Study: NCT03498131

Adverse event: Near-syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pacemaker insertion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 15 at risk

Adverse event: FLU LIKE SYMPTOMS AFTER 2ND SHINGRIX VACCINE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Acute non-reccurrent frontal sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Essential hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Type II diabetes
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 15 at risk

Adverse event: Night sweats
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 15 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Cold Sore, Right Upper Lip
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: POSITIVE JCV INDEX
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: COVID Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: BROKEN FINGER, LEFT HAND, 5TH FINGER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 15 at risk

Adverse event: Tenderness, left plantar surface of foot
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: DUPUYTREN'S CONTRACTURE, BILATERAL HANDS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Right foot pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pain, lower extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Weakness/tightness, lower extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Osteopenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Ankle sprain, left
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: BOWEL URGENCY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Adenomatous polyp, colon
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Exertional nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Increased Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: VISION CHANGES
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Tongue ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: LESION,RIGHT POSTERIOR DORSAL TONGUE
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 15 at risk

Adverse event: FATIGUE SECONDARY TO MELATONIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Intermittent balance issues
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Shivering secondary to 2nd covid vaccine
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Groggy in the mornings
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Increased balance difficulties
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Increased Weakness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Worsening increased weakness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Worsening increased balance difficulties
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Increased fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Worsening increased fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: SKIN SPLIT BETWEEN D1 AND D2 RIGHT FOOT
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: GENERALIZED DRYNESS
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Contact dermatitis, nose
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Cyst removal incision infection, back
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Cyst removal, back
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Rash, facial
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Scaring, extremities
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Chilblains, bilateral arms
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Squamous cell in situ, scalp
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: INTERMITTENT IRREGULAR MENSTRUAL CYCLES
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: IRREGULAR MENSTRUAL BLEEDING
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: Increased urinary urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 15 at risk

Adverse event: Intermittent Urinary Hesitancy
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: INCREASED FATIGUE
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 15 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 15 at risk

Adverse event: WORSENING DEPRESSION
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk

Adverse event: SLEEP ISSUES
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk

Adverse event: INCREASED DREAMING
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk

Adverse event: Increased stress
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk

Adverse event: Increased anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk

Adverse event: Restless during the night, unable to fall asleep
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk

Adverse event: Concussion
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Intermittent dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 15 at risk

Adverse event: INCREASED HEADACHES
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 15 at risk

Adverse event: INCREASED RESTLESS LEG SYNDROME
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: NUMBNESS BACK OF TONGUE
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: INTERMITTENT SENSORY DISTURBANCE, HEAD
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Increased numbness, toes
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: headaches upon waking in morning
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Worsening Memory Disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Worsening Trigeminal Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Carpel tunnel, left
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Median Neuropathy, Left Hand
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Acute viral syndrome with ageusia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Thyroid lobectomy
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 15 at risk

Adverse event: Thyroid/neck nodule increasing in size
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 15 at risk

Adverse event: Elevated liver function test
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Worsening hypercholesterolemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: LOSS OF TONE/SORENESS, LEFT GLUTEUS MUSCLE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: WORSENING OF LEG WEAKNESS, UPPER LEFT THIGH/QUAD, BILATERAL
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: SLIGHT DECREASE IN HAND DEXTERITY, LEFT
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: LOW BACK PINCHING SENSATION
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: WEAKNESS, GENERALIZED
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Medial left knee pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: RIGHT ANKLE TENDONITIS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: NAUSEA, SECONDARY TO WEAKNESS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: BILATERAL RECTUS RECESSION 9.0MM W/ADJUSTABLE SUTURE, LEFT EYE
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Temperature related pain, mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: FATIGUE SECONDARY TO MELATONIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: WORSENING OF BALANCE ISSUES
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: BASAL CELL CARCINOMA, RIGHT CHEEK
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: PAIN SECONDARY TO BASAL CELL CARCINOMA REMOVAL, RIGHT CHEEK
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: BASAL CELL CARCINOMA, RIGHT CHEEK, REMOVAL
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: SENSORY DISTURBANCE RIGHT CHEEK, SECONDARY TO BASAL CELL CARCINOMA REMOVAL
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: WELL HEALED SCAR SECONDARY TO BASAL CARCINOMA REMOVAL
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: SPITZ NEVUS,RIGHT ANTERIOR LATERAL ARM, BIOPSY
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: NEOPLASM, UNSPECIFIED, BIOPSY RIGHT ANTERIOR LATERAL ARM
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: DERMATOFIBROMA, RIGHT BUTTOCK
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Lentigo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: CHERRY ANGIOMA
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Xerosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: SPITZ NEVUS, RIGHT ANTERIOR LATERAL ARM
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: GIANT COMEDONE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Seborrhoeic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Rash, lower left buttocks
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Mild edema, bilateral legs
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Focal spongiotic dermatitis with many eosinophils
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Worsening of rash, multiple diffuse locations
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Epidemal inclusion cyst
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 15 at risk

Adverse event: Onychomyosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Tinea pedis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: left labial cysts
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Toe nail fungus, right
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: POSSIBLE URINARY TRACT INFECTION
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: POSSIBLE URINARY RETENTION
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: Increased urinary urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: Cervical friability/lesion (benign)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Vaginal prolapse
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: WORSENING OF FATIGUE
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk

Adverse event: WORSENING DEPRESSION
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 15 at risk

Adverse event: RESTLESS SLEEP
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk

Adverse event: Worsening insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk

Adverse event: Intermittent sleep issues
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk

Adverse event: ANXIETY/MOOD DISTURBANCES
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk

Adverse event: TWO NEW ENHANCING BRAIN LESIONS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: WORD FINDING ISSUES
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: RADIATING PAIN, LOW BACK DOWN RIGHT LEG
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: INTERMITTENT TINGLING BILATERAL FEET
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: DIZZINESS, SECONDARY TO WEAKNESS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Trigeminal neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk