Adverse Events

Link Group ID
VACCINATION 1-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE
VACCINATION 2-DELTOID MUSCLE-LEFT-PAIN AT INJECTION SITE
VACCINATION 2-DELTOID MUSCLE-RIGHT-PAIN AT INJECTION SITE
VACCINATION 1-DELTOID MUSCLE-RIGHT-PAIN AT INJECTION SITE

Reported Term for the Adverse Event
injection site swelling at injection site
proximal non-displaced fracture of the right fibula
exacerbation of history of left shoulder pain
exacerbation of gastroesophageal reflux disease
Exacerbation of degenerative joint disease
Back pain, subjectively described as sciatica
Bruising on the upper left arm deltoid region
Poison Ivy on both legs, both arms, and both wrists.
L middle finger sliced while fixing food
worsening of benign paroxysmal positional vertigo
poison ivy - Righ arm, both hands and legs
laparoscopic right inguinal hernia repair
Congenital right ureteropelvic junction obstruction
SORE INJECTION SITE ARM RADIATING TO NECK
1 MM BRUISING AT INJECTION SITE LEFT DELTOID
erythematous papular rash chest, forehead, cheek
right supraclavicular swollen lymph node
bilateral deep cervical swollen lymph nodes
Muscle Soreness in Arm of Injection site
pain extending from injection site to elbow
Muscle Soreness in arm of injection site
Altered Mobility of Left upper extremity
Left deep cervical chain lymph node swelling
Torn ligament left knee(no further information)
rash on left arm, lower bilateral legs, and lower back
worsening of rash to left arm, bilateral legs, lower back, stomach
Intermittent Bilateral Ankle Pain, Unspecified
Metallic Taste In Mouth Following Vaccination
ACCIDENTAL LEFT THUMB FINGER TIP AMPUTATION
NEOPLASM OF UNCERTAIN BEHAVIOR OF SKIN, LEFT EAR 2mm dark freckle or hemangioma
Left arm muscle tightness at injection site
Bruise on left arm around the injection site
Administration of correct study intervention from incorrect container (product administration error)
Atypical Lobular Hyperplasia Right Breast
Left arm localized soreness at injection site
SUBJECT DOSED WITH ANOTHER SUBJECTS DOSE
Right arm localized swelling at injection site
Right arm hyperpigmentation at injection site
POST-OP PAIN FROM LEFT ROTATOR CUFF REPAIR
LEFT UPPER ARM DERMATITIS AT INJECTION SITE
LOCALIZED LEFT ARM PAIN AT INJECTION SITE
MILD CONCENTRIC LEFT VENTRICULAR HYPERTROPHY
2ND TOE OF RIGHT FOOT BUG BITE INFECTION
1/2 CM BY 1/2 CM BRUISE AT INJECTION SITE
OPEN REDUCTION INTERNAL FIXATION RIGHT RADIUS
RIGHT ARM SORENESS SECONDARY TO INJECTION
BILATERAL STAPH INFECTION TO THE ELBOWS AND HANDS
ACHING UPPER BODY MUSCLES BILATERAL SHOULDERS
ACHING UPPER BODY MUSCLES BILATERAL ARMS
RIGHT LOWER EXTREMITY DEEP VEIN THROMBOSIS
Swollen lymph node - left armpit axillary
SIRVA - shoulder injury related to vaccine administration
Increased temperature of 99 degrees Fahrenheit
Shoulder pain located lateral to deltoid muscle, near acromion.
3mm induration in left antecubital area at the phlebotomy site
Worsening and continuing episode of Veritgo
Upper left arm pain - pain in the deltoid, bicep and tripep muscles with movement
Joint pain (hands, elbows, knees, and hips)
Sore arm - whole arm received investigational product
Injection site soreness - localized achiness
Worsening of of Gastroesophageal Reflux Disease
contact dermatitis, right thigh and right side of neck
diffuse rash(everywhere but more on neck,chest,back)
contact dermatitis on bilateral lower legs
Worsening of Gout Right Foot, First Digit
enlarged lymph nodes, right anterior cervical nodes
Pulmonary Embolism, bilateral, segmental and sub segmental
Urinary Retention (AE of Botox Injection)
CARDIAC STRESS TEST ABNORMAL, HOSPITALIZED
Pain at the injection side - Left Shoulder
Nasal swab site discomfort right nostril
Pruritus, extremities (Food or Cosmetics)
Urticaria, Bilateral Arms progressing to lower extremities
Elevated Blood Pressure without Dx of Hypertension
Soreness at the Left Shoulder - Injection site
Localized erythematoses dermal reaction Left deltoid at injection site
Left Upper extremity numbness ulnar distal numbness
Injury Secondary to Pedestrian-Car Accident
Left Superficial Femoral Vein Deep Vein Thrombosis
Worsening of osteoarthritis (left shoulder)
Bump under skin near injection site Left arm
Worsening of osteoarthritis (right knee)
Acute on Chronic Combined Systolic and Diastolic Congestive Heart Failure
NYHA Class IV Acute on Chronic Systolic Heart Failure
Joint pain (bilateral shoulders, knees, hips)
Exacerbation of Paroxysmal Atrial Fibrillation
Erythematous Papules around injection site
Subject was dosed with IP that had temperature excursion (product storage error)
Subject dosed with IP that had temperature excursion (product storage error)
Subject dosed with IP that had temperature excursion (product storage issue)
Intermittent Itching at Injection Site (Left arm)
Allergic Reaction to investigational product
Low grade fever post Covid Vaccination 4
Increased body temperature post Vaccination 4
Non-COVID viral Upper respiratory infection
invasive ductal carcinoma stage 1B, left breast
worsening cervical degenerative disc disease
squamous cell carcinoma in situ right parietal scalp
atrial fibrillation with rapid ventricular response
Swelling at injection site beginning two days post injection
soreness at the injection site beginning second day post injection
Redness at injection site beginning two days post injection
Subject developed cough after injection.
Subject developed chills after injection
muscle soreness at injection site, left deltoid
Fever; 101.4 day after 2nd injection. Fever rose to 101.7. Fever gone by next day. No OTC meds taken
Lethary; stated after 2nd injection felt run down & tired for 24 hrs. No OTC meds taken.
Chills; for a period of 24 hrs before going away. No OTC meds taken.
LEFT DELTOID ARM PAIN AT INJECTION SITE POST INJECTION
INJECTION SITE REACTION LEFT ARM INDURATION
ERYTHEMA AT INJECTION SITE LEFT UPPER ARM
LEFT SHOULDER MUSCLE ACHE AT INJECTION SITE
basal cell carcinoma removed from L side of nose
exacerbation of congestive heart failure
abrasions left arm (upper arm and forearm)
contact dermatitis of bilateral lower legs
Exacerbation of fibroadenoma of right breast
Closed Displaced Fracture of body Right Scapula
Closed Fracture of Rt Interior Pubic Ramus
temperature excursion - study intervention administered but not acceptable for use
SUBJECT DOSED WITH IP THAT HAD TEMPERATURE EXCURSION (PRODUCT STORAGE ERROR)
Worsening of skin fungal infection (both legs)
Worsening of Achilles Tendinitis (Right Foot)
increased ophthalmic intra ocular pressure
Intra abdominal infection post cholecystectomy
POST OP PAIN SECONDARY TO RIGHT HIP REPLACEMENT.
