ADAE

NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER

Analysis Race
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER

Reported Term for the Adverse Event
Post Surgical pain Spinal hardware removal
worsening of Obsessive Compulsive Disorder
Left deep cervical chain lymph node swelling
Sore (pain) left deltoid- at injection site
enlarged lymph nodes, right anterior cervical nodes
Exacerbation of fibroadenoma of right breast
allergic contact dermatitis involving all extremities (contact with poison sumac)
Torn medial and lateral left knee menisci
WORSENING Attention Deficit Hyper Activity Disorder
Red bump on right index finger at cuticle
Juvenile Osteochondrosis of bilateral fifth metatarsals
left supraclavicular lymph node swelling
transient feeling of pins and needles to torso
Allergic reaction to surgical dressings.
Fracture of middle phalanx of left index finger
Subcutaneous Tissue Abcess Right Earlobe
Left Middle Finger Middle Phalanx Fracture
localized peritonitis, without perforation or gangrene
Current severe episode of major depressive disorder without psychotic features without prior episode

Body System or Organ Class
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
CONGENITAL, FAMILIAL AND GENETIC DISORDERS
REPRODUCTIVE SYSTEM AND BREAST DISORDERS

Lowest Level Term
Laceration of kidney without mention of open wound into cavity

High Level Term
Attention deficit and disruptive behaviour disorders
Skull fractures, facial bone fractures and dislocations
Musculoskeletal and connective tissue pain and discomfort
Physical examination procedures and organ system status
Gastrointestinal and abdominal pains (excl oral and throat)
Gastrointestinal atonic and hypomotility disorders NEC
Upper respiratory tract signs and symptoms
Dental and gingival therapeutic procedures
Musculoskeletal and connective tissue disorders of spine congenital
Nail and nail bed conditions (excl infections and infestations)
Allergies to foods, food additives, drugs and other chemicals
Fat soluble vitamin deficiencies and disorders
Skin structures and soft tissue infections
Product administration errors and issues
Retinal bleeding and vascular disorders (excl retinopathy)
Abdominal and gastrointestinal injuries NEC
Lid, lash and lacrimal infections, irritations and inflammations
Musculoskeletal and connective tissue conditions NEC
Central nervous system disorders congenital NEC

High Level Group Term
Depressed mood disorders and disturbances
Cognitive and attention disorders and disturbances
External ear disorders (excl congenital)
Procedural related injuries and complications NEC
Musculoskeletal and connective tissue disorders NEC
Spleen, lymphatic and reticuloendothelial system disorders
Physical examination and organ system status topics
Gastrointestinal motility and defaecation conditions
Tendon, ligament and cartilage disorders
Musculoskeletal and connective tissue disorders congenital
Inner ear and VIIIth cranial nerve disorders
Upper respiratory tract disorders (excl infections)
Menstrual cycle and uterine bleeding disorders
Medication errors and other product use errors and issues
Retina, choroid and vitreous haemorrhages and vascular disorders
Glucose metabolism disorders (incl diabetes mellitus)
Ocular infections, irritations and inflammations
Therapeutic and nontherapeutic effects (excl toxicity)
Appetite and general nutritional disorders
Suicidal and self-injurious behaviours NEC

Primary System Organ Class
General disorders and administration site conditions
Musculoskeletal and connective tissue disorders
Injury, poisoning and procedural complications
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Respiratory, thoracic and mediastinal disorders
Congenital, familial and genetic disorders
Reproductive system and breast disorders

Event Due to Other Specify
unknown etiology but headache is more than 7 days post COVID vaccine
Most likely due to anxiety/fear of receiving an injection
Local adenopathy. Do not think related to study agent
bacterial infection secondary to puncture wound
overuse injury from running, patellar tendonitis
Environmental, unknown source, per investigator.
Mild swollen lymph node from probable microbial infection, per investigator. (b)(6)
subject chipped tooth while eating hard candy
no organic cause; multiple life stressors
ESCHERICHIA COLI INFECTION, SELF LACERATION
Inadequate Medication treatment for depression

Vaccine Phase
After unblinding and before Vaccination 3

AE data change post EUA snapshot
AEDECOD, AE outcome changed from EUA to sBLA
AE outcome, Actions to the AE, AERELTXT changed from EUA to sBLA
AERELTXT, Minor AE term changed from EUA to sBLA
AE outcome, Minor AE term changed from EUA to sBLA
AEDECOD, AE outcome, Actions to the AE, AERELTXT changed from EUA to sBLA
Actions to the AE changed from EUA to sBLA
AEDECOD, AE outcome, AERELTXT changed from EUA to sBLA
AE outcome, Actions to the AE changed from EUA to sBLA
AE outcome, AE onset date changed from EUA to sBLA