Adverse Event Analysis Dataset

NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER

Reported Term for the Adverse Event
TOOTH PAIN, LEFT LOWER SECOND MOLAR (FROM ROOT CANAL)
EXASPERATION OF POISON IVY RASH LEFT FOREARM/RIGHT UPPER THIGH
MACULOPAPULAR RASH ON CHEST AND ABDOMEN, ALLERGIC REACTION TO NEW SOAP
RASH, UPPER RT HIP (LIKELY DUE TO POISON IVY CONTACT)
POST-OPERATIVE PAIN, TORN LEFT KNEE MENISCUS
LEFT UPPER ARM ECCHYMOSIS, DUE TO INJURY
HIRSUTISM (UNWANTED HAIR GROWTH ON FACE)
LEFT UPPER ARM BRUISING @ THE INJECTION SITE
POISON IVY ALLERGIC CONTACT DERMATITIS - BILATERAL LEGS
SWELLING AT PROXIMAL JOINT 2ND DIGIT RIGHT HAND
LUMP RIGHT AXILLARY REGION IPSILATERAL-SAME SIDE OF VACCINATION SITE
BRUISING RIGHT POSTERIOR HAMSTRING UNKNOWN
WORSENING OF GASTROESOPHAGEAL REFLUX DISEASE
RIGHT EYE IRRITATION SECONDARY TO FOREIGN OBJECT IN EYE
LOCALIZED SWELLING TO RIGHT LOWER EXTREMITY
ELEVATED DIASTOLIC BLOOD PRESSURE GRADE 0 TO GRADE 2 POST VACCINATION
CIRCUMFERENTIAL REDNESS ABOVE INJECTION SITE ON LEFT ARM
CONTACT DERMATITIS (THIGHS, TRUNK, FOREARMS, ANKLES)
SKIN RASH LEFT CHEEK ON FACE (UNKNOWN ETIOLOGY)
CONTACT DERMATITIS BILATERAL ARMS AND BACK
CONTACT DERMATITIS RIGHT FOREARM AND RIGHT THIGH
JOINT ACHES IN SEVERAL JOINTS ALL OVER BODY
ELEVATED BLOOD PRESSURE WITHOUT DIAGNOSIS OF HYPERTENSION
SWOLLEN BLISTERED LIPS (INTERMITTENT ANGIOEDEMA)
PI NOTED INFLAMMATION OF OROPHARNYX AT DAY 15 VISIT
CORONARY CALCIUM SCAN ABNORMAL (ELEVATED)
FEELING OF "PINS AND NEEDLES" IN TONGUE [CAUSALITY, INVESTIGATIONAL PROTOCOL]
FEELING OF "PINS AND NEEDLES" IN EXTREMITIES [CAUSALITY, INVESTIGATIONAL PRODUCT]
CONFIRMED COVID 19 INFECTION (SYMPTOMATIC- FEVER, HEADACHE, HEAVY FEELING IN CHEST, BODY ACHES)
LEFT TRAPEZIUS REGION,TRANSIENT LOCAL MUSCLE PAIN RELATED TO INJECTION
POSTERIOR OROPHARYNX SLIGHT ERYTHEMA (THROAT)
NONSPECIFIC DERMATITIS (RASH ACROSS FOREHEAD AND UPPER BACK)
GENERALIZED JOINT ACHES (DAY 8-DAY 14 AFTER INJECTION)
ITCHING AROUND INJECTION SITE, NO REDNESS
CHEMICAL BURN (MIDDLE STERNUM AND LEFT LATERAL SUPERIOR CHEST)

Dictionary-Derived Term
Computerised tomogram coronary artery abnormal

Body System or Organ Class
Injury, poisoning and procedural complications
Musculoskeletal and connective tissue disorders
General disorders and administration site conditions
Respiratory, thoracic and mediastinal disorders
Reproductive system and breast disorders
Pregnancy, puerperium and perinatal conditions
Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lowest Level Term
Non ST segment elevation myocardial infarction
Elevated blood pressure reading without diagnosis of hypertension

High Level Term
Disturbances in initiating and maintaining sleep
Upper respiratory tract signs and symptoms
Abortions not specified as induced or spontaneous
Lower respiratory tract and lung infections
Haemorrhoids and gastrointestinal varices (excl oesophageal)
Gastrointestinal spastic and hypermotility disorders
Dental and periodontal infections and inflammations
Fat soluble vitamin deficiencies and disorders
Musculoskeletal and connective tissue pain and discomfort
Musculoskeletal and connective tissue infections and inflammations NEC
Abdominal and gastrointestinal injuries NEC
Paranasal sinus disorders (excl infections and neoplasms)
Endocrine abnormalities of gonadal function NEC
Vascular tests NEC (incl blood pressure)
Gastrointestinal and abdominal pains (excl oral and throat)
Menopausal effects on the genitourinary tract
Benign neoplasms gastrointestinal (excl oral cavity)
Gastrointestinal atonic and hypomotility disorders NEC
Gastrointestinal stenosis and obstruction NEC
Central nervous system haemorrhages and cerebrovascular accidents
Bacteria identification and serology (excl mycobacteria)
Skin neoplasms malignant and unspecified (excl melanoma)
Prostatic signs, symptoms and disorders NEC
Conjunctival infections, irritations and inflammations
Pharyngeal disorders (excl infections and neoplasms)
Musculoskeletal and connective tissue conditions NEC

High Level Group Term
Depressed mood disorders and disturbances
Abdominal hernias and other abdominal wall conditions
Purine and pyrimidine metabolism disorders
Endocrine investigations (incl sex hormones)
Glucose metabolism disorders (incl diabetes mellitus)
Procedural related injuries and complications NEC
Inner ear and VIIIth cranial nerve disorders
Gastrointestinal motility and defaecation conditions
Musculoskeletal and connective tissue disorders NEC
Upper respiratory tract disorders (excl infections)
Metabolic, nutritional and blood gas investigations
Cardiac and vascular investigations (excl enzyme tests)
Spleen, lymphatic and reticuloendothelial system disorders
Bone disorders (excl congenital and fractures)
Tendon, ligament and cartilage disorders
Bladder and bladder neck disorders (excl calculi)
Central nervous system vascular disorders
Haematology investigations (incl blood groups)
Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
Anterior eye structural change, deposit and degeneration
Skin neoplasms malignant and unspecified
Prostatic disorders (excl infections and inflammations)
External ear disorders (excl congenital)
Ocular infections, irritations and inflammations
Exposures, chemical injuries and poisoning

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

Recovered/Resolved with Sequelae,Spec
THIS WILL BE APART OF SUBJECT MEDICAL CONDITION
DUE TO SUBJECT BEING DIAGNOSIS IN 2000 BUT WAS NOT PRESCRIBED ANY MEDICATION. THIS WILL CONTINUE TO BE APART OF SUBJECT'S MEDICAL HISTORY

SMQ 09 Name
Central Nervous System Vascular Disorders