MOUTH PAIN SECONDARY TO TOOTH EXTRACTION
subjective fever, 99.8 degrees Fahrenheit
nodular interstitial infiltrate, RLL of lung
LUE - mild involuntary movement of muscle
worsening of radiculopathy, both upper extremities
closed fracture, transverse process of lumbar vertebra
L upper extremity pain - cervicular radiculopathy
Worsening of recurrent benign positional vertigo
Rash on left thigh, left calf, left forearm, right foot
PRURITUS AT FOREARMS BACK AND ABDOMEN WITHOUT RASH
ENLARGEMENT OF SUBCUTANEOUS MASS OVER RIGHT SHOULDER BLADE
Pulmonary Embolism with bilateral lower lobe Pulmonary embolisms
Administered Incorrect Dosage at Vaccination 1
administered incorrect dosage at vaccination 1
administered wrong dosage at vaccination 1
cough from wildfire smoke per provider and air quality index
Redness at injection site (2 inch diameter)
chest tightness consistent with skeletal pain
(Atopic Dermatitis) rash on arms, abd, head
ST ELEVATION MYOCARDIAL INFARCTION (STEMI)
INFILTRATING, POORLY DIFFERENTIATED ADENOCARCINOMA - STOMACH
Fall (patient tripped over shoe and hit the ground)
Worsening of Osteoarthritis Bilateral Knee
Worsening Carpal Tunnel Syndrome on right hand
Admin of incorrect investigation product
Worsening of WATER RETENTION in lower extremities
Sore Muscles after hip replacement (left hip and knee)
increased joint pain in shoulders and hands
pain at site of injection (left deltoid)
Atrial Fibrillation with Rapid Ventricular Response
Medication error involving Participant exposure to the incorrect investigational product
rash/skin irritation (dorsal side above sacrum, bilaterally below cervical vertebrae)
paroxysmal ventricular tachycardia (etiology unknown)
muscle pain of bilateral lower extremeties
Increased Back Pain secondary to Scoliosis
Sudden sensorineural hearing loss - Left Ear
Paroxysmal Atrial fibrillation with rapid ventricular response
Swollen Submandibular Gland Neck Right Side
Submandibular Gland facial swelling-Right side
Intermittent Muscle Strain-Under Left Armpit
Tooth Extraction-Lower Left Side Wisdom tooth
pain secondary to varicose vein in left thigh
Intermittent Pain at injection site-Right
New Onset Atrial Fibrillation with rapid ventricular response
Abnormal breast tissue on mammogram-left breast
Low Grade Temperature-99.6 degrees fahrenheit
2cm swelling at Injection Site Right Arm
2 centimeter redness at injection site- Right Arm
Joint Pain-Bilateral Shoulders, Bilateral Hips, Right Ankle and Right Elbow
Worsening atypical supra ventricular tachycardia
Pruitic/Burning Rash to Left and Right First and Second Interphalangeal Spaces
right hammer toe surgery - digits 2, 3, 4, and 5
ACUTE DIASTOLIC CONGESTIVE HEART FAILURE (CHF)
ACUTE NON ST ELEVATION MYOCARDIAL INFARCTION (MI) - NSTEMI
Kidney Bean Allergy - Allergy Test Findings
Egg White/Yolk Allergy - Allergy Test Finding
Wisdom Teeth Infection - Right lower quadrant
WORSENING OF BENIGN GLOMUS TUMOR ON LEFT RING FINGER
Prominent Reactive Lymph nodes in Cervical Area
Swollen Lymph Nodes - Left Axillary Region
Worsening of Chronic Congestive Heart Failure
Severe Soft Tissue Swelling of Right Lower Extemity
Worsening of Chronic Recurrent Infection of Right Total Knee Replacement
Cortical Irregularity of medial distal femur
new onset gastroesophageal reflux disease
WORSENING OF PERENNIAL ALLERGIC RHINITIS
WORSENING OF BENIGN PROSTATIC HYPERPLASIA
Worsening of Benign Prostatic Hyperplasia
UNSPECIFIED RIGHT EYE BACTERIAL INFECTION
Worsening of torn rotator cuff - shoulder, right
Administration of incorrect study intervention
Subject diagnosed with shingles on back of neck and side of face
Left Para clavicular lymph node enlargement
Infection right pinky toe (secondary to diabetes)
right knee superficial infection of the skin
Kidney Stone in Right Kidney (6mm stone)
Muscle pain in left deltoid at injection site
intraventricular hemorrhage, left occipital horn
Hornet sting, R thigh, with localized inflammatory response
Left subclavicular lymph node enlargement
Dermatitis of unknown origin on chest and bilateral arms
L ear bacterial otitis media (medical history)
worsening of compression fracture in spine
worsening of right wrist triangular fibrocartilage complex pain
woresen of inflammation bilateral eyes recurrent
motor vehicle accident while subject was driving
Cutaneous abscess of left upper extremity
EXASERBATION OF ATTENTION DEFICIT DISORDER
Atherosclerosis of native artery of both lower extremities
Left Lobular Breast Cancer, Stage I, Grade I
Superficial laceration to posterior head
Dizziness, secondary to Clonidine reaction
Left arm injection site pain post vaccine #1.
