-Related Severe TEAE Safety Set

Listing 16.2.7.10 Serious Treatment-Related Adverse Events Safety Set

Listing 16.2.7.11 Unsolicited Adverse Events Leading to Discontinuation from Study

Listing 16.2.7.12 Unsolicited Adverse Events Leading to Discontinuation from Participation

Listing 16.2.7.13 Unsolicited Medically-Attended Adverse Events Safety Set

Listing 16.2.7.14 Unsolicited Adverse Events Leading to Death Safety Set

Listing 16.2.7.18 Unsolicited Adverse Events - Vasculitis Safety Set

Listing 16.2.7.20 Unsolicited Adverse Events - Arthritis Safety Set

Listing 16.2.7.21 Unsolicited Adverse Events - Angioedema Safety Set

Listing 16.2.7.22 Unsolicited Adverse Events - Peripheral Neuropathy Safety Set

Listing 16.2.7.23 Unsolicited Adverse Events - Demyelinating Disease of Central Nervous

Listing 16.2.7.24 Unsolicited Adverse Events - Convulsions Safety Set

Listing 16.2.7.28 Unsolicited Adverse Events - Anaphylaxis Safety Set

Listing 16.2.7.30 Unsolicited Adverse Events - Autoimmune Disorder Safety Set

Listing 16.2.7.35 Unsolicited Adverse Events - Bell's Palsy Safety Set

Listing 16.2.12 Death Listing Safety Set

Treatment Group: Placebo

Start Date and Time TEAE/ Action Taken

Injury, poisoning and 2020-08-12 Yes/ 3 Yes/3 NR/ DRUG RECOVERED/

Note: Footnotes are listed on the last page.

Treatment Group: Placebo

Start Date and Time TEAE/ Action Taken

Note: Footnotes are listed on the last page.

Treatment Group: Placebo

Start Date and Time TEAE/ Action Taken

Skin and subcutaneous 2020-11-09 Yes/ 3 No NR/ NOT RECOVERED/

Note: Footnotes are listed on the last page.

Treatment Group: Placebo

Start Date and Time TEAE/ Action Taken

Note: Footnotes are listed on the last page.

Treatment Group: Placebo

Start Date and Time TEAE/ Action Taken

Note: Footnotes are listed on the last page.

Treatment Group: Placebo

Start Date and Time TEAE/ Action Taken

Note: Footnotes are listed on the last page.

Treatment Group: Placebo

Start Date and Time TEAE/ Action Taken

Note: Footnotes are listed on the last page.

Treatment Group: Placebo

Start Date and Time TEAE/ Action Taken

Note: Footnotes are listed on the last page.

Treatment Group: Placebo

Start Date and Time TEAE/ Action Taken

Note: Footnotes are listed on the last page.

Treatment Group: Placebo

Start Date and Time TEAE/ Action Taken

Musculoskeletal and 2020-09-16 Yes/ 3 No NR/ NOT RECOVERED/

Note: Footnotes are listed on the last page.

Treatment Group: Placebo

Start Date and Time TEAE/ Action Taken

Note: Footnotes are listed on the last page.

Treatment Group: Placebo

Start Date and Time TEAE/ Action Taken

Note: Footnotes are listed on the last page.

Treatment Group: Placebo

Start Date and Time TEAE/ Action Taken

Note: Footnotes are listed on the last page.

Treatment Group: Placebo

Start Date and Time TEAE/ Action Taken

Infections and 2020-12-09 Yes/ 3 Yes/2/3 NA/ NOT RECOVERED/