Pain at Injection Site 30 mins after dose
pain right shoulder injection site (serapin)
injection site reaction left arm myalgia
Injection site reaction left arm-myalgia
STEMI: ST elevation Myocardial Infarction
exacerbation of Degenerative Disc Disease
Fixed drug erruption on feet bilaterally
myalgia due to intramuscular injection into deltoid muscle
injection site pain post vaccination right arm
Myalgias (back muscles) post-vaccination #2
pain at injection site left arm post vaccine
Cellulitis due to spider bite right anterior leg
worsening of depression with suicidal ideation
Unknown study product administered (drug administration error)
Injection site redness on left arm (3 units on sponsor's caliper)
Generalized muscle aches due to exercise
generalized body aches due to shingrix vaccine
exacerbation of chronic obstructive pulmonary disease
POISONING DUE TO BROWN RECLUSE SPIDER VENOM
Diastolic Congestive Heart Failure with acute exacerbation
Administration of study intervention after expiry window(Expired drug administered)
motor vehicle accident/subject was the driver
ABNORMAL RBC MORPHOLOGY INCLUDING SICKLE CELLS
SWELLING AT THE INJECTION SITE (LEFT ARM)
REGIONALLY ADVANCED MELANOMA OF THE RIGHT INGUINAL AREA
ELEVATED TEMPERATURE FOR 3 DAYS AFTER THE INJCTION
allergic contact dermatitis on all extremities and trunk
CONTACT DERMATITIS FROM THE CREAM USED TO TREAT SHINGLES
COAGULATION DISORDER SECONDARY TO WARAFIN
Worsening osteoarthritis of the right knee
Pain at the Site of Injection Left Deltoid
Right Deltoid pain (post shingles vaccine injection)
Pain at the site of injection (Right deltoid)
Pain at site of injection (Right deltoid)
pain at the site of injection (left deltoid)
Pain at site of injection on the Right Arm
Maculopapular rash to abdomen, chest, back and upper arms
Pain at the site of injection (left deltoid)
Pain at the site of injection (right deltoid)
Pain at the site of injection (Left shoulder)
elevated temperature 100.0 degrees Fahrenheit
Pain at site of injection (left deltoid)
painful swelling on the left side of the neck
Pain at the Site of Injection on left Arm
Pain at the Site of injection on the Left Arm
Pain at the Site of Injection on Left Arm
elevated temperature 99.6 degrees Fahrenheit
Pain at the site of injection (Left Deltoid)
Pain at The Site of Injection on the Left Arm
right hand 4th and 5th distal phalanges fractures
Trigger finger ( left hand third finger)
Pain at site of injection ( left Deltoid)
Acute kidney injury on chronic kidney disease stage III
Angioedema (left hand center palm to heel of hand)
Undiagnosed Mental Disorder (not otherwise specified)
Basal cell skin cancer (right side of nose)
Worsening INTRAMURAL AND SUBSEROUS LEIOMYOMA OF UTERUS
Injection site soreness, left arm, post vaccine
Joint pain, back, hips, knees, shoulders
Pain at the injection site, post vaccination
left arm, deltoid muscle, injection site pain
left arm tenderness at injection site left
tenderness at the injection site Left arm
PULMONARY EMBOLISM/ BLOOD CLOTS IN UPPER RIGHT LOBE
tenderness at injection site- left deltoid
Itching at injection site- left deltoid muscle
Pain at injection site- left deltoid muscle
allerigic reaction to concomitant medication
INJECTION SITE DISCOMFORT, RESIDUAL, LEFT ARM
MODERATE EPISODE OF MAJOR DEPRESSIVE DISORDER W/ PSYCHOSIS
CHRONIC KIDNEY DISEASE, STAGE 2, WORSENING
CALCIFIED OBSTRUCTIVE PLAQUE, AORTIC ARCH
TOOTH, MECHANICAL TRAUMA, BACK MOLAR BILATERAL
INCREASED FREQUENCY PERIODIC LEG MOVEMENT
DEEP VEIN THROMBOSIS, LOWER EXTREMITY, RIGHT
WORSENING OF OSTEOARTHRITIS IN RIGHT KNEE
squamous cell carcinoma of the upper left arm
Sting by a yellow jacket left ring finger
Postoperative wound infection to left upper chest
Administration of Incorrect Study Intervention
Soreness in the upper arm around where injection was given
mild body itching-specific region: lateral aspect of right forearm and left side of neck
INTERMITTENT RIGHT EYE CONJUNCTIVE ERYTHEMA
Worsening of right adhesive capsulitis shoulder
Acute exacerbation of seasonal allergies
syncopal episode during vasovagal response during venous puncture
Left nonexudative age related macular degeneration
Bilateral Age Related combined form cataract
Asymmetric Bilateral Sensorineural Hearing Loss
Elevated Thyroid Stimulating Hormone, 5.0 UIU/ML
Administration of study intervention after expiry window (Expired drug administered)
Elevated Serum Prostate - Specific Antigen
Spasticity of bilateral lower extremities
Neoplasm of uncertain behavior right flank
Red bump on right index finger at cuticle
Juvenile Osteochondrosis of bilateral fifth metatarsals
Hip muscle pain bilateral exercise related
Malignant invasive ductal carcinoma left breast
Left Deltoid Soreness, at injection site
Erythematous, Macule upper anterior thigh
Bilateral Knee Pain (Patellar Tendonitis)
Escherichia coli urinary tract infection
Recurrence of Oropharyngeal Cancer, Left side
Skin, Left side Neck Basal Cell Carcinoma, Ulcerated
Soreness to left deltoid, at injection site
SQUAMOUS CELL CARCINOMA, RIGHT LATERAL TEMPLE
Injection site Left Arm Soreness (Vaccine Reaction)
injection site Left Arm Soreness (Vaccine Reaction)
bilateral submaxillary lymph node tenderness
Left Side of Neck to Injection Site Soreness
left deltoid muscle injection site tenderness
left deltoid muscle injection tenderness
right deltoid muscle injection site tenderness
worsened degenerative joint disease left shoulder
bilateral transient neck tissue swelling
Metastatic Squamous Cell Carcinoma of head and neck
skin lesion uncertain etiology tip of nose less than 0.5cm
worsened recurrent herpetic lesion, gluteal area
Hypothyroidism-Subject was prescribed Levothyroxine 50 po qd on 18sep2020
Administration of an incorrect study intervention
worsened left knee degenerative joint disease
allergic reaction bilateral hands, back, neck, left shoulder, right foot
Urinary retention with emergency catheter
osteomyelitis distal phalanx right 3rd toe
left arm (deltoid muscle) injection site tenderness
left deltoid muscle site injection soreness
allergic reaction to study investigational product
left deltoid-tenderness at injection site
left deltoid muscle tenderness at injection site
left deltoid muscle injection site soreness
Mild arm swelling at injection site - left arm
allergic reaction, one hive appearing on right armpit
allergic reaction, potentially related to study drug
lower abdominal pain(near inguinal hernia removal site-2005)
Postoperative wound infection at right hand, 5th digi
Dupytren's Contracture, right fifth digit
Dupuytren's Contracture, left fifth digit
Major Depressive Disorder, single episode
tingling of bilateral limbs, intermittent
Atrial fibrillation with rapid ventricular response
basal cell carcinoma (right fore arm, left temple)
arthroscopic labrum repair left shoulder
lymph node swelling right axillary and supra-clavicular
epistaxis in right nostril, post nasal swab collection
right calf skin burn due to contact with very hot motorcycle pipe exhaust.
Intermittent Rash (arms, legs, and abdomen)
UPPER RESPIRATORY INFECTION (COUGH, NASAL CONGESTION AND HEADACHE)
Left Knee Pain secondary to joint effusion
allergic reaction to poison oak (left arm)
tingling sensation - bilateral shoulders
soreness on the injection site (left arm)
EXACERBATION OF ATYPICAL SKIN LESION RIGHT THIGH- BENIGN
Malignant neoplasm of upper-outer quadrant of right breast in female, estrogen receptor positive
Dyshidrotic Eczema - Location(s): Right Hand and Right Toe
Worsening of Chronic Spastic Paraparesis
Decreased upward range of motion in vaccinated arm
worsening epigastric pain r/t acid reflux
Tingling on lower left arm at blood draw site.
pinching sensation in left lower arm after blood draw
Elevated Body Temperature T. Max 100.1 F
Hyperethesia left deltoid region on injection site
worsening of plantar fasciitis left foot
skin plaque injection area left upper extremity
uppper arm bicep pain (injection-related)
lymphadenopathy (left axillary, clavicle, elbow)
elevated body temperature, max temp 99.8
bilateral hand increased sensation to touch
elevated body temperature, temp. max 99.7
Worsening bilateral knee pain (persistent)
body temperature increased (tmax 100.1F)
elevated body temperature, max temp 99.0
elevated body temperature, max temp 103.3
puncture injury (stepped on nail) left foot
Range of upward motion decreased in Vaccinated arm
elevated body temperature, max temp 99.3
elevated body temperature, temperature 100.4
elevated body temperature, temperature 99.1
Warm Sensation at injection site left Arm
Muscle achiness in back (shoveling snow)
prickly skin sensation left arm (shoulder to elbow)
left deltoid muscle pain (injection site) (woke her in the night)
Upper Arm Soreness L Side, deltoid muscle area
intermittent point tenderness of left elbow at olecranon process
left supraclavicular lymph node swelling
transient feeling of pins and needles to torso
Migratory arthralgias-left wrist,right wrist,right elbow right shoulder, right rib. Only pain
injection site pain occurring >30 min after injection
Chills occurring >30 minutes post injection
Injection site pain > 30 minutes post injection
Injection site pain >30 minutes post vaccine
Mid Left Anterior Descending Coronary Artery Occlusion
Chills starting > 30 minutes post vaccine 2
injection site pain >30 minutes posit vaccine
Injection site pain >30 minutes post vaccine 2
Injection site pain >30 minutes post vaccine 1
Injection site pain began >30 minutes after vaccine administration
Injection site pain >30 minutes after vaccine administration
Chronic Obstructive Pulmonary Disease with acute exacerbation
Injection site pain >30 minutes post vaccine administration
fatigue >30 minutes after vaccine administration
muscle twitching in chest area post vaccine 2
Intermittent muscle twitching left chest
headache day 2 post vaccine 1 (lasted 4 hours)
allergic contact dermatitis caused by clothing irritation on sensitive skin in lower right abdomen
decreased mean corpuscular hemoglobin concentrate
localized peritonitis, without perforation or gangrene
Allergic reaction to surgical dressings.
Fracture of middle phalanx of left index finger
left arm pain at injection site with touch
left arm injection site pain with motion
left arm pain at injection site related to motion
left arm pain at injection site with movement
Left arm pain at injection site with touch
right arm pain with touch at injection site
Left arm injection site pain with motion
Left arem injection site pain with motion
Swelling in throat (no shortness of breath)
Left arm injection site pain with touch and movement
Right arm injection site pain with touch
Right arm injection site pain with movement and touch
hypopigmented nodule lesion right dorsal 2nd metacarpal
Injection site pain with touch & motion in deltoid muscles
left arm injection site pain with movement
Right arm pain at injection site with motion
Pain (with movement) in left arm at injection site
Injection site pain with touch in left arm
mild pain at site of injection (right arm)
Burning sensation at injection site (left arm)
Arm soreness (Right arm, injection site)
Worsening Depression- no prior hospitalizations for depression
PARTIAL TEAR OF THE RIGHT TRAPEZIUS MUSCLE (GRADE 1)
FRACTURE OF ROOF OF RIGHT ORBITAL (GRADE 3)
WIDENINNG OFACROMIOCLAVICULAR JOINT SPACE (GRADE 1)
Right Lateral Malleolar Fracture (Right Ankle)
Pain at study vaccine injection site ( Right arm)
1+right distal cervical lymph node enlarged
hemorrhagic cyst of the medial interpolar left kidney
worsening of carpal tunnel syndrome in lt hand
Left shoulder soreness (injection site pain)
UNKNOWN STUDY INTERVENTION ADMINISTERED (DRUG THERAPY)
Potential administration of study intervention after expiry window (Expired drug administered).
INJECTION SITE PAIN(SORENESS) LEFT DELTOID
Allergic Reaction to study investigational product
Potential administration of study intervention after expiry window (Expired drug administered)
INJECTION SITE PAIN (SORENESS) LEFT DELTOID
LOCAL INJECTION SITE SORENESS (LEFT) DELTOID
SUPERFICIAL ABRAISIONS, dorsal wrists, left
SUPERFICIAL ABRAISIONS, dorsal wrist, right.
INJECTION SITE PAIN (POST-INJECTION; EXACT START TIME UNKNOWN)
Non painful pressure Sensation left side body face, arm, leg
Enlarged Left Axillary and subclavicular lymph nodes
Itchy Pink Rash (bilateral forearms, upper back, top of head at forehead and scalp)
Urticaria on forehead, posterior neck, bilateral posterior hands and bilateral plantar areas
Golf ball sized injection site nodule right deltoid
Right Lower Lobe Pulmonary Artery Embolus
Diastolic dysfunction of the left ventricle
Post operative infection (sialolithiasis removal)
Rash, inner left arm, left fingers, right flank
worsening of paroxysmal atrial fibrillation
vascular disease (coronary artery disease)
exacerbation of degenerative disc disease
left deltoid soreness at site of injection
soreness at injection site, left deltoid
soreness, left arm beyond injection site
Nodule/lump left arm below injection site.
right axillary adenopathy with cortical thickening
left axillary adenopathy with cortical thickening
Left deltoid soreness at site of injection.
soreness at injection site (left deltoid)
soreness at injection site, right deltoid
Skin lesions, punctate erythematous (left forearm)
Rash on bilateral hands and left lower extremity.
Elevated temperature of 99.6 Fahrenheit.
Soreness in lymph node under arm on side of injection.
Pain at the injection site left after vaccination #3
administration of correct study intervention from incorrect container (product administration error)
A feeling of electric sensation for about 2 minutes
vertebral slipped disc cervicobrachial C5/C6
post operative wound healing disturbance
worsening herniated disc cervical vertebra
intervertebral disc protusion cervical spine
sore muscles (lower back and upper legs)
systemic injection reaction muscle joint pain
aggravated pain left foot (due to arthrosis)
Skin lesion:redness and swelling left upper arm 10cm below and ventral of injection site
reddering(5cm+5cm) left upper arm ( 10cm distal from injection site)
gagging lasting 5-10 seconds, with second episode today
moderate to strong fatigue after the injection lasting ~5-6 days
non-bloody diarrhea x2 - his fiance who is not participating in the study also experience diarrhea
feeling warm post vaccine #2 administration
Low grade fever, maximum temp of 100.3 F
Arthritis, first joint of fingers bilateral
Swollen lymph nodes neck area (left side )
Injection site pain (post administration of injection #2)
left arm soreness (vac #2 injection site)
left arm soreness (vac#2 injection site)
Localized rash on left shoulder s/p revaccination
Localized rash at injection site s/p revaccination
left arm soreness (vac #1 injection site)
left arm soreness (vac#1 injection site)
Swollen, tender left axillary lymph node
Left Arm Soreness (Vaccination #1 Injection Site
Increasing of systolic and diastolic blood pressure
Acute upper respiratory tract infections
Investigational product preparation error (correct dose administered)
lymphadenomegaly in the right submandibular
Orolabial Herpes (inside the cheek and close to the left lower anterior tooth)
Orolabial Herpes (close to the left molar teeth on both sides of the cheek and inside of the cheek)
lymphadenitis in the left lower cervical
Sensation of Irritation of Eye Proper (right eye)
odd sensation posterior to injection site
itchy maculopapular rash, anterior neck - suspected contact dermatitis
injection site soreness only with movement of left arm
laceration right 4th finger from kitchen knife
hypopigmented skin patch at prior injection site, right upper arm
Soreness at Injection site (left deltoid)
Soreness at Injection site (left Deltoid)
Soreness at injection site (left deltoid)
Diagnosis of Human Papilloma virus inection
Localized pruritis, left scapula, distal end
Diffuse weakness in extremities (Bilateral legs and Left arm)
Demodex parasitic infestation - bilateral eyes
Chronic Degenerative Changes in bilateral sacro iliac joints
Chronic Degenerative Changes in Pubic Symphyses
Chronic Degenerative Changes in Left Hip
Worsening of systemic arterial hypertension
Muscle pain (shoulders and neck, on the right body side)
supraclavicular adenomegaly at injection site
Fracture of the fourth cervical vertebra
Excoriations in various regions of the body
axillary lymphadenopathy in the left arm
Urticaria localised (neck and forearm plaques, 1 plaque in each of these locations)
Ipsilateral axillary lymph node enlargement
Linear erythematous lesions in the anterior thoracic region
Deep vein thrombosis in right lower limb
Pruritic Cutaneous Lesion (in the central region of the right arm next to the elbow)
Increased pain sensitivity in left hemicranial region
Soft tissue injury on left shoulder(injection site)
Erythema medial aspect on Humerus Left upper extremity (not by injection site)
PENILE INVASIVE MODERATELY DIFFERENTIAL KERATINIZING SQUAMOUS CELL CARCINOMA
New onset of joint pain left upper wrist
incorrect vaccine allocation/assigned to subject
Right index finger collateral nerve lesion
Acute urticaria (trunk, both arms and legs)
Exposure during pregnancy (female partner)
Worsening of chronic renal insufficiency
Pigmented ephitelioid melanoma of the vagina
Myalgia in the region of the shoulder and left shoulder blade
Myalgia of moderate intensity below the left shoulder blade
Programmed extraction of the right third molar
Torax pain. refered muscular. type opressive.
Skin rash on the back (dorsal and lumbar area)
non pruritic maculopapular cervical rash
SWELLING IN THE RIGHT AXILLA AND IPSILATERAL CERVICAL REGION
Well-differentiated multifocal neuroendocrine tumor of the stomach
Elective extraction of three third molars
Folliculitis in upper dorsal area and nape.
Rupture of the external meniscus of the left knee
Rupture of the anterior cruciate ligament of the left knee
closed fracture first phalanx right little finger
Skin rash in upper area of the back body, both sides of the neck and both sides of the abdomen
Drug exposed pregnancy ( female partner )
rotator cuff injury of the right shoulder
pruritic rash on arm, armpit and part of the left chest.
allergic reaction producing pruritus at the chin
pruritus upper region of both feet and palmar aspect of both wrists
Left leg paresthesia located in gastrocnemius muscles
Skin rash in the upper right thoracic region
Hallux fracture and second toe of the right foot
herpes simplex type 1 on the left wing of the nose
herpes simplex type 1 in the right nasal wing
Abdominal pain in the right upper quadrant
Sebaceous cyst infection in thoracic region
Right index finger partial distal phalanx amputation
Rupture of a cavity fix in a lower molar
Acute Paroxysmal Atrial Fibrillation with High Ventricular Response.
arterial hypertension associated with headache
Exacerbation of usual seasonal allergic rhinitis
exacerbation of seasonal allergic rhinitis
increased body temperature oral cavity register 37.2
Mild and intermittent epigastric abdominal pain.
exacerbation of Right hand pain secondary to previous Quervain's tenosynovitis
Left omalgia with irradiation to the left pectoral.
exacerbation of tendonitis in the left wrist
Acute coronary syndrome without ST-T segment elevation
Acute eczema in the cervical region and on the wrists
myalgia in left hemibody predominantly left arm and cervical region
left hand, ring finger, first phalange fracture.
Adenopathy in the left supraclavicular area
incised wound on middle finger of the left hand
Trauma to middle finger of the left hand
Pruritic erythematous rash of the legs, face, and trunk
worsening of generalized anxiety disorder
acute myocardial infarction with ST elevation
Paresthesias on the right side of the face
Vehicle collision (subject was riding a bicycle)
Pruritic rash on both legs gluteal region and both arms
skin rash in hemiright face, neck, torso, upper back, upper abdomen both arms from shoulder to hand
pruritus in hemiright face, neck, torso, upper back, upper abdomen both arms from shoulder to hand
interscapular muscle contracture in right dorsal region
Dysregulation of your insulin-dependent Diabetes Mellitus with poor management of blood glucose lev.
slight increase in temperature at injection site
Axillary and cervical lymphadenopathy ipsilateral to the injection site
interphalangeal joint arthralgias of both hands
right tibia anterior tuberosity fracture
Rupture of 2 teeth (upper right incisor and upper right canine)
Infection of the lower right first and second molar dental pulp
Itchy, erythematous maculopapular skin rash involving posterior neck, left arm, and trunk
Itchy rash on forehead and right buttock
boils in interglutal cleft and right inguinal region
Wrong IP dose. subject received 58mcg of iP
LEFT INFRACLAVICULAR ADENOPATHY, 5 mm IN DIAMETER.
Wrong IP dose. Subject received 58mcg of IP
Furunculosis in axillary and left inginal region
Wrong IP dose. Subject recieved a dose of 58 mcg.
Wrong IP dose. Subject recieved approximately a 58 mcg dose.
Wrong IP dose. subject received 58mcg of IP
wrong IP dose. subject received 58mcg of IP
Wrong IP dose. Subject received approximately a 58 mcg dose.
Wrong IP dose. subject receive 58mcg of iP
Erythema at the injection site of the left upper limb
exacerbation of previous pathology, knee meniscus injury.
predominantly right bilateral carpal tunnel syndrome
Paresthesia in the scapular and lumbar region
Cutting wound second phalanx of left hand
Left hemiarcaled upper premolar tooth pain
Oxacillin sensitive Staphylococcus aureus sepsis
Stabbing pain in scapular region bilateral intermittent
Odontogenic infection of the upper left second molar.
left supraclavicular and axillary adenomegaly
Supected Complicated Urinary Tract Infection
Exposure to Investigation product during pregnancy
Superficial incised wound on the forehead
ERYTHEMATOUS AND FLAKY SKIN INJURIES IN TRUNK AND THIGHS
muscle pain in the upper inner third of the rigth arm
Intermittent chest pain in the right pectoral
Papular rash in deltoid region of the right arm.
Cholestatic syndrome secondary to lithiasis
left arm and shoulder muscle contracture
Trauma to the posterior region of the right rib cage
Pustulosis in upper limbs and lumbar area.
multiple small itchy papules located on the left arm, extending from the injection site to the elbow
multiple small itchy papule located on the left arm, extending from the injection site to the elbow
Skin lesion on the thumb of the right hand
Bilateral moderate sensorineural hearing loss
skin allergy that was located in the neck and between the eyebrows
exacerbation of his psoriasis manifests itself in both legs, both elbows, gluteal region and back
HERPES ZOSTER RIGHT THORACIC of one dermatome
local pain in the left arm at injection site
hematoma 8 cm in diameter, external face of right leg
Paresthesia on the outer side of the right leg
excoriation on the thumb of the right hand
increase of frequency of hypoesthesia at the level of the left upper limb
grade 1 injury to the internal collateral ligament of the right knee
Second degree burn of the right arm and forearm.
Pruritic rash in lower back, abdomen and neck.
Mild and intermittent headache. Retro ocular location.
Itching with small vesicles, macules and scabs on the hands and feet.
Myopic choroidal neovascular membrane of the left eye
Pain and swelling in the first phalanx of your right index finger
Erythematous papules in the right malar region
Allergic reaction secondary to insect bite
High grade infiltrating urothelial carcinoma
Increased aspartate aminotransferase 113 U/l (normal range 5-40 U/l) 05-nov-2020
Increased alanine aminotransferase 164 U/l (normal range 15-45 U/l)
Dental piece extraction (lower left wisdom tooth)
meteorism (abdominal pain in the left iliac fossa)
Subject was dosed with IP that had temperature excursion (Product storage error)
Muscle pain at injection site of left arm
Bilateral swollen mandibular lymph nodes
Myalgia of bilateral shoulders and left arm
Rash to right upper arm, raised, tender, 5cm diameter
Atypical intraductal hyperplasia in left breast
Fracture of the anterior border of the right glenoid
Lymph node enlargement in the left armpit
Reactive axillary lymph node in the left arm
Axillary lymph nodes enlargement in left arm
Erythema nodosum on the inner face of the right thigh
Injection site pain and burning sensation
Backache (Exacerbation of pre-existing condition)
Worsening pain related to L5/S1 and L4/L5 disc protrusion
Uncomplicated E.coli urinary tract infection
Urticarial rash (upper body and bilateral arms)
Recurrence of Left Bells Palsy Left facial hemipareses
Change in bowel habits (increase in number of stools per day)
Change in bowel habits (change in stool consistency)
Local Soreness at Injection Site Left Arm
Left Arm Pain at Injection Site Reaction
injection site reaction-Left upper arm pain
Injection site Reaction (mild pain right upper arm)
Headache (R sided headache around R eye)
exposure during pregnancy subjects wife is pregnant
Left arm swelling at injection site after flu shot
Allergic Reaction to Investigational product
Intermittent Muscle Discomfort Right Upper Arm
increased pain with activities-right knee
ONE BLISTER (2.5 INCHES BELOW INJECTION SITE)
Left upper extremity pain at injection site
worsening of premenstrual syndrome symptoms
increased intensity of migraine without aura
Arm soreness at injection site only when exposed to cold temperature
mild arm pain injection site/soreness at the injection site
sporadic intense headache in the back of his head
left arm slightly tender at area of injection
local arm pain/soreness at the injection site
Closed trimalleolar fracture of right ankle
hyperglycemia (blood sugars 30 points higher than normal)
body aches - reactogenicity from the vaccine, not a covid illness happened within 24 hrs
headache was part of the reactogenicity of the medication because it happened in 24 hrs
fatigue reactogenicity from the vaccine because it was within 24 hours of vaccination
small rash on bilateral wrists and bilateral top of the feet
DIFFUSE MYALGIA - ADVERSE REACTION TO VACCINATION 1
HEADACHE - ADVERSE REACTION TO VACCINATION 1
CHILLS - ADVERSE REACTION TO VACCINATION 1
Local myalgia/tenderness at injection site
Arthralgia- generalized (not injection site arthralgia)
Injection site swelling (7 cm diameter using caliper)
Injection site redness (7cm in diameter using caliper)
Left lower back strain secondary to exercise
DIFFUSE MYALGIA - ADVERSE REACTION TO VACCINATION 2
HEADACHE - ADVERSE REACTION TO VACCINATION 2
MYALGIA - ADVERSE REACTION TO VACCINATION 2
CHILLS - ADVERSE REACTION TO VACCINATION 2
DIFFUSE GENERALIZED ARTHRALGIA AS REACTION RELATED TO 2ND VACCINATION
Diffuse Myalgia secondary to vaccine reaction
Arthralgias secondary to vaccine reaction - diffuse generalized
Warm sensation in the body (no fever when measured)
Myalgia (persistent soreness in left deltoid)
New or increased muscle ache, bilateral lower legs
Constipation with left lower quadrant pain
Sore and swollen underarm lymph node (both arms)
Acute posterior vitreous detachment (left eye)
Right eye blindness, diagnosed with Right Amaurosis Fugax
Injection site pain with radiation to elbow
New diagnosis of left ovarian complex cyst
Elevated Thyroid Stimulating Hormone Lab Test
Impingement Syndrome of Bilateral Shoulders
Right Lateral Lower Eyelid Basal Cell Carcinoma, Nodular Type
Basal Cell Carcinoma Right Lateral Lower Eyelid
Cystic lesion in medial patellofemoral retinaculum
Right eye herpes zoster keratitis (worsening)
Positive Herpes Simplex Virus Test Results
Swollen left superficial cervical lymph node
Subcutaneous Tissue Abcess Right Earlobe
Intraoperative hemorrhage during an elective laparoscopic ovarian cystectomy
Burn on right forearm. Classification AB
Cutting wound on the little finger of the right hand
Unintentional fine tremor of the left hand lasting one to two minutes
worsening of soft tissue tumor resembling lipoma
Herpes zoster in the right anterior thoracic region
exacerbation of benign prostatic hyperplasia
Lower urinary tract infection (cystitis)
Hypotension during blood sample collection
pain in left upper limb up to the middle finger of the hand.
Type 1 sprain on right ankle mild intensity
Abscessed lesion in the middle finger of the right hand
Cat bite on right hand with a puncture wound.
Colonic Polyp (Histologic analysis: tubular adenoma. Low-grade dysplasia)
Cutting skin lesion on left index finger
Irritating cough associated with foreign body aspiration
Worsening of Peripheral Vertiginous Syndrome
Rotator cuff injury of the right shoulder
pain at the injection site in the left arm
Mild trauma to the left knee while doing regular physical activity
edema in the left upper limb, arm, forearm and left hand
Head injury without loss of consciousness.
Rash in the arm contralateral to the application of the research product
herpes zoster related keratitis in left eye
Polychontusion plus cranial brain trauma without loss of consciousness
Left prearicular epidermal cyst infection
Epidermal cyst on right and left preauricular region
Paresthesia in the anterior aspect of the left thigh
Right displaced proximal humeral fracture
Fracture of proximal phalanx of second finger of left hand
maculopapular rash on the face, upper limbs and abdomen
Body temperature increased: thermal record 37.7 C
Right arm pain at the injection site of the research product
Periungual infection of the index finger
Exanthema located on thighs, groin and arms
Allergic reaction secondary to taking antibiotics

Lowest Level Term
Non ST segment elevation myocardial infarction
Degeneration of lumbar or lumbosacral intervertebral disc
Shoulder injury related to vaccine administration
Upper respiratory tract infection viral NOS
Atrial fibrillation with rapid ventricular response
ST segment elevation myocardial infarction
Type II diabetes mellitus inadequate control
Poisoning by central nervous system stimulants
Atherosclerosis of arteries of the extremities
Chronic obstructive airways disease exacerbated
Elevated prostate specific antigen [PSA]
Nonexudative senile macular degeneration of retina
Neoplasm of uncertain behavior, site unspecified
Squamous cell carcinoma of head and neck metastatic
Major depressive disorder, single episode
Estrogen receptor positive breast cancer
Burn of unspecified degree of unspecified site of hand
Fractional exhaled nitric oxide increased
Acute myocardial infarction, true posterior wall infarction
Exposure to sexually transmitted disease
Capsular contracture associated with breast implant
Non ST segment elevation acute coronary syndrome
Unspecified agent exposure during pregnancy
Burn of unspecified degree of unspecified site of upper limb

Dictionary-Derived Term
Shoulder injury related to vaccine administration
Blood thyroid stimulating hormone increased
Squamous cell carcinoma of head and neck
Fractional exhaled nitric oxide increased
Capsular contracture associated with breast implant

High Level Term
Gastrointestinal and abdominal pains (excl oral and throat)
Lid, lash and lacrimal infections, irritations and inflammations
Disturbances in initiating and maintaining sleep
Pharyngeal disorders (excl infections and neoplasms)
Musculoskeletal and connective tissue pain and discomfort
Benign neoplasms gastrointestinal (excl oral cavity)
Gastrointestinal atonic and hypomotility disorders NEC
Upper respiratory tract signs and symptoms
Retinal structural change, deposit and degeneration
Mental impairment (excl dementia and memory loss)
Peripheral vasoconstriction, necrosis and vascular insufficiency
Gingival disorders, signs and symptoms NEC
Physical examination procedures and organ system status
Lumbar spinal cord and nerve root disorders
Paranasal sinus disorders (excl infections and neoplasms)
Dental and gingival therapeutic procedures
Spinal cord and nerve root disorders NEC
Product administration errors and issues
Duodenal and small intestinal stenosis and obstruction
Exposures associated with pregnancy, delivery and lactation
Renal and urinary tract disorders congenital NEC
Iris and uveal tract infections, irritations and inflammations
Reproductive organ and breast histopathology procedures
Pulmonary thrombotic and embolic conditions
Conjunctival infections, irritations and inflammations
Ocular infections, inflammations and associated manifestations
Musculoskeletal and connective tissue conditions NEC
Ventricular arrhythmias and cardiac arrest
Abdominal and gastrointestinal injuries NEC
Musculoskeletal and connective tissue infections and inflammations NEC
Attention deficit and disruptive behaviour disorders
Skin neoplasms malignant and unspecified (excl melanoma)
Skin structures and soft tissue infections
Laryngeal and adjacent sites disorders NEC (excl infections and neoplasms)
Sepsis, bacteraemia, viraemia and fungaemia NEC
Lower respiratory tract and lung infections
Corneal infections, oedemas and inflammations
Nail and nail bed conditions (excl infections and infestations)
Spine and spinal cord therapeutic procedures
Chest and respiratory tract injuries NEC
Vascular complications associated with device
Lower respiratory tract inflammatory and immunologic conditions
Peritoneal and retroperitoneal fibrosis and adhesions
Vascular tests NEC (incl blood pressure)
Fracture treatments (excl skull and spine)
Urinary tract neoplasms unspecified malignancy NEC
Non-site specific necrosis and vascular insufficiency NEC
Gene mutations and other alterations NEC
Skull fractures, facial bone fractures and dislocations
Cervical spinal cord and nerve root disorders
Complications associated with device NEC
Erection and ejaculation conditions and disorders
Haemorrhoids and gastrointestinal varices (excl oesophageal)
Gastrointestinal stenosis and obstruction NEC
Thoracic cage fractures and dislocations
Neoplasms malignant site unspecified NEC
Prostate and seminal vesicles infections and inflammations
Central nervous system haemorrhages and cerebrovascular accidents
Product storage errors and issues in the product use system
Allergies to foods, food additives, drugs and other chemicals
Choroid and vitreous structural change, deposit and degeneration
Non-small cell neoplasms malignant of the respiratory tract cell type specified
Carbohydrate tolerance analyses (incl diabetes)
Dental and periodontal infections and inflammations
Granulomatous and deep cutaneous inflammatory conditions
Gastrointestinal spastic and hypermotility disorders
Metabolic acidoses (excl diabetic acidoses)
Lipid metabolism and deposit disorders NEC
Conjunctival and corneal bleeding and vascular disorders
Central nervous system vascular disorders NEC
Fat soluble vitamin deficiencies and disorders
Lower respiratory tract signs and symptoms
Ovarian and fallopian tube cysts and neoplasms
Menopausal effects on the genitourinary tract
Retinal bleeding and vascular disorders (excl retinopathy)
Cognitive and attention disorders and disturbances NEC
Female reproductive neoplasms unspecified malignancy
Structural and obstructive urethral disorders (excl congenital)
Gastrointestinal and hepatobiliary procedural complications
Gastrointestinal ulcers and perforation, site unspecified
Reproductive organ and breast imaging procedures
Pancreatic neoplasms malignant (excl islet cell and carcinoid)
Nervous system neoplasms unspecified malignancy NEC
Substance related and addictive disorders
Hepatic failure and associated disorders
Ovarian and fallopian tube disorders NEC
Conditions associated with abnormal gas exchange
Scleral structural change, deposit and degeneration
Speech articulation and rhythm disturbances
Lid, lash and lacrimal structural disorders
Skin and subcutaneous tissue ulcerations
Musculoskeletal and connective tissue disorders of limbs congenital
Ocular bleeding and vascular disorders NEC
Gastrointestinal mucosal dystrophies and secretion disorders
PRODUCT STORAGE ERRORS AND ISSUES IN THE PRODUCT USE
Renal structural abnormalities and trauma
Endocrine abnormalities of gonadal function NEC
Visual impairment and blindness (excl colour blindness)
Oropharyngeal, nasopharyngeal and tonsillar neoplasms malignant and unspecified
Non-site specific embolism and thrombosis
Obstructive bile duct disorders (excl neoplasms)
Anaesthetic and allied procedural complications
Non-site specific vascular disorders NEC
Aortic necrosis and vascular insufficiency
Respiratory tract and pleural neoplasms malignant cell type unspecified NEC
Skin and subcutaneous tissue disorders congenital NEC
Reproductive tract signs and symptoms NEC
Neoplasms unspecified malignancy and site unspecified NEC
Mood alterations with depressive symptoms
Prostatic signs, symptoms and disorders NEC
Central nervous system aneurysms and dissections
Retinal, choroid and vitreous infections and inflammations
Marrow depression and hypoplastic anaemias
Thoracic spinal cord and nerve root disorders
Central nervous system neoplasms malignant NEC
Paralysis and paresis (excl cranial nerve)
Tympanic membrane disorders (excl infections)
Neurological and psychiatric procedural complications
Respiratory and pulmonary function diagnostic procedures
Sexual function and fertility disorders NEC
Exposures to agents or circumstances NEC
Gastrointestinal necrosis and gangrene (excl gangrenous hernia)
Application and instillation site reactions
Male genital tract therapeutic procedures NEC
Reproductive neoplasms male unspecified malignancy
Breast complications associated with device
Penile disorders NEC (excl erection and ejaculation)
Reproductive neoplasms female benign NEC
Lymphoproliferative disorders NEC (excl leukaemias and lymphomas)
Scleral infections, irritations and inflammations
Medication errors, product use errors and issues NEC
Device physical property and chemical issues
Central nervous system and spinal infections
Abortions not specified as induced or spontaneous
Choroid and vitreous haemorrhages and vascular disorders
Abortion related conditions and complications
Food malabsorption and intolerance syndromes (excl sugar intolerance)
Uterine infections and inflammations (excl cervix)
Germ cell neoplasms site unspecified NEC
Respiratory tract and thoracic cavity procedural complications

High Level Group Term
Gastrointestinal motility and defaecation conditions
Upper respiratory tract disorders (excl infections)
Ocular infections, irritations and inflammations
Appetite and general nutritional disorders
Musculoskeletal and connective tissue disorders NEC
Anaemias nonhaemolytic and marrow depression
Ocular structural change, deposit and degeneration NEC
Tendon, ligament and cartilage disorders
Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Inner ear and VIIIth cranial nerve disorders
Anterior eye structural change, deposit and degeneration
Spleen, lymphatic and reticuloendothelial system disorders
Physical examination and organ system status topics
Therapeutic procedures and supportive care NEC
Procedural related injuries and complications NEC
Lower respiratory tract disorders (excl obstruction and infection)
Medication errors and other product use errors and issues
Abdominal hernias and other abdominal wall conditions
Uterine, pelvic and broad ligament disorders
Exposures, chemical injuries and poisoning
Renal and urinary tract disorders congenital
Reproductive organ and breast investigations (excl hormone analyses)
Blood and lymphatic system disorders congenital
Breast neoplasms malignant and unspecified (incl nipple)
Sexual dysfunctions, disturbances and gender identity disorders
Cognitive and attention disorders and disturbances
Depressed mood disorders and disturbances
External ear disorders (excl congenital)
Skin neoplasms malignant and unspecified
Menstrual cycle and uterine bleeding disorders
Glucose metabolism disorders (incl diabetes mellitus)
Electrolyte and fluid balance conditions
Cardiac disorders, signs and symptoms NEC
Cranial nerve disorders (excl neoplasms)
Reproductive neoplasms male malignant and unspecified
Hepatobiliary neoplasms malignant and unspecified
Suicidal and self-injurious behaviours NEC
Nervous system, skull and spine therapeutic procedures
Cervix disorders (excl infections and inflammations)
Bladder and bladder neck disorders (excl calculi)
Endocrine investigations (incl sex hormones)
Prostatic disorders (excl infections and inflammations)
Cardiac and vascular investigations (excl enzyme tests)
Renal and urinary tract neoplasms malignant and unspecified
Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
Purine and pyrimidine metabolism disorders
Pregnancy, labour, delivery and postpartum conditions
Vulvovaginal disorders (excl infections and inflammations)
Chromosomal abnormalities, gene alterations and gene variants
Cornification and dystrophic skin disorders
Skin and subcutaneous tissue disorders NEC
Miscellaneous and site unspecified neoplasms malignant and unspecified
Male reproductive tract infections and inflammations
Central nervous system vascular disorders
Bone disorders (excl congenital and fractures)
Respiratory and mediastinal neoplasms malignant and unspecified
Metabolic, nutritional and blood gas investigations
Skin and subcutaneous tissue therapeutic procedures
Haematology investigations (incl blood groups)
Water, electrolyte and mineral investigations
Product quality, supply, distribution, manufacturing and quality system issues
Bone, calcium, magnesium and phosphorus metabolism disorders
Neurological, special senses and psychiatric investigations
Manic and bipolar mood disorders and disturbances
Therapeutic and nontherapeutic effects (excl toxicity)
Decreased and nonspecific blood pressure disorders and shock
Personality disorders and disturbances in behaviour
Ocular haemorrhages and vascular disorders NEC
Renal and urinary tract investigations and urinalyses
Gastrointestinal neoplasms malignant and unspecified
Reproductive neoplasms female malignant and unspecified
Retina, choroid and vitreous haemorrhages and vascular disorders
Miscellaneous and site unspecified neoplasms benign
Cardiac and vascular disorders congenital
Nervous system neoplasms malignant and unspecified NEC
Schizophrenia and other psychotic disorders
Obstetric and gynaecological therapeutic procedures
Metabolic and nutritional disorders congenital
Musculoskeletal and connective tissue disorders congenital
Connective tissue disorders (excl congenital)
Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Skin and subcutaneous tissue disorders congenital
Endocrine neoplasms malignant and unspecified
Iron and trace metal metabolism disorders
Hypothalamus and pituitary gland disorders
Respiratory and pulmonary investigations (excl blood gases)
Male genital tract therapeutic procedures
Increased intracranial pressure and hydrocephalus
Penile and scrotal disorders (excl infections and inflammations)
Haematopoietic neoplasms (excl leukaemias and lymphomas)
Female reproductive tract infections and inflammations

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

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